Patent Application
20210145621
The current smart custom orthotic is a portable smart helmet, cap or splint device utilized for custom orthotics, wound care, trauma and critical care. Features of the current invention can reduce post injury trauma and adverse physiological events while also providing notifications that can assist medical intervention. Among other things, the smart custom cranial orthotic can be adapted to customize pressure applied to the wound or abnormal environment.
It is estimated that over 13 million living people have symptoms related to traumatic brain injury in the US and Europe populations alone1. Worldwide, the incidence is increasing due to the more readily available methods of motor transportation such as motorcycles and low-cost scooters. Even when helmeted, the transmitted force to the brain can lead to concussions, traumatic brain injury, to diffuse axonal injury (DAI) and death. It has been reported that over 20% of all concussions are sports-related in the US2.
As such, multiple efforts are focused on improving the materials in both sports-related and commercial helmets for protection. The ability to disperse forces through the helmet structures may reduce the harmful impact of accelerations and decelerations on the brain movement within the calvarium. The geometric structure and substance of the padding portion of the helmet (i.e. prismatic lattice) have been shown to reduce TBI3.
Specific focus has been on custom liners for helmets such as viscoelastic polymers which have been shown to reduce strain and strain-rates for head impact1. Penetrating brain injuries carry the highest mortality rates4. Retrospective analysis of the Iraq and Afghanistan wars revealed that numbers of penetrating TBIs exceeded closed TBIs by a ratio of 2:1 and 1.3:1 respectively5. The ability to control hemostasis with penetrating brain injuries in the field is quite difficult. Too much pressure can cause tonsillar herniation or brain injury and death, too little compression may result in excessive bleeding and shock. It is clear there is a need for specific wound care solutions in these scenarios.
In penetrating head trauma, closed head injuries and acquired cranial deformities from surgical intervention, multiple adverse clinical sequalae may result. The scalp provides a robust blood supply to the surrounding anatomic structures and disruption resulting from insult can lead to excessive blood loss and even death within a short period of time. Obtaining hemostasis is quite feasible in the operating theater or ambulatory medical setting, however in the field and away from medical help, scalp injuries may be difficult to control leading to hypotension, shock and death. Additionally, penetrating injuries to the scalp and underlying skull represent an even more severe clinical scenario where serious sequalae such as hemorrhagic shock, hypotension, hypothermia and low perfusion pressures can lead to further tissue damage and death. Lack of cerebral perfusion leads to hypoxemia and neuronal degradation. Hypotension and hypothermia in the face of a traumatic event have been shown to be critical contributing factors that lead to higher rates of secondary wound infections and significant downstream comorbidities.
Swelling from the above injuries can be rather profound at the time of injury, but may peak at 48 hours from injury. Compressive bandages are a first line treatment defense against hemorrhage. However, static application of the bandages without manipulation over the course of a physiologic response to injury may result in further injuries. Dressings applied at the initial time of injury may become too tight and in itself cause further injury or harm to the individual if variations to inflammation and swelling occur. Alternatively, hypobaric environments, such as during transport in flight also results in changes to both the perfusion pressures to the tissues as well as risk of wound infection.
Selective brain cooling has been shown provide neuroprotective capabilities after brain trauma. Induced hypothermia has been shown to minimize acute brain damage in animal models after penetrating ballistic-like brain injury (PBBI). These models have shown improved preservation of axonal integrity, cellular apoptosis, blood-brain barrier disruption, neuroinflammation and improved behavior outcomes both in TBI and PBBI. Reducing brain temperature by 2-3 degrees Celsius while maintaining corporal normothermia may have life-saving capabilities. Selectively cooling the brain may also allow for a greater time window to allow for transportation from the field to the medical facility where more effective strategies to treat repairable injuries may be obtained. However, focal cooling of the brain both in the field and in the medical arena without causing systemic lowering of temperature has been difficult to achieve in clinical practice. As above, hypothermia has been shown to be a critical factor in overall mortality, wound infection rates, blood coagulopathies, and overall hospital stay following severe traumatic injury.
Any discussion of references cited herein merely summarizes the disclosures of the cited references. Applicant makes no admission that any cited reference or portion thereof is relevant prior art. Applicant reserves the right to challenge the accuracy, relevancy and veracity of the cited references. Publications or presentations that may indicate a state-of-art include:
1. Siegkas P, Sharp D J, Ghajari M. The traumatic brain injury mitigation effects of a new viscoelastic add-on liner. Sci Rep. 2019 Mar. 5; 9(1):3471.
2. National Center for Injury Prevention and Control. Report to Congress on mild traumatic brain injury in the United States: steps to prevent a serious public health problem. Atlanta, Ga.: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2003
3. Khosroshahi S F, Duckworth H, Galvanetto U, Ghajari M. The effects of topology and relative density of lattice liners on traumatic brain injury mitigation. J Biomech. 2019 Dec. 3; 97:109376.
4. Fathalla H, Ashry A, El-Fiki A. Managing military penetrating brain injuries in the war zone: lessons learned. Neurosurg Focus. 2018 Dec. 1; 45(6):E6.
5. Orman J A, Geyer D, Jones J, Schneider E B, Grafman J, Pugh M J, Dubose J. Epidemiology of moderate-to-severe penetrating versus closed traumatic brain injury in the Iraq and Afghanistan wars. J Trauma Acute Care Surg. 2012 December; 73(6 Suppl 5):S496-502.
The present custom cranial orthotic device and system can address adverse events following trauma and can preserve brain hemodynamics, brain metabolism and neurobehavior during subacute injury period
The current device and system embodiments are directed towards a custom cranial orthotic that can provide real time biometric feedback from multiple different sensors. Therapeutic interventions such as hemostasis, compression, adaptive heating and cooling and improved wound care optimization are possible with the custom cranial orthotic device and system.
To address hemorrhage following injury, the orthotic has a custom foaming capability to adapt to any contour irregularity such as soft tissue scalp injury to even a concavity or convexity due to bony skull malposition. The foaming agents are able to expand into the defect or around the defect to provide focal compression and improved hemostasis. By providing diffuse pressure over a greater surface area in and around the wound, less pressure can be used to obtain hemostatic control. With penetrating injuries and concavities to the skull, the foam will expand into this area providing a more appropriate mold of the defect rather than conventional dressings that are difficult to contour in the face of a dirty or bleeding wound. A bladder interposition made of polyurethane or other polymeric materials may be implemented to ensure a watertight pressure application and enhanced rigidity to the foamed dressing.
Outside the foaming agents, a hard-collapsible shell can be applied. The shell is collapsible for ease of storage and transport on the individual or field equipment (i.e. ambulance or military vehicle). The composition of the shell will be strong enough that it can reduce against further traumatic events. The shell is also adjustable to provide finer and evenly distributed compression. Leaflets associated with the helmet provide control of external compression (more or less) supplied by the helmet or cap as required by medical parameters or when indicated by pressure sensors.
Within the scope of the current invention, biometric sensors can be positioned in the bladder, the outer shell or both. In select embodiments of the helmet or cap, biometric sensors such as pressure sensors can be place at multiple locations of the invention. Use of one or more pressure sensors can provide alerts indications and/or alerts of acceptable, excessive or insufficient pressures. Insufficient pressures may result in excessive hemorrhage, low cerebral perfusion pressures, secondary hypoxia and neurodegeneration such as axonal or glial death. Excessive pressures may result in brain herniation, soft tissue ischemia, cerebral vascular injury or stroke, and death. A biometric sensor communicates with communications module adapted to communicate with a computer distinct from the communications module. Communications module includes a transmitter or a transceiver allowing wireless communications with a remote computer that provides real real-time calculation/determination of the biometric(s) sensed. Communication modules can also include a memory, a microprocessor or processor and software (computer component) for calculating the biometric measurements sensed by the biometric sensors and controlling the helmet's heat/cooling semiconductors. Depending on medical treatment parameters, the remote computer or the communications module's computer module can be used to calculate sensed biometrics and control the heat/cooling semiconductors. In accordance with the present invention, the computer or computer module can calculate biometrics, including but not limited to, pressure, temperature, blood pressure, lactate levels, pH, sodium levels, potassium level, glucose levels, apoptotic factors, nitric oxide (NO) and SVO2 levels sensed by their respective sensors.
In selected embodiments of the current invention, semiconductors, such as micro-Peltier coolers, can be included in the bladder, the outer shell, foam or any combination to provide heating or cooling. The direction of the current flow through micro-semiconductors allows for either cooling or warming. Power for the semiconductors and other components of the current orthotic can be provided by batteries, a connection with an alternating current power source or a radio frequency energy supply.
Within the ambit of the current invention, micro-semiconductors can be rigid or flexible or a combination thereof. The semiconductors can utilize metallic thermal interfaces to dissipate heat or cold. Select preferred embodiments of the micro-semiconductors can utilize ferromagnetic foils that transition between paramagnetic and ferromagnetic states and can drive a metallic shuttle generating a squeezed-film cooling effect during oscillation. The thermal interfaces can induce vibration of fluids in proximity with the thermal interfaces. Select embodiments of the thermal interfaces can be provided with carbon nanotubes that can decrease thermal interface resistance. The carbon nanotubes can be grown on gadolinium foil. Use of carbon nanotubes can improve performance of the semiconductors.
It is believed that use of micro-semiconductors allows the application of different voltages and current across two distinct semiconductors, thereby generating a “heat flux” of hot or cold across the semiconductors' interfaces. Direction of current crossing the interfaces changes the generated heat flux from hot to cold or cold to hot such that the change the direction of current can result in a 25 degree Celsius deferential of temperature proximate the interfaces.
Helmet size and foam application can be of different dimensions. By way of illustration, caps sizes are available for the pediatric, adolescent and adult populations. Within the scope of the current invention, rather than a helmet, the outer shell can be oriented to fit around other body parts, limbs, torso or hands. Shells of the current invention can be provided with one or more tunnels that include one or fans. It is believed that assisting the circulation of cold or hot air at preselected temperatures can improve healing of the tissue. By way of illustration, induction of localized hypothermia can be utilized to protect tissue.
The current custom orthotic apparatus also has application in veterinary medicine. Custom foaming devices such as helmets and splints can be configured with external hard shells and adapted to treat and protect animal injuries from trauma or during the post-operative period for animals. Those animals include, but are not limited to equine, canine, feline or zoo animals.
An aspect of the present invention is to provide a customized orthotic.
Another aspect of the present invention is to provide an orthotic that is controlled by the orthotic's communications module or via wireless transmission from a computing device remote from the communications module.
Yet another aspect of the present invention is to provide an orthotic that provides adjustable pressures to different zones of the orthotic.
Still another aspect of the present invention is to provide sensors for the orthotic adapted to sense pressure and other biometrics.
Yet still another aspect of the present invention is to provide a customized orthotic including a bladder contacting the wound environment.
Another aspect of the present invention is to provide a customized cranial orthotic.
Still another aspect of the present invention is to provide collapsible shell allowing for easier transport of orthotic.
Yet still another aspect of the present invention is to provide an orthotic for use about the skull.
Still another aspect of the present invention is to provide an orthotic for use about a limb or other body part.
Another aspect of the present invention is to provide an orthotic for human or veterinary usage.
Still another aspect of the present invention is to utilize semiconductors to assist in control the temperatures of the wound environment.
Yet still another aspect of the present invention is to utilize a combination of tunnels and fans connected to the shell to circulate air about the wound environment.
A preferred embodiment of the current invention can be described as a cranial orthotic comprising: a) an exterior shell comprising: i) sections allowing selective zonal adjustment of pressures supplied to the sections and a wound environment of a skull, wherein the sections are collapsible when the cranial orthotic is not in use; ii) a removable vent; and iii) one or more ports extending through the exterior shell; the one or more ports adapted to receive foam; b) a bladder contacting an inward side of the exterior shell, wherein the bladder can receive foam; c) an array comprising sensors and a junction; the array contacting the inward side of the exterior shell or the bladder or a combination thereof, wherein the sensors sense zonal pressures associated with one or more sections of the shell; d) a plurality of semiconductors comprising thermal interfaces and ferromagnetic properties; the plurality of semiconductors connected to an inward side of the exterior shell or the bladder or a combination thereof, wherein relative to the positioning of each of the semiconductors about the wound environment and dependent on a direction of current flowing through the thermal interfaces, the current causes the semiconductor to heat or cool an area of the wound environment associated with the semiconductor's footprint; e) a detachable communications module, distinct from the shell, the bladder, the foam, the array and the junction, comprising a housing; the housing comprising: i) a first face to magnetically reciprocate with the junction; ii) an outward face comprising a touchscreen; and iii) a computer module comprising one or more of the following components: a microprocessor, a memory, a visual graphics unit, an audio unit, a transmitter or transceiver and a software for controlling the components, the cranial orthotic and displays by the touchscreen; f) the transmitter or transceiver adapted for wireless communications, via an available wireless cellular network and/or IEEE 802.11 protocol, with a cloud server or other computer remote from the communications module; and g) circuitry providing connections between the communications module, the array, the sensors and the semiconductors and a power source for the communications module.
Another preferred embodiment of the current invention can be described as an orthotic comprising: a) an exterior shell comprising one or more ports extending through the exterior shell; the one or more ports adapted to receive foam; b) an array comprising sensors and a junction; the array contacting a portion of and distinct from an inward side of the exterior shell, wherein the sensors sense zonal pressures associated with one or more sections of the shell; c) a detachable communications module comprising a housing; the housing, distinct from the shell, the foam, the array and the junction, comprising: i) a first face adapted to reciprocate with the junction; ii) a second face comprising a touchscreen; and iii) a computer module comprising one or more of the following components: a microprocessor, a memory, a visual graphics unit, an audio unit, a transmitter or transceiver and a software for controlling the components, the orthotic and displays by the touchscreen; d) the transmitter or transceiver adapted for wireless communications, via a wireless cellular network and/or IEEE 802.11 protocol, with a cloud server or other computer remote from the communications module; and e) circuitry providing connections between the communications module, the array, the sensors and a power source for the communications module.
Still another preferred embodiment of the current invention can be described as a detachable communications module adapted for use with a customizable orthotic helmet, cap or splint; the detachable communications module comprising a housing comprising: a) a first face adapted to reciprocate electromagnetically with a junction of an array conformed to fit about a wound environment facing side of a shell of the customizable orthotic helmet, cap or splint; the array comprising sensors and a junction; b) a computer module comprising one or more of the following components: a microprocessor, a memory, a visual graphics unit, an audio unit, a transmitter or transceiver and a software for controlling the components, the customizable orthotic and displays by the touchscreen; the transmitter or transceiver adapted for wireless communications, via a wireless cellular network and/or IEEE 802.11 protocol, with a cloud server or other computer remote from the communications module; c) circuitry providing connections between the communications module, the array, the sensors positioned on the shell of the orthotic helmet, cap or splint or a bladder inward from the shell and proximate the wound environment or both the shell and the bladder and a power source for the communications module; and d) a touchscreen positioned on a second side of the housing displaying data associated with wound environment to a user, thereby allowing the user of the communications module to control pressures supplied to the wound environment.
It is the novel and unique interaction of these simple elements which creates the system within the ambit of the present invention. Pursuant to Title 35 of the United States Code, select preferred embodiments of the current invention follow. However, it is to be understood that the descriptions of the preferred embodiments do not limit the scope of the present invention.
Although the disclosure hereof is detailed to enable those skilled in the art to practice the invention, the embodiments published herein merely exemplify the present invention.
As described above and with reference to
With a view toward
In use of helmet (20), bladder (40) contacts inward side (23) of exterior shell (22). When helmet (20) is provided with bladder (40), foam (300) can expand about a portion of bladder (40). Bladder (40) can function as an overflow valve for expanded foam (300), that when required can be trimmed and customized subsequent expansion of foam (300). Foaming agents may be composed of silicone, polyurethane, cellulose, bamboo, or other biodegradable agents and will be open cell of an open cell configuration to allow for application of negative pressure or evacuation of fluid when medically required. Foams (300) with open cell configurations allows for therapeutic agents to be applied to the wound environment (10) that can assist with hemostasis and healing. Reactions creating foams (300) biocompatible with tissues and are non-exothermic or gas producing. When medical parameters require, an aerosol spray or mixing-tip gun can be utilized to create foams (300) for wound environment (10). It has been discovered that the process creating foam (300) and fitting cap or helmet (20) in situ can be accomplished with a set up time under 10 minutes.
Select preferred embodiments of the current helmet (20) can be provided with an array (48) of sensors (50) and a junction (56) for releasably holding communications module (90). Array (48) can contact or be printed onto inward side (23) of exterior shell (22). Junction (56) includes circuitry allowing intercommunications with sensors (50) and communications module (90). Within the ambit of the current invention, junction (56) can be provided with a magnetic electroconductive T-pin connectable with communications module (90). When medical parameters require, the locations and number of sensors (50) positioned on array (48) can be altered and other sensors (50) can be incorporated into cap (20), bladder (40) or foam (300). Sensors (50) can sense biometrics such as pressure, temperature, blood pressure, lactate levels, pH, growth factors, hydrogen levels, sodium levels, potassium level, lactate levels, other electrolytes, cytokines, glucose levels, apoptotic factors, SVO2 and other biometric metric markers. Electroactive inks can be a sensor and printed directly or laminated through materials such as thermoplastic polyurethane (TPU) with an adhesive onto shell (22), bladder (40) or foam (300). Foams (300) can be composed of carbon nanotubules or multi-channel carbon-nanotubes to capture and sense specific ions, including but not limited to, H+, lactate, Na+, K+, glucose, cytokines, growth factors, other electrolytes or biometric markers.
Communications module (90) includes housing (92). Alarm (94) can audible or visual such as a LED positioned on outward side of housing (92). Alarm (94) is activated when a sensed pressure or biometric for the patient is outside of a predetermined range. The LED light ring changes colors when the sensed pressure or biometric is outside the predetermined range. By way of illustration, LED (94) can turn red with the pressures in helmet (20) are calculated to be excessive or blue to designate helmet (20) is incorrectly fitted, positioned or at risk for movement.
Housing (92) is provided with first face (96) adapted to be received by junction (56). In select preferred embodiments, a magnetic attraction between first face (96) and junction (56) assist in securing electrical connections between first face (96) and junction (56). As previously indicated, junction (56) can include a magnetic electroconductive T-pin connect to first face (96). Housing (92) can be provided with a tongue, rail or other device to assist in attaching housing (92) to shell (22) of helmet (20).
Housing (92) can be provided with second or outward or second face (100) visible by the user of communications module (90). An OLED or AMOLED touch screen (102) can be incorporated into outward face (100) to provide user access to communications module's (90) computer module (110) can be provided with one or more of the following components: microprocessor, memory, visual graphics unit, audio unit, transmitter or transceiver (120), circuitry interconnecting the components and software (180) for controlling the components and cap (20). Among other things, computer component can calculate pressures and biometrics sensed by sensors (50), control current flow to semiconductors (60) and generate displays of data on touchscreen (102). Within the scope of the current invention, touchscreen (102) can display data correlated and sensed by sensors (50) and semiconductors (60). The visualized, calculated and correlated data can be supplied detachable communications module (90), cloud server (140) or computer remote (130) remote from communications module (90) or a combination thereof allowing the user of touchscreen (102) to control application of pressure to wound environment (20). Pressures supplied to wound environment (10) can also be controlled by cloud server (140) or computer remote (130) remote from communications module (90). Touchscreen (102) can also display correlated data from biometric sensors (50) sensing one or more of pressure, temperature, blood pressure, lactate levels, pH, growth factors, hydrogen levels, sodium levels, potassium level, lactate levels, other electrolytes, cytokines, glucose levels, apoptotic factors or SVO2.
Helmet (20) is adapted for wireless communications via any wireless network such as available cellular networks and/or IEEE 802.11 protocol at a frequency of 2.4 GHz (Wi-Fi or Bluetooth). Transmitter or transceiver (120) can communicate with a Cloud server or computer (140), other computer (130) such as a mobile computing device (smart phone, tablet, etc.) or a personal computer or any type of computing device remote from orthotic (20). Among other things, devices remote from helmet (20) can be utilized to store data, calculate biometrics and/or control pressures applied by helmet (20) to the wound environment (10). For select preferred embodiments of sensors (50), one or more sensors (50) can be equipped with wireless capabilities to communicate wirelessly with communications module (90), cloud server or other computer (130).
Power sources for communications module (90) include but are not limited to rechargeable sources such as lithium ion, lithium iron phosphate, solid state, tab-less batteries or other usable power sources. Within the scope of the invention, the power source can be attached to housing (92). The rechargeable power sources can be detachable from housing (92) to engage the recharging energy supply.
Select preferred embodiments of the current invention have been disclosed and enabled as required by Title 35 of the United States Code.
This Application claims the benefit of Provisional Application 62/969,067—Wound Treatment Devices—filed on Feb. 1, 2020 and priority to U.S. application Ser. No. 15/289,071—Advanced Compression Garments and Systems —, filed Oct. 7, 2016 that claimed the benefit of U.S. Provisional Application 62/238,522, filed on Oct. 7, 2015.
| Number | Date | Country | |
|---|---|---|---|
| 62969067 | Feb 2020 | US | |
| 62238522 | Oct 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15289071 | Oct 2016 | US |
| Child | 17159242 | US |
