WO2021220100A1 - Dressing with rolled configuration - Google Patents

Dressing with rolled configuration Download PDF

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Publication number
WO2021220100A1
WO2021220100A1 PCT/IB2021/053132 IB2021053132W WO2021220100A1 WO 2021220100 A1 WO2021220100 A1 WO 2021220100A1 IB 2021053132 W IB2021053132 W IB 2021053132W WO 2021220100 A1 WO2021220100 A1 WO 2021220100A1
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WO
WIPO (PCT)
Prior art keywords
dressing
rolled
manifold
cover
rolled configuration
Prior art date
Application number
PCT/IB2021/053132
Other languages
French (fr)
Inventor
Shervin JAHANIAN
Jonathan G. REHBEIN
Enrique L. SANDOVAL
Richard Marvin Kazala Jr.
Luke Perkins
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 WO2021220100A1 publication Critical patent/WO2021220100A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0276Apparatus or processes for manufacturing adhesive dressings or bandages
    • A61F13/0289Apparatus or processes for manufacturing adhesive dressings or bandages manufacturing of adhesive dressings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/05Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]

Definitions

  • This disclosure relates generally to tissue treatment systems and more particularly, but without limitation, to dressings, systems, and methods relating to reduced-pressure therapy.
  • Treatment of wounds or other tissue with reduced pressure may be commonly referred to as "negative-pressure therapy,” but is also known by other names, including "negative- pressure wound therapy,” “reduced-pressure therapy,” “vacuum therapy,” “vacuum-assisted closure,” and “topical negative-pressure,” for example.
  • Reduced-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.
  • a dressing for reduced-pressure therapy on a treatment site may comprise: an attachment device having a treatment aperture; a manifold disposed over the treatment aperture; and a cover disposed over the manifold and coupled to the attachment device around the manifold; wherein the dressing comprises a rolled configuration in which at least a portion of the dressing is rolled, and the dressing is configured to be used in an unrolled configuration (e.g. having an unrolled, usage configuration in which the dressing is configured for use on the treatment site).
  • Some embodiments may further comprise a retaining device configured to releasably retain the dressing in the rolled configuration.
  • the retaining device may be removable from the dressing in the usage configuration.
  • the attachment device may comprise an adhesive, and the dressing may further comprise at least two release liners configured to releasably cover the adhesive.
  • the rolled configuration may be configured to reduce the footprint of the dressing.
  • the attachment device may be located on a tissue- contact surface, which is configured to contact the treatment site during usage.
  • the manifold may comprise porous foam.
  • the attachment device may be configured to create a sealed space between the cover and the treatment site, and the manifold may be configured to be positioned in the sealed space.
  • the attachment device may comprises a film layer and an adhesive .
  • Some embodiments may further comprise a tissue-contact layer coupled to the manifold and at least partially exposed through the treatment aperture.
  • the tissue-contact layer may comprise one or more of the following: a woven material, a non-woven material, a polyester knit material, and a fenestrated film.
  • the entire dressing in the rolled configuration may roll around (e.g. encircle) a central roll axis that is substantially perpendicular to a longitudinal centerline of the dressing.
  • the retaining device in some embodiments may comprise a low-tack adhesive on the cover.
  • the retaining device may be configured to couple the cover to the at least two release liners in the rolled configuration.
  • the at least two release liners may be configured to allow exposure of a free end portion of the attachment device without exposing a remainder of the attachment device.
  • Some embodiments may further comprise a core or removable roll spacer configured to be encircled or enwrapped by the dressing in the rolled configuration.
  • Some embodiments may further comprise a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion.
  • the central portion in the rolled configuration the central portion may not be rolled, and each of the wing portions may be rolled with a roll axis substantially parallel to the line of symmetry.
  • a first of the at least two release liners may span the central portion, and each of the wing portions may be spanned by another of the at least two release liners.
  • the retaining device in the rolled configuration the retaining device may be configured to releasably couple each of the rolled wing portions to the central portion (e.g. in proximity to the line of symmetry).
  • the manifold in the rolled configuration the manifold may not be rolled, and two or more portions of the cover extending beyond the manifold may be rolled. In some embodiments, portions of the cover may extend beyond the manifold on both sides of the manifold, for example symmetrically about a longitudinal centerline.
  • the retaining device may be configured to releasably couple each of the rolled portions to the cover in proximity to the longitudinal centerline (e.g. atop the manifold).
  • the retaining device may comprise tape.
  • the manifold may be elongate, with length longer than width, and may have a substantially uniform width and/or thickness.
  • the portions of the cover extending beyond the manifold may be rolled with a roll axis substantially parallel to the longitudinal centerline of the manifold, in the rolled configuration.
  • the portions of the cover that are rolled may be folded, for example so that the roll axis is folded.
  • the portion of the cover extending beyond the manifold longitudinally and located between the rolled portions may form two end portions separated by the manifold, and the end portions may be folded towards the manifold.
  • the end portions may be retained in the folded state by the retaining device, such as tape, and retaining the folded end portions may act to retain the rolled portions.
  • a first of the at least two release liners may span the manifold, each of the two or more portions extending beyond the manifold may comprise the attachment device, and each of the two or more portions extending beyond the manifold may be spanned by another of the at least two release liners.
  • Some embodiments may further comprise a removable roll spacer for each of the rolled portions, configured for the portions to encircle the removable roll spacer in the rolled configuration.
  • a dressing for reduced-pressure therapy on a treatment site may comprise: an attachment device having a treatment aperture; a manifold comprising a longitudinal centerline, the manifold configured to be in fluid communication with the treatment site through the treatment aperture; a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; a retaining device (such as an adhesive device) on the outer surface configured to releasably retain the dressing in a rolled configuration; and a port in the cover located on the outer surface of a free end of the dressing.
  • Some embodiments may further comprise a dressing interface configured to fluidly couple the port to a negative-pressure source.
  • the manifold may be elongate, with length longer than width, and may have a substantially uniform width and/or thickness.
  • the attachment device may comprise an adhesive
  • the dressing may further comprise at least two release liners configured to releasably cover the adhesive, wherein one of the at least two release liners may span the adhesive at the free end of the dressing and may be separately releasable from the adhesive (e.g. while the other of the at least two release liners remains in place covering the adhesive).
  • the at least two release liners may comprise a first release liner covering the attachment device at the free end, and a second release liner covering the remainder of the attachment device.
  • the retaining device may be located substantially in proximity to the free end.
  • the retaining device may comprise a low-tack adhesive extending substantially from the port lengthwise (e.g. extending substantially along the length of the dressing).
  • the dressing may comprise a rolled configuration in which at least a portion of the dressing is rolled, and a usage configuration in which the dressing may be configured for use on the treatment site; and in the rolled configuration, the dressing may encircle a central roll axis (e.g. with the length of the dressing encircling the central roll axis), with the longitudinal centerline of the dressing in a plane substantially perpendicular to the central roll axis.
  • the release liner in the rolled configuration may face outward, and the cover or outer surface may face inward.
  • Some embodiments may further comprise a removable roll spacer configured to be encircled by the dressing in the rolled configuration.
  • the removable roll spacer may be cylindrical about the central roll axis and/or configured to releasably adhere to the retaining device, to be sterilizable, and/or to not create particulates in use.
  • the dressing may be configured to be customizable in length.
  • a dressing for reduced-pressure therapy on a treatment site may comprise: a lower surface (e.g. a tissue-contact surface) having a treatment aperture; a manifold comprising a central portion, extending along a line of symmetry, and two or more wing portions each extending substantially perpendicular to the line of symmetry, wherein the manifold may be configured to be in fluid communication with the treatment site through the treatment aperture; a cover configured to be disposed over the manifold to form a sealed space.
  • the manifold may comprise foam, such as open-cell foam.
  • the dressing may be stored in a rolled configuration with the lower surface of the wing portions positioned over the cover.
  • each of the wing portions may fold over a top surface of the dressing (e.g. over the cover).
  • the central portion in the rolled configuration the central portion may not be rolled (e.g. the central portion may be substantially flat), and each of the wing portions may be rolled inward towards the central portion and/or line of symmetry, with a roll axis substantially parallel to the line of symmetry.
  • Some embodiments may further comprise one or more retaining device configured to releasably retain the wing portions in the rolled configuration.
  • the one or more retaining device may comprise a low-tack adhesive configured to releasably couple the wing portions to the central portion.
  • the low-tack adhesive may be located on the cover in proximity to the line of symmetry.
  • the two or more wing portions may comprise a first wing portion, a second wing portion, a third wing portion, and a fourth wing portion; the first wing portion may be symmetrical to the second wing portion across the line of symmetry; and the third wing portion may be symmetrical to the fourth wing portion across the line of symmetry.
  • Some embodiments may further comprise a box sized to receive the dressing in the rolled configuration.
  • the lower surface may comprise or consist essentially of an attachment device, for example configured to seal the dressing to the tissue site.
  • the cover may couple to the attachment device around the manifold.
  • the attachment device may comprise an adhesive; the dressing may further comprise a plurality of release liners configured to releasably cover the adhesive; and a first of the plurality of release liners may span the central portion, and each of the wing portions may be spanned by another of the plurality of release liners.
  • Some embodiments may further comprise two or more rolling cores (e.g. removable roll spacers), with each core configured to be encircled by one of the wing portions in the rolled configuration. For example, in the rolled configuration the central axis of each core may form the roll axis for the corresponding wing portion.
  • the manifold may comprise a first arm and a second arm joined by a stem; the first arm may comprise the first wing portion and the second wing portion; the second arm may comprise the third wing portion and the fourth wing portion; and the line of symmetry may extend through the stem, the first arm, and the second arm.
  • Some embodiments may further comprise a slip-sheet adjacent to the cover (e.g. the outer surface) of the rolled wings and configured to prevent each of the rolled wings from adhering to itself.
  • the attachment device may be positioned around the edge of the manifold and configured to surround the treatment site.
  • a method for applying a rolled dressing to a treatment site may comprise: providing the dressing in a rolled configuration with a longitudinal centerline of the dressing enwrapping a central roll axis and positioned with a free end; coupling the free end of the dressing to the treatment site; releasing the dressing from the rolled configuration; unrolling the dressing to a usage configuration; coupling the dressing to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing.
  • Some method embodiments may further comprise removing a first release liner from the free end of the dressing, prior to coupling the free end of the dressing to the treatment site.
  • Some embodiments may further comprise removing a second (or additional) release liner from the remainder of the dressing.
  • releasing the dressing from the rolled configuration may comprise uncoupling a retaining device.
  • the dressing in the rolled configuration the dressing may be rolled around a removable roll spacer, and the method may further comprise discarding the removable roll spacer after the dressing has been unrolled to the usage configuration.
  • Some embodiments may further comprise customizing the size of the dressing, for example by cutting the dressing to alter its length.
  • a method for applying a rolled dressing to a treatment site may comprise: providing the dressing in a rolled configuration, with a plurality of wing portions each rolled towards a central portion; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; for each wing portion, removing a corresponding release liner; for each wing portion, releasing the wing portion from the rolled configuration; for each wing portion, unrolling the wing portion to a usage configuration; for each wing portion, coupling the wing portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing.
  • releasing the wing portion from the rolled configuration may comprise uncoupling a retaining device.
  • each wing portion in the rolled configuration may be rolled around a removable roll spacer, and the method may further comprise discarding the removable roll spacer after each wing portion has been unrolled to the usage configuration.
  • a method for applying a rolled dressing to a treatment site may comprise: providing the dressing in a rolled configuration having an unrolled central portion spanning a manifold and two or more rolled portions of a cover extending beyond the manifold (e.g.
  • releasing the two or more rolled portions from the rolled configuration may comprise uncoupling a retaining device.
  • a method of positioning a dressing into a rolled configuration may comprise: providing the dressing with a length, a width, and a longitudinal centerline, wherein the length is greater than the width; and rolling the dressing perpendicular to a central roll axis to position the dressing in a rolled configuration, with the length of the dressing extending around the roll axis and the roll axis extending perpendicular to a plane of the longitudinal centerline.
  • Some embodiments may further comprise securing the dressing in the rolled configuration with a retaining device.
  • the dressing may further comprise an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing.
  • the method may further comprise applying the retaining device to the outer surface of the dressing.
  • the dressing may comprise a free end (which is configured to be accessible in the rolled configuration); and the method may further comprise attaching a dressing interface, which is configured to fluidly couple the manifold to a reduced-pressure source through the cover, to the outer surface of the free end.
  • Some embodiments may further comprise applying at least two release liners to cover the attachment device, wherein a first of the two release liners covers the attachment device at the free end of the dressing and is configured to allow exposure of the free end of the attachment device without exposing a remainder of the attachment device.
  • Some embodiments may further comprise providing a removable roll spacer defining the roll axis, wherein rolling the dressing perpendicular to a roll axis comprises rolling the dressing around the removable roll spacer.
  • Some embodiments may further comprise removably adhering the dressing in the rolled configuration to the removable roll spacer using the retaining device.
  • securing the dressing in the rolled configuration may further comprise removably adhering the outer surface of the dressing to the two or more release liners.
  • a method of positioning a dressing into a rolled configuration may comprise: providing the dressing comprising a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion; rolling each of the wing portions inward towards the line of symmetry to form a rolled configuration; and/or removably securing each of the wing portions in the rolled configuration with a retaining device.
  • the central portion of the dressing may be unrolled and/or substantially flat.
  • Some embodiments may further comprise providing a removable roll spacer for each of the wing portions, wherein rolling each of the wing portions may comprise rolling each of the wing portions around the removable roll spacer.
  • securing each of the wing portions in the rolled configuration may comprise removably adhering each of the wing portions to the central portion.
  • the dressing may comprise an adhesive attachment device located on the central portion and each of the wing portions, and the method may further comprise covering the adhesive of the central portion with a first release liner, and covering the adhesive of each of the wing portions with a corresponding release liner.
  • a method of positioning a dressing into a rolled configuration may comprise: providing the dressing comprising an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; rolling portions of the cover, which extend laterally beyond the manifold, inward towards the manifold to form a rolled configuration; and/or removably securing the rolled portions of the cover in the rolled configuration using a retaining device.
  • the manifold in the rolled configuration, may be unrolled and/or substantially flat.
  • each of the rolled portions may be rolled around a roll axis that is substantially parallel to a longitudinal centerline of the manifold. Some embodiments may further comprise folding the rolled portions (e.g. to form a fold in each of the rolled portions).
  • the attachment device may comprises an adhesive located on the manifold and each of the portions of the cover extending laterally beyond the manifold, and the method may further comprise covering the adhesive of the manifold with a first release liner, and covering the adhesive of each of the portions of the cover extending laterally beyond the manifold with a corresponding release liner. Some embodiments may further comprise providing a removable roll spacer for each rolled portion, wherein rolling the portions of the cover may comprise rolling each of the portions of the cover around the removable roll spacer.
  • a dressing kit may comprise: a dressing having a foam manifold and a cover disposed over the foam manifold to form an outer surface of the dressing, wherein the dressing may be retained in a rolled configuration having a first (e.g. reduced) footprint; and a box sized to receive the dressing in the rolled configuration (e.g. sized to correspond to the first footprint).
  • the box may be sized to have an interior footprint that is at least as large as the first footprint of the dressing.
  • the dressing in the rolled configuration may be located within the box.
  • the dressing may be configured to have an unrolled configuration with a second (e.g.
  • the foam manifold may not be degraded by the rolled configuration, even when retained in the rolled configuration for a plurality of years.
  • the foam manifold may have a size and shape after being unrolled substantially the same as before being rolled and/or may have manifolding (e.g. negative-pressure distribution) capabilities after being unrolled that are substantially the same as before being rolled.
  • Some embodiments may further comprise an adhesive device on the outer surface configured to retain the dressing in the rolled configuration by attaching a first portion of the dressing to a second portion of the dressing.
  • the first portion may comprise a wing portion
  • the second portion may comprise a central portion (e.g. in proximity to a longitudinal centerline and/or a line of symmetry for the dressing).
  • the first portion may comprise a free end of the dressing, and the second portion may comprise an interior portion of the dressing (e.g. away from the free end).
  • the first portion may comprise a portion of the cover extending beyond the manifold, and the second portion may comprise the manifold.
  • Figure 1 is a block diagram of an example embodiment of a therapy system that can provide reduced-pressure therapy in accordance with this specification
  • Figure 2 is a graph illustrating example pressure control modes that may be associated with some example embodiments of the therapy system of Figure 1;
  • Figure 3 is a graph illustrating another example pressure control mode suitable for some example embodiments of the therapy system of Figure 1 ;
  • Figure 4 is an exploded, isometric view of an example embodiment of a dressing that may be associated with an example embodiment of the therapy system of Figure 1;
  • Figure 5 is a top plan view of the dressing of Figure 4, illustrating additional details that may be associated with some examples;
  • Figure 6 is an isometric view of the example dressing of Figure 4 in an assembled state, in an exemplary rolled configuration, illustrating additional details that may be associated with some examples;
  • Figure 7 is an isometric view illustrating the example dressing of Figure 4 in an exemplary usage configuration and applied to a treatment site, which may be a leg of a patient;
  • Figure 8 is an isometric view of another example embodiment of a dressing that may be associated with an example embodiment of the therapy system of Figure 1, in an exemplary rolled configuration;
  • Figure 9 is a top plan view of the example dressing of Figure 8 in an exemplary usage configuration in place on an exemplary treatment site, illustrating additional details that may be associated with some examples;
  • Figure 10 is an isometric view of yet another example embodiment of a dressing that may be associated with an example embodiment of the therapy system of Figure 1;
  • Figure 11 is an isometric view of the example dressing of Figure 10 in an exemplary rolled configuration, illustrating additional details that may be associated with some examples.
  • Figure 12 is atop plan view of the example dressing of Figure 10 in an exemplary usage configuration in place on an exemplary treatment site, illustrating additional details that may be associated with some examples.
  • FIG. 1 is a block diagram of an example embodiment of a therapy system 100 that can provide reduced-pressure therapy to a tissue site in accordance with this specification.
  • tissue site in this context may refer 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, grafts, and incisions, 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 reduced pressure, such as a reduced-pressure source 105, a dressing 110, a fluid container, such as a container 115, and a regulator or controller, such as a controller 120, for example. Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 120 indicative ofthe operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include one or more sensors coupled to the controller 120, such as a first sensor 125 and a second sensor 130. As illustrated in the example of Figure 1, the dressing 110 may include a tissue interface 135, a cover 140, or both in some embodiments.
  • 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 reduced-pressure source 105 may be combined with the controller 120 and other components into a therapy unit.
  • components of the therapy system 100 may be coupled directly or indirectly.
  • the reduced-pressure source 105 may be directly coupled to the container 115, and may be indirectly coupled to the dressing 110 through the container 115. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts.
  • the reduced-pressure source 105 may be electrically coupled to the controller 120, 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 distribution component may be detachable, and may be disposable, reusable, or recyclable.
  • the dressing 110 and the container 115 are illustrative of distribution components.
  • a fluid conductor is another illustrative example of a distribution component.
  • a “fluid conductor,” in this context, may include a tube, pipe, hose, conduit, or other structure with one or more lumina or open pathways adapted to convey a fluid between two ends.
  • 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 interfaces or fluid ports to facilitate coupling and de-coupling other components.
  • a dressing interface may facilitate coupling a fluid conductor to the dressing 110.
  • such a dressing interface may be a SENSAT.R.A.C.TM Pad available from KCI of San Antonio, Texas.
  • a reduced-pressure supply such as the reduced-pressure source 105, may be a reservoir of air at a reduced 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 or “reduced 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. Further, 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 reduced pressure may refer to a decrease in absolute pressure, while decreases in reduced pressure may refer to an increase in absolute pressure.
  • the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa).
  • Common therapeutic ranges are between -50 mm Hg (-6.7 kPa) and -300 mm Hg (-39.9 kPa).
  • the container 115 is representative of a container, canister, pouch, or other storage component, which can be used to manage exudates and other fluids withdrawn from a tissue site.
  • a rigid container may be preferred or required for collecting, storing, and disposing of fluids.
  • fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with reduced-pressure therapy.
  • a controller such as the controller 120, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as the reduced- pressure source 105.
  • the controller 120 may be a microcontroller, which may include 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 reduced-pressure source 105, the pressure generated by the reduced-pressure source 105, or the pressure distributed to the tissue interface 135, for example.
  • the controller 120 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 the first sensor 125 and the second sensor 130, may be 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 125 and the second sensor 130 may be configured to measure one or more operating parameters of the therapy system 100.
  • the first sensor 125 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 125 may be a piezoresistive strain gauge.
  • the second sensor 130 may optionally measure operating parameters of the reduced- pressure source 105, such as the voltage or current, in some embodiments.
  • Signals from the first sensor 125 and the second sensor 130 may be suitable as an input signal to the controller 120, 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 120.
  • the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
  • the tissue interface 135 can be adapted to partially or fully contact a tissue site.
  • the tissue interface 135 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 135 may be adapted to the contours of deep and irregular shaped tissue sites.
  • any or all of the surfaces of the tissue interface 135 may have projections or an uneven, course, or jagged profile that can induce strains and stresses on a tissue site, which can promote granulation at the tissue site.
  • the tissue interface 135 may be a manifold or may include a manifold and additional layers, such as a tissue contact layer, depending on the desired treatment.
  • a “manifold” in this context may include any substance or structure providing a plurality of pathways adapted to collect or distribute fluid relative to a tissue.
  • a manifold may be adapted to receive reduced pressure from a source and distribute reduced pressure through multiple apertures to or from a tissue site, which may have the effect of collecting fluid from 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 or moving fluid relative to a tissue site.
  • a manifold may be a porous foam material having interconnected cells or pores.
  • open-cell foam, porous tissue collections, and other porous material such as gauze or felted mat generally include pores, edges, and/or walls adapted to form interconnected fluid channels.
  • Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways.
  • a manifold may additionally or alternatively include projections that form interconnected fluid pathways.
  • a manifold may be molded to provide surface projections that define interconnected fluid pathways.
  • the average pore size of foam may vary according to needs of a prescribed therapy.
  • the tissue interface 135 may be foam having pore sizes in a range of 400-600 microns.
  • the tensile strength of the tissue interface 135 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 tissue interface 135 may be reticulated polyurethane foam such as found in GRANUFOAMTM dressing or V.A.C. VERAFLOTM dressing, both available from KCI of San Antonio, Texas.
  • the thickness of the tissue interface 135 may also vary according to needs of a prescribed therapy. For example, the thickness of the tissue interface 135 may be decreased to reduce tension on peripheral tissue. The thickness of the tissue interface 135 may also affect the conformability of the tissue interface 135. In some embodiments, a thickness in a range of about 5-10 millimeters may be suitable.
  • the tissue interface 135 may be either hydrophobic or hydrophilic.
  • the tissue interface 135 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 135 may draw fluid away from a tissue site by capillary flow or other wicking mechanisms.
  • An example of hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WHITEFOAMTM dressing available from KCI 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 135 may further promote granulation at a tissue site when pressure within the sealed therapeutic environment is reduced.
  • any or all of the surfaces of the tissue interface 135 may have an uneven, coarse, or jagged profile that can induce microstrain and stress at a tissue site if negative pressure is applied through the tissue interface 135.
  • the tissue interface 135 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 135 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 135 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 140 may provide a bacterial barrier and protection from physical trauma.
  • the cover 140 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 140 may comprise or consist essentially of an elastomeric film or membrane that can provide a seal adequate to maintain a reduced pressure at a tissue site for a given reduced-pressure source.
  • the cover 140 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid.
  • the cover 140 may have a high moisture-vapor transmission rate (MVTR) in some applications.
  • MVTR moisture-vapor transmission rate
  • the MVTR may be at least 250 g/m A 2 per twenty- four hours in some embodiments (based on ASTM E96/E96M for upright cup measurement).
  • 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 140 may form an outer surface of the dressing 110.
  • An attachment device may be used to attach the cover 140 to an attachment surface, such as undamaged epidermis, a gasket, or another cover (e.g. at the treatment site).
  • the attachment device may take many forms.
  • an attachment device may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover 140 to epidermis around a tissue site.
  • some or all of the cover 140 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight between 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.
  • FIG. 2 is a graph illustrating additional details of an example control mode that may be associated with some embodiments of the controller 120.
  • the controller 120 may have a continuous pressure mode, in which the reduced-pressure source 105 is operated to provide a constant target reduced pressure, as indicated by line 205 and line 210, for the duration of treatment or until manually deactivated. Additionally or alternatively, the controller may have an intermittent pressure mode, as illustrated in the example of Figure 2.
  • the x-axis represents time
  • the y-axis represents reduced pressure generated by the reduced-pressure source 105 over time.
  • the controller 120 can operate the reduced-pressure source 105 to cycle between a target pressure and atmospheric pressure.
  • the target pressure may be set at a value of 125 mmHg, as indicated by line 205, for a specified period of time (e.g., 5 min), followed by a specified period of time (e.g., 2 min) of deactivation, as indicated by the gap between the solid lines 215 and 220.
  • the cycle can be repeated by activating the reduced-pressure source 105, as indicated by line 220, which can form a square wave pattern between the target pressure and atmospheric pressure.
  • the increase in reduced-pressure from ambient pressure to the target pressure may not be instantaneous.
  • the reduced-pressure source 105 and the dressing 110 may have an initial rise time, as indicated by the dashed line 225.
  • the initial rise time may vary depending on the type of dressing and therapy equipment being used.
  • the initial rise time for one therapy system may be in a range of about 20-30 mmHg/second and in a range of about 5-10 mmHg/second for another therapy system.
  • the repeating rise time as indicated by the solid line 220 may be a value substantially equal to the initial rise time as indicated by the dashed line 225.
  • Figure 3 is a graph illustrating additional details that may be associated with another example pressure control mode in some embodiments of the therapy system 100.
  • the x- axis represents time and the y-axis represents negative pressure generated by the reduced-pressure source 105.
  • the target pressure in the example of Figure 3 can vary with time in a dynamic pressure mode .
  • the target pressure may vary in the form of a triangular waveform, varying between a minimum and maximum reduced pressure of 50-125 mmHg with a rise time 305 set at a rate of +25 mmHg/min. and a descent time 310 set at -25 mmHg/min, respectively.
  • the triangular waveform may vary between reduced pressure of 25-125 mmHg with a rise time 305 set at a rate of +30 mmHg/min and a descent time 310 set at -30 mmHg/min.
  • the controller 120 may control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure may vary between a maximum and minimum pressure value that may be set as an input prescribed by an operator as the range of desired reduced pressure.
  • the variable target pressure may also be processed and controlled by the controller 120, which can vary the target pressure according to a predetermined waveform, such as a triangular waveform, a sine waveform, or a saw-tooth waveform.
  • the waveform may be set by an operator as the predetermined or time-varying reduced pressure desired for therapy.
  • the dressing 110 may include features that can treat a tissue site at an extremity of a patient, such as a leg, arm, ankle, wrist, or parts thereof, and an area of tissue around the tissue/treatment site and the extremity.
  • the tissue site may be an incision or other treatment target on one or both sides of a leg or ankle on a patient.
  • the dressing 110 may be configured to treat not only the incision or treatment target, but also, an area of tissue around the incision or treatment target, the leg, and the ankle as desired.
  • the dressing 110 may include an attachment device 404, a manifold 406, and the cover 140.
  • the attachment device 404 and other components may include a treatment aperture 408, and the manifold 406 may be configured to be fluidly coupled to a treatment site through the treatment aperture 408 (e.g. with the manifold 406 disposed over the treatment aperture 408).
  • the dressing 110 may optionally include an adhesive ring 410 that may be configured to bond a peripheral portion of the manifold 406 to a portion of the attachment device 404.
  • the adhesive ring 410 may be formed as part of the attachment device 404, or the adhesive ring 410 may be omitted with the attachment device 404 instead being coupled to the manifold 406 and/or cover 140 with another medically acceptable coupling apparatus.
  • the cover 140, the manifold 406, the optional adhesive ring 410, and the attachment device 404 may have similar shapes.
  • the attachment device 404 may be slightly larger than the manifold 406 to permit coupling of the attachment device 404 to the cover 140 around the manifold 406.
  • an adhesive may be disposed on a portion of the manifold 406 exposed through the treatment aperture 408.
  • the adhesive may be pattern-coated, and may cover up to 50% of the exposed portion or surface of the manifold 406.
  • the cover 140, the manifold 406, the attachment device 404, or various combinations may be assembled before application or at a treatment site.
  • the dressing 110 may be provided as a single unit.
  • the manifold 406 may include a first surface 412 and an opposing second surface 414. In some examples, at least a portion of the second surface 414, for example the tissue-facing surface, of the manifold 406 may be configured to face the treatment site through the treatment aperture 408. In some examples, the attachment device 404 may be positioned on or at a portion of the second surface 414 of the manifold 406. In some examples, the manifold 406 may include or be formed of a porous material, such as foam.
  • the attachment device 404 may be configured to create a sealed space between the cover 140 and the treatment site, and the manifold 406 may be configured to be positioned in the sealed space.
  • the attachment device 404 may be positioned around an edge 416 of the manifold 406 and configured to surround the treatment site.
  • the cover 140 may be disposed over the manifold 406 and coupled to the attachment device 404 around the manifold 406.
  • the cover 140 may be coupled to a portion of the attachment device 404 extending outward from the edge 416 of the manifold 406.
  • the cover 140 may be larger than the manifold 406, as illustrated in the example of Figure 4, and may have a perimeter or a flange 418 configured to be attached to the attachment device 404. Assembled, the cover 140 may be disposed over the first surface 412 (e.g. the outward-facing surface) of the manifold 406, and the flange 418 may be attached to the attachment device 404 around the manifold 406. For example, an adhesive may be used to adhere the flange 418 to the attachment device 404, or the flange 418 may be, without limitation, welded, stitched, or stapled to the attachment device 404.
  • the attachment device may comprise an adhesive applied to the flange 418 and configured to allow attachment of the flange 418 to the treatment site.
  • the cover 140 may also include a port 420 configured to allow fluid communication between the manifold 404 and a dressing interface 422 and/or a fluid conductor 424 (e.g. to apply negative pressure under the cover) as described herein.
  • the attachment device 404 may take many forms.
  • the attachment device 404 may include or be formed of a film or membrane that can provide a seal in a therapeutic reduced-pressure environment.
  • the attachment device 404 may be a polymer film, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid.
  • the attachment device 404 may have a thickness in the range of 25-50 microns. For permeable materials, the permeability may be low enough that a desired reduced pressure may be maintained.
  • the attachment device 404 may comprise a medically-acceptable adhesive, such as a pressure-sensitive adhesive.
  • the attachment device 404 may be a polymer film coated with an adhesive, such as an acrylic adhesive, which may have a coating weight between 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some examples to improve the seal and reduce leaks.
  • an adhesive such as an acrylic adhesive, which may have a coating weight between 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some examples to improve the seal and reduce leaks.
  • the attachment device 404 may include or be formed of a hydrocolloid.
  • the attachment device 404 may be configured or referred to as a sealing ring or a gasket member.
  • the dressing 110 may include a gasket member (not shown) in addition to the attachment device 404.
  • the gasket member may be a peripheral member, such as a hydrocolloid ring, and at least a portion of the attachment device 404 may be positioned between the manifold 406 and the gasket member on or at a surface of the manifold 406, such as the second surface 414, configured to face the area of tissue around the extremity.
  • the gasket member may have a similar or analogous shape as the adhesive ring 410, but the gasket member may be positioned on a surface of the attachment device 404 configured to face the extremity such that the gasket member is configured to be positioned between the extremity and the attachment device 404.
  • the dressing 110 may optionally further include a tissue contact layer 425, which may be coupled to a surface of the manifold 406, such as the second surface 414, and may be configured to be exposed to the treatment site.
  • the tissue contact layer 425 may be configured to be positioned in direct contact with the treatment site, for example forming a tissue-contact surface.
  • the tissue-contact surface may be formed by the manifold and/or the attachment device.
  • the tissue contact layer 425 may include or be formed of a material that substantially reduces or eliminates skin irritation while allowing fluid transfer through the tissue contact layer.
  • the tissue contact layer 425 may form a fluid control layer, configured to allow fluid communication between the treatment site and the manifold during reduced-pressure therapy, while minimizing backflow of fluids (such as exudate) from the manifold to the treatment site (e.g. to minimize maceration).
  • the tissue contact layer 425 may include or be formed of one or more of the following materials, without limitation: a woven material, a non-woven material, a polyester knit material, and a fenestrated fdm.
  • the attachment device 404 which may comprise an adhesive on a surface of the dressing 110 configured to face the treatment site (e.g. on the tissue-contact surface), may be covered by one or more release liners 428 prior to applying the dressing 110 at the treatment site.
  • the dressing 110 may include a first release liner 428a, a second release liner 428b, and a third release liner 428c.
  • the first release liner 428a may be positioned proximate to a first side 430 of the manifold 406 or the dressing 110
  • the second release liner 428b may be positioned proximate to a second side 432 of the manifold 406 or the dressing 110 (e.g.
  • the third release liner 428c may be positioned proximate to a fold axis or line or symmetry 434 of the manifold 406 or the dressing 110 (e.g. spanning a central portion of the manifold and/or dressing).
  • the central portion with the line of symmetry 434 may be located between the first side 430 and the second side 432, and the third release liner 428c may be positioned between the first release liner 428a and the second release liner 428b.
  • the third release liner 428c may be configured to be removed to expose an adhesive or portion of the attachment device 404 proximate to the line of symmetry 434 prior to removal of the first release liner 428a and the second release liner 428b.
  • Such a configuration may permit the central portion of the dressing 110 (e.g. in proximity to the line of symmetry 434) to be initially positioned or aligned at a treatment site, such as the extremity, while the first release liner 428a and the second release liner 428b protect other portions of the adhesive or the attachment device 404.
  • the dressing 110 may have two release liners, each of which may have perforations or slits (not shown here) configured to allow the release liners to be separated into smaller pieces for removal. Additionally, some embodiments may also have one or more casting sheet liners 436.
  • first release liner 428a, the second release liner 428b, and the third release liner 428c may provide stiffness to the attachment device 404 to facilitate handling and application.
  • the casting sheet liners 436 may cover the flange 418 to provide stiffness to the cover 140 for handling and application.
  • the one or more release liner 428 may be configured to releasably cover the attachment device 404, for example to protect and maintain the adhesive of the attachment device 404 until the time of application of the dressing 110 to the treatment site.
  • the dressing 110 may include the dressing interface 422, which may be fluidly coupled to the manifold 406 through the port 420 in the cover 140.
  • the dressing interface 422 may be coupled in the central portion of the manifold 406 (e.g. in proximity to the line of symmetry 434), and may be configured to be coupled to the reduced-pressure source through, for example, the fluid conductor 424, conduit, or tube coupled in fluid communication between the dressing interface 422 and the reduced pressure source 105.
  • Figure 5 is a top view of an example of the dressing 110, illustrating additional details that may be associated with some embodiments.
  • the dressing 110 may include features that can cover articulating joints, such as a knee, while still allowing for significant range of motion.
  • the dressing 110 of Figure 5 may generally comprise a manifold 406 having a stem 450, a first arm 515 joined to a first end of the stem 510, and a second arm 520 joined to a second end of the stem 510.
  • the manifold 406 may be characterized as a polyhedron or as a generalized cylinder.
  • the manifold 406 can be characterized as a generalized cylinder having a first surface 412 and an edge 416.
  • the edge 416 in Figure 5 bounds the stem 510, the first arm 515, and the second arm 520.
  • some portions of the edge 416 may be curved, and some portions may be straight.
  • the first arm 515 is bounded in part by a first edge portion 535 that is substantially straight
  • the second arm 520 is bounded in part by a second edge portion 540 that is substantially straight.
  • the first arm 515, the second arm 520, or both may be contoured at the extremities.
  • the stem 510 is generally configured to be positioned over an articular surface.
  • the width of the stem 510 may vary for different types of joints, and may be limited to minimize interference with articulation.
  • the stem 510 may be configured for positioning over a patella and have a width of 2-4 inches. In other examples, a width of 1-3 inches may be suitable for positioning over an olecranon.
  • the first arm 515 and the second arm 520 may flare away from the stem 510.
  • the width of the first arm 515 and the second arm 520 may each be greater than the width of the stem 510.
  • the face of the first surface 412 may be biconcave. More generally, portions of the edge 416 bounding the first arm 515 and the second arm 520 may converge toward the stem 510 to define a concave void adjacent to each side of the stem 510. In the example of Figure 5, the concave void is curved. In other examples, the edge 416 may have straight segments that converge toward a vertex at the stem 510.
  • Some embodiments of the manifold 406 may additionally be characterized by a line of symmetry 434 (which may be a longitudinal centerline, in some examples) through the stem 510, and each of the first arm 515 and the second arm 520 may be characterized by a span that is generally orthogonal to the line of symmetry 434.
  • a first span 550 between extremities 555 is characteristic of the first arm 515
  • a second span 560 between extremities 565 is characteristic of the second arm 520.
  • the first span 550 is greater than the second span 560.
  • a suitable ratio of the span of the first span 550 to the second span 560 may generally be in a range of 1.2 to 3.4.
  • a ratio of 1.2 to 1.6 may be particularly advantageous for some applications.
  • the first span 550 may be in a range of 30-65 centimeters and the second span 560 may be in a range of 20-45 centimeters.
  • the first span 550 may be in a range of 15- 50 centimeters and the second span 560 may be in a range of 8-25 centimeters.
  • each arm may comprise two wing portions 580, one on each side of the line of symmetry 434 and extending outward away from the line of symmetry 434.
  • each of the wing portions 580 may extend away from the line of symmetry 434 in a direction substantially perpendicular to the line of symmetry 434.
  • first wing portion 580a and the second wing portion 580b may be symmetrical across the line of symmetry 434 and may jointly form the second arm 520; and the third wing portion 580c and the fourth wing portion 580d may be symmetrical across the line of symmetry 434 and may jointly form the first arm 515.
  • first release liner 428a may cover the wing portions 580 on one side of the line of symmetry 434, and the second release liner 428b may cover the wing portions 580 on the other side of the line of symmetry 434.
  • a separate release liner may cover each wing portion 580 (which may allow the attachment device 404 on each wing portion 580 to be independently exposed), or a perforation line (not shown here) in the release liner 428 may allow exposure of the attachment device 404 on each wing portion 580 independently.
  • a central portion of the manifold or dressing may extend along the line of symmetry 434, and the wing portions 580 may extend outward (e.g. substantially perpendicularly) from the central portion.
  • the central portion may, for example, span the center of the first arm 515, the second arm 520, and the stem 510.
  • the third release liner 428c may cover the attachment device on the central portion.
  • one or more retaining device 582 may be configured to releasably retain the wing portions 580 in a rolled configuration.
  • the one or more retaining device 582 may comprise a low-tack adhesive configured to releasably couple each of the wing portions 580 to the central portion (e.g. in proximity to the line of symmetry 434).
  • the one or more retaining device 582 may be located on the cover 140 and/or the outer surface of the dressing 110.
  • the one or more retaining device 582 may comprise a separate retaining device for each wing portion 580, which may be located in proximity to the line of symmetry 434.
  • the one or more retaining device 582 may comprise a continuous line or area of low-tack adhesive extending substantially the length of the line of symmetry 434.
  • the retaining device 582 may be configured to be removable (e.g. once the wing portions 580 are unrolled into a usage configuration).
  • the one or more retaining device 582 may be configured so that, once the wing portions 580 are no longer retained, the retaining device 582 may be removed from the cover 140 without damaging the cover 140.
  • a fluid conductor 424 may be coupled to the dressing 110. As illustrated in Figure 5, the fluid conductor 424 may be coupled to the first arm 515, for example in the central portion (e.g. in proximity to the line of symmetry).
  • Figure 5 also illustrates an example of a dressing interface 422 that may be used to facilitate fluidly coupling the fluid conductor 424 to the manifold 406.
  • Some dressing 110 embodiments may comprise two configurations: a rolled configuration and a usage (e.g. unrolled) configuration.
  • the dressing 110 may be configured to be positionable in a rolled configuration and a usage configuration.
  • the rolled configuration may have a smaller footprint than the usage configuration.
  • the rolled configuration may have a footprint that is about % - 1 ⁇ 2 the size of the usage configuration.
  • when the dressing 110 is in the rolled configuration at least a portion of the dressing 110 may be rolled, for example to reduce the size of the footprint of the dressing 110.
  • footprint may mean a surface area occupied by the dressing.
  • the rolled configuration may include at least a rolled portion of the dressing 110.
  • the rolled configuration may comprise one or more rolls formed from at least a portion of the dressing 110.
  • each roll or rolled portion may comprise a roll axis, with at least a portion of the dressing 110 wrapped around, rolled around, positioned about, and/or encircling the roll axis.
  • the rolled configuration may comprise one or more roll axis, with at least a portion of the dressing 110 rolled around each such roll axis.
  • a first portion of the dressing 110 may be located in a plane above the roll axis, and a second portion of the dressing 110 may be located in a plane below the roll axis.
  • the dressing 110 in the rolled configuration may include a bend (e.g. around the roll axis), so that the first portion of the dressing may be located in a plane above the second portion of the dressing 110 (e.g. with the roll axis therebetween).
  • the attachment device 404 of the first portion may bend to extend over the cover and/or manifold of the second portion (e.g.
  • the dressing 110 in the rolled configuration may be configured with at least one roll (e.g. at least one rolled portion).
  • the dressing 110 may be configured for use on the treatment site.
  • the dressing 110 may be substantially unrolled (e.g. so that portions of the dressing do not roll around the roll axis) and/or flat in the usage configuration.
  • FIG. 6 is an isometric view of the dressing 110 of Figures 4-5 in an exemplary rolled configuration, illustrating additional details that may be associated with some examples.
  • the central portion may not be rolled (e.g. may be substantially flat), and each of the wing portions 580 may be rolled.
  • each wing portion 580 may roll inward towards the line of symmetry 434 and/or the central portion.
  • each wing portion 580 may be rolled around a roll axis 605, and each roll axis 605 may be substantially parallel to the line of symmetry 434.
  • the rolled wing portions 580 may lie atop the central portion in the rolled configuration, for example with the roll axis 605 for each of the wing portions 580 in a plane above the central portion.
  • the rolled wing portions 580 may be configured with the cover 140 or outer surface facing inward (e.g. towards the roll axis 605), in some embodiments, and the release liner 428 facing outward.
  • each wing portion 580 may be rolled around a removable roll spacer (not shown here).
  • a cylindrical removable roll spacer may define the roll axis 605 for each rolled wing portion in the rolled configuration (e.g.
  • each wing portion 580 rolled around, enwrapping, positioned about, and/or encircling the corresponding removable roll spacer.
  • the rolled configuration (e.g. the roll of each wing portion 580 about a roll axis 605) may be retained by the one or more retaining device 582.
  • the one or more retaining device 582 may releasably couple the release liner 428 of each rolled wing portion 580 to the cover 140 of the central portion (e.g. in proximity to the line of symmetry 434).
  • the rolled configuration (e.g. the roll of each wing portion 580 about a roll axis 605) may be retained due to the material forming the wing portion 580 being manufactured to take a set which biases each wing portion 580 towards the rolled configuration.
  • each wing portion 580 may naturally retain its roll shape until unrolled and adhered into place on the treatment site.
  • Figure 7 illustrates the dressing 110 of Figure 4 in an exemplary usage configuration and applied (e.g. unrolled and adhered) to an incision (not shown) on an exemplary treatment site (which may be an articulating joint, for example).
  • the articulating joint is a knee 705.
  • the stem 510 may substantially cover the top ofthe knee 705.
  • the manifold 406 is preferably oriented so that the first arm 515 and the fluid conductor 424 are superior to the knee 705.
  • the first arm 515 may cover and wrap around a portion of the leg superior to the knee 705, and the second arm 520 may cover and wrap around a portion of the leg inferior to the knee 705.
  • first arm 515 and the second arm 520 may be cut to reduce the first span 550, the second span 560, or both.
  • an extension portion e.g. a border
  • each of the wing portions 580 may be substantially unrolled from the roll axis and/or removable roll spacer, so that the tissue-contact surface may be located in proximity (e.g. contact) with the treatment site (for example, after removal of the release liners to expose the attachment device for affixing the dressing 110 in place on the treatment site).
  • exemplary methods for applying a rolled dressing may comprise: providing the dressing in a rolled configuration, with a plurality of wing portions each rolled towards a central portion; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; for each wing portion, removing a corresponding release liner; for each wing portion, releasing the wing portion from the rolled configuration; for each wing portion, unrolling the wing portion to a usage configuration; for each wing portion, coupling the wing portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site
  • releasing the wing portion from the rolled configuration may comprise uncoupling a retaining device. Some embodiments may further comprise removing the retaining device from the outer surface and/or cover of the dressing. In some embodiments, in the rolled configuration each wing portion may be rolled around a removable roll spacer, and the method may further comprise removing and/or discarding the removable roll spacer after each wing portion has been unrolled to the usage configuration. In some embodiments, when each wing portion has been released and/or unrolled and before each wing portion has been coupled to the treatment site, each wing portion may have a set which substantially holds the wing portion off of the treatment site (e.g. creating stand-off) until pressed firmly down and coupled (e.g.
  • the dressing positioning (e.g. of the wings) may be repositionable, to allow the user to fine tune the application of the dressing to the treatment site.
  • Some embodiments may further comprise removing the dressing, in the rolled configuration, from a box sized to correspond to the dressing in the rolled configuration (e.g. a box sized with an interior footprint that is smaller than the footprint of the dressing in the unrolled, usage configuration, but at least as large as the footprint of the dressing in the rolled configuration).
  • the dressing after unrolling the dressing, the dressing may not be degraded from having been in the rolled configuration (even if the dressing has been retained in the rolled configuration for a plurality of years).
  • Methods of manufacturing or positioning a dressing (for example, as shown in Figures 4-7) into a rolled configuration may comprise: providing the dressing comprising a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion; rolling each of the wing portions inward towards the line of symmetry to form a rolled configuration; and/or removably securing each of the wing portions in the rolled configuration with a retaining device.
  • the central portion of the dressing may be unrolled and/or substantially flat.
  • Some embodiments may further comprise providing a removable roll spacer for each of the wing portions, wherein rolling each of the wing portions may comprise rolling each of the wing portions around the corresponding removable roll spacer.
  • securing each of the wing portions in the rolled configuration may comprise removably adhering each of the wing portions to the central portion.
  • the attachment device may comprise an adhesive located on the central portion and each of the wing portions, and the method may further comprise covering the adhesive of the central portion with a first release liner, and covering the adhesive of each of the wing portions with a corresponding release liner.
  • Some embodiments may further comprise the step of introducing a set to the material of the dressing (e.g.
  • the dressing in the rolled configuration may be packaged within a pouch or a container (e.g. box) that is sufficiently rigid, structural, and/or protective to prevent the dressing in the rolled configuration (e.g. the rolls) from being crushed (e.g. flattened).
  • Some embodiments may further comprise placing the rolled dressing (e.g. in the rolled configuration) in a box, wherein the box is sized to receive the dressing in the rolled configuration.
  • the dressing in the rolled configuration may have a first (e.g. reduced) footprint that is substantially smaller than (e .g . % - 1 ⁇ 2 the size of) a second (e.g. unrolled) footprint of the dressing when in the usage configuration.
  • Some embodiments may further comprise selecting and/or providing the box having an interior footprint that is at least as large as the first footprint and smaller than the second footprint.
  • Some embodiments may further comprise storing the dressing in the rolled configuration (e.g.
  • storing the dressing in the rolled configuration for a plurality of years may not substantially degrade the dressing when it is unrolled for usage on a tissue site for negative-pressure therapy.
  • providing the dressing may comprise selecting a manifold for the dressing which is configured to not degrade (e.g. with respect to size, shape, and/or manifolding capabilities) when stored in the rolled configuration for a plurality of years.
  • Figures 8-9 illustrate an alternative dressing 110 embodiment, having a different shape and/or rolled configuration.
  • the dressing 110 of Figure 8 may have layers similar to those described with respect to Figure 4 (e.g. an attachment device, a manifold, and a cover).
  • the dressing 110 may comprise a manifold 406 that is elongate, with the length greater than the width.
  • the dressing 110 and/or manifold may include a longitudinal centerline 810.
  • the manifold 406 may have a substantially uniform width and/or thickness.
  • two or more portions 805 of the cover may extend beyond the manifold 406, for example with a first portion 805a extending laterally beyond the manifold 406 on one side of the longitudinal centerline 810, and a second portion 805b extending laterally beyond the manifold on the opposite side of the longitudinal centerline 810.
  • the first portion 805a and the second portion 805b may be symmetrical across the longitudinal centerline 810.
  • Figure 8 illustrates the dressing 110 in an exemplary rolled configuration.
  • the manifold 406 may not be rolled (e.g. the manifold may form a central portion that may be unrolled and/or substantially flat), and each of the two or more portions 805 of the cover extending beyond the manifold may be rolled.
  • the first portion 805a may be rolled with a roll axis 605a substantially parallel to the longitudinal centerline 810 of the manifold 406, and the second portion 805b may be rolled with a roll axis 605b substantially parallel to the longitudinal centerline 810.
  • each portion 805 extending beyond the manifold may be rolled inward towards the manifold 406 and/or the longitudinal centerline 810.
  • the outer surface (e.g. cover 140) of the dressing 110 for the rolled portions may face inward.
  • the release liner for the rolled portions 805 may face outward.
  • the rolled portions 805 may lie atop the tissue-contact surface in proximity to the manifold 406 in the rolled configuration (e.g. the rolled portions 805 may not extend downward substantially below the manifold 406 in the rolled configuration).
  • each of the portions 805 extending beyond the manifold e.g.
  • each removable roll spacer may be cylindrical and/or may have a length approximately equal to the length of the manifold 406.
  • the ends of the rolled portions 805 of the cover may be folded. For example, the ends may be folded inward longitudinally, so that the roll axis 605 for each of the rolled portions 805 may be folded over on top of itself.
  • the dressing 110 may further comprise the retaining device 582, configured to retain the dressing 110 in the rolled configuration.
  • each rolled portion 805 may be releasably retained in the rolled configuration.
  • the retaining device 582 may comprise tape and/or low-tack adhesive, which may couple the rolled portions 805 to the manifold 406 and/or central portion and/or may retain the folded ends in the folded position.
  • the folded ends of each rolled portion 805 may be coupled to the remainder of the rolled portion (e.g. the roll retaining device may comprise a fold retaining device 814, that then inherently retains the rolls).
  • the attachment device may span the manifold 406 and each of the at least two portions 805 extending beyond the manifold.
  • a first of the at least two release liners may span the manifold 406 and/or cover the attachment device underlying the manifold 406 (e.g. the central portion), and each of the two or more portions 805 extending beyond the manifold may be spanned and/or covered by another of the at least two release liners.
  • a release liner may cover the portion of the cover extending beyond the manifold laterally on either side of the manifold (e.g.
  • a release liner may cover the portion of the cover extending beyond the manifold longitudinally at either end.
  • Some embodiments may comprise three release liners, five release liners, or 3-5 release liners, for example depending on the specific dressing configuration. Some embodiments may not comprise a release liner, but for example may couple the dressing in place using tape or other such separate attachment device.
  • the port and/or dressing interface 422 may couple to the cover in proximity to the manifold 406 (e.g. atop the manifold 406 in the central portion of the dressing 110 and/or in proximity to the longitudinal centerline).
  • Figure 9 is a plan view illustrating the dressing 110 of Figure 8 in an exemplary usage configuration and in place on an exemplary treatment site.
  • each of the portions 805 of the cover beyond the manifold may be unrolled in the usage configuration, so that the tissue-contact surface may be located in proximity with the treatment site.
  • the fluid conductor 424 leading from the dressing interface 422 may fluidly couple the dressing 110 to a reduced-pressure source 105.
  • some methods for applying a rolled dressing may comprise: providing the dressing in a rolled configuration having an unrolled central portion spanning a manifold and two or more rolled portions of a cover extending beyond the manifold; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; releasing the two or more rolled portions from the rolled configuration; for each rolled portion, removing a corresponding release liner; for each rolled portion, unrolling the rolled portion to the usage configuration; for each rolled portion, coupling the rolled portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing.
  • releasing the two or more rolled portions from the rolled configuration may comprise uncoupling a retaining device. Some embodiments may further comprise removing the retaining device from the outer surface and/or cover of the dressing. Some embodiments may further comprise removing the dressing, in the rolled configuration, from a box. In some embodiments, after unrolling the dressing, the dressing may not be degraded from having been in the rolled configuration (even if the dressing has been retained in the rolled configuration for a plurality of years).
  • Methods of manufacturing and/or positioning a dressing (e.g. similar to that of Figures 8-9) into a rolled configuration may comprise: providing the dressing comprising an attachment device having a treatment aperture, a manifold disposed over the treatment aperture, and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; rolling portions of the cover, which extend laterally beyond the manifold, inward towards the manifold to form a rolled configuration; and/or removably securing the rolled portions of the cover in the rolled configuration using a retaining device.
  • the manifold in the rolled configuration, may be unrolled and/or substantially flat.
  • Some embodiments may further comprise folding the rolled portions (e.g. to form a fold in each of the rolled portions).
  • the attachment device may comprises an adhesive located on the manifold and each of the portions of the cover extending laterally beyond the manifold, and the method may further comprise covering the adhesive of the manifold with a release liner, and covering the adhesive of each of the portions of the cover extending laterally beyond the manifold with a corresponding release liner.
  • Some embodiments may further comprise providing a removable roll spacer for each rolled portion, wherein rolling the portions of the cover may comprise rolling each of the portions of the cover around the removable roll spacer.
  • Some embodiments may further comprise placing the rolled dressing (e.g.
  • the dressing in the rolled configuration may have a first (e.g. reduced) footprint that is substantially smaller than (e .g . % - 1 ⁇ 2 the size of) a second (e.g. unrolled) footprint of the dressing when in the usage configuration.
  • Some embodiments may further comprise selecting and/or providing the box having an interior footprint that is at least as large as the first footprint and smaller than the second footprint.
  • Some embodiments may further comprise storing the dressing in the rolled configuration (e.g. within the box) for up to a plurality of years (for example, up to 4 or 5 years).
  • storing the dressing in the rolled configuration for a plurality of years may not substantially degrade the dressing when it is unrolled for usage on a tissue site for negative-pressure therapy.
  • providing the dressing may comprise selecting a manifold for the dressing which is configured to not degrade (e.g. with respect to size, shape, and/or manifolding capabilities) when stored in the rolled configuration for a plurality of years.
  • Figures 10-12 illustrate yet another alternate dressing 110 embodiment, which may be similar to Figure 8 in structure (e.g. layers) but may have a different rolled configuration.
  • substantially the entire dressing 110 may roll around a central roll axis in the rolled configuration, and/or in some embodiments the central roll axis may be defined by a removable roll spacer with a removable roll spacer central axis forming the central roll axis about which the dressing 110 may be rolled.
  • the elongate dressing 110 has a length greater than its width, and a longitudinal centerline 810. In some embodiments, the length of the dressing 110 may be approximately 13 cm, 20 cm, 35 cm, 13-20 cm, 13-15 cm, 20-35 cm, or 90 cm.
  • the cover may be disposed over the manifold 406 and may form the outer surface 1005 of the dressing 110.
  • the retaining device 582 may be located on the outer surface 1005 (e.g. the exterior surface when applied to a treatment site) of the dressing 110 and may be configured to releasably retain the dressing 110 in the rolled configuration. In some embodiments, the retaining device 582 may be configured to be removable from the dressing 110 (e.g. without significantly damaging the dressing cover).
  • the retaining device 582 may comprise a low-tack adhesive.
  • the low-tack adhesive of the retaining device 582 may extend substantially from the port or dressing interface 422 lengthwise for the remainder of the length of the manifold 406 (for instance, extending continuously or intermittently along the longitudinal centerline 810 of the manifold 406) .
  • the retaining device 582 may be located at least on the outer surface 1005 of the free end 1010 (e .g . in proximity to the port and/or the dressing interface 422) and configured to couple the free end 1010 to the remainder of the rolled dressing 110.
  • the port in the cover and/or the dressing interface 422 may be located on a free end 1010 of the dressing 110, for example on the outer surface 1005.
  • the attachment device may comprise an adhesive.
  • the adhesive of the attachment device may extend substantially the length of the dressing 110, and at least two release liners may be configured to releasably cover the adhesive.
  • one of the at least two release liners may span and/or cover the adhesive at the free end 1010 of the dressing 110.
  • the free end release liner may be separately releasable from the adhesive (e.g. configured to allow exposure of the adhesive on the free end 1010, while the remainder of the at least two release liners remains in place covering the remainder of the adhesive).
  • a break perforation line 1015 in the release liner may be configured and located with respect to the free end 1010 to allow independent separation of the free end of the release liner from the remainder of the release liner.
  • Figure 11 illustrates the dressing 110 of Figure 10 in an exemplary rolled configuration, illustrating additional details that may be associated with some embodiments.
  • the entire dressing 110 may roll around, encircle, and/or enwrap a central roll axis 1105 (e.g. with the length of the dressing 110 extending around the central roll axis 1105).
  • the longitudinal centerline 810 of the dressing 110 may be located in a plane substantially perpendicular to the central roll axis 1105, in the rolled configuration.
  • the release liner may face outward, in some embodiments, and the cover (e.g. outer surface 1005) may face inward.
  • the retaining device 582 may be configured to releasably couple the cover to the release liner in the rolled configuration. In some embodiments, in the rolled configuration at least the free end 1010 of the cover may be releasably coupled to the release liner. In some embodiments, in the rolled configuration the cover may be releasably coupled to the release liner substantially along the length of the dressing 110 and/or manifold 406. In the rolled configuration, the free end 1010 of the dressing 110 may be accessible (e.g.
  • the free end release liner may be removed and/or the free end 1010 may be released from the retaining device 582 to be uncoupled from the remainder of the rolled dressing 110) while the dressing 110 is rolled; the opposite end 1107 (e.g. attached to the removable roll spacer and/or located within the roll of the dressing 110) may not be accessible in the rolled configuration (e.g. with the dressing 110 needing to be unrolled to the usage configuration to access the opposite end 1107).
  • Some embodiments may further comprise the removable roll spacer 1110, which may be configured to be encircled and/or enwrapped by the dressing 110 in the rolled configuration.
  • the removable roll spacer 1110 may be cylindrical and/or may have a central axis that may define or align with the central roll axis 1105. At least a portion of the dressing 110 length may be wrapped around the removable roll spacer 1110 in the rolled configuration, and in some embodiments the entire dressing 110 length may be rolled around the removable roll spacer 1110.
  • the dressing 110 may wrap around the removable roll spacer 1110 multiple times.
  • the removable roll spacer 1110 may comprise cardboard paper (e.g. typically with a polymer coating or film exterior) or foam.
  • the removable roll spacer 1110 may be sterilizable, configured to releasably adhere to the retaining device 582 (e.g. low-tack adhesive), and/or configured to not create particulates in use.
  • the retaining device 582 may releasably couple the dressing 110 to the removable roll spacer 1110 (e.g. at the opposite end 1107), for example in addition to releasably coupling the outer surface 1005 of at least the free end 1010 to the release liner (e.g. to maintain the rolled configuration).
  • the retaining device 582 may comprise a low-tack adhesive.
  • the retaining device 582 may comprise thermoplastic elastomer (TPE).
  • the retaining device 582 may be configured to couple the cover to the release liner in the rolled configuration with a hold strength of no more than one pound. In some embodiments, the retaining device 582 may be configured to couple to the cover more strongly than it couples to the release liner (while also being removable from the cover without substantially damaging the cover).
  • the dressing 110 may be configured to be customizable.
  • the dressing 110 may be configured to allow the length of the elongate dressing 110 to be customized (e.g. so that the length of the dressing 110 in the usage configuration may be less than or equal to the length of the dressing 110 in the rolled configuration).
  • the dressing 110 may be configured so that the length may be cut shorter, as needed for the specific treatment site.
  • Figure 12 illustrates the dressing 110 of Figure 10 in an exemplary usage configuration.
  • the dressing 110 has been unrolled onto the treatment site.
  • the dressing 110 may be adhered to the treatment site (e.g. by the attachment device, after removal of the release liners), with the manifold 406 in fluid communication with the treatment site.
  • the dressing interface 422 and the fluid conductor 424 may fluidly couple the manifold 406 through the cover to the reduced-pressure source 105, for example for reduced-pressure therapy.
  • methods for applying a rolled dressing may comprise: providing the dressing in a rolled configuration with a longitudinal centerline of the dressing enwrapping a central roll axis and positioned with a free end; coupling the free end of the dressing to the treatment site; releasing the dressing from the rolled configuration; unrolling the dressing to a usage configuration; coupling the dressing to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing.
  • Some method embodiments may further comprise removing a first release liner from the free end of the dressing, prior to coupling the free end of the dressing to the treatment site.
  • Some embodiments may further comprise removing a second release liner from the remainder of the dressing.
  • releasing the dressing from the rolled configuration may comprise uncoupling a retaining device.
  • Some embodiments may further comprise removing the retaining device from the outer surface and/or cover of the dressing.
  • the method in which the rolled configuration has the dressing rolled around a removable roll spacer, the method may further comprise discarding the removable roll spacer after the dressing has been unrolled to the usage configuration.
  • Some embodiments may further comprise removing the dressing, in the rolled configuration, from a box. In some embodiments, after unrolling the dressing, the dressing may not be degraded from having been in the rolled configuration (even if the dressing has been retained in the rolled configuration for a plurality of years).
  • Methods of manufacturing and/or positioning the dressing (e.g. as shown in Figures 10-12) into a rolled configuration may comprise: providing the dressing with a length, a width, and a longitudinal centerline, wherein the length is greater than the width; and rolling the dressing perpendicular to a central roll axis to position the dressing in a rolled configuration, with the length of the dressing extending around the roll axis and the roll axis extending perpendicular to a plane of the longitudinal centerline.
  • Some embodiments may further comprise removably securing the dressing in the rolled configuration with a retaining device.
  • the dressing may further comprise an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing.
  • the method may further comprise applying the retaining device to the outer surface of the dressing.
  • the dressing in the rolled configuration, may comprise a free end which is accessible; and the method may further comprise attaching a dressing interface, which is configured to fluidly couple the manifold to a negative-pressure source through the cover, to the outer surface of the free end.
  • Some embodiments may further comprise applying at least two release liners to cover the attachment device, wherein a first of the two release liners covers the attachment device at the free end of the dressing and is configured to allow exposure of the free end of the attachment device independently without exposing a remainder of the attachment device.
  • Some embodiments may further comprise providing a removable roll spacer defining the roll axis, wherein rolling the dressing perpendicular to a roll axis comprises rolling the dressing around the removable roll spacer.
  • Some embodiments may further comprise removably adhering the dressing in the rolled configuration to the removable roll spacer using the retaining device.
  • securing the dressing in the rolled configuration may further comprise removably adhering the outer surface of the dressing to the two or more release liners.
  • Some embodiments may further comprise placing the rolled dressing (e.g. in the rolled configuration) in a box, wherein the box is sized to receive the dressing in the rolled configuration.
  • the dressing in the rolled configuration may have a first (e.g. reduced) footprint that is substantially smaller than (e .g . % - 1 ⁇ 2 the size of) a second (e.g. unrolled) footprint of the dressing when in the usage configuration.
  • Some embodiments may further comprise selecting and/or providing the box having an interior footprint that is at least as large as the first footprint of the dressing and smaller than the second footprint of the dressing.
  • Some embodiments may further comprise storing the dressing in the rolled configuration (e.g.
  • storing the dressing in the rolled configuration for a plurality of years may not substantially degrade the dressing when it is unrolled for usage on a tissue site for negative-pressure therapy.
  • providing the dressing may comprise selecting a manifold for the dressing which is configured to not degrade (e.g. with respect to size, shape, and/or manifolding capabilities) when stored in the rolled configuration for a plurality of years.
  • a dressing kit may comprise: a dressing having a foam manifold and a cover disposed over the foam manifold to form an outer surface of the dressing, wherein the dressing may be retained in a rolled configuration having a first (e.g. reduced) footprint; and a box sized to receive the dressing in the rolled configuration.
  • the box may be sized to correspond to (e.g. receive) the first footprint of the dressing.
  • the box may be sized to have an interior footprint that is at least as large as the first footprint of the dressing.
  • the dressing in the rolled configuration may be located within the box.
  • the dressing may be configured to have an unrolled configuration with a second (e.g.
  • the second footprint when removed from the box, and the second footprint may be larger than the first footprint.
  • the first footprint may be about % - 1 ⁇ 2 or no more than half of the second footprint in size.
  • the interior footprint of the box may be less than the second footprint of the dressing, and often may be substantially less than the second footprint of the dressing (e.g. only slightly larger than the first footprint of the dressing).
  • the rolled configuration of the dressing may allow for the box to have an interior footprint sized between the first footprint of the dressing and the second footprint of the dressing.
  • the foam manifold may not be degraded by the rolled configuration, even when retained in the rolled configuration for a plurality of years.
  • the foam manifold may have a size and shape after being unrolled substantially the same as before being rolled and/or may have manifolding (e.g. negative-pressure distribution) capabilities after being unrolled that are substantially the same as before being rolled.
  • Some embodiments may further comprise an adhesive device or other retaining device on the outer surface configured to releasably retain the dressing in the rolled configuration by attaching a first portion of the dressing to a second portion of the dressing.
  • the first portion may comprise a wing portion
  • the second portion may comprise a central portion (e.g.
  • the first portion may comprise a free end of the dressing, and the second portion may comprise an interior portion of the dressing (e.g. a remainder of the dressing, away from the free end) .
  • the first portion may comprise a portion of the cover extending beyond the manifold, and the second portion may comprise the manifold.
  • the reduced-pressure source 105 can reduce pressure in the sealed therapeutic environment (e.g. when the dressing 110 is applied to the treatment site in the usage configuration). Reduced pressure applied to the tissue site through the manifold 406 in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site, as well as remove exudates and other fluids from the tissue site, which can be collected in the container 115.
  • downstream may refer to a location in a fluid path relatively closer to a source of reduced pressure or further away from a source of positive pressure.
  • upstream may refer to a location further away from a source of reduced pressure or closer to a source of positive pressure.
  • the controller 120 may receive and process data from one or more sensors, such as the first sensor 125.
  • the controller 120 may also control the operation of one or more components of the therapy system 100 to manage the pressure delivered to the tissue interface 135, such as the manifold 406 and associated components.
  • the controller 120 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 135.
  • the target pressure may be a fixed pressure value set by an operator as the target reduced pressure desired for therapy at a tissue site and then provided as input to the controller 120.
  • 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 120 can operate the reduced-pressure source 105 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 135.
  • the manifold 406 may have distinct pressure zones, and different target pressures and control modes may be applied to different pressure zones.
  • the systems, apparatuses, and methods described herein may provide significant advantages.
  • the system 100 can also reduce edema and bruising in a broader area of tissue surrounding or adjacent to a tissue site or treatment target, such as an incision.
  • the dressing 110 can reduce stress on an incision and maximize the treatment coverage area of patient extremities.
  • the dressing 110 can also be beneficial for managing edema and bruising of tissue sites without an incision or open wound, such as a sprain.
  • the dressing may be packaged, shipped, and/or stored with a reduced footprint (e.g.
  • the rolled configuration may not substantially degrade or otherwise negatively impact the dressing (e.g. when it is unrolled for use providing negative-pressure therapy to a tissue site), even if the dressing is stored in the rolled configuration for a number of years.
  • Some embodiments may also be configured to aid application of the dressing to a tissue site.
  • the dressing configuration may help to free a user’s hand, so that the user may utilize both hands during placement of the dressing on the tissue site.
  • Some dressing configurations may assist in preventing the dressing from adhering to itself during application to the treatment site.
  • Some dressing configurations may assist with effective placement of the dressing on large treatment sites and/or curved treatment sites.
  • test specimens of 35cm long dressing from the PREVENA PLUS PEEL & PLACETM Incision Management System were rolled around a cardboard tube and around a 1 ⁇ 2 inch foam spacer and placed within an oven for age testing. During age testing, the test specimens were maintained in the oven at 55 degrees Celsius for approximately four months, simulating four years of aging under normal conditions. After age testing, visual inspection of the dressing (e.g. looking for folds, creases, or degradation around the area of folding or rolling) did not detect degradation. Leak testing was also performed on the test specimens, and no significant (e.g. unresolvable) leaks were observed.

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Abstract

Disclosed embodiments may include dressings having a rolled configuration which may reduce the footprint of the dressing, for example during packaging, shipping, and/or storage, and a usage configuration which may be unrolled for application to and usage in providing negative-pressure therapy on a tissue site. The dressing may be configured so that rolling does not degrade the dressing. Dressing embodiments may have various shapes and/or rolled configurations. Additionally disclosed are other apparatus, dressings, systems, and methods.

Description

DRESSING WITH ROLLED CONFIGURATION
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/018,125, filed on April 30, 2020, which is incorporated herein by reference in its entirety.
TECHNICAL FIELD
[0002] This disclosure relates generally to tissue treatment systems and more particularly, but without limitation, to dressings, systems, and methods relating to reduced-pressure therapy.
BACKGROUND
[0003] Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome. Treatment of wounds or other tissue with reduced pressure may be commonly referred to as "negative-pressure therapy," but is also known by other names, including "negative- pressure wound therapy," "reduced-pressure therapy," "vacuum therapy," "vacuum-assisted closure," and "topical negative-pressure," for example. Reduced-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.
[0004] While the clinical benefits of reduced-pressure therapy are widely known, improvements to therapy systems, components, and processes may benefit healthcare providers and patients.
BRIEF SUMMARY
[0005] New and useful systems, apparatuses, and methods for managing tissue sites in a reduced-pressure therapy environment are set forth in the appended claims. The following description provides non-limiting, illustrative example embodiments to enable a person skilled in the art to make and use the claimed subject matter.
[0006] In some example embodiments, a dressing for reduced-pressure therapy on a treatment site may comprise: an attachment device having a treatment aperture; a manifold disposed over the treatment aperture; and a cover disposed over the manifold and coupled to the attachment device around the manifold; wherein the dressing comprises a rolled configuration in which at least a portion of the dressing is rolled, and the dressing is configured to be used in an unrolled configuration (e.g. having an unrolled, usage configuration in which the dressing is configured for use on the treatment site).
Some embodiments may further comprise a retaining device configured to releasably retain the dressing in the rolled configuration. In some embodiments, the retaining device may be removable from the dressing in the usage configuration. In some embodiments, the attachment device may comprise an adhesive, and the dressing may further comprise at least two release liners configured to releasably cover the adhesive. In some embodiments, the rolled configuration may be configured to reduce the footprint of the dressing. In some embodiments, the attachment device may be located on a tissue- contact surface, which is configured to contact the treatment site during usage. In some embodiments, the manifold may comprise porous foam. In some embodiments, the attachment device may be configured to create a sealed space between the cover and the treatment site, and the manifold may be configured to be positioned in the sealed space. In some embodiments, the attachment device may comprises a film layer and an adhesive . Some embodiments may further comprise a tissue-contact layer coupled to the manifold and at least partially exposed through the treatment aperture. In some embodiments, the tissue-contact layer may comprise one or more of the following: a woven material, a non-woven material, a polyester knit material, and a fenestrated film.
[0007] In some embodiments, in the rolled configuration the entire dressing may roll around (e.g. encircle) a central roll axis that is substantially perpendicular to a longitudinal centerline of the dressing. The retaining device in some embodiments may comprise a low-tack adhesive on the cover. In some embodiments, the retaining device may be configured to couple the cover to the at least two release liners in the rolled configuration. In some embodiments, the at least two release liners may be configured to allow exposure of a free end portion of the attachment device without exposing a remainder of the attachment device. Some embodiments may further comprise a core or removable roll spacer configured to be encircled or enwrapped by the dressing in the rolled configuration.
[0008] Some embodiments may further comprise a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion. In some embodiments, in the rolled configuration the central portion may not be rolled, and each of the wing portions may be rolled with a roll axis substantially parallel to the line of symmetry. In some embodiments, a first of the at least two release liners may span the central portion, and each of the wing portions may be spanned by another of the at least two release liners. In some embodiments, in the rolled configuration the retaining device may be configured to releasably couple each of the rolled wing portions to the central portion (e.g. in proximity to the line of symmetry).
[0009] In some embodiments, in the rolled configuration the manifold may not be rolled, and two or more portions of the cover extending beyond the manifold may be rolled. In some embodiments, portions of the cover may extend beyond the manifold on both sides of the manifold, for example symmetrically about a longitudinal centerline. In some embodiments, the retaining device may be configured to releasably couple each of the rolled portions to the cover in proximity to the longitudinal centerline (e.g. atop the manifold). In some embodiments, the retaining device may comprise tape. In some embodiments, the manifold may be elongate, with length longer than width, and may have a substantially uniform width and/or thickness. In some embodiments, the portions of the cover extending beyond the manifold may be rolled with a roll axis substantially parallel to the longitudinal centerline of the manifold, in the rolled configuration. In some embodiments, in the rolled configuration the portions of the cover that are rolled may be folded, for example so that the roll axis is folded. In some embodiments, in the rolled configuration the portion of the cover extending beyond the manifold longitudinally and located between the rolled portions may form two end portions separated by the manifold, and the end portions may be folded towards the manifold. In some embodiments, the end portions may be retained in the folded state by the retaining device, such as tape, and retaining the folded end portions may act to retain the rolled portions. In some embodiments, a first of the at least two release liners may span the manifold, each of the two or more portions extending beyond the manifold may comprise the attachment device, and each of the two or more portions extending beyond the manifold may be spanned by another of the at least two release liners. Some embodiments may further comprise a removable roll spacer for each of the rolled portions, configured for the portions to encircle the removable roll spacer in the rolled configuration.
[0010] In some example embodiments, a dressing for reduced-pressure therapy on a treatment site may comprise: an attachment device having a treatment aperture; a manifold comprising a longitudinal centerline, the manifold configured to be in fluid communication with the treatment site through the treatment aperture; a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; a retaining device (such as an adhesive device) on the outer surface configured to releasably retain the dressing in a rolled configuration; and a port in the cover located on the outer surface of a free end of the dressing. Some embodiments may further comprise a dressing interface configured to fluidly couple the port to a negative-pressure source. In some embodiments, the manifold may be elongate, with length longer than width, and may have a substantially uniform width and/or thickness. In some embodiments, the attachment device may comprise an adhesive, and the dressing may further comprise at least two release liners configured to releasably cover the adhesive, wherein one of the at least two release liners may span the adhesive at the free end of the dressing and may be separately releasable from the adhesive (e.g. while the other of the at least two release liners remains in place covering the adhesive). In some embodiments, the at least two release liners may comprise a first release liner covering the attachment device at the free end, and a second release liner covering the remainder of the attachment device. In some embodiments, the retaining device may be located substantially in proximity to the free end. In some embodiments, the retaining device may comprise a low-tack adhesive extending substantially from the port lengthwise (e.g. extending substantially along the length of the dressing). In some embodiments, the dressing may comprise a rolled configuration in which at least a portion of the dressing is rolled, and a usage configuration in which the dressing may be configured for use on the treatment site; and in the rolled configuration, the dressing may encircle a central roll axis (e.g. with the length of the dressing encircling the central roll axis), with the longitudinal centerline of the dressing in a plane substantially perpendicular to the central roll axis. In some embodiments, in the rolled configuration the release liner may face outward, and the cover or outer surface may face inward. Some embodiments may further comprise a removable roll spacer configured to be encircled by the dressing in the rolled configuration. In some embodiments, the removable roll spacer may be cylindrical about the central roll axis and/or configured to releasably adhere to the retaining device, to be sterilizable, and/or to not create particulates in use. In some embodiments, the dressing may be configured to be customizable in length.
[0011] In some example embodiments, a dressing for reduced-pressure therapy on a treatment site may comprise: a lower surface (e.g. a tissue-contact surface) having a treatment aperture; a manifold comprising a central portion, extending along a line of symmetry, and two or more wing portions each extending substantially perpendicular to the line of symmetry, wherein the manifold may be configured to be in fluid communication with the treatment site through the treatment aperture; a cover configured to be disposed over the manifold to form a sealed space. In some embodiments, the manifold may comprise foam, such as open-cell foam. In some embodiments, the dressing may be stored in a rolled configuration with the lower surface of the wing portions positioned over the cover. In some embodiments, the lower surface of each of the wing portions may fold over a top surface of the dressing (e.g. over the cover). In some embodiments, in the rolled configuration the central portion may not be rolled (e.g. the central portion may be substantially flat), and each of the wing portions may be rolled inward towards the central portion and/or line of symmetry, with a roll axis substantially parallel to the line of symmetry. Some embodiments may further comprise one or more retaining device configured to releasably retain the wing portions in the rolled configuration. In some embodiments, the one or more retaining device may comprise a low-tack adhesive configured to releasably couple the wing portions to the central portion. In some embodiments, the low-tack adhesive may be located on the cover in proximity to the line of symmetry. In some embodiments, the two or more wing portions may comprise a first wing portion, a second wing portion, a third wing portion, and a fourth wing portion; the first wing portion may be symmetrical to the second wing portion across the line of symmetry; and the third wing portion may be symmetrical to the fourth wing portion across the line of symmetry. Some embodiments may further comprise a box sized to receive the dressing in the rolled configuration. In some embodiments, the lower surface may comprise or consist essentially of an attachment device, for example configured to seal the dressing to the tissue site. In some embodiments, the cover may couple to the attachment device around the manifold. In some embodiments, the attachment device may comprise an adhesive; the dressing may further comprise a plurality of release liners configured to releasably cover the adhesive; and a first of the plurality of release liners may span the central portion, and each of the wing portions may be spanned by another of the plurality of release liners. Some embodiments may further comprise two or more rolling cores (e.g. removable roll spacers), with each core configured to be encircled by one of the wing portions in the rolled configuration. For example, in the rolled configuration the central axis of each core may form the roll axis for the corresponding wing portion. In some embodiments, the manifold may comprise a first arm and a second arm joined by a stem; the first arm may comprise the first wing portion and the second wing portion; the second arm may comprise the third wing portion and the fourth wing portion; and the line of symmetry may extend through the stem, the first arm, and the second arm. Some embodiments may further comprise a slip-sheet adjacent to the cover (e.g. the outer surface) of the rolled wings and configured to prevent each of the rolled wings from adhering to itself. In some embodiments, the attachment device may be positioned around the edge of the manifold and configured to surround the treatment site.
[0012] In some example embodiments, a method for applying a rolled dressing to a treatment site, may comprise: providing the dressing in a rolled configuration with a longitudinal centerline of the dressing enwrapping a central roll axis and positioned with a free end; coupling the free end of the dressing to the treatment site; releasing the dressing from the rolled configuration; unrolling the dressing to a usage configuration; coupling the dressing to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing. Some method embodiments may further comprise removing a first release liner from the free end of the dressing, prior to coupling the free end of the dressing to the treatment site. Some embodiments may further comprise removing a second (or additional) release liner from the remainder of the dressing. In some embodiments, releasing the dressing from the rolled configuration may comprise uncoupling a retaining device. In some embodiments, in the rolled configuration the dressing may be rolled around a removable roll spacer, and the method may further comprise discarding the removable roll spacer after the dressing has been unrolled to the usage configuration. Some embodiments may further comprise customizing the size of the dressing, for example by cutting the dressing to alter its length.
[0013] In some example embodiments, a method for applying a rolled dressing to a treatment site may comprise: providing the dressing in a rolled configuration, with a plurality of wing portions each rolled towards a central portion; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; for each wing portion, removing a corresponding release liner; for each wing portion, releasing the wing portion from the rolled configuration; for each wing portion, unrolling the wing portion to a usage configuration; for each wing portion, coupling the wing portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing. In some embodiments, releasing the wing portion from the rolled configuration may comprise uncoupling a retaining device. In some embodiments, in the rolled configuration each wing portion may be rolled around a removable roll spacer, and the method may further comprise discarding the removable roll spacer after each wing portion has been unrolled to the usage configuration.
[0014] In some example embodiments, a method for applying a rolled dressing to a treatment site may comprise: providing the dressing in a rolled configuration having an unrolled central portion spanning a manifold and two or more rolled portions of a cover extending beyond the manifold (e.g. laterally); removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; releasing the two or more rolled portions from the rolled configuration; for each rolled portion, removing a corresponding release liner; for each rolled portion, unrolling the rolled portion; for each rolled portion, coupling the rolled portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing. In some embodiments, releasing the two or more rolled portions from the rolled configuration may comprise uncoupling a retaining device.
[0015] In some example embodiments, a method of positioning a dressing into a rolled configuration may comprise: providing the dressing with a length, a width, and a longitudinal centerline, wherein the length is greater than the width; and rolling the dressing perpendicular to a central roll axis to position the dressing in a rolled configuration, with the length of the dressing extending around the roll axis and the roll axis extending perpendicular to a plane of the longitudinal centerline. Some embodiments may further comprise securing the dressing in the rolled configuration with a retaining device. In some embodiments, the dressing may further comprise an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing. In some embodiments, the method may further comprise applying the retaining device to the outer surface of the dressing. In some embodiments, the dressing may comprise a free end (which is configured to be accessible in the rolled configuration); and the method may further comprise attaching a dressing interface, which is configured to fluidly couple the manifold to a reduced-pressure source through the cover, to the outer surface of the free end. Some embodiments may further comprise applying at least two release liners to cover the attachment device, wherein a first of the two release liners covers the attachment device at the free end of the dressing and is configured to allow exposure of the free end of the attachment device without exposing a remainder of the attachment device. Some embodiments may further comprise providing a removable roll spacer defining the roll axis, wherein rolling the dressing perpendicular to a roll axis comprises rolling the dressing around the removable roll spacer. Some embodiments may further comprise removably adhering the dressing in the rolled configuration to the removable roll spacer using the retaining device. In some embodiments, securing the dressing in the rolled configuration may further comprise removably adhering the outer surface of the dressing to the two or more release liners.
[0016] In some example embodiments, a method of positioning a dressing into a rolled configuration may comprise: providing the dressing comprising a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion; rolling each of the wing portions inward towards the line of symmetry to form a rolled configuration; and/or removably securing each of the wing portions in the rolled configuration with a retaining device. In some embodiments, in the rolled configuration the central portion of the dressing may be unrolled and/or substantially flat. Some embodiments may further comprise providing a removable roll spacer for each of the wing portions, wherein rolling each of the wing portions may comprise rolling each of the wing portions around the removable roll spacer. In some embodiments, securing each of the wing portions in the rolled configuration may comprise removably adhering each of the wing portions to the central portion. In some embodiments, the dressing may comprise an adhesive attachment device located on the central portion and each of the wing portions, and the method may further comprise covering the adhesive of the central portion with a first release liner, and covering the adhesive of each of the wing portions with a corresponding release liner.
[0017] In some example embodiments, a method of positioning a dressing into a rolled configuration may comprise: providing the dressing comprising an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; rolling portions of the cover, which extend laterally beyond the manifold, inward towards the manifold to form a rolled configuration; and/or removably securing the rolled portions of the cover in the rolled configuration using a retaining device. In some embodiments, in the rolled configuration, the manifold may be unrolled and/or substantially flat. In some embodiments, each of the rolled portions may be rolled around a roll axis that is substantially parallel to a longitudinal centerline of the manifold. Some embodiments may further comprise folding the rolled portions (e.g. to form a fold in each of the rolled portions). In some embodiments, the attachment device may comprises an adhesive located on the manifold and each of the portions of the cover extending laterally beyond the manifold, and the method may further comprise covering the adhesive of the manifold with a first release liner, and covering the adhesive of each of the portions of the cover extending laterally beyond the manifold with a corresponding release liner. Some embodiments may further comprise providing a removable roll spacer for each rolled portion, wherein rolling the portions of the cover may comprise rolling each of the portions of the cover around the removable roll spacer.
[0018] In some example embodiments, a dressing kit may comprise: a dressing having a foam manifold and a cover disposed over the foam manifold to form an outer surface of the dressing, wherein the dressing may be retained in a rolled configuration having a first (e.g. reduced) footprint; and a box sized to receive the dressing in the rolled configuration (e.g. sized to correspond to the first footprint). In some embodiments, the box may be sized to have an interior footprint that is at least as large as the first footprint of the dressing. In some embodiments, the dressing in the rolled configuration may be located within the box. In some embodiments, the dressing may be configured to have an unrolled configuration with a second (e.g. unrolled) footprint when removed from the box, and the second footprint may be larger than the first footprint. In some embodiments, the interior footprint of the box may be at least as large as the first footprint of the dressing, but smaller than the second footprint of the dressing. In some embodiments, the foam manifold may not be degraded by the rolled configuration, even when retained in the rolled configuration for a plurality of years. For example, the foam manifold may have a size and shape after being unrolled substantially the same as before being rolled and/or may have manifolding (e.g. negative-pressure distribution) capabilities after being unrolled that are substantially the same as before being rolled. Some embodiments may further comprise an adhesive device on the outer surface configured to retain the dressing in the rolled configuration by attaching a first portion of the dressing to a second portion of the dressing. In some embodiments, the first portion may comprise a wing portion, and the second portion may comprise a central portion (e.g. in proximity to a longitudinal centerline and/or a line of symmetry for the dressing). In some embodiments, the first portion may comprise a free end of the dressing, and the second portion may comprise an interior portion of the dressing (e.g. away from the free end). In some embodiments, the first portion may comprise a portion of the cover extending beyond the manifold, and the second portion may comprise the manifold.
[0019] 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 example embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 is a block diagram of an example embodiment of a therapy system that can provide reduced-pressure therapy in accordance with this specification;
[0021] Figure 2 is a graph illustrating example pressure control modes that may be associated with some example embodiments of the therapy system of Figure 1;
[0022] Figure 3 is a graph illustrating another example pressure control mode suitable for some example embodiments of the therapy system of Figure 1 ;
[0023] Figure 4 is an exploded, isometric view of an example embodiment of a dressing that may be associated with an example embodiment of the therapy system of Figure 1;
[0024] Figure 5 is a top plan view of the dressing of Figure 4, illustrating additional details that may be associated with some examples;
[0025] Figure 6 is an isometric view of the example dressing of Figure 4 in an assembled state, in an exemplary rolled configuration, illustrating additional details that may be associated with some examples;
[0026] Figure 7 is an isometric view illustrating the example dressing of Figure 4 in an exemplary usage configuration and applied to a treatment site, which may be a leg of a patient;
[0027] Figure 8 is an isometric view of another example embodiment of a dressing that may be associated with an example embodiment of the therapy system of Figure 1, in an exemplary rolled configuration;
[0028] Figure 9 is a top plan view of the example dressing of Figure 8 in an exemplary usage configuration in place on an exemplary treatment site, illustrating additional details that may be associated with some examples; [0029] Figure 10 is an isometric view of yet another example embodiment of a dressing that may be associated with an example embodiment of the therapy system of Figure 1;
[0030] Figure 11 is an isometric view of the example dressing of Figure 10 in an exemplary rolled configuration, illustrating additional details that may be associated with some examples; and
[0031] Figure 12 is atop plan view of the example dressing of Figure 10 in an exemplary usage configuration in place on an exemplary treatment site, illustrating additional details that may be associated with some examples.
DESCRIPTION OF EXAMPLE EMBODIMENTS
[0032] The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and non-limiting.
[0033] Figure 1 is a block diagram of an example embodiment of a therapy system 100 that can provide reduced-pressure therapy to a tissue site in accordance with this specification. The term “tissue site” in this context may refer 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, grafts, and incisions, for example. The term “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.
[0034] The therapy system 100 may include a source or supply of reduced pressure, such as a reduced-pressure source 105, a dressing 110, a fluid container, such as a container 115, and a regulator or controller, such as a controller 120, for example. Additionally, the therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 120 indicative ofthe operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include one or more sensors coupled to the controller 120, such as a first sensor 125 and a second sensor 130. As illustrated in the example of Figure 1, the dressing 110 may include a tissue interface 135, a cover 140, or both in some embodiments.
[0035] 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. For example, in some embodiments, the reduced-pressure source 105 may be combined with the controller 120 and other components into a therapy unit. [0036] In general, components of the therapy system 100 may be coupled directly or indirectly. For example, the reduced-pressure source 105 may be directly coupled to the container 115, and may be indirectly coupled to the dressing 110 through the container 115. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts. For example, the reduced-pressure source 105 may be electrically coupled to the controller 120, and may be fluidly coupled to one or more distribution components to provide a fluid path to a tissue site. In some embodiments, 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.
[0037] A distribution component may be detachable, and may be disposable, reusable, or recyclable. The dressing 110 and the container 115 are illustrative of distribution components. A fluid conductor is another illustrative example of a distribution component. A “fluid conductor,” in this context, may include a tube, pipe, hose, conduit, or other structure with one or more lumina or open pathways adapted to convey a fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary. Moreover, some fluid conductors may be molded into or otherwise integrally combined with other components. Distribution components may also include interfaces or fluid ports to facilitate coupling and de-coupling other components. In some embodiments, for example, a dressing interface may facilitate coupling a fluid conductor to the dressing 110. For example, such a dressing interface may be a SENSAT.R.A.C.™ Pad available from KCI of San Antonio, Texas.
[0038] A reduced-pressure supply, such as the reduced-pressure source 105, may be a reservoir of air at a reduced 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” or “reduced 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. Further, 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 reduced pressure may refer to a decrease in absolute pressure, while decreases in reduced pressure may refer to an increase in absolute pressure. While the amount and nature of reduced pressure applied to a tissue site 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).
[0039] The container 115 is representative of a container, canister, pouch, or other storage component, which can be used to manage exudates and other fluids withdrawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with reduced-pressure therapy.
[0040] A controller, such as the controller 120, may be a microprocessor or computer programmed to operate one or more components of the therapy system 100, such as the reduced- pressure source 105. In some embodiments, for example, the controller 120 may be a microcontroller, which may include 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 reduced-pressure source 105, the pressure generated by the reduced-pressure source 105, or the pressure distributed to the tissue interface 135, for example. The controller 120 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.
[0041] Sensors, such as the first sensor 125 and the second sensor 130, may be 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. For example, the first sensor 125 and the second sensor 130 may be configured to measure one or more operating parameters of the therapy system 100. In some embodiments, the first sensor 125 may be a transducer configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured. In some embodiments, for example, the first sensor 125 may be a piezoresistive strain gauge. The second sensor 130 may optionally measure operating parameters of the reduced- pressure source 105, such as the voltage or current, in some embodiments. Signals from the first sensor 125 and the second sensor 130 may be suitable as an input signal to the controller 120, but some signal conditioning may be appropriate in some embodiments. For example, the signal may need to be filtered or amplified before it can be processed by the controller 120. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
[0042] The tissue interface 135 can be adapted to partially or fully contact a tissue site. The tissue interface 135 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. For example, the size and shape of the tissue interface 135 may be adapted to the contours of deep and irregular shaped tissue sites. Moreover, any or all of the surfaces of the tissue interface 135 may have projections or an uneven, course, or jagged profile that can induce strains and stresses on a tissue site, which can promote granulation at the tissue site.
[0043] In some embodiments, the tissue interface 135 may be a manifold or may include a manifold and additional layers, such as a tissue contact layer, depending on the desired treatment. A “manifold” in this context may include any substance or structure providing a plurality of pathways adapted to collect or distribute fluid relative to a tissue. For example, a manifold may be adapted to receive reduced pressure from a source and distribute reduced pressure through multiple apertures to or from a tissue site, which may have the effect of collecting fluid from a tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivering or moving fluid relative to a tissue site.
[0044] In some illustrative embodiments, the pathways of a manifold may be interconnected to improve distribution or collection of fluids at a tissue site. In some illustrative embodiments, a manifold may be a porous foam material having interconnected cells or pores. For example, open-cell foam, porous tissue collections, and other porous material such as gauze or felted mat generally include pores, edges, and/or walls adapted to form interconnected fluid channels. Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways. In some embodiments, a manifold may additionally or alternatively include projections that form interconnected fluid pathways. For example, a manifold may be molded to provide surface projections that define interconnected fluid pathways.
[0045] The average pore size of foam may vary according to needs of a prescribed therapy. For example, in some embodiments, the tissue interface 135 may be foam having pore sizes in a range of 400-600 microns. The tensile strength of the tissue interface 135 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. In some examples, the tissue interface 135 may be reticulated polyurethane foam such as found in GRANUFOAM™ dressing or V.A.C. VERAFLO™ dressing, both available from KCI of San Antonio, Texas.
[0046] The thickness of the tissue interface 135 may also vary according to needs of a prescribed therapy. For example, the thickness of the tissue interface 135 may be decreased to reduce tension on peripheral tissue. The thickness of the tissue interface 135 may also affect the conformability of the tissue interface 135. In some embodiments, a thickness in a range of about 5-10 millimeters may be suitable.
[0047] The tissue interface 135 may be either hydrophobic or hydrophilic. In an example in which the tissue interface 135 may be hydrophilic, the tissue interface 135 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 135 may draw fluid away from a tissue site by capillary flow or other wicking mechanisms. An example of hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WHITEFOAM™ dressing available from KCI 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.
[0048] The tissue interface 135 may further promote granulation at a tissue site when pressure within the sealed therapeutic environment is reduced. For example, any or all of the surfaces of the tissue interface 135 may have an uneven, coarse, or jagged profile that can induce microstrain and stress at a tissue site if negative pressure is applied through the tissue interface 135.
[0049] In some embodiments, the tissue interface 135 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 135 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 135 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.
[0050] In some embodiments, the cover 140 may provide a bacterial barrier and protection from physical trauma. The cover 140 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. For example, the cover 140 may comprise or consist essentially of an elastomeric film or membrane that can provide a seal adequate to maintain a reduced pressure at a tissue site for a given reduced-pressure source. In some example embodiments, the cover 140 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. The cover 140 may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least 250 g/mA2 per twenty- four hours in some embodiments (based on ASTM E96/E96M for upright cup measurement). Such drapes typically have a thickness in the range of 25-50 microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained. In some embodiments, the cover 140 may form an outer surface of the dressing 110.
[0051] An attachment device may be used to attach the cover 140 to an attachment surface, such as undamaged epidermis, a gasket, or another cover (e.g. at the treatment site). The attachment device may take many forms. For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive configured to bond the cover 140 to epidermis around a tissue site. In some embodiments, for example, some or all of the cover 140 may be coated with an adhesive, such as an acrylic adhesive, which may have a coating weight between 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.
[0052] Figure 2 is a graph illustrating additional details of an example control mode that may be associated with some embodiments of the controller 120. In some embodiments, the controller 120 may have a continuous pressure mode, in which the reduced-pressure source 105 is operated to provide a constant target reduced pressure, as indicated by line 205 and line 210, for the duration of treatment or until manually deactivated. Additionally or alternatively, the controller may have an intermittent pressure mode, as illustrated in the example of Figure 2. In Figure 2, the x-axis represents time, and the y-axis represents reduced pressure generated by the reduced-pressure source 105 over time. In the example of Figure 2, the controller 120 can operate the reduced-pressure source 105 to cycle between a target pressure and atmospheric pressure. For example, the target pressure may be set at a value of 125 mmHg, as indicated by line 205, for a specified period of time (e.g., 5 min), followed by a specified period of time (e.g., 2 min) of deactivation, as indicated by the gap between the solid lines 215 and 220. The cycle can be repeated by activating the reduced-pressure source 105, as indicated by line 220, which can form a square wave pattern between the target pressure and atmospheric pressure.
[0053] In some example embodiments, the increase in reduced-pressure from ambient pressure to the target pressure may not be instantaneous. For example, the reduced-pressure source 105 and the dressing 110 may have an initial rise time, as indicated by the dashed line 225. The initial rise time may vary depending on the type of dressing and therapy equipment being used. For example, the initial rise time for one therapy system may be in a range of about 20-30 mmHg/second and in a range of about 5-10 mmHg/second for another therapy system. If the therapy system 100 is operating in an intermittent mode, the repeating rise time as indicated by the solid line 220 may be a value substantially equal to the initial rise time as indicated by the dashed line 225.
[0054] Figure 3 is a graph illustrating additional details that may be associated with another example pressure control mode in some embodiments of the therapy system 100. In Figure 3, the x- axis represents time and the y-axis represents negative pressure generated by the reduced-pressure source 105. The target pressure in the example of Figure 3 can vary with time in a dynamic pressure mode . For example, the target pressure may vary in the form of a triangular waveform, varying between a minimum and maximum reduced pressure of 50-125 mmHg with a rise time 305 set at a rate of +25 mmHg/min. and a descent time 310 set at -25 mmHg/min, respectively. In other embodiments of the therapy system 100, the triangular waveform may vary between reduced pressure of 25-125 mmHg with a rise time 305 set at a rate of +30 mmHg/min and a descent time 310 set at -30 mmHg/min.
[0055] In some embodiments, the controller 120 may control or determine a variable target pressure in a dynamic pressure mode, and the variable target pressure may vary between a maximum and minimum pressure value that may be set as an input prescribed by an operator as the range of desired reduced pressure. The variable target pressure may also be processed and controlled by the controller 120, which can vary the target pressure according to a predetermined waveform, such as a triangular waveform, a sine waveform, or a saw-tooth waveform. In some embodiments, the waveform may be set by an operator as the predetermined or time-varying reduced pressure desired for therapy.
[0056] Referring to Figures 4-7, the dressing 110 may include features that can treat a tissue site at an extremity of a patient, such as a leg, arm, ankle, wrist, or parts thereof, and an area of tissue around the tissue/treatment site and the extremity. For example, the tissue site may be an incision or other treatment target on one or both sides of a leg or ankle on a patient. The dressing 110 may be configured to treat not only the incision or treatment target, but also, an area of tissue around the incision or treatment target, the leg, and the ankle as desired.
[0057] Referring more specifically to Figures 4-7, in some examples, the dressing 110 may include an attachment device 404, a manifold 406, and the cover 140. Some examples of the attachment device 404 and other components may include a treatment aperture 408, and the manifold 406 may be configured to be fluidly coupled to a treatment site through the treatment aperture 408 (e.g. with the manifold 406 disposed over the treatment aperture 408). Further, in some examples, the dressing 110 may optionally include an adhesive ring 410 that may be configured to bond a peripheral portion of the manifold 406 to a portion of the attachment device 404. In some examples, the adhesive ring 410 may be formed as part of the attachment device 404, or the adhesive ring 410 may be omitted with the attachment device 404 instead being coupled to the manifold 406 and/or cover 140 with another medically acceptable coupling apparatus. In some examples, the cover 140, the manifold 406, the optional adhesive ring 410, and the attachment device 404 may have similar shapes. The attachment device 404 may be slightly larger than the manifold 406 to permit coupling of the attachment device 404 to the cover 140 around the manifold 406. In some examples, an adhesive may be disposed on a portion of the manifold 406 exposed through the treatment aperture 408. In some embodiments, the adhesive may be pattern-coated, and may cover up to 50% of the exposed portion or surface of the manifold 406.
[0058] The cover 140, the manifold 406, the attachment device 404, or various combinations may be assembled before application or at a treatment site. In some embodiments, the dressing 110 may be provided as a single unit.
[0059] The manifold 406 may include a first surface 412 and an opposing second surface 414. In some examples, at least a portion of the second surface 414, for example the tissue-facing surface, of the manifold 406 may be configured to face the treatment site through the treatment aperture 408. In some examples, the attachment device 404 may be positioned on or at a portion of the second surface 414 of the manifold 406. In some examples, the manifold 406 may include or be formed of a porous material, such as foam.
[0060] In some examples, the attachment device 404 may be configured to create a sealed space between the cover 140 and the treatment site, and the manifold 406 may be configured to be positioned in the sealed space. For example, the attachment device 404 may be positioned around an edge 416 of the manifold 406 and configured to surround the treatment site. The cover 140 may be disposed over the manifold 406 and coupled to the attachment device 404 around the manifold 406. For example, the cover 140 may be coupled to a portion of the attachment device 404 extending outward from the edge 416 of the manifold 406. Further, the cover 140 may be larger than the manifold 406, as illustrated in the example of Figure 4, and may have a perimeter or a flange 418 configured to be attached to the attachment device 404. Assembled, the cover 140 may be disposed over the first surface 412 (e.g. the outward-facing surface) of the manifold 406, and the flange 418 may be attached to the attachment device 404 around the manifold 406. For example, an adhesive may be used to adhere the flange 418 to the attachment device 404, or the flange 418 may be, without limitation, welded, stitched, or stapled to the attachment device 404. In some embodiments, the attachment device may comprise an adhesive applied to the flange 418 and configured to allow attachment of the flange 418 to the treatment site. The cover 140 may also include a port 420 configured to allow fluid communication between the manifold 404 and a dressing interface 422 and/or a fluid conductor 424 (e.g. to apply negative pressure under the cover) as described herein.
[0061] The attachment device 404 may take many forms. In some examples, the attachment device 404 may include or be formed of a film or membrane that can provide a seal in a therapeutic reduced-pressure environment. In some example embodiments, the attachment device 404 may be a polymer film, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. The attachment device 404 may have a thickness in the range of 25-50 microns. For permeable materials, the permeability may be low enough that a desired reduced pressure may be maintained. In some embodiments, the attachment device 404 may comprise a medically-acceptable adhesive, such as a pressure-sensitive adhesive. In examples, the attachment device 404 may be a polymer film coated with an adhesive, such as an acrylic adhesive, which may have a coating weight between 25-65 grams per square meter (g.s.m.). Thicker adhesives, or combinations of adhesives, may be applied in some examples to improve the seal and reduce leaks.
[0062] In some examples, the attachment device 404 may include or be formed of a hydrocolloid. In some examples, the attachment device 404 may be configured or referred to as a sealing ring or a gasket member. In other examples, the dressing 110 may include a gasket member (not shown) in addition to the attachment device 404. In such an example, the gasket member may be a peripheral member, such as a hydrocolloid ring, and at least a portion of the attachment device 404 may be positioned between the manifold 406 and the gasket member on or at a surface of the manifold 406, such as the second surface 414, configured to face the area of tissue around the extremity. In some examples, the gasket member may have a similar or analogous shape as the adhesive ring 410, but the gasket member may be positioned on a surface of the attachment device 404 configured to face the extremity such that the gasket member is configured to be positioned between the extremity and the attachment device 404.
[0063] In some examples, the dressing 110 may optionally further include a tissue contact layer 425, which may be coupled to a surface of the manifold 406, such as the second surface 414, and may be configured to be exposed to the treatment site. In some embodiments, the tissue contact layer 425 may be configured to be positioned in direct contact with the treatment site, for example forming a tissue-contact surface. In other embodiments (e.g. without a tissue-contact layer), the tissue-contact surface may be formed by the manifold and/or the attachment device. The tissue contact layer 425 may include or be formed of a material that substantially reduces or eliminates skin irritation while allowing fluid transfer through the tissue contact layer. In some embodiments, the tissue contact layer 425 may form a fluid control layer, configured to allow fluid communication between the treatment site and the manifold during reduced-pressure therapy, while minimizing backflow of fluids (such as exudate) from the manifold to the treatment site (e.g. to minimize maceration). In some examples, the tissue contact layer 425 may include or be formed of one or more of the following materials, without limitation: a woven material, a non-woven material, a polyester knit material, and a fenestrated fdm.
[0064] In some examples, the attachment device 404, which may comprise an adhesive on a surface of the dressing 110 configured to face the treatment site (e.g. on the tissue-contact surface), may be covered by one or more release liners 428 prior to applying the dressing 110 at the treatment site. For example, as shown in Figure 4, the dressing 110 may include a first release liner 428a, a second release liner 428b, and a third release liner 428c. The first release liner 428a may be positioned proximate to a first side 430 of the manifold 406 or the dressing 110, the second release liner 428b may be positioned proximate to a second side 432 of the manifold 406 or the dressing 110 (e.g. with the first side 430 and the second side 432 opposite each other across a line of symmetry), and the third release liner 428c may be positioned proximate to a fold axis or line or symmetry 434 of the manifold 406 or the dressing 110 (e.g. spanning a central portion of the manifold and/or dressing). The central portion with the line of symmetry 434 may be located between the first side 430 and the second side 432, and the third release liner 428c may be positioned between the first release liner 428a and the second release liner 428b. In some examples, the third release liner 428c may be configured to be removed to expose an adhesive or portion of the attachment device 404 proximate to the line of symmetry 434 prior to removal of the first release liner 428a and the second release liner 428b. Such a configuration may permit the central portion of the dressing 110 (e.g. in proximity to the line of symmetry 434) to be initially positioned or aligned at a treatment site, such as the extremity, while the first release liner 428a and the second release liner 428b protect other portions of the adhesive or the attachment device 404. For example, a portion of the third release liner 428c may cover or be positioned over a portion of the first release liner 428a and/or the second release liner 428b such that the third release liner 428c may be removed prior to removal of the first release liner 428a and the second release liner 428b. In some examples, the dressing 110 may have two release liners, each of which may have perforations or slits (not shown here) configured to allow the release liners to be separated into smaller pieces for removal. Additionally, some embodiments may also have one or more casting sheet liners 436.
[0065] Additionally or alternatively, the first release liner 428a, the second release liner 428b, and the third release liner 428c may provide stiffness to the attachment device 404 to facilitate handling and application. Additionally or alternatively, the casting sheet liners 436 may cover the flange 418 to provide stiffness to the cover 140 for handling and application. The one or more release liner 428 may be configured to releasably cover the attachment device 404, for example to protect and maintain the adhesive of the attachment device 404 until the time of application of the dressing 110 to the treatment site.
[0066] In some examples, the dressing 110 may include the dressing interface 422, which may be fluidly coupled to the manifold 406 through the port 420 in the cover 140. In some embodiments, the dressing interface 422 may be coupled in the central portion of the manifold 406 (e.g. in proximity to the line of symmetry 434), and may be configured to be coupled to the reduced-pressure source through, for example, the fluid conductor 424, conduit, or tube coupled in fluid communication between the dressing interface 422 and the reduced pressure source 105.
[0067] Figure 5 is a top view of an example of the dressing 110, illustrating additional details that may be associated with some embodiments. In the example embodiment of Figure 5, the dressing 110 may include features that can cover articulating joints, such as a knee, while still allowing for significant range of motion. For example, the dressing 110 of Figure 5 may generally comprise a manifold 406 having a stem 450, a first arm 515 joined to a first end of the stem 510, and a second arm 520 joined to a second end of the stem 510.
[0068] In some embodiments, the manifold 406 may be characterized as a polyhedron or as a generalized cylinder. For example, in Figure 5 the manifold 406 can be characterized as a generalized cylinder having a first surface 412 and an edge 416. The edge 416 in Figure 5 bounds the stem 510, the first arm 515, and the second arm 520. In some embodiments, some portions of the edge 416 may be curved, and some portions may be straight. In Figure 5, for example, the first arm 515 is bounded in part by a first edge portion 535 that is substantially straight, and the second arm 520 is bounded in part by a second edge portion 540 that is substantially straight. In other embodiments, the first arm 515, the second arm 520, or both may be contoured at the extremities.
[0069] The stem 510 is generally configured to be positioned over an articular surface. The width of the stem 510 may vary for different types of joints, and may be limited to minimize interference with articulation. For example, in some embodiments, the stem 510 may be configured for positioning over a patella and have a width of 2-4 inches. In other examples, a width of 1-3 inches may be suitable for positioning over an olecranon.
[0070] As illustrated in the example of Figure 5, the first arm 515 and the second arm 520 may flare away from the stem 510. In some embodiments, the width of the first arm 515 and the second arm 520 may each be greater than the width of the stem 510. In some examples, the face of the first surface 412 may be biconcave. More generally, portions of the edge 416 bounding the first arm 515 and the second arm 520 may converge toward the stem 510 to define a concave void adjacent to each side of the stem 510. In the example of Figure 5, the concave void is curved. In other examples, the edge 416 may have straight segments that converge toward a vertex at the stem 510.
[0071] Some embodiments of the manifold 406 may additionally be characterized by a line of symmetry 434 (which may be a longitudinal centerline, in some examples) through the stem 510, and each of the first arm 515 and the second arm 520 may be characterized by a span that is generally orthogonal to the line of symmetry 434. In the example of Figure 5, a first span 550 between extremities 555 is characteristic of the first arm 515, and a second span 560 between extremities 565 is characteristic of the second arm 520.
[0072] In the example of Figure 5, the first span 550 is greater than the second span 560. A suitable ratio of the span of the first span 550 to the second span 560 may generally be in a range of 1.2 to 3.4. A ratio of 1.2 to 1.6 may be particularly advantageous for some applications. For example, in some embodiments the first span 550 may be in a range of 30-65 centimeters and the second span 560 may be in a range of 20-45 centimeters. In other examples, the first span 550 may be in a range of 15- 50 centimeters and the second span 560 may be in a range of 8-25 centimeters.
[0073] In some embodiments, each arm (e.g. first arm 515 and second arm 520) may comprise two wing portions 580, one on each side of the line of symmetry 434 and extending outward away from the line of symmetry 434. In some embodiments, each of the wing portions 580 may extend away from the line of symmetry 434 in a direction substantially perpendicular to the line of symmetry 434. In Figure 5, there are four wing portions: a first wing portion 580a, a second wing portion 580b, a third wing portion 580c, and a fourth wing portion 580d. For example, the first wing portion 580a and the second wing portion 580b may be symmetrical across the line of symmetry 434 and may jointly form the second arm 520; and the third wing portion 580c and the fourth wing portion 580d may be symmetrical across the line of symmetry 434 and may jointly form the first arm 515. In some embodiments, the first release liner 428a may cover the wing portions 580 on one side of the line of symmetry 434, and the second release liner 428b may cover the wing portions 580 on the other side of the line of symmetry 434. In some embodiments, a separate release liner may cover each wing portion 580 (which may allow the attachment device 404 on each wing portion 580 to be independently exposed), or a perforation line (not shown here) in the release liner 428 may allow exposure of the attachment device 404 on each wing portion 580 independently. In some embodiments, a central portion of the manifold or dressing may extend along the line of symmetry 434, and the wing portions 580 may extend outward (e.g. substantially perpendicularly) from the central portion. The central portion may, for example, span the center of the first arm 515, the second arm 520, and the stem 510. In some embodiments, the third release liner 428c may cover the attachment device on the central portion.
[0074] In some embodiments, one or more retaining device 582 may be configured to releasably retain the wing portions 580 in a rolled configuration. For example, the one or more retaining device 582 may comprise a low-tack adhesive configured to releasably couple each of the wing portions 580 to the central portion (e.g. in proximity to the line of symmetry 434). In some embodiments, the one or more retaining device 582 may be located on the cover 140 and/or the outer surface of the dressing 110. In some embodiments, the one or more retaining device 582 may comprise a separate retaining device for each wing portion 580, which may be located in proximity to the line of symmetry 434. In other embodiments, the one or more retaining device 582 may comprise a continuous line or area of low-tack adhesive extending substantially the length of the line of symmetry 434. In some embodiments, the retaining device 582 may be configured to be removable (e.g. once the wing portions 580 are unrolled into a usage configuration). For example, the one or more retaining device 582 may be configured so that, once the wing portions 580 are no longer retained, the retaining device 582 may be removed from the cover 140 without damaging the cover 140. [0075] In some embodiments, a fluid conductor 424 may be coupled to the dressing 110. As illustrated in Figure 5, the fluid conductor 424 may be coupled to the first arm 515, for example in the central portion (e.g. in proximity to the line of symmetry). Figure 5 also illustrates an example of a dressing interface 422 that may be used to facilitate fluidly coupling the fluid conductor 424 to the manifold 406.
[0076] Some dressing 110 embodiments may comprise two configurations: a rolled configuration and a usage (e.g. unrolled) configuration. For example, the dressing 110 may be configured to be positionable in a rolled configuration and a usage configuration. In some embodiments, the rolled configuration may have a smaller footprint than the usage configuration. For example, the rolled configuration may have a footprint that is about % - ½ the size of the usage configuration. In some embodiments, when the dressing 110 is in the rolled configuration, at least a portion of the dressing 110 may be rolled, for example to reduce the size of the footprint of the dressing 110. In some embodiments, footprint may mean a surface area occupied by the dressing. In some embodiments, the rolled configuration may include at least a rolled portion of the dressing 110. In some embodiments, the rolled configuration may comprise one or more rolls formed from at least a portion of the dressing 110. In some embodiments, each roll or rolled portion may comprise a roll axis, with at least a portion of the dressing 110 wrapped around, rolled around, positioned about, and/or encircling the roll axis. For example, the rolled configuration may comprise one or more roll axis, with at least a portion of the dressing 110 rolled around each such roll axis. In some embodiments, in the rolled configuration a first portion of the dressing 110 may be located in a plane above the roll axis, and a second portion of the dressing 110 may be located in a plane below the roll axis. For example, the dressing 110 in the rolled configuration may include a bend (e.g. around the roll axis), so that the first portion of the dressing may be located in a plane above the second portion of the dressing 110 (e.g. with the roll axis therebetween). In some embodiments, in the rolled configuration the attachment device 404 of the first portion may bend to extend over the cover and/or manifold of the second portion (e.g. with the attachment device 404 bending to be located above and below the manifold and/or cover in one or more portions of the dressing due to the roll configuration). In some embodiments, in the rolled configuration the dressing 110 may be configured with at least one roll (e.g. at least one rolled portion). In the usage configuration, the dressing 110 may be configured for use on the treatment site. For example, the dressing 110 may be substantially unrolled (e.g. so that portions of the dressing do not roll around the roll axis) and/or flat in the usage configuration.
[0077] Figure 6 is an isometric view of the dressing 110 of Figures 4-5 in an exemplary rolled configuration, illustrating additional details that may be associated with some examples. As shown in Figure 6, in the rolled configuration, the central portion may not be rolled (e.g. may be substantially flat), and each of the wing portions 580 may be rolled. For example each wing portion 580 may roll inward towards the line of symmetry 434 and/or the central portion. In some embodiments, each wing portion 580 may be rolled around a roll axis 605, and each roll axis 605 may be substantially parallel to the line of symmetry 434. In some embodiments, the rolled wing portions 580 may lie atop the central portion in the rolled configuration, for example with the roll axis 605 for each of the wing portions 580 in a plane above the central portion. In the rolled configuration, the rolled wing portions 580 may be configured with the cover 140 or outer surface facing inward (e.g. towards the roll axis 605), in some embodiments, and the release liner 428 facing outward. In some embodiments, each wing portion 580 may be rolled around a removable roll spacer (not shown here). For example, a cylindrical removable roll spacer may define the roll axis 605 for each rolled wing portion in the rolled configuration (e.g. with the central axis of the removable roll spacer corresponding to the roll axis 605 for the rolled wing portion 580), with each wing portion 580 rolled around, enwrapping, positioned about, and/or encircling the corresponding removable roll spacer.
[0078] In some embodiments, the rolled configuration (e.g. the roll of each wing portion 580 about a roll axis 605) may be retained by the one or more retaining device 582. For example, the one or more retaining device 582 may releasably couple the release liner 428 of each rolled wing portion 580 to the cover 140 of the central portion (e.g. in proximity to the line of symmetry 434). In other embodiments, the rolled configuration (e.g. the roll of each wing portion 580 about a roll axis 605) may be retained due to the material forming the wing portion 580 being manufactured to take a set which biases each wing portion 580 towards the rolled configuration. In such embodiments, each wing portion 580 may naturally retain its roll shape until unrolled and adhered into place on the treatment site.
[0079] Figure 7 illustrates the dressing 110 of Figure 4 in an exemplary usage configuration and applied (e.g. unrolled and adhered) to an incision (not shown) on an exemplary treatment site (which may be an articulating joint, for example). In the example of Figure 7, the articulating joint is a knee 705. As illustrated in the example of Figure 7, the stem 510 may substantially cover the top ofthe knee 705. The manifold 406 is preferably oriented so that the first arm 515 and the fluid conductor 424 are superior to the knee 705. The first arm 515 may cover and wrap around a portion of the leg superior to the knee 705, and the second arm 520 may cover and wrap around a portion of the leg inferior to the knee 705. In some embodiments, one or more of the first arm 515 and the second arm 520 may be cut to reduce the first span 550, the second span 560, or both. For example, an extension portion (e.g. a border) of the first arm 515, the second arm 520, or both may be cut so that the first arm 515 and the second arm 520 can fully wrap a portion of the leg superior and inferior to the knee 705, respectively. In the usage configuration, each of the wing portions 580 may be substantially unrolled from the roll axis and/or removable roll spacer, so that the tissue-contact surface may be located in proximity (e.g. contact) with the treatment site (for example, after removal of the release liners to expose the attachment device for affixing the dressing 110 in place on the treatment site). In the usage configuration, when the dressing 110 is in place on the treatment site, the manifold 406 may be in fluid communication with the treatment site, and the cover and the attachment device may form a seal to allow reduced-pressure therapy to the treatment site through the manifold 406. [0080] In application, exemplary methods for applying a rolled dressing (for example, similar to that in Figures 4-7) to a treatment site may comprise: providing the dressing in a rolled configuration, with a plurality of wing portions each rolled towards a central portion; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; for each wing portion, removing a corresponding release liner; for each wing portion, releasing the wing portion from the rolled configuration; for each wing portion, unrolling the wing portion to a usage configuration; for each wing portion, coupling the wing portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing. In some embodiments, releasing the wing portion from the rolled configuration may comprise uncoupling a retaining device. Some embodiments may further comprise removing the retaining device from the outer surface and/or cover of the dressing. In some embodiments, in the rolled configuration each wing portion may be rolled around a removable roll spacer, and the method may further comprise removing and/or discarding the removable roll spacer after each wing portion has been unrolled to the usage configuration. In some embodiments, when each wing portion has been released and/or unrolled and before each wing portion has been coupled to the treatment site, each wing portion may have a set which substantially holds the wing portion off of the treatment site (e.g. creating stand-off) until pressed firmly down and coupled (e.g. via adhesive of the attachment device) to the treatment site. In some embodiments, the dressing positioning (e.g. of the wings) may be repositionable, to allow the user to fine tune the application of the dressing to the treatment site. Some embodiments may further comprise removing the dressing, in the rolled configuration, from a box sized to correspond to the dressing in the rolled configuration (e.g. a box sized with an interior footprint that is smaller than the footprint of the dressing in the unrolled, usage configuration, but at least as large as the footprint of the dressing in the rolled configuration). In some embodiments, after unrolling the dressing, the dressing may not be degraded from having been in the rolled configuration (even if the dressing has been retained in the rolled configuration for a plurality of years).
[0081] Methods of manufacturing or positioning a dressing (for example, as shown in Figures 4-7) into a rolled configuration may comprise: providing the dressing comprising a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion; rolling each of the wing portions inward towards the line of symmetry to form a rolled configuration; and/or removably securing each of the wing portions in the rolled configuration with a retaining device. In some embodiments, in the rolled configuration the central portion of the dressing may be unrolled and/or substantially flat. Some embodiments may further comprise providing a removable roll spacer for each of the wing portions, wherein rolling each of the wing portions may comprise rolling each of the wing portions around the corresponding removable roll spacer. In some embodiments, securing each of the wing portions in the rolled configuration may comprise removably adhering each of the wing portions to the central portion. In some embodiments, the attachment device may comprise an adhesive located on the central portion and each of the wing portions, and the method may further comprise covering the adhesive of the central portion with a first release liner, and covering the adhesive of each of the wing portions with a corresponding release liner. Some embodiments may further comprise the step of introducing a set to the material of the dressing (e.g. to the wing portions), for example biasing the dressing (e.g. wing portion) towards the rolled position. In some embodiments, the dressing in the rolled configuration may be packaged within a pouch or a container (e.g. box) that is sufficiently rigid, structural, and/or protective to prevent the dressing in the rolled configuration (e.g. the rolls) from being crushed (e.g. flattened).
[0082] Some embodiments may further comprise placing the rolled dressing (e.g. in the rolled configuration) in a box, wherein the box is sized to receive the dressing in the rolled configuration. In some embodiments, the dressing in the rolled configuration may have a first (e.g. reduced) footprint that is substantially smaller than (e .g . % - ½ the size of) a second (e.g. unrolled) footprint of the dressing when in the usage configuration. Some embodiments may further comprise selecting and/or providing the box having an interior footprint that is at least as large as the first footprint and smaller than the second footprint. Some embodiments may further comprise storing the dressing in the rolled configuration (e.g. within the box) for up to a plurality of years (for example, up to 4 or 5 years). In some embodiments, storing the dressing in the rolled configuration for a plurality of years may not substantially degrade the dressing when it is unrolled for usage on a tissue site for negative-pressure therapy. In some embodiments, providing the dressing may comprise selecting a manifold for the dressing which is configured to not degrade (e.g. with respect to size, shape, and/or manifolding capabilities) when stored in the rolled configuration for a plurality of years.
[0083] Figures 8-9 illustrate an alternative dressing 110 embodiment, having a different shape and/or rolled configuration. In some embodiments, the dressing 110 of Figure 8 may have layers similar to those described with respect to Figure 4 (e.g. an attachment device, a manifold, and a cover). In some embodiments, the dressing 110 may comprise a manifold 406 that is elongate, with the length greater than the width. The dressing 110 and/or manifold may include a longitudinal centerline 810. In some embodiments, the manifold 406 may have a substantially uniform width and/or thickness. In some embodiments, two or more portions 805 of the cover may extend beyond the manifold 406, for example with a first portion 805a extending laterally beyond the manifold 406 on one side of the longitudinal centerline 810, and a second portion 805b extending laterally beyond the manifold on the opposite side of the longitudinal centerline 810. In some embodiments, the first portion 805a and the second portion 805b may be symmetrical across the longitudinal centerline 810.
[0084] Figure 8 illustrates the dressing 110 in an exemplary rolled configuration. As shown in Figure 8, in the rolled configuration, the manifold 406 may not be rolled (e.g. the manifold may form a central portion that may be unrolled and/or substantially flat), and each of the two or more portions 805 of the cover extending beyond the manifold may be rolled. For example, the first portion 805a may be rolled with a roll axis 605a substantially parallel to the longitudinal centerline 810 of the manifold 406, and the second portion 805b may be rolled with a roll axis 605b substantially parallel to the longitudinal centerline 810. In some embodiments, each portion 805 extending beyond the manifold may be rolled inward towards the manifold 406 and/or the longitudinal centerline 810. In some embodiments, in the rolled configuration the outer surface (e.g. cover 140) of the dressing 110 for the rolled portions may face inward. In some embodiments, in the rolled configuration the release liner for the rolled portions 805 may face outward. In some embodiments, the rolled portions 805 may lie atop the tissue-contact surface in proximity to the manifold 406 in the rolled configuration (e.g. the rolled portions 805 may not extend downward substantially below the manifold 406 in the rolled configuration). In some embodiments, each of the portions 805 extending beyond the manifold (e.g. on either side of the longitudinal centerline 810) may be rolled around, enwrap, and/or encircle a removable roll spacer (not shown here). In some embodiments, each removable roll spacer may be cylindrical and/or may have a length approximately equal to the length of the manifold 406. In some embodiments, the ends of the rolled portions 805 of the cover (e.g. that extend longitudinally beyond the manifold) may be folded. For example, the ends may be folded inward longitudinally, so that the roll axis 605 for each of the rolled portions 805 may be folded over on top of itself.
[0085] The dressing 110 may further comprise the retaining device 582, configured to retain the dressing 110 in the rolled configuration. In the rolled configuration, each rolled portion 805 may be releasably retained in the rolled configuration. In some embodiments, the retaining device 582 may comprise tape and/or low-tack adhesive, which may couple the rolled portions 805 to the manifold 406 and/or central portion and/or may retain the folded ends in the folded position. For example, the folded ends of each rolled portion 805 may be coupled to the remainder of the rolled portion (e.g. the roll retaining device may comprise a fold retaining device 814, that then inherently retains the rolls).
[0086] In some embodiments, the attachment device may span the manifold 406 and each of the at least two portions 805 extending beyond the manifold. In some embodiments, a first of the at least two release liners may span the manifold 406 and/or cover the attachment device underlying the manifold 406 (e.g. the central portion), and each of the two or more portions 805 extending beyond the manifold may be spanned and/or covered by another of the at least two release liners. In some embodiments, a release liner may cover the portion of the cover extending beyond the manifold laterally on either side of the manifold (e.g. on either side of the longitudinal centerline 810), and a release liner may cover the portion of the cover extending beyond the manifold longitudinally at either end. Some embodiments may comprise three release liners, five release liners, or 3-5 release liners, for example depending on the specific dressing configuration. Some embodiments may not comprise a release liner, but for example may couple the dressing in place using tape or other such separate attachment device. In some embodiments, the port and/or dressing interface 422 may couple to the cover in proximity to the manifold 406 (e.g. atop the manifold 406 in the central portion of the dressing 110 and/or in proximity to the longitudinal centerline). [0087] Figure 9 is a plan view illustrating the dressing 110 of Figure 8 in an exemplary usage configuration and in place on an exemplary treatment site. For example, each of the portions 805 of the cover beyond the manifold may be unrolled in the usage configuration, so that the tissue-contact surface may be located in proximity with the treatment site. The fluid conductor 424 leading from the dressing interface 422 may fluidly couple the dressing 110 to a reduced-pressure source 105.
[0088] In application, some methods for applying a rolled dressing (e.g. similar to that of Figures 8-9) to a treatment site may comprise: providing the dressing in a rolled configuration having an unrolled central portion spanning a manifold and two or more rolled portions of a cover extending beyond the manifold; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; releasing the two or more rolled portions from the rolled configuration; for each rolled portion, removing a corresponding release liner; for each rolled portion, unrolling the rolled portion to the usage configuration; for each rolled portion, coupling the rolled portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing. In some embodiments, releasing the two or more rolled portions from the rolled configuration may comprise uncoupling a retaining device. Some embodiments may further comprise removing the retaining device from the outer surface and/or cover of the dressing. Some embodiments may further comprise removing the dressing, in the rolled configuration, from a box. In some embodiments, after unrolling the dressing, the dressing may not be degraded from having been in the rolled configuration (even if the dressing has been retained in the rolled configuration for a plurality of years).
[0089] Methods of manufacturing and/or positioning a dressing (e.g. similar to that of Figures 8-9) into a rolled configuration may comprise: providing the dressing comprising an attachment device having a treatment aperture, a manifold disposed over the treatment aperture, and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; rolling portions of the cover, which extend laterally beyond the manifold, inward towards the manifold to form a rolled configuration; and/or removably securing the rolled portions of the cover in the rolled configuration using a retaining device. In some embodiments, in the rolled configuration, the manifold may be unrolled and/or substantially flat. Some embodiments may further comprise folding the rolled portions (e.g. to form a fold in each of the rolled portions). In some embodiments, the attachment device may comprises an adhesive located on the manifold and each of the portions of the cover extending laterally beyond the manifold, and the method may further comprise covering the adhesive of the manifold with a release liner, and covering the adhesive of each of the portions of the cover extending laterally beyond the manifold with a corresponding release liner. Some embodiments may further comprise providing a removable roll spacer for each rolled portion, wherein rolling the portions of the cover may comprise rolling each of the portions of the cover around the removable roll spacer. [0090] Some embodiments may further comprise placing the rolled dressing (e.g. in the rolled configuration) in a box, wherein the box is sized to receive the dressing in the rolled configuration. In some embodiments, the dressing in the rolled configuration may have a first (e.g. reduced) footprint that is substantially smaller than (e .g . % - ½ the size of) a second (e.g. unrolled) footprint of the dressing when in the usage configuration. Some embodiments may further comprise selecting and/or providing the box having an interior footprint that is at least as large as the first footprint and smaller than the second footprint. Some embodiments may further comprise storing the dressing in the rolled configuration (e.g. within the box) for up to a plurality of years (for example, up to 4 or 5 years). In some embodiments, storing the dressing in the rolled configuration for a plurality of years may not substantially degrade the dressing when it is unrolled for usage on a tissue site for negative-pressure therapy. In some embodiments, providing the dressing may comprise selecting a manifold for the dressing which is configured to not degrade (e.g. with respect to size, shape, and/or manifolding capabilities) when stored in the rolled configuration for a plurality of years.
[0091] Figures 10-12 illustrate yet another alternate dressing 110 embodiment, which may be similar to Figure 8 in structure (e.g. layers) but may have a different rolled configuration. For example, substantially the entire dressing 110 may roll around a central roll axis in the rolled configuration, and/or in some embodiments the central roll axis may be defined by a removable roll spacer with a removable roll spacer central axis forming the central roll axis about which the dressing 110 may be rolled.
[0092] In Figure 10, the elongate dressing 110 has a length greater than its width, and a longitudinal centerline 810. In some embodiments, the length of the dressing 110 may be approximately 13 cm, 20 cm, 35 cm, 13-20 cm, 13-15 cm, 20-35 cm, or 90 cm. The cover may be disposed over the manifold 406 and may form the outer surface 1005 of the dressing 110. The retaining device 582 may be located on the outer surface 1005 (e.g. the exterior surface when applied to a treatment site) of the dressing 110 and may be configured to releasably retain the dressing 110 in the rolled configuration. In some embodiments, the retaining device 582 may be configured to be removable from the dressing 110 (e.g. without significantly damaging the dressing cover). In some embodiments, the retaining device 582 may comprise a low-tack adhesive. For example, the low-tack adhesive of the retaining device 582 may extend substantially from the port or dressing interface 422 lengthwise for the remainder of the length of the manifold 406 (for instance, extending continuously or intermittently along the longitudinal centerline 810 of the manifold 406) . In other examples, the retaining device 582 may be located at least on the outer surface 1005 of the free end 1010 (e .g . in proximity to the port and/or the dressing interface 422) and configured to couple the free end 1010 to the remainder of the rolled dressing 110. The port in the cover and/or the dressing interface 422 may be located on a free end 1010 of the dressing 110, for example on the outer surface 1005.
[0093] In some embodiments, the attachment device may comprise an adhesive. For example, the adhesive of the attachment device may extend substantially the length of the dressing 110, and at least two release liners may be configured to releasably cover the adhesive. In some embodiments, one of the at least two release liners may span and/or cover the adhesive at the free end 1010 of the dressing 110. The free end release liner may be separately releasable from the adhesive (e.g. configured to allow exposure of the adhesive on the free end 1010, while the remainder of the at least two release liners remains in place covering the remainder of the adhesive). In some embodiments, a break perforation line 1015 in the release liner may be configured and located with respect to the free end 1010 to allow independent separation of the free end of the release liner from the remainder of the release liner.
[0094] Figure 11 illustrates the dressing 110 of Figure 10 in an exemplary rolled configuration, illustrating additional details that may be associated with some embodiments. In the rolled configuration as shown in Figure 11, the entire dressing 110 may roll around, encircle, and/or enwrap a central roll axis 1105 (e.g. with the length of the dressing 110 extending around the central roll axis 1105). For example, the longitudinal centerline 810 of the dressing 110 may be located in a plane substantially perpendicular to the central roll axis 1105, in the rolled configuration. In the rolled configuration, the release liner may face outward, in some embodiments, and the cover (e.g. outer surface 1005) may face inward. In some embodiments, the retaining device 582 may be configured to releasably couple the cover to the release liner in the rolled configuration. In some embodiments, in the rolled configuration at least the free end 1010 of the cover may be releasably coupled to the release liner. In some embodiments, in the rolled configuration the cover may be releasably coupled to the release liner substantially along the length of the dressing 110 and/or manifold 406. In the rolled configuration, the free end 1010 of the dressing 110 may be accessible (e.g. so that the free end release liner may be removed and/or the free end 1010 may be released from the retaining device 582 to be uncoupled from the remainder of the rolled dressing 110) while the dressing 110 is rolled; the opposite end 1107 (e.g. attached to the removable roll spacer and/or located within the roll of the dressing 110) may not be accessible in the rolled configuration (e.g. with the dressing 110 needing to be unrolled to the usage configuration to access the opposite end 1107).
[0095] Some embodiments may further comprise the removable roll spacer 1110, which may be configured to be encircled and/or enwrapped by the dressing 110 in the rolled configuration. The removable roll spacer 1110 may be cylindrical and/or may have a central axis that may define or align with the central roll axis 1105. At least a portion of the dressing 110 length may be wrapped around the removable roll spacer 1110 in the rolled configuration, and in some embodiments the entire dressing 110 length may be rolled around the removable roll spacer 1110. In some embodiments, the dressing 110 may wrap around the removable roll spacer 1110 multiple times. In some embodiments, the removable roll spacer 1110 may comprise cardboard paper (e.g. typically with a polymer coating or film exterior) or foam. In some embodiments, the removable roll spacer 1110 may be sterilizable, configured to releasably adhere to the retaining device 582 (e.g. low-tack adhesive), and/or configured to not create particulates in use. In some embodiments, the retaining device 582 may releasably couple the dressing 110 to the removable roll spacer 1110 (e.g. at the opposite end 1107), for example in addition to releasably coupling the outer surface 1005 of at least the free end 1010 to the release liner (e.g. to maintain the rolled configuration). In some embodiments, the retaining device 582 may comprise a low-tack adhesive. In some embodiments, the retaining device 582 may comprise thermoplastic elastomer (TPE). In some embodiments, the retaining device 582 may be configured to couple the cover to the release liner in the rolled configuration with a hold strength of no more than one pound. In some embodiments, the retaining device 582 may be configured to couple to the cover more strongly than it couples to the release liner (while also being removable from the cover without substantially damaging the cover).
[0096] In some embodiments, the dressing 110 may be configured to be customizable. For example, the dressing 110 may be configured to allow the length of the elongate dressing 110 to be customized (e.g. so that the length of the dressing 110 in the usage configuration may be less than or equal to the length of the dressing 110 in the rolled configuration). For example, the dressing 110 may be configured so that the length may be cut shorter, as needed for the specific treatment site.
[0097] Figure 12 illustrates the dressing 110 of Figure 10 in an exemplary usage configuration. In Figure 12, the dressing 110 has been unrolled onto the treatment site. The dressing 110 may be adhered to the treatment site (e.g. by the attachment device, after removal of the release liners), with the manifold 406 in fluid communication with the treatment site. The dressing interface 422 and the fluid conductor 424 may fluidly couple the manifold 406 through the cover to the reduced-pressure source 105, for example for reduced-pressure therapy.
[0098] In application, methods for applying a rolled dressing (such as that shown in Figures 10-12) to a treatment site may comprise: providing the dressing in a rolled configuration with a longitudinal centerline of the dressing enwrapping a central roll axis and positioned with a free end; coupling the free end of the dressing to the treatment site; releasing the dressing from the rolled configuration; unrolling the dressing to a usage configuration; coupling the dressing to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and/or applying reduced pressure to the treatment site through the dressing. Some method embodiments may further comprise removing a first release liner from the free end of the dressing, prior to coupling the free end of the dressing to the treatment site. Some embodiments may further comprise removing a second release liner from the remainder of the dressing. In some embodiments, releasing the dressing from the rolled configuration may comprise uncoupling a retaining device. Some embodiments may further comprise removing the retaining device from the outer surface and/or cover of the dressing. In some embodiments, in which the rolled configuration has the dressing rolled around a removable roll spacer, the method may further comprise discarding the removable roll spacer after the dressing has been unrolled to the usage configuration. Some embodiments may further comprise removing the dressing, in the rolled configuration, from a box. In some embodiments, after unrolling the dressing, the dressing may not be degraded from having been in the rolled configuration (even if the dressing has been retained in the rolled configuration for a plurality of years). [0099] Methods of manufacturing and/or positioning the dressing (e.g. as shown in Figures 10-12) into a rolled configuration may comprise: providing the dressing with a length, a width, and a longitudinal centerline, wherein the length is greater than the width; and rolling the dressing perpendicular to a central roll axis to position the dressing in a rolled configuration, with the length of the dressing extending around the roll axis and the roll axis extending perpendicular to a plane of the longitudinal centerline. Some embodiments may further comprise removably securing the dressing in the rolled configuration with a retaining device. In some embodiments, the dressing may further comprise an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing. In some embodiments, the method may further comprise applying the retaining device to the outer surface of the dressing. In some embodiments, in the rolled configuration, the dressing may comprise a free end which is accessible; and the method may further comprise attaching a dressing interface, which is configured to fluidly couple the manifold to a negative-pressure source through the cover, to the outer surface of the free end. Some embodiments may further comprise applying at least two release liners to cover the attachment device, wherein a first of the two release liners covers the attachment device at the free end of the dressing and is configured to allow exposure of the free end of the attachment device independently without exposing a remainder of the attachment device. Some embodiments may further comprise providing a removable roll spacer defining the roll axis, wherein rolling the dressing perpendicular to a roll axis comprises rolling the dressing around the removable roll spacer. Some embodiments may further comprise removably adhering the dressing in the rolled configuration to the removable roll spacer using the retaining device. In some embodiments, securing the dressing in the rolled configuration may further comprise removably adhering the outer surface of the dressing to the two or more release liners.
[00100] Some embodiments may further comprise placing the rolled dressing (e.g. in the rolled configuration) in a box, wherein the box is sized to receive the dressing in the rolled configuration. In some embodiments, the dressing in the rolled configuration may have a first (e.g. reduced) footprint that is substantially smaller than (e .g . % - ½ the size of) a second (e.g. unrolled) footprint of the dressing when in the usage configuration. Some embodiments may further comprise selecting and/or providing the box having an interior footprint that is at least as large as the first footprint of the dressing and smaller than the second footprint of the dressing. Some embodiments may further comprise storing the dressing in the rolled configuration (e.g. within the box) for up to a plurality of years (for example, up to 4 or 5 years). In some embodiments, storing the dressing in the rolled configuration for a plurality of years may not substantially degrade the dressing when it is unrolled for usage on a tissue site for negative-pressure therapy. In some embodiments, providing the dressing may comprise selecting a manifold for the dressing which is configured to not degrade (e.g. with respect to size, shape, and/or manifolding capabilities) when stored in the rolled configuration for a plurality of years. [00101] In some example embodiments, a dressing kit may comprise: a dressing having a foam manifold and a cover disposed over the foam manifold to form an outer surface of the dressing, wherein the dressing may be retained in a rolled configuration having a first (e.g. reduced) footprint; and a box sized to receive the dressing in the rolled configuration. In some embodiments, the box may be sized to correspond to (e.g. receive) the first footprint of the dressing. For example, the box may be sized to have an interior footprint that is at least as large as the first footprint of the dressing. In some embodiments, the dressing in the rolled configuration may be located within the box. In some embodiments, the dressing may be configured to have an unrolled configuration with a second (e.g. unrolled) footprint when removed from the box, and the second footprint may be larger than the first footprint. For example, the first footprint may be about % - ½ or no more than half of the second footprint in size. In some embodiments, the interior footprint of the box may be less than the second footprint of the dressing, and often may be substantially less than the second footprint of the dressing (e.g. only slightly larger than the first footprint of the dressing). Thus, the rolled configuration of the dressing may allow for the box to have an interior footprint sized between the first footprint of the dressing and the second footprint of the dressing.
[00102] In some embodiments, the foam manifold may not be degraded by the rolled configuration, even when retained in the rolled configuration for a plurality of years. For example, the foam manifold may have a size and shape after being unrolled substantially the same as before being rolled and/or may have manifolding (e.g. negative-pressure distribution) capabilities after being unrolled that are substantially the same as before being rolled. Some embodiments may further comprise an adhesive device or other retaining device on the outer surface configured to releasably retain the dressing in the rolled configuration by attaching a first portion of the dressing to a second portion of the dressing. In some embodiments, the first portion may comprise a wing portion, and the second portion may comprise a central portion (e.g. in proximity to a longitudinal centerline and/or a line of symmetry for the dressing). In some embodiments, the first portion may comprise a free end of the dressing, and the second portion may comprise an interior portion of the dressing (e.g. a remainder of the dressing, away from the free end) . In some embodiments, the first portion may comprise a portion of the cover extending beyond the manifold, and the second portion may comprise the manifold.
[00103] In operation, the reduced-pressure source 105 can reduce pressure in the sealed therapeutic environment (e.g. when the dressing 110 is applied to the treatment site in the usage configuration). Reduced pressure applied to the tissue site through the manifold 406 in the sealed therapeutic environment can induce macro-strain and micro-strain in the tissue site, as well as remove exudates and other fluids from the tissue site, which can be collected in the container 115.
[00104] In general, exudates and other fluids flow toward lower pressure along a fluid path. Thus, the term “downstream” may refer to a location in a fluid path relatively closer to a source of reduced pressure or further away from a source of positive pressure. Conversely, the term “upstream” may refer to a location further away from a source of reduced pressure or closer to a source of positive pressure.
[00105] In some example embodiments, the controller 120 may receive and process data from one or more sensors, such as the first sensor 125. The controller 120 may also control the operation of one or more components of the therapy system 100 to manage the pressure delivered to the tissue interface 135, such as the manifold 406 and associated components. In some embodiments, the controller 120 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 135. In some example embodiments, the target pressure may be a fixed pressure value set by an operator as the target reduced pressure desired for therapy at a tissue site and then provided as input to the controller 120. 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. After selecting a desired target pressure, the controller 120 can operate the reduced-pressure source 105 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 135. In some embodiments, the manifold 406 may have distinct pressure zones, and different target pressures and control modes may be applied to different pressure zones.
[00106] The systems, apparatuses, and methods described herein may provide significant advantages. For example, in addition to the benefits of increased development of granulation tissue and reduced healing times, the system 100 can also reduce edema and bruising in a broader area of tissue surrounding or adjacent to a tissue site or treatment target, such as an incision. The dressing 110, for example, can reduce stress on an incision and maximize the treatment coverage area of patient extremities. The dressing 110 can also be beneficial for managing edema and bruising of tissue sites without an incision or open wound, such as a sprain. In some embodiments, the dressing may be packaged, shipped, and/or stored with a reduced footprint (e.g. when in the rolled configuration), which may maximize usage of space effectively, improve sterile field area management in an operating room, and/or reduce packaging. In some embodiments, the rolled configuration may not substantially degrade or otherwise negatively impact the dressing (e.g. when it is unrolled for use providing negative-pressure therapy to a tissue site), even if the dressing is stored in the rolled configuration for a number of years. Some embodiments may also be configured to aid application of the dressing to a tissue site. For example, the dressing configuration may help to free a user’s hand, so that the user may utilize both hands during placement of the dressing on the tissue site. Some dressing configurations may assist in preventing the dressing from adhering to itself during application to the treatment site. Some dressing configurations may assist with effective placement of the dressing on large treatment sites and/or curved treatment sites.
[00107] While a dressing with a rolled configuration may offer benefits, testing has also demonstrated that such rolling of the dressing may not significantly degrade the dressing or affect its performance during negative-pressure therapy. For example, test specimens of 35cm long dressing from the PREVENA PLUS PEEL & PLACE™ Incision Management System were rolled around a cardboard tube and around a ½ inch foam spacer and placed within an oven for age testing. During age testing, the test specimens were maintained in the oven at 55 degrees Celsius for approximately four months, simulating four years of aging under normal conditions. After age testing, visual inspection of the dressing (e.g. looking for folds, creases, or degradation around the area of folding or rolling) did not detect degradation. Leak testing was also performed on the test specimens, and no significant (e.g. unresolvable) leaks were observed.
[00108] While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context. Components may also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations the dressing 110, the container 115, or both may be eliminated or separated from other components for manufacture or sale. In other example configurations, the controller 120 may also be manufactured, configured, assembled, or sold independently of other components.
[00109] Further, features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.

Claims

CLAIMS What is claimed is:
1. A dressing for reduced-pressure therapy on a treatment site, comprising: an attachment device having a treatment aperture; a manifold disposed over the treatment aperture; and a cover disposed over the manifold and coupled to the attachment device around the manifold; wherein the dressing comprises a rolled configuration in which at least a portion of the dressing is rolled, and the dressing is configured to be used for therapy in an unrolled configuration.
2. The dressing of claim 1, further comprising a retaining device configured to releasably retain the dressing in the rolled configuration.
3. The dressing of any of claims 1 -2, wherein the attachment device comprise an adhesive, the dressing further comprising at least two release liners configured to releasably cover the adhesive.
4. The dressing of any of claims 1-3, wherein, in the rolled configuration, the entire dressing is rolled to encircle a central roll axis that is substantially perpendicular to a longitudinal centerline of the dressing.
5. The dressing of any of claims 2-4, wherein the retaining device comprises a low-tack adhesive on the cover.
6. The dressing of any of claims 3-5, wherein the at least two release liners are configured to allow exposure of a free end portion of the attachment device without exposing a remainder of the attachment device.
7. The dressing of any of claims 1-6, further comprising a removable roll spacer configured to be encircled by the dressing in the rolled configuration.
8. The dressing of claim 3, further comprising a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion.
9. The dressing of claim 8, wherein, in the rolled configuration, the central portion is not rolled, and each of the wing portions are rolled with a roll axis substantially parallel to the line of symmetry.
10. The dressing of any of claims 8-9, wherein a first of the at least two release liners spans the central portion, and each of the wing portions is spanned by another of the at least two release liners.
11. The dressing of claim 3, wherein, in the rolled configuration, the manifold is not rolled, and two or more portions of the cover extending beyond the manifold are rolled.
12. The dressing of claim 11, wherein the manifold comprises a longitudinal centerline, and the portions of the cover extending beyond the manifold are rolled with a roll axis substantially parallel to the longitudinal centerline of the manifold, in the rolled configuration.
13. The dressing of claim 12, wherein in the rolled configuration, the portions of the cover that are rolled are folded so that the roll axis is folded.
14. The dressing of any of claims 11-13, wherein a first of the at least two release liners spans the manifold, each of the two or more portions extending beyond the manifold comprises the attachment device, and each of the two or more portions extending beyond the manifold is spanned by another of the at least two release liners.
15. A dressing for reduced-pressure therapy on a treatment site, comprising: an attachment device having a treatment aperture; a manifold comprising a longitudinal centerline, the manifold configured to be in fluid communication with the treatment site through the treatment aperture; a cover configured to be disposed over the manifold, the cover forming an outer surface of the dressing; an adhesive device on the outer surface configured to releasably retain the dressing in a rolled configuration; and a port in the cover located on the outer surface of a free end of the dressing.
16. The dressing of claim 15, wherein the attachment device comprises an adhesive, the dressing further comprising at least two release liners configured to releasably cover the adhesive, wherein one of the at least two release liners spans the adhesive at the free end of the dressing and is separately releasable from the adhesive.
17. The dressing of any of claims 15-16, wherein: the adhesive device comprises a low-tack adhesive extending substantially from the port lengthwise; the dressing comprises a rolled configuration in which at least a portion of the dressing is rolled, and a usage configuration in which the dressing is configured for use on the treatment site; and in the rolled configuration, the dressing encircles a central roll axis, with the longitudinal centerline of the dressing in a plane substantially perpendicular to the roll axis.
18. A dressing for reduced-pressure therapy on a treatment site, comprising: a lower surface having a treatment aperture; a foam manifold comprising a central portion, extending along a line of symmetry, and two or more wing portions each extending substantially perpendicular to the line of symmetry, the foam manifold configured to be in fluid communication with the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold to form a sealed space; wherein the dressing is stored in a rolled configuration with the lower surface of the wing portions positioned over the cover.
19. The dressing of claim 18, further comprising a box sized to receive the dressing in the rolled configuration.
20. The dressing of claim 18, wherein the lower surface of each of the wing portions folds over a top surface of the dressing.
21. The dressing of any of claims 2 and 5, wherein the retaining device is removable.
22. The dressing of claim 5, wherein the retaining device is configured to couple the cover to the release liner in the rolled configuration.
23. The dressing of any of claims 9-10, wherein in the rolled configuration, the retaining device is configured to releasably couple each of the rolled wing portions to the central portion.
24. The dressing of any of claims 11-14, wherein the retaining device is configured to releasably couple each of the rolled portions to the cover in proximity to the longitudinal centerline.
25. The dressing of any of claims 1-14 and 18-20, further comprising a port in the cover configured to fluidly couple the manifold to a negative-pressure source.
26. The dressing of any of claims 18, further comprising one or more low-tack retaining device configured to releasably retain the wing portions in the rolled configuration; wherein the one or more low-tack retaining device may comprise an adhesive located on the cover in proximity to the line of symmetry.
27. The dressing of claim 1, wherein the rolled configuration is configured to reduce the footprint of the dressing.
28. The dressing of claim 1, wherein the attachment device is located on a tissue-contact surface of the dressing.
29. The dressing of claim 1, wherein the manifold comprises porous foam.
30. The dressing of claim 1, wherein the attachment device comprises a fdm layer and an adhesive.
31. The dressing of claim 1, further comprising a tissue-contact layer coupled to the manifold and at least partially exposed through the treatment aperture.
32. The dressing of claim 31, wherein the tissue-contact layer comprises one or more of the following: a woven material, a non-woven material, a polyester knit material, and a fenestrated fdm.
33. The dressing of claim 1, wherein the attachment device is configured to create a sealed space between the cover and the treatment site, and the manifold is configured to be positioned in the sealed space.
34. The dressing of claim 4, wherein the dressing comprises a length, and the length of the dressing encircles the central rolling axis in the rolled configuration.
35. The dressing of claim 5, wherein the retaining device is located substantially in proximity to the free end.
36. The dressing of claim 5, wherein the retaining device extends substantially along the length of the dressing.
37. The dressing of claim 6, wherein the at least two release liners comprise a first release liner covering the attachment device at the free end, and a second release liner covering the remainder of the attachment device.
38. The dressing of claim 7, wherein the removable roll spacer is cylindrical about a central rolling axis.
39. The dressing of claim 7, wherein the removable roll spacer is configured to releasably adhere to the retaining device, to be sterilizable, and to not create particulates in use.
40. The dressing of claim 25, wherein the port is located on the outer surface of a free end of the dressing.
41. The dressing of claim 40, further comprising a dressing interface configured to fluidly couple the port to the negative-pressure source.
42. The dressing of claim 1, wherein the cover forms an outer surface of the dressing, and the attachment device at least partially forms a tissue-contact surface.
43. The dressing of claim 6, wherein in the rolled configuration, the release liner faces outward, and the cover faces inward.
44. The dressing of claim 1, wherein the manifold is elongate, with length longer than width, and has a substantially uniform width and/or thickness.
45. The dressing of claim 1, wherein the dressing is configured to be customizable in length.
46. The dressing of claim 9, wherein the wing portions roll inward towards the line of symmetry in the rolled configuration.
47. The dressing of claim 9, further comprising two or more removable roll spacers, with each removable roll spacer configured to be encircled by one of the wing portions in the rolled configuration.
48. The dressing of claim 8, wherein: the manifold comprises a first arm and a second arm joined by a stem; the first arm comprises a first wing portion and a second wing portion; the second arm comprises a third wing portion and a fourth wing portion; and the line of symmetry extends through the stem, the first arm, and the second arm.
49. The dressing of claim 9, further comprising a slip-sheet adjacent to the outer surface of the rolled wings and configured to prevent each of the rolled wings from adhering to itself.
50. The dressing of claim 8, wherein the attachment device is positioned around the edge of the manifold and configured to surround the treatment site.
51. The dressing of claim 8, wherein the line of symmetry extends lengthwise along the central portion, and in the rolled configuration the central portion is substantially flat.
52. The dressing of claim 12, wherein in the rolled configuration, the portion of the cover extending beyond the manifold and located between the rolled portions forms two end portions separated by the manifold, and the end portions are folded towards the manifold.
53. The dressing of claim 12, further comprising a removable roll spacer for each of the rolled portions, configured for the portions to encircle the removable roll spacer.
54. The dressing of claim 12, wherein the manifold is elongate, with length longer than width, and has a substantially uniform width and/or thickness.
55. The dressing of claim 12, wherein the retaining device comprises tape.
56. The dressing of claim 11, wherein the portions of the cover extend beyond the manifold on both sides of the manifold, symmetrically about the longitudinal centerline.
57. A method for applying a rolled dressing to a treatment site, comprising: providing the dressing in a rolled configuration with a longitudinal centerline of the dressing enwrapping a central roll axis and positioned with a free end; coupling the free end of the dressing to the treatment site; releasing the dressing from the rolled configuration; unrolling the dressing to a usage configuration; coupling the dressing to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and applying reduced pressure to the treatment site through the dressing.
58. The method of claim 57, further comprising removing a first release liner from the free end of the dressing, prior to coupling the free end of the dressing to the treatment site.
59. The method of claim 58, further comprising removing a second release liner from the remainder of the dressing.
60. The method of claim 57, wherein releasing the dressing from the rolled configuration comprises uncoupling a retaining device.
61. The method of claim 57, wherein in the rolled configuration the dressing is rolled around a removable roll spacer, further comprising discarding the removable roll spacer after the dressing has been unrolled to the usage configuration.
62. A method for applying a rolled dressing to a treatment site, comprising: providing the dressing in a rolled configuration, with a plurality of wing portions each rolled towards a central portion; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; for each wing portion, removing a corresponding release liner; for each wing portion, releasing the wing portion from the rolled configuration; for each wing portion, unrolling the wing portion to a usage configuration; for each wing portion, coupling the wing portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and applying reduced pressure to the treatment site through the dressing.
63. The method of claim 62, wherein releasing the wing portion from the rolled configuration comprises uncoupling a retaining device.
64. The method of claim 62, wherein in the rolled configuration each wing portion is rolled around a removable roll spacer, the method further comprising discarding the removable roll spacer after each wing portion has been unrolled to the usage configuration.
65. A method for applying a rolled dressing to a treatment site, comprising: providing the dressing in a rolled configuration having an unrolled central portion spanning a manifold and two or more rolled portions of a cover extending beyond the manifold; removing a first release liner from the central portion of the dressing; coupling the central portion of the dressing to the treatment site; releasing the two or more rolled portions from the rolled configuration; for each rolled portion, removing a corresponding release liner; for each rolled portion, unrolling the rolled portion; for each rolled portion, coupling the rolled portion to the treatment site to form a seal; fluidly coupling the dressing to a reduced-pressure source; and applying reduced pressure to the treatment site through the dressing.
66. The method of claim 65, wherein releasing the two or more rolled portions from the rolled configuration comprises uncoupling a retaining device.
67. A method of manufacturing a dressing, comprising: providing the dressing with a length, a width, and a longitudinal centerline, wherein the length is greater than the width; and rolling the dressing perpendicular to a roll axis to position the dressing in a rolled configuration, with the length of the dressing extending around the roll axis and the roll axis extending perpendicular to a plane of the longitudinal centerline.
68. The method of claim 67, further comprising securing the dressing in the rolled configuration with a retaining device.
69. The method of claim 68, wherein: the dressing further comprises an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; the method further comprising applying the retaining device to the to the outer surface of the dressing.
70. The method of claim 67, wherein in the rolled configuration, the dressing comprises a free end which is accessible; the method further comprising attaching a dressing interface, which is configured to fluidly couple the manifold to a reduced-pressure source through the cover, to the outer surface of the free end.
71. The method of claim 70, further comprising applying at least two release liners to cover the attachment device, wherein a first of the two release liners covers the attachment device at the free end of the dressing and is configured to allow exposure of the free end of the attachment device without exposing a remainder of the attachment device.
72. The method of claim 67, further comprising providing a removable roll spacer defining the roll axis, wherein rolling the dressing perpendicular to a roll axis comprises rolling the dressing around the removable roll spacer.
73. The method of claim 72, further comprising removably adhering the dressing in the rolled configuration to the removable roll spacer using the retaining device.
74. The method of claim 68, wherein securing the dressing in the rolled configuration further comprising removably adhering the outer surface of the dressing to the two or more release liners.
75. The method of claim 68, wherein securing the dressing in the rolled configuration further comprising removably adhering the outer surface of the free end of the dressing to at least one of the at least two release liners.
76. A method of manufacturing a dressing, comprising: providing the dressing comprising a central portion, extending along a line of symmetry, and two or more wing portions extending substantially orthogonal to the central portion; rolling each of the wing portions inward towards the line of symmetry to form a rolled configuration; and removably securing each of the wing portions in the rolled configuration with a retaining device.
77. The method of claim 76, wherein in the rolled configuration, the central portion of the dressing is substantially flat.
78. The method of 76, further comprising providing a removable roll spacer for each of the wing portions, wherein rolling each of the wing portions comprises rolling each of the wing portions around the removable roll spacer.
79. The method of 76, wherein securing each of the wing portions in the rolled configuration comprises removably adhering each of the wing portions to the central portion.
80. The method of 76, wherein the attachment device comprises an adhesive located on the central portion and each of the wing portions, the method further comprising covering the adhesive of the central portion with a first release liner, and covering the adhesive of each of the wing portions with a corresponding release liner.
81. A method of manufacturing a dressing, comprising: providing the dressing comprising an attachment device having a treatment aperture; a manifold configured to be at least partially exposed to the treatment site through the treatment aperture; and a cover configured to be disposed over the manifold and coupled to the attachment device around the manifold, the cover forming an outer surface of the dressing; rolling portions of the cover, which extend laterally beyond the manifold, inward towards the manifold to form a rolled configuration; removably securing the rolled portions of the cover in the rolled configuration using a retaining device.
82. The method of claim 81, wherein in the rolled configuration, the manifold is substantially flat.
83. The method of claim 81, further comprising folding the rolled portions.
84. The method of claim 81, wherein the attachment device comprises an adhesive located on the manifold and each of the portions of the cover extending laterally beyond the manifold, the method further comprising covering the adhesive of the manifold with a first release liner, and covering the adhesive of each of the portions of the cover extending laterally beyond the manifold with a corresponding release liner.
85. The method of claim 81, further comprising providing a removable roll spacer for each rolled portion, wherein rolling the portions of the cover comprises rolling each of the portions of the cover around the removable roll spacer.
86. A dressing kit, comprising: a dressing having a foam manifold and a cover disposed over the foam manifold to form an outer surface of the dressing, wherein the dressing is retained in a rolled configuration having a first footprint; and a box sized to receive the dressing in the rolled configuration.
87. The dressing kit of claim 86, wherein the dressing in the rolled configuration is located within the box.
88. The dressing kit of claim 87, wherein the dressing is configured to have an unrolled configuration with a second footprint when removed from the box, and the second footprint is larger than the first footprint.
89. The dressing kit of any of claims 86-88, wherein the foam manifold is not degraded by the rolled configuration, but has a size and shape after being unrolled substantially the same as before being rolled.
90. The dressing kit of any of claims 86-89, wherein the foam manifold is not degraded by the rolled configuration, but has manifolding capabilities after being unrolled that are substantially the same as before being rolled.
91. The dressing kit of any of claims 86-90, wherein the dressing further comprises an adhesive device on the outer surface configured to retain the dressing in the rolled configuration by attaching a first portion of the dressing to a second portion of the dressing.
92. The dressing kit of any of claims 88-91, wherein the box has an interior footprint at least as large as the first footprint of the dressing, but smaller than the second footprint of the dressing.
93. The dressing of claim 18, further comprising one or more retaining device configured to releasably retain the wing portions in a rolled configuration.
94. The dressing of claim 93, wherein: in the rolled configuration, the central portion is not rolled, and each of the wing portions are rolled with a roll axis substantially parallel to the line of symmetry; and the one or more retaining device comprises a low-tack adhesive configured to releasably couple the wing portions to the central portion.
95. The dressing of any of claims 93-94, wherein: the two or more wing portions comprises a first wing portion, a second wing portion, a third wing portion, and a fourth wing portion; the first wing portion is symmetrical to the second wing portion across the line of symmetry; the third wing portion is symmetrical to the fourth wing portion across the line of symmetry; the lower surface comprises an adhesive; the dressing further comprising a plurality of release liners configured to releasably cover the adhesive; and a first of the plurality of release liners spans the central portion, and each of the wing portions is spanned by another of the plurality of releaser liners.
96. The dressing of any of claims 1, 15, 18, and 86, wherein the manifold comprises open-cell foam.
97. The dressing of any of claims 1, 15, 18, and 86, wherein the manifold comprises reticulated polyurethane foam.
98. The dressing of any of claims 1, 15, 18, and 86, wherein the manifold comprises foam having pore sizes in a range of about 400-600 microns.
99. The dressing of any of claims 1, 15, 18, 86, and 96-98 wherein the manifold has a thickness of about 5-10 mm.
100. The dressing of any of claims 1, 15, 18, and 86, wherein the cover comprises a polymer drape.
101. The dressing of any of claims 1, 15, 18, and 86, wherein the cover comprises a polyurethane film.
102. The systems, dressings, apparatuses, and methods substantially as shown and described herein.
PCT/IB2021/053132 2020-04-30 2021-04-15 Dressing with rolled configuration WO2021220100A1 (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014140608A1 (en) * 2013-03-15 2014-09-18 Smith & Nephew Plc Wound dressing sealant and use thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014140608A1 (en) * 2013-03-15 2014-09-18 Smith & Nephew Plc Wound dressing sealant and use thereof

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