Device for wound therapy

TECHNICAL FIELD [0001] The invention relates generally to a wound healing device that can treat various types of chronic and acute wounds, including but not limited to the examples given, including infection wounds, vein ulcers, arterial ulcers, diabetic ulcers, burn wounds , amputated wounds, surgical wounds and the like. In particular, the present invention relates to wound healing devices that utilize vacuum therapy.

BACKGROUND OF THE INVENTION [0002] Vacuum therapy is one of the tools used to treat various wounds by practitioners in the field. Traditional devices are generally large and often require the use of complex devices such as suction pumps, vacuum pumps and complex electronic controllers. Accompanying devices can be containers that collect liquids / secretions from the wound, fluid transport lines, and regulators / transducers / pressure sensors. As a result, devices can be bulky, energy-consuming, relatively expensive and reusable as a rule. In addition, the complexity of traditional devices requires constant patient supervision, and the initial installation and any changes to the device should be done by a doctor or nurse. Currently, the typical cost of using such devices is in the order of $ 100 per day per patient.

[0003] The rising costs of health care and medical devices forces both patients and physicians to look for solutions that the patient will be able to use at home with limited supervision. In addition, patients are constantly demanding devices that can be moved more easily to allow travel and activity.

[0004] WO 01/85248 A1 describes an abdominal wound therapy device comprising a layer of porous foam material that is sandwiched between sheets of perforated elastomeric material. On the upper surface of the foam layer is located the suction pipe connector to connect to the vacuum source. Fluids are drawn by vacuum through the holes in the elastomeric sheath and through the foam to the joint. The adhesive elastomer sheet covers the entire dressing and sticks the edges to the skin surrounding the wound. A suitable vacuum device is attached to the suction tube connector.

US 2001/0029956 A1 describes a similar device. The fluid-impermeable wound cover is glued over the wound area. A foam cell with open cells or a rigid porous shield is placed under the wound cover over the wound. The vacuum pump provides suction under the wound cover. Fluid or wound secretions accumulate in the outer Erlenmeyer flask or other type of fluid trap. Placed between the fluid trap and the vacuum pump, the filter clogs when exposed to sufficiently large amounts of moisture, reducing suction.

US 2003/0040687 A1 describes a vacuum utilizing device according to the preamble of claim 1, comprising a porous tampon placed in a wound cavity and an airtight dressing fixed over the tampon so as to ensure the hermetic cavity of the wound. One end of the cord is attached to the dressing and the other end is connected to a vacuum source. The container is located along the duct to stop the secretions sucked out from the wound area when applying vacuum. Placed between the container and the vacuum source, the hydrophobic filter prevents contamination of the vacuum source with wound secretions.

DE 20 2005 019 670 U1 describes a wound healing device comprising an approximately hemispherical housing. The device is only optionally attached to a vacuum source to remove air and, if necessary, liquid from the inside of the housing.

US 5 549 584 A describes a wound healing device comprising a wound sheath that houses a wound dressing, a wound bag for collecting secretions from the wound and bellows to suck the secretions from the wound dressing into a collecting bag. In one embodiment, the wicking secretion pad is covered with a liquid impermeable outer sheet with holes. Each hole is covered by a sheet of hydrophobic filter.

BRIEF SUMMARY [0005] The object of the present invention is to improve the device according to the preamble of claim 1, which can be used by the patient at home, with limited supervision and is easily moved, to enable the patient's travel and activity. This object is achieved by the device according to claim 1.

[0006] The vacuum connector may be connected in some embodiments to a vacuum source, which may optionally be located within or adjacent to the housing. In other embodiments, the vacuum connector may include a connector that can be connected to a vacuum source located outside the housing. The terms connector and connector or connection as used herein may be used interchangeably.

[0007] In other embodiments, the wound healing device may have a modular structure, optionally including a wound interface module, liquid retention module, and vacuum source module. Each module of the wound healing device can be optionally replaced individually or in combination.

BRIEF DESCRIPTION OF THE VIEWS IN THE DRAWINGS [0008] These embodiments will become better understood by the following description and appended claims, analyzed in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments and should therefore not be construed as limiting the scope of the present invention. The embodiments will be described and explained in detail, taking into account their specificity, with references to the accompanying drawings below.

[0009] Figure 1 is a perspective view of one embodiment of a wound healing device.

[0010] Figure 2 is a side cross-sectional view of the wound healing device of Figure 1.

[0011] Figure 3 is a side cross-sectional view of another embodiment of a wound healing device comprising a drip gap as a liquid barrier.

[0012] Figure 4 shows the enlarged drip gap of the device of Figure 3 on an enlarged scale.

[0013] Figure 5 shows the upper cross-section of the drip gap of the device of Figure 3.

[0014] Figure 6 is a side cross-sectional view of another embodiment of a wound healing device comprising an internal vacuum pump as a source of vacuum.

[0015] Figure 7 is a side cross-sectional view of another alternative wound healing device comprising an internal vacuum pump as a source of vacuum.

[0016] Figure 8 is a side cross-sectional view of another embodiment of the wound healing device with elongated shape housing.

[0017] Figures 9A and 9B schematically show a wound healing device, illustrating a modular design solution for the device.

[0018] Figure 10 is a perspective view of a construction and absorbent material that can be placed inside a liquid retention chamber in a wound healing device.

[0019] Figure 11 is a side cross-sectional view of another embodiment of the wound healing device.

[0020] Figure 12 is a side cross-sectional view of another embodiment of the wound healing device.

[0021] transverse object [0022] transverse wound.

Figure 13 devices for the invention.

Figure 14 of another example shows a lateral wound treatment that is not a side view of an embodiment of a device for treating [0023] Figure 15 shows a lateral cross section of another embodiment of a wound healing device.

DETAILED DESCRIPTION [0024] It will be appreciated that the components of the embodiments, generally described and illustrated in the figures, may be arranged and designed in various configurations. Thus, the following more detailed description of the various embodiments represented in the figures does not limit the scope of the invention, but is merely representative of the various embodiments. Although various aspects of the embodiments are illustrated in the drawings, the drawings are not always drawn to scale unless indicated in the particular case.

[0025] The present invention may be implemented in other specific forms without departing from the idea or essential characteristics. The described embodiments should be regarded in all respects as illustrative only and not limiting. The scope of the invention is therefore indicated by the appended claims rather than by the present description. Any changes introduced within the meaning and scope of equivalence of the reservations fall within the scope of the reservations.

[0026] References in the present description to features, advantages or similar expressions do not mean that all the features and advantages that can be obtained in the present invention should be or are in each individual embodiment of the invention. Rather, expressions referring to features and advantages mean that a given feature, advantage or characteristic described with reference to an embodiment is characteristic of at least one embodiment of the present invention. Thus, discussing features and advantages and similar expressions throughout this description may or may not refer to the same embodiment.

[0027] Furthermore, the described features, advantages and characteristics of the invention may be combined in any suitable manner in one or more embodiments. One of ordinary skill in the art will recognize that the invention may be practiced without one or more of the features or advantages of a given embodiment. In other cases, additional features and advantages can be seen in some embodiments that are not found in all embodiments of the invention.

[0028] References herein to "one embodiment," "embodiment," or similar chambers, etc., for purposes of embodiments, mean that a particular feature, structure or characteristic described in relation to a given embodiment is at least in one embodiment of the present invention. Thus, the similarity of the phrases "in one embodiment", "in an embodiment" and similar expressions in the present description may or may not refer to the same embodiment.

[0029] The following description provides numerous specific details, such as examples of enclosures, barriers, providing a thorough understanding of the invention. However, one of ordinary skill in the art will recognize that the invention may be practiced without one or more specific details, or using other methods, components, materials, and so forth. In other cases, well-known structures, materials or operations, such as vacuum sources, are not shown or described in detail to avoid obscuring aspects of the invention.

[0030] In Figures 1 and 2 a device 10 for treating wounds is shown. Figure 1 is a perspective view of a wound healing device applied to a patient's body surface to at least partially enclose a wound. Figure 2 shows a side cross-section of the device of Figure 1.

of Figure 1, taken along the plane 2-2 for the Device 10 includes a housing 20 adapted to cover at least part of the wound. The housing 20 defines an inner space 22. In one embodiment, the inner space 22 may include a vacuum chamber 24 and a liquid holding chamber 40 separated by a liquid barrier 36. The liquid holding chamber 40 may include a liquid collector (not shown) to collect secretions from a wound or other liquid. The fluid transmission housing for the liquid vacuum source stores secretions from (is adapted to not shown). The wound reservoir, while transmitting the vacuum generated by the vacuum source to the wound. The terms vacuum and vacuum used throughout the description may be used interchangeably.

[0031] In one embodiment, the housing 20 is rigid or semi-rigid. The housing 20 of the device 10 essentially maintains its size and structure when applying vacuum, allowing a vacuum to be maintained inside the housing 20. Housing 20 may be made of any suitable material known to a person skilled in the art, including, but not limited to, rubbers, including polyurethane and dense plastics such as, but not limited to, polypropylene, polyvinyl chloride, polyethylene, acrylonitrile-based copolymer, such as is sold under the name Barex®, polyester, polystyrene, polyethylene, nylon, poly (chlorotriflurethylene), fluoropolymer, poly (tetrafluoroethylene), which are sold under the name Teflon®, silicone, neoprene or combinations thereof and similar materials.

[0032] wraps made,

In another embodiment, the housing 20 is a flexible barrier or surface supported by at least one adapted, rigid or semi-rigid structural support (not shown) located in the interior space 22 of the housing to maintain the shape of the device when the device is pressurized lower than atmospheric. In some embodiments, the structural support may be located outside the housing, or it may be integrated into the housing 20. The flexible barrier or surface wrap may be a thin polyurethane film with a skin-compatible adhesive, supported by a structural foam, located in the interior space 22 of the housing 20 Structural support or structural foam can be made of rigid or semi-rigid plastic and foam, e.g. made of polystyrene, polyester, polyether, polyethylene, silicone, neoprene, combinations thereof etc.

Alternatively, the liquid retention chamber 40, or the liquid collector disposed therein, may itself provide a structural support to maintain vacuum passages within the enclosure 20 after applying the vacuum.

[0033] In one embodiment, the housing 20 is semi-permeable. Examples of semi-permeable housings 20 may be essentially liquid impermeable, but somewhat water vapor and other gases permeable, while maintaining a vacuum under the housing 20 after providing a vacuum. For example, the housing material 20 may be made of polyurethane or other semi-permeable material, such as sold under the name Tegaderm®. In one embodiment, the enclosure 20 may have a water vapor transmission rate ("WVTR") of about 836 g / m2²/ day or more. However, in other embodiments, the WVTR may be less than about 836 g / m2²/day. In yet other embodiments, the housing material 20 may be substantially impermeable to both liquids and gases (including steam). Other examples of housing materials may include materials sold under the names Opsite®, Suresite®, Medfix® and Mefilm®.

[0034] The device may be made of a material that improves the comfort of use with wounds in various places. For example, the wound may be on an elbow or other joint such that the device may need to be adjusted to achieve good sealing around the wound area.

[0035] A vacuum source (not shown) is connected to the housing 20 in a manner that allows fluid transfer. Vacuum connection 30 can connect housing 20 and vacuum sources. The vacuum connection may include, but not limited to, examples known in the art for flexible or semi-rigid medical tubing, collectors, tubing, or other channels that can transfer vacuum from a vacuum source to housing 20. In one embodiment, the housing is equipped with a connector 32 or connector 32 that allows the housing 20 to be connected to a vacuum connection 30, or to an external vacuum source. The vacuum source may be located inside or outside the housing 20 and may be away from or adjacent to the housing. When the vacuum source is external to the enclosure 20 and is adjacent to the enclosure 20, a vacuum connection 30 is not necessary and the vacuum can be sent to the enclosure 20 directly from the vacuum source through the connector 32, or connector 32. In embodiments where the vacuum source is inside the housing 20, a connector 32 or connector 32 may not be needed. The vacuum source may be a micro vacuum pump or a normal vacuum pump. The pumps can be of any type known to those skilled in the art. The vacuum source can also be an osmotic or electroosmotic pump.

[0036] The vacuum source may include and may be operably connected to a power source or power supply, such as a battery. The power sources mentioned here may be, for example, electrical outlets, batteries and / or accumulators etc. The batteries may be integrated (non-replaceable), replaceable and / or rechargeable. The power source may be located adjacent to the vacuum source or may be located away so that a larger capacity energy source can be used that can operate throughout the duration of the treatment.

[0037] The connector 32 or connector 32 may simply be a vacuum port for connecting to the outlet of the vacuum source. The connector 32 or connector 32 can also be adapted to provide a more complex connection between the housing 20 and the vacuum source. The connector 32 or connector 32 may be attached to provide communication channels and / or lines between the control module in the vacuum source, or between the vacuum source module and the sensors located inside the housing 20.

[0038] In one embodiment, the connector 32 or connector 32 can transfer gases from the vacuum chamber 24, which, in turn, is connected to the liquid holding chamber 40 through the liquid barrier 36. In an alternative embodiment, the vacuum connection 30 is directly connected to the liquid retention chamber 40 through the liquid barrier 36. In another alternative embodiment, the outlet of the vacuum source is directly connected to the liquid barrier. The vacuum source, vacuum connection 30, vacuum chamber 24 and liquid barrier 36 may be outside or inside the housing.

[0039] The connector 32 or connector 32 may be a structural element associated with the housing 20 or vacuum source to allow connection of the housing 20 to the vacuum source. This connection can be accomplished by means of interference fit, latch, clamping etc. The connector 32 or connector 32 can also be made by gluing or by using a mechanical device, as is known in the art, to provide a connection that maintains communication between the vacuum source and the housing. The connector 32 or connector 32 is adapted to transfer the vacuum generated by the vacuum source to the housing 20.

[0040] The vacuum chamber 24 of the embodiment of the device 10, shown in Figure 1, is defined by the interior of the housing 20. The vacuum chamber 24 may be a void, or it may be filled with a porous material that allows communication with the vacuum. The vacuum chamber 24 sets up a positive fit for vacuum or pressure, which increases the distribution or transmission of vacuum pressure to the liquid collector. The vacuum chamber 24 can also be used to distribute the vacuum pressure more evenly to the liquid collector. Those skilled in the art will recognize that the vacuum chamber need not be defined by the housing 20, but may also be outside the housing. For example, the vacuum chamber 40 may be a conduit in a vacuum connection 30. The vacuum chamber 40 may also be in the space defined by the connector 32.

[0041] The liquid collector comprises at least one porous material that has a plurality of passages to allow fluid to flow through the liquid collector between the vacuum source and the wound. The liquid collector may contain structures and / or substances to retain liquids drawn from the wound. Such structures and / or substances may include sponges, foams, fibers, cotton fibers, vascular fibers, balls, fabrics or gases, super-absorbing polymers in various forms, gelling agents such as sodium carboxymethyl cellulose, sealing materials and combinations thereof. Such structures or substances have channels that provide gas flow and allow vacuum or vacuum to be delivered to the wound. These structures or substances also absorb and retain liquid drawn from the wound. Those skilled in the art will recognize that liquid in the form of wound secretions may contain solid components such as cell debris and other solids that are typically found in wound secretions.

[0042] The materials or structures of which the liquid collector is made form or contain interstitial spaces that serve as channels for underpressure. They allow fluid to flow from the wound to the vacuum source through the liquid collector. In one embodiment, the liquid collector may be a composite structure made of polyester fibers or artificial silk with superabsorbent sodium polyacrylate fibers arranged in the structure among other fibers to form a fibrous mesh. The super-absorbing fibers or particles are arranged discontinuously in the fibrous mesh so that the gas (vacuum) passages are open even when significant amounts of liquid are captured by the super-absorbing fibers or particles. The super-absorbing fibers may act as, or contain, knots inside the liquid container. When the liquid is absorbed by the liquid container, the liquid accumulates in the super-absorbing nodes without blocking the gas flow (vacuum) in the liquid container. In another embodiment, the secretions from the wound that enter the liquid reservoir are absorbed by the super-absorbing material and are immobilized in discontinuous regions within the fibrous mesh or other liquid collector material. Thus, the liquid collector retains the liquid when applying the vacuum as well as when the vacuum is turned off.

[0043] In another embodiment, the liquid collector has regions or zones that cannot be saturated or supersaturated. In these embodiments, the unsaturated zones or regions form passages for passing a vacuum or vacuum from the vacuum source through the liquid collector to the wound. Accordingly, the device 10 includes means for maintaining therapeutic pressure on the wound when the liquid collector absorbs liquid.

[0044] In one embodiment, the liquid collector, housing 30 and / or liquid retention chamber 40 are rigid enough to allow fluid to flow between the vacuum source and the wound through the liquid collector when the device is subjected to a pressure lower than atmospheric pressure. The device 10 has sufficient rigidity or structure such that the passages through the liquid collector remain open under vacuum, vacuum or vacuum pressure to the wound.

[0045] A liquid collector holding a liquid while exerting a certain mechanical force on the liquid collector. For example, the liquid collector can hold liquid even when the device 10 is squeezed by the user. This feature prevents the free liquid from seeping out of the liquid collector when the vacuum source is turned off, or when the liquid holding chamber or liquid collector needs to be replaced.

[0046] In one embodiment, the collector being fluid-permeable is a composite structure made of a structural fiber mesh with super-absorbing fibers disposed therein. This structure maintains sufficient structural integrity when applying a vacuum to keep open passages for the vacuum. Therefore, no additional structural support is needed.

[0047] Other means for retaining and collecting liquids which are known to a person skilled in the art may also be used having similar features. In some embodiments, the liquid collector, or liquid retention chamber 40, may have antibacterial properties, or may contain antibacterial agents.

[0048] The liquid reservoir may be inside the liquid holding chamber 40, or it may be part of a structure that defines the liquid holding chamber 40. As used herein, the term "liquid retention" or "liquid retention" generally means liquid retention. In some embodiments, the liquid retention chamber itself provides the required structural support so that the passages of the vacuum inside or through the housing are open after using the vacuum. Thus, the device has sufficient structure to retain the functionality of the device after applying the vacuum. As will be discussed in more detail below, the fill indicator may inform the user at a certain saturation level of the liquid collector.

[0049] The liquid barrier 36, in one embodiment, is located between the vacuum source and the liquid collector (not shown). The liquid barrier 36 prevents liquid from entering the liquid retention chamber 40 into the vacuum chamber 24. The liquid barrier 36 can also be a gas permeable membrane. As such, it can utilize any of a large family of suitable technologies that prevent liquid from from the liquid retention chamber 40 to enter the vacuum chamber 24 while allowing gas flow and thus transfer the hydrophobic, porous hydrophobic structure, vacuum, provided by vacuum connection 30. Those skilled in the art will recognize that the liquid barrier 36 may be in the form of a film, mat, membrane or other structure that is liquid impermeable. For example, the liquid barrier 36 may include a porous film, a hydrophobic membrane, or other or other means to prevent moisture from entering.

[0050] include, porous

Examples of porous hydrophobic films without limitation to the examples mentioned, and micro-porous polytetrafluoroethylene, polypropylene, polyvinylidene fluoride, acrylic polymers, polyethylene, or fibrous layers of each compound or combinations thereof. For example, porous hydrophobic films sold under the name Gore-Tex® or Millipore® may be suitable. Said hydrophobic films can also act as antibacterial filters and prevent bacteria from entering the liquid retention chamber into the vacuum source and vice versa. Other technologies that allow gas flow but prevent liquid flow can also be used as a suitable liquid barrier 36, as is apparent to those skilled in the art with the help of the present invention.

[0051] In the device 10 of Figure 2, the liquid barrier 36 is a porous hydrophobic film adapted to allow gas flow and at least significantly block the flow of liquid. Thus, when a vacuum source (not shown) is attached to the vacuum transfer means, which in the embodiment shown is the vacuum connection connector 30, the vacuum is supplied / sent through the vacuum chamber 24 to the retention chamber 40, drawing liquid from the wound area into the retention chamber 40 liquid.

[0052] In one embodiment, the wound healing device 10 comprises means for maintaining the operation of the device regardless of the orientation of the device. For example, the device may need to be placed in different areas on the patient's body and must operate at different angles, even when the device is completely inverted. In one embodiment, the means for maintaining the functionality of the device regardless of the orientation of the device includes a liquid barrier 36 that maintains moisture away from the vacuum source regardless of the orientation of the device. The means also include individual components of the device that are constructed to operate regardless of orientation. Means for maintaining the operation of the device regardless of the orientation of the device may include a liquid collector made of a material that gels and immobilizes wound secretions, thereby preventing clogging of vacuum passages by the free liquid. For example, when the liquid collector contains a mesh of fibers with super-absorbing nodes disposed within the mesh, the discharge can be turned into a gel in the hoses, removing liquid, while constantly providing passages for vacuum.

[0053] The device 10 may further include a wound interface that is in direct contact with the wound and may include one or more layers of varying thickness to adapt to the depth of the wound. The wound interface 41 can either be placed directly inside the wound or above the wound. The wound interface 41 is connected to the liquid retention chamber and is adapted to transfer fluid from the center of the wound to the liquid retention chamber 40. In one embodiment, the wound interface 41 transmits fluid using the wick effect. In another embodiment, the wound interface 41 transmits fluid using a capillary effect. The wound interface 41 may be porous to allow fluid to pass from the wound to be absorbed by the liquid collector located above. Alternatively, the wound interface 41 may partially or fully absorb wound fluids. The wound interface 41 can be a sheet, foam, gel, gauze, porous mesh, honeycomb, mop, confetti or combinations thereof.

[0054] The wound interface 41 may be either placed directly inside the wound or above the wound. Wound interface 41 can perform many functions, for example, it can be a layer that allows the delivery of vacuum to the wound, while allowing easy and painless removal from the wound area of ​​the liquid retention chamber when it reaches a certain level of absorption. The wound interface 41 may be a degradable copolymer film, such as is sold under the name Topkin®, or a layer that provides beneficial bio-agents in the form of special dressings, such as skin regeneration templates (e.g., sold under the name Integra®), bio - absorbing gels, foams and barriers that prevent tissue sticking (e.g. sold under the name Incert®), skin substitutes (e.g. sold under the name BioFill®), a layer that selectively maintains moisture in the wound area (e.g. alginates or dressings such as those sold under the name Alevyn®), a layer that is angiogenic (e.g. as sold under the name Theramers®) and / or a layer, which is antibacterial or contains antibacterial agents.

[0055] The wound interface 41 may take a variety of forms, including, but not limited to, a sheet, foam, gel, gauze or other space-filling porous structure, for example a ball bag, hairy mop, loose confetti, or honeycomb. Alternatively, the wound interface 41 may be a gel that fills the wound cavity and which turns into a porous structure after applying a vacuum. In one embodiment, the wound therapy device comprises a wound contact surface having at least one pore with a diameter greater than 100 microns.

[0056] Those skilled in the art will recognize that the wound interface 41 and the liquid collector can be combined in a variety of ways to accomplish teaching the invention. For example, the wound interface 41 and the liquid collector may be separate layers of one body. In one embodiment, each of the plurality of liquid collectors may be encapsulated in a pouch that acts as a wound interface. The capsule cover is made of a wound interface made of a porous material that is permeable to vacuum and body fluid. The liquid collector material is enclosed within said porous bag. In one embodiment, the wound interface prevents direct contact between the liquid collector material and the wound. However, it is contemplated that in some embodiments there may be some contact. Said combination of wound interface and fluid retention may take many forms, including cushions, tubes, self-supporting tubular structures, and similar structures in which the liquid collector may be encapsulated in the wound interface. These structures are flexible and can be formed into the right shape to fit any type of wound cavity. Alternatively, several of said pouches can be connected to each other or otherwise bound to form structures that can be inserted into a deep wound tunnel or deep wound cavity. For example, a connected tube chain can be formed that can be inserted inside the wound tunnel such that the entire cavity of the wound is filled with said structure. A flexible barrier housing material, such as Tegaderm, can then be used to cover the wound area and seal the skin around the wound area. A module containing a vacuum source is attached to a flexible barrier housing to create a vacuum within the wound cavity. Wound secretions enter the inside of the capsule through the permeable outer wound interface sheath and are absorbed inside the liquid collector. As before, the liquid collector allows the application of a vacuum to the wound, while simultaneously absorbing and retaining the liquid drawn from the wound.

[0057] As will be discussed in more detail below, the device 10 may include a skin protection layer. The skin protection layer can protect the healthy skin around the wound from damage or maceration as a result of undesired exposure of healthy skin to vacuum and moisture during wound healing. Said layer of skin protection allows "breathing" of healthy skin as well as easy and painless removal of the device from the wound area. The skin protection layer may first be glued separately to the skin, and the housing may then be glued to the skin protection layer. Alternatively, the skin protection layer may be integrated into the casing or wound interface. The skin protection layer can be the same as the casing material or it can be a gel.

[0058] When the device 10 is placed on the patient and activated, or connected to an external vacuum source via a vacuum connection 30, or simply through a connector 32, the device 10 provides a vacuum to the wound. The device 10 is generally attached to the patient's body surface using one of various seals known in the art, for example, in one embodiment, housing seal 28. The housing 20 of the device 10 may be adapted to seal the connection to the patient's body surface. In some embodiments, said seal may occur simply by placing the housing 20 on the body surface and creating a vacuum within the device 10. The device 10 may include a seal 28 to attach the device to the surface. Adhesives, gaskets and other seals or sealing technologies known to those skilled in the art can also be used as sealing 28, including the use of thin polyurethane foils coated with adhesive. Other suitable seals are known to those skilled in the art and can be used in the embodiments shown. In one embodiment, the device includes a leak detector operatively connected to the seal to control whether vacuum or vacuum is escaping from the device 10 through the seal 28.

[0059] In one embodiment, the seal 28 may be part of the housing 20, or it may be integrated into the skin protection layer. Those skilled in the art will recognize that the seal 28, the casing 20 and the skin protection layer can be combined in various ways to implement the idea of ​​the present invention.

[0060] Thus, in operation, the device 10 can be applied to the patient's wound area like a tampon, wherein a vacuum source attached to the vacuum connection 30 provides a vacuum to the wound. Before use, the device 10 may be packaged to avoid contamination. Such packaging may be a bag or envelope, or may include the use of an optional protective cover 16, with an optional drawstring 18 that is removed from the device prior to being placed on the patient. When supplying the vacuum to the wound area, the liquid is drawn into the liquid holding chamber 40 and kept in the liquid holding chamber 40 so that it cannot pass through the liquid barrier 36.

[0061] In Figure 3, another embodiment of the wound healing device 110 is shown in a lateral cross-section analogous to Figure 2. The wound healing device 110 of Figure 3 includes a housing 120 and a passage for a vacuum 130. In the device 110 of Figure 3, the vacuum passage 130 is a port 132 adapted to seal the external vacuum source through a vacuum connection 134 so that the vacuum source can provide a vacuum to device 110. In alternative embodiments, the vacuum source may be adjacent, inside or outside the enclosure 120. In the exemplary device 110, the vacuum source not shown may be shared by a series of devices 110 on one patient or on several patients because the liquid does not flow to the appropriate vacuum connections 134 from the appropriate devices 110. As with the device 10 in Figures 1 and 2, the wound treatment device 110 of Figure 3 may include a liquid retention chamber 140 and a vacuum chamber 124. In this embodiment, the vacuum chamber 124 itself serves as a liquid barrier 136, acting as a "gap droplet ', through which liquids drawn into the liquid retention chamber 140 cannot pass. "Drip gap" refers to the gap between the liquid holding chamber 140 and the vacuum connection 130. The surface tension of the liquid that occurs in the liquid retention chamber does not allow the droplets to jump over the "drop gap" and get into the vacuum connection. Thus, the "drop gap" acts as a liquid barrier, not allowing liquid to leave the liquid retention chamber 140.

[0062] In particular, the vacuum chamber 124 may be a cylindrical space in the inner space 122 of the housing 120, which, due to its size, does not allow liquid to enter from the liquid retention chamber 140 to the vacuum connection 130. The vacuum connection 130 may reach to the vacuum chamber 124 and may include at least one opening 138. The housing 120 may also include internal supports 126 that extend between the vacuum connection 130 and the circuit 142 of the liquid retention chamber 140 to maintain a proper distance between the vacuum connection 130 and the liquid retention chamber 140.

[0063] As a liquid barrier, a labyrinth may also be used to prevent the liquid from leaving the liquid retention chamber 140. The idea of ​​the labyrinth uses the principle of clumping and uses the structures used in commercially available mist eliminators, as chemistry engineers know. The liquid or mist that enters the maze sticks together and is recycled to the liquid holding chamber without entering the vacuum connection 130.

[0064] The wound healing device of figures 1 and 2 can be modified to take advantage of the advantages of the drip gap principle shown in figure 3, simply by omitting the liquid barrier 36. A drip gap or labyrinth can also be effectively used instead of a hydrophobic liquid barrier to maintain a vacuum inside the device regardless of the orientation of the device.

[0065] Referring again to Figure 3, the device

110 it may optionally include a liquid barrier 136 in the form of a porous hydrophobic membrane located between the liquid holding chamber 140 and the vacuum chamber 124.

[0066] vacuum

Figure 4 shows a detailed view of the chamber 124 and liquid barrier 136 of the device 110 of Figure 3, showing the contents of the wheel 4 of Figure 3. As shown, the internal supports 126 structurally maintain the vacuum connection 130 inside the vacuum chamber 124.

[0067] An exemplary structure, shape and construction of the vacuum chamber 124 of the device 110 is further illustrated in Figure 5, which shows a cross-section of the wound healing device 110 of Figures 3 and 4, taken along the plane 5-5 in Figure 3. The internal supports 126 run between vacuum connection 130 and circuit 142 to maintain a proper distance between vacuum connection 130 and liquid retention chamber 140. In figure 5, the vacuum chamber 124 has a cylindrical profile. It should be noted that changes in the size, volume or shape of the vacuum chamber 124 can be determined by one of ordinary skill in the art. Thus, elliptical, rectangular and other shapes, without being limited to the examples mentioned, are considered to fall within the scope of the present invention.

[0068] The liquid barrier and / or vacuum chamber configurations described above include a connection that forms part of the connection between the vacuum source and the wound, and which provides vacuum to the wound. Accordingly, said configurations form part of the means for transferring a vacuum between the vacuum source and the wound.

[0069] Figure 6 shows another embodiment of a device 210 for treating wounds in a lateral cross-section, analogous to that shown in Figure 2. The device 210 of Figure 6, as previously shown, comprises a housing 220 which surrounds the inner space. This embodiment of the wound healing device 210 is, however, configured to include a vacuum source 230 including a vacuum source 234 and a connector 232 that provides the vacuum to the vacuum chamber 224. The vacuum source 234 is operatively connected to a power source 238, which may also be inside the device 210 as shown. Furthermore, although the vacuum source 234 and power source 238 are shown inside the housing 220, in the auxiliary chamber 226 in figure 6, it should be noted that such a device may be located outside the housing 220, or may alternatively be located in the modular portion of the device 210, which can be removed or replaced if necessary.

[0070] In some embodiments, the vacuum may be delivered to the liquid retention chamber 240 and / or liquid collector through a pipe or other connector 232 or connector 232 attached to the vacuum pump 234. When the vacuum source

230 is an internal vacuum pump 234, the connector 232 can run from the pump 234 into the vacuum chamber 224, allowing gas to be transferred from the liquid holding chamber 240. When the vacuum source 230 is an internal vacuum pump 234, the outlet

235 is provided for a vacuum pump or other vacuum source for ventilation. The outlet may include a 237 filter to prevent germs from entering the interior, and vice versa. The connector opening 232 in the vacuum chamber 224 may include a filter 261, or may have similar characteristics to a liquid barrier 236 (e.g., in some embodiments, an antibacterial filter) to prevent liquid from entering the wound from vacuum source 230 and preventing entry germs from outside to the wound area. In addition, in some embodiments, the device 210 may include both input and output filters to prevent microorganisms from entering the outside of the housing 220 during ventilation. [0071] In operation, the wound healing device 210 may first be placed on the surface of the patient's body so as to at least partially cover the wound area. As mentioned earlier, the device 210 can be sealed to the body surface using either simply the suction produced by the device 210 or using a seal 228 selected from those known to those skilled in the art. The seal shown in figure 6

228 is an adhesive seal, covered with a cover 216 during storage, optionally including a drawstring 218. The device 210 may further include a wound interface 241 as described.

[0072] After the device 210 is attached to the patient, a vacuum source 234 is activated, reducing the internal pressure in the device 210. When a vacuum is created, liquids are drawn from the wound into the liquid retention chamber 240 of the device 210 and are blocked from entering further into the chamber vacuum 224 or vacuum source 230 through a liquid barrier 236. As in previous embodiments, the liquid barrier 236 may be of any type known to those skilled in the art, including, but not limited to, porous hydrophobic films, membranes, and porous hydrophobic structures such as sponges and / or foams.

[0073] The exemplary device 210 of Figure 6 may further include a pressure relief valve 260, a fill indicator 270 and a leak indicator (not shown). In certain specific embodiments, the housing 220 may further include means for controlling pressure within the housing. The means for controlling pressure may include, but are not limited to, a pressure relief valve, or pressure control valve, or other pressure controller. The pressure relief valve 260 can be used to maintain the therapeutic value of the vacuum in the inner space of the housing 220 (and thus within the liquid holding chamber 240 and at the wound surface). Pressure relief valves can be of any type available commercially. In one embodiment, the vacuum is maintained at a level between about 75 mm Hg and about 125 mm Hg. The pressure relief valve can be located in the device at any place where a vacuum is created. In one embodiment, a pressure relief valve 260 is located on the housing

220 so that it can respond to pressure changes in the liquid retention chamber 240. The pressure relief valve 260 can also be located on the vacuum source itself, or between the housing and the vacuum source 230. The pressure relief valve

260 it may further include an inlet filter (not shown) to prevent contamination of the device 210 and thus to further protect the wound area. The pressure relief valve can operate in a variety of ways, including opening at a set pressure, so that the surrounding air can enter the housing 220 and closing when it reaches the set pressure inside the housing

220, opening device 210 and turning off the vacuum source, or simply turning off the vacuum source. Specialists in the field of vacuum equipment.

[0074] They will notice that controlling pressure inside involves turning the source on or off

Wound healing device 210 may alternatively include a pressure controller for controlling the vacuum or pressure in the housing 220. The pressure controller may operate in conjunction with a vacuum (pressure) sensor to measure pressure within the wound cavity and / or above the wound, within the fluid retention chamber 240 . The vacuum sensor is connected to the vacuum source 234 by connecting the electronic circuit and the relay and controls the vacuum source. The vacuum sensor may alternatively be connected to a pressure relief (control) valve 260 to maintain the therapeutic pressure in the wound area. Vacuum (pressure) sensors or differential pressure sensors can provide a voltage output signal or current output signal that can be used by connecting an electronic circuit and a relay to turn the vacuum source on or off. Examples of such electronic vacuum sensors are commercially available from Honeywell under the trade name Sensotec sensors.

[0075] Alternatively, a vacuum switch or differential pressure switch can be used that cuts off the vacuum source 30 when the correct pressure has been reached, without a plurality of pressure relief valves. Such mechanical vacuum (pressure) switches are well known to practitioners in a given field and can be obtained, among others, from the companies MPL (MicroPneumatic Logic), Air Troll, and Air Logic.

[0076] In yet other embodiments, the device 210 may include a fill indicator that indicates when the liquid retention chamber 240 has a certain level of absorption. The fill indicator 270 may operate in a variety of ways known to a person skilled in the art. The indicators can be visual (e.g. changing color or LED) or acoustic. The fill indicator 270 may advantageously be located on the outer wall of the housing 220 or near the vacuum source 234. The fill indicator 270 may include a sensor located inside the housing that is electronically or mechanically connected to the fill indicator. Such a sensor can be located either between the liquid holding chamber 240 and the liquid barrier 236 or on the wall of the liquid holding chamber opposite the wound interface 241. Some sensors work by detecting the presence of free moisture in the liquid holding chamber 240, which means that the liquid holding chamber has reached a certain level of absorption. Alternatively, the fill indicator sensor may use the electrical conductivity of the component in a portion of the liquid retention chamber 240 to detect when moisture reaches a given zone and provide a signal to turn off the vacuum source 230. Other sensors are known in the art and are suitable for use in the devices described, including color change technology based on the moisture content of the material, or a change in physical characteristics or characteristics, vacuum sensors based on the detection of vacuum changes, galvanic, potentiometric and capacitive types . The device 210 may further include an overflow valve, such as a float valve in a vacuum connection, to prevent liquid from entering the vacuum source.

[0077] Alternatively, the wound treatment device 210 may also include an indicator of a lack of vacuum or leakage of the housing, or leakage (not shown). Such an indicator can be based on pump operation time, low vacuum signal from the vacuum sensor, visual indicators on the housing (e.g. a recess in the housing that flattens, or an embossing system on the housing that becomes visible when the vacuum has a certain level), low flow sensors, pressure-dependent color change, etc. The leakage indicator can be operatively connected to the seal. Wound healing device 210 may also optionally include a sensor for detecting oxygen or other gases and a sensor for measuring the temperature in the wound area. The device 210 may also include a blood detector. In one embodiment, the blood detector may use art-known optical technologies to detect the presence of blood within the housing 220.

[0078] In embodiments with sensors, other indicators, valves, switches, etc., the connector may be configured with channels, ports, inlets or outlets. For example, the connector 232 may include communication wires from a vacuum sensor, a fill indicator sensor, a leakage sensor or other sensors or indicators present in the interior of the housing 220. In addition, any communication between the pressure relief valve or the relief valve located on the housing 20 and the vacuum source can pass through such a connector. In some embodiments, the connector may also act as an on / off switch, wherein the vacuum source, as well as all other components of the device, begin to operate when the vacuum source is connected to the housing 20 via the connector.

[0079] Figure 7 illustrates yet another embodiment of the wound healing device 410. In wound healing device 410, the vacuum source 434 and associated power source 438 are spaced from the wound area and may or may not be within the housing. In some situations, offset may be beneficial for the wound. Similar to previous embodiments, the device 410 may include a housing 420 that includes an inner space 422. The space 422 is divided into a vacuum chamber 424, a liquid holding chamber 440 and an auxiliary chamber 426. However, as in the previously described embodiments, the location of the auxiliary chamber 426, or vacuum source 434 and power source 438 inside the housing is optional. When the vacuum source is an internal vacuum pump 434, an outlet 435 is provided for the vacuum pump for ventilation. The outlet may contain a filter 437 to prevent germs from entering from the outside in, and vice versa.

[0080] In this embodiment, the vacuum source 430 extends through the housing 420 into the vacuum chamber 424 through the outlet 432. Outlet 432 may include a filter 461 (e.g., in some embodiments, an antibacterial filter) to prevent excretions from entering the wound into vacuum sources 434. As in other embodiments, the device 410 may include a liquid barrier 436, e.g., a hydrophobic membrane, that will prevent fluid from flowing into the vacuum chamber 424, but will allow vacuum to enter the fluid retention chamber 440, causing fluid wound to enter the fluid retention chamber 440 . In some embodiments, the vacuum chamber 424 may include a porous hydrophobic foam. In other embodiments, the vacuum chamber 424 may be empty.

[0081] As mentioned, the device 410 can be sealed to the patient's body surface using either simply the suction produced by the device 410, or using a seal 428 selected from among types known by those skilled in the art. The seal 428 shown in Figure 7 is an adhesive seal, covered with a cover 416 during storage, optionally with a drawstring 418. The device 410 may further include a wound interface 441 as described.

[0082] Figure 8 illustrates an alternative embodiment of a wound healing device 510 that may assist in the treatment of wounds located in body parts involved in standing, sitting, or lying, i.e. on the heel of the foot or buttock. In these cases, it may be desirable for the wound dressing and components of the device in the areas of operation to be substantially matched to the surrounding body so as to avoid pressure on the device area that could be harmful to the treatment or cause additional wounds. In addition, it may be desirable to accumulate liquid or discharge from the wound at a location distant from, but adjacent to the wound area.

[0083] To this end, the device 510 shown in Figure 8 has an elongated housing structure 520 with a proximal end 527 adapted to cover at least a portion of the wound and a distal end 529 adapted to be positioned outside the perimeter of the wound. Wound interface 541 is located at the proximal end 527. In one embodiment, the vacuum source 530 is attached to the housing 520 adjacent the distal end 529. In another embodiment, a source of vacuum 530 is attached to the housing 520 adjacent the proximal end 527. The liquid holding chamber 540 extends from the wound interface 541 to a vacuum source 530. In this embodiment, the greater part of the liquid retention chamber 540 is at the end of the housing 520 adjacent to the vacuum source 530. The device 510 may also include a liquid barrier 536 located between the liquid holding chamber 540 and a vacuum or vacuum source 530. In one embodiment, the liquid retention chamber 540 extends from a location within the wound perimeter to a location outside the wound perimeter. In another embodiment, the housing 520 has a proximal end 527 adapted to cover at least a portion of the wound and a distal end 529 adapted to be positioned outside the perimeter of the wound.

[0084] Wound interface 541, located in the wound area, seals the wound and allows vacuum to be transmitted to the wound area. The 541 wound interface may be in contact with the ventricle running into place

Extended chamber 540 source placement

540 a liquid retention which positioning the vacuum source chamber 524 for liquid retention allows underpressure at a location other than the wound area.

[0085] Alternatively, the device 510 may have two separate housings: one housing 520a with a sealing surface 512 around the wound area and another housing 520b located at a distance from the wound area. The second housing 520b may or may not be sealed to the skin. Both housings 520a, 520b shown in Figure 8 can be constructed of a liquid impermeable flexible barrier, optionally supported by rigid or semi-rigid support structures 526. The housing 520b, comprising the vacuum chamber 524, may be located more conveniently in a place where the load caused by sitting, standing, or lying does not occur or where it can in principle be avoided. With low elongation, the device can be substantially flat above the wound area. In this configuration, the pressure applied to the device is spread over a larger area and is not directed at the wound.

[0086] The vacuum source 530 may include a vacuum pump 534 operatively connected to a power source 538, for example a battery. Vacuum source 530 may be outside of enclosure 520 as shown. However, it should be noted that alternative embodiments of the wound healing device 510 may include a pump 534, which may be a micro vacuum pump and / or power source 538, located inside the housing 520. The source of vacuum 530 may be an osmotic or electro-osmotic pump adjacent to or within the housing as mentioned above.

[0087] Figures 9A and 9B illustrate embodiments of a wound healing device 610, 610 'that has a modular structure. In this embodiment, the device 610, 610 'can be separated into three modules. However, more or less than three modules can be used, as will be appreciated by one of ordinary skill in the art with the help of this description. In the illustrated embodiments, the device 610, 610 'includes a wound interface module 641, 641', ​​a liquid retention module 640, 640 'and a vacuum pump module 630, 630'. As a result of the modular design, any of the combination of 610, 610 'device modules replaced as needed.

modules or can be [0088]

For example, if the module

640,

640 'liquid retention is filled to a certain level with secretions, it can be replaced by a new liquid retention module 640, 640', while maintaining the vacuum pump module 630, 630 '. Alternatively, the liquid retention module 640, 640 'may be replaced at regular intervals to prevent overflow and ensure adequate capacity. Similarly, wound interface module 641, 641 'may be replaced independently of the other modules.

[0089] In the embodiment of figure 9A, the liquid retention module 640 has a similar structure to the embodiments shown in figures 2 and 6. The liquid retention module 640 'of figure 9B has a similar structure to the embodiment shown in figures 3 and 4. Both embodiments of the device 610, 610 'include a liquid barrier 636, 636' to prevent secretions from entering the vacuum chamber 624, 624 '. The vacuum pump module 630, 630 'may include a vacuum source 634, 634' and, optionally, a power source 638, 638 '. When a vacuum source

634, 634 'is located inside, vacuum source 634, 634' is equipped with an outlet 635, 635 'for ventilation. Departure

635, 635 'may contain a filter 637, 637', which does not allow germs to enter from outside, and vice versa.

[0090] The wound interface module 641, 641 'of both embodiments can perform many functions as described above, for example, it is a layer or other structure that allows the delivery of vacuum to the wound, while allowing easy and painless removal from the wound area when changing the dressing . Alternatively, the wound interface may be a layer or other structure that provides beneficial bio-factors in the form of a special dressing, e.g. skin regeneration template, bio-absorbing gels, foams and barriers that prevent tissue sticking. The wound interface can also be a skin substitute, a layer for selectively maintaining moisture in the wound area, a angiogenic layer and an anti-bacterial layer. The wound interface can take a variety of forms, including, but not limited to, a sheet, foam, gel, gauze, or a porous mesh.

[0091] Figure 10 illustrates a structural support 772 that can be positioned inside a liquid retention chamber in a wound healing device. Structural support 772 may be formed and / or fitted to fit within a wound healing device. Structural support 772 may include structural support material 774 that is adapted to provide support for a wound healing device housing when applying a vacuum. The structural support material 772 may be made of rigid or semi-rigid plastic, etc. An absorbent material 776 is arranged between the structural support material 774 to absorb and retain wound exudate within the fluid retention chamber. As described above, the absorbent material 776 may include sponges, fibers, fabrics or gases; super-absorbing material, containing super-absorbing polymers, absorbing foams, gelling agents; seals etc.

In some embodiments, the absorbent material 776 can also serve as a structural support for the housing when a vacuum is created in the wound healing device.

[0092] Figure 11 represents another embodiment of the wound healing device 810, similar to the embodiment shown and described with reference to figure 2. The wound healing device 810 may include within the housing 820 a support structure 872. As shown in figure 10, the support structure 872 may include structural support material 874 and absorbent material 876 located within the liquid retention chamber 840.

[0093] Figure 12 is a cross-sectional view of an alternative design of the present wound healing device. Device 910 includes a vacuum source module 911 and a dressing module 913; connector 948 maintains the connection between the vacuum source module 911 and the dressing module 913. The connector 948 is adapted to transmit the vacuum generated by the vacuum source module 911 to the dressing module 913. The connector 948 can be an adhesive sheet. As mentioned above, the connector may be a feature of the dressing module 913, or the vacuum source module 911, or it may be a separate structure that allows the dressing module 913 to be connected to the housing module 911. The joint can be realized by means of a threaded connection, snap fastening, press fit, gluing, welding, etc. Dressing module 913 includes a housing 920, which, for example, may be a flexible barrier, or surface wrapper that forms the inner space 922. Said inner space 922 may further include a vacuum chamber 924 and a liquid collector 940, separated by a liquid barrier 936. The vacuum chamber 924 in this case is a structural element, for example made of plastic, with voids or channels in the center to provide a vacuum to the liquid retention chamber through the liquid barrier. Those skilled in the art will recognize that the device described with reference to Figures 1-11 can also be used in various configurations as dressing modules 913, 1013, 1113 and 1213 of Figures 12-15.

[0094] Vacuum source module 911 includes a housing 933, comprising a vacuum source 934, a vacuum switch 944 and a power source 938. The outlet 930 of the vacuum source and the inlet 952 of the vacuum source for the vacuum switch 944 are connected to the vacuum chamber 924 through holes 925 in the housing 920, made of a flexible barrier. The vacuum switch 944 can be replaced by a combination of vacuum sensor / electronic circuit / relay. it should be noted that the tubes may be not securely attached to the vacuum chamber to allow separation of modules 911 and 913 from one another.

[0095] Figure 13 shows a cross-section of a structure that is not the subject of the claimed invention. The device 1010 includes a vacuum source module 1011, a dressing module 1013 and a connector 1048 that connects the vacuum source module 1011 to the dressing module 1013. The dressing module 1013 includes a housing 1020 made of a flexible barrier / surface wrap that defines an inner space 1022. The inner space in this case is occupied by the liquid holding chamber 1040. Two holes

1025 they are made in a 1020 housing - one for connecting a vacuum source and the other for connecting a vacuum switch.

[0096] Connector 1048 is adapted to transmit the vacuum generated by the vacuum source module 1011 to the dressing module 1013. The connector 1048 may include an edge, or other structural element, either of the vacuum source module 1011 or the dressing module 1013. Connector 1048 can also be a separate element. The connector allows the vacuum source module 1011 to be attached to and maintains connection with the dressing module 1013. In one embodiment, the vacuum source module 1011 is press-fit with the dressing module 1013. In another embodiment, the dressing module 1013 is press-fit with the vacuum source module 1011. Modules 1011 and 1013 can cooperate threaded with each other. Modules 1011 and 1013 can also be snap-connected, or they can be connected to each other with a different type of connection. Those skilled in the art will recognize that modules 1011 and 1013 may be attached to each other in a variety of ways to implement the idea of ​​the present invention.

[0097] Vacuum source module 1011 has a housing 1033 containing a vacuum source 1034, a vacuum switch 1044 and a power source 1038. The housing 1033 is equipped with two openings 1025 - one for vacuum outlet 1030 from vacuum source 1034 and the other for inlet 1052 of vacuum source for vacuum switch 1044. Two liquid barrier films 1036 are located in the holes 1025. In one embodiment, the vacuum source module housing 1033 is attached to the dressing module housing 1020 using an adhesive 1048 water barrier such that the openings in the first housing and in the second housing are opposite the foil fluid barrier therebetween. Said embodiment is different from the previous embodiments due to the lack of a vacuum chamber inside the first housing, i.e. vacuum connection 1030 is connected directly to the liquid retention chamber 1040 through the liquid barrier 1036. The vacuum switch can be replaced by a combination of vacuum sensor / electronic circuit / relay. A fill level indicator 1070 along with a sensor 1066 is also shown.

[0098] Figure 14 shows a cross-section of yet another construction of the present wound healing device. As shown, the device 1110 includes a vacuum source module 1111 connected to a dressing module 1113. The dressing module 1113 has a housing 1120 made of a flexible barrier / surface wrap that defines an internal space 1122. The internal space is in this case occupied by the liquid retention chamber 1140. Vacuum source module 1111 is attached to the dressing module 1113 via connector 1132 or connector 1132. Vacuum source module 1111 includes a vacuum source 1134, vacuum sensor 1164 and power source 1138. Connector 1132 includes a channel that connects vacuum outlet 1130 from vacuum source 1134 with barrier film 1136 for liquid, located in the liquid holding chamber 1140. The connector 1132 also includes communication channels between the vacuum sensor 1160 located in the liquid retention chamber 1140 and the control module 1176 in the vacuum source module 1111. Control module 1178 may include electronic circuits and relays known in the art. Connections from the fill indicator sensor 1166, leakage sensor (not shown) etc. located inside the housing 1120 may also be part of the connector 1132 or connector 1132. In addition, any communication between the pressure relief valve and the relief valve located on the housing 1120 and the vacuum source 1134 can pass through such a connector 1132 or connector 1132. In some embodiments, the connector 1132 or connector 1132 can also act as an on / off switch , wherein the vacuum source 1134, as well as other components in the device, begin to operate automatically when module 1133 is connected to the housing 1120 via connector 1132. The vacuum sensor / electronic circuit / relay can be replaced by a vacuum switch. Shown indicator 1170 with sensor 1166 is also shown.

[0099] Figure 15 shows a cross-section of yet another alternative construction of the present wound healing device. The device 1210 is modular, like the embodiments described with reference to Figures 12-14, and includes a vacuum source module 1211 and a dressing module 1213. The dressing module 1213 includes an elongated housing 1220 made of a flexible barrier / surface wrap that defines an inner space 1222. The inner space is in this case occupied by the liquid holding chamber 1240, which may comprise a liquid collector as described previously. The dressing module 1213 includes a wound interface 1241 located at the proximal end of the housing 1220. A vacuum source 1234 is located at the other or distal end outside the housing 1220. The liquid holding chamber 1240 extends from the wound interface 1241 to the vacuum source 1234. A connector 1232 or connector 1232 is located between the housing 1233 of the vacuum source module 1233 and the housing 1220 of the dressing module 1213. The vacuum source module 1231 includes a vacuum source 1234, a pressure controller 1260 and a power source 1238. The pressure controller may be in the form of a pressure relief valve and may be used to maintain a therapeutic vacuum value in the inner space 1222 of the housing 1220 (and thus within the liquid retention chamber 1240 and on the wound surface 1241). Those skilled in the art recognize that a pressure relief valve can be located anywhere in a device where a vacuum is created. The pressure relief valve may also be located on the vacuum source 1234 itself, or on the vacuum connection 1230 (shown), or on the housing 1220.

[00100] The device 1210 may include a moisture dispenser

1280 and a vacuum dispenser 1282. A moisture dispenser 1280 can facilitate uniform absorption of fluid from the wound through the liquid retention chamber 12 and / or the liquid collector. Vacuum dispenser 1282 may facilitate uniform distribution of vacuum within the liquid retention chamber 1240 and / or the liquid collector. Examples of this type of 1282 vacuum dispenser and 1280 moisture dispenser include three-dimensional knitted interleaving fabrics manufactured by Gehring Textiles. Said interleaving fabrics may comprise two separate layers which are combined, in one fiber, an inner layer of surface fibers, of a knitting sequence, with an interleaving which has an orientation of fibers perpendicular to the surface fibers. Surface fibers can be made, without limitation to the examples mentioned, from cotton, nylon, polyester, neoprene, single polyurethane fibers, PBI, Nomex, Kevlar and glass fibers.

[00101] In one embodiment, the vacuum dispenser is a surfactant introduced into the liquid collector. The vacuum dispenser may also be a hydrophobic structure located at the inlet of the vacuum to the housing 1220. Those skilled in the art will recognize that the vacuum dispenser can prevent the inlet material from clogging the inlet by the liquid collector material.

[00102] The liquid collector chamber 1240 may be a plurality of layers. For example, 1242, vacuum dispenser 1282 Said layers may be liquid retention and / or made in one form or may include a liquid collector and a moisture dispenser 1280. located between the liquid collector 1242 and the liquid barrier 1236 (or vacuum chamber 1224), or between absorption layer 1242 and wound bed.

[00103] Without limitation, the disclosed devices and methods of using them may be useful in the treatment of patient surface wounds in treatment. These wounds may include, but are not limited to, infectious wounds, burn wounds, venous and arterial ulcers, diabetic ulcers and wounds, post-operative wounds surgical, pressure ulcers, etc. In addition, the use of said devices in various fields is contemplated according to the judgment of a specialist in the field.

[00104] According to one method of treating wounds or therapy using the devices described herein, the device having a housing with a fluid retention chamber is placed over at least part of the wound. Vacuum can be delivered to the wound using a vacuum source. Fluids or wound secretions may accumulate in the fluid retention chamber. In addition, the device can be replaced when filled with liquid. In modular embodiments, the liquid retention chamber module, wound interface module, or vacuum source may be replaced separately or in combination as required.

[00105] The method of assembling a wound healing device comprises the steps of providing a vacuum source module comprising a vacuum source that can generate a vacuum and a vacuum controller to control the amount of vacuum. The method also includes providing a dressing module having a casing to cover at least part of the wound area. The dressing module also includes a porous liquid collector, located inside the housing and connected to the wound area. The liquid collector is adapted to retain excretions from the wound and at the same time transfer the vacuum generated by the vacuum source module to the wound area. The dressing module may also include a liquid barrier located between the liquid collector and the vacuum source module. The dressing module may further include a seal for sealing the connection of the dressing module to the surface around the wound area. The method includes attaching the vacuum source module to the dressing module such that the vacuum source module transmits a vacuum to the dressing module and fixing the device adjacent the wound area. It will be appreciated by those skilled in the art that the method steps may be carried out in different orders to teach the implementation of the idea of ​​the invention.

[00106] In some of the described embodiments, the devices can be constructed to be cheap, light and either partially or completely disposable. In addition, the devices can be adapted to be easy to use, such that in some cases, the patient can use the device with limited medical supervision. In addition, devices can be constructed so that they can be used without paying attention to their orientation.

[00107] It is contemplated that the devices may take a variety of forms, including those that are completely disposable after filling, or partly disposable, for example only a vacuum source or liquid retention chamber. In the embodiments of the device 10 of Figures 1 and 2, for example, the entire device can be discarded and replaced when filled. This can be convenient for smaller wounds, wounds that are already advanced and wounds that are treated at home. Such methods and devices prevent and / or reduce contact with potentially infectious or hazardous body fluids.

[00108] It should be noted that although the enclosures described are shown in specific shapes, generally rounded, the shapes of the enclosures are not limited to specific forms and can be made in any preferred form. In some embodiments, the devices can be of a size and shape such that the vacuum chamber or liquid holding chamber can be sealed over the patient's wound, at least partially. The described housings and seals can be adapted to maintain a vacuum when the device is placed and sealed over at least part of the wound on the patient's body surface. Such seals can, in principle, be hermetic to prevent microbes from entering but do not have to be absolutely impermeable. It is contemplated that vacuum pressure is provided either continuously or periodically to maintain the vacuum within the therapeutic range.

[00109] When the vacuum is turned on after placing the device on the patient's wound, air is removed from the wound's surroundings, creating a vacuum within the housing cavity. At the same time, the liquid-absorbing material from the wound may begin to absorb secretions / liquid in the wound. Sustained vacuum over the wound area can promote tissue migration and wound closure. In some embodiments, the device may be in the form of a wrap or bandage, which may be changed more than once a day. Those skilled in the art will recognize that the device can continue to absorb and capture fluids when the device or vacuum is turned off.

In addition, the device may include a fill indicator that measures the presence of free moisture in the liquid retention chamber, which signals that the optional porous compress has reached a predetermined level of absorption. In turn, the fill indicator can be connected to an overflow valve to prevent liquid from the wound from entering the vacuum pump, or it can provide a signal that is used to immediately turn off the pump.

[00111] In all the above embodiments, when the devices are made as disposable, they can be removed partially or completely after use. In practice, multiple disposable devices may be provided to a patient as part of a treatment plan that may include multiple individual treatments using disposable devices at specific time intervals.

[00112] Without further consideration, it is believed that one skilled in the art can use the above description to fully utilize the present invention. The embodiments presented herein should be considered as illustrative only and not in any way limiting the scope of the present invention. Those skilled in the art will recognize that changes can be made to the details of the above-described embodiments without departing from the basic principles set forth herein. In other words, various modifications and improvements of the embodiments explicitly set forth in the above description are within the scope of the appended claims. It should be noted that the elements given with the term "more or less" should be treated in accordance with 35 USC § 112 p. 6. The scope of the invention is therefore defined by the following claims.

The following statements generally describe certain aspects of the present invention. The applicant reserves the right to combine reservations with any aspects described by the following statements:

1. Wound treatment device comprising:

a casing adapted to cover at least part of the wound;

a vacuum source connected to the housing in a manner enabling fluid transmission, a liquid collector located inside the housing and operatively connected to the wound, said liquid collector being adapted to retain discharge from the wound and at the same time send a vacuum generated by the source to the wound.

2. The wound healing device according to claim 1, wherein the liquid collector is a porous material forming a plurality of passages allowing fluid to flow through the liquid collector between the vacuum source and the wound.

3. The wound healing device of claim 2, wherein the liquid collector is rigid enough to allow fluid to flow between the vacuum source and the wound through the liquid collector when the device is subjected to a pressure lower than atmospheric pressure.

4. The wound healing device of claim 2, wherein the housing is rigid enough to allow fluid to flow between the vacuum source and the wound through the liquid collector when the device is exposed to a pressure lower than atmospheric pressure.

5. The wound healing device of claim 2, wherein the housing in combination with the liquid manifold are rigid enough to allow fluid to flow between the vacuum source and the wound through the liquid manifold when the device is exposed to a pressure lower than atmospheric pressure.

6. The wound healing device according to claim 1, wherein the liquid collector is adapted to hold the liquid by applying a certain amount of mechanical force to the liquid collector.

7. The wound healing device according to claim 1, wherein the vacuum source is inside the housing.

8. The wound healing device according to claim 1, wherein the vacuum source is outside the housing.

9. The wound healing device of claim 1, further comprising a vacuum chamber connected to the vacuum source in a manner that allows fluid flow.

Of 10. The wound healing device of claim 1, further comprising a liquid retention chamber.

11. The wound healing device according to claim 10, wherein the liquid collector is located inside the liquid retention chamber.

12. The wound healing device according to claim 11, wherein the liquid retention chamber is rigid enough to allow fluid to be transferred through the liquid collector between the vacuum source and the wound when the device is subjected to a pressure lower than atmospheric pressure.

13. The wound healing device according to claim 10, wherein the liquid retention chamber extends from a place inside the wound periphery to a place outside the wound perimeter.

14. The wound healing device according to claim 1, wherein the housing comprises a proximal end adapted to cover at least part of the wound and a distal end adapted to remain outside the perimeter of the wound.

15. The wound healing device according to claim 14, wherein the vacuum source is attached to the housing adjacent the distal end.

16. The wound healing device according to claim 14, wherein the vacuum source is attached to the housing near the proximal end.

17. The wound healing device of claim 1, further comprising means for supporting the operation of the device regardless of the orientation of the device.

18. The wound healing device of claim 1, wherein the vacuum source includes a power source.

19. The wound healing device according to claim 1, wherein the housing comprises one of the elements of a group consisting of polystyrene, polyester, polyether, polyethylene, silicone, neoprene and combinations thereof.

twenty. The wound healing device according to claim 1, wherein the housing comprises a flexible barrier.

21. The wound healing device according to claim 20, wherein the flexible barrier comprises polyurethane.

22. The wound healing device of claim 1, further comprising a seal for attaching the device to the surface.

23. The wound healing device of claim 1, further comprising a skin protection layer for protecting the skin of the user.

24. The wound healing device of claim 1, further comprising a vacuum dispenser connected to the liquid collector.

25. The wound healing device of claim 1, further comprising a moisture dispenser connected to the liquid collector.

26. The wound healing device of claim 1, wherein the liquid collector includes one of the elements of a group consisting of sponges, fibers, fabrics, gases, absorbent materials, adsorbent materials, polymers, gels, gelling agents, foams, sealing material and combinations thereof.

27. The wound healing device according to claim 1, wherein the liquid collector further comprises antibacterial agents.

28. The wound healing device of claim 1, further comprising a liquid barrier located between the liquid collector and the vacuum source.

29. The wound healing device according to claim 28, wherein the liquid barrier is a gas permeable membrane.

thirty. The wound healing device according to claim 28, wherein the liquid barrier is a hydrophobic structure.

31. The wound healing device of claim 1, further comprising a wound interface.

32. The wound healing device according to claim 31, wherein the wound interface comprises one of the elements of a group consisting of sheet, foam, gel, gauze, porous mesh, honeycomb structure, mop, confetti, stand alone tubular structure and combinations thereof.

33. The wound healing device of claim 31, wherein the wound interface layer comprises antibacterial agents.

34. The wound healing device according to claim 31, wherein the wound interface layer comprises a surface in contact with the wound, said surface comprising at least one pore with a diameter greater than about 100 microns.

35. The wound healing device of claim 1, further comprising an outlet for venting the vacuum source.

<td>36. Device</td><td>down</td><td>wound healing</td><td>according</td><td>statements</td><td> 35,</td>

<td colspan="2">wherein the outlet comprises</td><td>filter.</td><td></td><td></td><td></td>

<td>37. Device</td><td>down</td><td>wound healing</td><td>according</td><td>statements</td><td> 1,,</td>

<td>also containing</td><td colspan="2">an overflow valve</td><td></td><td></td><td></td>

<td>38. Device</td><td>down</td><td>wound healing</td><td>according</td><td>statements</td><td> 1,</td>

<td colspan="2">also containing</td><td>funds to</td><td colspan="3">pressure control</td>

<td>inside the casing.</td><td></td><td></td><td></td><td></td><td></td>

<td>39. Device</td><td>down</td><td>wound healing</td><td>according</td><td>statements</td><td> 38,</td>

<td>with funds to</td><td colspan="3">pressure control</td><td colspan="2">inside the casing</td>

contain pressure sensor.

<td>40. Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 1,</td>

<td>also containing</td><td>gas sensor.</td><td></td><td></td><td></td>

<td>41. Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 1,</td>

<td>also containing</td><td>oxygen sensor.</td><td></td><td></td><td></td>

<td>42. Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 1,</td>

<td>also containing</td><td colspan="2">temperature sensor.</td><td></td><td></td>

<td>43. Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 1,</td>

<td>also containing</td><td colspan="2">fill indicator.</td><td></td><td></td>

<td>44. Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 43,</td>

<td>with the indicator</td><td colspan="3">the fill contains a moisture detector.</td><td></td>

<td>45. Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 43,</td>

<td>with the indicator</td><td colspan="4">The fill contains a conductivity detector</td>

<td>power.</td><td></td><td></td><td></td><td></td>

<td>46. ​​Device</td><td>for healing wounds</td><td>according</td><td>statements</td><td> 22,</td>

further comprising a leak detector operably connected to the seal.

47. The wound healing device of claim 1, further comprising a blood detector.

48. The wound healing device of claim 1, wherein the device is adaptable, allowing use in wounds located at different locations.

49. Wound treatment device comprising:

a casing to cover at least part of the wound area;

a vacuum source connected to the housing in a manner that allows fluid flow;

a porous liquid collector, located inside the housing and connected to the wound area, the liquid collector forming a number of passages, and furthermore said liquid collector is adapted to stop secretions from the wound and at the same time send it through the passages in the liquid collector to the vacuum area of ​​the wound, generated by the source vacuum;

a liquid barrier located between the liquid collector and the vacuum source;

a wound interface located between the wound area and the fluid collector and a seal to seal the housing-skin connection around the wound area.

50. The wound healing device according to claim 49, wherein the liquid collector is rigid enough to allow at least one of the liquid collector passages to remain open when the device is subjected to a pressure lower than atmospheric pressure.

51. The wound healing device of claim 49, further comprising a skin protection layer for protecting the skin of the user.

52. The wound healing device according to claim 49, wherein the liquid collector comprises one of the group members, including sponges, fibers, fabrics, gases, absorbent material, adsorbent material, polymers, gels, gelling agents, foams, sealing material and combinations thereof.

53. The wound healing device according to claim 52, further comprising a vacuum dispenser connected to the liquid collector.

54. The wound healing device according to claim 53, further comprising a moisture dispenser connected to the liquid collector.

55. The wound healing device of claim 49, further comprising means for maintaining therapeutic wound pressure when the liquid collector absorbs fluid.

56. Wound treatment device comprising:

a casing intended to cover at least part of the wound area;

a vacuum source connected to the housing in a manner that allows fluid flow;

a porous liquid collector, located inside the housing and connected to the wound area, the liquid collector forming a plurality of passages, and, furthermore, said liquid collector is adapted to retain secretions from the wound and at the same time to send through the passages in the liquid collector to the vacuum area of ​​the wound produced by vacuum source;

a liquid barrier located between the liquid collector and the vacuum source;

vacuum dispenser connected to the liquid collector;

moisture dispenser connected to the liquid collector;

a wound interface located between the wound area and the liquid collector; a layer of skin protection;

a seal to seal the connection between the housing and the skin around the wound area and a pressure controller to control the pressure inside the housing.

57. Wound treatment device comprising:

a vacuum source module comprising a vacuum source that can generate a vacuum and a pressure controller for controlling the amount of vacuum;

dressing module containing:

a casing intended to cover at least part of the wound area;

a porous liquid collector located inside the housing and connected to the wound area, said liquid collector being adapted to retain wound secretions and at the same time to transmit the vacuum generated by the vacuum source module to the wound area;

a liquid barrier located between the liquid collector and the vacuum source module;

a seal for sealing the connection between the dressing module and the surface around the wound area, and a connector for maintaining the connection between the vacuum source module and the dressing module, said connector being adapted to transfer the vacuum generated by the vacuum source module to the dressing module.

58. A method of assembling a wound treatment device comprising the steps of:

providing a vacuum source module comprising a vacuum source that can generate a vacuum and a pressure controller for controlling the amount of vacuum;

providing a dressing module containing:

a casing to cover at least part of the wound area;

a porous wound collector located inside the housing and connected to the wound area, the liquid collector being adapted to retain wound secretions and at the same time to transmit the vacuum generated by the vacuum source module to the wound area;

a liquid barrier located between the liquid collector and the vacuum source module;

a seal to seal the connection between the dressing module and the surface around the wound area;

attaching the vacuum source module to the dressing module such that the vacuum source module transmits a vacuum to the dressing module and attaching the device adjacent to the wound area.

59. A wound healing device, in principle as described herein with reference to any of the embodiments of the invention illustrated in the accompanying drawings and / or examples.

60. A method of assembling a wound healing device as described herein with reference to any of the embodiments of the invention illustrated in the accompanying drawings and / or examples.

Kalypto Medical, Inc. Proxy:

79P30363PL00

EP 2 021 046 B1