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WO2025224365A1 - Bandage pour thérapie de plaie par pression négative (npwt) - Google Patents

Bandage pour thérapie de plaie par pression négative (npwt)

Info

Publication number
WO2025224365A1
WO2025224365A1 PCT/EP2025/061609 EP2025061609W WO2025224365A1 WO 2025224365 A1 WO2025224365 A1 WO 2025224365A1 EP 2025061609 W EP2025061609 W EP 2025061609W WO 2025224365 A1 WO2025224365 A1 WO 2025224365A1
Authority
WO
WIPO (PCT)
Prior art keywords
wound
membrane
adhesive
bandage
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/061609
Other languages
English (en)
Inventor
Machiel Van Der Leest
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guard Medical Sas
Original Assignee
Guard Medical Sas
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 Guard Medical Sas filed Critical Guard Medical Sas
Publication of WO2025224365A1 publication Critical patent/WO2025224365A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • 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
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/0256—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the parametric properties of the adhesive

Definitions

  • This invention relates to bandages in general, and more particularly to negative pressure wound therapy (NPWT) bandages.
  • NWT negative pressure wound therapy
  • bandages are used to provide wound care during healing. More particularly, bandages generally provide a covering for a wound so as to shield the wound from contaminants and microbes during healing. Most bandages also provide a closure feature to help hold the edges of the wound in close apposition during healing. Bandages also frequently include gauze or the like to receive exudates emerging from the wound during healing.
  • Negative pressure wound therapy (NPWT) bandages apply a negative pressure to a wound during healing. This negative pressure helps reduce the likelihood of contaminants and microbes entering the wound during healing, helps draw exudates from the wound during healing, and can promote beneficial biological responses at the wound site. More particularly, NPWT bandages typically comprise (i) an absorbent dressing configured to make a fully-sealed chamber around the perimeter of a wound (“the wound chamber”), (ii) a source of negative pressure, and (iii) a conduit extending between the fully-sealed wound chamber and the source of negative pressure.
  • the absorbent dressing can be applied to a wound so as to create a fully-sealed chamber around the perimeter of the wound, and the source of negative pressure can apply a negative pressure to the fully-sealed wound chamber, such that any contaminants and microbes present at the wound site are drawn away from the wound, exudates are drawn out of the wound, and beneficial biological responses are promoted at the wound site.
  • NPWT bandages are part of a large, complex NPWT system, in the sense that (i) the absorbent dressings are generally fairly large (e.g., they are sized to cover large open wounds), (ii) the sources of negative pressure are generally fairly large, and formed and located separate from the absorbent dressings (e.g., the sources of negative pressure typically comprise electrically-powered suction pumps or vacuum canisters), and (iii) the NPWT systems generally require substantial training to use. These NPWT systems also tend to be quite expensive.
  • NPWT bandage where the source of negative pressure is integrated with the absorbent dressing.
  • efforts have been made to provide an NPWT bandage where a manually-operated suction pump is integrated into the absorbent dressing.
  • NPWT bandages integrating a suction pump with the absorbent dressing tend to suffer from a variety of deficiencies, e.g., they have a complex design, and/or are expensive, and/or are complicated to use, and/or are bulky (including having a high profile), and/or cause additional trauma to the wound during use, and/or have poor pump efficiency, and/or lack a way of indicating the level of negative pressure created, and/or lack a way of limiting the level of negative pressure created, etc.
  • the NPWT bandage can cause trauma to the patient, e.g., blistering, capillary leakage, etc.
  • NPWT bandage which is simple, inexpensive, easy-to-use, small in size (including having a low profile), is atraumatic to the wound during use, has improved pump efficiency, incorporates an automatic pressure indicator for indicating the level of negative pressure created, and provides an automatic pressure limiter for limiting the level of negative pressure created.
  • NPWT bandage which is simple, inexpensive, easy-to-use, small in size (including having a low profile), is atraumatic to the wound during use, has improved pump efficiency, incorporates an automatic pressure indicator for indicating the level of negative pressure created, and provides an automatic pressure limiter for limiting the level of negative pressure created.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • said NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through said membrane from said wound-side surface to said atmosphere-side surface; and a pump assembly carried by said membrane, said pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of said wall structure is resilient; a wound-side passageway extending through said wall structure and communicating with the wound chamber through said opening formed in said membrane; a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said pump chamber but to prevent fluid from flowing through said wound-side passageway from said pump chamber to the wound chamber; an atmosphere-
  • the NPWT bandage is configured so that when the pressure differential between the pressure of the fluid within said pump chamber and atmospheric pressure is below a predetermined threshold, said pump body of said pump assembly will assume a substantially fully expanded configuration, and when said pressure differential between the pressure of the fluid within said pump chamber and atmospheric pressure is above said predetermined threshold, said pump body of said pump assembly will assume a substantially fully collapsed configuration.
  • the NPWT bandage is configured so that said pump body abruptly changes state between said substantially fully expanded configuration and said substantially fully collapsed configuration, and between said substantially fully collapsed configuration and said substantially fully expanded configuration, as said pressure differential crosses said predetermined threshold so as to effectively constitute a substantially “binary state” device.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • said NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through said membrane from said wound-side surface to said atmosphere-side surface; and a pump carried by said membrane and comprising a wall chamber disposed about a pump chamber, wherein at least a portion of said wall chamber is resilient, and further wherein said pump chamber communicates with the wound chamber through said opening formed in said membrane; wherein no part of said pump chamber is defined by the wound.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • said NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through said membrane from said wound-side surface to said atmosphere-side surface; and a pump carried by said membrane and comprising a wall chamber disposed about a pump chamber, wherein at least a portion of said wall chamber is resilient, and further wherein said pump chamber communicates with the wound chamber through said opening formed in said membrane; wherein said pump does not apply positive pressure to the wound.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • said NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through said membrane from said wound-side surface to said atmosphere-side surface; and a pump carried by said membrane and comprising a wall chamber disposed about a pump chamber, wherein at least a portion of said wall chamber is resilient, and further wherein said pump chamber communicates with the wound chamber through said opening formed in said membrane; wherein said pump is connected to the wound chamber such that a reduction in the volume of the pump chamber does not cause a change in pressure in the wound chamber.
  • the negative pressure wound therapy (NPWT) bandage is constructed so that it also provides a negative pressure decay “warning state” indicator.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; and a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient, and further wherein the pump chamber communicates with the wound chamber through the opening formed in the membrane; and an atmosphere-side passageway extending through the wall structure so as to fluidically connect the pump chamber to the atmosphere; such that when a compressive force is applied to the wall structure of the pump body, fluid within the pump chamber is forced out of the pump chamber via the atmosphere-side passageway, and when the compressive force applied to the wall structure of the pump body is thereafter
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; and a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient, and further wherein the pump chamber communicates with the wound chamber through the opening formed in the membrane; and an atmosphere-side passageway extending through the wall structure so as to fluidically connect the pump chamber to the atmosphere; wherein when a compressive force is applied to the wall structure of the pump body, fluid within the pump chamber is forced out of the pump chamber via the atmosphere-side passageway, and when the compressive force applied to the wall structure of the pump body
  • NGWT negative pressure wound therapy
  • the negative pressure wound therapy (NPWT) bandage includes a canister for collecting exudates.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber; and an atmosphere-side passageway extending through the wall structure and connecting the pump chamber to the atmosphere; and a canister configured to be in fluid communication with the wound chamber and the pump assembly, the canister comprising an interior chamber for collecting exudates exiting the wound chamber; wherein the pump assembly is configured to generate a negative air pressure within the wound chamber such that exu
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber; and an atmosphere-side passageway extending through the wall structure and connecting the pump chamber to the atmosphere; and a canister configured to be in fluid communication with the wound chamber and the pump assembly, the canister comprising an interior chamber for collecting exudates exiting the wound chamber; wherein the pump assembly is configured to generate a negative air pressure within the wound chamber such that
  • NGWT negative pressure wound therapy
  • the negative pressure wound therapy (NPWT) bandage includes a luer lock for suction attachment.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber through the opening in the membrane; and an atmosphere-side passageway extending through the wall structure and connecting the pump chamber to the atmosphere; and a suction source configured to be connected to the pump assembly for establishing negative air pressure within the wound chamber; wherein when the negative air pressure within the wound chamber is below a predetermined threshold, the pump body will assume a substantially fully expanded configuration
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber through the opening in the membrane; an atmosphere-side passageway extending through the wall structure and connecting the pump chamber and the atmosphere; and a suction source configured to be connected to the pump assembly for establishing negative air pressure within the wound chamber; wherein when the negative air pressure within the wound chamber is below a predetermined threshold, the pump body will assume a substantially fully expanded configuration
  • NGWT negative pressure wound therapy
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber through the opening in the membrane; and an atmosphere-side passageway extending through the wall structure and connecting the pump chamber to the atmosphere; and a connector for connecting a suction source to the pump assembly for establishing negative air pressure within the wound chamber; wherein when the negative air pressure within the wound chamber is below a predetermined threshold, the pump body will assume a substantially fully expanded configuration
  • the negative pressure wound therapy (NPWT) bandage is provided with a pump assembly that is laterally offset from a wound while remaining in fluid communication with the wound.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane comprising a first portion configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, and a second portion configured to extend laterally away from the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending from the wound-side surface to the atmosphere-side surface, the opening being in fluid communication with the wound chamber; and a pump assembly carried by the second portion of the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber through the opening in the membrane; and an atmosphere-side passageway extending through the wall structure and connecting the pump chamber to the atmosphere; wherein the pump assembly is configured to generate a negative air pressure within the wound chamber.
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane comprising a first portion configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, and a second portion configured to extend laterally away from the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending from the wound-side surface to the atmosphere-side surface, the opening being in fluid communication with the wound chamber; and a pump assembly carried by the second portion of the membrane, the pump assembly comprising: a pump body comprising a wall structure disposed about a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway extending through the wall structure and communicating with the wound chamber through the opening formed in the membrane; and an atmosphere-side passageway extending through the wall structure and connecting the pump chamber to the atmosphere; wherein the pump assembly is configured to generate a negative air pressure within the wound chamber
  • NGWT negative pressure wound therapy
  • a negative pressure wound therapy bandage for covering a wound, the bandage comprising a transparent top layer which captures a layer of foam against the wound, wherein the foam layer is provided with a series of windows which (i) allow direct visualization of the wound, and (ii) provide a metric along the length of the bandage to indicate whether the bandage needs to be replaced.
  • the foam layer also comprises perimeter serrations which allow the bandage to conform to a curved wound.
  • This novel negative pressure wound therapy bandage may be used with an on-board pump or with a pump located remote from the bandage (or with another source of suction, e.g., wall suction). This novel bandage may also be used without applying negative pressure to the wound.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending from the wound-side surface to the atmosphere-side surface, the opening being in fluid communication with the wound chamber; wherein the membrane comprises a transparent layer and an absorbent layer, wherein the absorbent layer is disposed on the wound-side of the membrane; wherein the absorbent layer comprises a plurality of windows extending through the absorbent layer; and further wherein the transparent layer of the membrane and the plurality of windows of the absorbent layer of the membrane permit visualization of the wound through the membrane; and a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure defining a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passageway
  • a bandage for covering a wound releasing exudate comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending from the wound-side surface to the atmosphere-side surface, the opening being in fluid communication with the wound chamber; wherein the membrane comprises a transparent layer and an absorbent layer, wherein the absorbent layer is disposed on the wound-side of the membrane; wherein the absorbent layer comprises a plurality of windows extending through the absorbent layer; and further wherein the transparent layer of the membrane and the plurality of windows of the absorbent layer of the membrane permit visualization of the wound through the membrane.
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending from the wound-side surface to the atmosphere-side surface, the opening being in fluid communication with the wound chamber; wherein the membrane comprises a transparent layer and an absorbent layer, wherein the absorbent layer is disposed on the wound-side of the membrane; wherein the absorbent layer comprises a plurality of windows extending through the absorbent layer; and further wherein the transparent layer of the membrane and the plurality of windows of the absorbent layer of the membrane permit visualization of the wound through the membrane; and a pump assembly carried by the membrane, the pump assembly comprising: a pump body comprising a wall structure defining a pump chamber, wherein at least a portion of the wall structure is resilient; a wound-side passage
  • NGWT negative pressure wound therapy
  • a method for covering a wound releasing exudate comprising: providing a bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending from the wound-side surface to the atmosphere-side surface, the opening being in fluid communication with the wound chamber; wherein the membrane comprises a transparent layer and an absorbent layer, wherein the absorbent layer is disposed on the wound-side of the membrane; wherein the absorbent layer comprises a plurality of windows extending through the absorbent layer; and further wherein the transparent layer of the membrane and the plurality of windows of the absorbent layer of the membrane permit visualization of the wound through the membrane; positioning the bandage over the wound so as to form a wound chamber between the membrane and the wound; and visualizing the absorbent layer of the membrane to determine whether the bandage needs to be removed from the wound and replaced with a new bandage.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; wherein the wound-side surface of the membrane comprises an outboard skin-contacting surface extending about the perimeter of the wound-side surface of the membrane, and an inboard skin-contacting surface extending inboard of the outboard skin-contacting surface, and further wherein the outboard skincontacting surface comprises a first adhesive and the inboard skin-contacting surface comprises a second adhesive; and a pump assembly connected to the membrane, the pump assembly comprising an inlet in fluid communication with the opening extending through the membrane and the wound chamber, and an outlet in fluid communication with atmosphere, the pump assembly being configured to generate a negative air pressure inside the wound chamber.
  • a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound
  • the NPWT bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; an intermediate foam layer disposed between the wound-side surface of the membrane and the wound, the intermediate foam layer comprising a lower wound-chamber contacting surface in fluid communication with the wound; wherein the wound-side surface of the membrane extends over the intermediate foam layer so as to present a skin-contacting lower surface; wherein at least one of the lower wound-chamber contacting surface of the intermediate foam layer and the skin-contacting lower surface of the membrane comprise an adhesive; and a pump assembly connected to the membrane, the pump assembly comprising an inlet in fluid communication with the opening extending through the membrane and the wound chamber, and an outlet in fluid communication with atmosphere, the pump
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; wherein the wound-side surface of the membrane comprises an outboard skin-contacting surface extending about the perimeter of the wound-side surface of the membrane, and an inboard skin-contacting surface extending inboard of the outboard skin-contacting surface, and further wherein the outboard skin-contacting surface comprises a first adhesive and the inboard skin- contacting surface comprises a second adhesive; and a pump assembly connected to the membrane, the pump assembly comprising an inlet in fluid communication with the opening extending through the membrane and the wound chamber, and an outlet in fluid communication with atmosphere, the pump assembly being configured to generate a negative air pressure inside the wound chamber; positioning the a negative pressure wound therapy (NPWT) bandage compris
  • a method for applying negative pressure to a wound comprising: providing a negative pressure wound therapy (NPWT) bandage comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface, an atmosphere-side surface, and an opening extending through the membrane from the wound-side surface to the atmosphereside surface; an intermediate foam layer disposed between the wound-side surface of the membrane and the wound, the intermediate foam layer comprising a lower wound-chamber contacting surface in fluid communication with the wound; wherein the wound-side surface of the membrane extends over the intermediate foam layer so as to present a skin-contacting lower surface; wherein at least one of the lower wound-chamber contacting surface of the intermediate foam layer and the skin-contacting lower surface of the membrane comprise an adhesive; and a pump assembly connected to the membrane, the pump assembly comprising an inlet in fluid communication with the opening extending through the membrane and the wound chamber, and an outlet in fluid communication with atmosphere,
  • NGWT negative pressure wound therapy
  • a bandage for covering a wound comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface and an atmosphere-side surface; wherein the wound-side surface of the membrane comprises an outboard skin-contacting surface extending about the perimeter of the wound-side surface of the membrane, and an inboard skin-contacting surface extending inboard of the outboard skin-contacting surface, and further wherein the outboard skincontacting surface comprises a first adhesive and the inboard skin-contacting surface comprises a second adhesive.
  • a bandage for covering a wound comprising: a membrane configured for disposition over a wound so as to form a wound chamber between the membrane and the wound, the membrane comprising a wound-side surface and an atmosphere-side surface; and an intermediate foam layer disposed between the wound-side surface of the membrane and the wound, the intermediate foam layer comprising a lower wound-chamber contacting surface in fluid communication with the wound; wherein the wound-side surface of the membrane extends over the intermediate foam layer so as to present a skin-contacting lower surface; wherein at least one of the lower wound-chamber contacting surface of the intermediate foam layer and the skin-contacting lower surface of the membrane comprise an adhesive.
  • Figs. 1-4 are schematic views showing a new and improved NPWT bandage formed in accordance with the present invention, with Figs. 2 and 3 being exploded views;
  • Fig. 4A is a schematic view showing, for two different size wound chambers (i.e., a 7.5 mL wound chamber and a 15 mL wound chamber), a maximum negative pressure that may be established with (i) a deformable pump body having two one-way valves (with one one-way valve being disposed on either side of the deformable pump body), and (ii) a deformable pump body having a single one-way valve (note: in the comparison shown in Fig. 4A, the volume of the pump chamber of the deformable pump body with 1 one-way valve is the same as the volume of the pump chamber of the deformable pump body with 2 one-way valves);
  • Figs. 5 and 6 are schematic views showing the pump body of the pump assembly of the NPWT bandage shown in Figs. 1-4 in its substantially fully expanded configuration (Fig. 5) and in its substantially fully collapsed configuration (Fig. 6);
  • Fig. 7 is a schematic view showing how the pump body of the pump assembly of the NPWT bandage shown in Figs. 1 -4 abruptly changes state between its substantially fully expanded configuration and its substantially fully collapsed configuration;
  • Fig. 8 is a schematic view showing how the pump bodies of the pump assemblies of prior art NPWT bandages gradually change state between their substantially fully expanded configuration and their substantially fully collapsed configuration;
  • Figs. 9-16 are schematic views showing exemplary use of the new and improved NPWT bandage shown in Figs. 1-4 (note that in Figs. 11 and 14-16, removable cap 100 (see below) is removed from the figures for clarity of illustration);
  • Figs. 17-20 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Fig. 20 A is a schematic view showing how the configuration of the pump body changes during use (note that in Fig. 20 A, only the outer boundary of the pump’s side wall 65 is shown, and the pump’s flange 75 and neck 77 are omitted, for clarity of illustration);
  • Figs. 21-25 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Figs. 26 and 27 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention, wherein the pump body is constructed so that it also provides a negative pressure decay “warning state” indicator;
  • Fig. 28 is a schematic view showing how the configuration of the pump body comprising a negative pressure decay “warning state” indicator changes during use (note that in Fig. 28, only the outer boundary of the pump’s side wall is shown, for clarity of illustration);
  • Fig. 29 is a schematic view showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Fig. 30 is a schematic view showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Fig. 31 is a schematic view showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Fig. 32 is a schematic view showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Figs. 33 and 34 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention.
  • Figs. 35-38 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention, wherein the wound chamber comprises a lateral extension, and wherein the pump assembly is in fluid communication with the lateral extension, so that the pump assembly is laterally offset from the wound while remaining in fluid communication with the wound;
  • Figs. 39-42 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention, wherein the wound chamber comprises a lateral extension, and wherein the pump assembly is in fluid communication with the lateral extension, so that the pump assembly is laterally offset from the wound while remaining in fluid communication with the wound;
  • Figs. 43-46 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention, wherein the wound chamber comprises a lateral extension, and wherein the pump assembly is in fluid communication with the lateral extension, so that the pump assembly is laterally offset from the wound while remaining in fluid communication with the wound;
  • Fig. 46 A is a schematic view showing another new and improved NPWT bandage formed in accordance with the present invention, wherein the wound chamber comprises a lateral extension, and wherein the pump assembly is in fluid communication with the lateral extension, so that the pump assembly is laterally offset from the wound while remaining in fluid communication with the wound;
  • Figs. 47, 48 and 49 are schematic views showing another new and improved NPWT bandage formed in accordance with the present invention, wherein the bandage comprises a transparent top layer which captures a layer of foam against the wound, wherein the foam layer is provided with a series of windows which (i) allow direct visualization of the wound, and (ii) provide a metric along the length of the bandage to indicate whether the bandage needs to be replaced, and further wherein the foam layer also comprises perimeter serrations which allow the bandage to conform to a curved wound - in this form of the invention, the NPWT bandage comprises an on-board pump which is laterally offset from the wound;
  • Fig. 50 is a schematic view showing further details of the foam layer of Figs. 47, 48 and 49;
  • Figs. 51 and 52 are schematic views showing various levels of exudate in the foam layer of the bandage of Fig. 47;
  • Figs. 53 and 54 are schematic views showing how the windows in the foam layer allow medical personnel to align the bandage along a wound line;
  • Fig. 55 is a schematic view showing perimeter serrations formed in the foam layer which allow the bandage to be curved so as to follow the path of a curved wound;
  • Figs. 56 and 57 are schematic views showing how the NPWT bandage of Figs. 47, 48 and 49 may be modified so as to position the on-board pump over a portion of the foam;
  • Figs. 58, 59 and 60 are schematic views showing how the NPWT bandage of Figs. 56 and 57 may be modified to remove the on-board pump, whereby to provide a general purpose bandage which comprises a transparent top layer which captures a layer of foam against the wound, wherein the foam layer is provided with a series of windows which (i) allow direct visualization of the wound, and (ii) provide a metric along the length of the bandage to indicate whether the bandage needs to be replaced, and further wherein the foam layer also comprises perimeter serrations which allow the bandage to conform to a curved wound;
  • Figs. 61-63 are schematic views showing another novel NPWT bandage formed in accordance with the present invention.
  • Figs. 64-66 are schematic views showing still another novel NPWT bandage formed in accordance with the present invention.
  • the present invention comprises the provision and use of a new and improved NPWT bandage which is simple, inexpensive, easy-to-use, small in size (including having a low profile), is atraumatic to the wound during use, has improved pump efficiency, incorporates an automatic pressure indicator for indicating the level of negative pressure created, and provides an automatic pressure limiter for limiting the level of negative pressure created.
  • NPWT Manually-Operated Negative Pressure Wound Therapy
  • a manually-operated negative pressure wound therapy (NPWT) bandage 5 having improved pump efficiency, an automatic pressure indicator for indicating the level of negative pressure created, and an automatic pressure limiter for limiting the level of negative pressure created.
  • NGWT negative pressure wound therapy
  • NPWT bandage 5 generally comprises a membrane (or sheet) 10 and a pump assembly 15.
  • membrane 10 is configured to make a fully-sealed chamber around the perimeter of a wound, whereby to define a wound chamber.
  • pump assembly 15 is configured to apply a negative pressure to the fully-sealed wound chamber, such that any contaminants and microbes present at the wound site are drawn away from the wound, exudates are drawn out of the wound, and beneficial biological responses are promoted at the wound site.
  • pump assembly 15 is designed to provide improved pump efficiency, an automatic pressure indicator for indicating the level of negative pressure created, and an automatic pressure limiter for limiting the level of negative pressure created, as will hereinafter be discussed.
  • membrane 10 comprises a flat planar sheet 20 formed out of a flexible, substantially air-impermeable material, e.g., Tegaderm from 3M Company (which has also been known as the Minnesota Mining and Manufacturing Company), so that it can conform to body contours and form a substantially air-tight chamber around the perimeter of a wound (i.e., the wound chamber).
  • Membrane 10 is characterized by a wound-side surface 25 and an atmosphere-side surface 30.
  • Membrane 10 is also characterized by an outer perimeter 35 and an inner opening 40.
  • An adhesive 45 is preferably disposed on wound-side surface 25 of membrane 10.
  • a release liner 50 is preferably disposed on wound-side surface 25 atop adhesive 45 so as to keep adhesive 45 covered until use.
  • a removable stiffener 55 is preferably disposed on atmosphere-side surface 30 of membrane 10.
  • Removable stiffener 55 serves to facilitate manipulation of NPWT bandage 5 (and particularly membrane 10) during removal of the NPWT bandage from its sterile packaging and during positioning of the NPWT bandage about a wound.
  • Removable stiffener 55 is intended to be removed from membrane 10 once NPWT bandage 5 has been secured about the wound site.
  • Removable stiffener 55 may be provided as a single element or, more preferably, removable stiffener 55 is provided as a pair of elements so as to facilitate removal from membrane 10 after NPWT bandage 5 has been secured about the wound site.
  • Pump assembly 15 comprises a pump body 60 having a generally cylindrical shape and comprising a side wall 65 and an inner chamber 70.
  • Pump body 60 is formed out of a resilient material, e.g., silicone, such that side wall 65 may be compressed inwardly by the application of an external force (e.g., squeezing by the thumb and forefinger of a user) and will then attempt to return to its original uncompressed state when the external force is removed.
  • a pump flange 75 is preferably formed on one side of pump body 60. As will hereinafter be discussed in further detail, pump body 60 extends through inner opening 40 of membrane 10, and the upper surface of pump flange 75 is secured to the woundside surface 25 of membrane 10 so that pump assembly 15 is secured to, and carried by, membrane 10.
  • Pump flange 75 is preferably formed out of a flexible material so that it can conform (to at least a limited extent) to body contours.
  • pump body 60 and pump flange 75 are formed integral with one another out of the same material, e.g., silicone.
  • side wall 65 of pump body 60 and pump flange 75 merge at a neck 77 (Fig. 5).
  • neck 77 has a relatively small width relative to the full diameter of pump body 60, with recesses 78 extending inwardly between membrane 10 and pump body 60, such that pump body 60 is mounted to pump flange 75 but is still free to radially compress/radially expand with minimal interference from pump flange 75.
  • a wound-side passageway 80 is formed in pump body 60 and communicates with inner chamber 70. Wound-side passageway 80 opens on the exterior of pump body 60 at a wound-side port 82.
  • An atmosphere-side passageway 85 is formed in pump body 60 and also communicates with inner chamber 70. Atmosphereside passageway 85 opens on the exterior of pump body 60 at an atmosphere-side port 87.
  • a wound-side one-way valve 90 is disposed in wound-side passageway 80 and is configured to permit fluid to enter inner chamber 70 through wound-side passageway 80 but to prevent fluid from exiting inner chamber 70 through wound-side passageway 80.
  • An atmosphere-side one-way valve 95 is disposed in atmosphere-side passageway 85 and is configured to permit fluid to exit inner chamber 70 through atmosphere-side passageway 85 but to prevent fluid from entering inner chamber 70 through atmosphere-side passageway 85.
  • fluid e.g., air, liquid, etc.
  • pump body 60 of pump assembly 15 when pump body 60 of pump assembly 15 is manually squeezed (e.g., by applying a compressive force to side wall 65 of pump body 60 with the thumb and forefinger of a user), fluid (e.g., air, liquid, etc.) within inner chamber 70 will be forced out of inner chamber 70 via atmosphere-side passageway 85, and when pump body 60 of pump assembly 15 is thereafter released (e.g., by relaxing the compressive force applied to side wall 65 of pump body 60 by the thumb and forefinger of a user), fluid (e.g., air, liquid, etc.) below wound-side surface 25 of membrane 10 (e.g., air, liquid, etc. within the wound chamber) will be drawn into inner chamber 70 through wound-side passageway 80 as the resilient side wall of the pump body returns to its uncompressed state.
  • fluid e.g., air, liquid, etc.
  • the present invention s approach of providing a pump assembly utilizing two one-way valves disposed on either side of a deformable pump body with an in-line configuration (i.e., wound-side one-way valve 90 and atmosphere-side one-way valve 95 disposed on either side of deformable pump body 60) provides a number of significant advantages which are not achievable with the prior art’s approach of providing a deformable pump body utilizing a single one-way valve.
  • the present invention s approach of providing a pump assembly utilizing two one-way valves disposed on either side of a deformable pump body with an in-line configuration (i.e., wound-side one-way valve 90 and atmosphere-side one-way valve 95 disposed on either side of deformable pump body 60) allows substantially the same maximum negative pressure to be established at the wound site regardless of the size of the wound chamber. This is not achievable with the prior art’s approach of providing a deformable pump body utilizing a single one-way valve.
  • the present invention s approach of providing a pump assembly utilizing two one-way valves disposed on either side of a deformable pump body with an in-line configuration (i.e., wound-side one-way valve 90 and atmosphere-side one-way valve 95 disposed on either side of deformable pump body 60) allows a greater constant selected maximum negative pressure to be achieved at the wound site than can be achieved at the wound site using a deformable pump body with a single one-way valve (which is reflective of the prior art’s approach).
  • Fig. 4A shows, for two different size wound chambers (i.e., a 7.5 mL wound chamber and a 15 mL wound chamber), a maximum negative pressure that may be established with (i) a deformable pump body having two one-way valves (with one one-way valve being disposed on either side of the deformable pump body), and (ii) a deformable pump body having a single one-way valve (note: in the comparison shown in Fig. 4A, the volume of the pump chamber of the deformable pump body with 1 one-way valve is the same as the volume of the pump chamber of the deformable pump body with 2 one-way valves).
  • Fig. 4 A shows that using a deformable pump body having two oneway valves (with one one-way valve being disposed on either side of the deformable pump body) to evacuate the wound chamber lets you establish substantially the same maximum negative pressure in the wound chamber regardless of the size of the wound chamber (i.e., it yields approximately -150.0 mm Hg for a 7.5 mL wound chamber and approximately -150.0 mm Hg for a 15 mL wound chamber), whereas using a deformable pump body having a single one-way valve does not (i.e., it yields approximately -80.0 mm Hg for a 7.5 mL wound chamber and approximately -50.0 mm Hg for a 15 mL wound chamber).
  • the NPWT bandage of the present invention allows substantially the same maximum negative pressure to be established at the wound site regardless of the size of the wound chamber, whereas prior art NPWT bandages do not.
  • This unique feature of the present invention is clinically significant, inasmuch as (i) it is generally desirable to establish a selected maximum negative pressure at the wound site (e.g., between about 60 mm Hg and about 180 mm Hg), and (ii) it is generally difficult to know in advance the volume of the wound chamber (e.g., due to variations in medical applications, variations in patient anatomy, etc.).
  • the present invention allows substantially the same maximum negative pressure to be established at the wound site regardless of the size of the wound chamber, the present invention allows the NPWT bandage to be engineered in advance (e.g., at the time of manufacture) to establish a selected maximum negative pressure at the wound site, whereas prior art NPWT bandages do not.
  • Fig. 4A shows that using a deformable pump body having two one-way valves (with one one-way valve being disposed on either side of the deformable pump body) to evacuate the wound chamber lets you establish a substantially higher maximum negative pressure in the wound chamber (i.e., it yields approximately -150.0 mm Hg for a 7.5 mL wound chamber and approximately -150.0 mm Hg for a 15 mL wound chamber) than can be established using a deformable pump body having a single one-way valve (i.e., it yields approximately -80.0 mm Hg for a 7.5 mL wound chamber and approximately -50.0 mm Hg for a 15 mL wound chamber).
  • the NPWT bandage of the present invention allows a substantially higher maximum negative pressure to be established at the wound site.
  • the pressure within inner chamber 70 of pump body 60 is generally equal to the pressure below wound-side surface 25 of membrane 10 (i.e., the pressure within inner chamber 70 of pump body 60 is generally equal to the pressure within the wound chamber).
  • pump assembly 15 also comprises a removable cap 100.
  • Removable cap 100 is configured to selectively close off atmosphere-side passageway 85 to fluid flow when removable cap 100 is inserted into atmosphere-side passageway 85 so as to close off atmosphere-side port 87.
  • Pump assembly 15 is mounted to membrane 10 such that pump assembly 15 is carried by membrane 10. More particularly, pump assembly 15 is mounted to membrane 10 by (i) passing pump body 60 of pump assembly 15 through inner opening 40 of membrane 10, (ii) bringing pump flange 75 up against wound-side surface 25 of membrane 10, and then (iii) adhering pump flange 75 to wound-side surface 25 of membrane 10 (e.g., by bonding, gluing, etc.). Note that pump assembly 15 and membrane 10 make a substantially air-tight connection.
  • pump body 60 of pump assembly 15 is carefully configured to provide (i) improved pump efficiency, (ii) an automatic pressure indicator for indicating the level of negative pressure created, and (iii) an automatic pressure limiter for limiting the level of negative pressure created, as will hereinafter be discussed.
  • pump body 60 of pump assembly 15 is specifically configured so that the pump body will abruptly change state between (i) a substantially fully expanded configuration where side wall 65 of pump body 60 and inner chamber 70 of pump body 60 have a substantially circular cross-section (see Fig. 5) when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure is below a given threshold, and (ii) a substantially fully collapsed configuration where side wall 65 of pump body 60 bows inwardly (see Fig. 6) when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure exceeds a given threshold.
  • pump body 60 of pump assembly 15 when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure is below a given threshold, pump body 60 of pump assembly 15 will assume its substantially fully expanded configuration (Fig. 5), and when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure is above a given threshold, pump body 60 of pump assembly 15 will assume its substantially fully collapsed configuration (Fig. 6).
  • pump body 60 of pump assembly 15 is configured so that it will abruptly change state between its substantially fully expanded configuration (Fig. 5) and its substantially fully collapsed configuration (Fig. 6) when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure crosses the aforementioned given threshold.
  • Fig. 7 is a graph showing the relationship between the diameter of side wall 65 of pump body 60 and the pressure differential between the pressure of a fluid within inner chamber 70 and atmospheric pressure.
  • pump assembly 15 is specifically configured to essentially behave as a substantially “binary state” device - it is either substantially fully expanded (Fig. 5) or substantially fully collapsed (Fig. 6).
  • the term “substantially “binary state” device” is intended to refer to a device which is inclined to assume either a substantially fully expanded condition or a substantially fully collapsed condition and, as used herein, the term “substantially “binary state” behavior” is intended to refer to the inclination of a device to assume either a substantially fully expanded condition or a substantially fully collapsed condition.
  • the substantially “binary state” behavior of pump body 60 is a consequence of forming the pump body with a side wall 65 having a substantially circular cross-section, which gives the pump body an “over-the-center” deformation characteristic, i.e., the side wall of pump body 60 has a “failure” mode where it abruptly transitions from its substantially fully expanded configuration to its substantially fully collapsed configuration, and has a “restoration” mode where it abruptly transitions from its substantially fully collapsed configuration to its substantially fully expanded configuration. See Fig. 7. Note that by forming pump assembly 15 so that side wall 65 of pump body 60 and pump flange 75 merge at a neck 77 (Fig.
  • pump body 60 has a substantially circular cross-section over substantially its entire circumference, with pump body 60 free to radially compress/radially expand with minimal interference from pump flange 75, so that pump body 60 can exhibit substantially “binary state” behavior.
  • Fig. 8 is a graph showing the relationship between the diameter of the side wall of a pump body having a domelike or square configuration and the pressure differential between the pressure of a fluid within an inner chamber of the pump body and atmospheric pressure.
  • pump assembly 15 is able to provide improved pump efficiency, an automatic pressure indicator for indicating the level of negative pressure created, and an automatic pressure limiter for limiting the level of negative pressure created.
  • pump assembly 15 effectively returns to its substantially fully expanded configuration as long as the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure is below the given threshold.
  • pump assembly 15 returns to its substantially fully expanded configuration between compressions (i.e., squeezes), and hence remains fully efficient as it applies a negative pressure to the wound chamber.
  • pump assembly 15 is able to function as an automatic pressure indicator for indicating the level of negative pressure created, i.e., so long as pump body 60 of pump assembly 15 returns to its substantially fully expanded configuration between squeezes, it will be readily apparent to an observer that the pressure within inner chamber 70 (and hence the pressure within the wound chamber) will be less than a given level.
  • pump body 60 provides a gradual change of state between an expanded configuration and a collapsed configuration when the pressure differential between the pressure of a fluid within an inner chamber of the pump assembly changes, in which case the pump assembly is not able to function as an automatic pressure indicator for indicating the level of negative pressure created.
  • pump assembly 15 is able to function as an automatic pressure limiter for limiting the level of negative pressure created since, as soon as pump body 60 assumes its substantially fully collapsed configuration, pump assembly 15 is no longer able to pump fluid from the wound chamber, essentially deactivating the pump assembly.
  • This is in marked contrast to the performance of prior art devices where the pump body provides a gradual change of state between an expanded configuration and a collapsed configuration when the pressure differential between the pressure of a fluid within an inner chamber changes, since the pump assembly is not effectively deactivated at a given pressure differential.
  • the pressure differential required to transition pump body 60 between its substantially fully-expanded configuration and its substantially fully-collapsed configuration may be “tuned” (i.e., tailored) to a particular level by varying one or more characteristics of pump body 60, e.g., by forming side wall 65 of pump body 60 out of a material having a particular durometer, by adjusting the thickness of side wall 65 of pump body 60, by adjusting the diameter of inner chamber 70 of pump body 60, etc.
  • pump body 60 transitions between its two states at a lower pressure (i.e., where pump body 60 transitions at a negative pressure lower than about 60 mm Hg), not enough suction is provided at the wound site to effectively draw contaminants and microbes away from the wound site and/or to effectively draw exudates away from the wound site and/or to promote beneficial biological responses at the wound site. It is also believed that where pump body 60 transitions between its two states at a higher pressure (i.e., where pump body 60 transitions at a negative pressure higher than about 180 mm Hg), the suction provided at the wound site may cause trauma to the tissue (e.g., blistering, capillary leakage, etc.).
  • pump body 60 of pump assembly 15 is configured so that it abruptly transitions between its substantially fully expanded configuration and its substantially fully collapsed configuration when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure exceeds 80 mm Hg.
  • pump assembly 15 returns to its substantially fully expanded configuration between squeezes of the pump body and maintains its pump efficiency as it applies suction to the wound chamber, and as soon as the negative pressure within the wound chamber exceeds 680 mm Hg (assuming atmospheric pressure is 760 mm Hg), pump assembly 15 will assume its substantially fully collapsed configuration, acting as an automatic pressure indicator to indicate that the level of negative pressure created at the wound site has exceeded 80 mm Hg and automatically deactivating pump assembly 15 so that the level of negative pressure created at the wound site cannot exceed 80 mm Hg.
  • NPWT bandage 5 has a low profile.
  • pump body 60 of pump assembly 15 is configured to be squeezed between the thumb and forefinger of a user, the compressive force being applied to pump body 60 is applied parallel to the surface of the skin, so that no trauma is applied to the wound during use (i.e., during pumping of pump assembly 15).
  • This is in marked contrast to prior art NPWT bandages which employ a dome-like configuration and require the compressive force to be applied toward the wound.
  • NPWT bandage 5 is intended to be used as follows. First, an NPWT bandage 5 is removed from its box. In one form of the invention, each individual NPWT bandage 5 is contained in a separate sterile package, with multiple sterile packages contained in a box. See Fig. 9.
  • an NPWT bandage 5 is removed from its sterile package (Fig. 10) so as to be ready for use (Fig. 11).
  • NPWT bandage 5 In order to apply NPWT bandage 5 to the wound site, release liner 50 is removed from wound-side surface 25 of membrane 10. See Fig. 12. Then NPWT bandage 5 is positioned against the skin of a patient so that wound-side surface 25 of membrane 10 is positioned against the wound, with adhesive 45 securing NPWT bandage 5 to the skin of the patient, thereby forming a substantially airtight seal with the skin of the patient about the perimeter of the wound chamber. See Fig. 13.
  • wound-side port 82 of wound-side passageway 80 of pump assembly 15 is open to the wound chamber.
  • a layer of gauze (or other absorbent wound dressing) 102 may be placed on the wound site prior to placing NPWT bandage 5 on the skin of the patient, so that the layer of gauze (or other absorbent wound dressing) is interposed between the wound and wound-side passageway 80 of pump assembly 15. As a result, exudate emerging from the wound will be taken up by the gauze (or other absorbent wound dressing).
  • the layer of gauze (or other absorbent wound dressing) 102 may be mounted to (i.e., secured to) the wound-side surface of membrane 10, e.g., such as at the time of manufacture, so that the layer of gauze (or other absorbent wound dressing) 102 is carried to the wound site by NPWT bandage 5 and is applied to the wound at the same time as the NPWT bandage 5.
  • NPWT bandage 5 secured to the skin of the patient, removable stiffener 55 is removed from atmosphere-side surface 30 of membrane 10. See Fig. 14.
  • NPWT bandage 5 may be used to apply negative pressure to the wound chamber. This is done by squeezing side wall 65 of pump body 60 between the thumb and forefinger of a user so as to compress pump body 60 into its substantially fully collapsed configuration, whereby to expel fluid (e.g., air, liquid, etc.) from inner chamber 70 of pump body 60 via atmosphere-side passageway 85 and atmosphere-side one-way valve 95. See Fig. 15. Note that fluid in inner chamber 70 of pump body 60 is prevented from exiting inner chamber 70 through wound-side passageway 80 due to the presence of woundside one-way valve 90.
  • fluid e.g., air, liquid, etc.
  • pump body 60 of pump assembly 15 remains in its substantially fully collapsed configuration even when side wall 65 of pump body 60 is not being manually compressed, pump assembly 15 will have been effectively deactivated, since it will be impossible to continue using the pump assembly with side wall 65 in its substantially fully collapsed configuration.
  • removable cap 100 may be used to seal atmosphere-side port 87 of atmosphere-side passageway 85.
  • NPWT bandage 5 is left in place on the wound for an appropriate period of time (e.g., a few days) so as to shield the wound from contaminants and microbes during healing, draw exudates out of the wound, and promote beneficial biological responses at the wound site.
  • atmosphere-side port 87 of atmosphere-side passageway 85 may be unsealed (i.e., by removing removable cap 100) and then pump assembly 15 may be used in the manner discussed above to re-establish the desired negative pressure in the wound chamber (i.e., by repeatedly squeezing and releasing side wall 65 of pump body 60).
  • NPWT bandage 5 may be removed from the skin of the patient by simply peeling membrane 10 away from the skin of the patient.
  • pump body 60 of pump assembly 15 is preferably specifically configured so that the pump body will abruptly change state between (i) a substantially fully expanded configuration where side wall 65 of pump body 60 and inner chamber 70 of pump body 60 have a substantially circular crosssection (see Fig. 5) when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure is below a given threshold, and (ii) a substantially fully collapsed configuration where side wall 65 of pump body 60 bows inwardly (see Fig. 6) when the pressure differential between the pressure of the fluid within inner chamber 70 and atmospheric pressure exceeds a given threshold.
  • this substantially “binary state” behavior of pump body 60 is achieved by forming the pump body with a substantially circular crosssection, which gives the body an “over-the- center” deformation characteristic, i.e., so that the side wall of pump body 60 has a “failure” mode where it abruptly transitions from a substantially fully expanded configuration to a substantially fully collapsed configuration, and has a “restoration” mode where it abruptly transitions from a substantially fully collapsed configuration to a substantially fully expanded configuration. See Fig. 7. As noted above, by forming pump assembly 15 so that side wall 65 of pump body 60 and pump flange 75 merge at a neck 77 (Fig.
  • pump body 60 has a substantially circular crosssection over substantially its entire circumference, with pump body 60 free to radially compress/radially expand with minimal interference from pump flange 75, so that pump body 60 can exhibit substantially “binary state” behavior.
  • pump body 60 can be modified so as to enhance the substantially “binary state” behavior of the pump body.
  • notches 105 can be formed in pump body 60 (e.g., at the “9 o’clock”, “12 o’clock” and “3 o’clock” positions) so as to enhance the substantially “binary state” behavior of the pump body by further inducing pump body 60 to assume only its substantially fully expanded configuration or its substantially fully collapsed configuration. Note that the more that pump body 60 exhibits true “binary state” behavior, the more that pump efficiency will improve and the better that pump assembly 15 will serve as an automatic pressure indicator and as an automatic pressure limiter.
  • pump body 60 generally has: a substantially fully expanded configuration prior to pumping; a collapsing and expanding configuration during pumping; a “vertically-oriented” substantially collapsed configuration after a given level of negative pressure has been achieved by pumping; and a substantially fully expanded configuration after the negative pressure has decayed below a given level.
  • the desired negative pressure can be re-established after transition to the substantially fully expanded configuration by renewed pumping.
  • Figs. 21 -25 there is shown another negative pressure wound therapy (NPWT) bandage 5 formed in accordance with the present invention.
  • the NPWT bandage 5 shown in Figs. 21-25 is substantially the same as the NPWT bandage 5 shown in Figs. 1-16, and the NPWT bandage 5 shown in Figs. 17-20, except that (i) in the construction shown in Figs. 21-25, membrane 10 comprises multiple layers which incorporate gauze (or other absorbent wound dressing), and (ii) in the construction shown in Figs. 21-25, pump assembly 15 has a modified construction and is secured to membrane 10 using a different approach.
  • gauze or other absorbent wound dressing
  • membrane 10 comprises a lower skin-contacting polyurethane layer 110 having a center opening 115, an intermediate foam (or gauze or other absorbent wound dressing) layer 120 for disposition over center opening 115 of lower skin-contacting polyurethane layer 110, and an upper polyurethane layer 125 for disposition over intermediate foam layer 120 and lower skin-contacting polyurethane layer 110.
  • upper polyurethane layer 125 is formed out of a substantially air-impermeable material.
  • upper polyurethane layer 125 and lower skin-contacting polyurethane layer 110 have the same size outer perimeter, so that upper polyurethane layer 125 does not contact the skin of the patient.
  • intermediate foam layer 120 has an outer perimeter which is (i) larger than the perimeter of center opening 115 of lower skin-contacting polyurethane layer 110, and (ii) smaller than the outer perimeter of the outer perimeters of lower skincontacting polyurethane layer 110 and upper polyurethane layer 125. In this way, when NPWT bandage 5 has its center opening 115 of lower skin-contacting polyurethane layer 110 positioned over a wound, fluid from the wound can pass through center opening 115 of lower skin-contacting polyurethane layer 110 to reach intermediate foam layer 120.
  • adhesive 45 is positioned on the wound side surface of lower skin-contacting polyurethane layer 110 so that a substantially air-tight seal may be established by NPWT bandage 5 about the perimeter of a wound (i.e., so as to form the aforementioned wound chamber).
  • An opening 130 is formed in upper polyurethane layer 125, and overlaps center opening 115 of lower skin-contacting polyurethane layer 110, so that wound-side passageway 80 of pump assembly 15 can access fluid (e.g., air, liquid, etc.) within the wound chamber (i.e., via opening 130 in upper polyurethane layer 125, the openings in intermediate foam layer 120, and center opening 115 of lower skin-contacting polyurethane layer 110) for evacuation during pumping of pump assembly 15.
  • fluid e.g., air, liquid, etc.
  • the pump assembly 15 utilized in the NPWT bandage 5 of Figs. 21-25 is generally similar to the pump assembly 15 described above, except that it comprises a pair of pedestals 135A, 135B for mounting pump assembly 15 to membrane 10. More particularly, pedestal 135A comprises one end of pump body 60 and is adhered (e.g., by an adhesive 137) to the upper surface of membrane 10 (i.e., to the upper surface of upper polyurethane layer 125) so that wound-side passageway 80 and wound-side one-way valve 90 are aligned with opening 130 in upper polyurethane layer 125 (and hence in fluid communication with the wound chamber).
  • pedestal 135A comprises one end of pump body 60 and is adhered (e.g., by an adhesive 137) to the upper surface of membrane 10 (i.e., to the upper surface of upper polyurethane layer 125) so that wound-side passageway 80 and wound-side one-way valve 90 are aligned with opening 130 in upper polyurethane layer 125 (and hence in fluid communication with
  • Pedestal 135B comprises the other end of pump body 60 and is adhered (e.g., by an adhesive 138) to the upper surface of membrane 10 (i.e., to the upper surface of upper polyurethane layer 125).
  • the intervening portion 140 of pump body 60 sits suspended between pedestal 135 A and pedestal 135B, elevated above upper polyurethane layer 125 of membrane 10, so that a space 145 is formed between intervening portion 140 of pump body 60 and upper polyurethane layer 135 of membrane 10.
  • intervening portion 140 of pump body 60 can be formed with a true circular cross-section, whereby to enhance the substantially “binary state” behavior of the NPWT bandage. It will be appreciated that pump body 60 may incorporate one or more of the aforementioned notches 105 so as to further enhance the substantially “binary state” behavior of the NPWT bandage.
  • pump body 60 can be configured to provide a negative pressure decay “warning state” indicator.
  • pump body 60 can provide a “warning state” indicator to indicate that a decay of the negative pressure has occurred, albeit not enough of a decay to cause the binary state transition of the pump body (i.e., from a substantially collapsed configuration to a substantially fully expanded configuration).
  • the pump body can provide a “warning state” indicator (to indicate that there is a decay of the negative pressure below a given level, albeit not enough of a decay to cause a binary state transition of the pump body from substantially fully collapsed to substantially fully expanded) by transitioning the pump body from its “vertically-oriented” substantially collapsed configuration (which occurs after a given level of negative pressure has been achieved) to a “horizontally-oriented” substantially collapsed configuration (which occurs after there has been some decay of the negative pressure, albeit not enough of a decay to cause a binary state transition of the pump body back to a substantially fully expanded configuration).
  • a “warning state” indicator to indicate that there is a decay of the negative pressure below a given level, albeit not enough of a decay to cause a binary state transition of the pump body from substantially fully collapsed to substantially fully expanded
  • Figs. 26 and 27 show an exemplary construction wherein a pump body, having notches 105 which are appropriate in number, configuration and disposition, can provide a “warning state” indicator (to indicate that there is a decay of the negative pressure below a given level, albeit not enough of a decay to cause a binary state transition of the pump body to a fully expanded configuration) by transitioning the pump body from its “vertically-oriented” substantially collapsed configuration (which occurs after a given level of negative pressure has been achieved) to a “horizontally-oriented” substantially collapsed configuration (which occurs after there has been some decay of the negative pressure, albeit not enough of a decay to cause a binary state transition of the pump body back to a substantially fully expanded configuration).
  • a “warning state” indicator to indicate that there is a decay of the negative pressure below a given level, albeit not enough of a decay to cause a binary state transition of the pump body to a fully expanded configuration
  • pump body 60 generally has: a substantially fully expanded configuration prior to pumping; a collapsing and expanding configuration during pumping; a “vertically-oriented” substantially collapsed configuration after a given level of negative pressure has been achieved by pumping; a “horizontally-oriented” substantially collapsed configuration after a given level of negative pressure has been achieved but there is a decay of the negative pressure, albeit not enough of a decay to cause a binary state transition of the pump body to a substantially fully expanded configuration; and a substantially fully expanded configuration after the negative pressure has decayed below a given level.
  • the desired negative pressure can be re-established after transition to the substantially fully expanded configuration by renewed pumping.
  • the negative pressure wound therapy (NPWT) bandage may include a canister for collecting the exudates.
  • a negative pressure wound therapy (NPWT) bandage 5 which includes a canister 200 for collecting exudates.
  • atmosphere-side one-way valve 95 of pump assembly 15 outputs to the interior 205 of canister 200 so that exudates 210 collect in canister 200.
  • canister 200 includes an opening which is covered by a membrane 215, wherein membrane 215 is gas permeable, but not fluid permeable, such that gases may escape from canister 200 but liquids will be trapped within canister 200.
  • canister 200 may be disposed between the wound chamber and wound-side one-way valve 90 of pump assembly 15. More particularly, in this form of the invention, interior 205 of canister 200 is in fluid communication with the wound chamber and is in fluid communication with wound-side one-way valve 90 of pump assembly 15, such that pumping pump assembly 15 will create a negative pressure within canister 200 and hence within the wound chamber.
  • canister 200 includes the aforementioned membrane 215 (which is gas permeable but not liquid permeable) adjacent to wound-side one-way valve 90 of pump assembly 15, such that gases may escape from canister 200, but liquids will be trapped within canister 200 and not pass into pump assembly 15.
  • canister 200 is disposed between the wound chamber and wound-side one-way valve 90 of pump assembly 15, in a manner similar to the construction of Fig. 30, except that pump assembly 15 is mounted atop canister 200.
  • canister 200 may be formed integral with pump body 60, or it may be formed separately from pump body 60 and simply be fluidly connected to pump body 60, but in any case canister 200 is preferably mounted to some portion of negative pressure wound therapy (NPWT) bandage 5 so that canister 200 moves in conjunction with the remainder of the bandage.
  • NGWT negative pressure wound therapy
  • canister 200 may contain (or have one or more of its internal surfaces coated with) an absorbent or superabsorbent material to absorb liquid exudates evacuated from the wound chamber.
  • canister 200 may contain (or have one or more of its internal surfaces coated with) absorbent or superabsorbent crystals or hydrocolloids or gel-forming matter.
  • Canister 200 may be used with any of the pump assemblies disclosed herein.
  • canister 200 may be used with pump assembly 15 shown in Figs. 1-4, pump assembly 15 shown in Figs. 17-20A, pump assembly 15 shown in Figs. 21-25, pump assembly 15 shown in Figs. 26- 28, etc.
  • NGWT negative pressure wound therapy
  • membrane (or sheet) 10 it may not be desirable to increase the size of pump assembly 15, since it is typically desirable for the pump assembly to maintain a low, non-intrusive profile.
  • increasing the size of membrane (or sheet) 10 while maintaining the size of pump assembly 15 can be clinically undesirable, since then many more pump compressions may be required in order to evacuate the large wound chamber to the correct negative pressure level.
  • increasing the size of membrane (or sheet) 10 while maintaining the size of pump assembly 15 has the effect of increasing the number of pump compressions required to establish the correct negative pressure level in the wound chamber.
  • clinical considerations for the size of the pump assembly, and clinical considerations for the number of pump compressions to be used to establish the correct negative pressure level in the wound chamber may limit, in a practical sense, the size of membrane (or sheet) 10.
  • negative pressure wound therapy (NPWT) bandage 5 may be configured for connection to a source of suction, such that a suction source can be applied to NPWT bandage 5 so as to establish the correct negative pressure level in the wound chamber without requiring compression of pump body 60.
  • NPWT bandage 5 may comprise one half 300 of a luer lock, and a suction line 305 may comprise the second half 310 of a luer lock, such that suction line 305 can be fluidly connected to atmosphere-side port 87 of pump body 60.
  • suction source 320 can apply suction to pump body 60. This suction is then automatically applied to the wound chamber, such that suction source 320 can establish negative pressure in the wound chamber.
  • NPWT bandage 5 still acts as a visual indicator of when the proper level of negative pressure has been established in the wound chamber, since pump assembly 15 transitions from its substantially fully expanded configuration to its substantially fully collapsed configuration when the proper level of negative pressure has been established in the wound chamber.
  • suction line 305 can then be disconnected from NPWT bandage 5.
  • pump assembly 15 can be used to re-establish the correct negative pressure level in the wound chamber, either by compressing pump body 60 or by reconnecting NPWT bandage 5 to suction source 320.
  • NPWT bandage 5 comprises one half of a luer lock, and suction line 305 comprises the second half of a luer lock.
  • suction line 305 comprises the second half of a luer lock.
  • the present invention is not restricted to the use of a luer lock connection - other types of fluid connectors may be used to connect suction line 305 to pump assembly 15.
  • NPWT bandage 5 serves as a visual indicator of when the proper level of negative pressure has been established in the wound chamber, i.e., by transitioning from its substantially fully expanded configuration to its substantially fully collapsed configuration.
  • NPWT bandage 5 can also function as a pressure limiter, so as to prevent suction source 320 from establishing too high a level of negative pressure in the wound chamber. This is done by forming each of the notches 105 as two interrupted notches 105A, 105B, with a full-thickness side wall portion 65C being disposed between the two interrupted notches 105A, 105B. See Fig. 33.
  • NPWT bandage 5 can also function as a pressure limiter, so as to prevent suction source 320 from establishing too high a level of negative pressure in the wound chamber.
  • Luer lock 300 may be used with any of the pump assemblies disclosed herein.
  • luer lock 300 may be used with pump assembly 15 shown in Figs. 1-4, pump assembly 15 shown in Figs. 17-20A, pump assembly 15 shown in Figs. 21-25, pump assembly 15 shown in Figs. 26- 28, pump assembly 15 shown in Figs. 29-31, etc.
  • the Wound Chamber Comprises A Lateral Extension. And Wherein The Pump Assembly Is In Fluid Communication With The Lateral Extension, So That The Pump Assembly Is Laterally Offset From The Wound While Remaining In Fluid Communication With The Wound
  • NPWT negative pressure wound therapy
  • the NPWT bandage may be positioned on the patient’s anatomy so that the primary portion of the wound chamber overlies the wound and the lateral extension of the wound chamber extends along the curve of the thigh so that the pump assembly may be positioned at the top of the upper leg, which is a more stable, and topographically less complicated, anatomical region for supporting the pump assembly.
  • the NPWT bandage may be positioned on the patient’s anatomy so that the primary portion of the wound chamber overlies the wound on the patient’s back and the lateral extension of the wound chamber extends along the curve of the patient’s torso so that the pump assembly may be positioned on the front of the patient, where it may be easily accessed by the patient.
  • NPWT bandage may be provided with a variety of different wound chamber configurations and pump dispositions, as appropriate for different applications.
  • Figs. 35-38 there is shown a negative pressure wound therapy (NPWT) bandage 5, wherein the wound chamber comprises a lateral extension, and wherein the pump assembly is in fluid communication with the lateral extension, such that the pump assembly may be laterally offset from the wound while remaining in fluid communication with the wound.
  • NPWT negative pressure wound therapy
  • the NPWT bandage 5 shown in Figs. 35-38 comprises a membrane 10 and a pump assembly 15.
  • Membrane 10 comprises a first portion 405 for disposition over a wound and a second portion 410 for extending laterally away from the wound and for supporting pump assembly 15 at an anatomical position that is spaced from the wound.
  • membrane 10 is generally similar to membrane 10 of the constructions shown in Figs. 21 -34 in that membrane 10 comprises a lower skin-contacting polyurethane layer 110, an intermediate foam layer 120 for disposition over lower skin-contacting polyurethane layer 110, and an upper polyurethane layer 125 for disposition over intermediate foam layer 120 and lower skin-contacting polyurethane layer 110.
  • upper polyurethane layer 125 is formed out of a substantially air- impermeable material. The outer perimeters of upper polyurethane layer 125 and lower skin-contacting polyurethane layer 110 are secured to one another, capturing intermediate foam layer 120 therebetween.
  • center opening 115 is formed in first portion 405 of lower skin-contacting polyurethane layer 110 of membrane 10, and opening 130 is formed in second portion 410 of upper polyurethane layer 125 of membrane 10.
  • Intermediate foam layer 120 is fluid communication with center opening 115 of first portion 405 and with opening 130 of second portion 410.
  • membrane 10 forms a wound chamber which is generally defined by the configuration of the intermediate foam layer 120.
  • This wound chamber generally comprises (i) a primary portion which overlies center opening 115 of first portion 405, and (ii) a lateral extension which extends from the primary portion of the wound chamber to pump assembly 15.
  • Pump assembly 15 is mounted to upper polyurethane layer 125 so that wound-side passageway 80 of pump assembly 15 can access fluid (e.g., air, liquid, etc.) within the lateral extension of the wound chamber, and hence access fluid within the primary portion of the wound chamber (i.e., via the porous cells of intermediate foam layer 120), whereby to draw fluid away from the wound site.
  • fluid e.g., air, liquid, etc.
  • the NPWT bandage 5 of Figs. 35-38 is positioned on the patient’s anatomy so that the primary portion of the wound chamber overlies the wound, and the lateral extension of the wound chamber extends along the patient’s anatomy so that the pump assembly may be laterally offset from the wound, e.g., positioned at another location which is a more stable, and/or topographically less complicated, and/or more easily accessible for the patient.
  • NPWT bandage 5 may then be used to apply negative pressure to the wound chamber so that fluid (e.g., air, liquid, etc.) can pass from the wound, through center opening 115 into the primary portion of the wound chamber, through the lateral extension of the wound chamber (e.g., through the porous cells of intermediate foam layer 120) and into pump assembly 15 via opening 130 in second portion 410 of upper polyurethane layer 125 of membrane 10.
  • fluid e.g., air, liquid, etc.
  • the NPWT bandage 5 of Figs. 35-38 may also be used at other complicated, or mobile, wound locations, including but not limited to, the foot (diabetic foot ulcers, etc.), a joint such as the ankle, knee, shoulder, or hip (after joint surgeries, ligament repair, arthroscopic procedures, joint replacements, etc.), the arm (lower or upper), the neck, the head, the spine or back (pump assembly 15 can be placed on the front of the body while the primary portion of the wound chamber is positioned over the wound), etc.
  • the anatomical location of the wound can provide a challenge for a wound dressing having an integrated pinch pump assembly, because of the configuration of the anatomy, or the mobility of the anatomical location, or the radius of curvature at the anatomical location, or the location of the wound (which may not be easy for the patient to directly visualize or manually reach), etc.
  • an NPWT bandage formed in accordance with the present invention wherein the wound chamber comprises a lateral extension, and wherein the pump assembly is in fluid communication with the lateral extension, so that the pump assembly is laterally offset from the wound while remaining in fluid communication with the wound, provides the ability to locate the pinch pump assembly at an easily accessible, and physically stable, anatomical location while still preserving air/fluid communication with the wound.
  • This novel NPWT bandage may comprise any number of geometries, including but not limited to:
  • a wound chamber having a lateral extension of various lengths (e.g., short, long, etc.), wherein the lateral extension is in line with the center of the dressing, with the pinch pump assembly being oriented at any angle to the centerline of the dressing; and
  • a wound chamber having a lateral extension of various lengths (e.g., short, long, etc.), wherein the lateral extension is located off the centerline of the dressing.
  • Figs. 39-42 show an alternative construction for a negative pressure wound therapy (NPWT) bandage 5, wherein the lateral extension of the wound chamber has a different length than that shown in Figs. 35-38.
  • Figs. 43-46 show an alternative construction for a negative pressure wound therapy (NPWT) bandage 5, wherein the pinch pump assembly extends transverse to the axis of the lateral extension of the wound chamber.
  • the second portion 410 of the wound chamber may extend parallel to, but be offset from, first portion 405 of the wound chamber (as opposed to being disposed adjacent to one end of first portion 405 of the wound chamber, such as is shown in the constructions ofFigs. 35-38, 39-42 and 43-46).
  • Pump assembly 15 is mounted to second portion 410 so as to be in fluid communication with the wound chamber (in the same manner described for the constructions ofFigs. 35-38, 39- 42 and 43-46), however, in the construction shown in Fig. 46 A, pump assembly 15 extends substantially parallel to first portion 405 of the wound chamber. Note that with the construction of Fig.
  • the footprint of negative pressure wound therapy (NPWT) bandage 5 may be more of a “square” (in the sense that the length and width of the bandage are more equal) than an “elongated rectangle” (in the sense that the length of the bandage is substantially greater than the width of the bandage) such as is shown in the constructions ofFigs. 35-38, 39-42 and 43- 46.
  • notches 105 formed in pump body 60 of the pump assembly shown in Figs. 17-20 and/or notches 105 formed in pump body 60 of the pump assembly shown in Figs. 26-28 may also be formed into the respective pump bodies of the NPWT bandages 5 shown in Figs. 35-38, Figs. 39-42 and Figs. 43- 46.
  • canister 200 may be used with the pump assemblies of the NPWT bandages 5 shown in Figs. 35-38, Figs. 39-42 and Figs. 43-46.
  • luer lock 300 may be used with the pump assemblies of the NPWT bandages 5 shown in Figs. 35-38, Figs.
  • Negative Pressure Wound Therapy Bandage For Covering A Wound.
  • the Bandage Comprises A Transparent Top Layer Which Captures A Layer Of Foam against The Wound.
  • the Foam Layer Is Provided With A Series Of Windows which (i) Allow Direct Visualization Of The Wound. And (ii) Provide A Metric Along The Length Of The Bandage To Indicate Whether The Bandage Needs To Be Replaced. And Further Wherein the Foam Layer Comprises Perimeter Serrations Which Allow The Bandage To Conform To A Curved Wound
  • the foregoing description discloses a variety of negative pressure wound therapy (NPWT) bandages which cover a wound and apply negative pressure to the wound so as to help prevent infection in the wound.
  • the NPWT bandages disclosed in the foregoing description generally comprise (i) a membrane 10 for disposition over a wound, and (ii) an on-board pump assembly 15 for applying, and maintaining, negative pressure at the wound site.
  • membrane 10 generally comprises (i) a lower skin-contacting polyurethane layer 110 having an opening 115 for disposition over the wound, (ii) an intermediate foam layer 120 for disposition over opening 115 in lower skin-contacting polyurethane layer 110 so as to be in contact with the wound, and (iii) an upper polyurethane layer 125 for disposition over intermediate foam layer 120 and lower skin-contacting polyurethane layer 110, wherein the outer perimeters of upper polyurethane layer 125 and lower skin-contacting polyurethane layer 110 are secured to one another, capturing intermediate foam layer 120 therebetween, and further wherein lower skin-contacting polyurethane layer 110 is provided with an adhesive for adhering membrane 10 to the skin of a patient.
  • Pump assembly 15 can be centered over the wound (see pump assembly 15 shown in the embodiments of Figs. 1-25) or can be laterally offset from the wound (see pump assembly 15 shown in the embodiments of Figs. 35-46).
  • Exudate is frequently released from the wound site, particularly in view of the negative pressure being applied to the wound.
  • it can be desirable to obtain an indication of the amount of exudate which is being produced by the wound since high exudate production may require the bandages to be changed more frequently (e.g., because the bandages may become saturated with exudate, or because the exudate may reach the pump, which can diminish pump function and/or cause exudate to be expelled from the pump).
  • bandage 500 for disposition over a wound likely to release exudate.
  • Bandage 500 is similar to the NPWT bandages disclosed in the foregoing description, except that upper polyurethane layer 125 of membrane 10 is replaced with an upper layer 505, and intermediate foam layer 120 of membrane 10 is replaced with foam layer 510.
  • upper layer 505 of bandage 500 is formed out of a transparent material (e.g., a film).
  • the transparent upper layer 505 of the bandage allows an observer to see through the upper layer of the bandage and to observe foam layer 510 (which absorbs the exudate) covering the wound.
  • Foam layer 510 (see Figs. 47-55) is provided with a series of windows 515 extending through the foam layer. Windows 515 allow direct visualization of the wound and provide a metric along the length of the bandage to indicate whether the bandage needs to be replaced. Note that in Figs. 50 and 53-55, only foam layer 510 of bandage 500 is shown for clarity of explanation.
  • FIGs. 51 and 52 visualization of foam layer 510 through transparent upper layer 505 allows an observer to visualize whether a large amount of exudate has migrated into the foam layer from the wound (the exudate is typically yellowish so it is easily seen against the base color of the foam, which is preferably white, light gray, etc.), and windows 515 provide a metric which extends along the length of the bandage (e.g., each of the windows is a “marker line” along the “ruler” of the bandage).
  • the quantity of exudate emitted by the wound is reflected by the amount of the foam which shows the presence of exudate (this can be quantified by viewing the portions of foam layer 510 which show exudate and counting the number of windows adjacent to the areas of foam layer 510 showing exudate).
  • the observer will have a sense of the quantity of exudate leaving the wound and can decide whether to change the bandage.
  • the amount of saturation of foam layer 510 is less than 50% (as shown in Fig.
  • the bandage may remain on the wound; if, however, the amount of saturation of foam layer 510 is greater than 50% (as shown in Fig. 52, which shows that the number of windows adjacent to the areas of foam layer 510 showing exudate 518 is four or more windows), then the bandage may be changed.
  • the decision may be made to change the bandage so as to keep the exudate from reaching the pump.
  • bandage 500 may be provided with markings 520 along the length of the bandage. Markings 520 may be formed on transparent upper layer 505 and/or foam layer 510 (see Figs. 50-55). As seen in Figs. 53 and 54, markings 520 may be used in combination with windows 515 in foam layer 510 to allow medical personnel to align bandage 500 along a wound line 525 when applying the bandage to the wound.
  • the perimeter of foam layer 510 may be formed with scalloped edges or perimeter serrations 530 (see Figs. 47-55). As seen in Fig. 55, scalloped edges or perimeter serrations 530 enable bandage 500 to be curved somewhat when being applied to the skin surface so that bandage 500 may be positioned over a non-linear incision. To this end, it is important to note that the portion of bandage 500 that is positioned over a wound must not be curved too much, as too much curvature of the bandage may cause wrinkling of the bandage, which can cause the seal around the wound chamber to fail.
  • the extent of curvature of the bandage that can be accommodated without disrupting the function of the bandage depends on a number of factors, including but not limited to the size and geometry (width and depth) of perimeter serrations 530 in foam layer 510, the ability of the upper layer 505 to deform, the ability of lower skin-contacting polyurethane layer 110 to deform, etc.
  • perimeter serrations may also be formed in upper layer 505 and/or in lower skin-contacting polyurethane layer 110 so as increase the degree of curvature that the bandage can accommodate (e.g., decrease “wrinkling” of upper layer 505 and lower skin-contacting polyurethane layer 110 when the bandage is positioned over a non-linear incision, so as to increase the degree of curvature that the bandage can accommodate without compromising the air-tight seal made with the skin).
  • bandage 500 is preferably a negative pressure wound therapy (NPWT) bandage with an on-board pump assembly 15, with pump assembly 15 being laterally offset from bandage 500 in this configuration, which configuration is substantially the same configuration of the NPWT bandage shown in Figs. 35-37.
  • NPWT negative pressure wound therapy
  • the aforementioned transparent upper layer 505, windows 515, markings 520 and perimeter serrations 530 may be provided with other NPWT bandages having a laterally offset pump assembly, e.g., such as the NPWT bandage shown in Figs. 39-42, and/or the NPWT bandage shown in Figs. 43-46.
  • bandage 500 is a negative pressure wound therapy (NPWT) bandage with an on- board pump assembly 15, with pump assembly 15 being positioned over a portion of upper layer 505 and foam layer 510.
  • NGWT negative pressure wound therapy
  • bandage 500 is configured to connect to a pump located remote from the bandage, or to another source of suction (e.g., wall suction).
  • a pump located remote from the bandage, or to another source of suction (e.g., wall suction).
  • bandage 500 may omit an on-board pump and/or omit connection to a pump located remote from the bandage, or to another source of suction (e.g., wall suction).
  • bandage 500 can essentially be used as a general purpose bandage.
  • lower skin-contacting polyurethane layer 110 of bandage 500 may be omitted, and upper layer 505 may be provided with (i) an adhesive for mounting foam layer 510 to upper layer 505, and (ii) an adhesive for adhering upper layer 505 to the skin of a patient.
  • the construction of Figs. 47-55 may omit lower skin-contacting polyurethane layer 110 of bandage 500, or the construction of Figs. 56 and 57 may omit lower skin-contacting polyurethane layer 110 of bandage 500, or the construction of Figs. 58, 59 and 60 may omit lower skin-contacting polyurethane layer 110 of bandage 500.
  • lower skin-contacting polyurethane layer 110 may also be omitted from any of the NPWT bandages shown in Figs. 21-46, with upper polyurethane layer 125 being provided with (i) an adhesive for mounting intermediate foam layer 120 to upper polyurethane layer 125, and (ii) an adhesive for adhering upper polyurethane layer 125 to the skin of a patient.
  • notches 105 formed in pump body 60 of the pump assembly shown in Figs. 17-20 and/or notches 105 formed in pump body 60 of the pump assembly shown in Figs. 26-28 may also be formed into the respective pump bodies of the bandage 500 shown in Figs. 47-49 and the bandage 500 shown in Figs. 56 and 57.
  • canister 200 may be used with the pump assemblies of the bandage 500 shown in Figs. 47-49 and the bandage 500 shown in Figs. 56 and 57.
  • luer lock 300 may be used with the pump assemblies of the bandage 500 shown in Figs. 47-49 and the bandage 500 shown in Figs. 56 and 57.
  • Negative Pressure Wound Therapy Bandage For Covering A Wound.
  • the Bandage Comprises Dual Adhesive Strips For Facilitating Comfortable Adherence And Sealing To Sensitive Skin
  • the foregoing description discloses a variety of negative pressure wound therapy (NPWT) bandages which cover a wound and apply negative pressure to the wound so as to help prevent infection in the wound.
  • the NPWT bandages disclosed in the foregoing description generally comprise (i) a membrane 10 for disposition over a wound, and (ii) an on-board pump assembly 15 for applying, and maintaining, negative pressure at the wound site.
  • membrane 10 generally comprises (i) a lower skin-contacting polyurethane layer 110 having an opening 115 for disposition over the wound, (ii) an intermediate foam layer 120 for disposition over opening 115 in lower skin-contacting polyurethane layer 110 so as to be in contact with the wound, and (iii) an upper polyurethane layer 125 for disposition over intermediate foam layer 120 and lower skin-contacting polyurethane layer 110, wherein the outer perimeters of upper polyurethane layer 125 and lower skin-contacting polyurethane layer 110 are secured to one another capturing intermediate foam layer 120 therebetween, and further wherein lower skin-contacting polyurethane layer 110 is provided with an adhesive for adhering membrane 10 to the skin of a patient.
  • Pump assembly 15 can be centered over the wound (see pump assembly shown in the embodiments of Figs. 1-25) or can be laterally offset from the wound (see pump assembly 15 shown in the embodiments of Figs. 35-46).
  • lower skin-contacting polyurethane layer 110 generally comprises an adhesive disposed about the perimeter of opening 115 configured to secure the NPWT bandage to the skin of a patient, thereby mounting the NPWT bandage to the skin of the patient and forming a substantially air-tight seal with the skin of the patient about the perimeter of the wound chamber.
  • that pump assembly 15 can be used to generate a negative air pressure within the wound chamber, whereby to draw exudate out of the wound over which opening 115 is centered and into intermediate foam layer 120 (i.e., such that exudate is removed from the wound into the NPWT bandage).
  • a strong adhesive i.e., an adhesive having sufficient tensile strength, shear strength, and peel strength such that significant force is required to detach the adhesive from the skin
  • a strong adhesive is normally required to fluidically seal lower skin-contacting polyurethane layer 110 to the skin of the patient.
  • the provision of a relatively large perimeter of strong adhesive about the perimeter of opening 115 can act to irritate the skin, particularly when the NPWT bandage is later removed from the skin of the patient at the conclusion of therapy.
  • a new and improved NPWT bandage that comprises a sufficient amount of strong adhesive to fluidically seal the lower skin-contacting polyurethane layer to the skin of the patient, while ensuring that the NPWT bandage remains mounted to the skin of the patient during the course of therapy using the NPWT bandage, but which does not irritate the skin or cause damage to the skin where the skin is particularly sensitive (e.g., friable).
  • NPWT bandage 605 generally comprises a membrane 610 for disposition over a wound, and an on-board pump assembly 615 for applying, and maintaining, negative pressure at the wound site.
  • Membrane 610 generally comprises a lower skin-contacting polyurethane layer 620 having an opening 625 for disposition over/around the wound to be treated, an intermediate foam layer 630 for disposition over opening 625 in lower skin-contacting polyurethane layer 620 so as to be in contact with the wound, and an upper polyurethane layer 635 for disposition over intermediate foam layer 630 and lower skin-contacting polyurethane layer 620.
  • lower skin-contacting polyurethane layer 620 does not extend to the outer perimeter of upper polyurethane layer 635 when NPWT bandage 605 is fully assembled.
  • a portion of upper polyurethane layer 635 defining an outboard skincontacting surface 640 extends radially beyond the outer perimeter of lower-skin contacting polyurethane layer 620 and lower skin-contacting polyurethane layer 620 defines an inboard skin-contacting surface 645. See Fig. 62.
  • a strong adhesive 650 (e.g., acrylic adhesive) is preferably applied to inboard skin-contacting surface 645, whereby to completely encircle (i.e., with a narrow bead of strong adhesive 650) opening 625.
  • a weak adhesive 655 (e.g., silicon adhesive) is preferably applied to outboard skin-contacting surface 640, whereby to completely encircle (i.e., with a wider strip of weak adhesive 655) lower skin-contacting polyurethane layer 620.
  • strong adhesive 650 comprises a tensile strength, shear strength, and/or peel strength when applied to the skin which is greater than the tensile strength, shear strength, and/or peel strength of weak adhesive 655.
  • inboard skin-contacting surface 645 and outboard skin-contacting surface 640 are preferably covered with a removable cover (e.g., wax paper) that can be selectively removed just prior to applying NPWT bandage 605 to the skin of a patient, as will be apparent to one of skill in the art in view of the present disclosure.
  • a removable cover e.g., wax paper
  • strong adhesive 650 can make a fluidically-tight seal against the skin of the patient about the perimeter of opening 625.
  • weak adhesive 655 can assist in securely mounting NPWT bandage 605 to the skin of the patient, without requiring the use of additional strong adhesive that may otherwise irritate sensitive skin.
  • strong adhesive 650 about the perimeter of opening 625 and disposing weak adhesive 655 coaxial to strong adhesive 650, it is possible to mount NPWT bandage 605 to the skin with adequate overall tensile strength, sheer strength, and/or peel strength to prevent or resist detachment from the skin in the same manner as a bandage comprising a much larger amount of exclusively strong adhesive 650 would prevent or resist detachment from the skin, without the downsides inherent in using strong adhesive 650 over a large area.
  • a strong adhesive is necessary to fluidically seal opening 625 about the perimeter of a wound so as to facilitate therapy using NPWT bandage 605
  • the amount of strong adhesive utilized i.e., applied to inboard skin-contacting surface 645) can be minimized.
  • a weaker (i.e., less irritating) adhesive i.e., applied to outboard skin-contacting surface 640
  • strong adhesive 650 may be applied to outboard skin-contacting surface 640 and weak adhesive 655 may be applied to inboard skin -contacting surface 645.
  • weak adhesive 655 can assist in securely mounting NPWT bandage 605 to the skin of the patient
  • strong adhesive 650 can make a fluidically-tight seal against the skin of the patient about the perimeter of inboard skin-contacting surface 645, without requiring the use of a strong adhesive that may otherwise irritate sensitive skin directly adjacent to a wound.
  • NPWT bandage 605 While membrane 610 has been discussed above in the context of NPWT bandage 605, dual adhesive strips (e.g., inboard skin-contacting surface 645 having strong adhesive 650 and outboard skincontacting surface 640 having weak adhesive 655) may be provided on the skincontacting surface of substantially any bandage that is used to perform negative wound pressure treatment on a patient. Stated more generally, the present invention recognizes the benefit of providing two different strength adhesives on an NPWT bandage or other wound dressing. Thus, the present invention is not limited to use with the novel NPWT bandage disclosed herein; substantially any bandage or dressing used to cover a wound may be modified to include dual adhesive strips without departing from the scope of the present invention.
  • NWT Negative Pressure Wound Therapy
  • Figs. 61 -63 show a novel NPWT bandage 605.
  • the aforementioned NPWT bandage 605 generally comprises a membrane 610 for disposition over a wound, and an on-board pump assembly 615 for applying, and maintaining, negative pressure at the wound site.
  • Membrane 610 generally comprises a lower skin-contacting polyurethane layer 620 having an opening 625 for disposition over/around the wound to be treated, an intermediate foam layer 630 for disposition over opening 625 in lower skin-contacting polyurethane layer 620 so as to be in contact with the wound, and an upper polyurethane layer 635 for disposition over intermediate foam layer 630 and lower skin-contacting polyurethane layer 620.
  • lower skin-contacting polyurethane layer 620 does not extend to the outer perimeter of upper polyurethane layer 635 when NPWT bandage 605 is assembled.
  • a portion of upper polyurethane layer 635 defining outboard skin-contacting surface 640 extends radially beyond the outer perimeter of lower-skin contacting polyurethane layer 620 and lower skin-contacting polyurethane layer 620 defines the aforementioned inboard skin-contacting surface 645. See Fig. 62.
  • strong adhesive 650 e.g., acrylic adhesive
  • weak adhesive 655 e.g., silicon adhesive
  • outboard skin-contacting surface 640 of upper polyurethane layer 635 whereby to completely encircle (i.e., with a wider strip of weak adhesive 655) lower skin-contacting polyurethane layer 620.
  • lower-skin contacting polyurethane layer 620 may be omitted entirely and strong adhesive 650 may be applied directly to the lower skin-contacting surface of intermediate foam layer 630 and/or the lower skincontacting surface of the aforementioned upper polyurethane layer 635 in order to (i) seal membrane 610 to the skin of a patient, and (ii) prohibit fluid flow out of the wound chamber (except into intermediate foam layer 630, see below).
  • Novel NPWT - 13 - bandage 605 A generally comprises the aforementioned membrane 610 for disposition over a wound, and the aforementioned on-board pump assembly 615 for applying, and maintaining, negative pressure at the wound site.
  • lower-skin contacting polyurethane layer 620 of membrane 610 is omitted and a lower skin-contacting adhesive 660 is applied directly to a lower skin-contacting surface of the aforementioned intermediate foam layer 630 and/or a lower skin-contacting surface of the aforementioned upper polyurethane layer 635.
  • lower skin-contacting adhesive 660 extends to the outer perimeter of upper polyurethane layer 635.
  • lower skincontacting adhesive 660 does not comprise a central opening (i.e., unlike the aforementioned lower skin-contacting polyurethane layer 620).
  • adhesive 660 e.g., strong adhesive 650 and/or weak adhesive 655 may be applied to a lower skin-contacting surface of intermediate foam layer 630 and/or a lower skin-contacting surface of upper polyurethane layer 635 in a manner which provides for (i) areas comprising adhesive, and (ii) areas lacking adhesive.
  • adhesive 660 can be applied to NPWT bandage 605A in a manner that prevents movement of exudate through the surface(s) to which adhesive 660 is applied, while simultaneously permitting movement of exudate through the surface(s) to which adhesive 660 is not applied, as will hereinafter be discussed in further detail.
  • lower skin-contacting adhesive 660 comprise a high moisture vapor transmission rate (MVTR), as will be apparent to one of ordinary skill in the art in view of the present disclosure.
  • MVTR moisture vapor transmission rate
  • lower skin-contacting adhesive 660 may be applied to the wound side surface of upper polyurethane layer 635 and intermediate foam layer 630 in a specific pattern of adhesive aliquots 662 (e.g., a diamond shaped pattern of aliquots 662) which permits membrane 610 to be sealed to the skin of the patient in the areas in which the adhesive has been applied to the wound side surface of upper polyurethane layer 635 and intermediate foam layer 630 (e.g., the diamond shaped areas), while permitting fluid to pass through gaps 664 that have not been coated with adhesive 660 (i.e., areas in between aliquots 662 of adhesive 660). In this way, membrane 610 will achieve the desired MVTR.
  • adhesive aliquots 662 e.g., a diamond shaped pattern of aliquots 662
  • aliquots 662 of adhesive 660 may be applied to the wound side surface of upper polyurethane layer 635 and/or intermediate foam layer 630 in a pre-determined, specific pattern selected so as to achieve the desired MVTR for NPWT bandage 605A. If desired, a plurality of different, pre-determined patterns of aliquots 662 of adhesive 660 may be used to cover different areas of the wound side surface of upper polyurethane layer 635 and/or intermediate foam layer 630 so as to achieve the desired MVTR for NPWT bandage 605 A.
  • a strip 665 of strong adhesive 650 is disposed on a lower surface 670 (i.e., the skin-contacting surface) of membrane 610 so as to encircle a central area 675 of lower skin-contacting adhesive 660 that is to be disposed over (and about) the wound that is to be treated.
  • strip 665 of strong adhesive 650 comprises a separate film having a coating of strong adhesive applied to the film, which film is applied to the skin-facing surface of upper polyurethane layer 635 (either over or instead of lower skin-contacting adhesive 660).
  • strip 665 of strong adhesive 650 may be a strong adhesive applied directly to the lower skin- facing surface of upper polyurethane layer 635 (either over or instead of lower skin-contacting adhesive 660). Alternatively and/or additionally, if desired, strip 665 of strong adhesive 650 may be applied around the outer perimeter of lower surface 670 of membrane 610.
  • lower skin- contacting surface 670 of membrane 610 is preferably covered with a removable cover (e.g., wax paper) that can be selectively removed just prior to applying NPWT bandage 605 A to the skin of a patient, as will be apparent to one of skill in the art in view of the present disclosure.
  • a removable cover e.g., wax paper
  • a weaker (i.e., less irritating) adhesive i.e., applied to portions of lower skin-contacting surface 670 of membrane 610) can be utilized.
  • the strong adhesive 650 of strip 665 and the specific pattern of adhesive (e.g., a diamond shaped pattern of aliquots 662 of adhesive 660) on lower skin-contacting surface 670 of membrane 610 may be provided on the skin-contacting surface of substantially any bandage that is used to perform negative wound pressure treatment on a patient.
  • the present invention recognizes the benefit of providing two different strength adhesives on an NPWT bandage or other wound dressing.
  • the present invention is not limited to use with the novel NPWT bandage disclosed herein; substantially any bandage or dressing used to cover a wound may be modified to include a strip of strong adhesive and a specific pattern (e.g., a diamond-shaped pattern) of adhesive without departing from the scope of the present invention.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un bandage pour thérapie de plaie par pression négative (NPWT) pour appliquer une pression négative sur une plaie, le bandage NPWT comprenant : une membrane configurée pour être disposée sur une plaie de façon à former une chambre de plaie entre la membrane et la plaie, la membrane comprenant une surface côté plaie, une surface côté atmosphère, et une ouverture s'étendant à travers la membrane de la surface côté plaie jusqu'à la surface côté atmosphère ; la surface côté plaie de la membrane comprenant une surface extérieure en contact avec la peau s'étendant autour du périmètre de la surface côté plaie de la membrane, et une surface intérieure en contact avec la peau s'étendant à l'intérieur de la surface extérieure en contact avec la peau, et en outre la surface extérieure en contact avec la peau comprenant un premier adhésif et la surface intérieure de contact avec la peau comprenant un deuxième adhésif ; et un ensemble de pompe relié à la membrane, l'ensemble de pompe comprenant une entrée en communication fluidique avec l'ouverture s'étendant à travers la membrane et la chambre de plaie, et une sortie en communication fluidique avec l'atmosphère, l'ensemble de pompe étant conçu pour générer une pression d'air négative à l'intérieur de la chambre de plaie.
PCT/EP2025/061609 2024-04-26 2025-04-28 Bandage pour thérapie de plaie par pression négative (npwt) Pending WO2025224365A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463639103P 2024-04-26 2024-04-26
US63/639,103 2024-04-26
US202463645540P 2024-05-10 2024-05-10
US63/645,540 2024-05-10

Publications (1)

Publication Number Publication Date
WO2025224365A1 true WO2025224365A1 (fr) 2025-10-30

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PCT/EP2025/061609 Pending WO2025224365A1 (fr) 2024-04-26 2025-04-28 Bandage pour thérapie de plaie par pression négative (npwt)

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WO (1) WO2025224365A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9999547B2 (en) * 2009-12-22 2018-06-19 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US20200146898A1 (en) * 2011-12-16 2020-05-14 Kci Licensing, Inc. Sealing systems and methods employing a hybrid switchable drape
WO2021090277A1 (fr) * 2019-11-08 2021-05-14 Kci Licensing, Inc. Champs ayant des régions ayant des propriétés adhésives supérieures
US20230310731A1 (en) * 2020-08-21 2023-10-05 Kci Manufacturing Unlimited Company Wound interface systems with integral contact surfaces

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9999547B2 (en) * 2009-12-22 2018-06-19 Smith & Nephew, Inc. Apparatuses and methods for negative pressure wound therapy
US20200146898A1 (en) * 2011-12-16 2020-05-14 Kci Licensing, Inc. Sealing systems and methods employing a hybrid switchable drape
WO2021090277A1 (fr) * 2019-11-08 2021-05-14 Kci Licensing, Inc. Champs ayant des régions ayant des propriétés adhésives supérieures
US20230310731A1 (en) * 2020-08-21 2023-10-05 Kci Manufacturing Unlimited Company Wound interface systems with integral contact surfaces

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