Dressings with area control for the limbs

Abstract

Provides management of tissue areas in one or more limbs of a patient using decompression therapy. [Solution] A manifold 406 for use with a dressing 110 for treating areas around a patient's limbs may include a recessed area 440 located at a first end 446 of the manifold. A folding shaft 434 may bisect the recessed area and extend from a first end of the manifold to a second end 438 of the manifold. The first portion of the manifold may extend perpendicular to the folding shaft toward a first side 430 of the manifold, and the second portion of the manifold may extend perpendicular to the folding shaft toward a second side 432 of the manifold opposite to the first side. The folding shaft may be configured to extend longitudinally along the limb. In addition, other devices, dressings, systems, and methods are disclosed.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 929,215, filed on November 1, 2019, and U.S. Provisional Patent Application No. 62 / 955,534, filed on December 31, 2019, which are hereby incorporated by reference in their entirety.

[0002] The present disclosure generally relates to tissue treatment systems, and more particularly, but not limited to, tissue area management of one or more extremities of a patient using negative pressure therapy.

Background Art

[0003] Clinical research and clinical practice have shown that reducing the pressure in the vicinity of a tissue site can enhance and accelerate the growth of new tissue at the tissue site. There are many applications of this phenomenon, but it has been found to be particularly advantageous for treating wounds. Regardless of the cause of the wound, whether it is trauma, surgery, or another cause, appropriate care of the wound is important for the outcome. Treatment of wounds or other tissues with negative pressure can generally be referred to as "negative pressure therapy", but is also known by other names including, for example, "negative pressure wound therapy", "vacuum - assisted closure", "vacuum therapy", "negative pressure occlusion", and "local negative pressure". Negative pressure therapy can provide many benefits including, for example, migration of epithelial and subcutaneous tissues, improvement of blood flow, and micro - deformation of tissues at the wound site. These benefits can generally increase the development of granulation tissue and reduce the healing time.

[0004] The clinical benefits of negative pressure therapy are widely known, but improvements in therapy systems, components, and processes can provide benefits to healthcare providers and patients.

Summary of the Invention

[0005] Novel and useful systems, apparatus, and methods for managing tissue sites in a negative pressure therapy environment are described in the appended claims. The following description provides non-limiting exemplary embodiments to enable those skilled in the art to fabricate and use the claimed subject matter.

[0006] In some exemplary embodiments, a dressing for treating a region around a limb by decompression may include an attachment device, a manifold, and a cover. The attachment device may include a treatment opening. The manifold may be configured to be at least partially exposed to a region around a limb through the treatment opening. The manifold may include a recess, a folding axis, a first adaptable area, and a second adaptable area. The recess may extend into the edge of the manifold at the first end of the manifold. The folding axis may bisect the recess and extend along the length of the manifold from the first end to the second end of the manifold. The first adaptable area may extend perpendicular to the folding axis along the width of the manifold and toward the first side of the manifold. The second adaptable area may extend perpendicular to the folding axis along the width of the manifold and toward the second side of the manifold opposite to the first side. At least a portion of the manifold's width may increase from the first end to the second end. The cover may be positioned on top of the manifold and configured to be coupled to mounting devices around the manifold.

[0007] In some exemplary embodiments, a method for treating a region around a limb with decompression may include applying a dressing including a folding axis to the limb such that the folding axis extends longitudinally along the limb. Furthermore, the method may include wrapping a first adaptable region of the dressing around the limb in a first direction and wrapping a second adaptable region of the dressing around the limb in a second direction opposite to the first direction. Furthermore, the method may include fluidly coupling a decompression source to a manifold of the dressing and delivering decompression from the decompression source to the manifold.

[0008] In some exemplary embodiments, a manifold for use with a dressing for treating a region around a limb by decompression may include a recess, a folding axis, a first adaptable region, and a second adaptable region. The recess may extend into the edge of the manifold at the first end of the manifold. The folding axis may bisect the recess and extend along the length of the manifold from the first end to the second end of the manifold. The first adaptable region may extend perpendicular to the folding axis along the width of the manifold and toward the first side of the manifold. The second adaptable region may extend perpendicular to the folding axis along the width of the manifold and toward the second side of the manifold opposite to the first side. The first adaptable region may be symmetrical with respect to the second adaptable region with respect to the folding axis.

[0009] In some exemplary embodiments, a manifold for use with a dressing for treating a region around a limb by decompression may include a recess, a folding axis, a first part, and a second part. The recess may be located at the first end of the manifold. The folding axis may bisect the recess and extend from the first end of the manifold to the second end of the manifold. The first part of the manifold may extend toward the first side of the manifold perpendicular to the folding axis. The second part of the manifold may extend toward the second side of the manifold opposite to the first side, perpendicular to the folding axis. The folding axis may be configured to extend longitudinally along the limb.

[0010] The purpose, advantages, and preferred modes of fabricating and using the claimed subject matter can be best understood by referring to the accompanying drawings together with the following detailed description of exemplary embodiments. [Brief explanation of the drawing]

[0011] [Figure 1] This is a block diagram of an exemplary embodiment of a therapeutic system capable of providing decompression therapy according to this specification.

[0012] [Figure 2] This graph shows exemplary pressure control modes that may be relevant to several embodiments of the treatment system shown in Figure 1.

[0013] [Figure 3] This graph shows another exemplary pressure control mode suitable for several exemplary embodiments of the treatment system shown in Figure 1.

[0014] [Figure 4] This is a top view of an exemplary embodiment of a dressing that may relate to an exemplary embodiment of the treatment system shown in Figure 1.

[0015] [Figure 5] Figure 4 shows an expanded perspective of the dressing, illustrating additional details that may be relevant to several examples.

[0016] [Figure 6] A side cut of the exemplary dressing of Figure 4 in its assembled state, along line 6-6 in Figure 4, provides additional details that may be relevant to several examples.

[0017] [Figure 7A] Figure 4 shows an exemplary step of applying the exemplary dressing to a patient's leg.

[0018] [Figure 7B] Figure 7A shows an exemplary subsequent or final step in the application of the exemplary dressing.

[0019] [Figure 8] This figure shows an exemplary dressing applied to a patient's arm, as shown in Figure 4.

[0020] [Figure 9] This is a top view of another exemplary embodiment of a dressing that may relate to one exemplary embodiment of the treatment system shown in Figure 1.

[0021] [Figure 10] A top view of yet another exemplary embodiment of a dressing that may be associated with an exemplary embodiment of the treatment system of FIG. 1.

[0022] [Figure 11] A top view of yet another exemplary embodiment of a dressing that may be associated with an exemplary embodiment of the treatment system of FIG. 1. **DETAILED DESCRIPTION OF THE INVENTION**

[0023] The following description of exemplary embodiments provides information that enables one skilled in the art to make and use the subject matter recited in the appended claims, but may omit certain specific details that are already well known in the art. Accordingly, the following detailed description is to be construed as illustrative and not restrictive.

[0024] FIG. 1 is a block diagram of an exemplary embodiment of a treatment system 100 that can provide negative pressure therapy to a tissue site. As used in this context, the term "tissue site" can broadly refer to a wound, defect, or other treatment target located on or within tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendon, or ligament. Wounds can include, for example, chronic, acute, traumatic, subacute, and lacerated wounds, partial thickness burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), skin flaps, graft tissue, and incisions. The term "tissue site" can also refer to an area of tissue that does not necessarily have a wound or defect, but rather an area where it may be desirable to add or promote the growth of additional tissue. For example, negative pressure may be applied to a tissue site to grow additional tissue that can be harvested and transplanted.

[0025] The treatment system 100 may include, for example, a pressure reduction source or pressure reduction supply source such as a pressure reduction source 105, a dressing 110, a fluid container such as a container 115, and a regulator or controller such as a controller 120. Additionally, the treatment system 100 may include sensors for measuring operating parameters and providing feedback signals indicating the operating parameters to the controller 120. As shown in Figure 1, for example, the treatment system 100 may include one or more sensors coupled to the controller 120, such as a first sensor 125 and a second sensor 130. As shown in the example in Figure 1, in some embodiments, the dressing 110 may include a tissue interface 135, a cover 140, or both.

[0026] Some components of the therapy system 100 may be housed within or used in conjunction with other components such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy. For example, in some embodiments, the decompression source 105 may be combined with the controller 120 and other components to form a therapy unit.

[0027] In general, the components of the treatment system 100 may be connected directly or indirectly. For example, the decompression source 105 may be directly connected to the container 115, or indirectly connected to the dressing 110 via the container 115. The connection may include a fluid connection, a mechanical connection, a thermal connection, an electrical connection, or a chemical connection (such as a chemical bond), or in some contexts, a combination of connections. For example, the decompression source 105 may be electrically connected to the controller 120, or fluidly connected to one or more distribution components to provide a fluid pathway to the tissue site. In some embodiments, the components may also be connected by physical proximity, by being integrated into a single structure, or by being formed from the same material piece.

[0028] The distribution components may be removable, disposable, reusable, or recyclable. The dressing 110 and container 115 are examples of distribution components. A fluid conduit is another example of a distribution component. In this context, “fluid conduit” can broadly include tubes, pipes, hoses, conduits, or other structures having one or more lumens or open passages adapted to carry fluid between two ends. Typically, a tube is an elongated cylindrical structure with some degree of flexibility, although its geometric shape and rigidity can vary. Also, some fluid conduits may be molded within other components or otherwise integrated with other components. The distribution components may also include interfaces or fluid ports to facilitate the coupling and uncoupling of other components. In some embodiments, for example, a dressing interface may facilitate coupling a fluid conduit to the dressing 110. For example, such a dressing interface may be a SENSAT.RAC® Pad, available from KCI in San Antonio, Texas.

[0029] The decompression supply unit, such as the decompression source 105, may be an air reservoir under decompression, or it may be a manual or electric device such as a vacuum pump, suction pump, wall suction port (available in many medical facilities), or micropump. "Negative pressure" or "decompression" generally refers to a pressure below local ambient pressure, such as the ambient pressure in the local environment outside the sealed therapeutic environment. Often, the local ambient pressure may also be atmospheric pressure where the tissue site is located. Furthermore, the pressure may be below the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise indicated, the pressure values ​​described herein are gauge pressures. A reference to an increase in decompression may refer to a decrease in absolute pressure, and a decrease in decompression may refer to an increase in absolute pressure. The magnitude and nature of the decompression applied to the tissue site may vary depending on the therapeutic requirements, but the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mmHg (-667 Pa) and -500 mmHg (-66.7 kPa). The typical therapeutic range is between -50 mmHg (-6.7 kPa) and -300 mmHg (-39.9 kPa).

[0030] Container 115 represents a container, canister, pouch, or other storage component that may be used to manage exudate and other fluids drawn from a tissue site. In many environments, rigid containers may be preferred or required for the collection, storage, and disposal of fluids. In other environments, fluids may be properly disposed of without being stored in rigid containers, and reusable containers can reduce waste and costs associated with decompression therapy.

[0031] A controller such as controller 120 may be a microprocessor or computer programmed to operate one or more components of the treatment system 100, such as a decompression source 105. In some embodiments, for example, controller 120 may be a microcontroller, which may include an integrated circuit including a processor core and memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. Operating parameters may include, for example, power applied to the decompression source 105, pressure generated by the decompression source 105, or pressure distributed to the tissue interface 135. Controller 120 may also be configured to receive one or more input signals, such as feedback signals, and may be programmed to modify one or more operating parameters based on the input signals.

[0032] Sensors such as the first sensor 125 and the second sensor 130 can be any device capable of operating to detect or measure a physical phenomenon or physical characteristic and to generally provide a signal indicating the detected or measured phenomenon or characteristic. For example, the first sensor 125 and the second sensor 130 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, the first sensor 125 may be a transducer configured to measure the pressure in an air passage and convert the measurement into a signal indicating the measured pressure. In some embodiments, for example, the first sensor 125 may be a piezoresistive strain gauge. In some embodiments, the second sensor 130 may optionally measure an operating parameter of the pressure reduction source 105, such as voltage or current. The signals from the first sensor 125 and the second sensor 130 may be suitable as input signals to the controller 120, but in some embodiments, some signal conditioning may be appropriate. For example, the signals may need to be filtered or amplified before they can be processed by the controller 120. Typically, a signal is an electrical signal, but it may also be represented in other forms, such as an optical signal.

[0033] The tissue interface 135 may be adapted to partially or completely contact the tissue site. The tissue interface 135 can take many forms and have many sizes, shapes, or thicknesses, depending on various factors, such as the type of treatment being performed or the nature and size of the tissue site. For example, the size and shape of the tissue interface 135 may be adapted to the contour of a deep, irregularly shaped tissue site. In addition, some or all of the surfaces of the tissue interface 135 may have protrusions or uneven, rough, or jagged edges, which can induce strain and stress on the tissue site, thereby promoting granulation tissue formation in the tissue site.

[0034] In some embodiments, the tissue interface 135 may be a manifold, or, depending on the desired treatment, may include a manifold and additional layers such as a tissue contact layer. In this context, “manifold” may include any material or structure that provides multiple passages adapted to collect or distribute fluid to the tissue. For example, the manifold may be adapted to receive a reduced pressure from a source and distribute the reduced pressure to or from the tissue site through multiple openings, which may have the effect of collecting fluid from the tissue site and drawing the fluid towards the source. In some embodiments, the fluid path may be reversed, or a secondary fluid path may be provided, to facilitate the delivery or movement of fluid to the tissue site.

[0035] In some exemplary embodiments, the manifold passages may be interconnected to improve fluid distribution or collection in the tissue area. In some exemplary embodiments, the manifold may be a porous foam material having interconnected bubbles or pores. For example, open-cell foams, porous tissue assemblies, and other porous materials such as gauze or felt mats generally include pores, edges, and / or walls adapted to form interconnected fluid channels. Liquids, gels, and other foams may also include openings and fluid passages, or may be cured to include them. In some embodiments, the manifold may additionally or alternatively include protrusions that form interconnected fluid passages. For example, the manifold may be molded to have surface protrusions that define interconnected fluid passages.

[0036] The average pore size of the foam may vary according to the requirements of the prescribed therapy. For example, in some embodiments, the tissue interface 135 may be a foam having a pore size in the range of 400 to 600 micrometers. The tensile strength of the tissue interface 135 may also vary according to the requirements of the prescribed therapy. For example, the tensile strength of the foam may be increased for intravenous infusion of topical therapeutic solutions. In some examples, the tissue interface 135 may be a mesh polyurethane foam, such as those found in GRANUFOAM® dressings or VACVERAFLO® dressings, both available from KCI in San Antonio, Texas.

[0037] The tissue interface 135 can be either hydrophobic or hydrophilic. In examples where the tissue interface 135 can be hydrophilic, it can also draw fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The draw-up properties of the tissue interface 135 allow fluid to be attracted away from the tissue site by capillary flow or other draw-up mechanisms. An example of a hydrophilic foam is a polyvinyl alcohol open-cell foam such as VACWHITEFORM® dressing, available from KCI in San Antonio, Texas. Other hydrophilic foams may include those made from polyethers. Other foams that may exhibit hydrophilic characteristics may include hydrophobic foams that have been treated or coated to impart hydrophilicity.

[0038] The tissue interface 135 may further promote granulation tissue formation at the tissue site when the pressure within the sealed therapeutic environment is reduced. For example, some or all of the surfaces of the tissue interface 135 may have an uneven, rough, or jagged shape, which can induce micro-strains and stresses at the tissue site when negative pressure is applied through the tissue interface 135.

[0039] In some embodiments, the tissue interface 135 may be constructed from a bioabsorbable material. Suitable bioabsorbable materials may include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). Polymer blends may also include, but are not limited to, polycarbonate, polyfumarate, and capralactone. The tissue interface 135 may further function as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 135 to promote cell growth. A scaffold is generally a substance or structure used to enhance or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Exemplary examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonate, or processed allograft materials.

[0040] In some embodiments, the cover 140 may provide a barrier against bacteria and protection from physical trauma. The cover 140 may also be constructed from a material that can reduce evaporation loss and provide a fluid seal between two components or between two environments, for example, a fluid seal between a therapeutic environment and a local external environment. For example, the cover 140 may include, or be substantially composed of, an elastomer film or membrane that can provide a suitable seal to maintain a reduced pressure at a tissue site with respect to a given decompression source. In some exemplary embodiments, the cover 140 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquids. In some applications, the cover 140 may have a high moisture-vapor transmission rate (MVTR). For example, in some embodiments (based on ASTM E96 / E96M for upright cup measurements), the MVTR may be at least 250 g / m² per 24 hours. Such drapes typically have a thickness in the range of 25–50 microns. For permeable materials, the permeability should generally be low enough to maintain the desired negative pressure.

[0041] The mounting device may be used to attach the cover 140 to an intact epidermis, gasket, or other mounting surface. The mounting device can take many forms. For example, the mounting device may be a medically acceptable pressure-sensitive adhesive configured to bond the cover 140 to the epidermis around the tissue site. In some embodiments, for example, some or all of the cover 140 may be coated with an adhesive such as an acrylic adhesive having a coating weight between 25 and 65 grams per square meter (gsm). In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve the seal and reduce leakage. Other exemplary embodiments of the mounting device may include double-sided tape, glue, hydrocolloid, hydrogel, silicone gel, or organogel.

[0042] Figure 2 is a graph illustrating additional details of exemplary control modes that may be relevant to several embodiments of the controller 120. In some embodiments, the controller 120 may have a continuous pressure mode, in which the decompression source 105 operates to provide a constant target decompression, as indicated by lines 205 and 210, for the duration of the treatment or until manually deactivated. Additionally or alternatively, the controller may have an intermittent pressure mode, as shown in the example of Figure 2. In Figure 2, the x-axis represents time, and the y-axis represents the decompression generated over time by the decompression source 105. In the example of Figure 2, the controller 120 can operate the decompression source 105 to circulate between target pressure and atmospheric pressure. For example, the target pressure may be set to a value of 125 mmHg, as indicated by line 205, for a specified time (e.g., 5 minutes), followed by a specified time of deactivation (e.g., 2 minutes), as indicated by the gap between the operating solid line 215 and the solid line 220. The circulation can be repeated by activating the pressure reduction source 105, as shown by line 220, which can form a square wave pattern between the target pressure and atmospheric pressure.

[0043] In some exemplary embodiments, the increase in pressure reduction from ambient pressure to target pressure may not be instantaneous. For example, the pressure reduction source 105 and dressing 110 may have an initial rise time, as shown by the dashed line 225. The initial rise time may vary depending on the type of dressing and therapy equipment used. For example, the initial rise time for one therapy system may be in the range of about 20-30 mmHg / second, while the initial rise time for another therapy system may be in the range of about 5-10 mmHg / second. If the therapy system 100 is operating in intermittent mode, the repeated rise time, as shown by the solid line 220, may be substantially equal to the initial rise time, as shown by the dashed line 225.

[0044] Figure 3 is a graph showing additional details that may relate to other exemplary pressure control modes in several embodiments of the treatment system 100. In Figure 3, the x-axis represents time, and the y-axis represents the negative pressure generated by the decompression source 105. In the example of Figure 3, the target pressure may change with time in dynamic pressure mode. For example, the target pressure may change in the form of a triangular waveform that varies between a minimum and maximum decompression of 50 to 125 mmHg, with an ascent time 305 set at a rate of +25 mmHg / min and a descent time 310 set at -25 mmHg / min, respectively. In other embodiments of the treatment system 100, the triangular waveform may vary between a decompression of 25 to 125 mmHg, with an ascent time 305 set at a rate of +30 mmHg / min and a descent time 310 set at -30 mmHg / min.

[0045] In some embodiments, the controller 120 can control or determine a variable target pressure in dynamic pressure mode, which can vary between a maximum and minimum pressure value, which can be set by the operator as an input defined as a desired range of pressure reduction. The variable target pressure may also be processed and controlled by the controller 120, which can vary the target pressure according to a predetermined waveform, such as a triangular waveform, a sinusoidal waveform, or a sawtooth waveform. In some embodiments, the waveform can be set by the operator as a predetermined pressure reduction desired for therapy or a pressure reduction that changes over time.

[0046] Referring to Figures 4 to 8, the dressing 110 may include features that can treat tissue sites on the patient's limbs 402, such as the legs, arms, ankles, wrists, or parts thereof, as well as tissue areas around the tissue sites and limbs 402. For example, the tissue site may be a cut or other treatment target on one or both sides of the patient's leg or ankle. The dressing 110 may be configured to treat not only the cut or treatment target, but also, if desired, tissue areas around the cut or treatment target, leg, and ankle.

[0047] Referring more specifically to Figures 4 to 6, in some examples the dressing 110 may include an attachment device 404, a manifold 406, and a cover 140. Some examples of the attachment device 404 and other components may include a therapeutic opening 408, and the manifold 406 may be configured to be at least partially exposed to the area of ​​tissue around the limb 402 through the therapeutic opening 408. Furthermore, in some examples the dressing 110 may optionally include an adhesive ring 410, which may be configured to bond the peripheral portion of the manifold 406 to a portion of the attachment device 404. In some examples the adhesive ring 410 may be formed as part of the attachment device 404, or the adhesive ring 410 may be omitted, and the attachment device 404 is instead bonded to the manifold 406 by another medically acceptable bonding device. In some examples the cover 140, the manifold 406, the optional adhesive ring 410, and the attachment device 404 may have similar shapes. The mounting device 404 may be slightly larger than the manifold 406 to allow the mounting device 404 to be coupled to the cover 140 around the manifold 406. In some examples, adhesive may be placed on a portion of the manifold 406 exposed through the treatment opening 408. In some embodiments, the adhesive may be pattern-coated to cover up to 50% of the exposed portion or surface of the manifold 406.

[0048] The cover 140, manifold 406, mounting device 404, or various combinations may be assembled before application or at the treatment site. In some embodiments, the dressing 110 may be supplied as a single unit.

[0049] The manifold 406 may include a first surface 412 and a second surface 414 on the opposite side. In some examples, at least a portion of the second surface 414 of the manifold 406 may be configured to face an area of ​​tissue around the limb 402 through a therapeutic opening 408. In some examples, the attachment device 404 may be positioned on or within a portion of the second surface 414 of the manifold 406. In some examples, the manifold 406 may include or be formed from a porous material such as foam.

[0050] In some examples, the mounting device 404 may be configured to create a sealed space between the cover 140 and the tissue area around the limb 402, and the manifold 406 may be configured to be positioned within the sealed space. For example, the mounting device 404 may be positioned around the edge 416 of the manifold 406 and configured to surround the tissue area around the limb 402. The cover 140 may be placed on top of the manifold 406 and coupled to the mounting device 404 around the manifold 406. For example, the cover 140 may be coupled to a portion of the mounting device 404 extending outward from the edge 416 of the manifold 406. Furthermore, the cover 140 may be larger than the manifold 406, as shown in the example in Figure 5, and may have a perimeter or flange 418 configured to be attached to the mounting device 404. When assembled, the cover 140 may be positioned on the first surface 412 of the manifold 406, and the flange 418 may be attached to the mounting device 404 around the manifold 406. For example, adhesive may be used to bond the flange 418 to the mounting device 404, or the flange 418 may be welded, sewn, or stapled to the mounting device 404, but is not limited to these. The cover 140 may also include an opening 420, which is configured to allow fluid communication between the manifold 404 and the dressing interface 422 and / or fluid conduit 424, as described herein.

[0051] The mounting device 404 can take many forms. In some examples, the mounting device 404 may include, or be formed from, a film or membrane that can provide a seal in a therapeutic decompression environment. In some exemplary embodiments, the mounting device 404 may be a polymer film, such as a polyurethane film, that is permeable to water vapor but impermeable to liquids. The mounting device 404 may have a thickness in the range of 25 to 50 micrometers. For permeable materials, the permeability may be low enough so that the desired decompression can be maintained. The mounting device 404 may also include a medically acceptable adhesive, such as a pressure-sensitive adhesive. In some examples, the mounting device 404 may be a polymer film coated with an adhesive, such as an acrylic adhesive, which may have a coating weight between 25 and 65 grams / square meter (gsm). In some examples, thicker adhesives, or combinations of adhesives, may be applied to improve the seal and reduce leakage.

[0052] In some examples, the mounting device 404 may contain or be formed from a hydrocolloid. In some examples, the mounting device 404 may be configured as a sealing ring or gasket member, or may be so named. In other examples, the dressing 110 may include a gasket member (not shown) in addition to the mounting device 404. In such examples, the gasket member may be a peripheral member such as a hydrocolloid ring, and at least a portion of the mounting device 404 may be positioned between the manifold 406 and the gasket member on or on the surface of the manifold 406, such as a second surface 414 configured to face an area of ​​tissue around the limb 402. In some examples, the gasket member may have a shape similar to or similar to the adhesive ring 410, but the gasket member may be positioned on the surface of the mounting device 404 configured to face the limb 402, thereby configuring the gasket member to be positioned between the limb 402 and the mounting device 404.

[0053] In some examples, the dressing 110 may further include a tissue contact layer 426, which may be bonded to a surface of the manifold 406, such as a second surface 414, configured to be exposed to areas of tissue around the limbs 402. The tissue contact layer 426 may be configured to be positioned in direct contact with areas of tissue around the limbs 402. The tissue contact layer 426 may include, or be formed from, a material that substantially reduces or eliminates skin irritation while allowing fluid movement through the tissue contact layer 426. In some examples, the tissue contact layer 426 may include, or be formed from, one or more materials, including but not limited to, woven materials, nonwoven materials, polyester knitted materials, and windowed films.

[0054] In some examples, mounting devices 404 or adhesives on the surface of the dressing 110 configured to face areas of tissue around the end 402 may be covered by one or more release liners 428 before the dressing 110 is applied to the tissue site. For example, as shown in Figure 5, the dressing 110 may include a first release liner 428a, a second release liner 428b, and a third release liner 428c. The first release liner 428a may be positioned close to the manifold 406 or a first side 430 of the dressing 110, the second release liner 428b may be positioned close to the manifold 406 or a second side 432 of the dressing 110, and the third release liner 428c may be positioned close to the manifold 406 or a folding axis 434 of the dressing 110. A third release liner 428c may be positioned between the first release liner 428a and the second release liner 428b. In some examples, the third release liner 428c may be configured to be removed in order to expose a portion of the adhesive or attachment device 404 adjacent to the folding axis 434 before the removal of the first release liner 428a and the second release liner 428b. Such a configuration may allow the folding axis 434 of the dressing 110 to be initially positioned or aligned in a tissue site such as a limb 402, while the first release liner 428a and the second release liner 428b protect the rest of the adhesive or attachment device 404. For example, a portion of the third release liner 428c may cover a portion of the first release liner 428a and / or the second release liner 428b, or be positioned on a portion of the first release liner 428a and / or the second release liner 428b, so that the third release liner 428c can be removed before the first release liner 428a and the second release liner 428b. In some examples, the dressing 110 has two release liners, each of which may have perforations or slits (not shown) configured to allow the release liner to be separated into smaller pieces for removal.Additionally, some embodiments may also have one or more cast sheet liners 436.

[0055] Additionally or alternatively, the first release liner 428a, the second release liner 428b, and the third release liner 428c can provide rigidity to the mounting device 404 to facilitate handling and application. Additionally or alternatively, a cast sheet liner 436 may cover the flange 418 to provide rigidity to the cover 140 for handling and application.

[0056] In some examples, the dressing 110 may include a dressing interface 422, which may be fluidically coupled to the manifold 406 through an opening 420 in the cover 140. The dressing interface 422 may be coupled toward a second end 438 of the manifold 406, and may be configured to be coupled to the pressure reducing source 105 through a fluid conduit 424, pipeline, or tube that is fluidly coupled between the dressing interface 422 and the pressure reducing source 105.

[0057] In some examples, the manifold 406 may include a recessed recess 440, a folding shaft 434, a first portion or adaptable region 442, and a second portion or adaptable region 444. The recessed recess 440 may be located at the first end 446 of the manifold 406 and may extend into the edge 416 of the manifold 406 at the first end 446. In some examples, the recessed recess 440 may extend into the edge 416 of the manifold 406 between the first end 446 and the second end 438 for about 15 percent to about 30 percent of the length 448 of the manifold 406. In some examples, the recessed recess 440 may be formed or configured in an arch or V-shape.

[0058] The folding shaft 434 may bisect the concave recess 440 and may extend along the length 448 of the manifold 406 from the first end 446 of the manifold 406 to the second end 438 of the manifold 406. The first end 446 of the manifold 406 may be located along the length 448 of the manifold 406 on the opposite side of the second end 438 of the manifold 406. The first adaptable region 442 may extend along the width 450 of the manifold 406 and toward the first side 430 of the manifold 406, perpendicular to the folding shaft 434. The second adaptable region 444 may extend along the width 450 of the manifold 406 and toward the second side 432 of the manifold 406 opposite to the first side 430, perpendicular to the folding shaft 434.

[0059] In some examples, at least a portion of the width 450 of the manifold 406 may increase from the first end 446 of the manifold 406 to the second end 438 of the manifold 406. For example, the first adaptable region 442 may include the first flared portion 452, and the second adaptable region 444 may include the second flared portion 454. The width 450 of the manifold 406 may be maximum from the first flared portion 452 to the second flared portion 454. In some embodiments, the width 450 of the manifold 406 between the first flared portion 452 and the second flared portion 454 may be between about 26 centimeters and about 30 centimeters. Furthermore, the length 448 of the manifold 406 between the first end 446 and the second end 438 may be between about 27 centimeters and about 30 centimeters.

[0060] In some examples, the first flared portion 452 and the second flared portion 454 may be located closer to the second end 438 of the manifold 406 than to the first end 446 of the manifold 406. In some examples, the first flared portion 452 may be located on the edge 416 of the manifold 406 on the first side 430 of the manifold 406, and the second flared portion 454 may be located on the edge 416 of the manifold 406 on the second side 432 of the manifold 406.

[0061] In some examples, the dressing 110 may include a first flap 456 in a first adaptable region 442 partially defined by a first bisecting portion 458 of the recessed recess 440, and a second flap 460 in a second adaptable region 444 partially defined by a second bisecting portion 462 of the recessed recess 440. The recessed recess 440 may be positioned between the first flap 456 and the second flap 460. In some examples, the first flap 456 and the second flap 460 may be configured to be positioned on opposing sides of the ankle, as shown in Figures 7A and 7B. Furthermore, in some examples, the first adaptable region 442 may be symmetrical to the second adaptable region 444 with respect to the folding axis 434.

[0062] For example, the thickness of the manifold 406 between the first surface 412 and the second surface 414 may vary according to a prescribed treatment. In some examples, the manifold 406 or a portion of the manifold 406 may include an open-cell foam of felt configured to increase rigidity. Additionally or alternatively, the manifold 406 may include foam segments having different densities.

[0063] Referring to Figures 7A and 7B, in some examples, the recessed area 440 of the dressing 110 may be sized and configured to accommodate the dorsal portion of the foot 464. In such examples, the folding axis 434 may be configured to extend longitudinally along the shin of the leg 466, and the first portion or adaptable area 442 and the second portion or adaptable area 444 may be configured to wrap around the ankle and calf of the leg 466. In other examples, the recessed area 440 of the dressing 110 may be sized and configured to accommodate a portion of the wrist 468 of the patient's arm 470, as shown in Figure 8. In such examples, the folding axis 434 may be configured to extend longitudinally along the arm 470, and the first adaptable area 442 and the second adaptable area 444 may be configured to wrap around the wrist 468 and arm 470.

[0064] Some examples of methods for treating areas around limbs 402 with decompression can also be illustrated with reference to Figures 7A and 7B. In some examples, such methods may include applying a dressing 110 to limbs 402 such that the folding axis 434 extends longitudinally along limbs 402. Furthermore, the method may include wrapping a first adaptable area 442 or portion around limb 402 in a first direction and wrapping a second adaptable area 444 or portion around limb 402 in a second direction opposite to the first direction. Furthermore, the method may include fluidly coupling a decompression source 105 to a manifold 406 and delivering decompression from the decompression source 105 to the manifold 406. In some examples, the method may include applying the folding axis 434 longitudinally along the shin of leg 466 and positioning the dorsal portion of the foot 464 of leg 466 within a concave recess 440. Furthermore, in some examples, the method may include positioning the first flap 456 and the second flap 460 on opposing sides of the ankle.

[0065] Furthermore, in some examples, the dressing 110 may further include an attachment device or adhesive on the surface of the dressing 110 configured to face an area of ​​tissue around the limb 402, and a plurality of release liners 428 that cover the attachment device or adhesive before the dressing 110 is applied. The method further includes removing one or more of the plurality of release liners 428, such as a third release liner 428c, that covers the attachment device or adhesive in a position close to the folding axis 434, before applying the folding axis 434 longitudinally along the limb 402, and before removing another liner of the release liners 428 or before wrapping the first adaptable area 442 or the second adaptable area 444.

[0066] Referring to Figures 9 to 11, the dressing 110 and manifold 406 may include additional shapes, as illustrated, to enhance or improve the ability of the dressing 110 and manifold 406 to accommodate various types and sizes of tissue sites and limbs, as desired. Referring to Figure 9, the manifold 406 may also be manifold 406a, where similar reference numerals refer to similar features or elements described in relation to other exemplary embodiments. In some examples, the recess 440 may be a first recess 440a, and the manifold 406a may additionally include a second recess 440b extending into the edge 416 of the manifold 406a at a second end 438 of the manifold 406a. In some examples, the second recess 440b may be larger than the first recess 440a, which can improve the ability of the manifold 406 to accommodate a range of patients with larger sizes.

[0067] Referring to Figure 10, in some examples, manifold 406 may be manifold 406b, where similar reference numerals refer to similar features or elements described in relation to other exemplary embodiments. The length 448 of manifold 406b in the example of Figure 10 may be between approximately 8 inches and approximately 10 inches. Furthermore, the width 450 of the exemplary manifold 406b between the first side 430 and the second side 432 adjacent to the first end 446 may be between approximately 6 inches and approximately 8 inches. Furthermore, the width 450 of the exemplary manifold 406b may increase towards, at, or adjacent to the second end 438 to a value between approximately 11 inches and approximately 13 inches. The first flared portion 452 and the second flared portion 454 of the exemplary manifold 406b may be located on the second end 438 of the manifold 406b, and the width 450 of the manifold 406b may be greatest between the first flared portion 452 and the second flared portion 454.

[0068] Referring to Figure 11, in some examples, manifold 406 may be manifold 406c, where similar reference numerals refer to similar features or elements described in relation to other exemplary embodiments. The length 448 of the manifold 406c in the example of Figure 11 may be between approximately 8 inches and approximately 10 inches. Furthermore, the width 450 of the exemplary manifold 406c between the first side 430 and the second side 432 adjacent to the first end 446 may be between approximately 6 inches and approximately 8 inches. Furthermore, the width 450 of the exemplary manifold 406c may increase toward, at, or adjacent to the second end 438 to a value between approximately 7 inches and approximately 9 inches, which is smaller than and less tapered than the example of Figure 10. Furthermore, the first flared portion 452 and the second flared portion 454 of the exemplary manifold 406c may be positioned on the second end 438 of the manifold 406c, and the width 450 of the manifold 406c may be greatest between the first flared portion 452 and the second flared portion 454.

[0069] In operation, the decompression source 105 can reduce the pressure in the sealed therapeutic environment. The decompression applied to the tissue site through the manifold 406 in the sealed therapeutic environment can induce macro and micro strains in the tissue site, remove exudate and other fluids from the tissue site, and collect the exudate and other fluids in the container 115.

[0070] Generally, exudates and other fluids flow along fluid pathways toward lower pressures. Therefore, the term "downstream" can refer to a location in the fluid pathway that is relatively closer to a pressure source or further away from a pressure source. Conversely, the term "upstream" can refer to a location that is further away from a pressure source or closer to a pressure source.

[0071] In some exemplary embodiments, the controller 120 can receive and process data from one or more sensors, such as a first sensor 125. The controller 120 can also control the operation of one or more components of the therapeutic system 100 to manage the pressure delivered to the tissue interface 135, such as a manifold 406 and associated components. In some embodiments, the controller 120 may include an input for receiving a desired target pressure and may be programmed to process data regarding the setting and input of the target pressure applied to the tissue interface 135. In some exemplary embodiments, the target pressure may be a fixed pressure value, which is set by the operator as the desired target pressure reduction for therapy at the tissue site and then provided to the controller 120 as input. The target pressure may vary depending on the tissue site, based on the type of tissue forming the tissue site, the type of injury or wound (if any), the patient's health condition, and the attending physician's preference. After selecting the desired target pressure, the controller 120 can operate the pressure reduction source 105 in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at the tissue interface 135. In some embodiments, the manifold 406 has separate pressure zones, and different target pressures and control modes can be applied to different pressure zones.

[0072] The systems, apparatus, and methods described herein can offer significant advantages. For example, in addition to the benefits of promoting granulation tissue development and reducing healing time, system 100 can also reduce edema and bruising in a wider area of ​​tissue surrounding or adjacent to a treatment target such as a tissue site or a cut. Dressing 110 can reduce stress on a cut, for example, and maximize the treatment area of ​​the patient's limb. Dressing 110 may also be useful for managing edema and bruising in tissue sites without cuts or open wounds, such as sprains.

[0073] As shown in several exemplary embodiments, it will be understood by those skilled in the art that the systems, apparatus, and methods described herein are subject to various modifications and alterations within the scope of the appended claims. Furthermore, descriptions of various alternative forms using terms such as “or” do not require mutual exclusivity unless clearly required by context, and the indefinite articles “a” or “an” do not limit the subject to a single case unless clearly required by context. Components may also be combined or excluded in various configurations for sale, manufacture, assembly, or use. For example, in some configurations, the dressing 110, the container 115, or both may be excluded or separated from other components for manufacture or sale. In other exemplary configurations, the controller 120 may also be manufactured, configured, assembled, or sold independently of other components.

[0074] The attached claims describe the novelty and inventive step of the subject matter described above, but the claims may also include additional subject matter not specifically described in detail. For example, certain features, elements, or embodiments may be omitted from the claims if they are not necessary to distinguish the novelty and inventive step from those already known to those skilled in the art. Features, elements, and embodiments described in the context of some embodiments may also be omitted, combined, or replaced by alternative features that serve the same, equivalent, or similar purposes, without departing from the scope of the invention as defined by the attached claims.

Claims

1. A dressing for treating the area around the limbs with decompression, A mounting device including a treatment opening, A manifold configured to be at least partially exposed to the region around the limbs through the treatment opening, At the first end, there is a concave recess extending into the edge of the manifold, The aforementioned concave recess is divided into two equal parts, and a folding shaft extends along the length of the manifold from the first end to the second end, A first adaptable region extending perpendicular to the folding axis along the width of the manifold and toward the first side of the manifold, A second adaptable region extending perpendicular to the folding axis along the width of the manifold and toward the second side of the manifold opposite to the first side, wherein at least a portion of the width of the manifold increases from the first end to the second end. A manifold including, A cover that is positioned on the manifold and configured to be coupled to the mounting device around the manifold, A dressing that includes [the following features].

2. The dressing according to claim 1, wherein the concave recess extends into the edge of the manifold between the first end and the second end for about 15 percent to about 30 percent of the length of the manifold.

3. The dressing according to claim 1, wherein the concave depression forms an arch or a V-shape.

4. The dressing according to claim 1, wherein the concave recess is sized to accommodate the dorsal portion of the foot, the folding shaft is configured to extend longitudinally along the shin of the leg, and the first and second adaptable regions are configured to wrap around the ankle and calf of the leg.

5. The dressing according to claim 1, wherein the concave recess is a first concave recess, and the manifold further includes a second concave recess at the second end that extends into the edge of the manifold, the second concave recess being larger than the first concave recess.

6. The dressing according to claim 1, wherein the first adaptable region includes a first flared portion, the second adaptable region includes a second flared portion, and the width of the manifold is maximum from the first flared portion to the second flared portion.

7. The dressing according to claim 6, wherein the first flared portion and the second flared portion are positioned closer to the second end of the manifold than to the first end.

8. The dressing according to claim 6, wherein the first flared portion is positioned on the edge of the manifold on the first side portion, and the second flared portion is positioned on the edge of the manifold on the second side portion.

9. The dressing according to claim 1, further comprising a first flap in a first adaptable region partially defined by a first bisecting portion of the concave recess, and a second flap in a second adaptable region partially defined by a second bisecting portion of the concave recess, wherein the concave recess is positioned between the first flap and the second flap.

10. The dressing according to claim 9, wherein the first flap and the second flap are configured to be positioned on opposing sides of the ankle.

11. The dressing according to claim 1, wherein the first adaptable region is symmetrical with respect to the second adaptable region with respect to the folding axis.

12. The dressing according to claim 1, wherein the mounting device is configured to create a sealed space between the cover and the region around the limbs, and the manifold is configured to be positioned within the sealed space.

13. The dressing according to claim 1, wherein the manifold includes a porous foam.

14. The dressing according to claim 1, wherein the mounting device comprises a film layer and an adhesive.

15. The dressing according to claim 1, wherein the attachment device comprises a hydrocolloid.

16. The dressing according to claim 1, wherein the mounting device is a gasket member.

17. The dressing according to claim 1, wherein the mounting device is positioned around the edge of the manifold and is configured to surround the area around the limbs.

18. The dressing according to claim 1, wherein the manifold includes a first surface and a second surface on the opposite side, and at least a portion of the second surface of the manifold is configured to face the area around the limb through the treatment opening, and the attachment device is positioned on the portion of the second surface of the manifold.

19. The dressing according to claim 18, wherein the cover is configured to be coupled to a portion of the mounting device that extends outward from the edge of the manifold.

20. The dressing according to claim 1, further comprising a gasket member, wherein at least a portion of the mounting device is positioned between the manifold and the gasket member on the surface of the manifold, which is configured to face the region around the limbs.

21. The dressing according to claim 1, further comprising a tissue contact layer bonded to the surface of the manifold configured to be exposed to the region around the limb, wherein the tissue contact layer is positioned in direct contact with the region around the limb.

22. The dressing according to claim 21, wherein the tissue contact layer is selected from the group consisting of woven fabric material, nonwoven fabric material, polyester knitted fabric material, and windowed film.

23. The dressing according to claim 1, further comprising a dressing interface fluidly coupled through the cover and toward the second end of the manifold, wherein the dressing interface is configured to be coupled to a pressure reducing source.

24. A method for treating the area around the limbs by decompression, The dressing according to claim 1 is applied such that the folding axis extends longitudinally along the limbs, The first adaptable region is wrapped around the limbs in a circumferential direction in the first direction, The second adaptable region is wrapped around the limbs in a circumferential direction in a second direction opposite to the first direction, The pressure reduction source is fluidly coupled to the manifold, To deliver reduced pressure from the reduced pressure source to the manifold and A method that includes this.

25. The method according to claim 24, wherein the limbs are legs, and the application of the dressing includes applying the folding axis longitudinally along the shin of the leg and positioning the dorsal portion of the foot of the leg within the concave recess.

26. The method according to claim 24, wherein the dressing further comprises a first flap and a second flap, and the method further comprises positioning the first flap and the second flap on opposing sides of the ankle.

27. The method according to claim 24, wherein the dressing further comprises an adhesive on the surface of the dressing configured to face the area around the limb, and a plurality of release liners covering the adhesive before the dressing is applied, the method further comprising removing one or more of the plurality of release liners covering the adhesive on the folding shaft before the folding shaft is applied longitudinally along the limb, and before another liner of the release liners is removed or before the first adaptable area or the second adaptable area is wrapped.

28. A manifold for use with dressings to treat the area around the limbs by decompression, At the first end, there is a concave recess extending into the edge of the manifold, The aforementioned concave recess is divided into two equal parts, and a folding shaft extends along the length of the manifold from the first end to the second end, A first adaptable region extending perpendicular to the folding axis along the width of the manifold and toward the first side of the manifold, A second adaptable region extending perpendicular to the folding axis along the width of the manifold and toward the second side of the manifold opposite to the first side, and In a manifold, A manifold in which the first compatible region is symmetrical with respect to the second compatible region with respect to the folding axis.

29. The manifold according to claim 28, wherein at least a portion of the width of the manifold increases from the first end to the second end.

30. The manifold according to claim 28, wherein the concave recess extends into the edge of the manifold between the first end and the second end for a period of about 15 percent to about 30 percent of the length of the manifold.

31. The manifold according to claim 28, wherein the concave recess forms an arch or a V-shape.

32. The manifold according to claim 28, wherein the concave recess is sized to receive the dorsal portion of the foot, the folding shaft is configured to extend longitudinally along the shin of the leg, and the first and second adaptable regions are configured to wrap around the ankle and calf of the leg.

33. The manifold according to claim 28, wherein the concave recess is a first concave recess, and the manifold further comprises a second concave recess at the second end that extends into the edge of the manifold, wherein the second concave recess is larger than the first concave recess.

34. The manifold according to claim 28, further comprising a first flap in a first adaptable region partially defined by a first bisecting portion of the concave recess, and a second flap in a second adaptable region partially defined by a second bisecting portion of the concave recess, wherein the concave recess is positioned between the first flap and the second flap.

35. The manifold according to claim 34, wherein the first flap and the second flap are configured to be positioned on opposing sides of the ankle.

36. The manifold according to claim 28, wherein the manifold includes a porous foam.

37. A manifold for use with dressings to treat the area around the limbs by decompression, The concave recess at the first end of the manifold, The aforementioned concave recess is divided into two equal parts, and a folding shaft extending from the first end to the second end of the manifold is provided. A first portion extending toward the first side of the manifold perpendicular to the folding shaft, A second portion extends perpendicular to the folding shaft toward the second side of the manifold, which is opposite to the first side, and In a manifold, A manifold in which the folding shaft is configured to extend longitudinally along the limbs.

38. The manifold according to claim 37, wherein the limbs are legs, the concave recess is sized to receive the dorsal portion of the foot, the folding shaft is configured to extend longitudinally along the shin of the leg, and the first and second portions are configured to wrap around the ankle and calf of the leg.

39. Systems, dressings, apparatus, and methods as substantially illustrated and described herein.

Images