Smart Custom Orthotic

Abstract

A portable customizable smart helmet, cap or splint for wound care, trauma and critical care.

Claims

1) 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.

2) The cranial orthotic of claim 1 comprising biometric sensors 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, nitric oxide levels or SVO2.

3) The cranial orthotic of claim 2 comprising an alarm, wherein the alarm is audible, visual or a combination thereof when the sensed pressure or other biometric for a patient is outside of a predetermined range.

4) The cranial orthotic of claim 1, wherein the display on the touchscreen was created by the communications module, the cloud server, the other computer remote from the communications module or a combination thereof.

5) The cranial orthotic of claim 4, wherein the display portrays a pressure map or a heat map or both associated with the wound environment.

6) The cranial orthotic of claim 4, wherein the thermal interfaces comprise carbon nanotubes adapted to decrease thermal interface resistance.

7) The cranial orthotic of claim 6, wherein one or more of the thermal interfaces induce vibration of fluids proximate the one or more of the thermal interfaces.

8) The cranial orthotic of claim 7 comprising tunnels and one or more fans connected to a surface of the cranial orthotic.

9) The cranial orthotic of claim 7, wherein up to about a 25 degree Celsius temperature differential is generated.

10) The cranial orthotic of claim 1, wherein the semiconductors are rigid or flexible or a combination thereof.

11) 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.

12) The orthotic of claim 7 comprising a bladder adapted to receive foam, wherein the bladder contacts the inward side of the exterior shell and the array contacts the inward side of the exterior shell or a portion of the bladder or both.

13) The orthotic of claim 12, wherein the first face reciprocates magnetically with the junction and the orthotic is a helmet, a cap or a splint.

14) The orthotic of claim 10 comprising a plurality of semiconductors comprising thermal interfaces; the plurality of semiconductors connected to 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.

15) The orthotic of claim 14 comprising: a) sections allowing selective zonal adjustment of pressures supplied to the sections and a wound environment, wherein the sections are collapsible when the orthotic is not in use; and b) a removable vent.

16) The orthotic of claim 14 comprising: a) biometric sensors 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, nitric oxide levels or SVO2; and b) the touchscreen displaying a pressure map or a heat map or both associated with the wound environment.

17) The orthotic of claim 14, wherein the semiconductors are rigid or flexible or a combination thereof.

18) The orthotic of claim 17, wherein: a) the semiconductors comprise ferromagnetic properties; and b) the thermal interfaces are adapted to induce vibration of fluids proximate the one or more of the thermal interfaces and comprise carbon nanotubes adapted to decrease thermal interface resistance.

19) The orthotic of claim 18 comprising tunnels and one or more fans connected to a surface of the orthotic.

20) 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.

21) The detachable communications module of claim 20 communicating with and controlling one or more semiconductors positioned on the shell, the bladder or both; the semiconductors adapted to heat or cool an area of the wound environment.

22) The detachable communications module of claim 21, wherein the touchscreen displays: a) data correlated and sensed by the sensors and received from the semiconductors; the correlated data supplied by the detachable communications module, the cloud server or the computer remote from the communications or a combination thereof allowing the user of the touchscreen to control application of pressure to the wound environment; the correlated data comprising biometric sensor data selected from the group consisting of one or more of the following: pressure, temperature, blood pressure, lactate levels, pH, growth factors, hydrogen levels, sodium levels, potassium level, lactate levels, other electrolytes, cytokines, glucose levels, apoptotic factors, nitric oxide levels or SVO2; and b) a pressure map or a heat map or both associated with the wound environment.

23) The detachable communications module of claim 22, wherein the housing comprises an audible alarm, a visible alarm or both when the sensed pressure or other biometric for a patient is outside of a predetermined range.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] FIG. 1 is a perspective of cap or helmet (20).

[0042] FIG. 2 is a perspective of outer shell and pneumatic bladder of helmet (20).

[0043] FIG. 3 portrays a method of creating foam for helmet (20).

[0044] FIG. 4 is a perspective of cap or helmet (20).

[0045] FIG. 5 is a perspective of array (48) adapted for fitting into helmet (20).

[0046] FIG. 6 is a lateral view of cap or helmet (20).

[0047] FIG. 7 is perspective of the inside of cap or helmet (20).

[0048] FIG. 8 is perspective of the inside of cap or helmet (20).

[0049] FIG. 9 is a perspective of an upper portion of cap or helmet (20).

[0050] FIGS. 10-18 are view of embodiments of the current cap or helmet (20).

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0051] 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.

[0052] As described above and with reference to FIGS. 1-18, subsequent to a traumatic insult, the present smart custom cranial orthotic (20) can be formed to correspond to a soft tissue or bony defect in the skull or other bone.

[0053] FIG. 1 is a perspective of cap or helmet (20). By way of illustration, exterior shell (22) of helmet (20) can be constructed of polyurethane, carbon fiber, poly-para-phenylene terephthalamide (Kevlar), polycarbonate, polypropylene, injection molded plastic, high density polyethylene (HDPE), acrylonitrile butadiene styrene (ABS), other polymers and equivalent materials or combinations thereof. Sections or leaflets (24) of exterior shell (22) provide for selective zonal adjustment of pressures that can be supplied by adjustments of leaflets (24) to the wound environment (10). When not in use, sections (24) are collapsible allowing for easier transport of helmet or cap (20). In select preferred embodiments, helmet (20) is provided with removable vent (28) and chin strap (18). Removable vent (28) can improve air movement under helmet (20) to assist with heat control. Removal of vent allows better access to patient's scalp for probes, medication applications, visual observations, and when required, placement of one or more additional sensors without removing helmet (20) from the patient.

[0054] With a view toward FIG. 3, for select preferred embodiments of the current invention, via port (200) of helmet (20), a multipart liquid can be injected creating foam (300) that fills the volume of the wound environment. Depending on medical parameters of the wound environment (10), foam (300) can be customized for a patient. The created foam or foam layer (300) is positioned inward of exterior shell (22) of cap (20). External bag (34) via adapter (32) can be attached to port (200) of cap (20) to deliver an expanding liquid. For example, a 2-part silicone foam can be mixed in external packet (34). External packet (34) includes at least two compartmentalized sections. Once the seal between the sections is broken, a catalyst causes foaming of the expanding liquid and subsequent volume expansion. When external bag (34) is attached to the port (300), the contents of bag (34) can be extruded into foam layer (300) to fill an underlying tissue defect (10) in a closed environment. This use can provide custom compression on any morphology of the wound environment.

[0055] 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.

[0056] 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.

[0057] FIGS. 7-9 portray semiconductors (60), such micro-Peltier devices, connected to inner side (23) of exterior shell (22), bladder (40), foam (300) or any combination thereof. Semiconductors (60) can have a footprint of less than 2 millimeters.sup.2 and the required circuitry interconnects each semiconductor (60) to junction (56) or another connector associated with cap (20). Heat/cool software controls the direction current flow for each semiconductor that results in semiconductor's (60) heating or cooling. Heat/cool software can be associated with memory of communications module (90) or at a location remote from helmet (20). Among other things, heat/cool software can generate a heat map of temperatures within helmet (30) to better quantify therapeutic intervention required. Whether in the field or the hospital, it is believed that the selective control of temperatures generated by semiconductors (60) inside helmet (20) can improve medical outcomes for the patient.

[0058] 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.

[0059] 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).

[0060] 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.

[0061] 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).

[0062] 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.

[0063] FIGS. 10-18 disclose different shells (22) of the current helmet (20). Sections or leaflets (24) are collapsible and can be flattened for more efficient storage. Among the many potential configurations for shells (22), gore map design, armadillo or nautilus telescoping segments and tulip flanges are portrayed. Although not shown, draw strings, zip ties, laces, hook and loop fasteners and Boa-type clip technology can assist with rapid formation of the shape of the in-use cap or helmet (20).

[0064] Select preferred embodiments of the current invention have been disclosed and enabled as required by Title 35 of the United States Code.