Source: https://patents.google.com/patent/ES2670710T3/en
Timestamp: 2019-12-10 08:08:40
Document Index: 756557006

Matched Legal Cases: ['art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 156', 'art 168', 'art 168', 'art 156', 'art 186', 'art 187', 'art 287', 'art 287', 'art 285', 'art 287', 'art 285', 'art 287', 'art 286', 'art 285', 'art 286', 'art 285', 'art 287', 'art 285', 'art 286']

ES2670710T3 - Dressing with differentially sized perforations - Google Patents
Dressing with differentially sized perforations Download PDF
ES2670710T3
ES2670710T3 ES17152232.9T ES17152232T ES2670710T3 ES 2670710 T3 ES2670710 T3 ES 2670710T3 ES 17152232 T ES17152232 T ES 17152232T ES 2670710 T3 ES2670710 T3 ES 2670710T3
ES17152232.9T
2013-10-30 Priority to US201361897640P priority Critical
2013-10-30 Priority to US201361897640P priority
2018-05-31 Publication of ES2670710T3 publication Critical patent/ES2670710T3/en
A dressing for treating a tissue site, comprising: a base layer having a periphery surrounding a central part and a plurality of openings arranged through the periphery and the central part, the openings in the periphery being larger than the openings in the central part, where the base layer is to cover the tissue site; an adhesive in fluid communication with the openings in the base layer; a sealing member having a periphery and a central part, the periphery of the sealing member positioned close to the periphery of the base layer, wherein the central part of the sealing member and the central part of the base layer define a wrap; a first drainage layer disposed in the envelope; a second drainage layer disposed in the envelope; an absorbent layer placed in fluid communication between the first drain layer and the second drain layer, wherein a peripheral part of the first drain layer is coupled to a peripheral part of the second drain layer that provides a wrap of the drainage layer surrounding the absorbent layer between the first and second drainage layers; and a conduit interface placed close to the sealing member and in fluid communication with the envelope.
Dressing with differentially sized perforations Field
This description generally refers to medical treatment systems and, more particularly, but not by way of limitation, to absorbent dressings, and systems for treating a tissue site with reduced pressure.
Depending on medical circumstances, reduced pressure may be used to, among other things, reduced pressure therapy to stimulate granulation at the tissue site, drain fluids at a tissue site, close a wound, reduce edema, promote perfusion and fluid management. Common dressings, systems and methods may be susceptible to leakage and blockage that may cause a reduction in the effectiveness of therapy or a complete loss of therapy. Such a situation may occur, for example, if the amount of fluid in the dressing or system exceeds the fluid capacity of the dressing or system. In addition, the formation of condensate in the dressing or system can create similar concerns. Leaks, blockages and condensate in the dressing or system may also be noticeable by a user and may lack visual appeal. The prevention of leaks and blockages can be particularly important when only a limited power supply is available for the reduced pressure source and other components. Thus, improvements in dressings, systems and methods that improve the management of fluid extracted from a tissue site are desirable to increase reliability, efficiency, visual attractiveness and the usable life of the dressing and the system.
Deficiencies with certain aspects of the dressings, systems and methods of tissue treatment are addressed as shown and described in a variety of illustrative, non-limiting embodiments herein.
A dressing for treating a tissue site is described, comprising a base layer having a periphery surrounding a central part and a plurality of openings disposed through the periphery and the central part, the openings in the periphery being larger than the openings in the central part, where the base layer is to cover the tissue site; an adhesive in fluid communication with the openings in the base layer; a sealing member having a periphery and a central part, the periphery of the sealing member positioned close to the periphery of the base layer, wherein the central part of the sealing member and the central part of the base layer define a wrap; a first drainage layer disposed in the envelope; a second drainage layer disposed in the envelope; an absorbent layer placed in fluid communication between the first drain layer and the second drain layer, wherein a peripheral part of the first drain layer is coupled to a peripheral part of the second drain layer that provides a layer wrap drainage surrounding the absorbent layer between the first and second drainage layers; and a conduit interface placed close to the sealing member and in fluid communication with the envelope.
A selection of option features is described in the dependent claims.
Other aspects, features and advantages of the illustrative embodiments will become apparent with reference to the drawings and the detailed description that follows.
FIG. 1 is a sectional view of an illustrative embodiment of a system for treating a tissue site that represents an illustrative embodiment of a dressing deployed at a tissue site;
FIG. 2 is a sectional view of the dressing of FIG. one;
FIG. 3 is a detailed view taken in reference to FIG. 3, represented in FIG. 1, illustrating the dressing of FIG. 1 placed next to the tissue surrounding the tissue site;
FIG. 4A is an exploded view of the dressing of FIG. 1, depicted without a conduit interface and with an illustrative embodiment of a release liner to protect the dressing before application at a tissue site;
FIG. 5 is a sectional view of an illustrative embodiment of a fluid management assembly according to the dressing and the system of FIG. one;
FIG. 6 is a sectional view of another illustrative embodiment of a fluid management assembly according to the dressing and system of FIG. one;
FIG. 7 is a sectional view of an illustrative embodiment of a conduit interface shown in the dressing of FIG. one;
FIG. 8 is a sectional view of another illustrative embodiment of a fluid management assembly suitable for use with the dressing and system of FIG. one;
FIG. 9A is a cross section of an illustrative embodiment of a multi-lumens conduit suitable for use with the dressing and system of FIG. one;
FIG. 9B is a cross section of another illustrative embodiment of a multi-lumens conduit suitable for use with the dressing and system of FIG. one;
FIG. 9C is a cross section of another illustrative embodiment of a multi-lumens conduit suitable for use with the dressing and system of FIG. one;
FIG. 9D is a cross section of another illustrative embodiment of a multi-lumens conduit suitable for use with the dressing and system of FIG. one; Y
FIG. 9E is a cross section of another illustrative embodiment of a multi-lumens conduit suitable for use with the dressing and system of FIG. one.
In the following detailed description of illustrative, non-limiting embodiments, reference is made to the accompanying drawings that are part of the present specification. Other embodiments can be used, and logical, structural, mechanical, electrical and chemical changes can be made without departing from the scope of the appended claims. To avoid details not necessary to enable those skilled in the art to implement the embodiments described herein, the description may omit certain information known to those skilled in the art. The following detailed description is not limiting, and the scope of the illustrative embodiments is defined by the appended claims. As used herein, unless otherwise indicated, "o" does not require mutual exclusivity.
With reference to the drawings, FIG. 1 represents an embodiment of a system 102 for treating a tissue site 104 of a patient. The tissue site 104 may extend through, or otherwise imply, an epidermis 106, a dermis 108, and a subcutaneous tissue 110. The tissue site 104 may be a subsurface tissue site as depicted in FIG. 1 extending below the surface of the epidermis 106. In addition, the tissue site 104 may be a surface tissue site (not shown) that predominantly resides on the surface of the epidermis 106, such as, for example, a incision. System 102 may provide therapy, for example, to epidermis 106, dermis 108 and subcutaneous tissue 110, regardless of the placement of system 102 or the type of tissue site. System 102 can also be used without limitation at other tissue sites.
In addition, the tissue site 104 may be the body tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue. Treatment of tissue site 104 may include removal of fluids, for example, exudate or ascites.
Continuing with FIG. 1, the system 102 may include an optional tissue interface, such as an interface manifold 120. In addition, the system 102 may include a dressing 124 and a reduced pressure source 128. The reduced pressure source 128 may be a component of an optional therapy unit 130 as shown in FIG. 1. In some embodiments, the reduced pressure source 128 and the therapy unit 130 may be separate components. As indicated above, interface manifold 120 is an optional component that can be omitted for different types of tissue sites or different types of therapy using reduced pressure, such as, for example, epithelialization. If equipped, the interface manifold 120 may be adapted to be placed near or adjacent to the site of the fabric 104, such as, for example, by cutting or otherwise forming the interface manifold 120 in any manner suitable to accommodate the site of the tissue 104. As described below, the interface manifold 120 may be adapted to be placed in fluid communication with the tissue site 104 to distribute a reduced pressure to the tissue site 104. In some embodiments, the interface manifold 120 it can be placed in direct contact with the fabric site 104. The fabric interface or the interface manifold 120 can be formed of any collector material or flexible reinforcement material that provides an empty space or treatment space, such as, by For example, a porous or permeable foam or foam-like material, a member formed with tracks, a graft or gauze. As a more specific, non-limiting example, the interface manifold 120 can be a polyurethane foam or open cell crosslinked polyether that allows good fluid permeability while under reduced pressure. One such foam material is the VAC® GranuFoam® material available from Kinetic Concepts, Inc. (KCI) of San Antonio, Texas. Any material or combination of materials can be used as the collector material for the interface manifold 120, provided that the collector material is operable to distribute or collect fluid. For example, herein, the term "collector" may refer to a substrate or structure that is provided to aid in the administration of fluids or in the removal of fluids from a tissue site through a plurality of pores, pathways or flow channels The
plurality of pores, pathways or flow channels may be interconnected to improve the distribution of fluids provided and removed from an area around the manifold. Examples of manifolds may include, without limitation, devices having structural elements arranged to form flow channels, cell foam, such as open cell foam, porous tissue collections, and liquids, gels and foams that include or cure by including channels of flow.
A material with a greater or lesser density than the GranuFoam® material for interface manifold 120 may be desirable depending on the application. Among the many possible materials, the following can be used: GranuFoam® material, Foamex® technical foam (
www.foamex.com), a nail structure molding bench, a stamped grid material such as those manufactured by Sercol Industrial Fabrics, 3D textiles such as those manufactured by Baltex of Derby, United Kingdom, gauze, a flexible member which contains a channel, a graft, etc. In some cases, ionic silver can be added to the interface manifold 120 by, for example, a microlink process. Other substances, such as antimicrobial agents, can be added to the interface manifold 120 as well.
In some embodiments, the interface manifold 120 may comprise a porous hydrophobic material. The hydrophobic characteristics of the interface manifold 120 can prevent the interface manifold 120 from directly absorbing fluid, such as exudate, from the tissue site 104, but allow the fluid to pass through.
Continuing with FIG. 1, the dressing 124 may be adapted to provide reduced pressure from the reduced pressure source 128 to the interface manifold 120, and to store the fluid extracted from the tissue site 104 through the interface manifold 120. The dressing 124 may include a base layer 132, an adhesive 136, a sealing member 140, a fluid management assembly 144 and a conduit interface 148. Components of the dressing 124 can be added or removed to suit a particular application.
With reference to FIG. 1-4B, the base layer 132 may have a periphery 152 surrounding a central part 156, and a plurality of openings 160 disposed through the periphery 152 and the central part 156. The base layer 132 may also have corners 158 and edges 159. The corners 158 and the edges 159 may be part of the periphery 152. One of the edges 159 may meet another one of the edges 159 to define one of the corners 158. In addition, the base layer 132 may have an edge 161 which substantially surrounds the central part 156 and positioned between the central part 156 and the periphery 152. The edge 161 may be free of the openings 160. The base layer 132 may cover the interface manifold 120 and the tissue surrounding the tissue site 104 so that the central part 156 of the base layer 132 is positioned adjacent or close to the interface manifold 120, and the periphery 152 of the base layer 132 is positioned adjacent or close to the tissue surrounding the site of the fabric 104. In this way , the P Faucet 152 of the base layer 132 may surround the interface manifold 120. In addition, the openings 160 in the base layer 132 may be in fluid communication with the interface manifold 120 and the tissue surrounding the tissue site 104.
The openings 160 in the base layer 132 may have any shape, such as, for example, circles, squares, stars, ovals, polygons, slits, complex curves, rectilinear shapes, triangles or other shapes. The openings 160 can be formed by cutting, by applying local RF energy or other suitable techniques to form an opening. As shown in FIG. 4A-4B, each of the openings 160 of the plurality of openings 160 may be substantially circular in shape, having a diameter and an area. The area of each of the openings 160 may refer to an open space or open area that defines each of the openings 160. The diameter of each of the openings 160 may define the area of each of the openings 160. For example , the area of one of the openings 160 can be defined by multiplying the square of half the diameter of the opening 160 by the value 3.14. Thus, the following equation can define the area of one of the openings 160: Area = 3.14 * (diameter / 2) A 2. The area of the openings 160 described in the illustrative embodiments herein may be substantially similar to the area in other embodiments (not shown) for openings 160 that may have non-circular shapes. The diameter of each of the openings 160 may be substantially the same, or each of the diameters may vary depending, for example, on the position of the opening 160 in the base layer 132. For example, the diameter of the openings 160 at the periphery 152 of the base layer 132 may be greater than the diameter of the openings 160 in the central part 156 of the base layer 132. In addition, the diameter of each of the openings 160 may be between about 1 millimeter to about 50 mm. In some embodiments, the diameter of each of the openings 160 may be between about 1 millimeter to about 20 millimeters. The openings 160 may have a uniform pattern or may be distributed randomly over the base layer 132. The size and configuration of the openings 160 may be designed to control the adhesion of the dressing 124 to the epidermis 106 as described below.
With reference to FIG. 4A-4B, in some embodiments, the openings 160 placed in the periphery 152 may be the openings 160a, the openings 160 placed in the corners 158 of the periphery 152 may be the openings 160b, and the openings 160 placed in the central part 156 can be openings 160c. 160a openings
they can have a diameter between about 9.8 millimeters to about 10.2 millimeters. Openings 160b
they can have a diameter between about 7.75 millimeters to about 8.75 millimeters. 160c openings
they can have a diameter between about 1.8 millimeters and about 2.2 millimeters. The diameter of each of the openings 160a can be separated from each other by a distance A between about 2.8 millimeters to about 3.2 millimeters. In addition, the diameter of at least one of the openings 160a may be separated from the diameter of at least one of the openings 160b by distance A. The diameter of each of the openings 160b
it can also be separated from each other by distance A. A center of one of the openings 160c may be separated from one center of another of the openings 160c in a first direction by a distance B between about 2.8 millimeters to about 3 , 2 mm. In a second direction transverse to the first direction, the center of one of the openings 160c may be separated from the center of another of the openings 160c by a distance C between about 2.8 millimeters to about 3.2 millimeters. As shown in FIG. 4A-4B, the distance B and the distance C can be increased for the openings 160c in the central part 156 that are placed close to or at the edge 161 compared to the openings 160c positioned away from the edge 161.
As shown in FIG. 4A-4B, the central part 156 of the base layer 132 may be substantially square with each side of the central part 156 having a length D between about 100 millimeters to about 108 millimeters. In some embodiments, the length D may be between about 106 millimeters to about 108 millimeters. The edge 161 of the base layer 132 may have a width E between about 4 millimeters to about 11 millimeters and may substantially surround the central part 156 and the openings 160c in the central part 156. In some embodiments, the width E may be between about 9 millimeters and about 10 millimeters. The periphery 152 of the base layer 132 may have a width F between about 25 millimeters to about 35 millimeters and can substantially surround the edge 161 and the central part 156. In some embodiments, the width F may be between about 26 millimeters to about 28 millimeters. In addition, the periphery 152 may have a substantially square exterior with each side of the exterior having a length G between about 154 millimeters to about 200 millimeters. In some embodiments, the length G may be between about 176 millimeters to about 184 millimeters. Although FIG. 4A-4B represent the central part 156, the edge 161 and the periphery 152 of the base layer 132 as having a substantially square shape, these and other components of the base layer 132 may have any shape to suit a particular application. In addition, the dimensions of the base layer 132 as described herein can be increased or decreased, for example, substantially in proportion to each other to suit a particular application. The use of dimensions in the proportions described above can improve the aesthetic appearance of a tissue site. For example, these proportions may provide a surface area for the base layer 132, regardless of shape, that is sufficiently soft to improve the movement and proliferation of epithelial cells at the site of tissue 104, and reduce the likelihood of tissue growing granulation in dressing 124.
The base layer 132 may be a soft and flexible material suitable for providing a fluid seal with the tissue site 104 as described herein. For example, the base layer 132 may comprise a silicone gel, a soft silicone, hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrenic copolymer gels, a foaming gel, a soft closed cell foam such as polyurethanes and polyolefins coated with an adhesive described below, polyurethane, polyolefin or hydrogenated styrenic copolymers. The base layer 132 may have a thickness between about 500 microns (| jm) and about 1,000 microns (jm). In some embodiments, the base layer 132 has a stiffness between about 5 Shore OO and about 80 Shore OO. The base layer 132 may be composed of hydrophobic or hydrophilic materials.
In some embodiments (not shown), the base layer 132 may be a hydrophobic coated material. For example, the base layer 132 can be formed by coating a spaced material, such as, for example, a woven, non-woven, molded or extruded mesh with a hydrophobic material. The hydrophobic material for the coating may be a soft silicone, for example. In this manner, the adhesive 136 can be extended through openings in the spaced material analogous to the openings 160 described below.
The adhesive 136 can be in fluid communication with the openings 160 in at least the periphery 152 of the base layer 132. In this way, the adhesive 136 can be in fluid communication with the tissue surrounding the tissue site 104 through of the openings 160 in the base layer 132. As described below and shown in FIG. 3, the adhesive 136 can be extended or pressed through the plurality of openings 160 to contact the epidermis 106 to secure the dressing 124, for example, to the tissue surrounding the site of the fabric 104. The openings 160 can provide sufficient contact of the adhesive 136 with the epidermis 106 to secure the dressing 124 around the site of the fabric 104. However, the configuration of the openings 160 and the adhesive 136, described below, may allow the release and repositioning of the dressing 124 around the site of the fabric 104.
At least one of the openings 160a in the periphery 152 of the base layer 132 can be placed at the edges 159 of the periphery 152 and can have an open or exposed inner cut at the edges 159 which is in fluid communication in a lateral direction with edges 159. The lateral direction may refer to a direction towards edges 159 and in the same plane as the base layer 132. As shown in FIG. 4A-4B, a plurality of the openings 160a in the periphery 152 may be placed next to or at the edges 159 and in fluid communication in a lateral direction with the edges 159. The openings 160a placed close to or at the edges 159 can be spaced substantially equidistant around periphery 152 as shown in FIG. 4A-4B. However, in some embodiments, the separation of the openings 160a near or at the edges 159 may be irregular. Adhesive 136 can be in fluid communication with edges 159 through openings 160a that are exposed at edges 159. In this manner, openings 160a at edges 159 can allow adhesive 136 to flow around edges 159 to improve adhesion of edges 159 around tissue site 104, for example.
Continuing with FIG. 4A-4B, the openings 160b at the corners 158 of the periphery 152 may be smaller than the openings 160a in other parts of the periphery 152 as described above. For a given geometry of the corners 158, the smaller size of the openings 160b in comparison to the openings 160a can maximize the surface area of the exposed adhesive 136 and in fluid communication through the openings 160b in the corners 158. For example , as shown in FIG. 4A-4B, edges 159 may cross substantially at a right angle, or about 90 degrees, to define corners 158. Also as shown, corners 158 may have a radius of about 10 millimeters. Three of the openings 160b having a diameter between about 7.75 millimeters to about 8.75 millimeters can be placed in a triangular configuration at the corners 158 to maximize the exposed surface area for the adhesive 136. The size and number of the openings 160b in the corners 158 can be adjusted as necessary, depending on the chosen geometry of the corners 158, to maximize the exposed surface area of the adhesive 136 as described above. In addition, the openings 160b at the corners 158 may be completely housed within the base layer 132, substantially preventing fluid communication in a lateral direction outside the corners 158. The openings 160b at the corners 158 that are completely housed within the base layer 132 can substantially prevent fluid communication of the outer adhesive 136 to the corners 159, and can provide improved handling of the dressing 124 during deployment at the site of the fabric 104. In addition, the outside of the corners 158 which is substantially free of adhesive 136 can increase the flexibility of corners 158 to improve comfort.
Similar to the openings 160b at the corners 158, any of the openings 160 can be adjusted in size and number to maximize the surface area of the adhesive 136 in fluid communication through the openings 160 for a particular application or geometry of the base layer 132. For example, in some embodiments (not shown) openings 160b or openings of another size, can be placed on the periphery 152 and on the edge 161. Similarly, openings 160b or openings of another size, can be place as described above in other locations of the base layer 132 that may have a complex geometry or shape.
Adhesive 136 may be a medically acceptable adhesive. Adhesive 136 can also be fluid. For example, adhesive 136 may comprise an acrylic adhesive, rubber adhesive, high adhesion silicone adhesive, polyurethane or other adhesive substance. In some embodiments, adhesive 136 may be a pressure sensitive adhesive comprising an acrylic adhesive with a coating weight of 15 grams / m2 (gsm) at 70 grams / m2 (gsm). The adhesive 136 may be a layer that has substantially the same shape as the periphery 152 of the base layer 132 as shown in FIG. 4A. In some embodiments, the layer of adhesive 136 may be continuous or discontinuous. The discontinuities in the adhesive 136 can be provided by openings (not shown) in the adhesive 136. The openings in the adhesive 136 can be formed after application of the adhesive 136 or by coating the adhesive 136 in patterns on a support layer, such as, for example, one side of the sealing member 140 adapted to face the epidermis 106. In addition, the openings in the adhesive 136 can be sized to control the amount of the adhesive 136 that extends through the openings 160 in the base layer 132 to reach the epidermis 106. The openings in the adhesive 136 can also be sized to improve the Humidity Vapor Transfer Rate (MVTR) of the dressing 124, described further below.
Factors that can be used to control the adhesion strength of dressing 124 may include the diameter and number of openings 160 in the base layer 132, the thickness of the base layer 132, the thickness and amount of the adhesive 136 and the tackiness of the adhesive 136. An increase in the amount of adhesive 136 extending through openings 160 generally corresponds to an increase in the adhesion strength of dressing 124. A decrease in the thickness of the base layer 132 generally corresponds to an increase in the amount of adhesive 136 that extends through the openings 160. In this way, the diameter and configuration of the openings 160, the thickness of the base layer 132 and the amount and stickiness of the adhesive used can be varied to provide a desired adhesion strength for dressing 124. For example, the thickness of the base layer 132 may be about 200 microns, the adhesive layer 136 may have a thickness of about 30 microns and a stickiness of 2,000 grams per 25 cm wide strip, and the diameter of the openings 160a in the base layer 132 may be about 10 millimeters.
In some embodiments, the tackiness of the adhesive 136 may vary in different locations of the base layer 132. For example, in locations of the base layer 132 where openings 160 are comparatively large, such as openings 160a, adhesive 136 may have a tackiness less than other locations of the base layer 132 where openings 160 are smaller, such as openings 160b and 160c. Thus, the locations of the base layer 132 having larger openings 160 and a lower tack adhesive 136 may have an adhesion force comparable to locations that have smaller openings 160 and a higher tack adhesive 136.
Clinical studies have shown that the configuration described herein for the base layer 132 and the adhesive 136 can reduce the appearance of blisters, erythema and leaks when in use. Such a configuration can provide, for example, an increase in patient comfort and an increase in the durability of the dressing 124.
With reference to the embodiment of FIG. 4B, a release liner 162 may be attached or placed adjacent to the base layer 132 to protect the adhesive 136 before application of the dressing 124 to the site of the fabric 104. Before
From the application of dressing 124 to the site of fabric 104, the base layer 132 can be placed between the sealing member 140 and the release liner 162. Removal of the release liner 162 can expose the base layer 132 and the adhesive 136 to application of dressing 124 to tissue site 104. Release liner 162 may also provide stiffness to assist with, for example, deployment of dressing 124. Release liner 162 may be, for example, plasticized paper, film or polyethylene. In addition, the release liner 162 may be a polyester material such as polyethylene terephthalate (PET) or a similar semicrystalline polar polymer. The use of a semi-crystalline polar polymer for the release liner 162 can substantially prevent wrinkles or other deformation of the dressing 124. For example, the semi-crystalline polar polymer may be highly oriented and be resistant to softening, swelling or other deformation that may occur when it is contacted with components of dressing 124, or when subjected to temperature or environmental variations, or sterilization. In addition, a release agent may be arranged on one side.
of the release liner 162 which is configured to contact the base layer 132. For example, the
Release agent may be a silicone coating and may have a suitable release factor to facilitate removal of the release coating 162 by hand and without damaging or deforming the dressing 124. In some embodiments, the releasing agent may be fluorosilicone. In other embodiments, release liner 162 may be uncoated or otherwise used without a release agent.
Continuing with FIG. 1-4B, the sealing member 140 has a periphery 164 and a central part 168. The
sealing member 140 may additionally include an opening 170, as described below. The periphery 164 of the sealing member 140 can be positioned close to the periphery 152 of the base layer 132 so that the central part 168 of the sealing member 140 and the central part 156 of the base layer 132 define a wrap 172. The adhesive 136 can be placed at least between the periphery 164 of the sealing member 140 and the periphery 152 of the base layer 132. The sealing member 140 can cover the site of the fabric 104 and the interface manifold 120 to provide a fluid seal and a sealed space 174 between the tissue site 104 and the sealing member 140 of the dressing 124. In addition, the sealing member 140 may cover another tissue, such as a part of the epidermis 106, which surrounds the tissue site 104 to provide the fluid seal between the sealing member 140 and the tissue site 104. In some embodiments, a part of the periphery 164 of the sealing member 140 may extend beyond the periphery 152 of the base layer 132 and enter into Direct contact with the tissue surrounding the tissue site 104. In other embodiments, the periphery 164 of the sealing member 140, for example, can be placed in contact with the tissue surrounding the tissue site 104 to provide the sealed space 174 without the base layer 132. In this manner, the adhesive 136 can also be placed at least between the periphery 164 of the sealing member 140 and the fabric, such as the epidermis 106, which surrounds the site of the fabric 104. The adhesive 136 can be disposed on a surface of the sealing member 140 adapted to face the site of the fabric 104 and the base layer 132.
The sealing member 140 can be formed of any material that allows a fluid seal. A fluid seal is a suitable seal to maintain a reduced pressure at a desired site given the particular reduced pressure source or system involved. The sealing member 140 may comprise, for example, one or more of the following materials: hydrophilic polyurethane; cellulosic products; hydrophilic polyamides; polyvinyl alcohol; polyvinylpyrrolidone; hydrophilic acrylics; hydrophilic silicone elastomers; an INSPIRE 2301 material from Expopack Advanced Coatings of Wrexham, United Kingdom which has, for example, an MVTR (inverted cup technique) of 14,400 g / m2 / 24 hours and a thickness of about 30 microns; a thin, uncoated polymer bandage; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; polyurethane (PU); EVA film; copolyester; silicones; a silicone bandage; a 3M Tegaderm® bandage; a polyurethane (PU) bandage such as one available from Avery Dennison Corporation of Pasadena, California; polyether block polyamide copolymer (PEBAX), for example, from Arkema, France; Expopack 2327; or other appropriate material.
The sealing member 140 may be vapor permeable and liquid impermeable, thereby allowing steam and inhibitor liquids to exit the sealed space 174 provided by the dressing 124. In some embodiments, the sealing member 140 may be a film , membrane, or flexible and breathable sheet that has a high MVTR of, for example, at least about 300 g / m2 for 24 hours. In other embodiments, a low or no steam vapor transfer bandage could be used. The sealing member 140 may comprise a range of medically suitable films having a thickness between about 15 microns (| jm) to about 50 microns (jm).
The fluid management assembly 144 may be disposed in the envelope 172 and may include a first drain layer 176, a second drain layer 180 and an absorbent layer 184. The absorbent layer 184 can be placed in fluid communication between the first drainage layer 176 and the second drainage layer 180. The first drainage layer 176 may have a grain structure (not shown) adapted to drain fluid along a surface of the first drainage layer 176. Similarly , the second drain layer 180 may have a grain structure (not shown) adapted to drain fluid along a surface of the second drain layer 180. For example, the first drain layer 176 and the second drain layer 180 may drain or otherwise transport the fluid in a lateral direction along the surfaces of the first drain layer 176 and the second drain layer 180, respectively. The surfaces of the first drain layer 176 and the second drain layer 180 may be normal with respect to the thickness of each of the first drain layer 176 and the second drain layer 180. The fluid drain along the first layer of
drainage 176 and the second drainage layer 180 can improve the distribution of the fluid over a surface area of the absorbent layer 184 which can increase the absorbent efficiency and resist fluid blockages. Liquid blockages can be caused, for example, by the grouping of fluids at a particular location in the absorbent layer 184 instead of being more evenly distributed through the absorbent layer 184. The laminated combination of the first drain layer 176 , the second drainage layer 180 and the absorbent layer 184 can be adapted as described above to maintain an open structure, resistant to blockage, capable of maintaining fluid communication with, for example, the tissue site 104.
With reference to the embodiments of the fluid management assembly 144 depicted in FIG. 1, 2, 5 and 6, a peripheral part 186 of the first drainage layer 176 can be coupled to a peripheral part 187 of the second drainage layer 180 to define an envelope of the drainage layer 188 between the first drainage layer 176 and the second drain layer 180. In some exemplary embodiments, the envelope of the drain layer 188 may otherwise surround or encapsulate the absorbent layer 184 between the first drain layer 176 and the second drain layer 180.
With reference specifically to FIG. 5 and 6, fluid management assembly 144 may include, without limitation, any number of drainage layers and absorbent layers as desired to treat a particular tissue site. For example, the absorbent layer 184 may be a plurality of absorbent layers 184 placed in fluid communication between the first drain layer 176 and the second drain layer 180 as described above. In addition, as depicted in FIG. 6, at least one intermediate drain layer 189 can be arranged in fluid communication between the plurality of absorbent layers 184. Similar to the absorbent layer 184 described above, the plurality of absorbent layers 184 and the at least one intermediate drain layer 189 they can be placed inside the envelope of the drainage layer 188. In some embodiments, the absorbent layer 184 may be disposed between the sealing member 140 and the interface manifold 120, and the first drainage layer 176 and the second drainage layer 180.
In the embodiments of FIG. 5 and 6, the sides 184a of the absorbent layers 184 can remain in fluid communication with each other to improve efficiency. Similarly, in the embodiment of FIG. 6, the sides 189a of the at least one intermediate drainage layer 189 can remain in fluid communication with each other and with the sides 184a of the absorbent layers 184. Furthermore, including additional absorbent layers 184 can increase the absorbent mass of the management assembly. of fluids 144 and in general provide greater fluid capacity. However, for a given absorbent mass, multiple light weight absorbent layers 184 can be used instead of a single heavy weight weight absorbent layer 184 to provide a larger absorbent surface area to further improve absorbent efficiency.
In some embodiments, absorbent layer 184 may be a hydrophilic material adapted to absorb fluid, for example, from tissue site 104. Suitable materials for absorbent layer 184 may include Luquafleece® material, Texsus FP2326, BASF 402C, Technical Absorbents 2317 available in Technical Absorbents (
www.techabsorbents.com), sodium polyacrylate superabsorbents, cellulosic products (carboxy methyl cellulose and salts such as CMC sodium) or alginates. Suitable materials for the first drain layer 176 and the second drain layer 180 may include any material having a grain structure capable of draining fluid as described herein, such as, for example, Libeltex TDL2 80 gsm.
The fluid management assembly 144 may be a pre-laminated structure manufactured in a single location or individual layers of material stacked on top of each other as described above. The individual layers of the fluid management assembly 144 can be bonded together or otherwise secured to one another without adversely affecting fluid management, for example, using a solvent or non-solvent adhesive, or by thermal welding. In addition, the fluid management assembly 144 can be coupled to the edge 161 of the base layer 132 in any suitable manner, such as, for example, by welding or an adhesive. Edge 161 that is free of openings 160 as described above can provide a flexible barrier between fluid management assembly 144 and tissue site 104 to improve comfort.
In some embodiments, the envelope 172 defined by the base layer 132 and the sealing member 140 may include an antimicrobial layer 190. The addition of the antimicrobial layer 190 may reduce the likelihood of excessive bacterial growth within the dressing 124 to allow the dressing 124 remains in place for a prolonged period. The antimicrobial layer 190 may be, for example, an additional layer included as part of the fluid management assembly 144 as depicted in FIG. 1 and 2, or a coating of an antimicrobial agent disposed at any suitable location within the dressing 124. The antimicrobial layer 190 may be composed of elemental silver or a similar compound, for example. In some embodiments, the antimicrobial agent may be formulated in any suitable manner in other components of dressing 124.
With reference to FIG. 1, 2 and 7, the conduit interface 148 can be placed close to the sealing member 140 and in fluid communication with the dressing 124 through the opening 170 in the sealing member 140 to provide reduced pressure from the pressure source reduced 128 to dressing 124. Specifically, the conduit interface 148 can be placed in fluid communication with the envelope 172 of the dressing 124. The conduit interface 148 can also be placed in fluid communication with the optional interface manifold 120. As shown, an optional liquid trap 192 can be placed in fluid communication between dressing 124 and
the reduced pressure source 128. The liquid trap 192 may be any suitable containment device having a sealed internal volume capable of retaining liquid, such as condensate or other liquids, as described below.
The conduit interface 148 may comprise a medical grade soft polymer or other flexible material. As non-limiting examples, the conduit interface 148 can be formed from polyurethane, polyethylene, polyvinyl chloride (PVC), fluorosilicone or ethylene propylene, etc. In some illustrative, non-limiting embodiments, the conduit interface 148 can be molded from DEHP-free PVC. The conduit interface 148 can be formed in any suitable manner such as by molding, casting, machining or extrusion. In addition, the conduit interface 148 can be formed as an integral unit or as individual components and can be coupled to the dressing 124 by, for example, adhesive or welding.
In some embodiments, the conduit interface 148 may be formed of an absorbent material having absorbent and evaporating properties. The absorbent material may be vapor permeable and liquid impermeable, thereby being configured to allow steam to be absorbed and evaporated from the material through penetration while inhibiting liquid penetration. The absorbent material may be, for example, a hydrophilic polymer such as a hydrophilic polyurethane. Although the term hydrophilic polymer may be used in the following illustrative embodiments, any absorbent material having the properties described herein may be suitable for use in the system 102. In addition, the absorbent material or hydrophilic polymer may be suitable for its use in various components of the system 102 as described herein.
The use of such hydrophilic polymer for the conduit interface 148 may allow liquids in the conduit interface 148 to evaporate, or otherwise dissipate, during operation. For example, the hydrophilic polymer may allow the liquid to penetrate or pass through the conduit interface 148 as vapor, in a gaseous phase, and evaporate in the atmosphere outside the conduit interface 148. Such liquids may be, by example, condensate or other liquids. The condensate can be formed, for example, as a result of a decrease in temperature within the duct interface 148 or other components of the system 102, relative to the temperature at the site of the fabric 104. The removal or dissipation of liquids duct interface 148 can increase visual appeal and prevent odor. In addition, such removal of liquids can also increase efficiency and reliability by reducing blockages and other interference with system components 102.
Similar to the conduit interface 148, the liquid trap 192 and other components of the system 102 described herein, can also be formed of an absorbent material or a hydrophilic polymer. The absorption and evaporation properties of the hydrophilic polymer can also facilitate the removal and dissipation of liquids residing in the liquid trap 192, and other components of the system 102, by evaporation. Such evaporation can leave behind a substantially solid or gel-like residue. The substantially solid or gel-like residue may be cheaper to dispose of than liquids, providing cost savings for the operation of the system 102. The hydrophilic polymer can be used for other components in the system 102 where liquid management is beneficial. .
In some embodiments, the absorbent material or hydrophilic polymer may have an absorbent capacity in a saturated state that is substantially equivalent to the mass of the hydrophilic polymer in an unsaturated state. The hydrophilic polymer may be completely saturated with steam in the saturated state and substantially free of steam in the unsaturated state. Both in the saturated state and in the unsaturated state, the hydrophilic polymer can retain substantially the same physical, mechanical and structural properties. For example, the hydrophilic polymer may have a hardness in the unsaturated state that is substantially the same as the hardness of the hydrophilic polymer in the saturated state. The hydrophilic polymer and the components of the system 102 that incorporate the hydrophilic polymer may also have a size that is substantially the same in both the unsaturated and saturated states. In addition, the hydrophilic polymer can remain dry, cool to the touch and pneumatically sealed in the saturated state and in the unsaturated state. The hydrophilic polymer can also remain substantially the same color in the saturated state and in the unsaturated state. In this way, this hydrophilic polymer can retain sufficient strength and other physical properties to remain suitable for use in the system 102. An example of such a hydrophilic polymer is offered under the trade name Techophilic HP-93A-100, available from The Lubrizol Corporation of Wickliffe, Ohio, United States. Techophilic HP-93A-100 is an absorbent hydrophilic thermoplastic polyurethane capable of absorbing 100% of the unsaturated mass of the polyurethane in water and having a Shore hardness or hardness of around 83 Shore A.
The conduit interface 148 can carry an odor filter 194 adapted to substantially prevent the passage of odors from the site of the fabric 104 out of the sealed space 174. In addition, the conduit interface 148 can carry a primary hydrophobic filter 195 adapted to substantially prevent the passage of liquids out of the sealed space 174. The odor filter 194 and the primary hydrophobic filter 195 may be arranged in the conduit interface 148 or other suitable location so that fluid communication between the reduced pressure source 128, or Optional therapy unit 130, and dressing 124 is provided through the odor filter 194 and the primary hydrophobic filter 195. In some embodiments, the odor filter 194 and the primary hydrophobic filter 195 can be secured within the conduit interface. 148 in any suitable manner, such as by adhesive or welding. In other embodiments, the odor filter 194 and the primary hydrophobic filter 195 may be placed in any location of
outlet in the dressing 124 which is in fluid communication with the atmosphere, the reduced pressure source 128 or the optional therapy unit 130. The odor filter 194 can also be placed in any suitable location in the system 102 that is in fluid communication with the tissue site 104.
The odor filter 194 may be composed of a carbon material in the form of a layer or particles. For example, the odor filter 194 may comprise a woven carbon cloth filter such as those manufactured by Chemviron Carbon, Ltd. of Lancashire, United Kingdom (
www.chemvironcarbon.com). The primary hydrophobic filter 195 may be composed of a material that is liquid impermeable and vapor permeable. For example, the primary hydrophobic filter 195 may comprise a material manufactured under the designation MMT-314 by WL Gore & Associates, Inc. of Newark, Delaware, United States or similar materials. The primary hydrophobic filter 195 can be provided in the form of a membrane or layer.
Continuing with FIG. 1,2 and 7, the reduced pressure source 128 provides reduced pressure to the dressing 124 and the sealed space 174. The reduced pressure source 128 may be any device suitable for providing reduced pressure, such as, for example, a vacuum pump , wall suction, hand pump or other source. As shown in FIG. 1, the reduced pressure source 128 may be a component of the therapy unit 130. The therapy unit 130 may include control circuitry and sensors, such as a pressure sensor, which can be configured to monitor the reduced pressure in the tissue site 104. The therapy unit 130 can also be configured to control the amount of reduced pressure of the reduced pressure source 128 that is applied to the tissue site 104 according to a user input and a reduced pressure feedback signal received from the site of tissue 104.
As used herein, "reduced pressure" generally refers to a pressure lower than the ambient pressure at a site of the tissue being treated. Typically, this reduced pressure will be less than atmospheric pressure. The reduced pressure may also be less than a hydrostatic pressure at a tissue site. Unless stated otherwise, the pressure values indicated herein are gauge pressures. While the amount and nature of the reduced pressure applied to a tissue site will typically vary by application, the reduced pressure will typically be between -5 mm Hg and -500 mm Hg, and more typically in a therapeutic range between -100 mm Hg and -200 mm Hg.
The reduced pressure supplied can be constant or varied (with standard or random), and can be delivered continuously or intermittently. Although the terms "vacuum" and "negative pressure" can be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site may be greater than the pressure normally associated with a full vacuum. Consistent with the use herein, an increase in reduced pressure or vacuum pressure typically refers to a relative reduction in absolute pressure. An increase in reduced pressure corresponds to a reduction in pressure (more negative in relation to ambient pressure) and a decrease in reduced pressure corresponds to an increase in pressure (less negative in relation to ambient pressure).
As shown in FIG. 7, a conduit 196 having an internal lumen 197 can be coupled in fluid communication between the reduced pressure source 128 and the dressing 124. The internal lumen 197 can have an internal diameter between about 0.5 millimeters and about 3 , 0 mm. More specifically, the internal diameter of the internal lumen 197 may be between about 1 millimeter to about 2 millimeters. The conduit interface 148 can be coupled in fluid communication with the dressing 124 and adapted to connect between the conduit 196 and the dressing 124 to provide fluid communication with the reduced pressure source 128. The conduit interface 148 can be coupled in fluid manner to conduit 196 in any suitable form, such as, for example, by means of an adhesive, solvent bonding or without solvent, welding or interference fit. The opening 170 in the sealing member 140 may provide fluid communication between the dressing 124 and the conduit interface 148. Specifically, the conduit interface 148 may be in fluid communication with the envelope 172 or the sealed space 174 through the opening 170 in the sealing member 140. In some embodiments, the conduit 196 can be inserted into the dressing 124 through the opening 170 in the sealing member 140 to provide fluid communication with the reduced pressure source 128 without use of the conduit interface 148. The reduced pressure source 128 can also be directly coupled in fluid communication with the dressing 124 or the sealing member 140 without the use of the conduit 196. The conduit 196 can be, for example, a tube Flexible polymer A distal end of the conduit 196 may include a coupling 198 to join the reduced pressure source 128.
The conduit 196 may have a secondary hydrophobic filter 199 disposed in the internal lumen 197 so that fluid communication between the reduced pressure source 128 and the dressing 124 is provided through the secondary hydrophobic filter 199. The secondary hydrophobic filter 199 may be, for example, a porous sintered polymer cylinder sized to accommodate the dimensions of the internal lumen 197 to substantially prevent the liquid from deviating from the cylinder. The secondary hydrophobic filter 199 can also be treated with an absorbent material adapted to swell when contacted with the liquid to block the flow of the liquid. The secondary hydrophobic filter 199 may be placed at any location within the internal lumen 197. However, placing the secondary hydrophobic filter 199 within the internal lumen 197 closer to the reduced pressure source 128, instead of the dressing 124, may allow a user detects the presence of liquid in the internal lumen 197.
In some embodiments, the conduit 196 and the coupling 198 may be formed of an absorbent material or a hydrophilic polymer as described above for the conduit interface 148. In this manner, the conduit 196 and the coupling 198 may allow liquids in the conduit 196 and coupling 198 to evaporate, or dissipate otherwise, as described above for conduit interface 148. Conduit 196 and coupling 198 can be, for example, molded from the hydrophilic polymer separately, as individual components. , or together as an integral component. In addition, a wall of the duct 196 defining the internal lumen 197 can be extruded from the hydrophilic polymer. The conduit 196 may be less than about 1 meter in length, but it may be any length to suit a particular application. More specifically, a length of about 1 foot or 304.8 millimeters can provide sufficient absorbent and evaporation surface area to accommodate many applications, and can provide cost savings compared to longer lengths. If an application requires additional length for conduit 196, the absorbent hydrophilic polymer can be coupled in fluid communication with a length of conduit formed by a non-absorbent hydrophobic polymer to provide additional cost savings.
With reference now to FIG. 8, FIG. 8 represents the dressing 124 which includes a fluid management assembly 244 suitable for use with the dressing 124 and the system 102. The fluid management assembly 244 may include a first drain layer 276, a second drain layer 280 and a absorbent layer 284 composed substantially of the same materials and properties as those described above in connection with the fluid management assembly 144. Thus, the first drain layer 276, the second drain layer 280, and the absorbent layer 284 are analogous to the first drainage layer 176, the second drainage layer 180, and the absorbent layer 184, respectively.
In the fluid management assembly 244, the second drain layer 280 may have a peripheral part 287. The second drain layer 280 and the peripheral part 287 of the second drain layer 280 may be placed in contact with the sealing member 140. The absorbent layer 284 may have a peripheral part 285 extending beyond the peripheral part 287 of the second drainage layer 280. The absorbent layer 284 may be placed adjacent or close to the second drainage layer 280 so that the peripheral part 285 of the absorbent layer 284 is in contact with the sealing member 140 surrounding the peripheral part 287 of the second drain layer 280. Similarly, the first drain layer 276 may have a peripheral part 286 which is extends beyond the peripheral part 285 of the absorbent layer 284. The first drain layer 276 may be placed adjacent or close to the absorbent layer 284 so that the peripheral part 286 of the first drainage layer 276 is in contact with the sealing member 140 surrounding the peripheral part 285 of the absorbent layer 284. Furthermore, the first drainage layer 276 can be placed adjacent or close to the base layer 132. In this way , at least the peripheral part 287, the peripheral part 285 and the peripheral part 286 in contact with the sealing member 140 can be coupled to the sealing member 140, such as, for example, by an adhesive coating disposed on a surface of the member sealing 140 facing the base layer 132. The adhesive coating may be analogous to the adhesive 136 which is applied across the surface of the sealing member 140 facing the base layer 132. The second drain layer 280, The absorbent layer 284 and the first drainage layer 276 may respectively have increasing surface areas to improve contact with the adhesive coating described above. In other embodiments, fluid management assembly 244 may include any number of absorbent layers and drainage layers to treat a particular tissue site.
In operation of the system 102 according to some illustrative embodiments, the interface manifold 120 may be arranged against or near the site of the fabric 104. The dressing 124 may then be applied over the interface manifold 120 and the site of the fabric 104 to form the space Sealing 174. Specifically, the base layer 132 can be applied by covering the interface manifold 120 and the tissue surrounding the tissue site 104. The materials described above for the base layer 132 have a tack that can hold the dressing 124 initially in your position The tack can be such that, if an adjustment is desired, the dressing 124 can be removed and reapplied. Once the dressing 124 is in the desired position, a force, such as by hand pressing, can be applied on one side of the sealing member 140 opposite the site of the fabric 104. The force applied to the sealing member 140 can cause at least some part of the adhesive 136 penetrates or extends through the plurality of openings 160 and comes into contact with the tissue surrounding the site of the fabric 104, such as the epidermis 106, to release the dressing 124 loosely around the tissue site 104. In this manner, the dressing configuration 124 described above can provide an effective and reliable seal against challenging anatomical surfaces, such as an elbow or heel, in and around the tissue site 104. In addition, dressing 124 it allows reapplication or relocation to, for example, correct air leaks caused by folds and other discontinuities in dressing 124 and tissue site 104. The ability to rectify fug This can increase the reliability of therapy and reduce energy consumption.
As the dressing 124 comes into contact with fluid from the tissue site 104, the fluid moves through the openings 160 towards the fluid management assembly 144, 244. The fluid management assembly 144, 244 drains or moves otherwise the fluid through the interface manifold 120 and away from the tissue site 104. As described above, the interface manifold 120 can be adapted to communicate fluid from the tissue site 104 instead of storing the fluid. Thus, the fluid management assembly 144, 244 can be more absorbent than the interface manifold 120. The fluid management assembly 144, 244 that is more absorbent than the interface manifold 120 provides an absorbent gradient through the dressing 124 that attracts fluid from tissue site 104 or interface manifold 120 to fluid management assembly 144, 244. Thus, in some
embodiments, fluid management assembly 144, 244 may be adapted to drain, pull, drag or otherwise attract fluid from tissue site 104 through interface manifold 120. In fluid management assembly 144, 244 , the fluid initially comes into contact with the first drainage layer 176, 276. The first drainage layer 176, 276 can distribute the fluid laterally along the surface of the first drainage layer 176, 276 as described above. for absorption and storage within the absorbent layer 184, 284. Similarly, the fluid that comes into contact with the second drain layer 180, 280 can be distributed laterally along the surface of the second drain layer 180, 280 for absorption within the absorbent layer 184, 284.
With reference to FIG. 9A-9E, in other embodiments, the conduit 196 may be a multi-lumen conduit 302. For example, FIG. 9A represents an illustrative embodiment of a multi-lumen duct 302a. The multi-lumen conduit 302a can have an external surface 306, a primary lumen 310, a wall 314 and at least one secondary lumen 318. Wall 314 can carry primary lumen 310 and at least one secondary lumen 318. The primary one lumen 310 can be substantially isolated from fluid communication with at least one secondary lumen 318 along the length of the multi-lumen duct 302a. Although it is shown in FIG. 9A as having a substantially circular cross-section, the outer surface 306 of the multiple lumens duct 302a may have any shape to suit a particular application. The wall 314 of the multiple lumen duct 302a may have a thickness between the primary lumen 310 and the outer surface 306. As shown in FIG. 9A, the at least one secondary lumen 318 may be four secondary lumens 318 carried by the wall 314 substantially parallel to the primary lumen 310 and around a perimeter of the primary lumen 310. The secondary lumens 318 may be separated from each other and substantially isolated from Fluid communication with each other along the length of the multi-lumen duct 302a. In addition, secondary lumens 318 can be separated from primary lumen 310 and substantially isolated from fluid communication with primary lumen 310. Secondary lumens 318 can also be placed concentric with respect to primary lumen 310 and substantially equidistant around the perimeter of primary lumen 310. Although FIG. 9A represents four secondary lumens 318, any number of secondary lumens 318 can be provided and placed in any way suitable for a particular application.
Similar to the internal lumen 197 of the conduit 196, the primary lumen 310 can be coupled in fluid communication between the reduced pressure source 128 and the dressing 124 as described above. In some embodiments, primary lumen 310 may be coupled in fluid communication between conduit interface 148 and reduced pressure source 128. In addition, analogous to internal lumen 197, reduced pressure may be provided through primary lumen 310 from the reduced pressure source 128 to dressing 124. In some embodiments, primary lumen 310 may be configured to extract fluid such as exudate from tissue site 104. Secondary lumens 318 can be coupled in fluid communication between therapy unit 130 and dressing 124. In some embodiments, the at least one secondary lumen 318 can be coupled in fluid communication between the conduit interface 148 and the therapy unit 130. In addition, the secondary lumens 318 may be in fluid communication with the lumen primary 310 in dressing 124 and can be configured to provide a reduced pressure feedback signal from dressing 124 to the therapy unit 130. For example, secondary lumens 318 may be in fluid communication with primary lumen 310 at duct interface 148 or another component of dressing 124.
The multiple lumens conduit 302a may be composed of an absorbent material or hydrophilic polymer, such as, for example, the absorbent material or hydrophilic polymer described above in connection with conduit interface 148, conduit 196 and coupling 198. absorbent material or the hydrophilic polymer may be vapor permeable and liquid impermeable. In some embodiments, at least a portion of the wall 314 and the outer surface 306 of the multiple lumens duct 302a may be composed of the absorbent material or the hydrophilic polymer. In this way, the multiple lumens duct 302a can allow liquids, such as condensate, in the multiple lumens duct 302a to evaporate, or otherwise dissipate, as described above. For example, the absorbent material or the hydrophilic polymer may allow the liquid to pass through the multi-lumen duct 302a as a vapor, in the gas phase, and evaporate in the atmosphere outside the multi-lumen duct 302a. Liquids such as tissue site exudate 104 can also evaporate or dissipate through the multiple lumen duct 302a in the same manner. This feature may be advantageous when the optional therapy unit 130 is used to monitor and control the reduced pressure at the tissue site 104. For example, the liquid present in the secondary lumens 318 may interfere with a reduced pressure feedback signal that it is transmitted to the therapy unit 130 through the secondary lumens 318. The use of the hydrophilic polymer for the multi-lumen duct 302a may allow the removal of such liquid to improve the visual attractiveness, reliability and efficiency of the system 102. After evaporation of the liquid in the multiple lumen duct 302a, other blockages of, for example, dissected exudate, solids or gel-like substances that were transported by the evaporated liquid may be visible for further remediation. In addition, the use of the hydrophilic polymer as described herein may reduce the occurrence of skin damage caused by the accumulation of moisture between the components of the system 102, such as the multiple lumens duct 302a and the skin of a patient. .
Represented in FIG. 9B is another illustrative embodiment of a multi-lumen duct 302b. Similar to the multi-lumen duct 302a, the multi-lumen duct 302b can have the outer surface 306,
the primary lumen 310, the wall 314 and the at least one secondary lumen 318 as described above. However, the wall 314 of the multiple lumens conduit 302b may include a first wall material 314a and a second wall material 314b. The first wall material 314a and the second wall material 314b may be composed of different materials to form the wall 314. For example, the first wall material 314a may comprise a substantially non-absorbent hydrophobic polymer, or other material, which is impermeable Steamed and impervious to liquids. The first wall material 314a can completely surround the primary lumen 310, defining the primary lumen 310 as shown in FIG. 9B. In some embodiments (not shown), the first wall material 314a may be placed around the primary lumen 310 without completely surrounding or defining the primary lumen 310. The second wall material 314b may comprise the same absorbent material or hydrophilic polymer described above for the multi-lumen duct 302a as being vapor permeable and liquid impermeable. As shown in FIG. 9B, the second wall material 314b may be placed in contact with fluids with at least one secondary lumen 318. The second wall material 314b may also define the at least one secondary lumen 318 and at least a portion of the external surface 306 of the 302b multi lumens duct. In some embodiments (not shown), the second wall material 314b can substantially surround the at least one secondary lumen 318 without fully defining the secondary lumen 318.
Continuing with FIG. 9B, the first wall material 314a may be substantially concentric around the primary lumen 310, and the second wall material 314b may be substantially concentric around and adjacent to the first wall material 314a. The first wall material 314a and the second wall material 314b may be molded, extruded together or otherwise combined with one another in any manner suitable to form the wall 314. The wall 314, which includes the first wall material 314a and the second wall material 314b, can provide cost savings while retaining the absorbent and evaporation properties of the hydrophilic polymer to remedy the liquid in the multi-lumen conduit 302b and the at least one secondary lumen 318. In addition, the use of the First wall material 314a as described herein may provide sufficient strength and other physical properties for the multiple lumens conduit 302b to remain in service under reduced pressure in the system 102 regardless of the physical properties of the second wall material. 314b. For example, the use of a non-absorbent hydrophobic polymer for the first wall material 314a may allow the use of absorbent hydrophilic polymers for the second wall material 314b that otherwise may not have sufficient strength for use under reduced pressure in the system 102.
The first wall material 314a can be combined with the second wall material 314b to form the wall 314 in various configurations for liquid remediation in the multi-lumen conduit 302 and the at least one secondary lumen 318. For example, with reference to FIG. 9C, an illustrative embodiment of a multi-lumen duct 302c is shown. Similar to the multiple lumens ducts 302a and 302b, the multiple lumens duct 302c can have the outer surface 306, the primary lumen 310, the wall 314 and the at least one secondary lumen 318. As shown in FIG. 9C, the wall 314 of the multiple lumens conduit 302c may include the first wall material 314a placed around the primary lumen 310 and the second wall material 314b disposed in separate portions around each of the secondary lumens 318. In this configuration, for example, the outer surface 306 may comprise both the first wall material 314a and the second wall material 314b. Also as shown in FIG. 9C, the first wall material 314a can completely surround the primary lumen 310. The second wall material 314b can be arranged as separate parts of each other and separated from the primary lumen in a radial configuration around the perimeter of the primary lumen 310. However In some embodiments, the second wall material 314b may be in fluid contact with the primary lumen 310 and may form a part of the outer surface 306. The amount of the second wall material 314b surrounding the secondary lumens 318 may be increased. or decrease to suit a particular application depending, for example, on the amount of anticipated liquid that is present and on the desired mechanical properties of the multi-lumen duct 302c.
Continuing with FIG. 9C, the first wall material 314a may have a receiver 320 configured to receive the second wall material 314b. The second wall material 314b surrounding the secondary lumens 318 may have a shape corresponding to the receiver 320 in the first wall material 314a. For example, each part of the second wall material 314b may have a narrowing 321a configured to engage with a corresponding narrowing 321b of the receiver 320. The narrowing 321b may be oriented opposite the narrowing 321a. As shown in FIG. 9C, the narrowing 321b of the receiver 320 may be narrowed from the outer surface 306 to a smaller dimension towards the primary lumen 310. The narrowing 321a may have a narrowing opposite the direction of the narrowing 321b described above so that the narrowing 321b is configured to receive and engage the narrowing 321a.
In some embodiments (not shown), the narrowing 321a of the second wall material 314b may be narrowed from the outer surface 306 to a larger dimension toward the primary lumen 310. The narrowing 321b of the receiver 320 may have a narrowing opposite the direction of the narrowing. 321a described above so that the narrowing 321b is configured to receive and couple the narrowing 321a. In this configuration, with the narrowing 321a of the second wall material 314b having a larger dimension towards the primary lumen 310, the opposite narrowing 321b of the receiver 320 can substantially prevent the second wall material 314b from separating from the receiver 320 in the first wall material 314a. The above embodiments for the narrowings 321a and 321b are non-limiting. Other forms and
configurations are suitable for coupling the first wall material 314a with the second wall material 314b, such as, for example, locking tabs or other mechanical elements.
The multiple lumens conduit 302 may include other materials and configurations for managing the liquid in the multiple lumens conduit 302 as described herein. For example, with reference to FIG. 9D, depicted is an illustrative embodiment of a 302d multi-lumen duct. Similar to the multiple lumens ducts 302a, 302b and 302c, the multiple lumens duct 302d can have the outer surface 306, the primary lumen 310, the wall 314 and the at least one secondary lumen 318. The multiple lumens duct 302d can additionally including an external absorbent layer 322. The external absorbent layer 322 may be placed around the wall 314 of the multiple lumens duct 302d. The external absorbent layer 322 can be placed, for example, along the entire length of the multi-lumens duct 302d or a portion of the length of the multi-lumens duct 302d. More specifically, the outer absorbent layer 322 can be placed in a part of the length of the multiple lumens duct 302d near the dressing 124.
Continuing with FIG. 9D, the wall 314 of the multiple lumens conduit 302d may comprise an absorbent material or a hydrophilic polymer, such as the absorbent material or the hydrophilic polymer described above for the multiple lumen conduit 302a as being vapor permeable and liquid impermeable . Although not shown in FIG. 9D, the wall 314 of the multiple lumens conduit 302d may include the first wall material 314a and the second wall material 314b as described above for FIG. 9B and 9C. The external absorbent layer 322 may be composed, for example, of the same absorbent material or hydrophilic polymer of the wall 314. In some embodiments, the external absorbent layer 322 may be composed of a second absorbent material or a second hydrophilic polymer that is permeable to vapor and impervious to liquids. The second absorbent material may have an absorbent capacity greater than the absorbent material or hydrophilic polymer comprising the wall 314 or the second wall material 314b. For example, the second absorbent material of the outer absorbent layer 322 may be able to absorb more than 100% of the unsaturated mass of the second water absorbent material. In this way, the external absorbent layer 322 can be configured to provide an absorbent gradient that increases in absorbent capacity away from the primary lumen 310 and to the outer surface 306. The absorbent gradient can pull, drain, drag or otherwise attract steam to the outer surface 306 for evaporation. In some embodiments, the thickness of the wall 314 can be reduced to improve the passage or penetration of steam through the wall 314 and into the external atmosphere. In embodiments (not shown) that include the first wall material 314a and the second wall material 314b, the external absorbent layer 322 may be placed at least around the second wall material 314b and in fluid contact with the second wall material 314b.
Continuing with FIG. 9D, the outer surface 306 of the multiple lumens duct 302d may have any shape to suit a particular application. For example, the external surface 306 may have a plurality of protuberances 326 and depressions 330 configured to increase the external surface area of the external surface 306. The increased surface area provided by the protuberances 326 and the depressions 330 may improve the capacity of the conduit of multiple 302d lumens to evaporate liquids.
With reference to FIG. 9E, depicted is an illustrative embodiment of a multi-lumen duct 302e having an oblong cross section. Similar to the multiple lumens ducts 302a, 302b, 302c and 302d, the multiple lumens duct 302e can have the outer surface 306, the primary lumen 310, the wall 314 and the at least one secondary lumen 318. However, FIG . 9E represents the at least one secondary lumen 318 of the multiple lumen duct 302e as a single secondary lumen 318 that can be transported by the wall 314 next to the primary lumen 310. Such a configuration can provide a substantially flat and low profile shape that can be improved. user comfort and can increase the flexibility of the 302e multi-lumen duct. For example, in this configuration, the multiple lumen duct 302e can be routed through tight spaces with a reduced risk of twisting or blocking fluid communication. Although not shown, additional lumens can be added in this substantially flat configuration, arranged laterally from primary lumen 310 and secondary lumen 318, as necessary to accommodate a particular application.
The above features described in connection with the multiple lumens ducts 302a, 302b, 302c, 302d and 302e can be used in combination with each other to suit a particular application. For example, the outer absorbent layer 322 described in the multiple lumens duct 302d can be used in combination with any of the multiple lumens ducts 302a, 302b, 302c and 302e. In addition, any of the multiple lumens ducts 302a, 302b, 302c, 302d and 302e can be used with padding (not shown) arranged around the outer surface 306, close to dressing 124, for example, to improve user comfort.
Although this specification describes advantages in the context of certain illustrative, non-limiting embodiments, various changes, substitutions, permutations and alterations can be made without departing from the scope of the appended claims. In addition, any feature described in connection with any embodiment may also be applicable to any other embodiment.
a base layer having a periphery surrounding a central part and a plurality of openings arranged through the periphery and the central part, the openings in the periphery being larger than the openings in the central part, where the base layer is for cover the tissue site;
an adhesive in fluid communication with the openings in the base layer;
a sealing member having a periphery and a central part, the periphery of the sealing member positioned close to the periphery of the base layer, wherein the central part of the sealing member and the central part of the base layer define a wrap;
a first drainage layer disposed in the envelope;
a second drainage layer disposed in the envelope;
an absorbent layer placed in fluid communication between the first drainage layer and the second drainage layer, wherein a peripheral part of the first drainage layer is coupled to a peripheral part of the second drainage layer that provides an envelope of the drainage layer surrounding the absorbent layer between the first and second drainage layers; Y
a conduit interface placed close to the sealing member and in fluid communication with the envelope.
2. The dressing of claim 1, wherein the adhesive is for fluid communication with the tissue surrounding the tissue site through the openings in the base layer.
3. The dressing of claim 1, wherein the adhesive is disposed on a surface of the sealing member facing the base layer.
4. The dressing of claim 1, wherein the first drainage layer has a grain structure that drains the fluid along a surface of the first drainage layer, and wherein the second drainage layer has a structure of grain that drains fluid along a surface of the second drainage layer.
5. The dressing of claim 1, wherein the absorbent layer is a plurality of absorbent layers, and wherein the plurality of absorbent layers are placed in fluid communication between the first drain layer and the second drain layer.
6. The dressing of claim 5, further comprising at least one intermediate drainage layer disposed in fluid communication between the absorbent layers.
7. The dressing of claim 1, further comprising an odor filter that prevents the passage of odors out of a sealed space between the sealing member and the tissue site, wherein the odor filter is transported through the conduit interface , and where the odor filter comprises carbon.
8. The dressing of claim 7, further comprising a primary hydrophobic filter that prevents the passage of liquids out of the sealed space, wherein the primary hydrophobic filter is transported through the conduit interface.
9. The dressing of claim 1, the base layer further comprising an edge that surrounds the central part and positioned between the central part and the periphery, the free edge being of the openings, wherein the edge is between 4 millimeters wide at 11 mm
10. The dressing of claim 1, wherein the openings in the periphery have a diameter between 9.8 millimeters to 10.2 millimeters, and wherein the openings in the central part have a diameter between 1.8 millimeters to 2, 2 millimeters
11. The dressing of claim 1, wherein the openings in the periphery each have a diameter, the diameter of at least one of the openings in the periphery being separated from the diameter of another of the openings in the periphery by a distance between 2.8 millimeters to 3.2 millimeters.
12. The dressing of claim 1, wherein the openings in the central part each have a center, the center of at least one of the openings in the central part being separated from the center of another of the openings in the central part in a first direction for a distance between 2.8 millimeters to 3.2 millimeters.
13. The dressing of claim 12, the center of at least one of the openings being in the central part separated from the center of another of the openings in the central part in a second direction for a distance between 2.8 millimeters to 3, 2 millimeters, the second direction being transverse to the first direction.
ES17152232.9T 2013-10-30 2014-09-19 Dressing with differentially sized perforations Active ES2670710T3 (en)
US201361897640P true 2013-10-30 2013-10-30
US201361897640P 2013-10-30
ES2670710T3 true ES2670710T3 (en) 2018-05-31
ID=51690454
ES17152232.9T Active ES2670710T3 (en) 2013-10-30 2014-09-19 Dressing with differentially sized perforations
US (2) US10016544B2 (en)
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AU (2) AU2014342903B2 (en)
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TR (1) TR201807060T4 (en)
WO (1) WO2015065614A1 (en)
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US20150119833A1 (en) 2015-04-30
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EP3384883A1 (en) 2018-10-10
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