METHODS AND DEVICES TO REDUCE THE LIKELIHOOD OF INJURY CAUSED BY CONCUSSION OR EXPLOSION FORCES

专利摘要:
methods and devices to reduce the likelihood of injury from concussion or blast forces. a method and device for reducing the harmful effects of radiation, blast, or concussion energy events includes applying pressure to at least one jugular vein to reduce the outflow of blood from the cranial cavity during or prior to the occurrence of the event. communicated. reducing blood flow from the cranial cavity increases intracranial volume and/or cerebrospinal fluid pressure to reduce the risk of traumatic brain injury and spinal cord injury. reducing the outflow of blood further increases intracranial pressure and volume, and thereby increases the pressure and volume of cochlear fluid, subretinal fluid, and cerebrospinal fluid to thereby reduce the risk of injury to the inner ear, internal structure eye and spinal column. in addition, increased intracranial pressure and volume reduces the likelihood of brain injury and any associated loss of olfactory function.
公开号:BR112015023647B1
申请号:R112015023647-2
申请日:2014-03-14
公开日:2021-09-08
发明作者:David W. Smith；Kevin John Vititoe；Jamison Joseph Float；Chad Michael Leeder
申请人:Tbi Innovations, Llc；
IPC主号:

专利说明:

TECHNICAL FIELD
[0001] The present disclosure is generally concerned with methods and devices to reduce the effects of exposure to incidents of concussion. BACKGROUND OF THE INVENTION
[0002] Head trauma (TBI) remains one of the most common causes of death and morbidity in people under 45 years of age, even in Western societies. About 1.7 million people suffer annually from TBI in the United States alone, resulting in an estimated total cost per year of more than 60 billion US dollars. Historically, the prevention of skull and brain injuries has focused on the use of helmets for external cranial protection. This approach has substantial flaws as helmets have provided benefit for only major penetrating brain injuries and skull fractures. These occur in a very small fraction of head injuries in the civil sphere. Military statistics have shown that, even on the battlefield, less than 0.5% of TCE are due to a penetrating object. However, both military personnel and athletes are subjected to high-speed acceleration-deceleration mechanisms that are not mitigated by helmets and lead to concussion injuries to the brain. In large part, the relative freedom of movement of the human brain within the cranial cavity predisposes to both linear and rotational force vectors, with resulting energy absorption that results in cell disruption and dysfunction, sometimes with delayed cell death.
[0003] The skull and spinal canal contain only nervous tissue, connective tissue and adipose cells and its interstitium, blood and cerebrospinal fluid (CSF). The non-fluid contents do not completely fill the rigid container delimited by the skull and bony spinal canal, leaving a "reserve volume" that is occupied by the fluid components. Changing the volume within a container for a given pressure change is called "compliance". Increases in the volume of the bony skull and spinal canal contents, within the reserve volume range, occur at low vessel pressures (due to the high compliance of the system). The acceleration or deceleration of the skull can result in a differential acceleration or deceleration between the skull and its contents when the brain and fluids collide with the interior of the skull. TBI can occur because of compression, stretching, or tearing of tissue and blood vessels as a result of the impact of the brain on the skull. Considering the semi-solid properties of the mammalian brain, this effect is referred to as "BLISSING".
[0004] Although helmets are effective in preventing infrequent penetration or skull fracture, they have little ability to limit the effects of SIGNALING. Mitigating FLADING by increasing the pressure of the fluid contents of the brain can significantly reduce the propensity for damage to the brain tissue or its blood vessels, reducing the compressibility of the brain. The reduction in compressibility results in reduced absorption of kinetic, acoustic, thermal, and vibrational energy by the brain.
[0005] The same concussion incidents that produce TBI can also have detrimental effects on the inner ear, spinal cord, and eye structures. Sensorineural hearing loss is observed to occur at a rate of 85% in TBI. Simultaneous injuries to the auditory system as a result of acute blast trauma and resulting traumatic brain injury accounted for a quarter of all injuries among Marines during Operation Iraqi Freedom during 2004 - the most common type of single injury . Hearing impairment has become the most prevalent military-related individual disability, with compensations totaling more than US$1 billion annually.
[0006] Although the blast of an explosion might be expected to cause rupture of the tympanic membrane and disruption of the ossicular chain (resulting in conductive hearing loss), available audiology reports have shown that pure neural sensory loss was the most prevalent type of loss hearing loss in patients. An observational study conducted from 1999-2006 found that 58 percent of active duty soldiers who complained of hearing loss were diagnosed with pure sensorineural hearing loss. Data from this study revealed that 38 percent of explosion-related TBI patients also reported sensorineural tinnitus (ringing in the ears).
[0007] The sites for sensorineural hearing loss are the structures of the inner ear referred to as the cochlea and vestibular apparatus (semicircular canals). Both structures are fluid-filled and therefore susceptible to energy absorption induced by MARULHAR. The cochlea's tympanic and vestibular canals are also filled with fluid and transmit pressure and fluid waves to the delicate hair cells of the organ of Corti. Auditory hair cells react directly to vibrations of the fluid in which they are immersed rather than transverse vibrations in the cochlear duct. The cochlea and its associated hair cells are particularly susceptible to the energy absorption of TAKING.
[0008] Approximately 30 ml (21%) of a total CSF volume of 140 ml resides within the spinal axis, and about a third of the compliance of the LCR system has been attributed to the spinal compartment. As in the brain, increasing the pressure of the cerebrospinal fluid within the spinal compartment reduces the spinal compartment's susceptibility to concussion injuries, increasing the elasticity of the spinal column contents, thus reducing the amount of energy absorbed by the spinal column contents when subjected to a concussion force.
[0009] Of the 207 serious eye injuries in a report of military casualties in Operation Iraqi Freedom OIF, 82 percent were caused by blast and blast fragmentation. Eye injuries accounted for 13 percent (19/149) of all battle injuries seen at a combat support hospital during Operations Desert Shield and Desert Storm. Hyphema (blood in the anterior chamber) and traumatic cataract were the most common findings in closed globe lesions, the majority (67%) of the eyes sustained an orbital lesion. Of service members who experience combat eye trauma (COT) in Operation Enduring Freedom, 66 percent also had TBI. Simply put, about two-thirds of combat-related eye injuries were energy absorptions from closed blast waves, resulting in rupture.
[0010] Head trauma, or incidents of concussion or related to explosions leading to TBI, have also been reported as the main cause of anosmia (loss or decreased olfactory function, ie sense of smell). Some studies report that a large proportion of patients with post-traumatic anosmia exhibit abnormalities in the olfactory bulbs and lower frontal lobes, suggesting, in the latter case, that reducing TBI may reduce the risk of anosmia. While loss or impairment of olfactory function can be more than a nuisance to humans, the same injury in Breecher dogs (eg, bomb-sniffing dogs) can be catastrophic. Breecher dogs are inherently exposed to the risk of concussion incidents and their primary purpose is to help soldiers avoid such an event. Preventing or reducing the likelihood of TBI and associated smell loss may be critical to the Breecher dog's mission.
[0011] Standard prophylactic measures designed to protect the brain from injury in the event of head trauma have so far included only several helmets. Helmets are designed primarily to protect the skull from penetrating injuries and fractures, but less from pathological brain movements, exemplified by classic cerebral concussion. Furthermore, helmets have no significant effect on injuries related to explosions in the ears, spinal column and eyes. SUMMARY OF THE INVENTION
[0012] Intracranial injuries due to exposure to external concussion forces remain a devastating condition for which extracranial protection has traditionally been used in the form of helmets. Although headguards are effective in preventing the most devastating intracranial injuries, penetrating injuries and skull fractures, they are limited in their ability to prevent concussions or injuries to structures within the skull. According to a disclosed method, the internal jugular vein (IVJ) is slightly compressed to increase cerebral blood volume and decrease intracranial compliance. This results in increased intercranial volume and resultant pressure and therefore reduced acceleration differential between the skull and its contents when subjected to concussive force. The reduction in differential acceleration between the skull and its contents means a reduction in the propensity for compression, stretching, or tearing of the brain or vascular tissues within the skull, leading to less energy absorption, and therefore to axonal and less traumatic glial disorders. Mild restriction of internal jugular vein flow also leads to an increase in cochlear pressure to reduce the risk of damage to the inner ear, an increase in pressure in the cerebrospinal fluid to reduce the risk of injury to the spinal column, and an increase in intraocular pressure to Protect the inner eye structure from concussion incidents.
[0013] In an attempt to mitigate intracranial roiling it is recognized that the single intracranial compartment that is most amenable to rapid, reversible change in volume and pressure is the blood space. The simplest and fastest way to increase the volume blood compartment is to inhibit its outflow by mechanically restricting one or more of the draining veins in the neck.
[0014] One aspect of the present disclosure, therefore, includes methods for reducing the likelihood of injury to an individual exposed to external concussion force, comprising: contacting one or more protrusions in the subject's neck, wherein each protrusion is located above a or more veins in the individual's neck; and applying external pressure to the lumps sufficient to restrict the flow of blood from the individual's head through one or more veins in the neck. In some modalities, the injury comprises one or more selected from the group consisting of traumatic brain injury, spinal concussion injuries, inner ear concussion injuries, and concussion injuries to the ocular or olfactory structures.
[0015] In some embodiments, the one or more veins in the individual's neck comprise one or more of an internal or external jugular vein. In some related modalities, restricting blood flow out of the individual's head results in an increase in fluid volume and pressure in the individual's intracranial cavity. The cranial volume is not fixed as the eyeballs and tympanic membranes may protrude slightly outward (as in the jugular tympanic reflex), additionally the foramen or opening of the cranial vault are all able to accommodate a larger volume. In some embodiments, external pressure applied to one or more veins in the neck is equivalent to a fluid pressure of 525 mm Hg.
[0016] Other aspects of the present disclosure encompass devices that reduce the risk of traumatic brain injury from concussion incidents in a human or animal subject by reducing the flow of one or more neck veins by compressing at least one of said veins . Devices of this aspect comprise at least one region (i.e., a bulge) that is directed inwardly and contacts the neck of the device user, thereby applying localized pressure to a neck vein.
[0017] In some embodiments, the device comprises a circumferential collar sized to encircle an individual's neck; and one or more inwardly directed protuberances integral with the collar; wherein the bulges are located on the collar so that they are disposed above one or more veins in the individual's neck when the collar is encircling the individual's neck; and wherein the collar is sized to exert sufficient pressure on the bulges to restrict the flow of blood from the individual's head through one or more veins in the neck.
[0018] In some related modalities, the circumferential collar is sized to be positioned between the individual's clavicle and cricoid cartilage.
[0019] In some related embodiments, the collar defines a cutout sized and positioned to provide clearance for the laryngeal prominence when the collar encircles the individual's neck.
[0020] In some related embodiments, at least a portion of the circumferential collar comprises an elastic material capable of stretching so as to increase the circumference of the collar. In some further related embodiments, the collar further comprises a compression indicator associated with said elastic material configured to provide a visual indication of the elongation of said portion as it envelops the individual's neck.
[0021] In some related embodiments, the circumferential collar comprises a rigid or semi-rigid portion defining a bridge spanning the laryngeal prominence.
[0022] In some related embodiments, the circumferential collar comprises a strap of flexible material and engagement elements at opposite ends of said strap configured to be engaged so as to engage the individual's neck. In some further related embodiments, the collar further comprises a rigid or semi-rigid portion defining a bridge spanning the laryngeal prominence, wherein engagement elements at opposite ends of the strap are configured to be engaged with corresponding ends of the rigid or semi-rigid laryngeal bridge. In some further related embodiments, the flexible material strap comprises an elastic material capable of being stretched so as to increase the circumference of the collar.
[0023] In some related embodiments, the circumferential collar further comprises one or more pockets disposed within the circumferential collar. In some further related embodiments, at least one of the pockets is disposed within the circumferential collar at a location other than above the protrusions. In some further related embodiments, at least one of the pouches is disposed at a location above one or more of the protuberances. In some additionally related embodiments, a bulge is defined by one or more pockets. In some further related embodiments, at least one of the pouches contains a reversibly compressible foam material, and wherein the interior of the foam-containing pouch is in fluid communication with the exterior of the pouch via a pressure relief valve. In some further related embodiments, the circumferential collar further comprises a pumping element in fluid communication with a pouch, through which the filling level of a pouch can be adjusted.
[0024] In some related embodiments, the circumferential collar further comprises a ratchet engagement adjustment system for cleat cable, comprising one or more cleat cable-type ratchet guides; and one or more receivers for said guides, each of the cable loop type ratchet guides being arranged to pass through a receiver. The receivers are configured to allow movement of a ratchet guide through the receiver in one direction, thus reducing the circumference of the circumferential collar, but preventing movement of the ratchet guide in the reverse direction. Additionally, the ratchet guides are configured to move away from the circumferential collar at a point below their corresponding receptors when pulled away from the circumferential collar at a force greater than or equal to a predetermined level.
[0025] In some related embodiments, the circumferential collar further comprises a ratchet engagement adjustment system for cable, comprising: one or more cables spanning at least a portion of the circumference of the collar; and one or more ratchet elements, with each ratchet element connected to at least one of the cables. In these embodiments, each of the ratchet elements is configured to adjust the circumference of the collar by adjusting the length of a cable spanning at least a portion of the circumference of the collar. In some further related embodiments, the ratchet engagement adjustment system further comprises a separate circumferential collar adjustment tool configured to reversibly engage the ratchet system. In some alternative embodiments, the ratchet engagement adjustment system further comprises an adjustment tool integral to the circumferential collar.
[0026] In some related embodiments, the device further comprises one or more discernible graphical or tactile reference points on an outer surface of the device.
[0027] In some related embodiments, the circumferential collar further comprises one or more sensors capable of detecting pulse rate, blood pressure, or other indications of proper placement and pressure of a bulge above a neck vein. In some further related embodiments, the device further comprises a transmitter operably linked to a sensor, wherein the transmitter is capable of transmitting a signal indicative of a reading from the sensor to an external device. In some further related embodiments, the device further comprises an electronic circuit operatively linked to a sensor, whereby the electronic circuit is configured to provide visual or audible cues of proper fit and/or alignment. In some embodiments, the visual cues may comprise light from a light emitting diode (LED). In some embodiments, auditory cues can comprise sound from a speaker.
[0028] In some embodiments, the device comprises a semicircular collar comprising an arcuate resilient strap having a general C, V or U shape and sized to surround a portion of an individual's neck; and one or more inwardly directed protuberances integral with the semicircular collar. In these embodiments, the bulges are located on the semi-circumferential collar so that they are disposed above one or more veins in the individual's neck when the collar is surrounding a portion of the individual's neck; and wherein the collar is sized to exert sufficient pressure on the bulges to restrict the flow of blood from the individual's head through one or more veins in the neck.
[0029] In some related modalities, the semi-circumferential collar is sized to be positioned between the individual's clavicle and cricoid cartilage.
[0030] In some related embodiments, the semi-circumferential collar has an opening at the front of the neck or at the back of the neck.
[0031] In some embodiments, the device comprises: a flexible material sized to enclose a minority of the circumference of an individual's neck; and one or more inwardly directed protuberances contacting an inner surface of said flexible material. In these embodiments, the flexible material is sized such that an inner surface of the flexible material extends beyond a bulge, and the bulges are of appropriate size and shape such that when placed in the throat above a vein in the individual's neck , the device restricts the flow of blood leaving the individual's head.
[0032] In some related embodiments, the flexible material comprises a plastic or fabric.
[0033] In some related embodiments, a portion of the flexible material that extends beyond a protrusion is coated with an adhesive.
[0034] In some related embodiments, the flexible material is an elastic material. Alternatively, in some related embodiments, the flexible material is an inelastic material.
[0035] In some related embodiments, a bulge is defined by an outward bending point of an arcuate resilient strip having an overall C, V, or U shape.
[0036] In some related embodiments, the devices are intended to be applied to an individual's neck in pairs. In some related embodiments, two such devices are connected to each other by a removable chain; where the detachable chain is sized to facilitate proper spacing and alignment when applying to an individual's neck.
[0037] In some embodiments, the device comprises an arcuate resilient strap having an overall C, V or U shape and sized to enclose a minority of an individual's neck, and one or more inwardly directed bulges. In these embodiments, when applied to an individual's neck, the arcuate resilient strap is configured to apply pressure to one or more nubs to restrict the flow of blood leaving the individual's head.
[0038] In some embodiments, the collar may comprise a textile. In related embodiments, the collar can comprise an elastic material.
[0039] In some embodiments, the circumferential or semi-circumferential collar may comprise a shape memory semi-rigid material, such as a suitable polymer (e.g., an elastomer) or shape memory alloy.
[0040] In some embodiments of this aspect of the disclosure, collar size and collar tension may be adjustable. In some embodiments of this aspect of the disclosure, the device may further comprise one or more standoff release mechanisms.
[0041] In some embodiments of this aspect of the present disclosure, at least one region of the device directed inwardly to contact an individual's neck may be formed by inflating a region of the collar, and wherein the device further comprises optionally, a pump for inflating the inflatable protrusion, or any region of said device, and, optionally, a source of pressurized gas or liquid for inflating the same. In some embodiments of this aspect of the disclosure, the device may further comprise a release valve to regulate pressure in said collar.
[0042] Another aspect of the disclosure encompasses embodiments of a method of increasing intracranial volume and pressure of an animal or human subject comprising: (i) wrapping the neck of a human or animal subject with a collar, wherein said collar has at least one region directed inwardly for contacting the neck of an animal or human subject; (ii) positioning at least one inwardly directed region to contact the neck in a region of the neck overlying a neck vein carrying blood from the subject's intracranial cavity; and (iii) applying pressure to the neck vein by pressing at least an inwardly directed region to contact the neck over the neck surface, thereby restricting the flow of blood leaving the individual's intracranial cavity, thereby increasing pressure and/or intracranial volume of the individual.
[0043] Other aspects of the present disclosure provide methods for mitigating injuries to the inner ear, ocular structure and spinal column, and for preventing loss of olfactory function. In the method to mitigate inner ear injuries, pressure is applied to the jugular veins to thereby increase the cochlear fluid volume and pressure during the concussion event. In the method to mitigate injuries to the ocular structure, pressure is applied to the jugular veins to thereby increase intraocular fluid pressure during the concussion event. In the method to mitigate injuries to the inner ear, pressure is applied to the jugular veins to thereby increase the volume and pressure of cerebrospinal fluid during the concussion event. Applying pressure to the jugular veins also reduces or prevents loss of sense of smell due to increased intracranial volume and pressure.
[0044] In any of the above aspects or embodiments of the invention, the devices are adapted to apply a pressure to the neck veins of less than or equal to 80 mm Hg, 70 mm Hg, 60 mm Hg, 50 mm Hg, 40 mm Hg, 30 mm Hg, or 20 mm Hg. Alternatively, the pressure applied to the neck veins is greater than or equal to 20 mm Hg, 30 mm Hg, 40 mm Hg, 50 mm Hg, 60 mm Hg, or 70 mm Hg. In some embodiments, the devices are adapted to apply pressures to the neck veins of 10-80 mm Hg, 15-60 mm Hg, 15-40 mm Hg, or 20-40 mm Hg.
[0045] In any of the above aspects or embodiments, the one or more neck veins comprise two, three, four, or more neck veins. Likewise, devices can have one, two, three, four, or more nubs. Each bulge can transmit pressure to a single neck vein or two or more neck veins simultaneously, depending on the size, shape, and location of the bulge.
[0046] As used herein, the term "circumferential collar" is used to describe a device which encompasses the entire circumference of the neck when the device is worn by a human or animal individual.
[0047] As used herein, the term "semi-circumferential collar" is used to describe a device which involves a majority (ie more than 50%) of the neck circumference when the device is worn by a human subject. or animal. The portion of the neck circumference that is not surrounded by a semi-circumferential collar can be disposed anywhere around the neck circumference, while the wrapped portion allows pressure to be applied to a vein in the wearer's neck. Typically, the open portion will be located either at the front of the throat (for example, in some embodiments, a semi-circumferential collar may surround the neck with the exception of an area substantially defined by laryngeal prominence), or the open portion will be located in the back of neck.
[0048] As used herein, the term "minority of the neck", in reference to the disclosed methods and devices, refers to a device that involves less than a majority (i.e., less than 50%) of the neck. In some embodiments, devices that involve a minority of the neck contact only a small portion of the neck, for example, a few inches. As described in more detail below, these devices may be only a few inches long and comprise the bulge that is placed over the neck vein to which pressure is to be applied, and a sufficient amount of a structural element, such as a flexible material, which optionally contains an adhesive, to securely affix the device to the individual's neck. In one embodiment, the devices comprise two distally located bulges that contact two neck veins, one on each side of the neck (eg, the left and right VJE or the left and right VJI). Alternatively, the device can be designed to contact only a single neck vein. In this embodiment, the devices can optionally be used in pairs as described herein. BRIEF DESCRIPTION OF THE DRAWINGS
[0049] Other aspects of the present disclosure will be more easily appreciated after reviewing the detailed description of its various modalities, described below, when taken in conjunction with the accompanying drawings.
[0050] FIGS. 1(a)-1(c) are top and side views of a compression collar in accordance with a described embodiment.
[0051] FIG. 2 is a top view of a compression collar in accordance with another disclosed embodiment.
[0052] FIG. 3 is a top view of a compression collar in accordance with another disclosed embodiment.
[0053] FIG. 4 is a top view of a compression collar of another embodiment incorporating a compression gauge.
[0054] FIG. 5 is a top view of an overlay to be mounted on the collar of FIG. 4.
[0055] FIG. 6 is a partial top view of the compression and overlap collar of FIGS. 4-5.
[0056] FIGS. 7(a)-7(c) are successive views of the compression collar overlay and indicator strips shown at different degrees of collar stretch.
[0057] FIG. 8 is a graph illustrating the change in intracranial pressure (ICP) as a consequence of VJI compression, p value < 0.01.
[0058] FIG. 9 is a graph illustrating the change in intracranial pressure (ICP) as a consequence of VJI compression, p-value 0.01.
[0059] FIG. 10 is a graph showing a representative plot of the physiological change observed in intracranial pressure (ICP) and intraocular pressure (IOP) over a fifteen-minute period caused by application (left arrow) and removal of VJI compression (arrow to right). Noteworthy is the rapid response observed in both the PIC and PIO and the corresponding volumes after a VJI compression, as well as the duration for which these changes are sustained.
[0060] FIG. 11A is a digital color image of corticospinal tracts for post-injury PPA without application of the VJI compression device in accordance with the disclosure.
[0061] FIG. 11B is a color digital image of corticospinal tracts for post-injury PPA, with application of the VJI compression device in accordance with the disclosure.
[0062] FIG. 12 is a graph illustrating the compression effect of VJI on axonal injury as indicated by PPA staining, p value < 0.01.
[0063] FIG. 13 shows an illustration of a circumferential collar made of an elastic material that can be used in various embodiments of the present invention.
[0064] FIG. 14 shows an illustration of an embodiment of the present invention comprising a circumferential collar, an opening and closing fastener, and two protrusions configured to apply pressure to a vein in a wearer's neck.
[0065] FIG. 15 shows an illustration of an embodiment of the present invention comprising a circumferential collar, an opening and closing fastener, a laryngeal bridge, and two protrusions configured to apply pressure to a vein in a wearer's neck.
[0066] FIG. 16 shows an illustration of an embodiment of the present invention comprising a circumferential collar comprising two pieces: a first piece (i.e. the front section) comprising two protrusions each configured to apply pressure to a vein in a wearer's neck, and a second piece (i.e., back section) comprising a fabric collar configured to be removably attached at both ends to the first piece.
[0067] FIG. 17 shows an illustration of an embodiment of the present invention comprising a circumferential collar, an opening and closing fastener, and two protrusions, both (comprising a pocket and a pressure release valve) configured to apply pressure to a neck vein of a user.
[0068] FIG. 18 shows an illustration of a semi-circumferential collar with a front opening that can be used in various embodiments of the present invention.
[0069] FIG. 19 shows an illustration of a semi-circumferential collar with a rear opening that can be used in various embodiments of the present invention.
[0070] FIGS. 20A-C show illustrations of exemplary embodiments of the present invention that apply pressure to appropriate positions in the neck without the use of a circumferential collar. These modalities are typically used as pairs, with a device worn one on each side of the neck. Optionally, the devices may further include a removable chain of the appropriate length between a pair of devices that acts as an alignment and spacing guide for neck application.
[0071] FIG. 21 is an illustration of another embodiment of the present invention which applies pressure to appropriate positions in the neck without the use of a circumferential collar. The device shown in FIG. 21 is similar to that of FIGS. 20A-B, but further includes a removable chain of the appropriate length between a pair of devices that acts as an alignment and spacing guide for neck application.
[0072] FIG. 22 is an illustration of another embodiment of the present invention that applies pressure to appropriate positions in the neck without the use of a circumferential collar. In this embodiment, the device comprises a resilient U-shaped strip with a protrusion disposed on one or both ends.
[0073] FIG. 23 is an illustration of a circumferential collar-type device of the present invention comprising a cable-gap cable-type ratchet engagement system, wherein the cable-gap is configured to release from the collar when pulled to or above a specific pressure.
[0074] FIG. 24 is an illustration of a circumferential collar-type device of the present invention comprising a rotary ratchet engagement adjustment system and an external adjustment tool.
[0075] FIG. 25 is an illustration of a circumferential collar-type device of the present invention comprising a rotary ratchet engagement adjustment system with an integral adjustment knob.
[0076] FIG. 26 is an illustration of the circumferential collar-type device of the present invention comprising one or more discernible graphical or tactile reference points on an outer surface of the device.
[0077] FIG. 27 is an illustration of another embodiment of the present invention wherein the device further comprises a sensor configured to detect pulse rate, blood pressure, or other indications of proper placement and pressure of a bulge above a neck vein, and means for transmitting a signal from the sensor to an external device.
[0078] The drawings are described in greater detail in the description and examples that follow. DETAILED DESCRIPTION
[0079] Details of some exemplary embodiments of the methods and systems of the present disclosure are presented in the description below. Other features, objects and advantages of the disclosure will be apparent to a person skilled in the art upon examination of the following description, drawings, examples and claims. All such additional systems, methods, features and advantages are intended to be included within this description, to be within the scope of the present disclosure, and to be protected by the appended claims.
Before the present disclosure is described in greater detail, it should be understood that this disclosure is not limited to the particular embodiments described, and as such may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, as the scope of the present disclosure will only be limited by the appended claims.
[0081] When a liquid in a tank or vessel experiences dynamic motion, a variety of wave interactions and liquid phenomena can exist. The oscillation of a fluid caused by external forces, called "spilling", occurs in moving vessels containing liquid masses. This ripple effect can be a serious problem in energy absorption, and therefore vessel stability and control. The present disclosure encompasses methods and apparatus for reducing the effects of TAKING in living creatures, and in particular in the spinal and intracranial regions of the animal or human subject.
[0082] The blast wave and collision injury mitigation is primarily based on the principle of energy absorption from fluid filled containers. As there is more room for fluid to move within a vessel, more energy can be absorbed (SINK), rather than being transmitted through the vessel. To reduce this energy absorption, one should try to get closer to elastic collisions. Elastic collisions are those that result in the absence of net transfer of energy, primarily acoustic, kinetic, vibrational, or thermal (also referred to as a coefficient of restitution (r) approaching 1.0). Various modalities described below can locally alter, elevate, or temporarily maintain an altered physiology of an organism to reduce the likelihood of energy absorption through DAZZLING whereby the restitution coefficient (r) is increased. The coefficient of restitution (r) indicates the variance of an impacting object far from being a full elastic collision (an (r) of 1.0 = no energy transfer). The explosion or absorption of energy in an organism can be seen as a collision of bodies and, therefore, defined as a transfer of energy through elastic or inelastic collisions. Mechanisms for biological fluids and molecules to absorb energy can thus be identified and the result means that mitigation of this uptake can be achieved through various techniques to reduce DARK. The dissipation of energy after an explosion is also enhanced through these techniques.
[0083] The absorption of MARULHAR can be reduced by increasing pressure or volume reversibly within the organs or cells of the body. Applying this concept to the contents of the skull, intracranial volume and pressure can be reversibly increased by a device that reduces the flow of one or more of the outflow cranial vessels. One modality of such a device would compress the outflow vessels enough to cause an increase in venous resistance, yet not enough to raise blood pressure an arterial pressure leading to the skull above about 80 mm Hg.
[0084] Mitigating SOUNDING by increasing the pressure of the fluid contents of the brain can significantly reduce the propensity for damage to the brain tissue or its blood vessels, reducing the compressibility of the brain. The reduction in compressibility results in reduced absorption of kinetic, acoustic, thermal, and vibrational energy by the brain.
[0085] Intracranial volume can also be reversibly increased by increasing pCO2 in arterial blood or by administering one or more medications to facilitate an increase in intracranial volume or pressure, including but not limited to Minocycline, growth factor similar to insulin 1, Provera and Vitamin A. Such techniques can be used in combination with the use of the devices disclosed herein.
[0086] With regard to the inner ear, it is known that the cochlear aqueduct is in direct communication with the cerebrospinal fluid (CSF) and the vein of the aqueduct drains directly into the internal jugular vein (VJI). Venous blood either empties directly into the inferior petrosal sinus or internal jugular vein, or circulates through other venous sinuses via the vestibular or cochlear aqueduct vein. Reducing internal jugular outflow would necessarily congest the cochlear vein and assume inner ear compliance, thus improving elastic collisions at the macroscopic, cellular and molecular level and thus reducing the energy allocation to these structures.
[0087] Approximately 30 ml (21%) of a total CSF volume of 140 ml resides within the spinal axis, and about one-third of the compliance of the LCR system has been attributed to the spinal compartment. As in the brain, increasing the pressure and volume of cerebrospinal fluid within the spinal compartment reduces the spinal compartment's susceptibility to concussion injuries, increasing the elasticity of the spinal column contents, thus reducing the amount of energy absorbed by the spinal column contents when subjected to a concussion force.
[0088] With regard to eye injuries, it is known that the woodpecker has a "pectin apparatus" that protects the globe of its eyeball from the impact of 1200 G of pecking. The only purpose of the pectin apparatus seems to be to increase the volume and pressure of the vitreous humor inside the eyeball. The pectin apparatus is located inside the eyeball and fills with blood to briefly raise intraocular pressure, thus maintaining firm pressure on the lens and retina to prevent injuries that could occur during the 80 million pecking strokes over the lifetime. of the woodpecker. Although humans do not have the pectin apparatus, it is possible to increase intraocular pressure by applying external pressure on the external jugular veins (EVJ).
[0089] One aspect of the present invention therefore encompasses a device that increases intracranial volume and pressure and/or intraocular pressure when used by an animal or human subject. The device is configured to apply pressure to the outflow vasculature in the neck (e.g., one or more internal and/or external jugular veins), thereby increasing the user's intracranial and/or intraocular pressures and volumes. In so doing, the device reduces the user's energy uptake due to concussion effects, thus reducing the likelihood of one or more brain, spine and eye injuries due to a concussion event. Devices of the present invention could preferably be used before, in anticipation of and during risky events of FLASHING and traumatic brain injury.
[0090] Safely and reversibly increasing cerebral blood volume by any amount up to 10 cm3 and pressure by any amount up to 70 mm Hg would serve to fill the cerebral vascular tree compliance and thus reduce the ability to absorb external energies through energy absorption from MARULHAR. With the application of measured pressure to the neck, cranial blood volume increases rapidly and remains at a new higher level. Moyer et al reported that cerebral arterial blood flow was not affected by obstruction of the outflow of venous blood from the brain. The relationship of venous pressure to blood volume shows a decrease in the increase in volume with each increase in neck pressure over the range of 40 to 70 mm of mercury. It is of interest that cranial blood volume increases by 10 to 30 percent (with this neck pressure). Similarly, CSF pressure also increases by compressing individual jugular veins. Under the same neck pressure, the average increase in CSF pressure is about 48%. These changes occur very quickly after the onset of pressure; jugular compression increases cerebral blood flow to a new level in less than 0.5 seconds. Although lower cranial pressure and volume increases can still have beneficial effects, the devices of the present invention are intended to increase cranial blood volume by at least 3 cm3 by applying at least 5 mm Hg of neck pressure. In some embodiments, the devices deliver between about 5-70 mm Hg, such as between about 5-60 mm Hg, such as between about 5-50 mm Hg, such as between about 5-40 mm Hg, such as. such as between about 5-30 mm Hg, such as between about 5-20 mm Hg, such as between about 5-10 mm Hg of pressure to the neck veins.
[0091] The devices of the present invention, therefore, can take many forms, but share the functional characteristic of constantly or intermittently applying pressure to one or more veins in the neck (specifically, but not limited to internal and external jugular veins, to veins to the cerebral spinal circulation, and more preferably to the inner jugular vein) to restrict the flow of blood from the brain. Thus, instant devices include at least one inwardly directed protrusion that is inwardly directed and contacts the neck of the device user, and at least one of the means for applying pressure to one or more protrusions such that the protrusions apply pressure. to one or more veins in the neck, thus restricting the flow of blood from the brain. Inwardly directed lumps that contact the user's neck
[0092] In some embodiments, the one or more inwardly directed protrusions are an integral part of the component of the device responsible for applying pressure to the neck. In alternative embodiments, the one or more inwardly directed protuberances are distinct from the component of the device responsible for applying pressure to the neck. It should be generally accepted that the protrusions may be of any suitable shape, for example, pointed or rounded, and comprising any suitable material, as defined by a rigid or semi-rigid plastic body, a thicker region of a collar, and the like.
[0093] In some embodiments, the bulges may be substantially defined by a pouch, in which pressure is exerted on the user's neck when the pouch is inflated or filled. In some related embodiments, the pouch can contain reversibly compressible foam that is in fluid communication with the external atmosphere. In accordance with other related embodiments, the interior of the bag is in fluid communication with the external atmosphere through a pressure release valve. In embodiments comprising a pouch, foam, and valve, these components can be configured so that the foam expands within the pouch, drawing air into the pouch through the pressure valve to inflate the pouch to a desired pressure. . However, the pressure release valve can be configured to allow air to be released from the bag by applying pressure to the device that would otherwise increase the amount of pressure applied to the neck to an uncomfortable or undesirable level. In other embodiments, the pouch may contain a gas or liquid and may be equipped or configured to interface with a pump mechanism such that the pressure of the pouch can be adjusted by the user. The pump mechanism can be any suitable pump mechanism as would be understood in the art, such as for example a power pump, or a hand-held compressible pump by which a liquid, gas or air can be applied to the bag. In certain embodiments, the device may further comprise a pressure sensor operatively connected to the pump or pouch mechanism through which the degree of inflation can be regulated as to the extent and duration of pressure applied to an underlying neck vein.
[0094] In some embodiments, the bulge comprises a spring or a resilient compressible material. In such embodiments, the spring or compressible resilient material is disposed within the protrusion such that application of the protrusion to the neck at least partially compresses the spring or compressible resilient material. The force exerted by the spring or at least partially compressed resilient compressible material ensures that the bulge maintains a desired pressure in the neck.
[0095] In some embodiments, the device may comprise an arcuate resilient strip having a general C, V or U shape. The strip may be formed of a spring-like resilient material through which the C-shaped strip, V or U is forced open as the device is applied. After application of the device, spring tension causes the strap to compress, resulting in the midpoint or arching point of the strap to extend in the direction of and apply pressure to the neck. Thus, in these embodiments, the midpoint or arching point of the straps are the bulges that contact the wearer's neck.
[0096] In some embodiments, at least a portion of an inwardly directed surface of the one or more protrusions may be coated with a suitable adhesive to facilitate placement of the protrusions in the neck, and prevent movement of the protrusion once it is in the correct location . Additionally or alternatively, in embodiments where the nubs are distinct from the component of the device that applies pressure to the neck, at least a portion of an outwardly directed surface of the one or more nubs may be coated with a suitable adhesive. In such embodiments, the design of the device can be such that a protrusion can be placed between a component that applies pressure to the neck and the neck itself. An outwardly directed surface of the protrusion would then contact an inwardly directed surface of the pressure-providing component of the device such that the adhesive on the outwardly directed surface of the protrusion would prevent movement of the protrusion once it is in place.
[0097] An exemplary modality of this type (discussed in more detail below) is composed of three pieces: two round or oval plastic protrusions (one for application on both sides of the neck) and an elastic collar. The device could be applied by first placing the collar around the neck, and then placing the plastic bulges between the collar and neck in the appropriate places to apply pressure to the internal jugular vein in both. sides of the neck. As will be appreciated for this example, a light adhesive coating on the inwardly directed and/or outwardly directed surfaces of the protrusions will help prevent movement of the protrusions once installed between the collar and neck. Alternatively, if the protrusions have an adhesive coating of sufficient strength at least on the inwardly directed surfaces, the protrusions may be placed at the appropriate locations on the neck prior to installation of the collar. In either case, the collar applies pressure to the bulges, which in turn put pressure on the neck veins.
[0098] In other embodiments of this type, two protrusions can be secured together with a chain of appropriate length to act as an alignment and spacing guide for application on both sides of the neck. In some embodiments, the chain can be removable so that once the protrusions are applied to the neck, the chain can be pulled or otherwise removed, leaving the protrusions in place on the wearer's neck.
[0099] In some embodiments, the bulges are compressible pads, or solid shapes sized to apply pressure substantially only to the internal jugular veins. Circumferential and Semi-Circumferential Necklace-Type Devices
[00100] In some embodiments, the device may be a circumferential or semi-circumferential collar. A circumferential collar is a collar that encircles the entire circumference of the neck when the device is worn by a human or animal individual. A semi-circumferential collar is a collar that wraps around the majority of the neck circumference when the device is worn by a human or animal individual. The portion of the neck circumference that is not surrounded by a semi-circumferential collar can be disposed anywhere around the neck circumference, while the wrapped portion allows pressure to be applied to the specifically located inwardly directed protrusions in order to of restricting the flow of blood leaving the brain. Typically, the open portion will be located at or in front of the throat (for example, in some embodiments, a semi-circumferential collar may surround the neck with the exception of an area substantially defined by laryngeal prominence, also known as the "Adam's apple ”), or the open portion will be located at the back of the neck.
[00101] In embodiments where the device comprises a circumferential collar, it is contemplated that the pressure applied to the neck may be due to an internal dimension of the collar being less than the diameter of the neck. This difference in the internal dimension of the collar can be achieved by any number of configurations dictated by the materials used to construct the collar. For example, in a collar comprising inelastic materials, the collar can be sized to apply adequate pressure when worn by an individual. In these embodiments, the size of the collar can be such that the collar is tailored to an individual and therefore does not require fit adjustments. Alternatively, the collar size may be adjustable by any of a number of means, some of which are discussed further below. In some embodiments, the collar may comprise an elastic material so that the inner dimension of the elastic collar is expanded when the collar is worn, and the collar applies pressure to the wearer's neck as a result of the compressive force exerted by the expanded elastic material. . Elastic materials can also confer the benefit of increased comfort for the wearer.
[00102] In embodiments where the device comprises a semi-circumferential collar, it is contemplated that the collar comprises an arcuate resilient strip having a general C, V or U shape. most, if not all, of the length of the necklace. In these embodiments, the collar thus semi-rigid defines a C, V or U shape which is expanded as the collar is applied to a wearer's neck. Spring tension of the expanded arcuate resilient strap causes a compressive force that holds the collar in place at the neck and applies the desired pressure to the neck veins.
[00103] In these embodiments, at least one inwardly directed pad or shape may be arranged at appropriate locations on opposite sides of the collar, such that inwardly directed pads or shapes are configured to contact the neck and apply pressure to a point above the inner jugular vein. In embodiments where the semi-circumferential collar is open at the front of the neck, the area of the neck not covered by the semi-circumferential collar may define a region approximating the laryngeal prominence, also known as the "Adam's apple". In such embodiments, the inwardly directed wad or shapes disposed on opposite sides of the collar may be located at or near the end ends of the arcuate resilient strip. In embodiments where the semi-circumferential collar is open at the back of the neck, the inwardly directed wads or shapes may not be disposed near the terminal ends, but may be disposed much closer to the midpoint of the strap.
[00104] In some embodiments where the device comprises a circumferential collar or a semi-circumferential collar that is open at the back of the neck, the device may comprise a laryngeal bridge that defines an indentation in the front of the neck. The size and shape of the laryngeal bridge can be configured so as to minimize the contact of the collar with the laryngeal prominence, so as to make the collar more comfortable for the wearer. In these embodiments, the laryngeal bridge may be of any suitable material so as to provide a rigid or semi-rigid continuation of the collar around the front of the neck. In some embodiments, the laryngeal bridge can comprise thickened or reinforced textile material, plastic, metal, or any combination thereof.
[00105] In some embodiments where the device comprises a circumferential collar, the device comprises two components: a front section comprising one or more inwardly directed protrusions and a laryngeal bridge, and a rear section comprising a length of tissue configured to be attached to Removable shape at both ends to the corresponding ends of the front section. In some embodiments, the length of fabric comprises an elastic material; alternatively, the length of fabric may comprise an inelastic fabric. Detachably connecting each end of the front to the corresponding end of the rear section can be made by any suitable method known in the art, such as a hook and ladder fitting, a hook and loop fitting, a snap fastener, a button, a chemical adhesive, or any of a number of attachment mechanisms that would be known to those skilled in the art. A device with a removable connecting means could also have a release mechanism whereby the breaking device can break or break apart at a predetermined force to prevent the device from being inadvertently removed or compressing too tightly.
[00106] Many of the devices described herein are described as potentially comprising an elastic material. More particularly, it is intended that these devices can comprise materials that are elastically stretchable around the circumference of an individual's neck. Elastic materials can be any material that, when stretched, will attempt to return to its natural state. Exemplary materials may include one or more of textiles, films (fabrics, non-wovens and fabrics), foams and rubbers (synthetic and natural), polychloroprene (eg NEOPRENE®), elastane and other polyurea-polyurethane copolymers (eg SPANDEX® , LYCRA®), fleece, warp knits or narrow stretch fabrics, raschel, knitting, milanese knits, satin, twill, nylon, cotton wool blend, yarn, artificial silk, polyester, leather, canvas, polyurethane, rubberized materials, elastomers, and vinyl. There are also a number of elastic materials which are breathable or absorb moisture which may be preferable during prolonged periods of use or use during periods of exercise. As noted above, elastic materials can provide the benefit of increased comfort to the wearer by providing sufficient compressive pressure, yet still remaining flexible to accommodate a full range of movement and/or muscle flexibility in the wearer.
[00107] Additionally, a device constructed of an elastic material may be partially reinforced, coated, or otherwise include one or more protective materials such as KEVLAR® (para-aramid synthetic fiber), DYNEEMA® (ultra high polyethylene molecular weight), ceramics or shear thickening fluids. Such reinforced materials can confer the benefit of increasing the tear resistance of the devices. As such, reinforced devices can give the user the advantage of protecting the neck from injury from lacerations.
[00108] In some embodiments, circumferential or semi-circumferential collars can be constructed with elastic or other materials that are fire resistant.
[00109] The device can span horizontally, the entire neck or only partially above and below the neck. The width of the devices described herein can range from a single filament (to a fraction of an inch) to the length of the exposed neck (up to 12 inches in humans or longer in other animals), length can range from 6 to 36 inches to encircle the neck. The width of the compression device can be as small as 1/4 of an inch but only limited by the height of the neck in larger widths, which would typically be less than 6 inches. The thickness of said device can range from a film of only a fraction of a millimeter to a maximum which can be uncomfortable while keeping the neck warm, such as 2-3 inches thick.
[00110] A device modality can be preformed for the user in a circular construction. This one-size-fits-all style can have a girdle-type that allows you to conform the device to any neck size. Alternatively, the device may have a first end and a second end, which are connected by a fastening element. A fastening element may be magnetic, a grip band, a hook and ladder fixture, a hook and loop fixture, a layered strip, one or more zip fasteners, one or more zippers, one or more snap fasteners , one or more buttons, one or more safety pin-type locking mechanisms, overlapping the electrostatic contact materials, or any of a number of connection mechanisms that would be known to a person skilled in the art. A device with a removable fastener could have a release mechanism whereby the breaking device can break or break apart at a predetermined force to prevent the collar from being inadvertently removed or compressing too tightly. A quick release or automatic release mode would be to apply small amounts of hook and ladder connections within a circular ring that would separate if too much force is applied to the device.
[00111] Another embodiment of the device could fasten such that the user would be able to pull on one end of the collar (like a choke collar for a dog) and the force exerted by the user effectively decreases the length or circumference of the device. When the desired neck compression is no longer needed (such as among football players) the user could then release the compression via a second gentle pull or by a separate release mechanism also positioned on the device.
[00112] Other ratchet engagement adjustment systems can be used in the collar-type devices described herein. For example, in one embodiment, a cable-gap cable-type ratchet engagement adjustment system (eg ZIP-TIE®) may be included. This type of system can include one or more standoff clip cables configured to release from the collar when pulled at or above a specific pressure, thus ensuring that the collar is not too tight. In alternative embodiments, a rotary ratchet engagement adjustment system may be included. In such embodiments, the system can be designed such that an external tool is employed for fit adjustment. Preferably, such systems utilize elastic materials and/or an adjustable closure system (as described above) such as a VELCRO® closure system to provide a coarse fit of the device. The ratchet adjustment system would then be used to precisely adjust the device specific to an individual user. As an alternative to an external tool system, rotary ratchet engagement adjustment systems which include an integrated adjustment knob, for example, a BOA® rotary ratchet engagement adjustment system as described in U.S. Pat. No. 8,381,362 and U.S. Pat. Pub. 2012/0246974.
[00113] In some embodiments, a circumferential or semi-circumferential collar may comprise a shape memory polymer. In such embodiments, the collar could be applied to a wearer's neck, then the appropriate stimulus would be applied to the shape memory polymer, causing the collar to shrink to fit.
[00114] In some embodiments, a circumferential or semi-circumferential collar may comprise a pocket whereby the pressure exerted by the collar on the wearer's neck can be adjusted through inflation or deflation of the pocket. In some related embodiments, the pouch can contain reversibly compressible foam that is in fluid communication with the external atmosphere. In accordance with other related embodiments, the interior of the bag is in fluid communication with the external atmosphere through a pressure release valve. In embodiments comprising a pouch, foam, and valve, these components can be configured so that the foam expands within the pouch, drawing air into the pouch through the pressure valve to inflate the pouch to a desired pressure. . However, the pressure release valve can be configured to allow air to be released from the bag by applying pressure to a bulge that would otherwise increase the amount of pressure applied to the neck to an uncomfortable or undesirable level. In other embodiments, the pouch may contain a gas or liquid and may be equipped or configured to interface with a pump mechanism such that the pressure of the pouch can be adjusted by the user. The pump mechanism can be any suitable pump mechanism as would be understood in the art, such as for example a power pump, or a hand-held compressible pump by which a liquid, gas or air can be applied to the bag. In certain embodiments, the device may further comprise a pressure sensor operatively connected to the pump or pouch mechanism through which the degree of inflation can be regulated as to the extent and duration of pressure applied to an underlying neck vein. In some embodiments, the pocket is arranged to include at least a portion of the collar that is not above a bulge. In some embodiments, the pouch is disposed across a majority of the circumference of the collar.
[00115] In some embodiments, a circumferential or semi-circumferential collar may further comprise a pocket or pocket. This pocket or pocket can be externally accessible, i.e. accessible while the collar is in use, or only accessible when the collar is removed. The dimensions of such a pocket or pocket may be such that the pouch or pocket is suitable for carrying one or more articles useful for the treatment of TCE-related calamities, such as a material which allows the administration of CO2, carbonic anhydrase tablets, methylene blue, DHA, anti-fainting salts, etc.
[00116] In some embodiments, a circumferential or semi-circumferential collar may further comprise an electrical circuit comprising a piezoelectric heat pump configured to change the temperature of the surface directed into the collar. Such a heat pump can be used to heat or cool the device, for example, up to 70° from ambient temperature.
[00117] In some embodiments, a circumferential or semi-circumferential collar may further comprise an electrical circuit configured to provide therapeutic electrical stimulation to the wearer's neck. For example, an electrical circuit can be configured to provide electrical nerve stimulation transcutaneously. Non-stick Type Devices
[00118] In some embodiments, the device may be a non-stick type device. Non-collar devices are devices that cover or involve a minority of the circumference of the neck when the device is worn by a human or animal individual. However, the portion of the neck circumference that is covered or enveloped by non-collar devices should include at least one or more areas of the neck above a neck vein, as described above. As with collar-type devices, non-collar devices also use inwardly directed bulges to apply pressure to the neck at specific locations to restrict the flow of blood from the brain. Any of the bulges described above may find use in non-stick type devices.
[00119] In some embodiments, the externally directed side of a protrusion may be covered by a flexible material that extends beyond the area defined by the protrusion. In these embodiments, at least a portion of this extended inwardly directed surface contacts the neck when the device is in the correct location. In some embodiments, at least a portion of the inwardly directed surface of the flexible material that contacts the neck is coated with an appropriate adhesive so that, when applied to the neck, the flexible material holds the bulge in an appropriate position and applies pressure to the neck. a vein in the neck. The flexible material can be elastic or non-elastic. The flexible material can be any suitable synthetic material or natural fabric or textile, or any suitable plastic.
[00120] Such embodiments may comprise a pair of combinations of materials / protrusions for application on both sides of the neck. Some related embodiments may comprise a pair of material/bulge combinations joined by a chain, as described above. The chain can be of appropriate length so as to serve as an aid to proper alignment and placement of the bulges in the correct locations on the neck. In some embodiments, the chain may be detachably attached to the pair of material/protrusion combinations so that after placement of the protrusions on either side of the neck, the chain is removed.
[00121] In some non-collar type devices, the device may comprise an arcuate resilient strip having a general C, V or U shape. In such embodiments, a bulge is intended to be located at or near the end of each arm of the strap, and that when the device is in the correct location, the strap extends around the front of the neck. In these embodiments, the strip, thus semi-rigid, defines a C, V or U shape that expands as the device is applied to a wearer's neck. Spring tension of the expanded arcuate resilient strap causes a compressive force that holds the device in place at the neck and applies the desired pressure to the neck veins via the bulges. In some embodiments, the arcuate resilient strap is sized and configured such that it does not traverse the front of the neck in the general area of the laryngeal prominence. Instead, the strap can cross the front of the neck in a position below the laryngeal prominence. Visual or Tactile Alignment Aids
[00122] Any of the modalities described above may further comprise one or more materials, and/or apply one or more construction methods, designed to provide the user or a third party observer with visual or tactile help to determine proper alignment and positioning of the lumps. For example, a necklace-type device may include a small band or fragment of a contrasting or reflective material, or a material with a different texture, at the midpoint of the neck. Alternatively or additionally, similar visual or tactile cues may be incorporated into any of the aforementioned devices so as to provide an outward indication of the position of a protrusion.
[00123] In addition, any of the above-described embodiments using elastic materials may comprise a double-layer elastic material that exposes a change in graphic or color when stretched sufficiently to apply an appropriate force to an underlying bulge. In such embodiments, the change in graphic or color can provide a visual indication to the user or third party that the device is applying at least sufficient compressive force. Embedded Sensors or Other Electronic Systems
[00124] Any of the above devices may also have one or more monitoring, recording and/or communication devices attached or incorporated into them. For example, the device may comprise a sensor capable of detecting one or more environmental parameters around the user, one or more physiological parameters of the user, or some combination thereof. Examples of environmental parameters that can be detected include the length of time the collar has been worn, barometric pressure, ambient temperature, humidity, acceleration/deceleration (ie G forces), positioning (vertical/in supine position), etc. Physiological parameters that can be detected include pulse rate, blood pressure, plethysmography, skin temperature, oxygen saturation, carboxyhemoglobin level, methemoglobin level, blood sugar, electrical flow, etc., of the human or animal using the device. Any such sensor can be used to monitor some environmental or physiological characteristic or aspect of user performance. Sensors capable of detecting blood pressure pulse, and/or plethysmography may serve the additional or alternative purpose of being used as an alignment and/or fitting aid, notifying the user when the bulge is properly placed over a vein in the neck and is exerting a adequate pressure so as to restrict blood flow.
[00125] In some related embodiments, a device may further comprise an electronic circuit capable of providing visual, auditory or tactile indications of malfunction, or an undesirable sensor reading. For example, an electronic circuit can be configured to vibrate the collar when a pulse or blood pressure sensor detects a reading that is greater or less than a predetermined value.
[00126] Additionally or alternatively, any of the above devices may comprise an electronic circuit configured to transmit the user's location. For example, any of the above devices may comprise electronic circuitry configured to transmit the user's GPS coordinates to track the user's location, or for search and rescue purposes.
[00127] Additionally or alternatively, any of the above devices may comprise an electronic circuit configured to transmit and/or receive voice communications between the user and a third person.
[00128] In some embodiments, the result of such a sensor may be visually or audibly communicated to the user or a third party from another component of the device, for example, an electronic circuit configured to provide a visual or audible indication (such as with a LED, piezoelectric speaker, etc.). In some embodiments, the device further comprises a communication means such that a signal from the sensor may be communicated to an external electronic device, such as a smartphone, laptop, or dedicated receiver.
[00129] These terms and specifications, including the examples, are intended to describe the invention by example, and not to limit the invention. It is expected that others will perceive the differences, which, while differing from the above, do not depart from the scope of the invention described and claimed herein. In particular, any of the functional elements described herein can be replaced by any other known element having an equivalent function. Exemplary modalities
[00130] Particular embodiments of a collar-type device are illustrated in FIGS. 1-3 Referring to FIGS. 1(a)-(c), a compression collar 10 includes an elongated strap 12 that can be provided in different sizes to wrap around the neck of the individual animal or human. In a specific embodiment the strap can be supplied in standard lengths of 14, 16 and 18 inches to fit the normal range of human neck sizes. The width in a specific example might be about 1.5 inches to fit within the anatomy of the neck, below the laryngeal prominence. To minimize collar prominence, the strap can be about 0.12 inches thick. Belt 12 may be formed of a breathable, dermatologically inert, non-irritating fabric material such as cotton or certain polyesters. Since the strap is intended to apply consistent pressure to the subject's jugular vein, the strap material is preferably generally elastic, but formed of an elastic material that will not permanently stretch appreciably over time. It can be appreciated that stretching the material so that the neutral length of the belt is longer than its original condition can render the belt 12 useless. On the other hand, the material of the strap must be sufficiently elastic or elastically stretchable to remain comfortable when worn for a long period of time, and to flex properly with the neck muscles. The effective length of the strap 12 is made adjustable by adding adjustable hook elements 16 and 18 at opposite ends of the strap. For example, in the embodiment shown in FIG. 1(a) the latch element 16 defines a serrated channel 16a which receives the resilient teeth 18a of the other element. The teeth 18a are angled to provide an outward force against the latch channel 16a to hold the teeth in place for a particular serration 16b. In the illustrated embodiment, seven serrations are shown which provide seven locations for engaging teeth 18a for precise adjustment of collar length. The two components 16, 18 can be sewn onto the belt 12 or permanently affixed in a conventional manner sufficient so that the engaging elements will not become free from the belt during use.
[00131] Two versions of the collar are shown in FIGS. 1(a) and 1(b). The version of FIG. 1(a) is provided for a male human and includes an indentation 14 at the location of the laryngeal prominence. Belt 12' of FIG. 1(b) does not include the clipping and may typically be provided for female human subjects. The cutout can be about 1.5 inches wide and about 0.5 inches deep to accommodate typical laryngeal prominence. It can be appreciated that collar 10 is engaged around the individual's neck so that indentation 14 is below and far enough away from the prominence to avoid any discomfort to the individual.
[00132] In another feature of the collars 10, 10', a pair of compressible pads 20 are provided spaced apart across the midline of the belt 12, 12'. The pads are sized and located to rest against the neck at the site of the jugular veins. In one embodiment the pads are spaced apart by about 2.5 inches, have a width/length dimension of 1.0-1.5 inches and a thickness of about 0.04 inches. As shown in FIG. 1(c) the pads may be partially embedded within the belt 12. The pads 20 may be formed of a breathable foam that exhibits good compression recovery. The pads can be formed from a material capable of exerting compression of 5-30 mm Hg when the collar is worn, such as a flexible polyurethane foam.
[00133] Additional compression collar modalities in FIGS. 2 and 3 which incorporate different coupling elements. For example, the collar 30 of FIG. 2 incorporates an array of pairs of spring fasteners 36 at one end that engages a pair of spring fasteners 38 at the opposite end. The pair of spring fasteners 36 may be spaced apart at predetermined intervals, such as % inch spacings to allow adjustment of collar diameter when used. The collar 50 in FIG. 3 incorporates a row of hooks 56 at one end that engages a corresponding row of loops 58 at the opposite end. The embodiment of FIG. 3 illustrates that the engagement elements need not be adjustable, although adjustability is preferred. In the embodiment of FIG. 3 this adjustability can be achieved by a connection of the VELCRO® type between the belt 52 and the row of loops 58. In particular, a pad interface of the VELCRO® type 59 can be used for mounting the loops 58 of the belt in different positions along the length of the strap. In another alternative, the VELCRO® interface can be between the two ends with VELCRO® type joining pads at each end.
[00134] In one aspect of the compression collars disclosed herein, the engagement elements are preferably configured to disengage or disconnect at a given load, so as to avoid the risk of choking or injuring the individual's neck and throat, if the collar is removed or grabbed. Thus, the engaging elements 16, 18 of FIG. 1, spring closures 36, 38 of FIG. 2 and the hook fitting 59 of FIG. 3 can be calibrated to disconnect when the collar is pulled with sufficient force. In another embodiment, the engagement elements, such as spring fasteners 36, 38, can be replaced by magnets or a set of magnets. The magnets are strong enough to maintain the desired pressure in the jugular veins when the collar is in use. The strength of the magnet can be calibrated to release at a given load. The escape feature can also be integrated into the belt, in addition to the hitch elements. For example, the belt may comprise a region between a pad 20 and an engaging member that has a reduced strength so that the belt tears under a given load. Alternatively, a non-adjustable hitch can be provided in this region, calibrated to disengage at a predetermined load.
[00135] In the embodiments of FIGS. 1 and 3, the jugular vein is compressed by pad 20. The pad has a predetermined thickness and compressibility. In an alternative embodiment, the pads are replaced with inflatable pouches 40, as shown in FIG. 2. In this embodiment a fluid line 46 connects the bags to a pump 42 and a release valve 44. The pump 42 may be the type that is hand tightened to draw atmospheric air into the bags. A one-way valve 43 is provided in fluid line 46 on pump 42 to maintain increasing air pressure within the bladder. The pump 42 can be constructed similar to a small motor suction pump. The pump can be configured to be manually depressed while the collar is in use. Release valve 44 can be manually activated to relieve bag pressure. The release valve can also be configured to automatically discharge when a certain pressure is reached to prevent over-inflation of the bags 40.
[00136] In an alternative embodiment the pump 42 can be a microfluid pump embedded within the belt 32. The pump can be electrically powered by a battery mounted inside the collar or it can be powered remotely, such as by a placed RF transmitter adjacent to the necklace. The pump can be remotely controlled by incorporating a transmitter/receiver inside the collar. The receiver can transmit pressure data indicating the pressure of fluid in bags 40 and the receiver can receive remotely generated commands to activate pump 42 to increase the pressure to an appropriate value. It is further contemplated that pump 42, whether manually or electrically operated, may include a pressure gauge that is readable on the outside of the collar to assist in inflating the pouches to the desired pressure.
[00137] The illustrated modalities include a necklace that completely surrounds the individual's neck. Alternatively, the compression device can only partially enclose the neck. In this embodiment, the device may comprise an arcuate resilient strip having a general C-shape shape. The strip may be formed of a spring-like resilient material, with compression pads mounted at the ends of the C-shape. therefore, functioning as a spring clip to exert pressure against the jugular vein. The spring effect of the C-shape can also help keep the device on the individual's neck, preferably at the back of the neck for better anatomical acquisition.
[00138] A compression collar 60, shown in FIG. 4, can incorporate a visual compression indicator that can be seen when the collar is fitted to a user. The collar 60 includes a strap 62 that can be configured like the straps 12, 32, 52 described above, and can incorporate compression pads 20, 40 arranged to apply pressure to the jugular vein when the strap encircles the subject's neck. The strap 62 is elastic so that the strap must be stretched or stretched when in use to apply the desired pressure to the VJI. The belt 62 includes an array 65 of strips 66, 67 of alternating colors. For example, strips 66 can be red (to signify a not ready condition), while strips 67 can be green (to signify a ready condition). Compression collar 60 further includes a liner 70, shown in FIG. 5, which includes a series of windows 72. The strips 66, 67 and 72 windows are of equal numbers (four in the illustrated embodiment), have the same width and are spaced the same dimension. In a specific embodiment the strips 66, 67 have a width of 2 mm, while the windows 72 have a width of 2 mm and are spaced apart by 2 mm.
[00139] As shown in FIG. 6, liner 70 is secured at one end 75 to belt 62. Opposite end 76 is not secured to belt to thereby allow the belt to stretch below the liner. In the embodiments described above, the entire strap is elastically stretchable. For the compression indicator at least the portion of the belt in the region of the liner 70 should be elastic and capable of elongating or stretching relative to the liner. Lining 70 is affixed to belt 62 so that all or a substantial portion of the "not ready" strips 66 are visible in windows 72 when the belt is in its neutral, unstretched configuration (i.e., before the collar is engaged in the individual), as shown in FIG. 7(a). When the collar is secured around the neck of the individual it will stretch and while stretching the straps 66, 67 it advances relative to the windows 72 of the skin 70. Therefore, as shown in FIG. 7(b), a portion of both bands 66, 67 will be visible through the windows. When the belt is stretched a predetermined amount to apply the desired pressure to the VJI, the "ready" strips 67 will be fully or substantially visible in each window 72, as shown in FIG. 7(c). If the strap is stretched too far, the “not ready” strips 66 will again be visible in the windows. The compression indicator achieved by the band 65 and liner 70 assembly thus provides a direct visual indication as to whether the collar is applying the desired amount of pressure to the VJI. The collar can be adjusted so that the “ready” strips 67 are visible by adjusting the engagement elements, or by using a collar having a different starting length. For example, for the collar 30 of FIG. 2, a different row of spring fasteners 36 can be joined to spring fasteners 38 to achieve the desired compression.
[00140] In the embodiments of FIGS. 4-7, matrix 65 includes four sets of pairs of parallel stripes 66, 67. However, other visual cues in any number of pairs can be used with appropriate modifications to windows 72 of the cladding. For example, matrix 65 may include visual cues “READY” and “NOT READY” or other suitable words to convey when ring 60 is applying an adequate amount of pressure to the VJI. Alternatively, the matrix may include a single indicia that is visible through a single window in the casing when the collar is properly fitted around the individual's neck. The compression indicator is preferably oriented on the collar at a location that is visible to the individual when looking at a reflective surface. Alternatively, the indicia on the strap 62 may be a tactile indicator that can be felt by the subject's finger through the window(s) in the casing.
[00141] Another aspect of the disclosure encompasses embodiments of a method for increasing intracranial volume and pressure of an animal or human subject comprising: (i) wrapping the neck of a human or animal subject with a collar, wherein said collar has at least one region directed inwardly for contacting the neck of an animal or human subject; (ii) positioning at least one inwardly directed region to contact the neck in a region of the neck overlying a neck vein carrying blood from the subject's intracranial cavity; and (iii) applying pressure to the neck vein by pressing at least one region against the neck. In certain modalities, this compression can be as much as 25 mm Hg, without any side effects and without impacting the carotid artery. It is believed that pressures as high as 80 mm Hg can be applied without endangering the carotid artery or jugular vein. For many applications of the method, the pressure applied to the neck vein or jugular vein can be 3-15 mm Hg. Applying pressure to the jugular vein can increase the ICP up to 30% above baseline pressure to protect the intracranial cavity from burst-related TAKING effects without any side effects.
[00142] According to an embodiment of the method, a compression collar such as collars 10, 10', 30 and 50 are placed low on the individual's neck and more particularly between the clavicle and the cricoid cartilage or laryngeal prominence . This location is away from the carotid sinus which is highest in the neck, so applying pressure to the neck will not compress the carotid artery. In the case of a male, cutout 14 of strap 12 is positioned directly below the laryngeal prominence.
[00143] The collar can be pre-sized for the individual so that it automatically provides the proper amount of compression when the ends of the collar are connected. Furthermore, as explained above, the engaging elements (ie the locking elements 16, 18, the spring fasteners 36, 38, the hooks 56, 58 or the VELCRO ® connection) can be configured to break or disengage if the pressure exceeds a desired value. This breakout feature can also be applied with the pump modality of FIG. 2 and in that case the chambers 40 can be inflated until the elements are disengaged, at which point the valve 44 can be actuated to relieve some pressure from the bags before refitting the collar on the individual's neck. In the alternative pump mode discussed above, where the pump is supplied with the pressure gauge, the chambers are inflated to the desired pressure indicated on the gauge. In most cases, the desired compression provided by the collar can be in the range of 15-20 mm Hg, although higher pressures are well tolerated and may be indicated for certain individuals.
[00144] It may be appreciated that the collar is only worn when the individual may be exposed to concussion events, such as an explosion during a military battle or dry contact during a sporting activity. Once exposure to such an event has ceased, the collar can be removed, although it may be beneficial to leave it in place until the individual is evaluated for concussion-related injuries.
[00145] Referring now to FIG. 13, a single unitary circumferential collar 100 is shown. Where the unitary circumferential collar 100 has no means of being opened for placement on the wearer, such a collar is intended to be made of an elastic material which allows the inner dimension of the collar to expand enough to pass through the wearer's head.
[00146] Referring now to FIG. 14, a circumferential collar-type device 102 is shown with pad-like protrusions 103, and an adjustable fastening element 104 (such as a VELCRO®-type connection). Adjustable clamping device allows for proper fit on a range of neck sizes. The collar-type device 102 can be made from elastic or non-elastic materials.
[00147] Referring now to FIG. 15, a similar circumferential collar-type device 102 is shown with pad-like protrusions 103, and an adjustable fastener device 104 (such as a VELCRO®-type connection). Adjustable clamping device allows for proper fit on a range of neck sizes. The collar-type device 102 can be made from elastic or non-elastic materials, and further comprises a semi-rigid or rigid laryngeal bridge 105.
[00148] Referring now to FIG. 16, a circumferential collar-type device 106 comprises a first piece (i.e., front section 107) and second piece (i.e., rear section 108). Front section 107 contains two protrusions 103 each configured to apply pressure to a vein in a user's neck. The back section 108 comprises a fabric collar section 109 configured to be removably attached (as by VELCRO® type fittings) at each end to the corresponding ends 110 and 111 of the front section 107. It is intended that the back section 108 can be made of elastic or non-elastic materials. It is further intended that the front section 107 may further comprise a semi-rigid or rigid laryngeal bridge (not shown).
[00149] Referring now to FIG. 17, a circumferential collar-type device 102 is shown with pad-like protrusions 103, and an adjustable fastening element 104 (such as a VELCRO®-type connection). Adjustable clamping device allows for proper fit on a range of neck sizes. The collar-type device 102 can be made from elastic or non-elastic materials. In this embodiment, the two pad-like protrusions 103 each comprise a pocket (not shown) and a pressure release valve 112 configured to apply pressure to a vein in a user's neck.
[00150] Referring now to FIG. 18, a semi-circumferential collar 113 with a front opening is shown. As the semi-circumferential collar 113 is opened at the front 114, the collar 113 is intended to comprise a rigid or semi-rigid material, and the collar 113 is to be worn by sliding the collar over the wearer's neck from the back to the front.
[00151] Referring now to FIG. 19, a semi-circumferential collar 115 with a rear opening 116 is shown. As the semi-circumferential collar 115 is opened at the rear, the collar 115 is intended to comprise a rigid or semi-rigid material, and the collar 115 is to be worn by sliding the collar over the wearer's neck from front to rear.
[00152] Referring now to FIGS. 20A-C, exemplary embodiments that apply pressure to the proper positions on the neck without the use of a circumferential collar are shown. These modalities are typically used as pairs, with one device worn on each side of the neck. FIG. 20A shows that each device comprises a pad-like protrusion 103 covered by a flexible material 117 that extends beyond the area defined by the protrusion. If such devices are used without a collar, it is intended that at least a portion of the inwardly directed surface 118 of the material which extends beyond the area defined by the protrusion is coated with an appropriate adhesive. An inwardly directed surface of the protrusion 103 may also be coated with a suitable adhesive. In these embodiments, the flexible material 118 can be elastic or non-elastic. FIG. 20B shows a similar embodiment which differs by employing an arcuate resilient strip 119 having a general C, V or U shape to form a protrusion 120. As discussed above, the strip may be formed of a spring-like resilient material through of which the C, V or U shaped strip is straightened as the device is applied. After application of the device, spring tension causes the strap to compress, resulting in the midpoint or arching point of the strap to extend in the direction of and apply pressure to the neck. FIG. 20C shows the device illustrated in FIG. 20B further comprising a removable chain 121 between the pair of devices which facilitates the alignment and spacing of the devices during neck application.
[00153] FIG. 21 is an illustration of another embodiment of the present invention which applies pressure to appropriate positions in the neck without the use of a circumferential collar. The device shown in FIG. 21 is similar to that of FIGS. 20A-B, but further includes a removable chain 121 of appropriate length between a pair of devices 122. Each device comprises a bulge 103 and one device is intended to be applied to both sides of the neck. Removable chain 121 aids in alignment and spacing when applying devices 122 to the neck.
[00154] FIG. 22 is an illustration of another embodiment of the present invention that applies pressure to appropriate positions in the neck without the use of a circumferential collar. In this embodiment, the device comprises a resilient U-shaped strip 123, with a protrusion 103 disposed at or near each end. In some embodiments, protrusions 103 may be integral with resilient strip 123. The embodiment shown in FIG. 22 is of alternative design, wherein the protrusions 103 are integral with devices 122 which are connected at each end of the resilient strip 123. The U-shaped resilient strip 123 is of appropriate size and shape, and is suitably resistant to bending. such that when the strip is folded open, the protrusions 103 can be placed on the neck at appropriate locations and the strip exerts a sufficient compressive force so as to reduce the flow of venous blood from the head.
[00155] FIG. 23 is an illustration of a circumferential collar-type device of the present invention comprising a cable-gap cable-type ratchet engagement adjustment system. In the depicted device, the pull-away loop handle 124 is configured to release the collar 125 when pulled at or above a certain pressure, thus ensuring that the collar 125 is not too tight.
[00156] FIG. 24 is an illustration of a circumferential collar-type device of the present invention comprising a rotary ratchet engagement adjustment system and an external adjustment tool. In this embodiment, the fit of the collar 125 is fitted with an integral cable system 126. An external tool 127 is used to shorten or lengthen the integral cable 126, thus allowing fine control of the fit adjustment.
[00157] FIG. 25 is an illustration of a circumferential collar-type device of the present invention comprising a rotary ratchet engagement adjustment system with an integral adjustment knob. Similar to the embodiment described above, the collar socket 125 is fitted with an integral cable system 126. In this embodiment, however, an internal ratchet dial 128 is used to shorten or lengthen the integral cable 126, thus allowing fine control of the fit. plug-in.
[00158] FIG. 26 is an illustration of the circumferential collar-type device of the present invention comprising one or more discernible graphical or tactile reference points on an outer surface of the device. As described above, the graphical or tactile reference points can be of any suitable design and/or materials. In the exemplary embodiments shown in FIG. 26, graphical or tactile reference points can be placed to indicate the midpoint of the device for alignment in the center of the front of the neck (e.g., shown with piece of fabric 130), indicate the location of the bulges (e.g. , shown with fabric patches 132), or both (shown with fabric trace 131).
[00159] FIG. 27 is an illustration of another embodiment of the present invention wherein device 135 further comprises an (unnumbered) sensor configured to detect pulse rate, blood pressure, or other indications of proper placement and pressure of a bulge above a neck vein, and means for transmitting a signal from the sensor to an external device 136. Example 1
[00160] Materials and Methods: Two groups of ten (total of 20) male Sprague-Dawley rats weighing between 350 and 400 grams were used. Animals were housed under 12 hours light/12 hours dark conditions with feed and water available ad libitum.
[00161] Marmarou impact acceleration injury model in rats: anesthesia was induced and maintained with isoflurane using a modified medical anesthesia apparatus. Body temperature was controlled for approximately 10 minutes of procedures using a homeothermic heating blanket with a rectal probe, and adequate sedation was confirmed by evaluating the response to heel tendon pinching. Animals were shaved and prepared in a sterile manner for surgery, followed by subcutaneous injection of 1% local anesthetic lidocaine at the planned incision site. A 3 cm midline incision in the scalp was made and periosteal membranes separated, exposing bregma and lambda. A 10 mm diameter and 3 mm thick metal disc was attached to the skull with cyanoacrylate and centered between bregma and lambda.
[00162] The animal was placed bent over a foam bed with the metal disc directly under a Plexiglas tube. A bronze plate weighing 450 g was dropped once through the tube from a height of 2 meters, striking the disc. The animal was then ventilated with 100% oxygen while the skull was inspected, the disc removed, and the incision repaired. When the animal recovered spontaneous breaths, anesthesia was discontinued and the animal was returned to its home cage for post-surgical observation. Buprenorphine was used for postoperative analgesia. Example 2
[00163] Experimental protocol: This work involved two groups, each consisting of 10 animals for a total of 20 animals. Two groups were used, a control injury group and an experimental injury group. In the experimental injury group, rats were fitted with a 15 mm wide collar with two compression balls designed to cover the VJIs and were tight enough to provide moderate compression of the veins without compromising the airway. The collar was then fixed around the circumference with a Velcro fastener. The collar was left in place for three minutes before administering the experimental brain injury.
[00164] Evaluation of Intracranial Pressure Measurement (PIC) of Intracranial Reserve Volume: ICP was measured in five animals using the FOP-MIV pressure sensor (FISO Technologies, Quebec, Canada), as described by Chavko, et al. The rat's head was shaved and sterilely prepared for surgery. The rat was fixed in a stereotaxic apparatus (model962; Dual Ultra Precise Small Animal Stereotaxic Instrument, Kopf Instruments, Germany) and a 3 cm midline incision was made in the scalp. Periosteal membranes were separated, exposing both bregma and lambda. A 2 mm burr was made with a flow rate of 0.9 mm from bregma and 1.5 mm from the midline. The fiberoptic probe was then inserted to a depth of 3 mm into the brain parenchyma.
[00165] Measurement of intraocular pressure (IOP): IOP was measured in all animals using the TonoLab rebound tonometer (Colonial Medical Supply, Franconia, NH), as described in the literature, IOP measurements were taken after induction of anesthesia in all animals and a second time in the experimental group after application of the UV compression device. After application of the VJI compression device to the experimental injury group, IOP readings were taken every 30 seconds while the compression device was in place.
[00166] Tissue Preparation and Immunohistochemical Labeling: At 7 days after injury all animals (n=20) were anesthetized and immediately transcardially perfused with 200 ml of cold 0.9% saline solution to wash all blood. This was followed by infusion of 4% paraformaldehyde in Millings buffer for 40 minutes. The whole brain, brainstem and rostral spinal cord were removed and immediately placed in 4% paraformaldehyde for 24 hours. After 24 hours of fixation, the brain was blocked by cutting the brainstem above the pons, cutting the cerebellar peduncles, and then making sagittal cuts lateral to the pyramids. The resulting tissue, containing the corticospinal tracts and medial lemniscus, areas previously shown to produce traumatically injured axons, was then sagittal cut on a 50 micron-thick vibratome.
[00167] The tissue was subjected to temperature-controlled microwave antigen retrieval using techniques described above. The tissue was pre-incubated in a solution containing 10% normal serum and 0.2% Triton X in PBS for 40 minutes. For amyloid precursor protein (PPA) labeling, tissue was incubated with polyclonal antibodies raised in rabbits against beta PPA (#51-2700, Zymed, Inc., San Francisco, CA) at a 1:200 dilution in NGS a 1% in PBS overnight. Following incubation in primary antibodies, tissue was washed 3 times in 1% NGS in PBS, then incubated in an Alexa 488 fluorophore-conjugated secondary IgG antibody (Molecular Probes, Eugene, OR), diluted 1:200 for two hours. The tissue was subjected to a final wash in 0.1 M phosphate buffer, then mounted using an anti-fading agent and covered by slides. Slides were sealed with acrylic and stored in the dark in a laboratory refrigerator.
[00168] Fluorescent Microscopy and Image Analysis: Tissue was examined and images obtained using an Olympus AX70 fluorescence microscope system (Olympus; Tokyo, Japan). Ten digital images were obtained from each animal's tissue and the images were then randomized. Individual injured axons were independently counted and data were stored in a spreadsheet (Microsoft Corp., Redmond, WA). Differences between group means were determined using paired t-tests and considered significant if the probability value was less than 0.05.
[00169] Stereological Quantification of Axonal Lesion: A stereological method was used to determine an unbiased estimate of the number of PPA positive axons per cubic millimeter in the corticospinal tract and medial lemniscus. The optical fractionator technique using a Stereoinvestigator 9.0 (MBF Bioscience, Inc., Williston, VT) and an Olympus AX70 microscope with 4x and 40x objectives was performed. Sagittal plane PPA stained samples were examined at low magnification and regions of interest were removed incorporating the corticospinal tract and medial lemniscus. The software then randomly selected 50 micron count frames with a depth of 15 microns, and PPA positive axons were tagged. The region of interest (ROI) volume was determined using the Cavalieri method, the sum volume of the count frames was calculated, the total sum of injured axons within the count frames was calculated, and an estimate of the number of positive axons PPA per cubic millimeter was calculated. Example 3
[00170] Measurement of Intracranial Volume Pressure (ICP): The ICP was assessed before and after application of the VJI compression device. The baseline PIC was 10.23 ± 1.68 mm Hg and was increased to 16.63 ± 2.00 mm Hg after a compression of the VJI (FIG. 8: p<0.01). Notably, this greater than 30% increase from baseline occurred within seconds of a VJI compression. Intraocular pressure (IOP) measurement: IOP measurements were taken before and after application of the VJI compression device, similar to PIC recordings. Baseline IOP was 11.18 ± 2.27 mm Hg and was raised to 16.27 ± 3.20 mm Hg after a VJI compression (FIG. 9: p<0.01).
[00171] The 31% increase observed in IOP after a VJI compression is very similar to that observed in PIC after a VJI compression, both in magnitude and speed of response (FIG. 10).
[00172] TCE- Impact Acceleration Model: None of the animals died as a result of head trauma. The animals tolerated the collar application without any adverse effects observed for the duration of the experiment. Specifically, there were no outward or visible signs of discomfort, intolerance or breathing difficulties. All recovered without complications and exhibited normal behavior and eating habits until the day of sacrifice. At necropsy, the brains were grossly normal in appearance.
[00173] Stereological Analysis of PPA Positive Axons: To determine the density of injured axons in the corticospinal tracts and medial lemniscus, the stereological optical fractionator method was used. Compared to the normal anatomy found in previous experiments with sham animals, control animals without the collar demonstrated focal PPA labeling within several contiguous swollen and terminal axon segments, consistent with impaired axoplasmic transport in traumatic axonal injury. After microscopic digital image acquisition from various areas within the corticospinal tract and medial lemniscus of several tissue slices, PPA positive axon counts in animals that received the VJI compression collar demonstrated far fewer PPA positive axons in a frequency much more similar to false animals compared to those subjected to lesions without UV compression (Figs. 4A and 4B). These abnormal axons demonstrated morphological characteristics typical of traumatic injuries, swelling and disconnection mainly. By qualitative analysis, the experimental group showed (m ± sd) 13,540 ± 9808 vs 77,474 ± 25,325 (p<0.01) of PPA/mm3 positive axons in the control group (FIG. 12). Example 4
[00174] Two groups of 10 adult male Sprague-Dawley rats were subjected to an impact-accelerating traumatic brain injury. Before the injury, the experimental group had the application of a 15 mm wide cervical collar, which had two compression spheres along the internal jugular veins (VJIs). The control group had only the experimental lesion. Intracranial pressure (ICP) and intraocular pressure (IOP) were measured before and after VJI compression to assess collar performance. All rats were sacrificed after a 7-day recovery period, and brainstem white matter tracts were subjected to fluorescent immunohistochemical processing and beta-amyloid precursor protein (PPA) labeling, a marker of axonal damage. Digital imaging and statistical analyzes were used to determine whether NO compression resulted in a decrease in the number of injured axons. Example 5
[00175] All animals survived the experimental paradigm and no adverse reactions were observed after applying the collar. In the experimental group, VJI compression resulted in an immediate and reversible increase in ICP and IOP, by approximately 30%, demonstrating physiological changes secondary to the application of a collar. Most notably, the quantitative analysis showed 13,540 PPA positive axons in the experimental group versus 77,474 in the control group (p < 0.0), a marked reduction greater than 80%.
[00176] Using a standard acceleration-deceleration impact laboratory model of moderate TBI, a reduction in axonal damage, after a compression of the VJI as indicated by immunohistochemical staining of PPA, was shown. Compression of the VJI reduces TAM-mediated brain damage by increasing intracranial blood volume and reducing compliance and potential for brain movement within the confines of the skull. Example 6
[00177] Internal versus External Brain Protection: Compression of the VJI for 3 minutes before head injury led to physiological changes in intracranial compliance, as evidenced by a modest increase in ICP and IOP while simultaneously sharply reducing the pathological index of primary neuronal injury in the standardized TBI mouse model. The reduction in brain volume compliance may impede the differential movements between the skull and brain that lead to energy absorption and primary and secondary neuronal damage. These pathological changes include axonal tear that disrupts axoplasmic transport, resulting in axonal swelling and activation of apoptotic cascades, as evidenced in this model by a statistically significant reduction in PPA-injured axon counts.
[00178] In the animal model of the present disclosure, the application of the collar increased the PIC and IOP by 30% and 31%, respectively. The effect of jugular vein compression on ICP is clinically well known. The Queckenstadt test is used to indicate CSF continuity between the skull and spinal cord. In this test, the ICP is increased by compressing the VJIs while the CSF pressure is measured in the spine through a lumbar puncture. Increases in ICP have also been shown to occur with the placement of tight fitting neck stabilization collars that are likely to compress the VJIs. The compression of VJIs, which can occur when wearing tight-collared shirts or ties, has also been shown to increase IOP. Notably, only mild compression pressure is needed to partially occlude the VJIs as these are a low pressure system. As cerebral arterial blood inflow continues after partial obstruction of the cerebral venous outlet, venous and intracerebral pressure increases until jugular venous resistance is overcome or blood drainage is redirected to other venous channels. In both cases, there is a reduction in intracranial compliance and a modest increase in ICP.
[00179] The immunohistochemical assay used in the studies of the present disclosure is specific for axonal injury and results in a reliable range of measured injured neurons. Additionally, the Marmarou model of acceleration-deceleration injury is an accepted and well-studied methodology, through which the extent of TBI is quantified. The reduction in injured axons, as evidenced by a marked reduction in PPA counts, in the experimental group with the VJI compression device is highly statistically significant (p<0.01). Additionally, the change in ICP was measured after applying the collar to five rats. The results show that each study rat had a reduction in axon damage greater than the 95% confidence interval of the control group.
[00180] In a further aspect of the present invention, it has been found that applying compression to the internal jugular vein not only reduces the risk of TBI, but also the risk of damage to the inner ear (specifically Noise Induced Hearing Loss or Loss Explosion-Induced Auditory), spinal cord and eye structures. As far as the ear is concerned, reducing the outflow of the VJI will congest the cochlear vein and thus fix inner ear compliance or, more particularly, the fluid within the inner ear. Since the auditory hair cells react directly to vibrations in the cochlear fluid, they are particularly susceptible to energy absorption from FLAVOR. Increasing fluid pressure within the inner ear reduces the compressibility of fluid within the inner ear structure so that energy from explosions is mechanically transmitted through the inner ear rather than being absorbed by it in the form of fluid vibration. Note that increasing fluid pressure does not generally reduce transverse vibrations of the cochlear duct and thus the transmission of energy from explosions through the inner ear can further lead to perforation of the eardrum. But in many cases, ruptured eardrums will heal or can be repaired. On the other hand, SOUNDING-related injuries to thin auditory hair cells do not heal and cannot be repaired.
[00181] With respect to the spinal cord, it has been found that the application of the pressure techniques of the VJI described here reduces the fluid compliance along the spinal axis and therefore reduces the risk of spinal injuries related to explosions. The Spinal Injury Mode is similar to the Inner Ear Injury Mode in that the spinal cord tracts can be thought of as the sensitive filaments in a fluid environment. Fluid vibration due to SOUNDING can injure and even rupture spinal cord tissue. Increasing the LCR pressure by compressing the VJI in accordance with the procedure disclosed herein will significantly reduce LCR vibration due to blast energy. In addition, increasing the CSF pressure increases the spinal column's axial load-bearing capacity which can reduce the likelihood of spinal column collapse due to the blast energy.
[00182] With regard to the structure of the eye, the mode of injury is similar to that of the inner ear and spine in that vibrations (inelastic collisions) of the vitreous humor can lead to permanent damage to the inner structure of the eye itself. As demonstrated by the increase in intraocular volume of a woodpecker pectin apparatus and the pressure that protects the internal structure of the eye; using the compression strip to apply pressure to the IJV, as disclosed herein intraocular pressure can be increased 36-60%. Safely and reversibly increasing the CSF and thus intraocular pressure, using the compression strap disclosed herein, can prevent or at least significantly reduce the absorption of vibrations and energy from the vitreous humor within the eye, thereby reducing the risk of explosion-related injuries.
[00183] Finally, as discussed above, the incidents of concussion leading to TBI have also been found to be the main cause of anosmia (loss or impairment of olfactory function, ie sense of smell). Increased intracranial pressure, as described above, can reduce the risk of TBI and the impairment of capacity associated with olfactory function. In the case of Breechers or sniffer dogs the collar can be sized to fit the animal's neck and the pressure adjusted to take into account the greater thickness of the throat in the VJI than in a human individual.
[00184] The above description addresses traumatic injuries related to explosions in the intracranial cavity, such as TBI, and injuries to the inner ear, spinal cord, and ocular structure. The compression devices disclosed herein can thus be worn by military personnel during battle and removed when in a non-combat situation. While certainly less dramatic, certain sports can expose the intracranial cavity to concussion forces that create the risk of these same traumatic injuries, especially football. The compression collar disclosed here would be worn by the sports participant on the playing court, as well as a large number of industrial activities or other potential occupations or professions with TBI risks. The collar arrangements disclosed herein are relatively non-intrusive and the "break" functionality described above eliminates the risk of the collar being inadvertently pulled.

权利要求:
Claims (13)
[0001]
1. A device for applying pressure to one or more veins in an individual's neck, characterized in that it comprises: a flexible material (117) sized to encircle a minority of the circumference of an individual's neck; and one or more inwardly directed protuberances (103, 120) contacting an inner surface (118) of said flexible material (117); wherein the flexible material (117) is sized such that an inner surface (118) of the said material extends beyond the bulge (103, 120), and said bulges are of suitable size and shape such that when placed in the neck above a vein in the individual's neck, said device restricts the flow of outward blood. of the individual's head and where the device is of the collarless type.
[0002]
2. Device according to claim 1, characterized in that said protrusion is defined by an outwardly bending point (120) of an arcuate resilient strip (119) having a general shape in the shape of a C, V, or U.
[0003]
Device according to claim 1 or 2, characterized in that a portion of said material (117) which extends beyond the bulge (103, 120) is coated with an adhesive.
[0004]
4. Device according to any one of claims 1 to 3, characterized in that said neck vein includes the internal jugular vein or the external jugular vein.
[0005]
5. Device according to any one of claims 1 to 4, characterized in that said one or more protrusions (103, 120) exert a pressure on said one or more neck veins equivalent to a fluid pressure within the range from 1 mmHg to about 70 mmHg.
[0006]
6. Device according to claim 5, characterized in that said one or more protrusions (103, 120) exert a pressure on said one or more neck veins equivalent to a fluid pressure within the range of 5 mmHg to about 25 mmHg.
[0007]
7. System for applying pressure to two or more veins in the neck of an individual, characterized in that it comprises a pair of devices (122) of the type defined in any one of claims 1 to 6, connected to each other by a removable chain (121) sized to facilitate spacing and alignment of each device (122) over a neck vein during application to an individual's neck.
[0008]
8. System according to claim 7, characterized in that each of the devices (122) is adapted to exert a pressure on said two or more neck veins equivalent to a fluid pressure within the range of 5 mmHg to about of 70 mmHg.
[0009]
9. System according to claim 7 or 8, characterized in that the removable chain (121) is sized to facilitate alignment of each device (122) on an external jugular vein.
[0010]
10. System according to claim 7 or 8, characterized in that the removable chain (121) is sized to facilitate alignment of each device (122) on an internal jugular vein.
[0011]
A method of applying pressure to one or more veins in the neck of a subject, the method comprising: contacting one or more protrusions (103, 120) of a device, of the type defined in any one of claims 1 to 6, to the subject's neck, where each bulge (103, 120) is located above one or more veins in the subject's neck; and applying localized pressure through the bulges (103, 120) to one or more neck veins sufficient to restrict the flow of blood leaving the individual's head through the one or more neck veins.
[0012]
12. Method according to claim 11, characterized in that the device is applied to an internal jugular vein and/or external jugular vein.
[0013]
13. Method according to claim 11 or 12, characterized in that the device applies a pressure equivalent to a fluid pressure within the range of 1 mmHg to about 70 mmHg.

类似技术:

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公开号 | 公开日 | 专利标题

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BR112015023647B1|2021-09-08|METHODS AND DEVICES TO REDUCE THE LIKELIHOOD OF INJURY CAUSED BY CONCUSSION OR EXPLOSION FORCES

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JP2020012227A|2020-01-23|Device and system for mitigating traumatic brain and other injuries caused by concussive or blast forces

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同族专利:

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公开号 | 公开日

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EA031307B1|2018-12-28|

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CA2897410C|2018-03-13|

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BR112015023647A2|2017-07-18|

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JP2016514495A|2016-05-23|

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IL269358A|2020-08-31|

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WO2014143853A2|2014-09-18|

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EP2777411A1|2014-09-17|

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EA201591670A1|2016-05-31|

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EP3173019A1|2017-05-31|

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CL2015002715A1|2016-02-19|

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AU2013202088A1|2014-10-02|

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US20140276278A1|2014-09-18|

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EP2777411B1|2016-10-12|

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DK2777411T3|2017-01-30|

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WO2014143853A3|2014-11-06|

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US20200187957A1|2020-06-18|

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IL269358D0|2019-11-28|

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US10499928B2|2019-12-10|

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US20150133992A1|2015-05-14|

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MX2019005560A|2019-08-12|

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PL2777411T3|2017-08-31|

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AU2013202088B2|2014-12-18|

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JP6487414B2|2019-03-20|

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MX364951B|2019-05-15|

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EP3632246A1|2020-04-08|

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MX2015012907A|2016-07-20|

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IL241665A|2019-10-31|

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ES2616497T3|2017-06-13|

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CA2812131C|2015-09-22|

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JP2019112760A|2019-07-11|

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NZ712221A|2016-11-25|

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PT2777411T|2017-01-24|

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US8900169B2|2014-12-02|

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CA2897410A1|2013-06-18|

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CA2812131A1|2013-06-18|

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法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2020-01-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2021-08-10| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2021-09-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/03/2014, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

---

申请号 | 申请日 | 专利标题

---

US13/841,195|US8900169B2|2013-03-15|2013-03-15|Methods and devices to reduce the likelihood of injury from concussive or blast forces|

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US13/841,195|2013-03-15|

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PCT/US2014/028004|WO2014143853A2|2013-03-15|2014-03-14|Methods and devices to reduce the likelihood of injury from concussive or blast forces|

---