JP2008531130A - Load-reducing bandage and wound healing system - Google Patents

Abstract

An improved lightening dressing for transferring pressure out of a patient's foot wound. The bandage has a wound opening (12) formed through the bandage to surround the wound site. The bandage has an external shape that is substantially adapted to the shape of the foot pressure distribution during load bearing. The first layer of bandage (14) interfaces and cushions the foot during load bearing. The first layer is sufficient material to limit the pressure increasing at the wound site and within the bandage adjacent to the wound site. The offloading layer (16) is made of a material of sufficient thickness and hardness to be engaged with the first layer and reduce pressure at the wound site.

Description

(reference)
This application claims priority from US patent application Ser. No. 11 / 065,469 filed on Feb. 24, 2005 and US Patent Application No. 60 / 772,244, filed Sep. 30, 2005. And the specifications of these applications are hereby incorporated by reference in their entirety.

(Technical field)
The present application is directed to an improved wound dressing, which is also part of a wound healing system. More particularly, the present application is directed to a multilayer wound dressing to maximize the pressure or load transferred from the wound site during load bearing.

(background)
Physical off-loading is an essential factor in the healing of plantar surface ulcers. Symptoms of peripheral neuropathy in diabetic patients cause sensory loss, so skin wounds and complete damage leading to ulcers can occur without pain or with minimal pain. These wounds are difficult to heal because ongoing physical damage does not feel as pain to the patient at all. Such wounds can only be treated by treatments that involve protecting the wound from physical damage. A method for treating plantar ulcers includes providing a cast that is in total contact with the foot, which provides sufficient physical protection. This method is not ideal for application in practitioners and endocrinologists' medical practice environments where such wounds are usually treated. This is because this method requires both skilled professional practice in application, as well as frequent follow-up, and is time consuming to apply. In addition, patients perceive casts as inconvenient in the early stages of such wounds, and such wounds are often perceived by patients as not a serious problem. An alternative healing method is to require the patient to follow a non-weight bearing regimen by using a wheelchair, crutch or walker. Such complete physical protection is only possible with full patient compliance. This alternative rarely proves effective in healing wounds in a reasonable amount of time because of poor compliance at all. Alternatives for unloading pressure from the wound are discussed in US Pat. While such wound healing systems offer improvements over conventional casting and non-load-tolerant methods, the systems often allow medical personnel to properly shape, fit and apply to patients. Have difficulty.

New alternatives have been developed that further reduce plantar pressure at the wound site, are convenient for application by medical personnel, and are acceptable to the patient.
US Pat. No. 6,610,897 US Pat. No. 6,720,470

(Simple outline of the present invention)
An improved load reducing bandage (“LRD”) and an improved footbed have been developed to increase physical offloading performance by reducing plantar surface pressure at the wound site during load bearing. Shown in The bandage and footbed combination of the present application is simple to apply for medical practitioners and is easy to use for the patient and create a more favorable environment for wound healing.

(Improved load-reducing bandage)
Improved load-reducing bandage ("LRD") characteristics include bandage geometry, incorporation of new offloading materials, multiple material layers, bandage thickness, and an improved footbed or provider custom Including the use of bandages in other footgears that do not need to be damaged.

  During the development of this LRD, it was learned that the bandage geometry or bandage shape played an important role in providing a contact area on the rest of the patient's foot surface. The LRD of the present application is a shape that substantially corresponds to and substantially corresponds to the load bearing area (eg, the front of the foot) of a typical foot surface. The concentration of pressure in these areas provides a risk factor for the development of foot ulcers in patients diagnosed with diabetic neuropathy. By adjusting the LRD geometry to match the region of interest of the foot, the present invention can be used to transfer loads out of the wound site and thereby reduce plantar pressure. Efficiently maximize the contact area.

  Different geometric shapes of the bandage can be provided for different areas or regions of the foot. Preferably, bandages are provided for the metatarsal head region, heel region and thumb region. This is because these are typical load bearing areas of the plantar surface, and there is substantially the greatest risk to the development of foot ulcers. A wound opening or offloading aperture may be provided in each bandage. The position and diameter of the wound opening can be varied based on the representation of the wound or wound site. The LRD for each of the regions covers essentially all of the foot's regional load-bearing anatomy. For example, the LRD for the metatarsal head region is placed under the front of the foot and covers essentially all of the load bearing portion of the front of the foot except the wound site, Maximize pressure dispersion.

  In particular, the metatarsal head region geometry has a structure designed to engage or substantially engage pressure distribution during load bearing. In the design of the present application, a load relief bandage for the metatarsal head region can be used either on the front of the left foot or on the front of the right foot. This is because the bandage can be aligned with the pressure distribution surface of the front region of either foot by rotation of the bandage. The heel region LRD and the thumb region LRD can also be exchanged between the right foot and the left foot. In the metatarsal head region, the LRD function is almost similar to the insole, allowing the patient to walk more normally when worn alone. In an alternative embodiment, the metatarsal LRD geometry may be enlarged to provide a full contact surface with the metatarsal head. In addition, additional attachment mechanisms (eg, anchor straps) can be provided to maintain the position of the LRD.

  To minimize the plantar pressure that increases in the area adjacent to or around the wound during load bearing, the LRD of the present application includes multiple layers of material. Each of the layers is made of a material that achieves a specific purpose. Furthermore, the thickness of each of the layers can be varied. A buffer layer is provided that interfaces with the plantar surface of the foot. The buffer layer serves to reduce and / or limit the increasing pressure around the wound opening or offloading aperture of the LRD and in an area very close to the LRD adjacent to the wound site, and further the LRD skin interface It is also useful to limit the shear force at. In non-load bearing situations, the cushioning layer around the wound opening may have a substantially square edge portion that cushions under pressure. If the material selected for the buffer layer is not buffered under pressure, contouring of the edge portion around the wound opening may be required.

  An offloading layer secured to the buffer layer is provided on the surface remote from the foot. The offloading layer is thick and stiff enough to maximize the reduction in plantar pressure at and around the wound site.

  A conforming layer that is secured to the offloading layer may also be provided on the surface opposite the buffer layer. The conforming layer serves as a flexible interface between the offloading layer and the contact surface (eg, floor, footbed or other footgear) that is engaged by the foot and bandage combination. The additional flexibility resulting from the use of the conforming layer provides additional conformity to the foot surface engaged with the LRD, as well as additional offloading of plantar pressure around the wound site and wound site. Also provide.

  Optionally, an adhesive layer and / or other attachment means as described above may be provided on the surface of the buffer layer to secure engagement with the foot. Peel-off double-sided tape or other medically suitable adhesive can be used to allow convenient application by the patient or medical personnel. Alternatively, a wrap with Velcro®, strap or other convenient attachment mechanism can be used to secure the LRD in place.

  As noted above, the thickness of each of the buffer layer, offloading layer, and conforming layer can be varied. In general, further pressure reduction at the wound site is obtained by increasing the thickness of the bandage. The LRD should be thick enough to provide substantial offloading of the wound site while walking without causing the patient to greatly change their normal gait pattern. Thus, the ideal thickness allows the patient to maintain a stable gait during walking, while maximizing pressure offloading from the wound site with minimal pressure gain over the surface area of the LRD. Enable.

  Other characteristics and advantages of the LRD of the present application include the ability of a bandage adapted to deliver additional wound treatment to promote healing. For example, an occlusive membrane may be used between the layers of the LRD to create a “well” associated with the wound opening. Various wound healing therapies (eg, antibiotics, antimicrobials, growth factors and cell-based therapies, and exudate absorption) can be delivered to the wound via placement in the well. Alternatively, the membrane layer may consist of a wound contact material attached on the aperture of the LRD buffer layer to provide support for the skin surrounding the wound and prevent protrusion of the skin surface into the aperture area. In a preferred embodiment, the membrane layer is permeable and porous, allowing the wound drainage to pass through the absorbent, if desired.

(Improved footbed)
In addition, an improved footbed of the present application or a footgear having a commercially available footbed can also be used in connection with the LRD of the present application. The improved footbed design includes multiple layers of material that are thick enough to allow the LRD to automatically match or form the footbed, while the LRD It also provides a solid support for a portion of the plantar surface that is not engaged with. The footbed also helps to maintain a properly placed LRD on the foot and reduce the potential shift of the LRD relative to the wound site.

  The improved footbed layer is: a top layer for engagement with the LRD; an intermediate layer having a “landing zone” portion, preferably when it is pressed into the landing zone under load Can automatically fit around the periphery of the LRD, or use a viscoelastic material to form the periphery of the LRD, have at least the same thickness as the LRD, and can include a support zone portion of a somewhat hard material, An intermediate layer; and a bottom layer to provide a rigid surface for supporting the footbed. In the mid layer, the landing zone portion is provided substantially in the area of the foot where the wound is present, with a support zone provided in the other area of the foot. Alternatively, an improved footbed can be provided without a top layer. In a preferred embodiment, the viscoelastic material of the intermediate layer landing zone minimizes potential shifts in the LRD by fitting around or shaping the periphery of the LRD geometry. .

  The improved footbed geometry or external shape is adapted for engagement with the desired footgear. The combination of an improved LRD and an improved footbed is preferably used in a suitable footgear to provide an improved wound healing system for significant plantar pressure reduction at the wound site.

  Other features and advantages will become apparent from the following detailed description and the accompanying drawings.

(Detailed description of the present invention)
The load relief bandage and footbed described herein are shown and provide physical offloading by reducing the pressure on the plantar surface at the wound site during load bearing. The combination of LRD and footbed is easy to apply for those practicing medical care, making it easier for patients to use and create a more favorable environment for wound healing.

(Load reduction bandage)
Referring to FIG. 1, a load relief bandage 10 or “LRD” of the present application is shown. The LRD of the present application is provided with an external bandage geometry, which is formed to substantially correspond to the typical load bearing area of the foot. 2a and 2b displayed bare foot pressure distribution, with high plantar pressure measured in the highlighted area indicated by H. FIG. Obviously, the plantar pressure within the foot load bearing region can vary greatly. In FIG. 2a, the highlighted areas with increased pressure during load bearing include the anterior area of the foot (eg, metatarsal head, thumb region), as well as the heel area. On the other hand, in FIG. 2b, the measured value of the central area of the foot shows the area where the pressure has increased.

  The external geometry of the LRD of the present application preferably covers essentially the increased pressure or load bearing anatomy of the foot, depending on the region. As a result, in FIG. 3a, the LRD has a substantially lobular structure to engage the pressure distribution in the head region of the metatarsal bone at the front of the foot, which is symmetrical. In FIG. 3b, an LRD having an external geometry for use with pressure distribution in the heel region is illustrated as having an oval structure. In FIG. 3c, an LRD having an external geometry for use with pressure distribution in the thumb region is illustrated as an oval. Further in FIG. 13, an LRD having an external geometry covering the entire metatarsal region is provided. This leaflet shape is further elongated in the lateral direction to better engage and support the lateral metatarsal head and is substantially asymmetric in its external geometry.

  The LRD includes an offloading aperture through the wound opening 12 or LRD to enclose the wound site, and the position and diameter of the aperture varies based on the representation of the wound or wound site. The wound opening can be formed by conventional stamping methods and can be provided in one or more standard locations (eg, a central location, a right location and / or a left location). If the opening of the LRD is specially formed or modified for a patient by a medical practitioner, the preferred method of forming or modifying is by a suitable cutting tool (eg, scalpel or scissors). In the illustrated embodiment, the LRD has a circular structure with an approximately 1 inch (25 mm) diameter aperture that extends through all three layers of material. It should be understood that the wound openings may be provided in other non-circular shapes and appropriate sizes to further assist wound healing. The aperture serves to offload the area around the ulcer. In addition, a rounded edge surrounding the aperture as in FIG. 15 is also provided to allow a smooth pressure transition from the supporting top buffer layer to the offloading aperture. This alleviates stress concentration at the aperture edge without exposing a harder layer of other LRD materials (eg, EVA). A round aperture edge is essentially a constant radius with a 5 mm cut.

  The load relief dressing of the present application can also be interchangeable between the feet and can be used on either the left foot or the right foot. This is because the rotation of the bandage can align the bandage with either foot pressure distribution and / or wound location. Further, the LRD 10 of the present application preferably consists of a plurality of material layers of foam material, where a particular layer consists of offloading or load reducing foam. Preferably, the LRD has a total thickness in the range of about 3-25 mm and the layers of material are laminated together. The preferred thickness of the LRD allows the patient to maintain a stable gait during walking, while allowing maximum offloading of pressure from the wound site during load bearing.

  The first layer 14 of the LRD is for interfacing with the surface of the plantar during load bearing, particularly to cushion the foot around the wound opening. The first buffer layer 14 is preferably a polyurethane foam material (e.g., a soft, supporting Poron (R) that is sufficient to limit the pressure that increases at the wound opening and within the bandage at the wound opening. Trademark) material). Other available shear-reducing gel materials (e.g., cloth-coated shear-reducing gels, Silipos Wonderflex silicone gel) can also be used to provide improved fit. Because the silicone layer reduces shear forces at the skin / LRD interface, it effectively reduces discomfort or irritation that can be perceived by the patient. The buffer layer 14 has a Shore A hardness of between 5 and 30 with a durometer. The thickness of the buffer layer 14 is between 0-12 mm, more preferably in the range of about 3-4 mm.

  A second offloading or load reducing layer 16 is engaged with the buffer layer 14 of the first material. The offloading layer 16 is of sufficient thickness and hardness to reduce plantar pressure at and around the wound site. Preferably, the harder material used for the offloading layer is an ethylene vinyl acetate foam material. The offloading layer 16 has a Shore A hardness of between 15 and 60 with a durometer. The thickness of the offloading layer 16 is between 0 and 12 mm. Acor Orthopedic, Inc., which is slightly harder than the other layers. From Microcel Puff® EVA or JMS Plastics Supply, Inc. A material such as Cloud EVA can be used to prevent the ulcer area from bottoming out. As illustrated in FIG. 3a, only the buffer layer 14 and the offloading layer 16 may be provided to the LRD.

  An optional third matching layer 18 is engaged with the offloading layer 16. Including a third matching layer provides several unexpected benefits. The third layer allows the thickness of the offloading layer 16 to be reduced. This is because the conforming layer 18 also provides pressure offloading at the wound site. As a result, LRD provides equivalent pressure offloading, but is more flexible and is better adapted to the plantar surface. The conformable layer is sufficient material to provide a flexible interface with the contact surface (eg, floor, footbed or other footgear) engaged by the foot during load bearing or during walking As a result, it provides better traction while walking. The material of the conforming layer 18 is sufficient to conform to the surface of the foot during load bearing conditions during load bearing to provide offloading of additional pressure from the wound. The conforming layer reduces the impact stress during load bearing and maintains or restores its dimensional properties under non-loading conditions, which returns to its original shape with respect to the number of load bearing cycles applied Means that. In the illustrated example of FIGS. 14 and 20a, the lower contoured portion or edge 200 of the matching layer of the LRD is 3-20 mm to about 10-14 mm, more specifically 15 mm to 12.7 mm. With an elliptic quadrant Q. This contour provides a more streamlined fit when the LRD is pressed into memory foam or other material of the footbed. The material used for the conforming layer comprises a polyurethane foam material with a durometer of 5-30 Shore A hardness and has a thickness of 0-12 mm. In a preferred embodiment, a viscoelastic material (eg, a very hard Poron® with slow recovery) is used to improve the overall flexibility of the LRD and its deformation under load bearing conditions. Can be used to increase traction during walking.

  As shown in FIGS. 4a, 4b, and 4c, the thickness of the individual layers can be varied to obtain the desired configuration that maximizes the pressure for a particular patient. The preferred optimum thicknesses illustrated in FIG. 4a are, for example, buffer layer 14: about 3 mm, offloading layer 16: about 6 mm, and matching layer 18: about 3 mm.

  A further optional adhesive layer (s) 20 may also be provided on the surface of the buffer layer to secure engagement with the LRD foot. Peel-off double-sided tape or other medically suitable adhesives (e.g. DuoDerm <(R)>, Tegasorb <(R)>, Allevyn <(R)> by ConvaTec) can all be used. In FIGS. 5a and 5c, the LRD prior to removal of the peel-off adhesive backing 22 is illustrated. FIG. 5 b illustrates an LRD in which the peel-off backing is removed, but the remaining adhesive portion 24 covers the wound opening 24. Such application may be desirable when the adhesive layer applied to the skin on the wound is an exudate absorber (eg, Versiva® by ConvaTec). 5c and 5d, the illustrated LRD has an adhesive layer 20, which also includes a wound opening 12 therethrough. FIGS. 7 a and 7 b illustrate an LRD applied to a patient's foot using an adhesive layer and the wound opening 12 is aligned on the wound W. FIGS. In FIG. 7c, the LRD is further secured to the foot using a self-adhesive wrap or other bandage, although it will be appreciated that other attachment mechanisms may be used.

  In the LRD illustrated in FIG. 6, an occlusive membrane layer 26 is provided between the buffer layer 14 and the offloading layer 16. As shown in FIG. 6, a “well” or cavity 28 is formed in the wound opening and membrane layer 26 to support the desired wound healing treatment. In the embodiment of FIG. 6, an Aquacel® wound dressing by ConvaTec is provided in the well 28. Various therapies (eg, antibiotics, antibacterials, growth factors and cell-based therapies and other exudate absorbers) can be placed in the well and delivered to the wound. This can be achieved by integration of the membrane layers in the bandage 10 or by custom packing of the LRD wound opening 12 by a medical practitioner.

  Additional alternative embodiments of membrane layer 26 'can also be provided as in Figs. In this embodiment, the membrane layer 26 ′ is a section of wound contact material (eg, Tegapore® available from 3M), which is in particular in contact with the open wound and optionally Thus, it is contemplated that drainage from the wound will pass through the absorbent. This membrane layer 26 'is strong enough to support the skin surrounding the wound, but the engagement of the skin does not apply a significant amount of pressure to the wound. Such wound contact materials are also permeable, which allows the wound to be viewed during and after application of the LRD. In the embodiment of FIG. 18, the membrane layer 26 ′ is a circular section with a diameter of about 50 mm, which is between the top buffer layer 14 and an additional attachment mechanism in the form of a strap or dorsal anchor strap 202. Glue firmly.

  As shown in FIGS. 17, 19 and 20 a, the anchor strap 202 provides an extension of the skin adhesive layer 20, which crosses the boundary of the buffer layer 14 of the LRD 10 in both the central and lateral directions. Elongate. The LRD 10 is glued to the dorsal anchor strap 202, which wraps the side of the foot and includes an adhesive for attachment to the dorsal surface D as in FIG. 20b. The strap is preferably a nylon woven fabric material that is laminated with an acrylic skin adhesive that forms an adhesive layer 20. The use of an attachment mechanism such as anchor strap 202 provides additional contact areas for adhesion to maintain LRD 10 in place. As further illustrated in FIG. 19, an additional adhesive layer 20 'on the anchor strap provides improved adhesion for securing the LRD to the bottom surface of the foot. In a preferred embodiment, the adhesive layer 20 'is a DuoDERM® CGF adhesive product from ConvaTec. As best shown in FIG. 16, the top portion of the adhesive layer 20 ′ contacts the skin (once the release liner is removed) and the opposing surface is adhered under the anchor strap 202.

  The manufacture of the LRD of the present application includes laminating the desired foam materials in the desired order to achieve the preferred thickness. A preferred laminate adhesive comprises a versatile cement (eg, Duall-888 from RH Products, Inc.). The foam layer can then be machined to the desired external geometry to form the previously described wound opening 12. The adhesive layer (s) 20, 20 'or other attachment mechanism for securing the LRD to the foot can then be applied. Finally, any desired wound healing treatment can be incorporated into the bandage.

(Footbed and wound healing system)
Figures 8a-8d and 21 illustrate an improved footbed of the present application. Although the use of LRD alone is intended and provides additional wound healing, typical wound healing practices generally include a protective insole and associated footgear. However, the effectiveness of such footgear depends on patient compliance while the risk of trauma to the wound site is higher. In this application, a preferred embodiment of an improved LRD is provided for use in an improved footbed.

  In the improved footbed 30 of the present application, a material layer is provided that is thick enough to allow the LRD to automatically fit or mold the footbed. Have A layer of material may also be provided that provides a hard support for the plantar surface that is not engaged with the LRD. The footbed of the present application is properly placed on the foot and reduces the LRD shift relative to the wound site as shown in FIG. 9b. The external geometry of the footbed is configured to engage within any desired outer footgear.

In preferred embodiments of the present application, three or four material layers are provided. In the three-layer embodiment of FIG. 8a, a top layer 32 is provided for engagement with the LRD 10 (as shown in FIG. 9a), the top layer 32 is made of polyurethane material or PPT and is about 1 mm to 6 mm thick, preferably the top layer of the footbed is 1.5 mm support cell urethane (eg, Poron® from Rogers Corp.) which adds cushioning and shock absorption. Help, top layer 32;
The middle layer 34 is a middle layer 34 having a “landing zone” portion 36, usually in the front region of the foot of the footbed, where the LRD is pressed into the landing zone in the front region of the foot under load. Preferably available from Tempur-pedic® or Tempur-Med® suppliers to automatically fit or mold around the LRD 10 when supporting the rest of the foot Or viscoelastic materials or Rubberlite Inc. A viscoelastic polyurethane product such as Visco-CEL V0570 available from is used. The landing zone of the intermediate layer is preferably made of a material that can be compressed to a thickness that allows the surface of the foot to which the LRD is secured to be at a level having approximately the surface of the footbed. As a result, the LRD and footbed provide a surface that allows normal walking gait and equally supports the foot in load bearing and non-load bearing sections. The intermediate layer is an intermediate layer 34 having at least the same thickness as the LRD, or a thickness between 10 mm and 30 mm, more preferably about 19 mm to 20 mm;
The bottom layer 38 is made of a more rigid material (eg, an ethylene vinyl acetate (“EVA”) material) and provides a thickness of about 1 mm to 6 mm to provide a rigid and strong surface to support the footbed 30. That is the bottom layer 38. As a result, the total footbed thickness can range from 12 mm to 42 mm, preferably about 30 mm.

  In the four material embodiments of FIGS. 8b, 8c and 8d and FIG. 21, a support zone portion or heel portion 40 of a somewhat hard material (eg, EVA), an extra hard memory foam such as Plasizote, or EVA and A combination with a viscoelastic material may also be provided as part of the intermediate layer 34. As shown in FIGS. 8b and 8d, the landing zone portion 34 is provided with a support zone that supports other areas of the foot that are not engaged with the LRD 10 in the area of the foot where the wound is present. The use of such materials in the support zone portion 40 provides better heel support and a self-fit heel cup over time.

  As shown in FIG. 9 c, the landing zone 36 of the top layer 32 and the intermediate layer 34 fits or molds around the LRD 10. As shown, the combination of the LRD 10 in the foot bed 30 serves to reduce or offload the pressure of the wound W during load bearing, which includes the indentation I and the recess I formed in the foot bed 30 by the LRD. The wound opening 12 can be seen by a relief section R located in the LRD adjacent to the wound. The manufacture of the improved footbed of the present application includes laminating the desired material layers in the desired order to achieve the preferred thickness and properties. Alternatively, the layers of material can be projected or cut together and glued together to form the desired pattern in the intermediate layer 34.

  The improved LRD 10 of the present application can also be used with many conventional footbeds. As shown in FIG. 11, the LRD 10 is used with a Don Joy footbed 30 'having two material layers. In FIG. 12, the LRD 10 is shown engaged with a Royce Medical insole 30 ″ having a hexagonal plug 31 in the insole that is removed to conform to the external geometry of the LRD 10. Further, if a commercially available single layer footbed is used, a thermoforming material such as Plasizote (not shown) may be used with the present LRD 10.

  An improved foot bed 30, LRD and foot gear 44 combination, or wound healing system 42 of the present application is shown in FIGS. 10a, 10b, 21 and 22. FIG. Preferably, the improved footbed 30 and improved LRD 10 combination used within a suitable footgear 44 provides an improved wound healing system 42 for significantly reducing plantar pressure at the wound site. To do. FIG. 22 illustrates a wound medical shoe available from Darco for offloading the area of the foot to be treated. This type of footgear provides the depth needed to securely accommodate the footbed 30. There is also sufficient padding inside the shoe to protect the patient's foot. The use of such shoes, while other prior art, adds the compatibility and freedom to support increased patient compliance when compared to the more cumbersome pedestrian boot footgear. Such a footgear may include a rocker outsole for pressure relief at the front of the foot.

  While embodiments of the present invention have been described in detail herein, those skilled in the art will recognize that various modifications and alternatives may be developed in view of the entire teachings of the present disclosure. As a result, these arrangements are exemplary only and are not intended to limit the scope of the invention given by any equivalent and all equivalents.

FIG. 1 illustrates a perspective view of one of the improved LRD embodiments of the present application. 2a-2b illustrate samples of pressure distribution on various areas of the foot during load bearing (eg, walking) FIGS. 3a-3c illustrate schematic perspective views of the improved LRD of the present application for the metatarsal head region, heel region, and thumb region, respectively. 4a-4c illustrate a side view of an improved LRD having various thicknesses in various layers. Figures 5a to 5d illustrate the surface of an improved LRD for engagement with a foot having an adhesive layer; 5a to 5b have a covered wound opening and 5c to 5d are open With a wound opening. FIG. 6 illustrates a partial perspective view of a wound opening having a membrane layer formed between LRD layers and forming a well having exudate absorbing material supported therein. 7a-7c illustrate a bottom view of a patient's foot supporting the LRD of the present application, a side view of the foot, and a view of a wrapped foot. 8a-8d illustrate perspective views of various embodiments of the improved footbed of the present application. FIGS. 9a-9c illustrate the use of an improved footbed with an improved LRD, where FIG. 9a shows the approximate location of the improved LRD relative to the footbed in use. FIG. 9b shows the use of an improved footbed where the patient's foot is engaged with the wrapped improved LRD, with the landing zone portion conforming to the LRD. FIG. 9c shows the memory characteristics of the material used for the landing zone portion of the LRD. Figures 10a-10b show a wound healing system with an improved LRD and an improved footbed on a patient's foot in a conventional footgear. FIGS. 11a and 11b illustrate the use of the improved LRD of the present application used with one embodiment of a commercially available insole. Figures 12a and 12b illustrate the use of an improved LRD used with another embodiment of a commercially available insole. FIG. 13 illustrates an alternative embodiment of an improved LRD showing a top buffer layer having an asymmetric configuration. FIG. 14 illustrates a side view of an improved LRD having a contoured surface in the conforming layer. FIG. 15 is a perspective view of an improved LRD wound opening having a rounded aperture edge. FIG. 16 is a perspective view of an alternative embodiment of an improved LRD having an attachment mechanism in the form of an anchor strap for securing the LRD to the foot. FIG. 17 illustrates an improved LRD with an anchor strap. FIG. 18 is a partial cross-sectional view of an improved LRD having a membrane layer secured over a round aperture wound opening. FIG. 19 is a top view of the improved LRD of FIG. 16 with the peel-off adhesive removed with the backing removed and ready for application. FIG. 20a illustrates a bottom view of the improved LRD of FIGS. FIG. 20b illustrates the improved LRD of FIG. 20a secured to the foot. FIG. 21 illustrates a four material footbed of the present invention. FIG. 22 illustrates a footgear for use in connection with the present invention.

Claims (24)

A load relief dressing for transferring pressure out of a patient's foot wound, the load relief dressing comprising:
A wound opening formed through the bandage to surround the wound site;
A first layer of the bandage for interfacing and cushioning a foot during load bearing, wherein the first layer is at and adjacent to the wound opening A first layer of material sufficient to limit the pressure increasing in the bandage;
An offloading layer engaged with the first layer of material that is sufficiently thick and stiff to reduce pressure at the wound site;
A conforming layer of material sufficient to provide a flexible interface with the contact surface engaged with the offloading layer and engaged by the foot during load bearing, To adapt to the surface of the foot during load conditions, to provide further offloading of pressure from the wound during load bearing, to reduce impact stress during load bearing, and non-resistant A load-reducing dressing with a conforming layer that is sufficient to maintain dimensional characteristics under load conditions. A load relief dressing for transferring pressure out of a patient's foot wound, the load relief dressing comprising:
A wound opening formed through the bandage to surround the wound site;
A first layer of the bandage for interfacing and cushioning a foot during load bearing, wherein the first layer is at and adjacent to the wound opening A first layer of material sufficient to limit the pressure increasing in the bandage;
An offloading layer comprising an offloading layer engaged with the first layer of material that is sufficiently thick and stiff to reduce pressure at the wound site.   3. The first layer of claim 1 or claim 2, wherein the first layer further supports an attachment mechanism disposed intermediate the first layer and the patient's foot for securing the load relief bandage to the foot. Load-reducing bandage.   The load relief dressing according to claim 1 or claim 2, wherein the dressing has a geometry that is substantially adapted to the pressure distribution of the patient's foot during load bearing.   The load relief dressing according to claim 4, wherein the wound opening may be placed through any portion of the dressing to properly surround the wound site.   3. The load reducing bandage according to claim 1 or claim 2, wherein the bandage has a leaflet geometry.   3. A load reducing bandage according to claim 1 or claim 2, wherein the bandage has a geometric shape that is substantially oval in structure.   The membrane layer further comprising a membrane layer disposed between two adjacent layers of the dressing, wherein the membrane layer supports a wound healing treatment material at a location adjacent to the wound to promote wound healing. 5. The load reducing bandage according to 5.   The load relief dressing according to claim 5 or 8, further comprising a membrane layer disposed over the wound opening of the dressing, wherein the membrane layer provides support to a skin surface surrounding the wound.   The load relief dressing according to claim 3, wherein the attachment mechanism comprises one or more adhesive layers.   The load relief dressing according to claim 3, wherein the attachment mechanism comprises a strap for enclosing the patient's foot. A load relief dressing for transferring pressure out of a patient's foot wound, the load relief dressing comprising:
A wound opening formed through the bandage to surround the wound site,
The bandage substantially engages the surface of the patient's foot that supports the pressure distribution of the patient's foot during load bearing,
The bandage has a shape that substantially conforms to the shape of the pressure distribution of the foot during such load bearing,
The wound opening can be placed anywhere within the bandage to properly surround the wound site,
Load-reducing bandage. A wound healing system for healing a wound on a patient's foot, the wound healing system comprising:
A load relief bandage to be attached to an area of the foot near the wound, whereby the load relief bandage provides support to the foot of the area and reduces the load on the wound; And a load relief dressing comprising a wound opening surrounding the wound;
A footbed for engagement with a patient's foot having the load relief bandage, the footbed having a base portion and a landing zone portion, the landing zone portion being in contact with the load relief dressing For engagement, having a thickness approximately equal to or greater than the thickness of the load relief bandage, and sufficiently compressible to fully fit the load relief bandage during load bearing A wound healing system comprising a material, wherein the base portion supports the landing zone portion and provides a rigid base for supporting the patient during load bearing.   The wound healing system of claim 13, wherein the footbed is engaged in a footgear worn by a patient.   The landing zone portion of the footbed is substantially disposed within a head region of a metatarsal bone of a patient's foot, the landing zone portion being secured to the landing zone portion and proximal to the landing zone portion. And / or disposed near a support zone portion located at the distal end, the support zone portion being made of a hard material to support a portion of the foot and not engaged with the load relief dressing; 14. A wound healing system according to claim 13, wherein the base portion supports the landing zone portion and the support zone portion. An improved footbed for transferring pressure out of a patient's foot wound,
Material that has a flat surface that is adapted to be under the foot and is hard enough to support the footbed in a suitable footgear or to engage the floor by the patient during load bearing With a base part consisting of
The base portion supports a landing zone portion thereon, the landing zone portion being for engagement with a load relief bandage that is engaged by a patient's foot and approximately equal to the thickness of the load relief bandage Or made of a material that has a thickness greater than the thickness and is sufficiently compressible to fully fit the load relief dressing during load bearing,
The base portion supports a support zone portion, and the support zone portion is arranged to surround the landing zone portion to support a portion of a patient's foot that is not engaged with a load relief bandage. ,
Improved footbed.   The improved footbed of claim 16, wherein the landing zone portion comprises a viscoelastic foam material. A load relief dressing for transferring pressure out of a patient's foot wound, the load relief dressing comprising:
A wound opening formed through the bandage to surround the wound site,
The bandage substantially engages the surface of the patient's foot that supports the pressure distribution of the patient's foot during load bearing,
The bandage has an external shape that substantially conforms to the shape of the pressure distribution of the foot during such load bearing,
The dressing has a first layer for interfacing with the foot during load bearing and cushioning the foot, the first layer within the dressing near the wound opening and the wound opening. Made of enough material to limit the pressure increasing at
The bandage is made of a material that is thick and stiff enough to reduce pressure at the wound site and to provide a flexible interface with the contact surface engaged by the foot during load bearing A base layer that conforms to the surface of the foot during load bearing conditions, provides additional offloading of pressure from the wound during load bearing and reduces impact stress during load bearing , Maintain dimensional characteristics under non-load bearing conditions,
Load-reducing bandage.   19. The first layer further supports one or more adhesive layers disposed intermediate the first layer and a patient's foot to secure the load relief bandage to the foot. Load-reducing bandage.   19. The load relief dressing of claim 18, wherein the dressing is replaceable and can be used on either the patient's right foot or the patient's left foot.   19. A load reducing bandage according to claim 18, wherein the bandage has a leaflet geometry.   19. A load reducing bandage according to claim 18, wherein the bandage has a geometric shape that is substantially oval in structure.   19. The membrane layer further comprising a membrane layer disposed between two adjacent layers of the bandage, wherein the membrane layer supports a wound healing treatment material at a location adjacent to the wound to promote wound healing. The described load-reducing bandage.   23. A load reducing dressing according to claim 18 or claim 22, further comprising a membrane layer disposed over the wound opening of the dressing, the membrane layer supporting a skin surface surrounding the wound.

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