Patent Application
20170280813
The present invention relates generally to the field of protecting the human brain upon a trauma. More specifically, the present invention provides an apparatus and methods to reduce an intensity of the mechanical waves from the trauma to the human brain.
Closed head trauma has been understood mostly by physicians looking over surgical findings, radiologic imaging studies and autopsy series of deceased human beings. It has been described as ‘coup-contrecoup’ injury or ‘acceleration-deceleration injury’, based on location of damaged brain tissues and an obvious sequence of events of a sudden forward movement of the brain toward an impact followed by a bouncing-back recoil of the brain. There has been a good deal of consensus as to how an injury to a direct impact site of a brain tissue would occur, but theories are abound to explain mechanisms of the contrecoup injury to the brain tissue. As of 2016, these include ‘positive pressure theory’, ‘rotational shear stress theory’, ‘angular acceleration theory’, ‘cerebrospinal fluid displacement theory’ and ‘negative pressure theory’. Yet none of these theories have been able to propose and verify unifying mechanisms of the brain injury of the so-called contrecoup injury and other associated injuries. In addition, there has not been a validation of a cause and an effect on a series of cases of chronic traumatic encephalopathy sustained by many combat soldiers and athletes. It stands to reason that we may have been blindsided by anatomic findings of the injury and the intricate nature and complex composition of the human head.
Injury to a human tissue can be understood by principles of mechanical waves in physics. A prime example of this which has been utilized for diagnostic purpose of human diseases over many decades is ultrasonographic evaluation of the human tissue. An ultrasound probe emits a range of ultrasonographic waves that are transmitted through the human tissue and a part of the ultrasonographic waves are reflected upon each tissue back to the ultrasound probe. The reflected ultrasonographic waves are registered by the ultrasound probe, which then are electronically interpreted to produce visualized images. Principles of ultrasonographic imaging technique essentially follow the principles of mechanical waves in physics, with the mechanical waves for the ultrasonographic imaging being ultrasound waves. What it means is that no matter how complex and intricate the human tissue would be, the human tissue is no exception for understanding consequences of a delivery of mechanical waves to said human tissue. An impact of a trauma to the human body should be understood as the delivery of mechanical waves to the human body which then undergoes intercellular and intracellular changes including macro- and micro-structural changes. Changes in electrochemical, molecular and signaling pathways of the tissue must occur, but as of now, we are at an early stage of our understanding of pathogenesis of the trauma and its consequences.
One of the extensively studied mechanical waves starting with a sudden big impact energy is seismologic waves which primarily consist of body waves traveling the earth's inner layer and surface waves rippling across the surface of the earth. The body waves comprises P (primary) waves which behave like sound waves and compress objects along their path, and S (secondary) waves which move through solid materials but not liquid materials. Of various physical properties of both the P and S waves, the boundary effects of the waves and the transfer function for the waves would potentially be important for the pathogenesis of the injury to the brain as the human head is a multi-layered structure consisting of several tissues with each having a distinctively different physical property. Layered from a surface to a deep portion of the brain, the head consists of skin and soft tissue underlying the skin, skull, dura mater, arachnoid membrane, leptomeninges and brain tissue proper in sequence. Inside the brain tissue proper, there are blood vessels and fluid sacs named as ventricular space lined by the leptomeninges.
All of these tissues would be damaged simultaneously in an instant without differences in a degree of the damage if the human head sustains a blunt trauma that has P and S waves having an amplitude and a frequency exceeding a tolerability limit of all of the tissues of the human head. However, there would be differences in the degree of the damage to each tissue of the human head if the amplitude and frequency of the P and S waves of the blunt trauma are within the tolerability limit of the tissues. Upon a blunt trauma to the human head which has an amplitude and a frequency of the P and S waves within the tolerability limit of the tissues, presence of a collected liquid in the head such as in blood vessels and ventricles and differences in proportion of liquid content of the tissues would play a role by the transfer function of medium in differences in the degree of the damage to the tissues of the human head. The amplitude of the P and S waves of the blunt trauma may be amplified or deamplified based on a transfer function of the blood vessels, ventricles and a liquid content of the brain tissue proper. In the field of ultrasonographic imaging of human tissue, it is a well-known phenomenon to obtain an augmented amplitude of reflected ultrasound waves back from a tissue behind a fluid sac, which is called acoustic enhancement. It is conceivable to anticipate such amplification of the P and S waves from a tissue behind large sized blood vessels and ventricles located in a relatively linear path from an original site of the blunt trauma on the human head. It is intriguing to note that two of the most common sites of the chronic traumatic encephalopathy are thalamus and amygdala just below the fluid filled lateral and third ventricles of brain, which suggests that an amplitude of the mechanical waves of an impact on a frontal or a vertex portion of a skull coming to the thalamus and the amygdala via the lateral and thrid ventricles may be amplified by presence of a cerebrospinal fluid inside the lateral and third ventricles by a mechanism of the transfer function of a medium similar to the acoustic enhancement of the ultrasonographic imaging.
The surface waves which is known to ripple across the surface of the earth would also be applicable to our understanding of the pathogenesis of the injury to the human head as the brain is relatively spherically round in configuration and encased by the skull which serves to contain the brain in a bowl configuration. Upon a blunt trauma to the human head which has an amplitude and a frequency of the Love waves and the Rayleigh waves of the surface waves within the tolerability limit of the tissues, both the brain and skull may develop resonant amplification of the surface waves, increasing a damage potential of the blunt trauma to the brain.
Both the boundary effects of and transfer function for the P and S waves of the blunt trauma would be useful for mitigating the injury to the brain tissues. If both the P and S waves of the blunt trauma run into a single boundary generated by a single dividing layer inside a protective shell for the human head at an angle, which is understood as a fixed end for the boundary effects in physics term, there is no displacement at the single boundary of the single dividing layer inside the protective shell but stress (amplitude) of the P and S waves on the single boundary of the single dividing layer of the protective shell is known to be temporarily doubled from the original stress of the P and S waves as long as the P and S waves are maintained within the shell. If the P and S waves are released from the shell upon an impact on the single boundary of the single dividing layer of the shell, an amplitude of the P and S waves on the single boundary of the single dividing layer is to be proportionally reduced. If the protective shell has two boundaries, incident P and S waves to the first boundary of the first dividing layer will be both reflected back and transmitted to the second boundary of the second dividing layer. Similarly, a part of the P and S waves will be reflected from the second boundary of the second dividing layer, heading back to an opposite side of the first boundary of the first dividing layer, and the other part will be transmitted to the brain tissue. The reflected P and S waves from the second boundary of the second dividing layer will collide at the first boundary of the first dividing layer with another P and S waves bouncing back from an original site of the blunt trauma toward the first boundary of the first dividing layer, thus neutralizing at the first boundary of the first dividing layer the amplitude of stress from the P and S waves from both the second boundary of the second dividing layer and the original site of the blunt trauma to an extent. If the P and S waves on to the second boundary of the second dividing layer are released from the shell upon the impact much the same way as the P and S waves on to the first boundary of the first dividing layer are released, an overall amplitude of the P and S waves to the second boundary of the second dividing layer will be accordingly reduced. If there are multiple boundaries and the P and S waves are released upon their impact on each boundary of a dividing layer before the P and S waves get to the brain tissue, the amplitude of the P and S waves to the brain tissue will be reduced proportionally to the number of the boundaries of the dividing layers.
A transfer function of a medium for P and S waves depends on fundamental frequency of the medium, which may amplify or deamplify the P and S waves coming from a source. Of solid materials, rigid elastic materials, liquid materials and gaseous materials, the gaseous materials such as air have the lowest fundamental frequency. If the P and S waves from the original site of the blunt trauma go through a gas medium before reaching the brain tissue, these waves will be deamplified resulting in a decrease in an amplitude of the waves to the brain tissue.
Resonant amplification of the surface waves rippling through the protective shell and the human head should also be deamplified as the surface waves in phase with the P and S waves would amplify the P and S waves, increasing the damage potential of the blunt trauma. One way of reducing the resonant amplification of the surface waves is to use the free-end boundary effect at a circular rim end of each boundary of a dividing layer inside the protective shell. At the circular rim end of the boundary of the dividing layer which is free-ended in physics term, traveled waves from the blunt trauma generate zero stress to the circular rim end but displacement of the circular rim end is temporarily doubled. If the free-ended circular rim end is made displaced freely without reflecting back or transmitting the surface waves to other boundaries, the free-ended circular rim end of the boundary of the dividing layer will oscillate on its own upon arrival of the traveled surface waves without further amplification.
Intensity of an amplitude of the mechanical waves delivered to the brain tissue depends on a mass (weight) of a source generating the mechanical waves multiplied by a velocity of an impact from the source and a mass (weight) of a victim and a stopping distance of the impact by the victim colliding with the source: KE=½×mv2 where KE is kinetic energy before an impact, m is mass in kg and v is velocity in meter/second. Since the stopping distance of the impact by the victim is a relatively fixed value (a head does not fall off from a body) and the velocity of the impact from the source could be a relatively fixed value depending on a type of collision, for an example in a collision during a close body fighting sequence, the weight of both the source and victim for the most part would determine the amplitude of the mechanical waves from the impact. What this suggests is that an one-size-fits-all protective headgear is not proper for a group of human beings with a range of different body weights. A person with a lighter body weight as a source of an impact of a blunt trauma on the other person will incite a less powerful amplitude of mechanical waves of the impact than a person with a heavier weight. By the same token, a person with a heavier weight as a victim of a blunt trauma to the head may not be protected well by a protective headgear which is known to protect a person with a lighter weight. Different types of an impact of the blunt trauma would change the velocity of the source of the impact and of the victim. For examples, a collision of a professional bicyclist at a high speed to a stationary object such as a utility pole on street should be different from two football players wrestling with each other and abutting each other's head.
There are two methods to reduce the amplitude of the mechanical waves delivered to the brain tissue, using the multi-layered protective shell with the aforementioned principles: one method is to increase the number of the boundaries inside the protective shell as practically many as possible to a point there would not be a serious tissue injury to the brain tissue; the other is to pressurize the protective shell with a gas and to let the gas released upon an impact from the blunt trauma. If an amplitude of mechanical waves of a blunt trauma does not exceed a resistive pressure of an impacted gas inside the protective shell, the amplitude of the mechanical waves will go through the layered boundaries in the way described above except that the impacted gas would not be released and some of the mechanical waves will transform to heat and some others transmitted to the brain tissue. If the amplitude of the mechanical waves of the blunt trauma exceeds the resistive pressure of the impacted gas inside the protective shell, then a portion of the impacted gas will be released from the protective shell upon the impact of the blunt trauma. It results in a depletion of a portion of an impact energy carried in the impacted gas, which is a decrease in the amplitude of the mechanical waves reaching the brain tissue. While the number of the layered boundaries of the protective shell is fixed once manufactured, the pressure of the gas in the protective shell can be variably adjustable based on a weight of a person wearing the protective shell and anticipated types and scenarios of an injury. Combining both methods for the protective shell would therefore be more advantageous to using either method alone.
To achieve the goals of reducing an amplitude of mechanical waves of a blunt trauma to a human head and resonance of the mechanical waves delivered to the human head, the present invention comprises a pressurizable and ventable outer balloon shell, conforming to the human head, which encloses a number of independent inner layers stacked up inside the pressurizable and ventable outer balloon shell. The pressurizable and ventable outer balloon shell is inflated and pressurized by a gas which is quantifiably releasable upon the blunt trauma through gas valves to atmosphere once a threshold for venting is exceeded by the mechanical waves of the blunt trauma. Pressure of the gas inside the pressurizable and ventable outer balloon shell is made variably adjustable and monitored by a pressure sensor device which has an alarm function of both a sound alarm and flashing lights. The independent inner layer comprises a sheet to which a number of individual ventable gas cells are attached, arranged in a mosaic pattern. Around a rim of the pressurizable and ventable outer balloon shell, there is provided an enlarged space in which each inner layer ends up with a ruffled free-ended margin. Under the pressurizable and ventable outer balloon shell, there is provided an inner hard shell which covers the human head. A soft padding is provided in between the human head and the inner hard shell. The inner hard shell is at least three layered with an outer layer and an inner layer made of same materials as for the outer layer and a mid layer made of materials having a lower fundamental frequency than that of the materials for the outer and inner layers.
In one embodiment, the pressurizable and ventable outer balloon shell comprises a dome configured in a substantially hemispherical bowl shape and a ballooned rim adjoining a lower circumferential margin of the dome. The pressurizable outer balloon shell is an airtight inflatable shell, and has a pressurized-gas intake valve located on a lower surface of a posterior ballooned rim and a group of pressure-triggerable gas release valves located on the lower surface of the ballooned rim along the circumference of the ballooned rim. On a side of an outer surface of the ballooned rim, the pressure sensor device having the alarm function of the sound alarm and flashing lights is installed, which measures an internal pressure of the pressurizable outer balloon shell. The dome and the adjoining ballooned rim are configured to slidably encase the inner hard shell. Both the pressurizable outer balloon shell and the inner hard shell are configured to cover an area of the human head comprising a part of frontal, an entire parietal, a majority of temporal and an entire occipital region. The pressurizable outer balloon shell is made of a thermoplastic elastomer such as polyurethane elastomer, high-density polyethylene based elastomer or polyamide based elastomer which withstands a range of internal pressure of the pressurizable outer balloon shell above atmospheric pressure over a range of temperature from 0° F. to 175° F. and a blunt impact without material failure.
In one embodiment, the pressurized-gas intake valve is in a configuration of Schrader-type valve for pressurized gas embedded inside the lower surface of the posterior ballooned rim with an opening of the pressurized-gas intake valve disposed on the lower surface, without protruding parts beyond the lower surface. In one embodiment, the pressure-triggerable gas release valves are configured in a spring-operated pressure release valve which is a quick release valve. The spring is configured as compression spring which provides resistance to a range of axial compressive pressure up to a predetermined set pressure limit beyond which the spring yields to the axial compressive pressure. The pressure-triggerable gas release valves are embedded inside the lower surface of the circumference of the ballooned rim in a way at least one gas vent is assigned to each anatomic region of the head, which is to facilitate release of the impacted gas from the impacted region of the head to the nearest pressure-triggerable gas release valve without dissemination of the impacted gas around an internal space of the protective outer shell. It is to reduce rippling surface waves traveling across the protective outer shell, thereby reducing resonant amplification of the amplitude of the mechanical waves.
In one embodiment, the dome and the ballooned rim at the lower circumferential margin of the dome are made as a single piece without connecting parts or seams, not as two separate pieces affixed together, which is to avoid material failure upon repetitive impacts of the blunt trauma. Both the dome and ballooned rim provide an airtight, inflatable and pressurizable space which encloses a number of independent inner layers in a dome configuration concentrically stacked up. Both an outer wall and an inner wall of the dome, made of the semirigid elastomers, are configured to be reversibly and depressibly deformable at an angle to a planar surface of the wall upon an impact of the blunt trauma. The outer and inner wall of the dome and the ballooned rim are not physically attached to the independent inner layers, but form a closed enclosure to enclose the independent inner layers in the dome configuration conforming to the dome of the dome and the ballooned rim in a way the independent inner layers do not move freely inside the enclosure. The ballooned rim provides a space in which a free-ended circumferential margin of the independent inner layers is enclosed.
In one embodiment, the independent inner layer is configured as three-ply sheet having an inner ply made of a thermoplastic elastomer, a mid ply of a woven cloth fabric and an outer ply of the thermoplastic elastomer. The three plies are compressed together under heat to meld the thermoplastic elastomer plies with the cloth ply to impart enough hardness to maintain the dome configuration with reversible deformability over a range of temperature and enough tear strength to withstand repetitive deformative impacts from the blunt trauma without material failure, while dampening a fundamental vibration frequency of the thermoplastic elastomer by a lower fundamental vibration frequency of the woven cloth fabric. A plurality of individual ventable gas cells are fixedly attached to an inner surface of the independent inner layer, with each ventable gas cell separated from the other ventable gas cell by a distance and arranged in the mosaic pattern. In a space between each ventable gas cell, the independent inner layer is perforated with small holes that go through an entire three-ply sheet of the independent inner layer. The circumferential margin of the independent inner layer is free-ended without attachment to an inner wall of the ballooned rim and is made corrugated and slit a number of times at a right angle to the margin for a distance to produce a plurality of strips in ruffled configuration. The ruffled free-ended circumferential margin of the independent inner layer is packed in the ballooned rim, which provides stationary anchoring of the independent inner layer inside the protective outer shell without physical attachment to the inner wall of the ballooned rim.
In one embodiment, the ventable gas cell is configured in a relatively broad base fixedly glued to a semi-elliptical top of a relatively short vertical height fixedly attached to the broad base to form a relatively flat semi-elliptical dome. The broad base is fixedly attached to the inner surface of the independent inner layer and the semi-elliptical dome protrudes in a direction away from the inner surface of the independent inner layer. The ventable gas cell is made of a plurality of thermoplastic elastomers which impart bulging distensibility and compressible deformability to the semi-elliptical dome. The semi-elliptical dome is a two-ply sheet, having an outer ply bonded with an inner ply under heat to form an inseparable sheet. The outer ply is made of one thermoplastic elastomer and has a higher hardness on the Shore scale than the inner ply made of a different thermoplastic elastomer. In a relatively mid-line of the semi-elliptical dome, there is provided a gas vent slit of a length along a longitudinal axis of the semi-elliptical dome through which gas is to be vented out. The slit is a two-ply structure, having an outer slit made on the outer ply and an inner slit made on the inner ply. The outer slit is offset with the inner slit on the longitudinal axis of the semi-elliptical dome, with the outer slit separated by a distance from the inner slit in a way that the outer ply covers the inner slit for the offset distance between the outer slit and the inner slit. The offset configuration of the two slits is to let the semi-elliptical dome distended by a pressurized gas which cannot escape through the inner slit from the semi-elliptical dome unless both the outer and inner slits are open. The semi-elliptical dome is compressible into two halves with each half on one side of the outer slit by compression on each half of the semi-elliptical dome on each side of the outer slit. If the compression of the semi-elliptical dome is deep enough toward the broad base, both the outer slit and inner slit are open and let the pressurized gas vented out from the ventable gas cell. On one side of the semi-elliptical dome, there is provided a gas intake opening with an one-way valve underneath the inner ply of the semi-elliptical dome through which a gas moves into the ventable gas cell upon pressure. When the gas is pumped into the pressurizable outer balloon shell through the Schrader-type valve located in the lower surface of the posterior ballooned rim, it distends the pressurizable outer balloon shell and at the same time distends the ventable gas cells through the gas intake opening of the semi-elliptical dome of the ventable gas cells of the independent inner layer. Upon an impact of the blunt trauma to the pressurizable and ventable outer balloon shell, not only does the pressurizable and ventable outer balloon shell release the pressurized gas, thereby reducing an amplitude of mechanical waves from the impact delivered to the pressurizable and ventable outer balloon shell, but also the pressurizable and ventable outer balloon shell compartmentalizes a region for releasing the pressurized gas from the region of the blunt trauma to preferentially reduce the amplitude of the impact of the blunt trauma at the site of the impact.
In one embodiment, the independent inner layers are concentrically stacked up inside the pressurizable and ventable outer balloon shell in a way a semi-elliptical dome of a ventable gas cell of the first independent inner layer touches an outer ply of the second independent inner layer disposed underneath the first independent inner layer. The semi-elliptical dome of the gas cell of the first independent inner layer is arranged with a group of the ventable gas cells of the second independent inner layer in an interlaced configuration along the vertical axis of the semi-elliptical dome. An edge of a border of the broad base of one ventable gas cell of the second independent inner layer is aligned with a convex portion of one side of the semi-elliptical dome of the ventable gas cell of the first independent inner layer along the vertical axis of the semi-elliptical dome. The other convex portion of the other side of the semi-elliptical dome of the ventable gas cell of the first independent inner layer is aligned with an edge of a border of the broad base of the other ventable gas cell of the second independent inner layer. This stacking-up configuration of ventable gas cells minimizes an area of contact between two sequentially stacked-up independent inner layers, which is to reduce transmission of the mechanical waves through the stacked-up independent inner layers. Additional independent inner layers are stacked up in the same configuration as for the first and second layers.
In one embodiment, a gas pressure in the pressurizable and ventable outer balloon shell is monitored by a piezoresistive pressure sensor device which is a sealed pressure sensor type and battery-operated. It is configured to measure a range of operational pressure of the gas inside the pressurizable and ventable outer balloon shell and to generate both the sound alarm and flashing lights. A pressure sensor circuit board with a battery of the pressure sensor device is affixed to the inner wall of the ballooned rim and an alarm part of the pressure sensor device protrudes through the wall of the ballooned rim to an outer surface of the ballooned rim for a piezoelectric speaker generating the sound alarm and a visual display for flashing lights. The visual display part comprises color-coded light emitting diodes which flash a certain type of color such as blue if the gas pressure inside the pressurizable and ventable outer balloon shell is above or red if below a certain threshold of the gas pressure that the pressurizable and ventable outer balloon shell is set to maintain for proper operational protection of a head of a user.
In one embodiment, a gas pressure in the pressurizable and ventable outer balloon shell is variably adjustable over a range of pressure according to a sum of a maximum anticipated body weight of a source and a known weight of a victim of a blunt trauma, and to an anticipated maximum gravitation force of the blunt trauma which depends on a velocity of the blunt trauma. A heavy weight of the source and a high velocity of the anticipated type of the trauma would require a higher gas pressure; a lower gas pressure would suffice for a light weight of the user and a slow velocity of the anticipated type of the trauma. For an example, an average body weight of football players according to the National Football League Prototypes Data for Draft Guides in 2011 is 240 lbs, ranging from 180 lbs of kick returners and place kickers to 300 lbs of offensive guards and offensive tacklers. Therefore, the range of the average body weight for the pressure adjustment for the gas pressure ranges from 360 lbs to 600 lbs, since the blunt trauma is a bidirectional event, as the gas pressure to withstand a collision should tolerate the sum of the weight of both the source and victim. Assuming that up to 10% standard deviation would be permissible for the average weight, the weight scale for titrating the gas pressure then should be between 320 lbs to 660 lbs. In the football example, the maximum gravitational force of an impact by a person is known to be 150 g. Since the amplitude of the mechanical waves of the blunt trauma temporarily is doubled at a fixed boundary of a skull, a gravitational force that needs to be withstood by the pressurizable and ventable outer balloon shell should be 300 g±30 g (10% S.D.). To add a safety margin over the maximum value of 330 g, a 400 g would be in theory suitable for adjusting the gas pressure. The known range of gravitational forces being responsible for a concussion of a brain is from 60 g to 170 g, indicating a need to reduce the gravitational force which a victim could sustain without the concussion to below 60 g±6 g (10% S.D.). Adding a safety margin to this, it would be reasonable for the pressurizable and ventable outer balloon shell to reduce a delivered gravitational force to the brain of the victim to less than a 30˜40 g. If a velocity of the impact of the blunt trauma is 30 mph, a time from the very first contact between the source and the victim to a full impact would be about 20˜30 milliseconds. In this scenario, the pressurizable and ventable outer balloon shell should release the pressurized gas within 20˜30 milliseconds to lower the gravitational force to less than 30˜40 g delivered to the brain to avoid the concussion. Calculations should be different for young children or light weighted people and for other types of trauma scenarios such as motor vehicle accidents or a cyclist hitting a stationary object at a high speed or hitting a pedestrian walking on a street.
In one embodiment, the inner hard shell is provided in a dome configuration, and comprises at least three layers with both the outer and inner layer made of an impact resistant polymer such as carbon-fiber-reinforced-polymer or glass-fiber reinforced nylon and the mid layer made of a plurality of non-polymeric porous materials such as woven cloth fabrics. All three layers are bonded tightly to protect the skull against fracture upon the impact of the blunt trauma to the head. The mid layer of the non-polymeric porous materials serves to reduce transmission of the amplitude of the blunt trauma through the inner hard shell on both ways, i.e., from a source of the blunt trauma to a victim and from the victim to the source.
As described below, the present invention provides a mechanical-waves dispersing protective headgear apparatus and methods of use. It is to be understood that the descriptions are solely for the purposes of illustrating the present invention, and should not be understood in any way as restrictive or limited. Embodiments of the present invention are preferably depicted with reference to
9B show a schematic view of the pressurizable and ventable outer balloon shell.
It is to be understood that the aforementioned description of the apparatus and methods is simple illustrative embodiments of the principles of the present invention. Various modifications and variations of the description of the present invention are expected to occur to those skilled in the art without departing from the spirit and scope of the present invention. Therefore the present invention is to be defined not by the aforementioned description but instead by the spirit and scope of the following claims.
