See-through, reduced-pressure dressings and systems.

treatment of linear wounds) presented 'in Mayo'SU' 'FS · 2008; US Provisional Patent Application Serial Number 61 / 057,800, entitled Reduced-Pressure, Compression System and Apparatus for Use on a Curved Body Part filed in May 30 of 2008; the Provisional US Patent Application series number 61 / 057,797, entitled Reduced-Pressure, Compression System and Apparatus for Use on Breast Tissue, filed May 30, 2008; the Provisional US Patent Application series number 61 / 057,805, entitled SuperAbsorbent, Reduced-Pressure Wound Dressing and System filed May 30, 2008; the Provisional US Patent Application series number 61 / 057,810, entitled Reduced-Pressure, Compression System and Apparatus for use on a Joint filed May 30, 2008; the Provisional US Patent Application series number 61 / 121,362, entitled Reduced-Pressure Wound Treatment System Employing an Anisotropic Drape, filed December 10, 2008; and the Provisional Patent Application

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MEXICAN INSTITUTE

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US Serial No. 61 / 144,067, entitled —MnHncnd-Prpssure, Compression System and Apparatus for Use on a Joint filed on January 12, 2009. All of these provisional applications they are incorporated herein by reference for all purposes.

BACKGROUND

The present invention relates generally to medical treatment systems, and more particularly, to reduced pressure wound treatment systems suitable for use with linear wounds, such as surgical wounds.

Doctors perform millions of surgical procedures each year around the world. Many of the procedures are performed as open surgeries, and a growing number are performed using minimally invasive surgery, such as arthroscopic, laparoscopic, and endoscopic procedures. As an example, the American Society for Aesthetic Plastic Surgery reports that there were more than 450,000 liposuction procedures in the United States in 2007.

Surgical procedures include acute wounds, eg, a linear incision or wound, in the skin and related tissue. In addition to surgical wounds, linear wounds are also caused by trauma. In many

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MEXICAN INSTITUTE L'E LA MONEDAD industrial

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cases, the linear wound is closed ¹ Itfí'í'toaiÍdu ........ fix mechanical yachts, such as staples, sutures, or adhesives, and then the wound is covered only with a sterile, dry bandage. Often the bandage must be removed to observe the wound to monitor the progress of the wound and to check for infection or other tissues. Ά unless otherwise noted, as used herein, or does not require mutual exclusivity.

SUMMARY

Disadvantages with certain aspects of wound care are addressed by illustrative embodiments herein. The present invention can be used on a linear wound, wound area, or other wound. Linear wound generally refers to a laceration or incision whether in a line or not. In accordance with an illustrative embodiment, a transparent dressing device for use with a reduced pressure system to treat a linear wound in a patient includes a closure dressing holder to provide a closure force when under reduced pressure and a limb sealant to cover the closure dressing holder and provide a seal over the closure dressing holder. The closure dressing holder and sealing member are formed of sufficiently transparent materials to allow perception of color from a point external to the delivery device.

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MEXICAN INSTITUTE

OF INDUSTRIAL FROPÜDAD

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transparent dressing. The cell dressing support may include a top wall and a bottom wall. The top wall and bottom wall are coupled in a separate relationship. The bottom wall includes a central portion, a first side portion, and a second side portion. A first closure member is formed on the first side portion, and a second closure member is formed on the second side portion. When placed under reduced pressure, the first closure member and the second closure member move towards each other.

In accordance with another illustrative embodiment, a system is presented for treating a wound in a patient with reduced pressure that allows visual observation of the wound during treatment. The system includes a transparent dressing support for placement on the patient's epidermis over the wound; a transparent sealing subsystem to provide a fluid seal on the closure bracket; and a reduced pressure subsystem for supplying reduced pressure to the sealing subsystem. The sealing subsystem and the reduced pressure subsystem are operated to supply reduced pressure to the transparent dressing backing after which the system develops a directed force performed on the wound and supplies reduced pressure to the wound. The transparent members are operated to allow light to pass through so that the color,

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Shadows of color, or a wound edge '' on the wound may be perceived from a location external to the system.

In accordance with another illustrative embodiment, a method of manufacturing a transparent dressing device includes the steps of forming a backing to provide a directed force to a wound treatment area when under reduced pressure and providing a transparent sealing member to cover the support and that allows a fluid seal on the support and the epidermis of the patient. The step of forming a support includes forming a support of a transparent material.

In accordance with another illustrative embodiment, a dressing device for use with a reduced pressure treatment system on a patient includes a holder for positioning over a wound in the patient and for providing a directed force when under reduced pressure; a sealing member for covering the support and providing a fluid seal over the support and a portion of the epidermis of the patient; and a visual inspection device for visually detecting the color of the wound in the patient. Still other illustrative modalities are presented below.

Other features and advantages of the illustrative embodiments will become apparent with reference to the drawings and the following detailed description.

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BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the method and apparatus of the present invention may be obtained by reference to the following Detailed Description when taken in conjunction with the accompanying Drawings wherein:

Figure 1 is a schematic perspective view, with a portion in cross section, of an illustrative embodiment of a system for treating a linear wound in a patient;

Figure 2 is a schematic, perspective view of an illustrative embodiment of a closure dressing holder for use in treating a linear wound in a patient;

Figure 3A is a schematic cross section of an illustrative embodiment of a system for treating a linear wound in a patient;

Figure 3B is a schematic cross section of a detail of Figure 3A;

Figure 3C is a schematic cross section of a detail of Figure 3A;

Figure 4A is a schematic, perspective view of an illustrative embodiment of a closure dressing holder for use in treating a linear wound in a patient;

Figure 4B is a perspective view,

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45 MEXICAN TITLE

OF INDUSTRIAL PKOF1ETY

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Partially exploded view of the dressing support shown in Figure 4 showing an illustrative embodiment of a tube connector;

Figure 4C is a cross section of the closure dressing holder of Figure 4A;

<td>The</td><td>Figure 4D</td><td>it's a</td><td>detail of</td><td>dressing support</td>

<td>closing of</td><td>the figure</td><td>4C;</td><td></td><td></td>

<td>The</td><td>Figure</td><td>5 is</td><td>a sight</td><td>in perspective,</td>

<td>schematic</td><td colspan="2">of a modality</td><td>illustrative</td><td>of a support of</td>

closure dressing for use in treating a linear wound in a patient;

Figure 6 is a schematic cross section of a portion of an illustrative embodiment of a system for treating a linear wound in a patient;

Figure 7 is a schematic cross section of an illustrative embodiment of a portion of a system for treating a linear wound in a patient; Y

Figure 8 is a schematic perspective view, with a portion in cross section, of an illustrative embodiment of a system for treating damaged subcutaneous tissue that allows the wound to be viewed from a point external to the system.

DETAILED DESCRIPTION OF THE PREFERRED MODE

In the following detailed description of the preferred embodiments, reference is made to the drawings

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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companions that form a part of it, and in 'Tos which, by way of illustration, are shown, by way of illustration, specific preferred modalities in which the

<td>invention.</td><td>These modalities are</td><td>describe</td><td>on</td><td>detail</td>

<td>enough</td><td>to allow the</td><td>experts in</td><td>the</td><td>matter</td>

<td>practice</td><td>the invention, and must</td><td>be understood</td><td>what</td><td>they can</td>

<td>be used</td><td>other modalities and what</td><td colspan="2">can be done</td><td>changes</td>

logical, structural, mechanical, electrical and chemical without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims.

Referring to Figures 1-3, an illustrative embodiment of a reduced pressure system 10 is presented for treating a linear wound 12, such as a laceration or, more typically, an incision 14. The reduced pressure system 10 may contain or support the periincisíonal tissue, improve the tensile strength of the incision 14; compress the subcutaneous tissue 20; remove interstitial fluid, which can help reduce or eliminate edema; and isolate linear wound 12 from sources

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INSTITUTO MEXICANO DZ LA FRCFltDAD INDUSTRIAL

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infectious.

The reduced pressure system 10 may be particularly well suited for use with patients at risk, eg, obese patients, diabetic patients, smokers, etc.

Although linear wound 12 may extend to different depths, in this example incision 14 extends through epidermis 16, dermis 18, and into subcutaneous tissue 20. Damaged subcutaneous tissue 22 includes, in this illustration, a subcutaneous recess. 24 or dead space. Although not shown in this embodiment, linear wound 12 can have any number of closure devices employed in linear wound, eg, mechanical closure devices (suture, staples, clips, etc.), adhesives, bonding, etc. The wound can be or include a graft.

The reduced pressure system 10 may include a dressing device 40, which may be placed over the linear wound 12 and used with reduced pressure to deliver a directed force, which may include a compressive force 42 or a closing force 44 (or a force inward relative to an outer edge of the dressing device). The dressing device 40 may include a closure dressing holder 46 which under reduced pressure develops the directed force, for example, compressive forces 42 or closure forces 44. The closure holder 46

IMPI

MEXICAN INSTITUTE

Say THE PROPERTY

INDUSTRIAL

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closure dressing 46 can be formed with a support body

fifty. The closure dressing holder 46 is preferably made of a material that allows flexion and is still rigid enough to provide a closure force.

Support body 50 may include a first closure member 52 and a second closure member 54. Additional closure members, such as members 56, 58, 60, and 62, may be included. A sealing subsystem 70 and a pressure subsystem reduced 90 cooperate with the closure dressing holder 46 to develop the directed force, for example, the closure force 44 or the compressive force 42.

The closure dressing holder 46 may be made of a material that helps distribute reduced pressure to the

<td>wound</td><td>linear</td><td colspan="2">12, provides</td><td>the force</td><td>compressive 42, and,</td><td>to</td>

<td>through</td><td>of the</td><td>members of</td><td colspan="2">closing, by</td><td>example, member</td><td>from</td>

<td>closing</td><td> 56,</td><td>provides</td><td>a</td><td>force</td><td>closing 44</td><td> —</td>

<td colspan="2">preferentially</td><td>e a force</td><td>what</td><td colspan="3">is substantially within</td>

<td colspan="2">from the plane of</td><td>the epidermis</td><td> 16.</td><td>What's more,</td><td>the material for</td><td>the</td>

closure dressing support 46 is preferably translucent or transparent to a degree that light can pass through allowing someone to view linear wound 12 through support material from a point external to the reduced pressure system 10. which closure dressing holder 46 can be formed is described

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IMPI

INSTO UTO MEXICANO DE LA I KCPIlDAD INDUSTRIAL below. ____________

As previously noted, the reduced pressure system 10 may allow wound color, color shades, wound edge, or other characteristics to be visually perceived from a point external to the reduced pressure system 10. As such, the color, color shades, nature of the wound edge, or other characteristics can be determined by a healthcare provider without requiring removal of the dressing device 40 and thus the increased risk of complications and pain from a change can be avoided. of dressing. As such, the expense of another dressing device 40 or part thereof can also be avoided. Reduced pressure system 10 can also provide compressive force 42 to linear wound 12 and that force can help linear wound 12, subcutaneous tissue 22, or subcutaneous hollow 24 to heal and can stabilize linear wound 12 against cutting. The reduced pressure system 10 can also help to remove exudates from the linear wound 12 and can help to close the wound 24.

The sealing subsystem 70 may include the sealing member 72. The sealing member 72 has a first side 74 and a second, inward-facing side 76. A portion of the sealing member 72 may extend beyond the closure dressing support 46, for example, beyond edge 48, to form a lid, or a roof extension

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Ol la moheda · INDUSTRIAL

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77, which has a 78 first side and an inwardly smeared sprjiim4ft-Jindn nri 79.

The sealing member 72 can be any material that provides a fluid seal that allows the reduced pressure to be maintained.

The sealing member, for example, can be a semi-permeable or impermeable elastomeric material. Elastomeric means having the properties of an elastomer. Generally refers to a polymeric material that has rubber-like properties. More specifically, most elastomers have elongation rates greater than 100% and a significant amount of resilience. The resilience of a material refers to the ability of the material to recover from elastic deformation. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, ethylene propylene rubber, butyl rubber monomer, polysulfide ethylene propylene, diene, chlorosulfonated polyethylene, rubber

<td colspan="2">polyurethane,</td><td>movie</td><td colspan="4">EVA, co-polyester, and silicones. The</td>

<td>eg emplos</td><td colspan="2">specific</td><td>from</td><td>materials</td><td>of the member</td><td>sealer</td>

<td>include</td><td>a</td><td>cover</td><td>from</td><td>silicone,</td><td>3M cover</td><td>Tegaderm®,</td>

<td>cover</td><td colspan="3">acrylic (such</td><td>like a</td><td>available</td><td>by Avery</td>

<td>Dennison)</td><td>, or</td><td colspan="2">a cover</td><td>cutting.</td><td></td><td></td>

<td></td><td>A</td><td>apparatus</td><td colspan="2">sealant 80, or</td><td>device</td><td>of Union,</td>

can be used to help provide a fluid seal

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INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL between the cover extension 77 and the epidermis of the patient 16. In the present embodiment, the sealing device 80 may be an adhesive 82 that is applied to the second, inward-facing side 79 of the cover extension 77 to provide such a seal against the epidermis 16. The sealing apparatus 80 may be used to hold the sealing member 72 against the patient's epidermis 16 or another layer, such as a gasket or additional sealing member. The sealing apparatus 80 can take numerous forms. For example, the sealing apparatus 80 may be a medically acceptable pressure sensitive adhesive that extends around a periphery of the sealing member 72.

The reduced pressure subsystem 90 includes a reduced pressure source 92, or therapy unit. Reduced pressure source 92 provides reduced pressure. Reduced pressure source 92 can be any device for supplying reduced pressure, such as a vacuum pump, wall suction, or other source. While the amount and nature of reduced pressure applied to a fabric will typically vary according to the application, the reduced pressure will typically be between -5 mm Hg and -500 mm Hg and more typically between -100 mm Hg and -300 mm Hg. In one embodiment, the reduced pressure is maintained around -200 mm Hg. The reduced pressure source 92, for convenience and mobility purposes, may be a unit operated by

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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battery that is capable of providing continuous and intermittent reduced pressure. The reduced pressure source 92, or therapy unit, may include a container 94, or container, and may be provided with windows 96 to allow the patient or healthcare provider to observe the full state of the container 94. The reduced pressure subsystem 90 further includes a reduced pressure supply conduit 98, or medical tube, that fluidly couples to a reduced pressure interface 100, such as a port 102. The reduced pressure supply conduit 98 and the reduced pressure interface 100 allows the reduced pressure to be supplied to the sealing subsystem 70.

As used herein, "reduced pressure" generally refers to a pressure less than ambient pressure in a linear wound 12, tissue site, or treatment site undergoing treatment. In most cases, this reduced pressure will be less than the atmospheric pressure at which the patient is located. Alternatively, the reduced pressure can be less than a hydrostatic pressure at the tissue site. Unless otherwise indicated, pressure values ​​stated herein are standard pressures. The reduced pressure delivered can be constant or varied (patterned or random) and can be delivered continuously or

MEXICAN INSTITUTE Λ

Say THE PROPERTY C'XwZÜÍA-.Z 5 /

INDUSTRIAL intermittent. Although the terms vario 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 more than the pressure normally associated with a full vacuum. Consistent with use herein, an increase in reduced pressure or vacuum pressure typically refers to a relative decrease in absolute pressure.

The closure dressing holder 46 can be made of a polymer and is preferably a soft polymer. In an illustrative embodiment, the closure dressing holder 46 is a material having a 50 Shore A durometer, but other materials and features are possible. The closure dressing support 46 and support body 50 may be made of a transparent material, such as a sealing member 72, to allow for color, color shading, wound edge, or other characteristics of the wound. linear wound 12 are observed from a point external to the reduced pressure system 10 (see Figure 6). A color change, or change in the shade of a color, of linear wound 12 may signify the onset of infection or other issues, and such visual cues provide useful information to the healthcare provider. The support body 50 can be made of a flexible closure support material, for example, a soft polymer, a medical grade silicone,

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or other suitable material. The closure dressing holder 46 may be extruded, pour molded, injection molded, blow molded, or formed by other manufacturing techniques. Flexible means capable of moving enough to generate the closing force inward.

Referring now primarily to Figure 2, the closure dressing support 46 is shown with a plurality of openings 64 formed on a second, inward-facing side or surface 49 of a second wall 55, or bottom wall, of the support body. 50. Apertures 64 are formed under a central portion 66, and in particular, near the center line 68 of the support body 50. A detail showing an opening 64 is shown in Figure 3C. A first wall 53, or top wall, and second wall 55 engage in spaced relationship to form a hollow region or central compartment 57. Referring again primarily to Figure 2, apertures 64 facilitate reduced pressure transmission through the support body 50 to linear wound 12. Additional openings in various patterns may be provided in the support body 50 to facilitate communication of reduced pressure to the patient's epidermis 16, and, in particular, to the linear wound 12. One or more openings, such as the opening 65, can be formed on a first side 47 of the first wall 53

IMPI

MEXICAN INSTITUTE

Di LA IWíWAD tj ^ -zaa INOUSTídAl of the supporting body 50. The members have rierr ^ 5? 54. 56.

58, 60, and 62 are shown on the second, inward-facing side 49. Closure members 52, 56, and 58 are located on a first side side of central portion 66 and closure members 54, 60, and 62 are located on a second lateral side of the central portion 66.

As clearly shown in Figures 3Ά and 3B, an oblique surface 69 has an angle formed with respect to an imaginary plane that extends vertically (vertical for the orientation shown in Figure 2). Oblique surface 69, which is opposite surface 63, is shown at an angle 61 with respect to a vertical reference plane 59 formed at the apex of oblique surface 69.

In operation, when treatment is desired, the closure dressing support 46 is positioned over the linear wound 12 with the central portion 66 on the linear wound 12 proximal to a central wound area 45. If the closure dressing holder 46 is not pre-fabricated with the sealing member 72 applied to the first side 47, then the sealing member 72 is applied on the first side 47 of the closure dressing holder 46 and beyond the closure holder. closure dressing 46 to form the cap extension or cover extension 77. Either the cover extension 77 is tapered down or an adhesive is applied

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

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to provide a fluid seal.-, antea, ..to the mipmhrr, sealant 72 and the epidermis of the patient 16. Fluid seal, or seal, means a seal suitable to maintain the reduced pressure at the desired location given the particular reduced pressure subsystem included.

The reduced pressure subsystem 90 is fluidly coupled to the sealer subsystem 70 through the reduced pressure interface 100.

The reduced pressure source is activated and develops and supplies reduced pressure through the reduced pressure supply conduit to the reduced pressure interface 100.

When activated, the reduced pressure source supplies reduced pressure to the sealing subsystem 70 the reduced pressure causes the closure dressing holder 46 to develop the compressive force

42. The geometry of the closure dressing holder 46 may cause a bending moment to develop around the central portion 66 thereby causing the closure members

52, 54,

6, 58, 60, develop a resultant downward and inward force (for the orientation shown). This action produces the directed force, eg, compressive force 42 or closing force 44. These forces can be experienced at or near linear wound 12.

Referring mainly to Figure 2, the development of the closing force or compressive force is

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described in more detail. Each one do -— Iaa^{1 1} Oblique awpegíÍei'go 69 between adjacent closure members, 58 and 56, 56 and 52, 52 and 54, 54 and 60, and 60 and 62, form part of a triangle-shaped rim, each having an apex: first apex 67, second apex 71, central apex 75, third apex 83, and fourth apex 85. As reduced pressure enters opening 65, central compartment 57 is evacuated until all or some of the apex 67, 71, 75, 83, and 85 find the first wall 53. Reduced pressure from central compartment 57 is also supplied through apertures 64 and can provide a force driving the apex higher, or attempting to make the angle associated with each apex smaller.

As a result of one or more of these actions, the members

<td>closure 52,</td><td> 54,</td><td> 56, 58, 60,</td><td>and 62 are driven</td><td colspan="2">towards the line</td>

<td>central 68</td><td>Y, </td><td>via</td><td>friction against</td><td>epidermis</td><td>of</td>

<td>patient of</td><td>the</td><td>members of</td><td>closure 52, 54, 56,</td><td>58, 60, and</td><td> 62,</td>

<td>the force</td><td>from</td><td>close it</td><td>develops in the</td><td>epidermis</td><td>of</td>

patient. Compressive force can develop as first wall 53 and second wall 55 are pushed under reduced pressure toward the patient or in the direction from first wall 53 to second wall 55.

Referring now primarily to Figures 4A, 4B, 4C, and 4D, another illustrative embodiment of a closure dressing holder 146 is presented.

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MEXICAN INSTITUTE OF INDUSTRIAL CURRENCY

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Closure 146 has a flat support body with a first closure member 152 and a second closure member 154. A third closure member 156 and a fourth closure member 158 are also shown. Closure members 152 and 156 they are formed on a first side or first portion 153 which is one side of a central plane 168, or central portion, and can extend the length of the closure dressing holder 146. The closure members 154 and 158 are formed on a second portion or side 155, which is on the other side of the central plane 168.

A central channel area 157 can help support body 50 to flex in that region as a bending moment develops under reduced pressure. The bending moment helps to press closure members 152, 154, 156, and 158 toward the epidermis of the patient and can provide directed force, for example, compressive force and closure force directed toward the central wound area (e.g. example, area 45 in Figure 1). The shape of the support body 50 in this illustrative embodiment has been chosen for strength and ease in extruding a material, eg, silicone, and thus the support body 50 collapses or moves in a desired manner to develop the directed force, for example, forces, compressive or closing. The closure dressing holder 146 can be made of a transparent material or at least

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Mexican Institute of Industrial Property

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partially transparent so that the closure dressing holder 146 can help the color, color shading, wound edge, or other features of the linear wound to be seen underneath the closure dressing holder 146 from an exterior point to a system using the closure dressing holder 146.

As shown in Figures 4A and 4B, a tube connector 199 can be used to provide reduced pressure to the closure dressing holder. Tube connector 199 is sized and configured to mate with central channel area 157 in closure dressing holder 146. Tube connector 199 fluidly couples to a reduced pressure supply conduit 198 whereby the Reduced pressure is supplied to the closure dressing holder 146. Apertures 151 allow reduced pressure to be communicated within closure dressing holder 14. 6. As clearly shown in Figure 4C, an opening 164 may be formed in a portion of closure dressing holder 146 to help communicate reduced pressure. to the linear wound below.

Referring now mainly to Figures 4C4D, the development of the closing force or a compressive force will be described in more detail. In this illustrative embodiment, support body 150 is extruded with a central compartment 123 and a plurality of compartments.

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Six of the plurality of compartments 111. 113, 115, 117, 119, and 121 are formed in the first portion 153. The central compartment 123 is formed substantially adjacent to the central channel 157. Six of the plurality of compartments 125, 127, 129 , 131, 133, 135, and 137 are formed in the second portion 155. In this embodiment, only the central compartment 123 receives reduced pressure and does so through the openings 151.

The plurality of compartments, for example compartments

111, 113,

115, 117, 119, 121, 125,

127,

129,

131, 133, 135, and 137, are formed using a first top wall), a second bottom wall), and a plurality of network members 143. The plurality of compartments provide strength to prevent the first wall 139 from collapsing against the second wall 141, except that a lower portion 145 of the central channel 157 is designed to collapse under reduced pressure against a shelf portion 161 of the central compartment

123. It should be noted that the first closure member 152 and second closure member 154 are spaced apart and dimensioned and configured to provide a treatment channel 163. The treatment channel 163 may have a dome cut 165 and oblique walls 167. The first closure member closure 152 is formed in a first lateral portion with respect to central plane 168, and second closure member 154 is formed in

<img file="MX359709B_D0032.tif" />

IMPI

INSTITUTO MEXICANO t&gt; t LA FROflEDAU INDUSTRIAL a second lateral portion with respect to the central plane 168.

As the reduced pressure is supplied to the openings 151, the reduced pressure enters the central compartment 123 and is supplied through the opening 164 into the treatment channel 163. The reduced pressure causes the lower portion 145 of the central channel 157 collapse and touch the shelf portion 161 of the central compartment 123. Furthermore, the reduced pressure in the treatment channel 163 pushes the oblique walls 169 towards each other. One or more of these actions causes the support body 150 to flex, or bend, about the central plane 164 and thus urges the closure members toward the central plane 164. The plurality of compartments preferably do not collapse and continue to provide strength. Furthermore, as the reduced pressure pushes the closure dressing holder 146 inward, that is, in the direction from the first wall 139 to the second wall 141, a compressive force develops.

Referring now primarily to Figure 5, another embodiment of a closure dressing holder 246 is presented. The closure dressing holder 246 includes a support body 250 formed with a first closure member 252 on a first side 253, or first side side, and a second closure member 254 on a second side 255, or second side

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INSTITUTE Mkx; c.

D £ LA FEOriD INDUSTRIAL SIDE. The first and second closure members 252 have oblique walls that face upward (for the orientation shown) toward the absorbent material holder 236. With respect to a central portion 268, a liner piece 265, or liner, may cover and hold closure members 252 and 254. A space between closure members 252 and 254 forms an absorbent material holder 236 containing absorbent material 238. The shape of the absorbent material 238 and the substance of the absorbent material 238 may be operable to help keep an underlying linear wound (eg, linear wound 12 in Figure 1) dry and clean.

Materials that can be used for absorbent material 238 include hydrophobic materials, hydrophilic materials, and all materials listed elsewhere that can be used for a formed dressing backing 532 described below (see Figure 8). Liner 265 and closure members 252 and 254 can be made of a transparent material that allows closure dressing holder 246 to be used with a system that allows a healthcare provider to view color, color shades, border wound, or other linear wound characteristics under the closure dressing holder 246 from a point external to the closure dressing holder 24 6 (see Figure 6 for an example) and

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- IMPI

MEXICAN INSTITUTE

Dt THE PROPERTY

INDUSTRIAL external to the system. _

In operation, the closure dressing holder 246 may develop a bending moment under reduced pressure causing the lower portion of the first closure member 252 and the lower portion of the second closure member 254 to press down (for the orientation shown) and inward into the epidermis of the patient causing both a compressive force and a closing force toward the linear wound. The reduced pressure supplied to the absorbent material holder 236 can bring the first closure member 252 and the second closure member 254 closer together and thus provide the closure force. The closure dressing support 246 is sized and configured so that the absorbent material 238 can be in contact with the linear wound and thus helps to remove any fluid that may have emanated from the linear wound. Any such fluid would be supplied at a reduced pressure interface and then supplied via a reduced pressure conduit to a container under the influence of a reduced pressure source.

The illustrative closure dressing supports 46, 146, and 246 presented above may be provided for visual determination of color, color shading, wound edge, or other characteristics of the wound from a location external to the closure dressing support. Is

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KST1 MEXICAN TUTO OF INDUSTRIAL PROPERTY

<img file="MX359709B_D0035.tif" />

This feature is also possible with other types of dressings as will now be described. Referring now to Figure 6, a portion of a reduced pressure treatment system 310 is shown. The reduced pressure treatment system 310 includes a transparent dressing device 340, having a support body 350. The support body 350 can be made of any number of materials, such as a support mesh or support foam, stipulating that the pore space in the foam (non-opaque foam) or between structural elements of the material allows sufficient light to pass. through the material so that the color, color shades, wound edge, or other characteristics of a linear wound 312 can be observed from a point external to the reduced pressure treatment system 310, for example, they can be seen in a line of sight location shown by reference numeral 384. For example, support body 350 can be formed of silicone or porous foam, for example, a GranuFoam® material available from Kinetic Concepts, Inc. from San Antonio, Texas. The density and size of the pore can be varied to help provide the characteristic of transparency.

In an alternative illustrative embodiment, a window 386, such as a window made of clear silicone, may be placed over a portion of the material.

INSTITUTE ΜίΧΙΟΛΝΟ Uf LA PKOPltDAU INDUSTRIAL

<img file="MX359709B_D0036.tif" />

so that when reduced pressure is applied to the support body 350 and the window 386 is compressed further down into the support material, the linear wound 312 becomes visible through the window 386 from a point of view. exterior to support body 350 and system 310. For example, a patient or healthcare provider may see linear wound 312 in line of sight 388.

In another alternative, illustrative embodiment, clear beads can be used as or included within the support body 350. The beads can be installed within the support body such that under negative pressure, the beads gather over the wound allowing the patient to or healthcare provider view through wound from outside or outside of support body 350 and system 310. Body support 350 can be a mesh material that the beads can displace as they come together under reduced pressure.

In another embodiment, a window can be made such that when the reduced pressure is removed from the support body 350, a deflected portion moves to the side allowing one to view the linear wound 312. For example, two portions of the support body 350 they can be assembled as the reduced pressure compresses the two portions, but when the reduced pressure is removed, the portions separate and allow a clear view of the linear wound.

<img file="MX359709B_D0037.tif" />

OF THE INDUSTRIAL FF.

<img file="MX359709B_D0038.tif" />

As such, it will be appreciated that numerous visual inspection devices are used to allow the color and other characteristics of the wound to be visually detected. The visual inspection device may be a transparent support and a transparent sealing member, a window 386, a support material that allows adequate light to pass through, a plurality of clear beads, or a movable portion of a support that allows visual inspection when not. is under reduced pressure.

Support body 350 is shown covered by a sealing member 372 that extends beyond support body 350, for example, beyond edge 348, to form a cover extension 377. Cover extension 377 can be sealed to form a fluid seal between the sealing member 372 and the patient's epidermis 314 using a sealing apparatus 380, such as a covered tape 383 or other sealing device.

Referring now primarily to Figure 7, a portion of an illustrative system 410 for treating a linear wound 412 is presented. The system 410 includes a dressing device 440. The dressing device 440 includes a dressing holder 446, having a body dressing body 450. Dressing body 450 can be formed with two portions: the first side, or first side portion 453, and a second side, or second side portion 455. The first

<img file="MX359709B_D0039.tif" />

portion 453 and second portion

455 they can be connected integrally or they can be two separate pieces. The first portion 453 is formed with closure members 452 and 456. The second portion 455 is formed with closure members 454 and 460. Under reduced pressure, the closure members 452, 454, 456, and 460 develop both a compressive and a compressive force. a closing force toward linear wound 412. The dressing body 450 is shown covered by a sealing member 472 which is sealed with a sealing apparatus 480 to provide a seal against the epidermis of the patient 416.

A first wall 437 in the first portion 453 and a second wall 439 in the second portion 455 together may form an absorbent material holder 436 to hold an absorbent material 438. The absorbent material 438 can be held against the linear wound 412 to aid in . removing any fluid, eg, exudates, when the dressing device 440 is placed under reduced pressure.

Referring now primarily to Figure 8, an illustrative transparent wound treatment system 510 is presented that allows the healthcare provider to view a treatment site, eg, linear wound 512, wound area, a portion of intact epidermis 514 , etc., and can provide a compressive force. The transparent wound treatment system 510 can be provided for the treatment of damaged tissue

<img file="MX359709B_D0040.tif" />

subcutaneous and may allow the treatment site to be viewed from a location external to the transparent wound management system 510.

The transparent wound treatment system 510 is shown in a peri-incisional region around the linear wound 512, which is through the epidermis 514, dermis 516, reaching into a hypodermis, or subcutaneous tissue 518. The subcutaneous tissue 518 can include numerous types of tissues, such as muscle or fat tissue. A damaged subcutaneous tissue site 520 is shown extending outward from linear wound 512 and includes, in this case, a subcutaneous defect, dead space, or gap 522. The damaged subcutaneous tissue site 520 may be caused by surgical procedures, such as liposuction. Damaged subcutaneous tissue site 520 can include voids, such as gap 522, open spaces, and various defects that can be problematic for a number of reasons, such as fluid accumulation that can result in edema.

Linear wound 512 can be closed using any closure technique or device, such as staples, sutures, or adhesive, but is shown in this illustrative embodiment with a staple 513. The transparent wound treatment system 510 can be used to treat an area and , in particular, can be used to treat a subcutaneous tissue site 520 and the tissue around the site of

<img file="MX359709B_D0041.tif" />

INSTI TUTO MEXICANO

C't LA l'SCl'ltDAD INDUSTRIAL subcutaneous tissue 520, but the transparent wound management system 510 can also be used to treat the more limited area of ​​a linear wound 512.

The transparent wound treatment system 510 includes a dressing device 530, which includes the formed dressing holder 532, a sealing subsystem 560, and a reduced pressure subsystem 580. In operation, the transparent wound treatment system 510 can develop the directed force, which may include a net compressive force, represented by reference numerals 524, that is performed at the subcutaneous tissue site 520. As described below, the formed dressing support 532 can be formed and configured to allow the compressive force 524 to be fairly evenly distributed over the epidermis of the patient 514. Otherwise, if there are areas of substantially increased force compared to other areas in the epidermis 514, skin irritation may result.

Directed force can also include closing force, or inward force, that is, a force toward an interior portion of dressing device 530. Closing force is represented by reference numerals 526. Closing force 526 remains substantially within the plane of the epidermis 514. In other words, the closing force 526 operates primarily

<img file="MX359709B_D0042.tif" />

<img file="MX359709B_D0043.tif" />

within the epidermis 514.

Aderáis, transparent wound treatment

510 is operable to deliver reduced pressure to linear wound 512 and, depending on the healing phase and nature of linear wound 512, through linear wound 512 so that the reduced pressure is at the level of any subcutaneous void 522 to help roughly gather the tissues in that region as well as help remove any air or other fluid.

The dressing device 530 includes the formed dressing support 532 having a first side 534 and a second, inward-facing side 536. The formed dressing support 532 can be sized or shaped to substantially fit the estimated area of ​​the subcutaneous tissue site. damaged 520 although a larger or smaller size can be used in different applications. The formed dressing holder 532 has an edge 538. The formed dressing support 532 can be made from a number of different medical support materials, ie, materials suitable for use in medical applications and which can be made sterile. In an illustrative embodiment, the formed dressing support 532 is made of a medical support material that is a collection material. In an illustrative embodiment, the formed dressing backing 532 is made of backing material which is a foam-like material.

<img file="MX359709B_D0044.tif" />

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX359709B_D0045.tif" />

permeable and porous and, more parFÍr.nlarnipntP · a cross-linked, open-cell polyether or polyurethane foam that allows good permeability of wound fluids while under reduced pressure. One such foam material that has been used is VAC® GranuFoam® material available from Kinetic Concepts, Inc. (KCI) of San Antonio, Texas. Any material or combination of materials can be used for the support material as long as the support material is operable to distribute, or collect, reduced pressure.

The term "harvest" as used herein generally refers to a substance or structure that is provided to assist in the application of reduced pressure to, supplying fluids to, or withdrawing fluids from a tissue site. The support material can also be a combination or layer of materials; for example, a first hydrophilic foam backing layer can be positioned adjacent to a second hydrophobic foam backing layer to form the backing material. The term "fluid" as used herein generally refers to gas or liquid, but also includes any other flowable material, including but not limited to gels, colloids, and foams.

The cross-linked pores of the Granufoam® material, which are typically in the range of about 400 to 600

IMPI

MEXICAN INSTITUTE

OF INDUSTRIAL PROPERTY perform the function of other materials.

doctor,

The o, microns, are useful to carry collection, but density of the Granufoam® support material can be used, typically in the range of about 1.3 lb / ft³ - 1.6 lb / ft³ (20.8 kg / m³ - 25.6 kg / m³). A material with a higher density (smaller pore size) than Granufoam® material may be desirable in some situations. For example, Granufoam® material or similar material with a density greater than 1.6 lb / ft can be used.³ (25.6 kg / m³). As another example, the material

Granufoam® or similar material with a density greater than 2.0 lb / ft³ (32 kg / m³) or 5.0 lb / ft³ (80.1 kg / m³) or even more can be used. The denser the material, the higher the compressive force that can be generated for a given reduced pressure. If a foam with a density less than the tissue at the tissue site is used as the medical support material, a lifting force may develop.

The support material can be a cross-linked foam to which felt is then added to a thickness of approximately 1/3 the original thickness of the foam. Among the many possible materials, the following can be used: GranuFoam® material or a Foamex® technical foam (www.foamex.com). In some cases, it may be desirable to add ionic silver to the support material in

<img file="MX359709B_D0046.tif" />

INSTITUTE ΜΕλΙΟΛΓ '! UL THE INDUSTRIAL PROPERTY

<img file="MX359709B_D0047.tif" />

a micro-bonding process or adding ra-s — at support material, such as antimicrobial agents. The support material can be isotropic or anisotropic depending on the exact orientation of the directed force that is desired during reduced pressure.

The backing material can be made anisotropic by adding filaments, adding felt a portion, selectively adding adhesive, etc.

The support material could be a bio-absorbent material.

The sealing subsystem 560 includes a sealing member 562, or cover, that is analogous to the sealing member 72. The sealing member 562 can be coupled to the formed dressing support 532. For example, the sealing member 562 and formed dressing support 532 can be coupled using adhesives, such as acrylic adhesive, silicone adhesive, hydrogel, hydrocolloid, etc. As another example, the sealing member 562 and the formed dressing support 532 can be joined by heat bonding, ultrasonic bonding, and radio frequency bonding, etc. Coupling can occur in patterns or completely. The structure can be added to the joint to cause the sealing member 562 to behave anisotropically in a desired direction, ie, to make an anisotropic cover material. An anisotropic covering material helps the dressing device 530 to move primarily in a given direction,

<img file="MX359709B_D0048.tif" />

MEXICAN INSTITUTE

OF INDUSTRIAL PROPERTY

<img file="MX359709B_D0049.tif" />

that is, only about one h prm pjp n

In the illustrative embodiment of Figure 8, the sealing member 562 may be dimensioned to extend beyond the formed dressing support 532, for example, beyond the edge 538 at an end 533, to form a cover extension 564, or extension. The cover extension 564 has a first surface 566 and a second inward facing surface 568. The sealing member 562 can be sealed against the epidermis 514 of the patient using a sealing apparatus 569, which helps provide a seal and allows reduced pressure to be maintained by the reduced pressure subsystem 580 at the treatment site. The sealant 569 can take numerous forms, such as an adhesive 570; a sealing tape, or cover strip or tape; two-sided cover tape; pasta; hydrocolloid; hydrogel; or other sealing device. If a tape is used, the tape can be formed of the same material as the sealing member 562 with a pre-applied, pressure sensitive adhesive. Pressure sensitive adhesive 570 may be applied to the second inward facing surface 568 of cover extension 564. Pressure sensitive adhesive 570 provides a seal between sealing member 562 and epidermis 514 of the patient. Before the sealing member 562 is secured to the patient, the pressure sensitive adhesive 570 may have

<img file="MX359709B_D0050.tif" />

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MEXICAN INSTITUTE &lt;-7 h

OF THE PROPERTY VÚ .. 4

INDUSTRIAL strips or a backing covering the adhesive sensi'bΓδ ~ 5 '*' pTe'sré-n

570.

Reduced pressure subsystem 580 includes a reduced pressure source 582, or therapy unit, which can take different forms. Reduced pressure source 582 provides reduced pressure as part of transparent wound treatment system 510. Reduced pressure source 582 can be any device for supplying reduced pressure, such as a vacuum pump, wall suction, or other source. While the amount and nature of reduced pressure applied to a fabric will typically vary according to the application, the reduced pressure will typically be between -5 mm Hg and -500 mm Hg and more typically between -100 mm Hg and -300 mm Hg. To maximize patient ease and mobility, Reduced Pressure Source 582 can be a single-use, battery powered, reduced pressure generator that facilitates application in the operating room and provides mobility and convenience for the patient during the phase. rehabilitation.

In the illustrative embodiment of Figure 8, the reduced pressure source 582 is shown as having a battery compartment 584 and a container region 586 with windows 588 providing a visual indication of the fluid level within the container region 58 6. A filter membrane interposed, such as hydrophobic filter or

<img file="MX359709B_D0051.tif" />

MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY

<img file="MX359709B_D0052.tif" />

olephobic, it can be sandwiched between a reduced pressure LUmini j Li'W conduit, or tube, 590 and the reduced pressure source 582.

The reduced pressure developed by the reduced pressure source 582 is supplied through the reduced pressure supply conduit 590 to a reduced pressure interface 592, which may be an elbow port 594. In an illustrative embodiment, elbow port 594 is a port of TRAC® technology available from KCI of San Antonio, Texas. The reduced pressure interface 592 allows the reduced pressure to be supplied to the sealing subsystem 560 and realized within an interior portion of the sealing subsystem 560. In this illustrative embodiment, the elbow port 594 extends through the sealing member 562 and into formed dressing support 532.

In operation, the transparent wound treatment system 510 is applied to the linear wound 512. The transparent wound treatment system 510 can be applied to the linear wound 512 in the operating room after a surgical procedure on the patient. The second, inward-facing side 536 of the formed dressing support 532 is positioned against the epidermis of the patient 514 with the formed dressing support 532 on the site of damaged subcutaneous tissue 520 and with a portion of the formed dressing support 532 on the linear wound 512.

<img file="MX359709B_D0053.tif" />

MEXICAN INSTITUTE

Dt INDUSTRIAL PROPERTY

<img file="MX359709B_D0054.tif" />

The 530 dressing device can be, ipepsi on_______for typical application included in the procedure performed by a healthcare provider. The dressing device 530 can be sized, shaped, and configured to function with different anatomical applications, such as the abdomen, chest, arms, thighs, etc.

he he

If the sealing member sealing member 562 is placed

562 still on the formed dressing

532 extending beyond the support to form the extensions of extensions of has not mated, first side 534 of with of dressing covered a portion formed 532

564 .

The covers 564 can then be tapered down or an adhesive 570 used to form a seal between the sealing member 562 and the sealing epidermis only needs to be suitable for the patient 514. The to allow the transparent wound treatment system 510 to maintain reduced pressure. in the desired treatment area. The reduced pressure interface 592 and the reduced pressure source 582 are fluidly coupled using the reduced pressure supply conduit 590. The reduced pressure source 582 can then be activated and the reduced pressure supplied to the formed dressing support 532.

As pressure is reduced in the formed dressing support 532, the formed dressing support 532 compresses and contracts laterally and forms a semi-substrate41

<img file="MX359709B_D0055.tif" />

IMPI

INSTITUTE MLXíCÁfiO DE LA PR'jí '.' Eh'ÁD

INDUSTRIAL rigid, and a number of beneficial forces and actions may take place. The reduced pressure is further transmitted through the formed dressing support 532 so that the reduced pressure is supplied to the linear wound 512. At least in the early stages of the healing process, the reduced pressure can also be realized through the linear wound 512 and toward subcutaneous tissue site 520. As such, the reduced pressure can help close defects, such as subcutaneous void 522, and generally provide stability to the area. The reduced pressure delivered to the formed dressing support 532 also develops the compressive force 524 which again can provide stability and therapy. The compressive force 524 is more than fair in the upper part of the epidermis 514. The compressive force 524 extends downward deeper and can be experienced at the subcutaneous tissue site 520. The force

<td>compressive can</td><td>to help</td><td>to close</td><td colspan="2">defects</td><td colspan="2">to proportionate</td>

<td>stability.</td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>Can</td><td>to be</td><td>desirable</td><td>Apply</td><td>the</td><td>system</td><td>from</td>

<td>treatment of</td><td>wound</td><td colspan="2">transparent 510</td><td>on</td><td>fourth</td><td>from</td>

operation and allowing the transparent wound treatment system 510 to remain in the patient until adequate healing has occurred. In this regard, it may be desirable to form the sealing member 562, formed dressing support 532, and any other layer of materials.

<img file="MX359709B_D0056.tif" />

INSTITUTE Mc'CCANO DE LA FKOMEDAD INDUSTRIAL

<img file="MX359709B_D0057.tif" />

Transparent lenses that allow the healthcare provider to obtain visual cues about the healing of the linear wound 512 and damaged subcutaneous tissue site 520 without having to remove the dressing device 530.

In accordance with an illustrative embodiment, a transparent dressing device for use with a reduced pressure system to treat a linear wound in a patient includes a closure dressing holder to provide a closure force when under reduced pressure and a limb sealant to cover the closure dressing holder and provide a seal over the closure dressing holder. The closure dressing holder and sealing member are formed of sufficiently transparent materials to allow perception of color from an external point of the transparent dressing device. The closure dressing holder may include a top wall and a bottom wall. The top wall and bottom wall are coupled in a separate relationship. The bottom wall includes a central portion, a first side portion, and a second side portion. A first closure member is formed on the first side portion, and a second closure member is formed on the second side portion. When placed under reduced pressure, the first closure member and the second closure member move towards each other.

In accordance with an illustrative embodiment, a

<img file="MX359709B_D0058.tif" />

ME-UCANO INSTITUTE

Say LA MSÍffiDAr »rNDuwajAi

<img file="MX359709B_D0059.tif" />

system for treating a wound in a spiraxs — ran pre-siór. reduced and allowing visual observation of the wound during treatment includes a dressing holder for placement in a portion of the patient's epidermis over the wound. The dressing holder is formed of a transparent material. The system further includes a sealing subsystem to provide a seal over the closure bracket and the epidermis of the patient and a reduced pressure subsystem to supply a reduced pressure to the sealing subsystem. The sealing subsystem and the reduced pressure subsystem are operated to supply reduced pressure to the dressing support. The dressing support, sealed subsystem, and reduced pressure subsystem are operated to develop a directed force and to deliver reduced pressure to the wound. The sealing subsystem includes a transparent sealing member. The dressing support and sealing subsystem are operated to allow light to pass through so that colored shadows from the wound can be perceived from a location external to the system. The dressing holder has a first surface, a second inward-facing surface, and includes an oblique end formed from a portion of the dressing holder. The dressing support is formed of a medical support material that has a density greater than 20 kg / m³. The dressing holder has the characteristic of evenly distributing a force

<img file="MX359709B_D0060.tif" />

<img file="MX359709B_D0061.tif" />

directed when under pressure 'reáüci'dá ^

Although the present invention and its advantages have been described in the context of certain illustrative, non-limiting embodiments, it should be noted that various changes, substitutions, permutations, and alterations can be made without departing from the scope of the invention as defined by the appended claims. . It will be appreciated that any feature that is described in a connection to any mode may also be applicable to any other.