US20110112492A1 - Wound dressing with micropump - Google Patents

Wound dressing with micropump Download PDF

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Publication number
US20110112492A1
US20110112492A1 US12/936,255 US93625509A US2011112492A1 US 20110112492 A1 US20110112492 A1 US 20110112492A1 US 93625509 A US93625509 A US 93625509A US 2011112492 A1 US2011112492 A1 US 2011112492A1
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United States
Prior art keywords
wound
micropump
dressing
backing
wound dressing
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Abandoned
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US12/936,255
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English (en)
Inventor
Vivek Bharti
Matthew T. Scholz
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3M Innovative Properties Co
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Individual
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Priority to US12/936,255 priority Critical patent/US20110112492A1/en
Publication of US20110112492A1 publication Critical patent/US20110112492A1/en
Assigned to 3M INNOVATIVE PROPERTIES COMPANY reassignment 3M INNOVATIVE PROPERTIES COMPANY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BHARTI, VIVEK, SCHOLZ, MATTHEW T.
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/82—Membrane pumps, e.g. bulbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/78—Means for preventing overflow or contamination of the pumping systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96—Suction control thereof
    • A61M1/962—Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00536—Plasters use for draining or irrigating wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/0054—Plasters use for deep wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body

Definitions

  • skin ulcers are a common problem among many diabetics, and are often brought on by poor blood circulation and nerve damage associated with diabetes and/or vascular disease.
  • the treatment of such ulcers often involves grafting skin from a relatively healthy donor site to an ulcerous wound site.
  • Split thickness surgical skin graft techniques may be employed to obtain skin grafts from donor sites that can then heal spontaneously.
  • Full thickness skin grafts on the other hand, generally require closure of the donor site.
  • many wounds can become stalled in a “chronic condition” in which further healing does not occur and, in fact, wound may actually increase in size and depth.
  • Wound dressings have been used in the medical industry to protect and/or facilitate healing of open wounds. Although various types of dressing materials have been successfully employed, membranes comprising semi-permeable materials are often preferred because they can increase patient comfort and lower the risk of infection. Semi-permeable membranes generally pass moisture vapors, but are generally impervious to liquids. Thus, they can promote healing by permitting a wound site to “breathe”. An industry standard is TegadermTM sold by 3M Company, St. Paul, Minn. Although transparent dressings can “breathe”, they often do not have sufficient moisture vapor transmission rates (MVTR) to allow evaporation of excess wound fluid exudate. If allowed to accumulate and/or remain over the wound optimal wound healing will not occur.
  • MVTR moisture vapor transmission rates
  • the micropump is said to pull a vacuum on the wound bed (see e.g. paragraph 0034). This appears fundamentally impossible with the arrangement disclosed. Because the micropump is located within a sealed cavity having no exit from the dressing, a vacuum cannot be generated without exhausting fluid (air or liquid) from the wound cavity. As described and illustrated the inlet and outlet of the micropump are both within the wound cavity compartment.
  • a further problem with the composite dressing design disclosed in US Patent Publication No. 2007/0078366 is that many (or perhaps most) wounds that require vacuum therapy can generate large volumes of fluid.
  • the disclosure provides that removal of fluid from the dressing occurs by opening an access door (see paragraph 0033) and removing the saturated absorbent layer. For many wounds this could require frequent changes which is inconvenient, unnecessarily exposes the healthcare worker to body fluids, and requires significantly more labor than current systems which collect the exudate into a canister.
  • the configuration of the system disclosed eliminates the use of “fluid traps” which can become filled and thus contaminate the reusable motorized micropumps associated therewith. Such systems also must be shut down in order to drain the trap.
  • the positive pressure wound fluid accumulation devices of the present invention may be replaced without interrupting the wound therapy.
  • the micropump dressing systems are significantly smaller than prior art negative pressure therapy devices, less complicated, and quiet. This allows for greater patient comfort and easy ambulation for those patients that are capable.
  • the wound dressing may optionally include at least one of a number of actives including for example, medicaments, anti-infective agents, antimicrobials, antiseptics (for example polyhexamethylene biguanide (hereinafter, “PHMB”), chlorhexidine, silver, iodine, an iodophor, benzalkonium chloride, hydrogen peroxide as well as the antiseptics disclosed in the following pending applications: US 2005/0089539, US2006/0051385, US2006/0052452, and US2006/0051384 which are incorporated herein by reference), antibiotics, analgesics, local anesthetics, anti-inflammatory agents, healing factors, vitamins, growth factors, enzyme inhibitors such as matrix metalloproteinase (MMP) inhibitors, and nutrients and/or one of a microbead packing and/or absorbent foam.
  • actives including for example, medicaments, anti-infective agents, antimicrobials, antiseptics (for example polyhexam
  • cutting plane refers to an imaginary plane in relation to a three-dimensional object.
  • a cutting plane oriented in a y-z plane is useful for separating individual electrically responsive elements.
  • the cutting plane or cutting location is perpendicular to the x-dimension of the article for dividing the elements, where faces of the alternating conductive regions of the conductive layer are exposed and coincident to one of the two faces of the element after separation.
  • interstices refers to a space between things or parts.
  • the interstices between the conductive regions of the conductive layer refer to the space between the regions extending in the x-dimension.
  • the interstices of an electrically responsive element may contain polymeric nonconductive material.
  • the interstices may also be referred to as nonconductive regions.
  • reference plane refers to an imaginary plane in relation to a three-dimensional object.
  • a reference plane oriented in a y-z plane is coincident and parallel to the surface of the conductive regions of the conductive layer, or to a face of an article or electrically responsive element.
  • the reference plane is perpendicular to the x-dimension and parallel to the cutting plane(s).
  • the reference plane may also be a cutting plane.
  • FIG. 1 is a plan view of one embodiment of a wound dressing according to the present invention.
  • FIG. 2 is a cross-sectional view of the wound dressing of FIG. 1 taken along line 2 - 2 in FIG. 1 .
  • FIG. 3 is a cross-sectional view of the wound dressing of FIGS. 1 and 2 located over a wound W.
  • FIG. 6 is a schematic representation of a unit cell.
  • FIG. 9 is a schematic representation of an article comprising electrically responsive elements repeating in the x-dimension.
  • FIG. 10 is a schematic representation of an article having at least two electrically responsive elements presented in the x-, y- and z-dimensions.
  • FIG. 16 is a view similar to the view of FIG. 3 illustrating the wound dressing and micropump system wherein the micropump is in fluid communication with the wound dressing.
  • FIG. 17 is a block diagram of components that may be supplied in one exemplary embodiment of a wound dressing kit.
  • FIG. 19 is an exemplary embodiment of a tubular micropump.
  • FIG. 20 is an exemplary embodiment of a diaphragm micropump.
  • the composite wound dressing apparatus of the present disclosure promotes healing of a wound via the use of a micropump system.
  • Fluid removed from the wound dressing may include gases and/or liquids (which may contain dispersed solid particles such as necrotic tissue, blood clots, etc.). The fluid removal can be performed without removing or otherwise disturbing the medical dressing.
  • the dressing may be applied over surgical wounds, cosmetic surgical procedures, burns, cuts, scrapes and ulcers of various types, e.g. diabetic, decubitus, peripheral vascular disease, venous stasis and trauma ulcers.
  • the term “sealed environment” means that fluids (and solids) from the ambient atmosphere surrounding the exterior of a medical dressing attached over a wound cannot freely enter the sealed environment.
  • the sealed environment preferably includes a hermetic seal between the medical dressing and the surface surrounding the wound such that a negative pressure can be maintained in the sealed environment. It may, for example, be preferred that the medical dressing be capable of holding (at least temporarily as described herein) a vacuum of 100 mmHg (i.e., a pressure that is 100 mmHg below atmospheric pressure) and perhaps a vacuum as much as 200 mmHg.
  • Fluid removal from the sealed environment may be useful to provide negative or reduced pressure therapies to a wound over which the medical dressing is located.
  • the sealed environment created by a medical dressing of the present invention may preferably be maintained at a negative pressure (i.e., pressure below the ambient atmospheric pressure) in the absence of active vacuum source in fluid communication with the sealed environment.
  • the medical dressings of the present invention may be used to maintain a sealed environment with a negative or reduced pressure in the periods between active removal of fluids from the sealed environment.
  • the medical dressings can provide a negative or reduced pressure environment with only intermittent or periodic fluid removal.
  • Deterioration of the negative pressure within the sealed environment defined by the medical dressing may be caused by a variety of sources. For example, some of the deterioration may be due to the diffusion of gas into the sealed environment through the backing of the medical dressing and/or the adhesive attaching the medical dressing to a subject. Another source of negative pressure deterioration in the sealed environment may be caused by gases and/or liquids entering the sealed environment from the subject (i.e., through the wound itself and/or the tissue surrounding the wound).
  • the openings in the medical dressings be one-way valves.
  • the valve allows fluid flow in one direction (out of the sealed environment) and restricts or prevents flow in the opposite direction (into the sealed environment).
  • the valve allows fluid flow in one direction (into the sealed environment) and restricts or prevents flow in the opposite direction (out of the sealed environment).
  • the dressing also includes an adhesive on the interior surface of the backing layer such that the dressing can be adhered to a subject over a wound with the interior surface facing a wound.
  • the adhesive 39 may cover all or part of the interior surface 22 in a continuous and/or pattern coated fashion.
  • the adhesive 39 as depicted in FIG. 2 is provided only around the perimeter or border of the backing 21 such that the adhesive 39 forms a frame around a central part of the interior surface 22 of the backing 21 .
  • Many other arrangements are possible.
  • One arrangement is depicted in FIG. 3 in which the dressing 12 is located over a wound W while the adhesive 39 is attached to the tissue (e.g., skin) surrounding the wound W.
  • the dressing 12 along with the wound W and the tissue surrounding the wound, preferably define a sealed environment in which the wound W is isolated from the surrounding environment.
  • the interior surface 22 of the backing 21 faces the sealed environment in which the wound is located while the external surface 24 of the backing 21 faces away from the wound W.
  • the adhesive 39 extend continuously around the entire perimeter of the backing 21 such that the dressing 12 , when attached to a subject, can form a sealed environment over a wound, with the bounds of the sealed environment being defined by the interior surface 22 of the backing 21 as adhered to the subject over a wound by the adhesive 39 .
  • the most preferred liner is 1-60BKG-157 paper liner available from Daubert, which is a super calendared Kraft paper with a water-based silicone release surface.
  • the wound dressing may be linerless and delivered in roll form such as described in U.S. Pat. No. 5,803,086.
  • the wound dressing is preferably a single piece but may be formed from two or more pieces that come together to form seams as taught in U.S. Pat. No. 4,969,880 incorporated herein by reference.
  • the medical dressing include absorbent material such as a wound packaging material, to absorb fluids (e.g., liquids) entering the sealed environment.
  • absorbent material such as a wound packaging material
  • fluids e.g., liquids
  • examples of potentially suitable absorbent materials may include, but are not limited to, hydrophilic foams, woven materials, nonwoven materials, etc. and combinations thereof.
  • the absorbent material be both absorbent and capable of releasing at least some (preferably a majority) of any absorbed fluids when a vacuum is applied to the sealed environment through a valve. By releasing absorbed fluids during the removal of fluids from the sealed environment, the ability of the absorbent material to absorb fluids may be regenerated—which may prolong the useful life of the medical dressing.
  • FIG. 4 is a plan view of the interior surface 422 of the backing 420 of a medical dressing 410 .
  • the medical dressing 410 may include adhesive that is exposed over the entire interior surface 422 except for the area occupied by the stand-off element 450 .
  • the adhesive may be continuous or pattern-coated, although regardless of the coating, it may be preferred that the adhesive be capable of providing a hermetic seal such that a negative pressure can be obtained in the sealed environment.
  • One example of a potentially suitable pattern for pattern-coated adhesive may be a grid pattern. It may be preferred that the valve 430 be located within the area of the backing 420 that is occupied by the stand-off element 450 , although in some embodiments, the valve 430 may be located proximate the perimeter of the stand-off element 450 .
  • the stand-off element 450 includes some form of structure on one or more surfaces that provides open fluid pathways such that fluids within the sealed environment defined by the medical dressing 410 can be removed through the valve 430 . If, for example, a stand-off element 450 is not provided and the interior surface 422 of the dressing 410 were to seal against a wound or the skin surrounding a wound, the removal of fluids from the sealed environment by the micropump could be hindered.
  • the stand-off element 450 preferably is capable of maintaining open fluid pathways to facilitate fluid removal through the valve 430 even when the sealed environment is at a negative pressure relative to atmosphere, that is, the fluid pathways preferably resist collapsing—even under negative pressure.
  • the medical dressing depicted in FIG. 4 includes only one stand-off element 450 and one valve 430
  • the medical dressings of the present invention may include, for example, more than one valve in connection with that same stand-off element.
  • the use of multiple valves may be beneficial if, for example, one of the valves is poorly placed relative to the sealed environment, malfunctions, becomes clogged, etc.
  • the medical dressings of the present invention may include more than one stand-off element, with each of the stand-off elements potentially associated with one or more valves to facilitate fluid removal from the sealed environment.
  • the use of more than one stand-off element in connection one medical dressing may be beneficial if, for example, one of the stand-off elements is poorly placed relative to the sealed environment, becomes clogged, etc.
  • the stand-off elements used in the medical dressings of the present invention may take a wide variety of forms.
  • the stand-off element may be formed directly in the interior surface of the backing (by, e.g., embossing, abrading, molding, cutting, etc.).
  • the stand-off element take the form of a separate article (e.g., a film, etc.) having channels or other structures embossed, abraded, molded, cut, or otherwise formed therein.
  • the separate article forming the stand-off element may preferably be attached to the backing by any suitable technique or combination of techniques (e.g., adhesives, heat sealing, thermal welding, etc.).
  • the active agents may be provided as a fluid and/or may be carried within a fluid that is delivered to the internal volume.
  • Some potentially suitable active agents may include, e.g., antimicrobials, antibiotics, analgesics, healing factors such as vitamins, growth factors, nutrients and the like. Examples of other potentially suitable agents may be described in U.S. Pat. No. 6,867,342.
  • an active agent could be supplied to the sealed environment continuously or intermittently.
  • an active agent could be delivered to the sealed environment and allowed to remain in place (i.e., resident) for a selected period of time (e.g., several hours) followed by, e.g., delivery of a second active agent, delivery of negative pressure therapy, etc.
  • the initial active agent could be removed before delivery of the second agent or it could be allowed to remain in place.
  • the sealed environment could be rinsed with, e.g., saline or another flushing solution before placing the sealed environment in a negative pressure condition, before delivery of a second agent, etc.
  • the wound dressing micropump system includes a micropump that applies a subatmospheric pressure to the wound to effectively draw wound fluid or exudate out of the wound bed and encourage interstitial fluid to flow into the wound bed from surrounding tissues.
  • the wound dressing apparatus in the form of wound dressing and micropump system is extremely portable which allows the patient greater mobility than is available when an external vacuum source is used.
  • the micropump of the present invention is sufficiently small to allow even greater mobility than other semi-portable configurations wherein the patient must carry the micropump in a support bag, as is disclosed for example in US Patent Application Publication No. 2007/0055209. The patient does not need to be restricted for any period of time while the wound is being treated.
  • the present invention utilizes a micropump which contacts the wound fluid directly.
  • the excess wound fluid is passed through the micropump.
  • the micropump is preferably self priming and able to pump out air trapped between the sealed dressing and the wound bed, although manual removal of air by manipulation of the wound dressing and/or micropump is also contemplated.
  • the micropump is turned on and the air is pumped out creating a vacuum.
  • vacuum refers to pressures less than the surrounding atmospheric pressure.
  • the pressure is reduced by 5-250 mm mercury (Hg) (e.g. down to an absolute pressure of 500-740 mmHg but this will depend on the atmospheric pressure).
  • the pressure is not reduced by more than 200 mmHg and more preferably by not more than 175 mm Hg.
  • the pressure is reduced by at least 5 mmHg, 25 mmHg, more preferably at least 50 mmHg and most preferably at least 75 mm Hg in order to remove sufficient interstitial fluid.
  • the most preferred electroresponsive elements are electroactive polymers such as elastomers (polyurethanes, silicone rubber, Zetpole, VHB), visco-elastic polymers, and copolymers or terpolymers (PVDF, PVDF-TrFE, PVDF-HFP, PVDF-TrFE-HFP etc.) as further described below.
  • the electroresponsive element also may be polymer composite film such as polymer-ceramics wherein the ceramic element may be PZT, PZN-PT, Polymer-carbon nanotubes, carbon fibers, Polyamide-PZT fibers etc.
  • the electroresponsive element can be a magnetorestrictive material.
  • a magnetorestrictive material as used herein is one that changes dimension by application of a magnetic field.
  • a preferred magnetorestrictive material is Terfenol-D.
  • suitable magnetorestrictive materials may be Ferromagnetic Shape Memory Alloy Materials (FSMA) that exhibit a twinning mechanism similar to that observed in traditional shape memory alloy materials such as NiTi and CuZn. In the FSMA the shape change may be initiated using an applied magnetic field.
  • FSMA Ferromagnetic Shape Memory Alloy Materials
  • Galfenol an iron/gallium alloy termed Galfenol at the Naval Surface Warfare Center (Clark et al.). See Clark, A.
  • a current rather than voltage, may be used to drive the displacement of the actuator comprising magnetorestrictive materials.
  • a representative electroresponsive actuator 5 comprises first 100 and second 105 electrically responsive elements as illustrated in FIG. 5 .
  • An electrically responsive element 100 is further described in U.S. Pat. No. 4,627,138 (Im); U.S. Pat. No. 5,997,880 (Friedl et al.); U.S. Pat. No. 5,153,859 (Chatigny et al.); and International Publication No. WO 02/096647A1 (Hilmas et al.).
  • Electroresponsive actuator 5 comprises first 100 and second 105 electrically responsive elements, which are unpoled, and extend along an x-dimension.
  • the first 40 and second 41 conductive layers each have conductive regions 43 , 53 , 44 , 54 .
  • the first conductive layer 40 has first 43 and second 53 conductive regions
  • the second conductive layer 41 has third 44 and fourth 54 conductive regions.
  • the conductive regions 43 , 53 , 44 , 54 are arranged as illustrated in FIG. 5 , so that a first surface 43 a, 53 a of first 43 and second 53 conductive regions of first conductive layer 40 and a second surface 44 b, 54 b of third 44 and fourth 54 conductive regions of second conductive layer 41 are alternatingly exposed to one of two opposing faces 120 , 130 of the elements 100 , 105 .
  • first 120 and second 130 faces are coincident to first 43 a, 53 a and second surfaces 44 b, 54 b of each respective conductive region 43 , 53 and 44 , 54 . Further, first 120 and second 130 opposing faces are parallel to the cutting 20 , 24 and reference planes 10 . The two faces 120 , 130 are exposed to recover a single electronically responsive element 100 after separation at one or more cutting planes 20 or at a reference plane 10 and a cutting plane 20 .
  • the x-dimension of the electroresponsive actuator 5 comprising at least two elements 100 , 105 refers to the width or cross-web dimension of the electroresponsive actuator 5 , and the subsequent electrically responsive elements 100 , 105 resulting from the electroresponsive actuator 5 after separating at a cutting plane 20 .
  • the x-dimension of an element 100 may be in a range of 0.01 micrometer to 1 centimeter.
  • the x-dimension is in a range of 1 micrometer to 0.1 centimeter, and more preferably, the x-dimension is in a range of 10 micrometers to 0.01 centimeter.
  • the y-dimension relates to the length or down-web dimension of an article comprising at least two elements 100 , 105 .
  • the y-dimension also refers to the elements 100 , 105 after separation by a cutting plane 20 from the electroresponsive actuator 5 .
  • the elements 100 , 105 may each have a specific y-dimension as determined by a given application.
  • the element 100 may be separated from the electroresponsive actuator 5 in the x-z plane, which is perpendicular to the y-dimension.
  • the y-dimension of the element 100 may be in a range of 0.01 micrometer to 1 centimeter.
  • the y-dimension is in a range of 1 micrometer to 0.1 centimeter, and more preferably, the y-dimension is in a range of 10 micrometers to 0.01 centimeter.
  • Separation of the elements 100 , 105 may be accomplished with techniques including die cutting, laser cutting, shear slitting, score slitting, hot wire engaged slitting and combinations thereof.
  • a trim portion or inoperative element of the electroresponsive actuator 5 extending in the x-direction away from either of the faces 120 , 130 may result after separation of the elements 100 , 105 at a reference 10 or cutting 20 , 24 planes.
  • the trim portion or inoperable element may comprise irregularly shaped surfaces or faces formed during extrusion through a die orifice and drawdown of the electroresponsive actuator 5 . The trim portion may be recycled for other applications.
  • Conductive regions 43 , 53 are discontinuous in the x-dimension having interstices 25 containing nonconductive material 47 .
  • third conductive region 44 of the second conductive layer 41 has a first surface 44 a, second surface 44 b, a third surface 44 c and a fourth surface 44 d.
  • Fourth conductive region 54 of the second conductive layer 41 has a first surface 54 a, a second surface 54 b, a third surface 54 c, and a fourth surface 54 d.
  • Third and fourth conductive regions 44 , 54 are also discontinuous in the x-dimension having interstices 25 containing nonconductive material 47 .
  • Nonconductive layer 42 comprises nonconductive material 47 which extends continuously in the x- and y-dimensions.
  • a cross-section of electroresponsive actuator 5 as illustrated in FIG. 5 has at least two electrically responsive elements 100 , 105 in the x-z plane.
  • the cross-section shows a nonconductive layer 42 having a third 42 c and fourth 42 d surfaces.
  • the nonconductive layer 42 is located in between a first 40 and second 41 conductive layers.
  • the first conductive layer 40 is adjacent to the third surface 42 c of the nonconductive layer 42
  • the second conductive layer 41 is adjacent to the fourth surface 42 d of the nonconductive layer 42 .
  • the first conductive layer 40 has at least first 43 and second 53 conductive regions
  • the second conductive layer 41 has at least third 44 and fourth 54 conductive regions, where the interstices 25 between conductive regions 43 , 53 , 44 , 54 may contain a polymeric nonconductive material 47 .
  • Conductive regions 43 , 53 and 44 , 54 of conductive layers 40 and 41 respectively, repeat in the x-dimension.
  • the unit cell 15 of FIG. 6 comprises first 120 and second 130 opposing faces.
  • the first face 120 is parallel to the reference plane 10
  • the second face 130 is parallel to a cutting plane 20 .
  • the reference 10 and cutting 20 planes are parallel in the y-z plane.
  • Electrically responsive elements 100 , 105 are separable at a cutting plane 20 and/or reference plane 10 where the first surface 43 a of the first conductive region 43 and the second surface 44 b of the third conductive region 44 are exposed on the first 120 and second 130 opposing faces, respectively.
  • the unit cell 15 of FIG. 6 illustrates a nonconductive layer 42 having a third surface 42 c adjacent to the fourth surface 43 d of the first conductive region 43 of the first conductive layer 40 .
  • the fourth surface 42 d of the nonconductive layer 42 is adjacent to the third surface 44 c of the third conductive region 44 of the second conductive layer 41 .
  • the interstices 25 may contain polymeric nonconductive material 47 .
  • the electronically responsive elements 100 , 105 of the electroresponsive actuator 5 of FIG. 5 are unpolarized for use as components of a group selected from actuators, sensors, pyroelectric devices, capacitors, and piezoelectric devices. These elements 100 , 105 typically comprise alternating layers of conductive and nonconductive materials. The number of layers of an element 100 may be defined by the design of the layering assembly used with appropriate extrusion equipment or other process considerations. Similarly, the dimensions of an element 100 may be subject to the design of a particular construction and a defined user application.
  • the conductive 40 , 41 and nonconductive 42 layers of an element 100 of FIG. 5 have controlled thicknesses.
  • the thickness of the layers is based on the layering assembly 400 design and corresponding downstream extrusion equipment.
  • the element 100 preferably has conductive layers 40 , 41 that are as thin as possible for subsequent use in a device without losing conductivity.
  • the nonconductive 42 and conductive 40 , 41 layers are typically symmetrical and preferably as thin as possible in order to maximize the electrical conductivity of the elements within a device.
  • the first 120 and second 130 opposing faces are used to separate first 100 and second 105 elements at cutting planes 20 , 24 and/or reference plane 10 .
  • the cutting 20 , 24 and/or reference 10 planes expose the first surface 43 a of first conductive region 43 , and the second surface 44 b of the third conductive region 44 to the first 120 and second 130 opposing faces of the elements 100 , 105 as illustrated in FIG. 6 .
  • the unit cell 15 of FIG. 6 may be used as component of a first device 600 illustrated in FIG. 7 .
  • the first device 600 may be coated with a second conductive material 510 on the first 120 and second 130 opposing faces.
  • the first surface 43 a of the first conductive region 43 and the second surface 44 b of the third conductive region are exposed at the first 120 and second 130 faces of FIG. 6 , respectively.
  • the first device 600 may comprises additional alternating conductive 40 , 41 and nonconductive 42 layers extending in the z-direction.
  • a device 610 comprising an element 100 having thin layer thicknesses typically has a voltage level of less than 10 volts. As the thickness of the layers decreases, the lower the applied driving voltage needed for a given application.
  • the device 610 may also have a modulus of elasticity in a range of 0.1 MPa-10 GPa.
  • FIG. 9 illustrates an article 180 having at least first 100 and second 105 electrically responsive elements, where the elements 100 , 105 are repeating in the x-dimension.
  • the elements 100 , 105 are separable by one or more cutting planes 20 , 24 .
  • the exposed first 120 and second 130 opposing faces of the elements 100 , 105 result from separation of the elements 100 , 105 at the cutting 20 , 24 and/or reference 10 planes.
  • First conductive layer 40 comprises first 43 and second 53 conductive regions which are discontinuous in the x-dimension.
  • third 44 and fourth 54 conductive regions of the second conductive layer 41 are discontinuous in the x-dimension.
  • the elements 100 , 105 are made from the unit cell 15 as illustrated in FIG. 6 .
  • the electroresponsive actuator 5 of FIG. 5 contains a plurality of electronically responsive elements 100 , 105 , where the elements are separable by n ⁇ 1 cutting planes 20 , 24 .
  • the cutting planes 20 , 24 are perpendicular to the x-dimension of the article.
  • a plurality of elements 100 , 105 comprises n unit cells 15 having n ⁇ 1 cutting planes 20 , 24 , wherein n is at least 3.
  • FIG. 10 illustrates a three-dimensional perspective of electroresponsive actuator 5 having at least two electrically responsive elements 100 , 105 separable at cutting 20 , 24 and reference 10 planes.
  • Conductive layers 40 , 41 are continuous in the y-dimension, and discontinuous in the x-dimension.
  • Nonconductive layer 42 alternates with the conductive layers 40 , 41 where the nonconductive layer 42 is continuous in the x- and y-dimensions.
  • Nonconductive material 47 occupies the interstices 25 between conductive regions 43 , 53 of first conductive layer 40 , and conductive regions 44 , 54 of the second conductive layer 41 .
  • FIG. 11 illustrates article 190 having at least first 100 and second 105 electrically responsive elements, where the elements 100 , 105 have alternating conductive 40 , 41 and nonconductive 42 layers repeating in the z-dimension.
  • the elements 100 , 105 are separable at cutting planes 20 , 24 .
  • the first 40 conductive layer comprises first 43 and second 53 conductive regions
  • the second 41 conductive layer comprises third 44 and fourth 54 conductive regions repeating in the x-dimension.
  • the cutting planes 20 , 24 for separating the elements 100 , 105 are perpendicular in the x-dimension. The separation of the elements 100 , 105 along cutting planes 20 , 24 of article 190 may result in multilayered elements for specific applications.
  • FIG. 12 illustrates a cross-sectional view in the y-z plane of element 100 .
  • the first face 120 of element 100 shows alternating conductive 40 and nonconductive 42 layers.
  • the layers include a first conductive layer 40 , and a nonconductive layer 42 .
  • the element 100 comprises first conductive layer 40 , nonconductive layer 42 , nonconductive material 47 of nonconductive region 48 of second conductive layer 41 as illustrated in FIG. 5 , followed by a nonconductive layer 42 .
  • Nonconductive material 47 may fill the interstices 25 or nonconductive region 48 located between the conductive regions of the first conductive layer 40 , where a conductive region does not extend to the reference plane 10 of first face 120 .
  • FIG. 13 illustrates a cross-sectional view in the y-z plane of element 100 .
  • the second face 130 of element 100 shows alternating conductive 41 and nonconductive 42 layers.
  • the layers include nonconductive material 47 of nonconductive region 48 of first conductive layer 40 as illustrated in FIG. 5 , a nonconductive layer 42 , and a second conductive layer 41 , followed by a nonconductive layer 42 .
  • Nonconductive material 47 fills the interstices 25 or nonconductive region 48 of first conductive layer 40 of FIG. 12 between the conductive regions.
  • Second conductive layer 41 comprises polymeric conductive material 49 of third conductive region 44 , which is continuous in the y-dimension.
  • FIG. 14 illustrates a cross-sectional view in an x-y plane of electroresponsive actuator 5 comprising at least first 100 and second 105 electrically responsive elements separable at cutting planes 20 , 24 and/or reference plane 10 .
  • Elements 100 , 105 are shown with first 43 and second 53 conductive regions of the first conductive layer 40 having interstices 25 filled with a nonconductive material 47 .
  • the first surface 43 a of the first conductive region 43 is coincident with reference plane 10 , where the second surface 43 b does not extend to the first cutting plane 20 .
  • the first surface 53 a of second conductive region 53 of the first conductive layer 40 is coincident with the first cutting plane 20 , where the second surface 53 b does not extend to the second cutting plane 24 .
  • Third surface 43 c of a first conductive region 43 and third surface 53 c of second conductive region 53 are the uppermost surfaces in the x-y plane illustrated in FIG. 14 .
  • Each of the alternating conductive layers 40 , 41 may be made of different materials or combinations of materials which may further comprise particles or fillers for conductivity.
  • each of the nonconductive layers 42 may include the analogous material or combination of materials to that used in the conductive layers 40 , 41 , although each individual nonconductive layer 42 may include different materials or combinations of materials from the other nonconductive layers.
  • the nonconductive layers 42 may further comprise particles to enhance electrical conductivity of an element 100 of a device.
  • the first polymeric material and organic particles form a polymeric conductive material 49 of the conductive layers 40 , 41 .
  • a first polymeric material is elastomeric.
  • Examples of a first polymeric material include silicone elastomers, acrylic elastomers, polyurethanes, polybutadienes, thermoplastic elastomers, polybutadiene-acrylonitrile copolymers and combinations thereof.
  • thermoplastic first polymeric material examples include pressure sensitive adhesives, fluoropolymers and polymers comprising silicone and acrylic moieties, and the like.
  • fluoropolymers include homopolymers such as polyvinylidene difluoride (PVDF), copolymers such as polyvinylidene fluoride-trifluoroethylene P(VDF-TrFE), polyvinylidene fluoride-chlorofluoroethylene P(VDF-CFE), polyvinylidene fluoride-hexafluoropropylene P(VDF-HFP), polyvinylidene fluoride-trifluoroethylene-chlorofluoroethylene P(VDF-TrFE-CFE), polyvinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene P(VDF-TrFE-CTFE), polyvinylidene fluoride-tetrafluoroethylene-chlorotrifluoroethylene, polyvinylidene fluoride
  • organic conductive particles or fillers examples include graphite, carbon nanotubes, carbon black, and combinations thereof. These materials may be added to the first polymeric material to form a polymeric conductive material 49 for the conductive layers 40 , 41 .
  • the first polymeric material may be mixed, blended, compounded or by other means with organic materials or fillers to achieve a uniform mixture of materials suitable for forming conductive layers 40 , 41 .
  • the first polymeric material may be blended or mixed with inorganic particles to form conductive layers 40 , 41 .
  • inorganic particles or fillers include silver, copper, nickel, aluminum, platinum, palladium, derivatives and combinations thereof. These materials may have irregular shapes or defined structures suitable for forming conductive layers 40 , 41 .
  • the first polymeric material may be blended or mixed with inorganic coated particles to form conductive layers 40 , 41 .
  • inorganic coated particles include gold, silver, palladium, platinum and combinations thereof.
  • Optional additives to combine with the conductive first polymeric material may further include dopants, doping agents and combinations thereof.
  • Doping agents comprises iodine, peroxides, Lewis acids and protic acids for doping by oxidation, sodium, potassium and calcium for doping by reduction.
  • the nonconductive layer 42 comprises a polymeric nonconductive material 47 .
  • the polymeric nonconductive material 47 may comprise a first polymeric material as described above. Mixtures or blends of the first polymeric material with other polymeric materials may be utilized to form a nonconductive layer 42 .
  • Additives to increase the dielectric constant may be added or compounded with the first polymeric material of nonconductive layer 42 . Examples additives include BaTiO 3 , lead zirconate titanate (PZT), PT (lead titanate) composites, PTCa and combinations thereof. These additives may be compounded with the first polymeric material.
  • the nonconductive 42 and conductive 40 , 41 layers being continuous in the y-dimension or the down-web dimension are substantially uniform in thickness to plus or minus 10 percent.
  • the multilayer construction can be obtained by multilayer extrusion process as described in U.S. Pat. No. 4,627,138.
  • the conductive layer also referred to as an electrode
  • U.S. Ser. No. 11/684,700 can be patterned as further described in Applicant's copending application U.S. Ser. No. 11/684,700, filed on Mar. 12, 2007 and incorporated by reference in its entirety. This process helps to control of the desired size of actuator rather than having full width depending upon the die lip as described in above patent.
  • Methods for coextruding multiple layer webs, and related equipment are described in U.S. Pat. Nos. 6,949,283 (Kollaja et al.) U.S. Pat. No. 5,825,543 (Ouderkirk et al.) and U.S. Pat. No. 5,783,120 (Ouderkirk et al.).
  • Multilayer construction can also be achieved by laminating each electroactive layer having electrode layers on the top and bottom.
  • the lamination process can be done in multiple ways such as using adhesive, heat lamination, using solvent (such as described in U.S. Pat. No. 5,997,800) to soften the top surface.
  • the pumps described in the document identified above include a power source (e.g., a battery), micropumps used in connection with the present invention may be manually powered.
  • examples of some other potentially suitable manually powered pumps may include, e.g., devices that include resilient cavities that can be compressed and, when returning to their pre-compression states, provide a vacuum force at the inlet of the pump (e.g., bulbs, hemovacs, etc.).
  • the medical dressings of the present invention and any micropumps used therewith to remove fluids from sealed environments be capable of quickly connecting with each other to form a fluid-tight seal during removal of fluids from the sealed environments defined by the medical dressings.
  • the medical dressing itself may preferably be featureless (e.g., present only the smooth external surface of the backing), while the micropump includes a seat that provides a surface capable of sealing against the featureless backing to form the required fluid-tight seal.
  • the medical dressings and micropumps may include more conventional connections/fittings to provide a fluid-tight connection between the micropumps and the medical dressings.
  • fittings may be useful where, e.g., the micropump is to be connected to the medical dressing for an extended period of time, e.g., for more than 2 minutes.
  • the wound dressing may include a fitting that attaches to the external surface of the backing using, e.g., a pressure sensitive adhesive, etc.
  • the fitting may, for example, include a tubing connector, Luer lock fitting, etc. designed for longer-term connection to a micropump.
  • the adhesive used to attach the fitting to the medical dressing may be releasable, i.e., the fitting may potentially be removed from the dressing while the dressing remains in place over a wound, such that any sealed environment defined by the medical dressing remains intact during removal of the fitting.
  • Preferred pumps are micropumps.
  • Preferred micropumps are diaphragm pumps having at least one deformable element. These micropumps may be actuated by a number of means including the use of electroactive polymers (EAP), piezoelectric pumps using ceramic piezoelectric elements such as PZT, ionic Polymer Metal Composites (IMPC) as well as composites incorporating carbon nanotubes or other conductive elements that enhance the electroactive response.
  • EAP electroactive polymers
  • IMPC ionic Polymer Metal Composites
  • EAP Micropumps disclosed in herein which preferably comprise multilayer EAP elements made, for example, as taught in U.S. Pat. No. 4,627,138 as well as EAP pumps disclosed in Pope et. al. Dielectric Elastomer Laminates for Active Membrane Pump Applications, Proc. Of SPIE Vol. 5385, 2004, pp 60-67; traveling wave pumps such as that described in U.S. Pat. No. 5,961,298.
  • Suitable EAP materials include polyurethanes such as those disclosed in U.S. Pat. No.
  • a check valve or other means may be required to regulate pressure, particularly for pumps able to create a vacuum of more than 100 mmHg below atmospheric pressure. This may be accomplished via a check valve that opens at a predetermined pressure drop and allows air into the wound bed. If a check valve is used it preferably has a membrane element that will filter out microorganisms and prevent them from entering the wound bed.
  • the micropump is equipped with a pressure sensor and a control circuit that slows the pump speed at a predetermine pressure set point. The set point is preferably variable and easily set by the clinician. A read out of the pressure may be desired.
  • the micropump is self limiting and unable to create a vacuum more than the desired maximum vacuum, e.g. more than about 150 mmHg.
  • the micropump may be driven by AC or DC power and may be from a line or battery source.
  • the micropump is driven by a small disposable battery source.
  • the power source may be located in a package with the micropump or it may be at a remote site and connected to the micropump.
  • the battery is capable of driving the micropump for at least 2 hours of continuous operation. More preferably, the battery is capable of driving the micropump for at least 8 hours, even more preferably at least 1 day, more preferably still for multiple days of continuous operation.
  • the micropumps are more energy efficient to avoid the need for large battery sources.
  • the micropump is secured directly to the wound dressing either through the interior portion of the dressing or at the periphery.
  • an inlet tube may be unnecessary.
  • the micropump also can be remote from the dressing and attached via an inlet tube.
  • the micropump may have multiple inlets and exit ports and/or multiple micropumps may be employed on a single dressing.
  • Such inlet means may be a simple tube which passes fluid from the wound bed into the micropump. The inlet of the inlet tube may then need to be protected by a porous filter element.
  • the inlet means may be a simple flexible tube or may be other means such as the fluid control articles described in U.S. Pat. No. 6,420,622 or the drain tubes described in U.S. Pat. No. 4,398,910.
  • micropump When the micropump is not connected directly to the dressing it is preferably a tubular configuration such as micropump embodiments shown in FIGS. 18 and 20 that can be sealed between the dressing and the skin surface and pass between the wound bed (inlet) and the exterior.
  • the micropump exit is preferably in fluid communication with a reservoir further described below and designed to collect the excess wound fluid.
  • the fluid reservoir may be a vented rigid container, a flexible container, or a vented flexible container. In a rigid container a vent is required in order to reduce or eliminate pressure build-up in the container.
  • the container may be a simple vacuum canister such as used routinely in surgery, a canister or it may be a simple deflated flexible pouch that fills to capacity with excess wound fluid.
  • the reservoir may be empty or may be filled with an absorbent that solidifies the fluid as it absorbed.
  • the reservoir is a flexible pouch similar to that used in ostomy appliances and it may be flushable.
  • the present invention can accommodate ambulatory patients by supplying a discrete system of a wound dressing, micropump and interchangeable small fluid reservoir collection pouches.
  • the collection pouch can be constructed of any suitable polymeric material but is preferably an odor barrier such as disclosed in U.S. Pat. No. 7,270,860.
  • the collection reservoir may have a means for alerting the patient or care giver that it should be changed. This alert can be an electronic means or a passive means.
  • Preferred fluid reservoirs can be a flexible pouch similar to that used in ostomy appliances such as those disclosed in U.S. Pat. No. 7,214,217.
  • the pouches may even be flushable as disclosed in U.S. Pat. No. 7,179,245.
  • the fluid reservoir may be as simple as a vacuum canister such as used routinely in surgery, a canister such as described in U.S. Pat. No. 4,569,674.
  • One or more micropumps 850 may also be provided in the kit 800 , with the micropumps 850 attached to the wound dressing(s) 810 and/or provided as separate articles for the user to attach at their discretion and or one or more fittings 884 adapted for attachment to the external surfaces of the dressings 810 as discussed herein, where the fittings 884 can be used to provide connections between the wound dressing and/or valves in the dressings 810 and the micropumps 850 .
  • the kit 800 may also include one or more intermediate wound packing materials 870 as described herein.
  • the electroactive actuator displacement can be further increased by modifying the actuator structure.
  • mechanical structures that will enhance the displacement include multilayer laminates of electroactive materials, unimorph (e.g. a piezoelectric disk cemented to a thin metal disk), bimorph (e.g. a cantilever that consists of two active layers.
  • electrical activation of a piezoelectric bimorph cause one layer to extend and the other layer to contract
  • recurved benders corrugated benders, spiral or helical designs.
  • Recurve Piezoelectric-Strain-Amplifying Actuator Architecture in IEEE/ASME TRANSACTIONS ON MECHATRONICS, VOL. 3, NO. 4, December 1998, 293, James D. Ervin and Diann Brei.Nonconductive polymer materials are described in U.S. Pat. Nos. 6,605,246, 6,343,129, and 5,977,585.
  • Nonconductive polymer actuator materials include fluoropolymers and polymers comprising silicone and acrylic moieties, and the like.
  • fluoropolymers include homopolymers such as polyvinylidene difluoride (PVDF) copolymers such as polyvinylidene fluoride-trifluoroethylene P(VDF-TrFE), polyvinylidene fluoride-chlorofluoroethylene P(VDF-CFE), polyvinylidene fluoride-hexafluoropropylene P(VDF-HFP), polyvinylidene fluoride-trifluoroethylene-chlorofluoroethylene P(VDF-TrFE-CFE), polyvinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene P(VDF-TrFE-CTFE), polyvinylidene fluoride-tetrafluoroethylene-chlorotrifluoroethylene, polyvinylidene fluoride-trifluoroethylene
  • Electroactive materials include: (a) Ceramic actuator material containing lead such as lead zirconate titanate (PZT), lead zirconate niobate:lead titanate (PZN:PT), lead magnesium niobate:lead titanate (PMN:PT), barium titanate (BaTiO 3 ); (b) Conductive polymers such as polyaniline, trans polyacetylene, polypyrrole, polythiophenes, polyethyldioxithiophene, carbon nanotubes etc.; (c) Ionic Polymer metal composite (IPMC) films, such as NafionTM and FlemionTM or styrene/divinylbenzene, perfluorinated alkenes based polymers doped with metal ions such as Pt(NH 3 ) 4 HCl; (d) Polymer gels actuators include polyacrylonitrile, polyacrylic acid gel, polyacrylic acid-poly vinylalcohal; and any combinations of
  • the backings used in connection with the present invention may be high moisture vapor permeable film backings Issued U.S. Pat. Nos. 3,645,835 and 4,595,001 describe methods of making such films and methods for testing their permeability.
  • the film (and any adhesive used thereon as described herein) may transmit moisture vapor at a rate equal to or greater than human skin.
  • the adhesive-coated film may, e.g., transmit moisture vapor at a rate of at least 300 g/m 2 /24 hrs/37° C./100-10% RH, more preferably at least 700 g/m 2 /24 hrs/37° C./100-10% RH, and most preferably at least 2000 g/m 2 /24 hrs/37° C./100-10% RH using the inverted cup method as described in U.S. Pat. No. 4,595,001.
  • the backings may also preferably be conformable to anatomical surfaces. As such, when the backing is applied to an anatomical surface, it conforms to the surface even when the surface is moved.
  • the backing may also be conformable to animal anatomical joints. When the joint is flexed and then returned to its unflexed position, the backing may stretch to accommodate the flexion of the joint, but is resilient enough to continue to conform to the joint when the joint is returned to its unflexed condition.
  • Examples of some potentially suitable backings may include elastomeric polyurethane, polyester, or polyether block amide films. These films combine the desirable properties of resiliency, high moisture vapor permeability, and transparency.
  • a relatively high moisture vapor permeable backing may not be required.
  • some other potentially useful backing materials may include, e.g., metallocene polyolefins and SBS and SIS block copolymer (e.g., KRATON type) materials could be used.
  • the backings be kept relatively thin to, e.g., improve conformability.
  • the backings be formed of (e.g., consist essentially of) polymeric films with a thickness of 200 micrometers or less, or 100 micrometers or less, potentially 50 micrometers or less, or even 25 micrometers or less.
  • the particulates or beads may, in some embodiments, be contained within a flexible bag or other structure to facilitate removal of the wound packing (unless, e.g., the wound packing material is bioabsorbable and/or biodegradable).
  • a preferred polyurethane foam may be hydrophilic and capable of spontaneously absorbing deionized water such as WILSORB foam (available from Illbruck). Preferred hydrophilic packing components will absorb a 100 microliter drop of deionized water when gently placed in contact with the foam in less than 60 seconds and preferably in less than 30 seconds.
  • the pressure sensitive adhesives that may preferably be used in the wound dressings of the present invention may include adhesives that are typically applied to the skin such as the acrylate copolymers described in U.S. Pat. No. RE 24,906, particularly a 97:3 iso-octyl acrylate:acrylamide copolymer.
  • Another example may include a 70:15:15 isooctyl acrylate:ethyleneoxide acrylate:acrylic acid terpolymer, as described in U.S. Pat. No. 4,737,410 (Example 31).
  • Other potentially useful adhesives are described in U.S. Pat. Nos. 3,389,827; 4,112,213; 4,310,509; and 4,323,557. Inclusion of medicaments or antimicrobial agents in the adhesive is also contemplated, as described in U.S. Pat. Nos. 4,310,509 and 4,323,557.
  • Release liners may be supplied with the wound dressings of the present invention to protect the pressure sensitive adhesive used to attach the dressings to the patient and create the sealed environment.
  • Release liners that may be suitable for use in the wound dressing of the present invention can be made of supercalendered kraft paper, glassine paper, polyethylene, polypropylene, polyester or composites of any of these materials.
  • the liners are preferably coated with release agents such as fluorochemicals or silicones.
  • release agents such as fluorochemicals or silicones.
  • U.S. Pat. No. 4,472,480 describes low surface energy perfluorochemical liners.
  • the liners may preferably be in the form of papers, polyolefin films, polyolefin coated paper or polyester films coated with silicone release materials.
  • a specific release liner may be made in conjunction with the selection of a pressure sensitive adhesive.
  • Those skilled in the art will be familiar with the processes of testing a new adhesive against different liners or a new liner against different adhesives to arrive at the combination of qualities desired in a final product.
  • the considerations pertinent to the selection of a silicone release liner can be found in Chapter 18 of the Handbook of Pressure Sensitive Adhesive Technology, Van Nostrand-Reinhold, 1982, pp. 384-403.
  • U.S. Pat. No. 4,472,480 also describes considerations pertinent to the selection of a perfluoropolyether release liner.
  • the backings used in the wound dressings of the present invention may be so flexible and supple such that when a release liner is removed from the backing, the backing may tend to fold and adhere to itself, interfering with the smooth, aseptic application of the dressing to a patient's skin.
  • Alternative carriers and/or delivery systems may include frames, handles, stiffening strips, etc. as disclosed in issued U.S. Pat. Nos. 6,742,522; 5,979,450; 6,169,224; 5,088,483; 4,598,004; D 493,230; etc. Still another potentially suitable delivery system may be described in U.S. Patent Application Publication No. US 2007/0156075 A1.
  • the backings can be delivered linerless as described in, e.g., U.S. Pat. No. 5,803,086.
  • FIG. 15 is a cross-sectional schematic diagram of this example.
  • a TegadermTM (3M Company, Maplewood Minn.) wound dressing 102 is used to seal a wound cavity defined by the wound bed “WB” and the wound dressing.
  • the wound cavity is filled with a wound packing 110 .
  • a diaphragm micropump is fixed to the exterior surface of the wound dressing backing The micropump extracts fluid (air and wound exudate) and moves this fluid through the exudate collection line to a to a flexible collection pouch 150 .
  • the collection pouch is designed very similar to an ostomy bag and can be worn in a similar manner.
  • the collection pouch may be sealed or vented. In a preferred embodiment it is not vented. If vented, it may include a vent filter to reduce order that may be generated from the wound fluid.
  • a valve is placed in the exudate collection line 140 which may be used to collect samples of wound fluid for analysis.
  • An orifice, 126 is made through the dressing that communicates with pump inlet opening 125 .
  • the pump inlet 125 of the micropump leads to a chamber, 123 , having a self sealing elastomeric one-way inlet valve, 122 . Fluid enters the inlet chamber passes into a pumping chamber 129 and exits through the exit chamber 127 .
  • An exit valve, 124 is placed at the entrance to the outlet chamber.
  • the one-way inlet and exit valves are shown as an elastomeric umbrella valve which may be obtained from Vernay Laboratories, Yellow Springs, Ohio. Both umbrella valves are normally closed valves. Although shown with a single inlet and outlet valve, multiple inlet and multiple outlet valves may be used.
  • the inlet and outlet valves need to have a “cracking pressure”. That is, a finite minimum pressure which causes them to open. This ensures a good seal. Without a good tight hermetic seal the micropump will not operate at low flow rates.
  • the umbrella valve elastomeric stem is designed to be stretched to provide a strain force sufficient to bias the valves into a normally close condition.
  • duck bill valves may be used that have a defined cracking pressure.
  • Duckbill valves also are available from Vernay Laboratories.
  • the micropump also includes a diaphragm, 130 , that is capable of displacement sufficient to move the fluid.
  • valves ( 122 and 124 ) and diaphragm, 128 may be eliminated and replaced with a digital pulse activated actuated pump system as described in US Patent Application Publication No. 2004/0234401 in which multiple actuators are in direct contact with the fluid.
  • a preferred piezoelectric micropump is a 1/10 scale version of a Model BPH-414D piezoelectric pump available from MEDO USA.
  • This micropump is capable of pulling a vacuum of 161 mmHg below atmospheric pressure without the need for priming. It is a desired property of the micropumps that they be self-priming (i.e. no priming necessary).
  • Multiple cells with smaller diaphragms may also be used to generate higher inlet vacuum and higher exit pressure.
  • a battery sends current to the actuator which causes the diaphragm to displace up, down, or both up and down. This movement displaces the fluid in the pumping chamber creating a positive pressure at the exit valve and a negative pressure at the inlet valve.
  • the maximum vacuum i.e. pressure less than atmospheric
  • a controller may be provided that can allow the clinician to adjust the flow rate and/or vacuum created.
  • wound packing material 110 Preferred wound packing materials include hydrophobic open cell polyurethane foam, open cell hydrophilic polyurethane foam such as Aquazone foam available from Foamex International, Linwood, Pa.
  • Foams may have pore sizes of 30-200 pores per inch but are preferably 50-150 PPI. Densities may be from 1 to 5 lb/ft 3 (16-80 kg/M 3 ) but are preferably 1.5 to 3 lb/ft 3 (25-50 kg/M 3 ).
  • the wound dressing system also may comprise a wound contact layer 108 .
  • the wound contact layer may be a separate component but preferably is bonded to the wound packing material. Bonding may be accomplished by thermal or adhesive methods.
  • FIG. 5 shows the wound contact layer as a separate component.
  • Suitable wound contact layers include TegaporeTM, (3M Company, Maplewood, Minn.) or XEROFLOTM (Kendall Corp. a division of Covidien, Mansfield, Mass.).
  • Other suitable wound contact layers include gels such as alginate gels and alginate fabrics such as TegadermTM Alginate (3M Company, Maplewood, Minn.) or carboxymethylcellulose nonwoven fabrics such as Aquacel Ag (Convatec a division of E. R. Squibb & Sons, LLC, UK)
  • the wound dressing evacuation system of Example 1 is employed except that the micropump is supplied separately in a kit with the wound dressing.
  • the kit comprises the micropump, wound dressing, wound packing material with an integral (bonded) wound contact layer, evacuation line and wound fluid exudate collection pouch.
  • the wound packing/contact layer is cut to size and placed in the wound.
  • the dressing is placed over the entire wound making certain to seal well to the surrounding tissue and forming a hermetic seal.
  • the micropump comprises a pressure sensitive adhesive on its base.
  • the micropump is positioned over the preformed orifice in the dressing ( 126 ).
  • the micropump may be reusable (but preferably only on a single patient) and applied to several dressings in succession as needed.
  • the wound dressing evacuation system of Example 1 is employed.
  • the housing of the micropump must be rigid enough to prevent it from collapsing during operation. Thus, this can create a pressure point.
  • the micropump is sealed in a conformable elastomer which acts as a cushioning device and prevents sharp pressure points.
  • the wound dressing evacuation system of Example 2 is employed except that the micropump is placed off the dressing and adhered to the skin or to a separate secural device.
  • the micropump is connected to the wound dressing through an inlet line (tubing) and a port which is secured to the dressing over the orifice with, for example, an adhesive, heat seal, or solvent weld.
  • Example 1 The wound dressing evacuation system of Example 1 is employed except that the wound dressing further comprises a frame on the perimeter of the top surface in order to facilitate delivery as described in U.S. Pat. Nos. 5,088,483 and 5,738,642 which are incorporated herein by reference.
  • the film was kept pre-stretched by stretching in over and securing it to a glass ring. Due to sticky nature of VHB tape, no other tape was use to stick the VHB to glass ring and also to make multilayer actuator films.
  • the gold electrode was coated on the both sides of pre-stretched film using Pelco SC-6 sputter coater. A paper circular mask was used to get desired shape (2.5 cm and 4 cm diameter) of the gold electrode. The strip of 2.0 mm ⁇ 20 mm of 3M 1181 copper conductive tape was used to make connections at the edge of each gold coating.
  • the first actuator film is coated as explained above.
  • the second actuator film was stretched 400% in both directions and than carefully laminated to first layer.
  • the top electrode of first layer is used as a bottom electrode of 2 nd layer.
  • a strip of copper tape was attached to the gold electrode before laminating another layer.
  • polyurethane (Tegaderm 1621) was laminated on the top of the actuator stack.
  • the polyurethane film did not have any electrode on the top.
  • This film was then removed from glass ring and laminated to the top cover of a pump housing. The top cover was placed on the bottom of the pump housing with the polyurethane layer down.
  • the multilayer actuator diaphragm was activated (induced to move in the Z axis) by applying a AC voltage using Trek model #610E voltage amplifier connected with function generator HP 3314A.
  • the 10 mmHg pressure was achieved using 5-layers of VHB and One layer of polyurethane film.
  • a conductive polymer micropump useful in this invention is commercially available from EAMEX Corporation, Osaka Japan and has an actuator comprising a modified polypyrrol polymer—(PPy-CF 3 SO 3 ).
  • the micropump specifications of a few of these micropumps are described below.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Otolaryngology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)
US12/936,255 2008-04-04 2009-04-01 Wound dressing with micropump Abandoned US20110112492A1 (en)

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US4269808P 2008-04-04 2008-04-04
PCT/US2009/039058 WO2009124100A1 (en) 2008-04-04 2009-04-01 Wound dressing with micropump
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US10653823B2 (en) 2020-05-19
CN102046121A (zh) 2011-05-04
US20150250931A1 (en) 2015-09-10
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JP2011516167A (ja) 2011-05-26
EP2282707A1 (en) 2011-02-16

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