Smart Tourniquet

Abstract

A multilayer smart tourniquet applied about a wound environment or injured tissue. The smart tourniquet can be supplied with sensors and micro heating and cooling units.

Claims

1) A tourniquet adapted for use about a wound environment or an injured tissue; the tourniquet comprising: a) an inner layer proximate the wound environment or an injured tissue; the inner layer comprising; i) a plurality of sensors attached to the inner layer, wherein at least some of the sensors sense pressure; and ii) a first port adapted to receive and distribute a first portion of an expandable foam conforming to the wound environment; b) a bladder contacting an outward side of the inner layer; the bladder sandwiched between the inner layer and an outer layer of the tourniquet, wherein the bladder comprises a second port adapted to input a second portion of the expandable foam into the bladder, thereby causing the inner layer to conform to all or a portion of the wound environment; c) a plurality of semiconductors comprising thermal interfaces and ferromagnetic properties; the plurality of semiconductors connected to the inner layer, the foam 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; d) a receptacle distinct from the inner layer, the bladder and the outer layer; the receptacle adapted to releasably hold a communications module to the tourniquet, wherein the receptacle comprises a junction for the tourniquet's electrical connections; e) one or more of the inner layer, the bladder and the outer layer comprising: compositions, fabrics or combinations thereof causing the inner layer, the bladder or the outer layer to function as synthetic muscle when the compositions or fabrics are activated by on/off electric current such that micro-increments of compressive, static or decompressive forces are delivered to the wound environment or the injured tissue; f) a detachable communications module, distinct from the receptacle, comprising a housing adapted for connection with the junction; the housing comprising: i) a first face magnetically reciprocating 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 tourniquet and displays by the touchscreen; g) 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 h) circuitry providing connections between the communications module, the junction, the sensors and the semiconductors and a power source for the communications module.

2) The tourniquet of claim 1, wherein at least some of the plurality of sensors sense one or more of the following biometrics: 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.

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

4) The tourniquet of claim 2, wherein the display on the housing's touchscreen was created by the communications module, the Cloud server, the other computer remote from the communications module or a combination thereof.

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

6) The tourniquet of claim 4, wherein the inner layer comprises one or more therapeutic zones including one or more of the following compositions: analgesic, anesthetic, anti-inflammatory, antimicrobial, hemostatic and vasoconstrictive agents, growth factors or a combination thereof.

7) The tourniquet of claim 6, wherein one or more of the pressure sensors are incorporated into one or more loops associated with the outer layer.

8) The tourniquet of claim 4, wherein the thermal interfaces induce vibrations of fluids proximate the thermal interfaces and comprise carbon nanotubes adapted to decrease thermal interface resistance.

9) The tourniquet of claim 8, wherein up to about a 25 degree Celsius temperature differential is generated.

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

11) A tourniquet adapted for use about a wound environment or an injured tissue; the tourniquet comprising: a) an inner layer comprising; i) a plurality of sensors attached to the inner layer, wherein at least some of the sensors sense pressure; and ii) a first port adapted to receive and distribute a first portion of an expandable foam conforming to the wound environment; b) heating and cooling semiconductors connected to the inner layer, wherein an activated semiconductor heats or cools its footprint on the wound environment or injured tissue; c) the inner layer and the outer layer comprising: compositions, fabrics or combinations thereof causing the inner layer or the outer layer to function as synthetic muscle when the compositions or fabrics are activated by on/off electric current and deliver micro-increments of compressive, static or decompressive forces to the wound environment or injured tissue; d) a receptacle, distinct from the layers, comprising a junction for the tourniquet's electrical connections, wherein the receptacle is adapted to releasably hold a communications module; e) a communications module, distinct from the receptacle, comprising a housing adapted for connection with the junction; the housing comprising: i) a first face magnetically reciprocating 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 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 a software for controlling the components, the tourniquet and displays by the touchscreen; and f) circuitry providing connections between the communications module, the junction, the sensors and the semiconductors and a power source for the communications module.

12) The tourniquet of claim 11, wherein: a) at least some of the plurality of sensors sense one or more of the following biometrics: 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 or SVO2; or b) the inner layer comprises one or more therapeutic zones including one or more of the following compositions: analgesic, anesthetic, anti-inflammatory, antimicrobial, hemostatic and vasoconstrictive agents, growth factors or a combination thereof.

13) The tourniquet of claim 12 comprising a bladder layer sandwiched between the inner layer and an outer layer, wherein the bladder layer comprises a second port adapted to input a second portion of the expandable foam into the bladder layer, wherein the bladder layer causes the inner layer to conform to all or a portion of the wound environment; 14) The tourniquet of claim 13, wherein one or more of the pressure sensors are incorporated into one or more loops associated with the outer layer.

15) The tourniquet of claim 13, wherein the heating and cooling semiconductors are connected to the inner layer, the foam, the bladder or a combination thereof and comprise thermal interfaces and carbon nanotubes.

16) The tourniquet of claim 15 comprising one or more straps, hook and loop fasteners, hooks and catches, zippers or any combination thereof.

17) A detachable communications module adapted for use with a customizable multilayered tourniquet applied to a wound environment or injured tissue; the detachable communications module comprising a housing comprising: a) a first face adapted to reciprocate magnetically with an electrical connectivity junction of the customizable multilayered tourniquet; the junction proximate a receptacle distinct from the junction and layers of the customizable multilayered tourniquet; the receptacle adapted to releasably hold the housing; 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 multilayered tourniquet and displays by a 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 junction, a plurality of biometric sensors, synthetic muscle, a power source for the communications module and semiconductors comprising thermal interfaces and ferromagnetic properties, wherein relative to the positioning of each of the semiconductors about the wound environment or injured tissue 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 or injured tissue associated with the semiconductor's footprint; and d) the touchscreen positioned on a second side of the housing visible to a user; the touchscreen displaying interactive data associated with the wound environment or injured tissue to the user; the displayed data allowing the user to control operations of the semiconductors and the synthetic muscle contained in one or more layers of the customizable multilayered tourniquet.

18) The detachable communications module of claim 17, wherein the displayed data allows the user of the communications module to control: a) delivery of micro-increments of compressive, static or decompressive forces to the wound environment or injured tissue; and/or b) heating or cooling footprints supplied by one or more semiconductors to the wound environment or injured tissue.

19) The detachable communications module of claim 17, wherein the biometric sensors sense one or more of the following biometrics: 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 or SVO2.

20) The detachable communications module of claim 17, wherein the displayed data was created by the communications module, a Cloud server, another computer remote from the communications module or a combination thereof.

21) The detachable communications module of claim 18 comprising an audible, visual or a combination thereof alarm activated when the sensed biometric or a therapeutic for a patient is outside of a predetermined range.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] FIG. 1 portrays a preferred embodiment of tourniquet (10) with some structures of tourniquet (10) cut away to show an example of a wound environment (200).

[0041] FIG. 2 discloses a section of a preferred inner layer of tourniquet (10).

[0042] FIG. 3 is an exploded perspective of inner layer (20) and communications module (100).

[0043] FIG. 4 portrays communications module (100), Cloud server or computer (400) and other computers (500) such as a mobile computing device (smart phone, tablet, etc.) or a personal computer or any other type of computing device remote from tourniquet (10).

[0044] FIG. 4a discloses interface (104) of communications module (100).

[0045] FIG. 5 is a perspective of outer layer (150) of tourniquet (10) positioned outward of inner layer (20) or bladder (80).

[0046] FIG. 6 is another perspective of outer layer (150) of tourniquet (10).

[0047] FIG. 7 is another perspective of outer layer (150) of tourniquet (10).

[0048] FIG. 8 is another perspective of outer layer (150) of tourniquet (10).

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0049] 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.

[0050] Preferred embodiments of Tourniquet (10) are disclosed in FIGS. 1-8.

[0051] FIG. 1 portrays a preferred embodiment of tourniquet (10) applied to patient's extremity (190) with some structures of tourniquet (10) cut away to show an example of a wound environment (200).

[0052] The current smart tourniquet (10) includes inner layer (20), outer layer (150) and communications module (100) connected to receptacle (120). Select preferred embodiments can be provided with an optional bladder (80) disposed outward from inner layer (20) and inward from outer layer (150).

[0053] FIG. 2 discloses a section of a preferred inner layer of tourniquet (10). Inner layer (20) can be a flexible, soft and stretchable fabric constructed of one or more polymers or finely knit fabrics. By way of illustration, capillary vessel dilation can occur while absorbing heat away from the skin and inner layer (20) can be provided with a far infrared radiation fabric or bio ceramic-integrated fabric that can improve microcirculation about wound environment (200). Preferred embodiments of inner layer (20) can include hydrophobic adhesive polymers or equivalents that can assist in reducing movements of tourniquet (10) about wound environment (200) of extremity (190). Hydrophobic adhesive polymers or equivalents can be woven into or laminated onto inner layer (20). Inner layer (20) can include compositions impermeable to higher viscosity liquids and fluids. The inner layer (20) can be provided with one or more therapeutic zones (22) including one or more of the following: analgesic, anesthetic, anti-inflammatory, antimicrobial, hemostatic and vasoconstrictive agents, growth factors or any other medically beneficial composition combination thereof.

[0054] Select preferred embodiments of inner layer (20) are provided with semiconductors (24), e.g., micro-Peltier units. Although not shown in the Drawings, tourniquet (10) includes required circuitry interconnecting connecting semiconductors (24) to communications module (100). Current flow direction through semiconductors (24) controls whether semiconductors (24) generate heat or cooling. Footprints of semiconductors (24) can be less than 2 millimeters.sup.2to limit potential soft tissues injuries associated with wound environment (200) and nearby skin. Among other things, semiconductors (24) cooling and heating can assist in managing tissue swelling, contraction or secondary defect formation. When a patient is hypothermic, it may result in microcirculation collapse through higher vascular resistance and lead towards greater soft tissue ischemia or death. Heating the extremity may preserve perfusion to the effected extremity. Alternatively, cooling the extremity may assist in hemostasis and hemorrhage control. Power for semiconductors (24) and other components of the current tourniquet can be provided by batteries, a connection with an alternating current power source or a radio frequency energy supply. Among other things, heat/cool software can generate a heat map of temperatures within tourniquet (10) 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 (24) inside tourniquet (10) can improve medical outcomes for the patient. Inner layer (20) can be provided with a first port (30) adapted to couple with a device distinct from tourniquet (10) such as bag (240).

[0055] FIG. 3 is an exploded perspective of inner layer (20), optional bladder (80) and communications module (100). In preferred embodiments of the current invention, sensors (60) are associated with inner layer (20). Sensors (60) can be pressure sensing sensors. When engineering parameters require, sensors (60) can be sandwiched between first surface (26) and a second surface of inner layer (20) or bladder (80).

[0056] Sensors (60) can be printed onto inner layer (20) or include adhesive layers such as pressure sensitive adhesives (PSA), cement, heat activated polymers. Sensors (60) can be printed directly on inner layer (20) or be transferred on a TPU film through heat activation. For select embodiments, sensors (60) can be composed of electroactive inks (i.e copper, silver, platinum, carbon or combination), graphene or carbon nanotubes. One or more sensors (60) are capable of sensing biometrics, including but not limited to, pressure, temperature, blood pressure, lactate levels, pH, sodium levels, potassium level, glucose levels, apoptotic factors, nitric oxide and SVO2. Tourniquet (10) is provided with circuitry (66) connecting the one or more sensors (60) to communications module (100).

[0057] As previously indicated, bladder (80) can be disposed between inner layer (20) and outer layer (150). Bladder (80) is provided with second port (62) adapted to couple with a device distinct from tourniquet (10) such as bag (240).

[0058] Bladders (80) can include polymers such as polyurethane (PU) materials. When medical parameters require, bladder (80) can include compositions such as graphene or carbon nanotubes capable of acting as synthetic muscle when electric current is supplied to bladder (20). Use of synthetic muscle can provide increased compression, electronically controlled compression, or sequential compression of inner layer (20). Although not shown in the Drawings, tourniquet (10) is provided with circuitry adapted to connect synthetic muscle (80) to communications module (100).

[0059] Bag (240) includes nozzle (242) configured for engagement with port (82) of bladder (80). By way of illustration, bag (240) can include two compartmentalized liquids for creating silicone foam. When a seal separating bag's (240) compartments is broken, a silicon foam expansion reaction adapted to fill volume of wound environment (200) is catalyzed. The silicon foam expansion can be deployed about wound environment by extrusion directly into wound environment (200), into first port (30) of inner layer (20) or second port (82) of bladder (80) for subsequent filling of wound environment (200). Use of the current tourniquet (10) allows customized compression on any morphology to wound environment (200), i.e. large defect, amputation, etc. It has been discovered in situ set up of creating a foam layer for an underlying tissue defect can be accomplished in 10 minutes or less.

[0060] Tourniquet (10) is provided with receptacle (120) adapted to releasably hold communications module (100). Receptacle (120) can be distinct from inner layer (20) and composed of TPU materials, silicone, PU or other materials acceptable in the art. Receptacle (120) is provided with a junction for electrical connections and interconnected with some or all of the circuitry of tourniquet (10). In select preferred embodiments, receptacle (120) can be provided with one or more lips or rails to releasably hold communications module (100) to tourniquet (10). Among other things, removability of communications module (100) from tourniquet (10) allows cleaning or changing one or more layers (20, 80, 150) without damaging communications module (100).

[0061] FIG. 4 portrays communications module (100), Cloud server or computer (400) and other computer (500) such as a mobile computing device (smart phone, tablet, etc.) or a personal computer or any other type of computing device remote from tourniquet (10). FIG. 4a discloses interface (104) of communications module (100).

[0062] Within the ambit of the current invention, communications module (100) can be provided with one or more of the following components: microprocessor (110), memory (112), visual graphics unit (130), touchscreen (140), audio unit (150), battery (160), transmitter or transceiver (170), circuitry interconnecting the components and software (180) for controlling the components. Housing (102) of communications module (100) can include interface (104) adapted to communicate with circuity (66) and junction of inner layer (10). Examples of potential interfaces (104) include pins, T-pins, magnets, metallic conductors or electroconductive materials. Touchscreen (102) can be an OLED or AMOLED touch screen (102) incorporated into an outward face of communications module (100). Within the scope of the current invention, tourniquet (10) can generate a visual or audible alarm when calculated preselected medical parameters are outside predetermined ranges.

[0063] Power sources for communications module (100) 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 (102). The rechargeable power sources can be detachable from housing (102) to engage the recharging energy supply.

[0064] Tourniquet (10) 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 (170) can communicate with a Cloud server or computer (400), other computer (500) such as a mobile computing device (smart phone, tablet, etc.) or a personal computer or any type of computing device remote from tourniquet (10). Among other things, devices remote from tourniquet (10) can be utilized to store data, calculate biometrics and/or control pressures applied by tourniquet (10) to the wound environment (200). By way of illustration, calculations of sensed biometric data can generate an alarm alerting the user of prolonged ischemic times associated with wound environment (200).

[0065] In other preferred embodiments of tourniquet (10), communications module (100) can also calculate biometrics and/or control pressures applied by tourniquet (10) to the wound environment (200). Within in the scope of the current invention, sensors (60) can be provided with transmitters or transceivers (72) for direct wireless communications with communications module (100) or other computing device remote from tourniquet (10).

[0066] FIG. 5 is a perspective of outer layer (150) of tourniquet (10) positioned outward of inner layer (20) or bladder (80). Outer layer (150) can be composed of compressive materials and or woven fabrics capable of providing uniform distribution of pressure over soft tissue within lumen (12) of tourniquet (10). Cords (152) are incorporated with outer layer (150) and utilized to manually control compressive forces supplied by inner layer (20). In select preferred embodiments, outer layer (150) can include a dial apparatus (BOA® system) for cords (152) that can provide micro-control of compressive forces supplied to inner layer (20). The compressive materials can include far infrared technologies adapted to assist in improving microcirculation about wound environment (200). In select preferred embodiments of current tourniquet (10), on/off application of electric current to weaves of outer layer (150) can cause outer layer (150) to function as synthetic muscle and deliver micro-increments of compressive, static or decompressive forces to wound environment (200) or injured tissue. It is believed that outer layer's (150) provision of gentle compression assists with venous hemostasis and lessons venous hypertension. When medical parameters require, semiconductors (24) or other communications hardware can be incorporated into outer layer (150). Outer layer (150) can include components for communication with communications module (100).

[0067] FIG. 6 is another perspective of outer layer (150) of tourniquet (10) applied to patient (P). Outer layer (150) can be provided with rings (154) with loops (156). This embodiment is intended for use with larger vessel diameter compression and intervention such as arteries and larger bore or diameter veins. In operation, one or more rods (158) are inserted through loops (156). Twisting or rotation of rods (158) can be performed (distal to proximal) to one or more loops (156) until the bleeding is stopped. Twisted rods (158) can be secured by hook and loop fasteners (162) attachable to outer layer (150). Rods (158) can be composed of lightweight materials (carbon fiber, nylons, nylon with glass, quarts tpt, etc). Rods (158) can be segmented and connected, multiple and/or collapsible for ease of storage. When rods (158) are not twisted, one or more rods (158) can provide segmental and rigid or semi-rigid fixation to the coronal plane to the patient's extremity (190). Rods (158) can be locked for providing rigid support along outer layer (150) of tourniquet (10). Segments of rods (158) can function as a splint. Select preferred embodiments of outer layer (150) can include a pocket for storage. Rings (154) can be composed of semi-rigid polymers or fabrics. One or more loops (156) can be provided with pressure sensors.

[0068] User interactive visual graphics of the calculated and correlated pressures, temperatures and sensed biometrics are visible on touch screen (140) of communications module (100) and/or computing devices (400, 500) remote from tourniquet (10). In select embodiments, the visual graphics can be color coded. Within the scope of the current invention, touchscreen (102) can display interactive data correlated and sensed by sensors (50) and semiconductors (60). The interactive, visualized, calculated and correlated data can be supplied to detachable communications module (100), cloud server (400) or computer remote (500) remote from communications module (100) or a combination thereof allowing the user of touchscreen (102) to control application of pressure to wound environment (200). Pressures supplied to wound environment (200) can also be controlled by cloud server (400) or computer remote (500) remote from communications module (100). Touchscreen (102) can also display interactive correlated data from biometric sensors (60) 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 or SVO2. Touchscreen (102) can also display a pressure map or a heat map or both associated with wound environment (200) or injured tissue.

[0069] With reference to FIG. 8, another preferred embodiment of tourniquet (10) shows that outer layer (150) is provided with segmented rods (158) and loops (156). Segmented rods (158) can be utilized as one or more splints on one or more sides of outer layer (150). It is believed that his embodiment can be useful to support an extremity (190) of patient (P) having a femur fracture. Although not shown in the Drawings, tourniquet (10) can include a zipper spanning the length of tourniquet (10) for quicker application to an extremity. Other embodiments of tourniquet (10) can be provided with straps, hook and loop fasteners, hooks and catches, zippers or any combination to secure the tourniquet about the wound environment and improve the tourniquet's post application stability.

[0070] When medical parameters require, tourniquet (10) can be folded back on itself to generate additional pressure or compression. When required, one or more longitudinal ends of tourniquet (10) can be closed off for use in a stump compression. For a below the knee amputation, length of tourniquet (10) is adequate to extend beyond the knee. Tourniquet (10) is portable, flat, lightweight, transportable and is adapted for use in in hospital and field settings.

[0071] Select preferred embodiments of the current invention have been disclosed and enabled as required by Title 35 of the United States Code.