WO2013043972A1 - Negative pressure wound therapy apparatus including a fluid port and methods - Google Patents

Negative pressure wound therapy apparatus including a fluid port and methods Download PDF

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Publication number
WO2013043972A1
WO2013043972A1 PCT/US2012/056491 US2012056491W WO2013043972A1 WO 2013043972 A1 WO2013043972 A1 WO 2013043972A1 US 2012056491 W US2012056491 W US 2012056491W WO 2013043972 A1 WO2013043972 A1 WO 2013043972A1
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WO
WIPO (PCT)
Prior art keywords
conduit segment
flexible membrane
negative pressure
surface
wound
Prior art date
Application number
PCT/US2012/056491
Other languages
French (fr)
Inventor
Peiter POTTERS
Original Assignee
Avery Dennison Corporation
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
Priority to US201161538270P priority Critical
Priority to US61/538,270 priority
Application filed by Avery Dennison Corporation filed Critical Avery Dennison Corporation
Publication of WO2013043972A1 publication Critical patent/WO2013043972A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0086Connectors therefor, e.g. detachable from hand-piece

Abstract

Negative pressure wound therapy apparatus comprise a flexible membrane including an evacuation port. In one example, a fluid port is attached to the evacuation port, wherein the fluid port includes a first conduit segment snappingly connected to a second conduit segment. In addition or alternatively, a first conduit segment can include a cutting edge configured to cut an evacuation port in a flexible membrane. In further examples, methods of treating a wound of a skin layer are provided with the step of cutting an evacuation port through a flexible member with a first conduit segment and/or snapping a second conduit segment to a first conduit segment.

Description

NEGATIVE PRESSURE WOUND THERAPY APPARATUS INCLUDING A FLUID PORT AND METHODS

Cross-Reference to Related Application

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 61/538,270 filed September 23, 2011, which is incorporated herein by reference in its entirety.

Field

[0002] The present invention relates to negative pressure wound therapy apparatus, systems and methods. More specifically, the present invention relates to a negative pressure wound therapy apparatus including a fluid port. In further examples, the present invention also more specifically relates to methods of treating a wound of a skin layer with a flexible membrane provided with a fluid port.

Background

[0003] Conventional negative pressure wound therapy devices are typically used to facilitate healing of a wound on a layer of skin. Known devices can include relatively complicated installation procedures and/or cumbersome tube configurations used to place the wound in a negative pressure environment. Brief Summary of the Invention

[0004] The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present invention.

[0005] In accordance with one aspect of the disclosure, a negative pressure wound therapy apparatus comprises a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane. The flexible membrane is configured to be mounted over a wound of a skin layer. An adhesive layer is provided on the first surface and configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area. A fluid port is mounted to the evacuation port and includes a cutting edge configured to cut the evacuation port in the flexible membrane.

[0006] In accordance with another aspect of the disclosure, a negative pressure wound therapy apparatus comprises a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane. The flexible membrane is configured to be mounted over a wound of a skin layer. An adhesive layer is provided on the first surface and configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area. A fluid port is attached to the evacuation port and configured to be placed in fluid communication with the sealed area. The fluid port includes a first conduit segment snappingly connected to second conduit segment.

[0007] In accordance with still another aspect of the disclosure, a system for inducing and maintaining a wound of a skin layer in a negative pressure environment comprises a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane. The flexible membrane is configured to be mounted over a wound of a skin layer. An adhesive layer is provided on the first surface. The adhesive layer is configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area. A fluid port is mounted to the evacuation port, wherein the fluid port includes a cutting edge configured to cut the evacuation port in the flexible membrane. A vacuum device is configured to evacuate a fluid out the evacuation port, wherein the vacuum device is configured to generate a predetermined negative pressure within the sealed area.

[0008] In accordance with yet another aspect of the disclosure, a system for inducing and maintaining a wound of a skin layer in a negative pressure environment comprises a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane. The flexible membrane is configured to be mounted over a wound of a skin layer. An adhesive layer is provided on the first surface, wherein the adhesive layer is configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area. A fluid port is attached to the evacuation port and configured to be placed in fluid communication with the sealed area. The fluid port includes a first conduit segment snappingly connected to a second conduit segment. A vacuum device is configured to evacuate a fluid out the evacuation port, wherein the vacuum device is configured to generate a predetermined negative pressure within the sealed area.

[0009] In accordance with a further aspect of the disclosure, a method of treating a wound of a skin layer comprises the step of providing a flexible membrane including a first surface and a second surface, an adhesive layer on the first surface, and a fluid port with a first conduit segment. The method further includes the steps of cutting an evacuation port through the flexible membrane with the first conduit segment and positioning the first conduit segment to extend through the evacuation port. The method further includes the step of mounting the flexible membrane over the wound by engaging the adhesive layer with the skin layer such that the wound is contained within a sealed area and the first conduit segment is in fluid communication with the sealed area while extending through the evacuation port. The method also includes the step of evacuating fluid with the first conduit segment to establish a negative pressure within the sealed area.

[0010] In accordance with still another aspect of the disclosure, a method of treating a wound of a skin layer comprises the step of providing a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane, an adhesive layer on the first surface of the flexible membrane, and a fluid port with a first conduit segment including a first passage and a second conduit segment including a second passage. The method further includes the steps of attaching the fluid port with respect to the evacuation port and mounting the flexible membrane over the wound by engaging the adhesive layer with the skin layer such that the wound is contained within a sealed area in fluid communication with the first passage of the first fluid conduit segment. The method further includes the step of snapping the second conduit segment to the first conduit segment such that the second passage of the second conduit segment is in fluid communication with the first passage of the first conduit segment. The method also includes the step of evacuating fluid with the fluid conduit segments to establish a negative pressure within the sealed area.

[0011] Other features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description of the various embodiments and specific examples, while indicating preferred and other embodiments of the present invention, are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications.

Brief Description of the Drawings

[0012] These, as well as other objects and advantages of this invention, will be more completely understood and appreciated by referring to the following more detailed description of the presently preferred exemplary embodiments of the invention in conjunction with the accompanying drawings, of which:

[0013] FIG. 1 is a schematic illustration of an example negative pressure wound therapy apparatus and system;

[0014] FIG. 2 illustrates a cross sectional view of the negative pressure wound therapy apparatus along line 2-2 of FIG. 1;

[0015] FIG. 3 illustrates a cross sectional view of an example fluid port as shown in FIGS. 1 and 2;

[0016] FIG. 4 illustrates a cross sectional view of another example fluid port;

[0017] FIG. 5 illustrates a cross sectional view of yet another example fluid port;

[0018] FIG. 6 illustrates a cross sectional view of still another example fluid port;

[0019] FIG. 7 illustrates a partial cross sectional exploded view of a further example fluid port;

[0020] FIG. 8 illustrates a partial cross sectional exploded view of another example fluid port;

[0021] FIG. 9 is an exploded cross sectional view of example portions of the negative pressure wound therapy apparatus of FIG. 1;

[0022] FIG. 10 illustrates example steps of positioning a packing material in a wound and attaching a flange to the packing material;

[0023] FIG. 11 illustrates the optional step of cutting an evacuation port through a flexible membrane with a first conduit segment;

[0024] FIG. 12 illustrates the evacuation port being aligned with the first conduit segment; [0025] FIG. 13 illustrates the example steps of positioning the first conduit segment to extend through the evacuation port and attaching the flange to the flexible membrane with an adhesive layer;

[0026] FIG. 14 illustrates an example initiation of an optional step of snapping a second conduit segment to the first conduit segment; and

[0027] FIG. 15 illustrates an example completion of the step of snapping of FIG. 14.

Detailed Description of the Invention

[0028] The present invention is now illustrated in greater detail by way of the following detailed description which represents the best presently known mode of carrying out the invention. However, it should be understood that this description is not to be used to limit the present invention, but rather, is provided for the purpose of illustrating the general features of the invention.

[0029] Aspects of the disclosure disclose negative pressure wound therapy apparatus/system 100 that can facilitate healing of wounds, such as incisions, damage tissue recesses, burns or other skin conditions. Placing the wound 1002 under negative pressure within a sealed area 1050 can help fight infection, stimulate cellular regeneration, remove contaminants (e.g., liquids, gases, debris, microorganisms) and/or provide other benefits withi n or around the wound 1002 site.

[0030] FIG. 1 is a schematic illustration of one example of a negative pressure wound therapy apparatus 100 including a flexible membrane 110 with an evacuation port 112 extending between a first surface 114 and a second surface 116 of the flexible membrane 110. As shown in FIGS. 1 and 2, the flexible membrane 110 is configured to be mounted over a wound 1002 of a skin layer 1000. For example, the flexible membrane 110 can be precut to a size appropriate for the wounded area.

[0031] As shown, the evacuation port 112 can be a hole with a relatively small size compared to the overall footprint of the flexible membrane 110. As shown, the hole can be circular although other shapes may be provided in further examples. Moreover, the evacuation port 112 can alternatively be provided as a perforated area, a slit area, a scored area or other structural configuration to allow fluid evacuation from the first surface 114 to the second surface 116 at the location of the evacuation port 112. As discussed more fully below, examples of the disclosure can optionally use a fluid port 130 of the negative pressure wound therapy apparatus 100 to help bore, punch, tear or otherwise form the evacuation port 112.

[0032] As shown in FIG. 2, an adhesive layer 120 can also be provided on the first surface 114 of the flexible membrane 110. As described more fully below, the adhesive layer 120 is configured to mount the flexible membrane 110 to the skin layer 1000 about the wound 1002 to seal the wound 1002 within a sealed area 1050.

[0033] Referring to FIGS. 1 and 2, the negative pressure wound therapy apparatus 100 can also include a fluid port 130 mounted to the evacuation port 112. In one example, the fluid port 130 can include a first conduit segment 150 with an outer end 154 that can be spaced away from the second surface 116 of the flexible membrane 110.

[0034] In further examples, the fluid port 130 can include a flange 140. If provided, the flange 140 can help properly orient the first conduit segment 150. For instance, as shown, a base 152 of the first conduit segment can be attached to the flange such that the outer end 154 is spaced away from the flange 140. As such, the fluid port 130 can include a first conduit segment 150 extending through the evacuation port 112 from the first surface 142 of the flange 140. As shown, the flange 140 can substantially surround a base 152 of the first conduit segment 150. As such, the flange 140 can act as a footer to naturally position the first conduit segment 150 in a proper upright orientation.

[0035] Moreover, the optional flange 140 can also help provide a seal against fluid, debris or other contaminants that might otherwise enter the sealed area 1050 in a negative pressure condition. For example, the first surface 142 of the flange 140 can be attached to the adhesive layer 120 of the flexible membrane 110. As such, fluid, debris or other outside contaminants can be prevented from entering the sealed area. Rather, in some examples, the adhesive layer 120 can provide a fluid tight seal at the interface between the fluid port 130 and the flexible membrane 110.

[0036] In still further examples, the flange 140 can help anchor the first conduit segment 150 in a consistent lateral position relative to the wound 1002 and/or provide further connection with other portions of the negative pressure wound therapy apparatus 100. For example, as shown in FIG. 2, the negative pressure wound therapy apparatus 100 can include a packing material 1004 (e.g., foam or gauze) configured to be positioned within the sealed area 1050. The flange 140 can include a second surface 144 facing away from the flexible membrane 110. In such examples, the fluid port 130 may include an adhesive layer 170 on the second surface 144 of the flange 140 to attach the fluid port 130 to the packing material 1004.

[0037] As shown in FIG. 2, further examples can permit the packing material 1004 to engage the adhesive layer 120 on the first surface 114 of the flexible membrane 110 to further attach the packing material 1004 to the flexible membrane 110. As such, a more secure anchoring of the negative pressure wound therapy apparatus 100 with respect to the wound 1002 can be achieved. For example, one or both of the layers of adhesive 120, 170 can help inhibit lateral shifting of the fluid port 130 relative to the wound 1002.

[0038] If provided, the packing material 1004 can be prepped with a saline solution and may further be provided with an antimicrobial property - e.g., by the material type used or subsequent treatment of the packing material 1004 with an antimicrobial agent. The antimicrobials may be incorporated into the packing material 1004 or other components of the negative pressure wound therapy apparatus 100. Such antimicrobials can reduce bacterial contamination of the apparatus. Example antimicrobials can comprise chlorhexidine that may be incorporated into attachment adhesives. In further examples, coatings including antimicrobials may be applied to wetted surfaces of the negative pressure wound therapy apparatus 100. In still further examples, outer surfaces and/or the fluid port 130 of the negative pressure wound therapy apparatus 100 may be provided with an antimicrobial coating to aid in hygiene.

[0039] In further examples, the fluid port 130 can include a cutting edge 132 configured to cut the evacuation port 112 in the flexible membrane 110. As shown, the outer end 154 of the first conduit segment 150 can be provided with the cutting edge 132. The cutting edge may face upwardly and away from the first surface 142 of the flange 140 although the cutting edge may face other directions in further examples. The illustrated cutting edge 132 comprises a serrated edge although a knife-edge, or other cutting edge configurations may be provided in further examples. The cutting edge 132, if provided, can be designed to cut through the flexible membrane 110 in various manners. For example, as shown in FIG. 11, the illustrated serrated cutting edge can cut to tear away a portion 118 of the flexible membrane 110 to generate the evacuation port 112. In one example, the cutting edge 132 can be rotated relative to the flexible membrane 110 to bore the evacuation port 112 into the flexible membrane 110. The evacuation port 112 may also be bored into the flexible membrane 110 by grinding away a portion of the membrane with a serrated cutting edge comprising a surface of edge serrations. In further examples, the cutting edge 132 can act as a hole punch by a translational motion. For instance, as shown in broken lines in FIG. 11, a template 180 with an aperture 182 can be provided on one side of the flexible membrane 110 wherein a corresponding cutting edge (e.g., the periphery of the first conduit segment) acts from the opposite side of the flexible membrane. As such, the template 180 can be translated relative to the cutting edge in an axial direction along a punch axis 119 to punch out the evacuation port 112. As such, it will be appreciated that the cutting edge 132, if provided, can help avoid typical inappropriate hole size and/or locations and unfortunate ripping or tearing associated with typical application procedures. Indeed, the cutting edge 132 can provide ease of assembly by allowing the evacuation port 112 to be formed in the appropriate location and with the appropriate size. As such, simplified application of the negative pressure wound therapy apparatus can be achieved on with an appropriate sized evacuation port at the desired location depending on the wound characteristics. The cutting edge 132 can be designed to provide the evacuation portion without other tools, thereby simplifying the application procedure. Moreover, as the evacuation port is provided at the desired location and with the appropriate size, ripping or tearing at the evacuation port can be avoided.

[0040] In further examples, the fluid port 130 can further comprise a second conduit segment 160 snappingly connected to the first conduit segment 150. For instance, the outer end 154 of the first conduit segment 150 can comprise a first snap structure 156 snappingly connected to a second snap structure 162 of the second conduit segment 160. As such, a fluid port 130 can be attached to the evacuation port 112 and configured to be placed in fluid communication with the sealed area 1050, wherein the fluid port 130 includes the first conduit segment 150 in fluid communication with the second conduit segment 160. As shown in FIG. 2, the outer end 154 of the first conduit segment 150 can comprise the first snap structure 156 although the snap structure may be provided in other locations, such as the base 152 or a neck 153 between the outer end 154 and the base 152. Moreover, the first snap structure can optionally include the cutting edge 132 in further examples. For instance, as shown in FIG. 2, the first snap structure 156 of the first conduit segment 150 includes the optional cutting edge 132. As such, example fluid ports can provide the outer end 154 of the first conduit segment 150 with both the first snap structure 156 and the cutting edge 132. In further examples, the cutting edge may be provided by other portions of the fluid port. For example, the cutting edge may be provided at the outer end while the snap structure is provided at the base 152 or the neck of the first conduit segment 150.

[0041] The snapping connection between the first snap structure 156 and the second snap structure 162 can also provide fluid communication between a first passage 158 of the first conduit segment 150 and a second passage 164 of the second conduit segment 160. Indeed, as shown in FIG. 3, the first passage 158 may be joined in series with the second passage 164 to provide an effective overall conduit system that can be quickly established by way of the snapping connection. Moreover, as shown in the illustrative examples, the snapping connection between the first snap structure 156 and the second snap structure 162 can provide a fluid tight connection between the first passage 158 and the second passage 164. The fluid tight connection may be provided by a close tolerance fit, interference fit, gasket or other configurations designed to provide a fluid tight joint between the first and second passages 158, 164.

[0042] Example fluid ports can be provided wherein the first conduit segment is permanently connected to the second conduit segment. Alternatively, as shown in FIG. 2, the first conduit segment 150 may be removably connected to the second conduit segment 160 to allow quick connection to place the sealed area 1050 under a negative pressure condition. Furthermore, the second conduit segment may be decoupled from the first conduit segment to allow release of a tethering connection between the vacuum device and the patient as described more fully below.

[0043] Various fluid ports may be incorporated with aspects of the disclosure. Example fluid ports are shown in FIGS. 2-8 although other fluid port constructions may be provided in further examples. Moreover, all the illustrated examples of the fluid ports 230, 330, 430, 530, 630 are shown to include a substantially identical serrated cutting edge 232, 332, 432, 532, 632, although other cutting edge constructions may be provided. Furthermore, example fluid ports in accordance with aspects of the disclosure may not include a cutting edge.

[0044] FIG. 3 illustrates the example fluid port shown in FIGS. 1 and 2 that are discussed more fully above. As shown in FIG. 3, the snapping connection between the first conduit segment 150 and the second conduit segment 160 can be designed to provide an adjustable joint, such as a ball and socket joint. For instance, one of the first snap structure and the second snap structure can comprise a ball while the other comprises a socket to provide an adjustable connection. For example, as shown in FIG. 3, the first snap structure 156 of the first conduit segment 150 can include a spherical "ball" segment while the second snap structure 162 of the second conduit segment 160 is provided with a socket segment configured to snappingly receive the spherical segment of the first conduit segment 150. As shown in FIG. 3, the adjusta ble connection can allow rotation of the second conduit segment 160 relative to the first conduit segment 150 in a direction 190 about a vertical axis 192 of the fluid port 130. In addition or alternatively, the adjustable connection can allow pivoting of the second conduit segment 160 relative to the first conduit segment in a direction 194. Providing an adjustable connection can avoid tangling or undesirable transfer of forces generated based on repositioning of the tubing arrangement of the vacuum device.

[0045] FIG. 4 illustrates a cross sectional view of another example fluid port 230. As shown, unless noted, the fluid port 230 can include similar or identical structure to the fluid port 130 discussed with respect to FIGS. 1-3 above. Indeed, the fluid port 230 can include a first conduit segment 250 and a second conduit segment 260 with the second conduit segment 260 snappingly connected to the first conduit segment 250 to place the first conduit segment 250 in fluid communication with the second conduit segment 260.

[0046] As further shown in FIG. 4, the first conduit segment 250 can include a neck 253 between an outer end 254 and a base 252 of the first conduit segment 250. The neck 253 of the first conduit segment 250 can comprise a first snap structure 256 snappingly connected to a second snap structure 262 of the second conduit segment 260. In further examples, the first snap structure may be provided at the outer end 254 or the base 252 of the first conduit segment 250. In the illustrated example, the first snap structure 256 can comprise a segmented or continuous groove at least partially or entirely circumscribing the neck 253. The second snap structure 262 can comprise a complementary peripheral rib that may extend as a continuous or segmented ring within a reception area defined by the second conduit segment 260. If the first snap structure 256 comprises a continuous groove circumscribing the entire neck 253 (as shown), the second conduit segment 260 may be designed to rotate in an unrestricted manner in a direction 290 about a vertical axis 292 of the fluid port 230. Alternatively, the first snap structure 256 can also comprise a groove extending in an arc partially circumscribing the first conduit segment 250. In such designs, the second conduit segment 260 may only be designed to rotate within a certain rotation range with respect to the first conduit segment 250.

[0047] The snapping connection between the first snap structure 256 and the second snap structure 262 can also provide fluid communication between a first passage 258 of the first conduit segment 250 and a second passage 264 of the second conduit segment 260. Moreover, the snapping connection between the first snap structure 256 and the second snap structure 262 can provide a fluid tight connection between the first passage 258 and the second passage 264. As further illustrated in FIG. 4, the first conduit segment 250 may be removably connected to the second conduit segment 260 to provide a quick connect/disconnect feature.

[0048] FIG. 5 illustrates a cross sectional view of another example fluid port 330. As shown, unless noted, the fluid port can include similar or identical structure to the fluid ports 130 and 230 discussed with respect to FIGS. 1-4 above. For example, as shown, the fluid port 330 of FIG. 5 can be substantially identical to the fluid port 230 of FIG. 4. As shown in FIG. 5, the first and second snap structures can be switched. As such, it is possible to provide a first conduit segment 350 with a first snap structure 356 comprising a segmented or continuous rib and a second conduit segment 360 with a second snap structure 362 comprising a segmented or continuous groove. If the second snap structure 262 comprises a continuous groove circumscribing the entire neck reception area of the second conduit segment 360 (as shown), the second conduit segment 360 may be designed to rotate in an unrestricted manner in a direction 390 about a vertical axis 392 of the fluid port 330. Alternatively, the second snap structure 362 can also comprise a groove extending in an arc partially circumscribing the reception area of the second conduit segment 260. In such designs, the second conduit segment 360 may only be designed to rotate within a certain rotation range with respect to the first conduit segment 350.

[0049] FIG. 6 illustrates a cross sectional view of another example fluid port 430. As shown, unless noted, the fluid port can include similar or identical structure to the fluid port 130, 230 and 330 discussed with respect to FIGS. 1-5 above. Indeed, the fluid port 430 can include a first conduit segment 450 and a second conduit segment 460 with the second conduit segment 460 snappingly connected to the first conduit segment 450 to place the first conduit segment 450 in fluid communication with the second conduit segment 460. Unlike the previous configurations, a nonremovable snapping connection exists between the first and second conduit segments 450, 460. For example, the first snapping structure 456 can comprise a one way groove and the second snapping structure 462 can comprise a one way rib. As shown in FIG. 6, once the one way rib of the second snapping structure 462 is snappingly received in the one way groove of the first snapping structure 456, disengaging the coupling connection may be difficult or impossible without damaging the structures. As such, FIG. 6 provides just one example wherein a nonremovable connection may exist. The one way groove and rib construction can permit rotation of the second conduit segment 460 relative to the first conduit segment 450 in a direction 390 about a vertical axis 492 although limited or nonrotatable constructions may be possible in further examples.

[0050] FIG. 6 further shows that the fluid port 430 may include a rubber O-ring 466 or gasket made from a sealing material. The O-ring 466 can be designed to provide a fluid tight connection in further examples.

[0051] FIG. 7 illustrates a partial cross sectional exploded view of another example fluid port 530. The fluid port 530 demonstrates a continuous rib and groove arrangement that may be incorporated in any of the example fluid ports 230, 330, 430 shown in FIGS. 4-6 above. Indeed, as shown, a first snapping structure 556 of the first conduit segment 550 can comprise a continuous rib that circumscribes a neck 553. A second snapping structure 562 of the second conduit segment 560 can comprise a complimentary groove circumscribing an interior reception area of the second conduit segment 560. Once snappingly connected, the second conduit segment 560 can be rotated in an unrestricted manner in direction 590 about a vertical axis 592 of the fluid port 430.

[0052] FIG. 8 illustrates a partial cross sectional exploded view of yet another example fluid port 630. The fluid port 630 demonstrates a plurality of protrusions that are each configured to be received in a corresponding recess of a plurality of recesses to lock the rotational position of a second conduit segment 660 relative to a first conduit segment 650. For example, as shown, the first snapping structure 656 of the first conduit segment 650 can comprise a plurality of protrusions that are each configured to be snappingly received in a corresponding recess of a plurality of recesses 662 to lock the rotational position of the second conduit segment 660 relative to the first conduit segment 650. As such, once snappingly connected, the second conduit segment 660 will be locked from rotating relative to the first conduit segment 650 about a vertical axis 692.

[0053] As shown in FIGS. 10-12, the negative pressure wound therapy apparatus 100 can also include a release liner 122 attached to the adhesive layer 120 of the flexible membrane 110. Likewise, as shown in FIG. 3, the adhesive layer 170 of the fluid port 130 may be provided with a similar release liner 172. The release liners 122, 172 are configured to protect the adhesive layers 120, 170 from contamination during storage and/or transport before application of the flexible membrane 110 to the skin layer 1000 and application of the fluid port 130 to the packing material 1004. A pull tab or other configuration may be provided to facilitate pealing of the release liners 122, 172 from the respective adhesive layers 120, 170. For example, the release liners 122, 172 may include one or more pull tabs extending beyond the flexible membrane 110 or the flange 140 to allow easy gripping and pealing of the release liners 122, 172 beginning from an edge of the respective flexible membrane 110 and flange 140. [0054] Turning back to FIG. 1, the negative pressure wound therapy apparatus 100 can also include a vacuum device 1010 configured to evacuate a fluid out the evacuation port 112. Various known vacuum devices 1010 may be retrofitted to provide the desired negative pressure to the fluid port. FIG. 1 schematically illustrates just one example vacuum device 1010 that can include a connecting tube 1020 may be attached to a container 1030 configured to trap any liquid or debris 1032 drawn from the sealed area 1050 through the fluid port. Another connecting tube 1040 may also be provided for fluid communication with a pressure regulating device 1060.

[0055] The pressure regulating device 1060 of the vacuum device 1010 can include a pump 1062 actuated by a controller 1064. A pressure sensor 1066 can provide pressure information to the controller 1064 to allow proper actuation of the pump 1062 to achieve the desired negative pressure within the system and, consequently, within the sealed area 1050. The pressure sensor 1066 can also send information to a display area 1068 to visually represent the pressure within the system to a user of the vacuum device 1010. Although not shown, a user interface may be provided to allow the user to preselect desired negative pressure levels within the system, equalize pressure within the system, or carry out other functional tasks.

[0056] The flexible membrane 110 can comprise various materials depending on the particular application. In one example, the flexible membrane 110 comprises a thin polymeric film (e.g., polyurethane) that can acts as a cover film. In further examples, the flexible membrane 110 can comprise a material that is permeable to water vapor and gases. As such, negative pressure within the sealed area 1050 may diminish over time. At such time, the vacuum device 1010 may easily be applied to again evacuate fluid, liquid or other matter from the sealed area 1050 to again provide the sealed area 1050 with the desired negative pressure condition.

[0057] The adhesive layers 120, 170 can be any suitable adhesive, such as a pressure- sensitive adhesive (e.g., acrylic-based, rubber-based, or silicone-based) or a curable-adhesive, such as a UV-curable adhesive. It may be noted that if a UV-curable adhesive is used, adjacent membranes (e.g., the flexible membrane) and/or the flap may need to be transparent. In further examples, one or both of the adhesive layers 120, 170 can comprise a hydrocolloid such as the hydrocolloid material disclosed in any one of U.S. Patent No 7,335,416 that issued on February 6, 2008, U.S. Patent No 6,710,100 that issued on March 23, 2004, U.S. Patent No 6,583,220 that issued on June 24, 2003, U.S. Patent No 6,326,421 that issued on December 4, 2001, U.S. Patent Application No. 12/866,750 filed August 9, 2010, and U.S. Provisional Patent 61/467,553 filed March 25, 2011, which are herein incorporated by reference in their entireties.

[0058] The release and/or carrier liners can be a sheet of paper or polymeric film having a release coating, such as a silicone release coating.

[0059] The fluid port can comprise elastomeric material although metal (e.g., stainless steel) may be used one or both of the fluid conduit segments or portions of the segments. In one example, the fluid conduit segments are formed from an injection molding process although other fabrication techniques may be used in further examples.

[0060] Methods of treating a wound on a skin layer will now be described with reference to the fluid port 130 illustrated in FIGS. 2 and 3 with the understanding that similar methods may be carried out with any of the fluid ports in accordance with concepts of the disclosure.

[0061] As shown in FIG. 9, a method of treating a wound 1002 of a skin layer 1000 the optional packing material 1004 and/or nonadherent web or other layer 1006 may be provided. A prep wipe 1008 may be used to prep the area around the wound 1002 before or after cleaning the wound 1002 and/or irrigating the wound 1002, e.g., with a sterile saline. The first conduit segment 150 of the fluid port 130 can further be provided and the release liner 172 can be removed to expose the adhesive layer 170 on the second surface 144 of the first conduit segment 150. [0062] As shown in FIG. 10, the nonadherent web 1006 may then be used to line the wound 1002 and then the packing material 1004 may be used to fill the wound 1002 area. The first conduit segment 150 can then be pressed down in the desired location to attached the second surface 144 of the flange 140 to the packing material 1004. As further illustrated in FIG. 10, the flexible membrane 110 can then be positioned over the wound 1002 and oriented at a desired mounting location over the skin layer 1000. At the desired mounting location, a desired target area 117 of the flexible membrane 110 can be positioned over and aligned with the cutting edge 132 of the first conduit segment 150.

[0063] As shown in FIG. 11, the cutting edge 132 can then be used to cut the evacuation port 112 into flexible membrane 110 with the first conduit segment 150. As shown, the flange 140 surrounds the base 152 of the first conduit segment 150 and flares outwardly to define an oversized footprint with the second surface 144 of the flange 140. The flange 140 therefore provides a relatively large bearing surface to distribute force across the packing material 1004 as the evacuation port 112 is cut into the flexible membrane 110 with the cutting edge 132.

[0064] As shown in FIG. 12, once the evacuation port 112 is formed, the flexible membrane 110 can be withdrawn and then the release liner 122 can be removed. As shown in FIG. 13, once the release liner 122 is removed, the outer end 154 of the first conduit segment 150 can be inserted through the evacuation port such that the adhesive layer 120 seals with the first surface 142 of the flange 140 and the surface of the skin layer 1000 while the first conduit segment 150 extends through the evacuation port 112. Still further, as shown in FIG. 13, the adhesive layer 120 can also attach the packing material 1004 to the flexible membrane 110. As also shown in FIG. 13, the flexible membrane 110 can then be mounted over the wound 1002 by engaging the adhesive layer 120 with the skin layer 1000 such that the wound 1002 is contained within the sealed area 1050. As further illustrated, once sealed, the flange 140 and the packing material 1004 can also be positioned within the sealed area that is in fluid communication with the first passage 158 of the first conduit segment 150.

[0065] As further illustrated in FIG. 13, the second conduit segment 160 can then be positioned over the outer end 154 of the first conduit segment 150. As shown in FIGS. 14 and 15, the second conduit segment 160 can then be snapped to the first conduit segment 150 such that a first passage 158 of the first conduit segment 150 is in fluid communication with a second passage 164 of the second conduit segment 160. As shown in FIG. 14, snapping can begin by engaging an outer periphery 166 of a reception area 168 of the second conduit segment 160 with the outer end 154 of the first conduit segment 150. Sufficient pressure can cause a temporary deformation of the outer periphery 166 as indicated by the deformation arrows 169. The oversized footprint of the flange 140 can reduce the bearing stress on the packing material 1004, thereby reducing pressure concentrations within the wound 1002 as the second conduit segment 160 is pressed down against the first conduit segment 150 to achieve the snapping connection. As shown in FIG. 15, once sufficiently depressed, the outer end 154 is fully received within the reception area 168 to snap the first and second conduit segments together. As shown, the snap connection can be designed to provide an audible snapping signal 196 and/or a vibrational signal 198 that can be sensed by one conducting the connecting procedure. Once the noise is heard and/or the vibration is felt, there is an element of certainty that the desired fluid connection between the first passage 158 and the second passage 164 has been achieved.

[0066] Once mounted, the method can further include the step of evacuating fluid with the fluid port 130, for example, with the vacuum device 1010 illustrated in FIG. 1. For instance, an end 1022 of the can be mounted over a corresponding end of the second conduit segment 160 such that the passage of the tube 1020 is in fluid communication with the sealed area 1050 by way of the passages of the fluid port 130. Next, a user can enter the desired negative pressure and activates the vacuum device 1010. Under instruction from the controller 1064, the pump 1062 is activated to evacuate fluid (e.g., liquid or gasses) and/or debris from the sealed area 1050. Once the desired predetermined negative pressure is sensed by the pressure sensor 1086, the controller 1064 deactivates the pump 1062. Debris and fluid (e.g., liquid or gas) may also be evacuated from the wound 1002 area to be stored by the container 1030. Evacuating fluid (e.g., liquid or gas) and/or debris can allow drainage of undesirable fluids and/or debris from the wound site that may help fight infection by removing debris, e.g., microorganisms entrained in the liquid. Removing fluid and/or debris can further help draw blood flow and consequently oxygen into the wound site to help facilitate healing of the wound 1002.

[0067] As debris/fluid 1032 fills the container 1030 and/or air leaks into the system, a pressure may begin to equalize in the sealed area 1050. The pressure sensor 1066 and controller 1064 can be designed to control the pressure within a certain pressure range. As such, once a predetermined pressure is reached, the controller 1064 can reactivate the pump 1062 to maintain the sealed area 1050 with the desired negative pressure conditions.

[0068] The inventors hereby state their intent to rely on the Doctrine of Equivalents to determine and assess the reasonably fair scope of their invention as it pertains to any apparatus, system, method or article not materially departing from but outside the literal scope of the invention as set out in the following claims.

Claims

CLAIMS What is claimed is:
1. A negative pressure wound therapy apparatus comprising:
a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane, wherein the flexible membrane is configured to be mounted over a wound of a skin layer;
an adhesive layer on the first surface, wherein the adhesive layer is configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area; and
a fluid port mounted to the evacuation port, wherein the fluid port includes a cutting edge configured to cut the evacuation port in the flexible membrane.
2. The negative pressure wound therapy apparatus according to claim 1, wherein the cutting edge comprises a serrated edge.
3. The negative pressure wound therapy apparatus according to any one of the preceding claims, wherein the fluid port includes a flange with a first surface attached to the adhesive layer.
4. The negative pressure wound therapy apparatus according to claim 3, wherein the fluid port further includes a first conduit segment extending through the evacuation port from the first surface of the flange.
5. The negative pressure wound therapy apparatus according to claim 4, wherein the flange surrounds a base of the first conduit segment.
6. The negative pressure wound therapy apparatus according to any one of claims 3-5, further comprising a packing material configured to be positioned within the sealed area, wherein the flange includes a second surface facing away from the flexible membrane, and the fluid port includes an adhesive layer on the second surface of the flange attaching the fluid port to the packing material.
7. The negative pressure wound therapy apparatus according to any one of claims 1-3, wherein the fluid port includes a first conduit segment with an outer end spaced away from the second surface of the flexible membrane.
8. The negative pressure wound therapy apparatus according to claim 7, wherein the outer end of the first conduit segment includes the cutting edge.
9. The negative pressure wound therapy apparatus according to any one of claims 1 and 3, wherein the fluid port includes a first conduit segment with an outer end spaced away from the second surface of the flexible membrane, the outer end of the first conduit segment includes the cutting edge, and the cutting edge comprises a serrated edge.
10. The negative pressure wound therapy apparatus according to any one of claims 1-9, wherein the fluid port further comprises a second conduit segment, wherein the outer end of the first conduit segment comprises a first snap structure snappingly connected to a second snap structure of the second conduit segment.
11. The negative pressure wound therapy apparatus according to claim 10, wherein the snapping connection between the first snap structure and the second snap structure provides fluid communication between a first passage of the first conduit segment and a second passage of the second conduit segment.
12. The negative pressure wound therapy apparatus according to claim 11, wherein the snapping connection between the first snap structure and the second snap structure provides a fluid tight connection between the first passage and the second passage.
13. The negative pressure wound therapy apparatus according to any one of claims 10-12, wherein the first snap structure of the first conduit segment includes the cutting edge.
14. The negative pressure wound therapy apparatus according to claim 13, wherein the cutting edge comprises a serrated edge.
15. The negative pressure wound therapy apparatus according to any one of the preceding claims, wherein the adhesive layer on the first surface of the flexible membrane comprises a hydrocolloid.
16. A negative pressure wound therapy apparatus comprising:
a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane, wherein the flexible membrane is configured to be mounted over a wound of a skin layer; an adhesive layer on the first surface, wherein the adhesive layer is configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area; and
a fluid port attached to the evacuation port and configured to be placed in fluid communication with the sealed area, wherein the fluid port includes a first conduit segment snappingly connected to a second conduit segment.
17. The negative pressure wound therapy apparatus according to claim 16, wherein the first conduit segment is removably connected to the second conduit segment.
18. The negative pressure wound therapy apparatus according to any one of claims 16 and 17, wherein the fluid port includes a flange with a first surface attached to the adhesive layer, wherein the first conduit segment extends through the evacuation port from the first surface of the flange.
19. The negative pressure wound therapy apparatus according to claim 18, wherein the flange surrounds a base of the first conduit segment.
20. The negative pressure wound therapy apparatus according to any one of claims 18 and 19, further comprising a packing material configured to be positioned within the sealed area, wherein the flange includes a second surface facing away from the flexible membrane, and the fluid port includes an adhesive layer on the second surface of the flange attaching the fluid port to the packing material.
21. The negative pressure wound therapy apparatus according to any one of claims 16-20, wherein the first conduit segment includes an outer end spaced away from the second surface of the flexible membrane.
22. The negative pressure wound therapy apparatus according to claim 21, wherein the outer end of the first conduit segment includes a cutting edge.
23. The negative pressure wound therapy apparatus according to any one of claims 21 and 22, wherein the outer end of the first conduit segment comprises a first snap structure snappingly connected to a second snap structure of the second conduit segment.
24. The negative pressure wound therapy apparatus according to claim 23, wherein the snapping connection between the first snap structure and the second snap structure provides fluid communication between a first passage of the first conduit segment and a second passage of the second conduit segment.
25. The negative pressure wound therapy apparatus according to any one of claims 23 and 24, wherein the snapping connection between the first snap structure and the second snap structure provides a fluid tight connection between the first passage and the second passage.
26. The negative pressure wound therapy apparatus according to any one of claims 16-25, wherein the adhesive layer on the first surface of the flexible membrane comprises a hydrocolloid.
27. A system for inducing and maintaining a wound of a skin layer in a negative pressure environment comprising: a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane, wherein the flexible membrane is configured to be mounted over a wound of a skin layer;
an adhesive layer on the first surface, wherein the adhesive layer is configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area;
a fluid port mounted to the evacuation port, wherein the fluid port includes a cutting edge configured to cut the evacuation port in the flexible membrane; and
a vacuum device configured to evacuate a fluid out the evacuation port, wherein the vacuum device is configured to generate a predetermined negative pressure within the sealed area.
28. The negative pressure wound therapy apparatus according to claim 27, wherein the adhesive layer on the first surface of the flexible membrane comprises a hydrocolloid.
29. A system for inducing and maintaining a wound of a skin layer in a negative pressure environment comprising:
a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane, wherein the flexible membrane is configured to be mounted over a wound of a skin layer;
an adhesive layer on the first surface, wherein the adhesive layer is configured to mount the flexible membrane to the skin layer about the wound to seal the wound within a sealed area;
a fluid port attached to the evacuation port and configured to be placed in fluid communication with the sealed area, wherein the fluid port includes a first conduit segment snappingly connected to a second conduit segment; and a vacuum device configured to evacuate a fluid out the evacuation port, wherein the vacuum device is configured to generate a predetermined negative pressure within the sealed area.
30. The negative pressure wound therapy apparatus according to claim 29, wherein the adhesive layer on the first surface of the flexible membrane comprises a hydrocolloid.
31. A method of treating a wound of a skin layer comprising the steps of:
providing a flexible membrane including a first surface and a second surface, an adhesive layer on the first surface, and a fluid port with a first conduit segment;
cutting an evacuation port through the flexible membrane with the first conduit segment;
positioning the first conduit segment to extend through the evacuation port;
mounting the flexible membrane over the wound by engaging the adhesive layer with the skin layer such that the wound is contained within a sealed area and the first conduit segment is in fluid communication with the sealed area while extending through the evacuation port; and
evacuating fluid with the first conduit segment to establish a negative pressure within the sealed area.
32. The method according to claim 31, wherein the step of cutting includes engaging a cutting edge of the first conduit segment with the flexible membrane.
33. The method according to claim 31, wherein the step of cutting includes engaging a serrated cutting edge of the first conduit segment with the flexible membrane.
34. The method according to any one of claims 31-33, further comprising the step of providing the fluid port with a flange, wherein the step of positioning the first conduit segment includes attaching a first surface of the flange with the adhesive layer of the flexible membrane with the first conduit segment extending through the evacuation port from the first surface of the flange.
35. The method according to any one of claims 31-34, further comprising the steps of: positioning a packing material in the wound before the step of mounting the flexible membrane over the wound; and
attaching a second surface of the flange to the packing material with a layer of adhesive before the step of mounting the flexible membrane over the wound,
wherein, after the step of mounting the flexible membrane, the packing material and the flange are both contained within the sealed area.
36. The method according to any one of claims 31-34, further comprising the step of positioning a packing material in the wound before the step of mounting the flexible membrane over the wound, wherein, after the step of mounting the flexible membrane, the packing material is contained within the sealed area.
37. The method according to any one of claims 31-36, further comprising the steps of: providing the fluid port with a second conduit segment; and
snapping the second conduit segment to the first conduit segment such that a first passage of the first conduit segment is in fluid communication with a second passage of the second conduit segment.
38. A method of treating a wound of a skin layer comprising the steps of:
providing a flexible membrane including an evacuation port extending between a first surface and a second surface of the flexible membrane, an adhesive layer on the first surface of the flexible membrane, and a fluid port with a first conduit segment including a first passage and a second conduit segment including a second passage;
attaching the fluid port with respect to the evacuation port;
mounting the flexible membrane over the wound by engaging the adhesive layer with the skin layer such that the wound is contained within a sealed area in fluid communication with the first passage of the first fluid conduit segment;
snapping the second conduit segment to the first conduit segment such that the second passage of the second conduit segment is in fluid communication with the first passage of the first conduit segment; and
evacuating fluid with the fluid conduit segments to establish a negative pressure within the sealed area.
39. The method according to claim 38, further comprising the steps of:
providing the fluid port with a flange;
attaching a first surface of the flange with the adhesive layer of the flexible membrane with the first conduit segment extending through the evacuation port from the first surface of the flange.
40. The method of claim 39, further comprising the steps of:
positioning a packing material in the wound before the step of mounting the flexible membrane over the wound; and attaching a second surface of the flange to the packing material with a layer of adhesive before the step of mounting the flexible membrane over the wound,
wherein, after the step of mounting the flexible membrane, the packing material and the flange are both contained within the sealed area.
41. The method according to any one of claims 338 and 39, further comprising the step of positioning a packing material in the wound before the step of mounting the flexible membrane over the wound, wherein, after the step of mounting the flexible membrane, the packing material is contained within the sealed area.
PCT/US2012/056491 2011-09-23 2012-09-21 Negative pressure wound therapy apparatus including a fluid port and methods WO2013043972A1 (en)

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US61/538,270 2011-09-23

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