GB2569995A

GB2569995A - Conversion sealed puncture device for wound negative pressure treatment

Info

Publication number: GB2569995A
Application number: GB1800309.5A
Authority: GB
Inventors: Arnold Peter
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-01-09
Filing date: 2018-01-09
Publication date: 2019-07-10
Also published as: GB201800309D0

Abstract

A sealed puncture device having an adhesive material around its perimeter for attachment to a backing layer of a dressing and incorporating one or more vanes or blades to create one or more punctures as a conduit for negative pressure maintained by a substantial seal and delivering negative pressure to a wound surface. The device may comprise a ported vacuum tube fixed to it such that the vacuum pressure is communicated to the wound. Actuation of the puncture may occur by application of negative pressure, or manual manipulation. Described as being a device to be adhered to the backing component of any one of various available moist wound healing dressings in order to convert them into negative pressure dressings.

Description

FIELD OF THE INVENTION

The invention is related to the general field of wound treatment, and to the more specific field of devices for therapy by negative pressure vacuum.

BACKGROUND OF THE INVENTION

It is well known that wounds should be protected from environmental infections by covering them, and that they must be kept moist to allow accelerated healing, and yet too much fluid at the wound surface leads to maceration and can delay healing and cause infections. In the 1980s through to recent years advanced wound dressings proliferated to cover wounds and to maintain moist wound healing conditions while managing fluid. In the 1990s negative pressure devices were developed to apply vacuum under air-tight wound covers for wound treatment. The vacuum can be used to provide suction to remove wound exudate and other materials from the wound often but not necessarily through sponge gauze or other materials, to maintain a protective cover over the wound, to exert forces that improve wound healing, and to also apply fluids and factors followed by their removal. In advanced wound dressings and in negative pressure wound therapy it is well known to also apply biomaterials, antiseptics, gels, debriders, polymers and other materials to the wound surface under a sealed dressing design that maintains seal integrity to maintain and improve the optimum conditions for healing.

Over time, advanced wound dressings developed strategies designed to prolong their usefulness, manage larger volumes of wound exudate, and extend their ability to retain adhesiveness around the wound so that dressing changes would be minimized. To achieve this, these devices incorporated absorbent layers and laminates, moisture permeable fluid handling backings, and stronger and more appropriate adhesives. For example, products incorporated foam technologies to improve absorbency, sophisticated backing polymers and laminates to manage vapour permeability, and swell-able fibre technology to improve absorbency.

The earliest devices for vacuum assisted wound therapy used surgical drains or other similar tubes with a ported distal end, under the edge of surgical wound coverings and applied an adhesive, occlusive material, or paste around the circumference of the tube to maintain the air-tight seal. The other end of the tube was connected to a pressure regulated hospital vacuum system, and sufficient negative pressure was applied to drain the wound and assist in healing. The goal of these surgical practices was to reduce the frequency of dressing changes and the risk of infection as compared to conventional dressings. See, e.g., Μ. E. Chariker, et al, "Effective Management of Incisional and Cutaneous Fistulae with Closed Suction Wound Drainage", Contemporary Surgery, vol. 34, June 1989, pages 59-63. Other similar devices connected the end of a vacuum suction tube into a foam pad or other wound packing, and further surgical innovations were practiced using additional and separate fluid supply tubes for introducing medications to flush the wound through the wound packing.

Adhesives are used to connect dressings to skin and many varieties and technologies have been developed and described in numerous academic summaries. In negative pressure wound care, the adhesive seal around the vacuum tube or tubes which run under the edge of the backing component tends to cause wrinkles or breaches of the air-tight seal during robust use in the clinic. Companies have developed a range of sealing strips and integrated negative pressure dressing designs to ensure that good seals are maintained during use. Devices have been developed to indicate when leaks occur and to prevent blockages of tubing during use, and electronic circuits and hardware have been developed to create pumps that can tolerate leakages of up to 2 litres per minute before the devices create an audible or visible alarm to indicate leakage. Vacuum tube innovations include connections that include using a tube with a flared or flanged distal end that can be fixed directly to the backing component over a hole punched into the cover, as shown in U.S. Pat. No. 3,367,332 (Groves). A number of practical solutions have been developed to improve placement of tubes into the foam to aid sealing; for example U.S. Pat. No. 6,345,623 (Heaton) discloses an approach in which a suction head having a vacuum tube connector is placed on a foam pad in the wound, then a surgical drape with a hole in its center is placed over the suction head such that the connector protrudes up through the hole.

There are a number of features of advanced wound dressings in general that are considered by individuals schooled in the art to be obstacles to the use of advanced wound care dressings for negative pressure wound therapy. The dressings tend to use high moisture vapour permeability to manage fluid and this would appear to be an obstacle to creating an effective seal. If the dressing allows vapour permeability, then it may not create a seal. These dressings are often designed to transmit litres of fluid vapour per metre squared per day. Many schooled in the art believe that the design of many advanced wound dressings does not suggest that these products would be able to be used as negative pressure dressings due to inappropriate porosity or compressibility, however our invention demonstrates utility and that the pore size of wound contact and other layers within the advanced wound dressing are compatible when incorporated into negative pressure wound contact devices through use of the sealed puncture device. Specifically many schooled in the art consider that pore sizes that are either very large open-pore (for example greater than 1000 micron pore size) or too small (for example less than 10 micron) or closed foam structures, or that foam or material compressibility has to maintain tightly controlled compressibility to achieve clinical benefit. It is generally believed that a resilient material compressibility, with a defined pore size is required for negative pressure wound therapy. It is generally believed that the composite structure of advanced wound dressings would not provide a distributed conduit for negative pressure. It is also believed that a sizable port would need to be created within the backing layer of a closure dressing to effectively transmit the negative pressure to the wound surface to aid clinical outcome.

In their efforts to improve over these prior art devices, the present inventors considered several design objectives; including ease of creating an effective seal with existing dressing backing materials, ease of creating a perforation or perforation series as a conduit for negative pressure, positioning of the conduit on the dressing backing surface to optimize wound healing, the relationship between the conduit perforation size, the dressing seal to the skin surface, and the pump capacity. Also, the inventors explored the use of very large and very small porosity materials and materials from nanometre closed porosity up to woven and non woven structures with porosity measured in millimetres, and found that all these materials provided effective use. Also, the inventors explored materials with a wide range of compressibility. The objective of these improvements was providing greater variety of negative pressure use with the full variety of existing advanced wound dressings. These efforts determined that it would be preferable to locate the conduit seal device on the outside of the backing components of existing advanced wound dressings using a device that created the conduit seal with the backing component of existing advanced wound dressings. In addition to providing a more secure seal, locating the tube attachment on the outside of the backing component allows the constituent design features of existing advanced wound dressings to be used where they already promote tissue growth and wound healing, and the backing component of these dressings is able to create an integral seal and conduit in this fashion.

Locating the vacuum tube attachment on the outside of the backing component of wound dressings can be accomplished by a device that is integrally attached to an adhesive conformable perimeter that attaches to the primary cover and that has a tube through which it is a conduit for negative pressure. Within the device is a perforating edge, blade, vane or fin, or multiples of these, that is located over a hole or holes in the tubing direction, with or without a means to restrict fluid from being aspirated into the tubing. In some examples the backing material is pliant and conformable so that it is sucked up into the blade containing element of the device by the negative pressure allowing automated piercing on applying the negative pressure such that the aspiration begin on application of negative pressure to the device. However, another design consideration for the present invention was that it would be an advantage over prior vacuum dressings to provide the tube attachment in the form of a sealed puncture array within a moulded or wrinkled material that can be applied to a backing component, rather than as an integral part of the outer surface of the cover. This feature allows the same sealed puncture to be used with primary wound dressing covers of different sizes and shapes, and allows the caregiver to locate the sealed puncture in the most convenient location over the wound, as opposed to using an integral device in which the tube is attached over a hole at a fixed location on the primary cover. As an additional advantage, the same sealed puncture can be detached and reused on a new primary cover when the dressing is changed, and in the rare event of a sealed puncture needing to be replaced, it can be replaced without removing the primary cover from the wound. As materials in the sealed puncture component do not interact with the wound and are designed to be under negative pressure, the device may also benefit from the additional advantage that materials may be used that are not normally for exposure to human skin.

In the course of developing a vacuum assisted wound system using a tube attachment patch, the inventors discovered that the sealed puncture device can be used by itself to provide a vacuum applicator over many wound dressing types and that design features in the dressings created initially to provide absorption, non-adherence, cavity packing and other benefits allowed successful distribution of negative pressure throughout the dressing and through to the wound surface, and that the existing dressing adhesives created sufficient sealing to enable successful negative pressure wound therapy.

These and other advantages and aspects of the invention will become apparent upon reading the detailed description and drawings which follow.

BRIEF SUMMARY OF THE INVENTION

In the aspect of the invention relating to the sealed puncture device attachment to enable partial-vacuum assisted negative pressure wound therapy for use with advanced wound dressings, the invention provides an attachment device in the form of a sealed puncture mechanism that can be attached to the backing component of conformable advanced wound dressings. The sealed puncture forms a substantial vacuum integrity seal to the backing component, and a vacuum tube is fixed to the sealed puncture device such that the sealed puncture can be oriented on the backing component to locate the tube in an area appropriate for negative pressure clinical therapy and or to avoid further damage allowing vacuum pressure to be communicated to the wound. The sealed puncture has an adhesive area around its perimeter for attaching the sealed puncture device to the backing material at any convenient location on the cover providing a substantial vacuum integrity and seal that enables transmission of negative pressure to the dressing materials and ultimately through to the wound surface. The caregiver merely applies the device to the dressing cover and applies the negative pressure to the tubing through to the sealed puncture device ensuring the actuator vanes, blades or other piercing unit are creating the appropriate channel for negative pressure transmittal. In some examples of the device the caregiver is required to actuate a lever, twist blades, or apply other means to engage the piercing unit. In other embodiments the device works when negative pressure is applied.

In one embodiment, the sealed puncture device consists of an adhesive perimeter and rigid central frame with rigid piercing vanes or blades designed to puncture the conformable backing layer of advanced wound dressings and connected to a frame holding the vacuum tube, or holding a plurality of tubes including the vacuum tube. In a preferred version of this embodiment, there are two tubes in a spaced parallel relationship in the frame, and the sealed puncture element may be applied to the primary backing cover of the dressing centrally on the dressing. An arrangement of flanges and barriers around the vanes and blade structures are used to ensure effective piercing of the backing layer under application of a manual mechanism or the application of negative pressure. An indicator means can be used to show that actuation has occurred. The flanges prevent the backing component from being drawn against or into the ports and blocking them. Other tubes may be used for monitoring pressure in the system or monitoring some other parameter of the dressing or wound, or tubes may be used to supply medication or flushing fluids to the wound. The frame may also be formed as an enclosure that creates an effective suction chamber around a ported portion of the tube or tubes. The sealed puncture device includes a transparent thin film bonded to the sides of the frame which extends outward from the frame and has adhesive material applied to it at the perimeter of the patch.

In another embodiment, the sealed puncture device consists of a sheet of rigid material having a thickness rigidity and sharpness substantially greater than that of the backing component. This rigid material has a porous side with piercing elements and a sealed rigid side with a tubing connector. Piercing elements embedded into the puncture device are constructed to pierce the backing component of the dressing but are designed to be sufficient to pierce the backing layer of an advanced wound dressing, but not the absorbent layers beneath. These are arranged in an array that guarantees sufficient vacuum flow even in the event of some piercing elements becoming blocked or malfunctioning through some attrition. The sealed puncture device is placed on the backing of a composite advanced wound care device by the care giver and negative pressure is then applied. An indicator device within the tubing moves up the tubing as the dressing vacuum is established and it reaches an indicator level that provides confirmation for both a seal and actuation. On actuation an array of apertures is cut into in the backing layer sheet by the device actuation, and a vacuum tube is attached to the device and provides vacuum through the aperture or apertures. The sealed puncture device has an adhesive area around its perimeter to maintain the seal with the dressing.

In the aspect of the invention relating to vacuum assisted wound dressings, the tube attachment devices may also be used in combination with normal negative pressure systems, their foams, cannisters, absorbent containers, and drape systems.

In one example of the invention a standard dressing comprising a thin hydrocolloid backing layer, coated with an adhesive and containing a fibrous absorbent material on the wound surface layer was used to cover a wound model comprising latex with holes to simulate wound fluid. In this embodiment of the invention, the fibrous layer was stitched together creating permanent small holes less than 1mm in diameter as conduits for negative pressure. A sealed puncture device was applied and secured to the backing layer through use of an adhesive film, and actuated by applying negative pressure to the tubing attached to the sealed puncture device. When negative pressure was applied, gases in the dressing were evacuated, and the surface of the dressing was drawn towards the simulated wound surface of the wound model. As liquid was applied to the wound model through to the dressing, this was evacuated into the negative pressure line through the sealed puncture device.

In another example of the invention, a foam layer stuck to the latex surface of the wound model by an adhesive coated backing film, was used as an example of a standard bordered advanced wound care foam dressing. The sealed puncture device invented here was applied to the backing surface and sealing between the sealed puncture device and the backing surface achieved by way of the adhesive coated film surrounding the device which was then actuated by applying negative pressure. The backing film was pulled against the vanes in the sealed puncture device by the negative pressure and the vanes caused the backing layer to be punctured, resulting in a conduit for the negative pressure from the pump through tubing and connectors, through the sealed puncture device and through into the dressing. Application of gas or liquid through the wound model caused the pump to run and a flow of liquid or gas migrated towards containers connected to the negative pressure caused by the pump.

Many dressing types were used to demonstrate the utility of this invention from simple film dressings comprising occlusive and non-occlusive films coated with a variety of acrylic, silicone, pressure sensitive and other adhesives, many foam dressings, hydrocolloid, hydrogel, and fibrous gelling dressings backed with film, foam and hydrocolloids. Although materials used in the construction of wound dressings may appear to be impermeable, we found that all non-backing materials used in these wound dressings have some porosity, and even closed cell foams have micro structures with open porosity. Therefore, we found that contrary to popular belief these materials could transmit negative pressure to the wound surface. It is also commonly thought that successful negative pressure wound therapy requires an occlusive backing over very porous foam where the foam porosity is visibly large and might commonly be between radii of 100 and 500 nm sized holes.

In the invention described herein, we have found that pore size is not relevant to either the ability to create a vacuum, or the ability to have a beneficial wound surface action. The invention disclosed herein was exemplified with and makes use of wound dressing structures where total porosity (not individual pore size) within materials of the dressings exceeds the porosity of the backing layer and where the pump capacity exceeds the leak capacity of the backing layer, the sealed puncture device, and other leaks.

The invention was demonstrated with many actuator systems including blade designs using polymer and metal mechanical actuator systems. These were blades inserted within the device that were positioned so that on application of the negative pressure, a caregiver actuated a manual lever to X* X» χ·\ 4- lx. lx* ** X* lx *X* x-r ί I 4- x^ Ixk x\ *X. X·* *X* X·* 4- V 4- X"x xJ I *X* 4- lx. Χ·\Χ»Χ·\ xj/Μ fl xx\x t a *·, x\ X* X·* lx* I xJ X\ X· » B t x\ *x x\ xj X\ X· XT *xr x\ xj 4- X·* penetrate the backing layer but were insufficiently large to penetrate through to the wound surface through lower layers of the dressings.

In other examples of the invention, the vanes or blades were positioned over tubing manifolds so that the action of applying negative pressure caused the backing layer to be drawn into the tubing manifold against the blades resulting in the backing layer becoming punctured sufficiently to transmit negative pressure.

In another version of the invention, the actuator systems comprised needles and microneedles that were continued into the tubing. These devices provided control over the relationship between tubing size and gauge of the needles.

DESCRIPTION OF THE INVENTION

In the drawings, and description which follow, a device is described for attaching a vacuum tube to a wound dressing and creating a conduit for negative pressure as shown in embodiments in which the device is a sealed puncture device that can be adhered to the backing component in any one of various available moist wound healing dressings in order to convert them into negative pressure dressings, such that they become connectable to pumps, wall suction, chambers, absorbent containers, and collection devices for treatment of wounds with negative pressure wound therapy (NPWT). Thus, a thin-film wound dressing of a standard size or shape can be attached to a negative pressure pump device with a substantial vacuum integrity seal by way of the sealed puncture device. Beneath the film dressing a full range of wound healing layers can be applied by a care giver with the range of beneficial advanced wound materials including foams, non-adherent layers, antimicrobials, open and closed cell foams, hydrocolloids, gauze, hydrogels, open cell woven and non-woven materials, and many other beneficial materials, and all supported beneath the film or other backing component in an orientation suited for patient care and maintaining the integrity of the air-tight seal, following which a small air opening is created by the sealed puncture device as illustrated in a number of embodiments contained herein. Several embodiments of the device, not intended to be exhaustive or limiting, are described herein.

The embodiment of sealed puncture deviceshown in FIGS. 2 and 3, has an adhesive material applied around its perimeter to attach the sealed puncture in a close proximity to the backing layer of an advanced wound dressing creating a substantial vacuum integrity seal to the backing component. A vacuum tube is fixed to the sealed puncture device such that the sealed puncture device can be oriented on the backing component to locate the tube in an area of the wound dressing which is complementary to allow vacuum pressure to be communicated to the wound. In a preferred embodiment shown in FIGS. 2 and 3, the tube attachment to the sealed puncture device is connected to the lower layers of the dressing by way of actuating blades that create small apertures or orifices in the backing layer of the dressing and that this negative pressure causes the dressing to push against the wound surface having clinical benefits including but not exclusively extraction of wound fluid and constituents from the wound and compressing arterioles and vessels within the tissue creating a transient partial hypoxia leading to biochemical effects and changes in the wound that are beneficial to healing and reduced scarring.

Although a single aperture or orifice of a small size is sufficient to transmit sufficient vacuum negative pressure to assist vacuum assisted wound healing, an array of apertures provides more robust practical utility.

Benefit to the wound is optimized when the size and number of apertures created within the backing dressing exceeds the potential for apertures to block and the potential for leaks within the overall system. Leaks attributed to wrinkles within all layers of the dressing including the sealing layer in the dressing, the dressing backing layer, and the peripheral adhesive on the sealed puncture device, are all additive and are proportional to the cross-sectional area of all the individual wrinkles at the narrow point of the wrinkle. Such wrinkles can be evaluated by considering their dimensional similarity to fine standardized gauge needles, and as negative pressure transmits through these wrinkle apertures it flows in a manner not dissimilar to its flow through standard gauge needles. Standard gauge needles can therefore be used as a model for transmission of negative pressure. Leakage from the overall system is closely related to pi-r-squared for the combined radii of all wrinkles, and at constant pressure within the system, the number of apertures required to maintain negative pressure at the wound surface was related to this cross-sectional area. During modelling of flow, it is useful to standardize flow rates through standardized tubes as models of wrinkle-based-leakage and puncture apertures. The Stubs Iron Wire Gauge system (also known as the Birmingham Wire Gauge and not the same as, though similar to, the Stubs Steel Wire Gauge) is used to specify thickness or diameter of metal wire, strip, and tube products. The gauge starts at the lowest gauge number of 50 or 00000, corresponding to the largest size of 0.500" (12.7mm) to the highest gauge number of 36, corresponding to the smallest size of 0.004" (0.102mm). To maintain negative pressure the total aperture size created by the sealed puncture device must exceed pi-r-squared for the combined radii of all wrinkles throughout the use of the product. Using such modelling it is apparent that an array of puncture apertures across layered interfaces of the dressing is preferred to ensure that the flow through the sealed puncture device after actuation creates a flow greater than leaks.

It was also determined (FIG 6) that the negative pressure transmits through many unexpected dressing constructions including closed cell foams, swollen hydro fibres, and simple non-adherent petrolatum products. Although prior art suggests that negative pressure wound therapeutic benefits can only be achieved with certain pore size foams and gauzes (typically 100 to 1000 nanometre pore sizes, we found that all materials tested transmitted substantial flow rates of liquids 10 to 20 ml per minute at 80 to 150 mmHg, and that all were able to create a compressive force on the wound model that indicated clinical efficacy would be achieved. We also demonstrated that compressive forces were consistently at affective levels with all materials tested under these levels of negative pressure.

It is not necessary to orientate the sealed puncture device to achieve distributed negative pressure. However, there may be clinical reasons to avoid the positioning of the sealed puncture device over sensitive or painful regions and within this invention nothing prevented positioning from being determined by the clinical care giver.

In situations where the risk of blockage or leakage is high, several sealed puncture devices can be applied to the same dressing. Where several wounds are being treated on the same patient, several sealed puncture devices can be applied to a number of dressings and these can be connected to a single absorbent, cannister, and pump. Tubes and components within the system may be adapted for monitoring the operation of the vacuum assisted wound therapy, such as sensing excessive air flow as an indication of a leak in or around the wound dressing components. Also, additional tubes mn\/ ho incortod thrni ioh nnoninoc mndo in tho hnrkincr rnmnnnont nr nthor rooinnc nf tho droccino to the surface or layers above the wound and used to deliver liquids to flush the wound or apply medication. Another alternative is that the vacuum tube could be a multiaxial tube with two or more lumens, one lumen for applying the vacuum pressure and others for other purposes such as monitoring the operation of the wound dressing or delivering fluids.

Fig 4 is a schematic closeup of a preferred manual version of the sealed puncture device to which the negative pressure tube or tubes can be physically connected. In this version, a plastic or metal frame adhered to the backing layer by a periphery of adhesive laminated polymer sheet, contains a relatively robust plastic or metal grid (Fig 4.1) through which negative pressure will deform and suck a pliable backing material such as a thin occlusive or semi occlusive dressing, (for example film composed of less than ten mil thickness or preferably less than 1 mil thickness polyurethane), and this film will be sucked into the apertures between the grid (Fig 4.2), which then supports the edges of the film as it is excised (Fig 4.3) by a blade comprising a sharpened metal grid or sharp pointed plastic grid which is manually actuated to excise across the deformed backing layer. After this, apertures in the backing film allow the negative pressure to suck vapour and liquids away from the wound through the advanced wound dressings. These materials are evacuated to the top surface of the advanced wound dressing and into the tube or tubes, and the dressing layers will be compressed against the wound tissues creating beneficial wound healing effects.

In another iteration of the invention (Fig 5) the sealed puncture device contains a radial array of blades which are actuated before, during or after sealing to the backing layer such that the blades create apertures within the backing material. Once the backing material has been punctures, the array can be withdrawn from the dressing by rotating it in a clockwise direction. This version has the benefit that the blades are retracted and can be used to re-puncture blockages. Retraction has benefits including but not exclusive to safety, irritation, and improved aperture formation. A large variety of materials can be used to manufacture the blades, vanes and puncturing components of the sealed puncture device.

The variety of tubing sets, manifold, film, blade and vane materials that can be used to create the sealed puncture device is large. The examples provided in this invention disclosure do not exhaust or limit the potential number of designs and materials. For example, microneedle arrays or quite blunt but hard plastic protrusions can be used to create punctures. Many variants of blade dimensions, numbers, shape, sharpness and orientation provide additional embodiments of the invention. To have utility in this invention, the cutting ability of vanes or blades on activation must exceed the tensile strength and elasticity under blade duress of the backing layer so that the vane or blade will puncture the backing layer.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view of a wound dressing under evaluation; layer 1 and layer 2 represent materials commonly used in advanced wound dressings. FIG. 2 is a view of the wound dressing with one embodiment of the sealed puncture device in action. FIG. 3 is a close up view of one embodiment of a single blade or vane of one embodiment of a sealed puncture device illustrated in FIG 2 when it has been attached to a backing component over a wound 3.1 before application, 3.2 on application to the backing cover, 3.3 on applying negative pressure, and 3.4 with continued negative pressure with the blade or vane deformed by sub layers of the dressing in use. FIG. 4 is a close up cross-sectional view of another manual embodiment of the sealed puncture device showing the manual activation of the blade to excise the backing cover at the time of application of negative pressure. 4. 1 prior to application, 4.2 application of negative pressure, 4.3 blade actuation, 4.4 flow of negative pressure. FIG. 5 shows a planar view of another manual embodiment of the puncture element of a sealed puncture device embodiment where 5.1 shows a planar layer view of the device illustrating vanes or blades contained within, such that these vanes are activated by the care giver turning the device anticlockwise to puncture a backing layer, and clockwise to disengage the vanes once the puncture has been achieved. 5.2 shows the cross-sectional view illustrating the profile as the vanes engage to puncture a backing layer. FIG. 6 shows a range of dressing types used with the device described in this invention.

Claims

Claims (9)

1. A sealed puncture device having an adhesive material around its perimeter for attachment to the backing layer of a dressing, and incorporating one or more vanes, blades, or other means to create one or more punctures as a conduit for negative pressure maintained by a substantial seal and delivering negative pressure to the wound surface.

2. A sealed puncture device as described in claim 1 having a ported vacuum tube fixed to it such that the vacuum pressure is communicated to the wound.

3. A sealed puncture device as described in claim 1 for attachment to wound dressing structures where porosity between layers of the dressings exceeds the porosity of the backing layer and where the pump capacity exceeds the leak capacity of the backing layer, the sealed puncture device, and other leaks.

4. A sealed puncture device as described in claim 1 where the sharp vane force is greater than the tear resistance force of the backing layer.

5. A sealed puncture device as described in claim 1 where actuation of the puncture results from application of negative pressure or manual manipulation.

6. A sealed puncture device as described in claim 1 where the cross-sectional area of the punctures exceeds the likely leak and blockage rate such that negative pressure can be successfully communicated to layers beneath the backing layer.

7. A sealed puncture device as described in claim 1 where an array of puncture holes is created.

8. A sealed puncture device as described in claim 1 where a plurality of connectors are available to allow a multitude of sealed puncture devices to be connected or a number of pumps, absorbents, cannisters or other components to be connected.

9. A sealed puncture device as described in claim 1 where orientation and distance from the pump do not reduce clinical benefits of the negative pressure.