Method and apparatus for reducing tissue injury from prolonged mechanical contact reaction force countermeasures

Abstract

Provided herein are methods and apparatus for reducing tissue injury from prolonged mechanical contact reaction force countermeasures. In some embodiments, for example, devices are provided that comprise a load bearing support material that comprises one or more integrated elements disposed within one or more contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material, which integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on a user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

Description

METHOD AND APPARATUS FOR REDUCING TISSUE INJURY FROM PROLONGED MECHANICAL CONTACT REACTION FORCE COUNTERMEASURESCROSS-REFERENCE TO RELATED APPLICATONS

[0001] This application claims priority to, and the benefit of, U.S. Provisional Patent Application Ser. Nos. 63 / 639,580, filed April 26, 2024, the disclosure of which is incorporated herein by reference.BACKGROUND

[0002] Healthy living tissue, such as skin and associated underlying tissue below the skin, can become injured and oftentimes permanently damaged, deep tissue pressure injury, due to prolonged compression of skin and underlying tissue that leads to a reduction of blood flow in skin and underlying tissue. Given that blood flow is essential to deliver oxygen and other nutrients to tissues, a prolonged, stationary physical contact of the skin of humans and other mammals with load-bearing support structures that gives rise to mechanical contact reaction forces leads to a prolonged disturbance of homeostatic physiological control mechanisms of living tissue over an extended period of time that are necessary to maintain the healthy state of living tissue, i.e., tissue homeostasis a reduction in blood flow and tissue perfusion. Skin and tissue damage occurs most frequently among individuals who cannot reposition themselves often occurring among the elderly, those having limited mobility, or among persons with neurological deficits, such as those with spinal cord injury. The presence of external mechanical contact reactive forces that arise from stationary contact of a human with external load bearing structures, such as, occurs with humans with limited mobility that rely upon mobility devices, such as wheelchairs, and immobilized human subjects who are bedridden. For people with limited mobility, e.g., those who are wheelchair bound or bedridden, pressure sores, also known as pressure ulcers, pressure injuries, decubitus ulcers, and bed sores, commonly occur on areas of the skin that are typically located over hard bony tissue structures, such as, the hip, lower back, tailbone or buttocks, shoulder blades, elbows and heels. Pressure sores can develop as a result of pressure alone, or pressure combined with forces of friction and shear, and they can progress across different levels of severity based on depth of damage from mild tissue damage to necrosis. Pressure-induced tissue injuries of varying severity can have a negativeimpact on the quality of life of the affected individuals, strain healthcare organizational resources dealing with hospital-acquired pressure injuries and pose a significant financial burden on the healthcare system. Also, hospital-acquired pressure injuries strain healthcare organizational resources worldwide, increasing organizational cost of care and workload and negatively impact the quality of life of affected patients.

[0003] There are a number of treatments for pressure injuries based upon the severity of the pressure injury. These include changing the position of affected subjects and where possible, movement, the use of specially designed mattresses and cushions, dressings to protect the ulcer and help it heal, creams and ointments, antibiotics if the ulcer is infected and cleaning the ulcer.

[0004] To date, however, there exist only a limited number of technologies that are aimed to prevent pressure sores. These include continuous, low-pressure support surfaces that utilize more pressure-compliant, mattress pads and mattresses that help to relieve contact pressure on the skin that are intended to lower the risk of developing pressure ulcers. More advanced pressure sore prevention technologies include airfluidized beds, beds with sensing technology, and mattresses or overlays that alternate contact pressure by redistributing contact pressure that are automatically controlled by sensory feedback systems.

[0005] However, there exist no pressure sore prevention technology to date that have purposely exploited the use of a method and apparatus that provides direct countermeasures to mechanical contact reaction forces that can passively and actively reduce or eliminate prolonged contact pressure and internal stress risers that otherwise lead to contact pressure-induced tissue injury. The present disclosure represents such an approach.SUMMARY

[0006] In some aspects, the present disclosure relates to a pressure sore and ulcer prevention system that eliminates the prolonged contact induced pressures that compress the skin and underlying tissue leading to reduced blood flow that, otherwise, is essential to deliver oxygen and other nutrients to tissues. In some embodiments, the devices and related aspects disclosed herein eliminate prolonged skin contact with reaction forces which is a root cause of pressure sores. In some embodiments, thedevices of the present disclosure utilize passive and active integrated elements to prevent pressure sores from occurring by maintaining adequate blood flow in tissue. In some embodiments, contact reaction force reduction elements can be used with a wide range of support structures and medical needs. In some embodiments, integrated elements can be individually and collectively addressable from sensor feedback control. The subject matter of the present disclosure overcomes the limitations of current pressure sore prevention technologies and is also capable of restoring tissue blood perfusion and is compatible with wheelchair and bed support systems. These and other attributes of the present disclosure will be apparent upon a complete review of this specification, including the accompanying figures.

[0007] In some aspects, the present disclosure provides a device that includes a load bearing support material that comprises one or more integrated elements disposed within one or more contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material. The integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on a user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0008] In other aspects, the present disclosure provides a method of reducing tissue injury in a user. The method comprises positioning the user in one or more contact regions of a load bearing support material in which the load bearing support material comprises one or more integrated elements disposed within the contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material. The integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on the user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements.BRIEF DESCRIPTION OF DRAWINGS

[0009] The following detailed description of exemplary embodiments of the invention will be better understood when read in conjunction with the appended drawings. Itshould be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

[0010] FIG. 1 A is an image of a pressure sore.

[0011] FIG. 1 B depicts aspects of pathophysiology associated with tissue compression.

[0012] FIG. 1 C depicts the most at-risk areas of a user positioned on a mattress.

[0013] FIG. 2 depicts an exemplary reduced skin contact reaction force pressure system.

[0014] FIG. 3 depicts exemplary elements comprised of vacant holes located within a support system.

[0015] FIG. 4 depicts exemplary integrated elements within support structure in communication with suction system.

[0016] FIG. 5 depicts simulation of internal stress concentrations arising from simulated bony prominences.

[0017] FIG. 6 depicts stress concentration factors in excess of bulk loads arising from simulated U, Conic and V-shaped bony prominences.

[0018] FIG. 7 depicts effect of stress concentration risers due to bulk loads on experimental blood flow rate absent of any prominences and with U. Conic and V- shaped prominences.

[0019] FIG. 8 depicts effect of negative pressure on experimental flow rate under a 53 lb bulk load with integrated elements having vacant holes connected to a suction device.DEFINITIONS

[0020] In order for the present disclosure to be more readily understood, certain terms are first defined below. Additional definitions for the following terms and other terms may be set forth throughout the specification. If a definition of a term set forth below is inconsistent with a definition in an application or patent that is incorporated by reference, the definition set forth in this application should be used to understand the meaning of the term.

[0021] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.Thus, for example, a reference to “a method” includes one or more methods, and / or steps of the type described herein and / or which will become apparent to those persons skilled in the art upon reading this disclosure and so forth.

[0022] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Further, unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In describing and claiming the methods, systems, and devices, the following terminology, and grammatical variants thereof, will be used in accordance with the definitions set forth below.

[0023] About. As used herein, “about” or “approximately” or “substantially” as applied to one or more values or elements of interest, refers to a value or element that is similar to a stated reference value or element. In certain embodiments, the term “about” or “approximately” or “substantially” refers to a range of values or elements that falls within 25%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or less in either direction (greater than or less than) of the stated reference value or element unless otherwise stated or otherwise evident from the context (except where such number would exceed 100% of a possible value or element).DETAILED DESCRIPTION

[0024] The present disclosure relates to methods, devices, and systems that create / induce regions of reduced external contact reaction forces in the presence of a load transferred to a support structure, such as a mattress by the outer skin layer of a human or other user. The prolonged reduction of mechanical contact reaction forces created / induced by these methods, devices, and systems abates the compression of skin and underlying tissue, as well as, rises in internal stress concentrations of underlying tissue due to bony prominences which prevents the prolonged reduction of blood flow in tissues and subsequent pressure injuries to skin and pressure ulcers within living tissue.

[0025] In some embodiments, for example, the present disclosure provides a device or system that comprises a load bearing support material that comprises one or more integrated elements disposed within one or more contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material. The integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on a user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material. In some embodiments, the integrated elements comprise one or more distinct surface and bulk volumetric material features. To illustrate, FIG. 2 depicts an exemplary system according to some embodiments of the present disclosure. As shown, system 200 includes a load bearing support material (shown as a mattress) on which a user is positioned. As also shown, there are multiple integrated elements (depicted as voids or openings 208) disposed in the load bearing support material. Voids 208 communicate with channel 202, which in turn is operably connected to negative pressure source 204 (e.g., a vacuum pump). Negative pressure source 204 is configured to apply negative pressure to voids 208 when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material. In some embodiments, vacuum cups comprise voids 208. As also shown, pressure gauge 206 is operably connected to channel 202 to monitor the negative pressure applied at the voids 208.

[0026] In some embodiments, negative pressure source 204 is configured to continuously or intermittently apply negative pressure to voids 208 when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material. In some embodiments, negative pressure source 204 is configured to apply negative pressure to voids 208 in a range of about 1 mmHg to about 500 mmHg. In some embodiments, voids 208 comprise porous and / or non-porous material having bulk stress, compressive and shear (E, K,^ / ) moduli that produce reduced contact reaction forces relative to bulk moduli of the load bearing support material. In some embodiments, the voids passively exertminimal to no mechanical contact reaction forces on the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material. In some embodiments, the voids comprise diameters in a range of about 0.1 mm to about 10 cm. In some embodiments, the voids comprise depths in a range of about 0.1 mm to about 30 cm.

[0027] Typically, the contact regions of the load bearing support material are configured to substantially align with one or more bony prominences of the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material. The bony prominences of the user can include, for example, a heel, a sacrum, an elbow, a shoulder blade, a head, an ankle, a leg, a knee, a thigh, a greater trochanter, a hip, a shoulder, a ear, a face, a rib, and / or the like.

[0028] In some embodiments, the devices and systems of the present disclosure comprise a wearable apparatus, a self-contained unit, an article of furniture, or a portion thereof. In some embodiments, for example, the devices, systems, and other aspects disclosed herein can be directly or indirectly attached or otherwise worn by the user at specified anatomical locations, such as the high-risk locations depicted in FIG. 1 C. In some embodiments, the article of furniture or the portion thereof comprises a mattress fabricated from memory foam or the like. In some embodiments, the article of furniture or the portion thereof comprises a chair or a cushion. In some embodiments, the devices and systems of the present disclosure comprise a wheelchair. In some embodiments, the load bearing support material comprises a mechanically compliant material. In some embodiments, the load bearing support material comprises a porous material.

[0029] In some embodiments, systems include the devices of the present disclosure. In some of these embodiments, systems include a sensor, a processor operably connected to the sensor, and a memory communicatively coupled to the processor, the memory storing instructions which, when executed on the processor, perform operations comprising: monitoring blood flow in skin and underlying tissue of the user using the sensor when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing supportmaterial. In some embodiments, the sensor comprises an optical sensor, an ultrasound sensor, a thermal sensor, a spectroscopic sensor, a magnetic resonance sensor, a fluorescence sensor, and / or the like. In some embodiments, systems include one or more feedback sensors disposed within sensory communication of one or more of the integrated elements, a processor operably connected to the feedback sensors, a memory communicatively coupled to the processor, the memory storing instructions which, when executed on the processor, perform operations comprising: receiving feedback control data from the feedback sensors when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0030] EXAMPLE: Device for the Prevention of Bed Sores

[0031] Pressure sores are a significant health concern, prevalent in 5%-15% of hospital patients and even more so in intensive care units. Notably, 70% of cases occur in individuals over 70, a higher risk demographic. Pathophysiology of pressure sores includes: tissue compression, cell stress, stress concentration, deformation of blood vessels, ischemia and reduction of flow of nutrients to tissue, and tissue necrosis. FIGS. 1A-1 C depict various aspects of pressure sores. In particular, FIG. 1 A is an image of a pressure sore 100, FIG. 1 B depicts aspects of pathophysiology associated with tissue compression 102, and FIG. 1 C depicts the most at-risk areas of a user 104 positioned on a mattress. Accordingly, the present example illustrates a therapy to prevent pressure sores by addressing their root cause, utilizing negative pressure to decompress tissue and increase blood flow.

[0032] Exemplary Specifications

[0033] To illustrate, FIG. 2 depicts an exemplary reduced skin contact reaction force pressure system. As shown, the device is a memory foam mattress with integrated vacuum cups. A tubing system connects the cups to a vacuum pump and pressure gauge. The memory foam facilitates conformation to the patient’s body, allowing the cups to form a seal. To further illustrate, FIG. 3 depicts exemplary elements comprised of vacant holes located within a support system, while depicts exemplary integrated elements within support structure in communication with suction system.Table 1

[0034] Virtual Modeling

[0035] FIG. 5 depicts simulation of internal stress concentrations arising from simulated bony prominences. The scale on the right side depicts variation of Von Mises’s stress arising from U, Conic and V bony prominences. FIG. 6 depicts stress concentration factors 600 in excess of bulk loads arising from simulated U, Conic and V- shaped bony prominences. Bony prominences are shown to act as stress risers. High stress risers lead to increased tissue compression.Table 2

[0036] Concept Verification

[0037] FIG. 7 depicts effect of stress concentration risers due to bulk loads on experimental blood flow rate absent of any prominences and with U. Conic and V-shaped prominences. FIG. 8 depicts effect of negative pressure on experimental flow rate under a 53 lb bulk load with integrated elements having vacant holes connected to a suction device.

[0038] Discussion

[0039] Pressure sores form as a result of multiple factors, including ischemia, cell deformation, and reperfusion injury, all downstream from tissue compression. Our virtual modeling demonstrated that tissue compression is increased at stress risers such as bony prominences. Flow rate data from our physical models validated these virtual models. An increase in flow rate occurred consistently after placement of an open cup underneath the various prominences tested. Vacuum application to this tissue resulted in an additional increase in flow. We believe the open-cup design allows tissue under high stress concentrations to decompress by shifting weight to lower stress concentration areas. Current literature supports our findings that the application of negative pressure results in an increase in flow to healthy tissue. We show herein the basis for a therapeutic device using an open-cup design that establishes biomechanically suitable conditions for the application of negative pressure technology, in order to prevent pressure sores.

[0040] Some further aspects are also defined in the following clauses:

[0041] Clause 1 : A device, comprising a load bearing support material that comprises one or more integrated elements disposed within one or more contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material, which integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on a user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0042] Clause 2: The device of Clause 1 , wherein the device comprises a wearable apparatus, a self-contained unit, an article of furniture, or a portion thereof.

[0043] Clause 3: The device of Clause 1 or Clause 2, wherein the article of furniture or the portion thereof comprises a mattress.

[0044] Clause 4: The device of any one of Clauses 1 -3, wherein the mattress is fabricated from memory foam.

[0045] Clause 5: The device of any one of Clauses 1 -4, wherein the article of furniture or the portion thereof comprises a chair or a cushion.

[0046] Clause 6: The device of any one of Clauses 1 -5, wherein the load bearing support material comprises a mechanically compliant material.

[0047] Clause 7: The device of any one of Clauses 1 -6, wherein the load bearing support material comprises a porous material.

[0048] Clause 8: The device of any one of Clauses 1 -7, wherein the integrated elements comprise one or more distinct surface and bulk volumetric material features.

[0049] Clause 9: The device of any one of Clauses 1 -8, wherein the integrated elements comprise one or more voids disposed in the load bearing support material.

[0050] Clause 10: The device of any one of Clauses 1 -9, wherein the voids passively exert minimal to no mechanical contact reaction forces on the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0051] Clause 11 : The device of any one of Clauses 1 -10, wherein the voids comprise diameters in a range of about 0.1 mm to about 10 cm.

[0052] Clause 12: The device of any one of Clauses 1 -1 1 , wherein the voids comprise depths in a range of about 0.1 mm to about 30 cm.

[0053] Clause 13: The device of any one of Clauses 1 -12, further comprising: one or more channels that communicate with the voids; and one or more negative pressure sources operably connected to the channels, which negative pressure sources are configured to apply negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0054] Clause 14: The device of any one of Clauses 1 -13, wherein one or more vacuum cups comprise the voids.

[0055] Clause 15: The device of any one of Clauses 1 -14, further comprising one or more pressure gauges operably connected to the channels and / or the negative pressure sources.

[0056] Clause 16: The device of any one of Clauses 1 -15, wherein the negative pressure sources are configured to continuously or intermittently apply the negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0057] Clause 17: The device of any one of Clauses 1 -16, wherein the negative pressure sources are configured to apply the negative pressure to the voids in a range of about 1 mmHg to about 500 mmHg.

[0058] Clause 18: The device of any one of Clauses 1 -17, wherein the voids comprise porous and / or non-porous material having bulk stress, compressive and shear (E, K, ) moduli that produce reduced contact reaction forces relative to bulk moduli of the load bearing support material.

[0059] Clause 19: A system comprising device of any one of Clauses 1 -18, wherein the system further comprises: a sensor; a processor operably connected to the sensor; and a memory communicatively coupled to the processor, the memory storing instructions which, when executed on the processor, perform operations comprising: monitoring blood flow in skin and underlying tissue of the user using the sensor when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0060] Clause 20: The system of any one of Clauses 1 -19, wherein the sensor is selected from the group consisting of: an optical sensor, an ultrasound sensor, a thermal sensor, a spectroscopic sensor, a magnetic resonance sensor, and a fluorescence sensor.

[0061] Clause 21 : A system comprising device of any one of Clauses 1 -20, wherein the system further comprises: one or more feedback sensors disposed within sensory communication of one or more of the integrated elements; a processor operably connected to the feedback sensors; and a memory communicatively coupled to the processor, the memory storing instructions which, when executed on the processor, perform operations comprising: receiving feedback control data from the feedback sensors when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0062] Clause 22: The device of any one of Clauses 1 -21 , wherein the contact regions of the load bearing support material are configured to substantially align with one or more bony prominences of the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0063] Clause 23: The device of any one of Clauses 1 -22, wherein the bony prominences of the user are selected from the group consisting of: a heel, a sacrum, an elbow, a shoulder blade, a head, an ankle, a leg, a knee, a thigh, a greater trochanter, a hip, a shoulder, a ear, a face, and a rib.

[0064] Clause 24: A method of reducing tissue injury in a user, the method comprising positioning the user in one or more contact regions of a load bearing support material, wherein the load bearing support material comprises one or more integrated elements disposed within the contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material, which integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on the user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements.

[0065] Clause 25: The method of Clause 24, wherein the device comprises a wearable apparatus, a self-contained unit, an article of furniture, or a portion thereof.

[0066] Clause 26: The method of Clause 24 or Clause 25, wherein the article of furniture or the portion thereof comprises a mattress.

[0067] Clause 27: The method of any one of Clauses 24-26, wherein the mattress is fabricated from memory foam.

[0068] Clause 28: The method of any one of Clauses 24-27, wherein the article of furniture or the portion thereof comprises a chair or a cushion.

[0069] Clause 29: The method of any one of Clauses 24-28, wherein the load bearing support material comprises a mechanically compliant material.

[0070] Clause 30: The method of any one of Clauses 24-29, wherein the load bearing support material comprises a porous material.

[0071] Clause 31 : The method of any one of Clauses 24-30, wherein the integrated elements comprise one or more distinct surface and bulk volumetric material features.

[0072] Clause 32: The method of any one of Clauses 24-31 , wherein the integrated elements comprise one or more voids disposed in the load bearing support material.

[0073] Clause 33: The method of any one of Clauses 24-32, wherein the voids passively exert minimal to no mechanical contact reaction forces on the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0074] Clause 34: The method of any one of Clauses 24-33, wherein the voids comprise diameters in a range of about 0.1 mm to about 10 cm.

[0075] Clause 35: The method of any one of Clauses 24-34, wherein the voids comprise depths in a range of about 0.1 mm to about 30 cm.

[0076] Clause 36: The method of any one of Clauses 24-35, further comprising: one or more channels that communicate with the voids; and one or more negative pressure sources operably connected to the channels, which negative pressure sources are configured to apply negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0077] Clause 37: The method of any one of Clauses 24-36, wherein one or more vacuum cups comprise the voids.

[0078] Clause 38: The method of any one of Clauses 24-37, further comprising one or more pressure gauges operably connected to the channels and / or the negative pressure sources.

[0079] Clause 39: The method of any one of Clauses 24-38, wherein the negative pressure sources are configured to continuously or intermittently apply the negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0080] Clause 40: The method of any one of Clauses 24-39, wherein the negative pressure sources are configured to apply the negative pressure to the voids in a range of about 1 mmHg to about 500 mmHg.

[0081] Clause 41 : The method of any one of Clauses 24-40, wherein the voids comprise porous and / or non-porous material having bulk stress, compressive and shear(E, K, ) moduli that produce reduced contact reaction forces relative to bulk moduli of the load bearing support material.

[0082] Clause 42: The method of any one of Clauses 24-41 , wherein the contact regions of the load bearing support material are configured to substantially align with one or more bony prominences of the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

[0083] Clause 43: The method of any one of Clauses 24-42, wherein the bony prominences of the user are selected from the group consisting of: a heel, a sacrum, an elbow, a shoulder blade, a head, an ankle, a leg, a knee, a thigh, a greater trochanter, a hip, a shoulder, a ear, a face, and a rib.

[0084] Although this disclosure contains many specific embodiment details, these should not be construed as limitations on the scope of the subject matter or on the scope of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments. Certain features that are described in this disclosure in the context of separate embodiments can also be implemented, in combination, in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments, separately, or in any suitable sub-combination. Moreover, although previously described features may be described as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can, in some cases, be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.

[0085] Particular embodiments of the subject matter have been described. Other embodiments, alterations, and permutations of the described embodiments are within the scope of the following claims as will be apparent to those skilled in the art. While operations are depicted in the drawings or claims in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed (some operations may be considered optional), to achieve desirable results.

[0086] Accordingly, the previously described example embodiments do not define or constrain this disclosure. Other changes, substitutions, and alterations are also possible without departing from the spirit and scope of this disclosure.

Claims

WHAT IS CLAIMED IS:1 . A device, comprising a load bearing support material that comprises one or more integrated elements disposed within one or more contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material, which integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on a user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

2. The device of claim 1 , wherein the device comprises a wearable apparatus, a self-contained unit, an article of furniture, or a portion thereof.

3. The device of claim 2, wherein the article of furniture or the portion thereof comprises a mattress.

4. The device of claim 3, wherein the mattress is fabricated from memory foam.

5. The device of claim 2, wherein the article of furniture or the portion thereof comprises a chair or a cushion.

6. The device of claim 1 , wherein the load bearing support material comprises a mechanically compliant material.

7. The device of claim 1 , wherein the load bearing support material comprises a porous material.

8. The device of claim 1 , wherein the integrated elements comprise one or more distinct surface and bulk volumetric material features.

9. The device of claim 1 , wherein the integrated elements comprise one or more voids disposed in the load bearing support material.

10. The device of claim 9, wherein the voids passively exert minimal to no mechanical contact reaction forces on the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.11 . The device of claim 9, wherein the voids comprise diameters in a range of about 0.1 mm to about 10 cm.

12. The device of claim 9, wherein the voids comprise depths in a range of about 0.1 mm to about 30 cm.

13. The device of claim 9, further comprising: one or more channels that communicate with the voids; and one or more negative pressure sources operably connected to the channels, which negative pressure sources are configured to apply negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

14. The device of claim 13, wherein one or more vacuum cups comprise the voids.

15. The device of claim 13, further comprising one or more pressure gauges operably connected to the channels and / or the negative pressure sources.

16. The device of claim 13, wherein the negative pressure sources are configured to continuously or intermittently apply the negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

17. The device of claim 13, wherein the negative pressure sources are configured to apply the negative pressure to the voids in a range of about 1 mmHg to about 500 mmHg.

18. The device of claim 13, wherein the voids comprise porous and / or non-porous material having bulk stress, compressive and shear (E, K,> / ) moduli that produce reduced contact reaction forces relative to bulk moduli of the load bearing support material.

19. A system comprising device of claim 1 , wherein the system further comprises: a sensor; a processor operably connected to the sensor; and a memory communicatively coupled to the processor, the memory storing instructions which, when executed on the processor, perform operations comprising: monitoring blood flow in skin and underlying tissue of the user using the sensor when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

20. The system of claim 19, wherein the sensor is selected from the group consisting of: an optical sensor, an ultrasound sensor, a thermal sensor, a spectroscopic sensor, a magnetic resonance sensor, and a fluorescence sensor.21 . A system comprising device of claim 1 , wherein the system further comprises: one or more feedback sensors disposed within sensory communication of one or more of the integrated elements; a processor operably connected to the feedback sensors; and a memory communicatively coupled to the processor, the memory storing instructions which, when executed on the processor, perform operations comprising: receiving feedback control data from the feedback sensors when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

22. The device of claim 1 , wherein the contact regions of the load bearing support material are configured to substantially align with one or more bony prominences of the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

23. The device of claim 22, wherein the bony prominences of the user are selected from the group consisting of: a heel, a sacrum, an elbow, a shoulder blade, a head, an ankle, a leg, a knee, a thigh, a greater trochanter, a hip, a shoulder, a ear, a face, and a rib.

24. A method of reducing tissue injury in a user, the method comprising positioning the user in one or more contact regions of a load bearing support material, wherein the load bearing support material comprises one or more integrated elements disposed within the contact regions of the load bearing support material and in communication with one or more contact planes of the load bearing support material, which integrated elements are structured to reduce one or more mechanical contact reaction forces exerted on the user by the load bearing support material relative to the load bearing support material in the absence of the integrated elements.

25. The method of claim 24, wherein the device comprises a wearable apparatus, a self-contained unit, an article of furniture, or a portion thereof.

26. The method of claim 25, wherein the article of furniture or the portion thereof comprises a mattress.

27. The method of claim 26, wherein the mattress is fabricated from memory foam.

28. The method of claim 25, wherein the article of furniture or the portion thereof comprises a chair or a cushion.

29. The method of claim 24, wherein the load bearing support material comprises a mechanically compliant material.

30. The method of claim 24, wherein the load bearing support material comprises a porous material.31 . The method of claim 24, wherein the integrated elements comprise one or more distinct surface and bulk volumetric material features.

32. The method of claim 24, wherein the integrated elements comprise one or more voids disposed in the load bearing support material.

33. The method of claim 32, wherein the voids passively exert minimal to no mechanical contact reaction forces on the user when the user is positioned in the contactregions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

34. The method of claim 32, wherein the voids comprise diameters in a range of about 0.1 mm to about 10 cm.

35. The method of claim 32, wherein the voids comprise depths in a range of about 0.1 mm to about 30 cm.

36. The method e of claim 32, further comprising: one or more channels that communicate with the voids; and one or more negative pressure sources operably connected to the channels, which negative pressure sources are configured to apply negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

37. The method of claim 36, wherein one or more vacuum cups comprise the voids.

38. The method of claim 36, further comprising one or more pressure gauges operably connected to the channels and / or the negative pressure sources.

39. The method of claim 36, wherein the negative pressure sources are configured to continuously or intermittently apply the negative pressure to the voids when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

40. The method of claim 36, wherein the negative pressure sources are configured to apply the negative pressure to the voids in a range of about 1 mmHg to about 500 mmHg.41 . The method of claim 36, wherein the voids comprise porous and / or non-porous material having bulk stress, compressive and shear (E, K,- ) moduli that produce reduced contact reaction forces relative to bulk moduli of the load bearing support material.

42. The method e of claim 24, wherein the contact regions of the load bearing support material are configured to substantially align with one or more bony prominences of the user when the user is positioned in the contact regions of the load bearing support material at least proximal to the contact planes of the load bearing support material.

43. The method of claim 42, wherein the bony prominences of the user are selected from the group consisting of: a heel, a sacrum, an elbow, a shoulder blade, a head, an ankle, a leg, a knee, a thigh, a greater trochanter, a hip, a shoulder, a ear, a face, and a rib.

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