SYSTEMS, METHODS AND DEVICES FOR PREVENTING TISSUE DAMAGE

Abstract

A sensor interface device (e.g., orthotic device or immobilization device) is disclosed. More specifically, described is an individualized sensor device and system to prevent tissue damage resulting from, for example, pressure, torsion, temperature, shear, altered blood flow, reduced oxygen tension, pH levels, tissue conductivity, tissue viscoelasticity, infection and sweat chloride levels. In particular embodiments, the systems, devices and related methods are used for preventing ambulation and mobility related plantar tissue related damage and immobilizing tissues.

Claims

1. A sensor interface device comprising a skin-contact surface configured for engagement with a subject's skin, wherein the skin-contact surface is configured to a) measure skin-contact variables within a subject's skin or on a subject's skin engaged with the skin-contact surface, wherein the skin-contact variables are selected from pressure, torsion, shear, temperature, blood flow, oxygen tension, pH levels, tissue turgor, hydration, skin compliance, skin conductivity, tissue viscoelasticity, presence of offending microorganisms, contaminants, noxious materials, chemicals, and sweat constituents, and chloride levels; and b) identify regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing altered levels of said variables through a comparing of measured skin-contact variables with established norms for such measured skin-contact variables, wherein the established norms for such measured skin-contact variables are no risk for tissue damage, risk for experiencing tissue damage, and experiencing tissue damage; and c) implement a change within the structure of the skin-contact surface upon identification of a region within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing altered levels of said variables, wherein such an implemented change within the structure of the skin-contact surface is configured to ameliorate said altered variable within the identified region.

2. The sensor interface device of claim 1, further comprising one or more sensors configured to measure skin-contact variables within a subject's skin engaged with the skin-contact surface.

3. The sensor interface device of claim 2, wherein the one or more sensors are each configured to measure pressure, temperature, blood flow, oxygen tension, pH levels, tissue fluid, tissue conductivity, tissue viscoelasticity and sweat chloride levels within a subject's skin engaged with the skin-contact surface.

4. (canceled)

5. The sensor interface device of claim 1, further comprising a processor, wherein the processor is used for the comparing of measured skin-contact variables with established norms for such measured skin-contact variables occurs and the identification of regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage.

6. The sensor interface device of claim 5, wherein the processor utilizes one or more algorithms for such comparing of measured skin-contact variables with established norms for such measured skin-contact variables occurs and the identification of regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage.

7. The sensor interface device of claim 6, wherein the one or more algorithms are configured to a) receive the measured skin-contact variables obtained with the skin-contact surface, b) compare the received measured skin-contact variables with established norms for such measured skin-contact variables occurs, c) identify regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage based upon the comparison of the received measured skin-contact variables with established norms for such measured skin-contact variables occurs, and d) direct the skin-contact surface to implement a change within the structure of the skin-contact surface upon identification of a region within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage, wherein such an implemented change within the structure of the skin-contact surface is configured to ameliorate tissue damage within the identified region.

8-10. (canceled)

11. The sensor interface device of claim 10, wherein the particular subject population is a subject population having either type 1 or type 2 diabetes, a subject with compromised vascularity, a war fighter, or an athlete.

12. The sensor interface device of claim 10, wherein the particular subject population is a subject population experiencing compromised vascularity, atherosclerosis, and/or sensation.

13. The sensor interface device of claim 1, wherein if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region within the subject's skin engaged with the skin-contact surface as experiencing pressure within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that pressure on the skin of the subject is redistributed from the region within the subject's skin identified as experiencing pressure within the established norm for risk for experiencing tissue damage or experiencing tissue damage.

14. The sensor interface device of claim 1, wherein if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region within the subject's skin engaged with the skin-contact surface as experiencing a temperature within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is a change in temperature of the skin-contact surface such that the temperature on the skin of the subject is changed within the subject's skin identified as experiencing a temperature within the established norm for risk for experiencing tissue damage or experiencing tissue damage.

15-16. (canceled)

17. The sensor interface device of claim 1, wherein if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region within the subject's skin engaged with the skin-contact surface as experiencing blood flow within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that blood flow at the region within the subject's skin identified as experiencing blood flow within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

18. The sensor interface device of claim 1, wherein if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region within the subject's skin engaged with the skin-contact surface as experiencing oxygen tension at or above the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that oxygen tension at the region within the subject's skin identified as experiencing oxygen tension, inflammation or change in temperature within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

19. The sensor interface device of claim 1, wherein if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region within the subject's skin engaged with the skin-contact surface as experiencing pH at or above the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that pH at the region within the subject's skin identified as experiencing pH within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

20. The sensor interface device of claim 1, wherein if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region within the subject's skin engaged with the skin-contact surface as experiencing sweat chloride levels within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that sweat chloride levels at the region within the subject's skin identified as experiencing sweat chloride within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

21-23. (canceled)

24. The sensor interface device of claim 1, wherein the device is an article of clothing or a section thereof, a patch, bandage, wrap, shawl, stocking, sock, glove, hat, bed sheet, blanket, mattress, bed, seat, seat cushion, or pad.

25. (canceled)

26-28. (canceled)

29. The sensor interface device of claim 1, wherein the implemented change within the structure of the skin-contact surface is localized or systemic vibration, change in temperature, massage, pressure, or tension, localized or systemic electrical stimulation, or localized or systemic re-alignment.

30-32. (canceled)

33. The sensor interface device of claim 1, wherein said device comprises a plurality of detection zones.

34-68. (canceled)

69. A system, comprising a sensor interface device of claim 1 and a processor.

70-75. (canceled)

76. An orthotic device comprising a skin-contact surface configured for engagement with a subject's skin, wherein the skin-contact surface is configured to a) measure skin-contact variables within a subject's skin or on a subject's skin engaged with the skin-contact surface, wherein the skin-contact variables are selected from pressure, torsion, shear, temperature, blood flow, oxygen tension, pH levels, tissue turgor, hydration, skin compliance, skin conductivity, tissue viscoelasticity, presence of offending microorganisms, contaminants, noxious materials, chemicals, and sweat constituents, and chloride levels, wherein said skin is on at least a portion of the subject's foot; and b) identify regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage through a comparing of measured skin-contact variables with established norms for such measured skin-contact variables, wherein the established norms for such measured skin-contact variables are no risk for tissue damage, risk for experiencing tissue damage, and experiencing tissue damage; and c) implement a change within the structure of the skin-contact surface upon identification of a region within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage, wherein such an implemented change within the structure of the skin-contact surface is configured to ameliorate tissue damage within the identified region.

77-81. (canceled)

Description

DESCRIPTION OF THE DRAWINGS

[0022] FIG. 1 shows an exemplary device of embodiments of the present invention. FIG. 1A shows a construct (sensor device) without a sensor. FIG. 1B shows a construct with a sensor. FIG. 1C shows a sensor device with a plurality of zones without sensors. FIG. 1D show a sensor device with a plurality of zones with sensors.

[0023] FIG. 2 exemplary methods steps of a sensor device of embodiments of the present invention. FIG. 2A shows a baseline before measurement of parameters. FIG. 2B shows identification of a region determined to be at risk. FIG. 2C shows identification of regions that react to modify or relieve risk. FIG. 2D shows a cross sectional view of an exemplary sensor device with identification of a region at risk and removal or pressure in regions at risk.

[0024] FIG. 3 shows an exemplary orthotic device of embodiments of the present invention. FIG. 3A shows a construct (orthotic device) without a sensor. FIG. 3B shows an orthotic device with a sensor. FIG. 3C shows an orthotic device with a plurality of zones without sensors. FIG. 3D show an orthotic device with a plurality of zones with sensors.

[0025] FIG. 4 exemplary methods steps of an orthotic device of embodiments of the present invention. FIG. 4A shows a baseline before measurement of parameters. FIG. 4B shows identification of a region determined to be at risk. FIG. 4C shows identification of regions that react to modify or relieve risk. FIG. 4D shows a cross sectional view of an exemplary orthotic device with identification of a region at risk and removal or pressure in regions at risk.

DETAILED DESCRIPTION OF THE INVENTION

[0026] A sensor interface device (e.g., orthotic device or immobilization device) is disclosed. More specifically, described is an individualized sensor device and system to prevent tissue damage resulting from, for example, pressure, torsion, temperature, shear, altered blood flow, reduced oxygen tension, pH levels, tissue conductivity, tissue viscoelasticity, infection and sweat chloride levels. In particular embodiments, the systems, devices and related methods are used for preventing ambulation and mobility related plantar tissue related damage and immobilizing tissues.

[0027] The present invention addresses this need.

Definitions

[0028] As used herein, the terms sensor interface device and sensor devices refer to devices that sense one or more variables (e.g., pressure, torsion, shear, temperature, blood flow, oxygen tension, pH levels, tissue turgor, hydration, material properties (e.g., compliance, conductivity, tissue viscoelasticity, presence of offending microorganisms, contaminants, noxious materials, chemicals, and sweat constituents, chloride levels) detected in skin or tissue (e.g., at the interface of the device and a surface of the skin or tissue) and identify regions that have levels of the variable outside of a normal or desired range (e.g., determined by an established norm). In some embodiments, sensor devices react to a level of a variable outside of the normal range and correct the level of the variable to a normal or desired range. In some embodiments, correcting the level of the variable treats or prevents a complication of a disease or condition.

[0029] As used herein, the term orthotic device refers to a sensor device designed to be used on a bottom surface of a foot (e.g., inserted in a shoe).

[0030] As used herein, the term established norms for such measured skin-contact variables refers to a normal or desired value of a variable measured using a device described herein. In some embodiments, the established norm are determined based on the average or typical value for a specific subject or a population average (e.g., for a general population or a specific population including the subject).

I. Sensor Technology

[0031] Provided herein are sensor devices and uses thereof. Exemplary devices are shown in FIGS. 1-4.

[0032] FIG. 1A shows construct (sensor device) 1 without sensor. FIG. 1B shows a sensor device with sensor 2. FIG. 1C-D shows an exemplary sensor device 1 comprising regions 3, without (1C) and with (1D) sensors 2.

[0033] FIG. 2A-D shows an exemplary sensor device 1 in use. In FIG. 2A, sensor device 1 with regions 3 and sensors 2 is shown at baseline (e.g., prior to use). FIG. 2B shows detection of region 4 at risk of damage. FIG. 2C shows regions 5 that react to modify the region at risk and prevent damage. FIG. 2d shows a cross-section view of sensor device 1 showing region at risk 4.

[0034] FIG. 3A shows construct (orthotic device) 6 without sensor. FIG. 6B shows an orthotic device 6 with sensor 2. FIG. 3C-D shows an exemplary orthotic device 6 comprising regions 3, without (3C) and with (3D) sensors 2.

[0035] FIG. 4A-D shows an exemplary orthotic device 6 in use. In FIG. 4A, orthotic device 6 with regions 3 and sensors 2 is shown at baseline (e.g., prior to use). FIG. 4B shows detection of region 4 at risk of damage. FIG. 4C shows regions 5 that react to modify the region at risk and prevent damage. FIG. 4D shows a cross-section view of orthotic device 6 showing region at risk 4.

[0036] In particular, the devices of the present invention provides sensor (e.g., orthotic) devices comprising a skin-contact surface configured for engagement with a subject's skin or outer envelope tissue surface, wherein the skin-contact surface is configured to a) measure variables detectable at the device-skin/tissue interface, (both on the skin and within the skin) either singly or in combination, of a subject's skin engaged with the skin-contact surface, wherein the skin-contact variables are selected from pressure, torsion, shear, temperature, blood flow, oxygen tension, pH levels, tissue turgor, hydration, material properties (e.g., compliance, conductivity, tissue viscoelasticity, presence of offending microorganisms, contaminants, noxious materials, chemicals, and sweat constituents, chloride levels; b) identify regions on or within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage through a comparing of measured skin-contact variables with established norms for such measured skin-contact variables, wherein the established norms for such measured skin-contact variables are no risk for tissue damage, risk for experiencing tissue damage, and experiencing tissue damage; and c) implement a change within the structure of the skin-contact surface upon identification of a region within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage, wherein such an implemented change within the structure of the skin-contact surface is configured to ameliorate tissue damage within the identified region.

[0037] Such devices are not limited to a particular manner of measuring skin-contact variables. In some embodiments, the devices further comprise one or more sensors configured to measure extent of skin contact, degree of conformality, skin-contact variables on or within a subject's skin engaged with the skin-contact surface. The present invention is not limited to particular types or kinds of sensors. In some embodiments, the one or more (e.g., 2, 3, 4, 5, 10, 20, 50, 100, 1000, or more) sensors are each configured to measure pressure, temperature, shear, torsion, blood flow, oxygen tension, pH levels, microbial contamination, chemical contamination, tissue material properties, tissue conductivity, tissue viscoelasticity, sweat chloride and other sweat constituent levels on or within a subject's skin engaged with the skin-contact surface. In some embodiments, the one or more sensors are separately configured to measure pressure, temperature, shear, torsion, blood flow, oxygen tension, pH levels, microbial contamination, chemical contamination, tissue material properties, tissue conductivity, tissue viscoelasticity and sweat chloride and other sweat constituent levels within a subject's skin engaged with the skin-contact surface.

[0038] Other types of sensors may be used in addition to, or in place of, those described. For example, GPS sensors, microelectromechanical systems (MEMS) sensors, geomagnetic sensors, accelerometers, gyroscopes, or other types of sensors may be employed to provide movement or kinematic information that is unavailable from, or that is redundant to, other sensors.

[0039] In some embodiments, sensors are commercially available from any number of vendors.

[0040] In some embodiments, the device is divided into regions ranging from a single zone to a multiplicity of zones (e.g., 4, 8, 16, 32, 64, 128, or another number of zones). In some embodiments, each zone contains a single or multiple array or group of sensors. In some embodiments, the sensors function individually or in groups, or in various combinations. In some embodiments, the sensors are multiplexed. The zones serve to measure one or more of the parameters described above in discrete regions (e.g., singly or in a multiplex format).

[0041] In some embodiments, zones comprise a single or multiple types of reactive elements or means, to alter the progression, ameliorate or change the ongoing tissue response to detected tissue from the sensors (described further below and in FIGS. 2 and 4).

[0042] In some embodiments, reactive elements include, for example, contained bladders to elevate and isolate an afflicted zone (e.g., a zone detected or determined via the sensing elements or other means to be at risk for tissue damage or causing pain or discomfort). Other means of reactive change include, but are not limited to, reactive polymeric, metallic or composite materials that change shape or configuration upon being activated and/or energized, e.g. swelling with heating, bending with heating or chemically changing form, electroactive polymers, thermoactive materials, and nitinol. Other means of reactivity, actuation and energizing include chemical means (e.g., reactions yielding physical material and compositional change; compressed gas, magnetic means, rehydration of a desiccated material or any other means to physically alter the configuration of a regions or regions of the construct). The net dominant effect of all means of actuation is to physically deform and alter the extent/degree of conformity of the orthotic device surface with the apposed tissue (e.g., plantar foot surface).

[0043] In some embodiments, the devices further comprise a processor or are in a system comprising a process, computer (e.g., tablet, laptop, smart phone), and/or display screen. Such embodiments are not limited to a particular type or kind of processor. In some embodiments, the processor is used for the comparing of measured skin-contact variables with established norms for such measured skin-contact variables occurs and the identification of regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage. In some embodiments, the processor utilizes one or more algorithms for such comparing of measured skin-contact variables with established norms for such measured skin-contact variables occurs and the identification of regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage.

[0044] In some embodiments, the processor and system can function for full or partial on board data storage, data processing and telemetry. In some embodiments, data is directly downloaded or sent via telemetry (e.g., via near field, blue tooth, nested loops, etc.) to a user.

[0045] Such embodiments are not limited to particular algorithms. For example, in some embodiments, the one or more algorithms are configured to a) receive the measured skin-contact variables obtained with the skin-contact surface, b) compare the received measured skin-contact variables with established norms for such measured skin-contact variables occurs, c) identify regions within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage based upon the comparison of the received measured skin-contact variables with established norms for such measured skin-contact variables occurs, and d) direct the skin-contact surface to implement a change within the structure of the skin-contact surface upon identification of a region within the subject's skin engaged with the skin-contact surface experiencing or at risk for experiencing tissue damage, wherein such an implemented change within the structure of the skin-contact surface is configured to ameliorate tissue damage within the identified region, e.g., containing a single or range of reactive element or means.

[0046] Such embodiments are not limited to a particular established norm. For example, in some embodiments, the established norms are specific for the subject. In some embodiments, the established norms are specific for a patient population at risk for tissue related damage (e.g., for the cyclistdefined stresse.g. time, pressure and temperature for a century ride or stage of a major race, for the diabetic population, individuals suffering from compromised vascularity, or the war fighter with extensive tissue stress (e.g., associated with a long march.). In some embodiments, the established norms are specific for athletes exerting high amounts of stress at a particular tissue region (e.g., bicyclists, runners, etc.). In some embodiments, the particular subject population is a subject population at risk for developing tissue damage resulting from one or more of pressure, temperature, shear, torsion, compaction, chemical or microbial contamination or exposure, altered blood flow, oxygen tension, pH levels, and sweat chloride and other constituents.

[0047] The devices of the present invention are not limited to particular implementation scenarios.

[0048] For example, in some embodiments, if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region on or within the subject's skin engaged with the skin-contact surface as experiencing pressure within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that pressure on the skin of the subject is redistributed from the region within the subject's skin identified as experiencing pressure within the established norm for risk for experiencing tissue damage or experiencing tissue damage.

[0049] In some embodiments, if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region on or within the subject's skin engaged with the skin-contact surface as experiencing a temperature within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is a change in temperature of the skin-contact surface such that the temperature on the skin of the subject is changed (e.g., increased or decreased) within the subject's skin identified as experiencing a temperature within the established norm for risk for experiencing tissue damage or experiencing tissue damage.

[0050] In some embodiments, if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region on or within the subject's skin engaged with the skin-contact surface as experiencing blood flow within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that blood flow at the region within the subject's skin identified as experiencing blood flow within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

[0051] In some embodiments, if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region on or within the subject's skin engaged with the skin-contact surface as experiencing oxygen tension at or above the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that oxygen tension at the region within the subject's skin identified as experiencing oxygen tension within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

[0052] In some embodiments, if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region on or within the subject's skin engaged with the skin-contact surface as experiencing pH at or above the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that pH at the region within the subject's skin identified as experiencing pH within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

[0053] In some embodiments, if the comparing of measured skin-contact variables with established norms for such measured skin-contact variables indicates a region on or within the subject's skin engaged with the skin-contact surface as experiencing sweat chloride levels within the established norm for risk for experiencing tissue damage or experiencing tissue damage, then the implemented change within the structure of the skin-contact surface is re-alignment of the skin-contact surface such that sweat chloride levels at the region within the subject's skin identified as experiencing sweat chloride within the established norm for risk for experiencing tissue damage or experiencing tissue damage is improved.

[0054] Similarly, the devices are not limited to a particular implemented change. In some embodiments, the implemented change within the structure of the skin-contact surface is localized or systemic vibration. In some embodiments, the implemented change within the structure of the skin-contact surface is localized or systemic undulation. In some embodiments, the implemented change within the structure of the skin-contact surface is localized or systemic electrical stimulation. In some embodiments, the implemented change within the structure of the skin-contact surface is localized or systemic re-alignment.

[0055] In some embodiments, the measuring, identifying and implementing occurs automatically. In some embodiments, the implementing occurs either automatically or manually.

[0056] In certain embodiments, the present invention provides systems comprising such an device and a processor. In some embodiments, the systems further comprise a visual display (e.g., a computer display, a smart phone, a smart tablet, etc.).

[0057] In certain embodiments, the devices are configured to store information obtained with the device.

[0058] In certain embodiments, the system has a display means to identify regions of the detected variable. In some embodiments, the display is physical (e.g., a small screen or hand held or wearable device or watch or virtual) telemetered or otherwise sent to a display device (e.g., computer, phone, watch or the like. In some embodiments, the display has the outline of the contacting surface, e.g. the sole of the foot. In some embodiments, regional information is displayed of single or multiple variables. In some embodiments, the ability to send back a signal to create change in surrounding regions, to an identified hot spot is described and is contained within the system. The system, as outlined above, is able to react in one or a multiplicity of zones, either automatically or manually.

II. Support and Orthotic Devices

[0059] In some embodiments, the sensor interface devices and systems described herein are utilized in a support or orthotic device. In some exemplary embodiments, the devices and systems described herein are used in the treatment and prevention of wounds.

[0060] As described above, the TCC is the gold standard for treating ulcers, however, very few people actually use the gold-standard TCC (fewer than 2% of patients receive the TCC as their primary means of offloading) (Wu, S. C., Jensen, J. L., Weber, A. K., Robinson, D. E. & Armstrong, D. G. Use of pressure offloading devices in diabetic foot ulcers: do we practice what we preach. Diabetes Care 31, 2118-2119 (2008)). In addition, The RCW offloads as well as the TCC in the lab (Lavery, L. A., Vela, S. A., Lavery, D. C. & Quebedeaux, T. L. Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcerations. A comparison of treatments. Diabetes Care 19, 818-821 (1996)) but the RCW does not heal people as well as the TCC in randomized studies (Armstrong, D. G. et al. Offloading the diabetic foot wound: a randomized clinical trial (Abstract). Diabetes 50, A76 (2001)). The RCW fails largely because people are not wearing the device (Armstrong, D. G., Lavery, L. A., Kimbriel, H. R., Nixon, B. P. & Boulton, A. J. Activity Patterns of Patients With Diabetic Foot Ulceration: Patients with active ulceration may not adhere to a standard pressure off-loading regimen. Diabetes Care 26, 2595-2597 (2003)). For this reason, embodiments of the present disclosure provide a technique to render the removable (Armstrong, D. G. et al. Technique for Fabrication of an Instant Total-Contact Cast for Treatment of Neuropathic Diabetic Foot Ulcers. J. Am. Podiatr. Med. Assoc. 92, 405-408 (2002)) RCW irremovable. These devices behave better than its removable counterpart and about as well as the gold standard (Katz, I. A. et al. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care 28, 555-559 (2005); Armstrong, D. G., Lavery, L. A., Wu, S. & Boulton, A. J. M. Evaluation of Removable and Irremovable Cast Walkers in the Healing of Diabetic Foot Wounds: a Randomized Controlled Trial. Diabetes Care 28, 551-554 (2005)).

[0061] While removable walkers rendered irremovable and TCCs appear to be useful techniques for managing this high-risk patient population, covering a wound in a neuropathic extremity (at high risk for amputation) for days or even weeks inspires neither confidence nor information to the clinician. There exist a body of evidence that indicates that tracking wound analytes such as inflammatory cytokines, temperature, pH and other materials are an effective means of identifying potential risk for wound deterioration and infection (Armstrong, D. G. & Giovinco, N. A. Diagnostics, theragnostics, and the personal health server: fundamental milestones in technology with revolutionary changes in diabetic foot and wound care to come. Foot Ankle Spec. 4, 54-60 (2011); Armstrong, D. G., Lew, E. J., Hurwitz, B. & Wild, T. The Quest for Tissue Repair's Holy Grail: The Promise of Wound Diagnostics or Just another Fishing Expedition. Wound Medicine).

[0062] Accordingly, in some embodiments, provided herein are improved devices and system that meet the unmet need for treating and preventing wounds. In some embodiments, the devices described herein allow easy access to wounds on the plantar surface of the foot without removal and reapplication of the entire device. The devices have added comfort, providing the immobilization of a TCC with a more universal outside shell or boot configuration that may be filled on an individual basis, like a mold-cast, to provide the TCC effect.

[0063] The wound may be any type of wound, or damaged area of tissue, and may include wounds from trauma, surgery, or other causes, such as a diabetic ulcer. The tissue site, which includes the wound, may be the bodily tissue of any human, animal, or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue. Treatment of the tissue site may include removal of fluids, e.g., exudate, or delivery of reduced pressure.

[0064] In some embodiments, devices immobilize the plantar surface for force (stress, i.e. force/area) distribution, while at the same time allowing for comfort of the distal leg and upper foot.

[0065] In some embodiments, devices (e.g., boots) comprise portals, windows or means for opening to allow access to the plantar surface of the foot, to the effected ulcer area, the adjacent area or any area of the foot/leg involved. The means for opening include, but are not limited to, multiple components of boot that attach together, e.g., a hinged system, screws, fasteners, a polymer window that is removed.

[0066] In some embodiments, devices comprise a drainage component to remove fluid, blood, exudate, sweat, other effluent, pus, etc. In some embodiments, devices incorporate a vacuum (e.g., negative or subatmospheric pressure means) to act as a wound vacuum.

[0067] In some embodiments, devices incorporate a pulsation component to mobilize edema, exudate and infiltrates. In some embodiments, pulsation is used independently or in a set synchromy with negative pressure. In some embodiments, pulsation adds the advantage of therapeutic vessel recruitment, remodeling and growth. The majority of wounds suffer from inadequate vascularization as a result of atherosclerosis or microvascular disease. Pulsation has been demonstrated to induce recruitment and growth of blood vessels, reducing ischemia, enhancing oxygenation and improving healing (18-24). In some embodiments, pulsation is global in the device (e.g., utilized with a defined or variable frequency or compartmentalized to regional domains in the device). This is termed local conditioning or precondition or reconditioning.

[0068] The devices described herein find use in feet and any other appendage (e.g., arm, etc.) or body part.

[0069] In some embodiments, the devices are orthotic devices. In some embodiments, orthotic devices are insoles, arch supports, etc. In some embodiments, the orthotic device is inserted into footwear. In some embodiments, an orthotic device is configured for contact with a subject's plantar region.

[0070] In some embodiments, the device is constructed of any suitable material (e.g., high density or ultra-high density memory foam, silicone, latex, neoprene, plastizote, Poron, ethylene vinyl acetate (EVA), polyethylene (PE) foam, polyurethane (PU) foam, polycarbonate, metal, etc.). In some embodiments, the device comprises structural and cushioning layers. In some embodiments, an anti-fungal, anti-microbial and anti-sweat top cloth may be laminated to the top layer of the device.

[0071] In some embodiments, the orthotic device is a part of a shoe, floor mat, carpet, and/or car seat. In some embodiments, the orthotic device is configured to be received within a shoe.

[0072] In certain embodiments, the present invention provides methods for preventing ambulation related tissue damage through use of an device (e.g., orthotic device) of the present invention through incorporation of such a device within the subject's shoes.

[0073] The devices described herein allow for protection of a tissue or body part while providing real-time feedback as to the status of a wound or other parameter. The present invention is not limited to the devices, systems, and methods described herein. Additional embodiments and uses are specifically contemplated.

[0074] All publications and patents mentioned in the above specification are herein incorporated by reference as if expressly set forth herein. Various modifications and variations of the described methods and compositions of the invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention that are obvious to those skilled in relevant fields are intended to be within the scope of the invention.