Cephalic expansion apparatus and the method of using to treat head injury

An apparatus and method to treat head injury. The apparatus includes a cephalic expansion reservoir to allow a swollen brain to expand without increasing intracranial pressure. The apparatus has a port for fluid exchange and for the attachment of monitors of physical, chemical and electrical activity. The method includes attaching the apparatus to the skin with biological adhesives, removing the bone for replacement after treatment, treating the injured patent with appropriate therapy including filling the expansion reservoir with an appropriate fluid.

FIELD OF THE INVENTION 
The present invention relates generally to an apparatus and a method for 
treating severe head injury. The apparatus is a flexible container which 
adapts to the skull contour of an injured patient. The flexible container 
allows the injured swollen brain to expand into a sterile chamber of 
fluid. Furthermore, there are ports for access to the flexible container 
for the exchange of fluid and the monitoring of the patient's status. The 
apparatus and the procedures can be used to treat a variety of brain 
diseases and brain injury which result in swelling of the brain. 
BACKGROUND OF THE INVENTION 
Throughout history head injury has been very common and has occurred in all 
levels of society. When a force vector is directed through the head each 
layer of contact, that is, the skin, bone, and brain is affected 
proportionately to the force involved. The skin can be crushed, cut or 
abraded. The bone can be bruised, cracked or depressed. The brain can be 
concussed, bruised (contused) or lacerated. When the brain is contused or 
lacerated, swelling occurs. The swelling can result from injury or 
disruption to a variety of cellular components of the brain including the 
endothelial membranes of blood vessels, membranes or support cells of 
brain cells and cellular membranes of the neuron. The increase in 
intracranial pressure is proportional to the volume of brain injured. 
Standard methods of intensive care management, which include steriods, 
mannitol, head elevation, hyperventilation, and fluid restriction, are 
only partially successful in the treatment of serious head injuries. Even 
with these treatment regimes there is a mortality rate of greater than 
50%. 
It is known that the severity of head injury is directly proportional to 
the increased pressure inside the head cavity housing the brain. For 
example, if intracranial pressure greater than 20 Torr is present the 
mortality rate is estimated at 45%. Doubling the pressure to 40 Torr 
increases the mortality rate to 74%. Increasing the pressure to 60 Torr, 
results in a 100% mortality rate. These mortality figures assume that 
current neural intensive care has occurred. Thus, at present, there is no 
method of treatment which can successfully treat severe head injury except 
early diagnosis and decompression of epidural, subdural and intracerebral 
hematomata. Currently, only methods of prevention are helpful. Thus, 
although the use of seat belts, air bags, restricted ethanol intake, 
careful driving, etc. all result in fewer severe head injuries, none of 
these approaches are helpful after the injury has occurred. 
Major head injury primarily affects young people between the ages of 15-40 
years of age. They are in their most productive years and in many cases 
provide the major support for their families. Thus it is important that a 
successful method of treatment be developed. The cephalic expansion 
apparatus and method of the present invention provides a new treatment 
increasing the chances of survival after severe head injury with brain 
swelling. 
SUMMARY OF THE INVENTION 
An object of the present invention is the provision of an apparatus for 
allowing the brain to expand without injury. 
An additional object of the present invention is the provision of an 
apparatus for monitoring the brain while allowing the brain to expand. 
A further object of the present invention is the provision of an apparatus 
for the treatment of brain trauma. 
Yet another object of the present invention is the provision of a method 
for the treatment of brain injury. 
Thus, in accomplishing the foregoing objects one aspect of the present 
invention is an apparatus for the treatment of brain trauma comprising a 
flexible container for holding sterile fluid and allowing a swollen brain 
to expand. This flexible container can be attached to the scalp of the 
skull of an individual by the use of a biological adhesive. The biological 
adhesive forms a water-tight attachment between the container (polymer) 
and the skin (keratin). The apparatus contains a water-tight locking means 
for sealing the container after attachment to the head. Sterile fluid can 
be introduced into the sealed container through access ports. In addition, 
the access ports can receive cortical surface electrodes and other probes 
for monitoring the electrical, physical and chemical activity of the brain 
and surrounding fluid. 
The invention also includes a method of treating severe head injury 
comprising the steps of preparing and sterilizing the scalp of the head. 
Applying adhesive strips to the scalp for forming a water-tight seal 
between the scalp, the adhesive strips and the flexible container which is 
attached to the scalp. Performing a craniotomy, removing the bone flaps 
and preserving the bone flaps for replacement after the treatment. Sealing 
the cephalic expansion apparatus by closing the flexible container. 
Filling the flexible container with a cooled, pH adjusted sterile fluid, 
and monitoring the physical, electrical and chemical parameters of the 
brain and the fluid during the treatment. Removing the cephalic expansion 
apparatus and replacing the bone flaps after the brain swelling has 
subsided. 
Further objects features and advantages will be apparent from the following 
description of the preferred embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
In the description which follows like parts are marked throughout the 
specifications and drawings with the same referenced numerals. The 
drawings are not necessarily to scale and certain features of the 
invention may be exaggerated in scale or shown in schematic form in the 
interest of clarity and conciseness. It will be readily apparent to one 
skilled in the art that various substitutes and modifications may be made 
to the invention disclosed herein, without departing from the scope and 
spirit of the invention. 
FIGS. 1, 2, and 3 show the various parts of the cephalic expansion 
apparatus 9 including a flexible container 10 for holding sterile fluid 
and allowing a swollen brain to expand. The flexible container can be a 
variety of shapes and sizes to fit a head. In the preferred embodiment an 
elliptical shape is used. The upper side 11 of the unfilled flexible 
container is shown. The broken lines represent the shape of the flexible 
container when fluid filled and attached to a skull for treatment. The 
outer inferior surface 13 of the flexible container 10 is applied to a 
shaved, deoiled and adhesive prepared scalp 16 (FIG. 4). The inferior 
scalp contact section 17 of the flexible container 10 contains special 
scalp contact strips 18. These contact strips 18 include a special 
biological adhesive. Contact strips 18 are incised when the skin is 
incised. An irrigation tube 21 can be attached to a port 22 in the 
flexible container 10. The port 22 has reinforcement 24 to help support 
the irrigation tube. Although a single irrigation tube 21 and port 22 can 
be used the preferred embodiment includes a plurality of irrigation tubes 
21 and ports 22. In the preferred embodiment the ports 22 and irrigation 
tubes 21 are located along the bottom of the flexible container 10. An 
expandable reinforceable flap 33 is located in a 360.degree. direction 
directly adjacent to the scalp adhesive part 27 of the flexible container 
10. 
When the flexible container 10 is applied, FIG. 5, to the scalp 16, the 
water-tight locking means 30 is initially closed. The adhesive strips 18 
are applied in situ, and the inferior expansion flap 33 is folded down. A 
nasal canual 36, oral airway 39 and endotracheal tube 42 are also shown. A 
cephalo-cervical head rest 46 and collar support 43 are also shown. 
In FIG. 6, the flexible container 10 is opened exposing the interior 
surface 45 of the inferior surface 13 which is adherent to the treated 
scalp 16. In FIG. 7 the special adhesive strip 18 and scalp 16 have been 
incised 48. The scalp 16 with the scalp contact section 17 of the flexible 
container 10 adhering by a water-tight bond have been retracted laterally. 
Hemostasis is accomplished by electrocautery. The frontal 51, parietal 54 
and occipital calvaria are examined and the coronal 57 and sagittal 
sutures 60 are identified in preparation for craniotomy. The scalp is 
retracted 48 and sutured to the flexible container 10. 
FIG. 8 shows the line 63 along which the craniotomy is performed. In FIG. 9 
the two free bone flaps 66 are carefully removed from the general dura 69 
and dura over the superior sagittal sinus 72. Two bilateral parallel 
incisions 73 adjacent to the superior sagittal sinus 72 and two bilateral 
incisions 74 parallel to the coronal suture 57 are made and the dura 69 is 
opened and retracted laterally (FIG. 10). Hemostasis is accomplished by 
bipolar electrocautery. Generous amounts of 37.degree. C. saline are used 
to irrigate the injured cortex 84. Swollen gyri 87 and sulci 90 are shown. 
After the dura 69 is sutured to the galea aponeurotica 93, the flexible 
container 10 is closed by bringing the two flaps 75 medially (e.g., in the 
direction of the arrows shown in FIG. 11). After observing for any 
bleeding the water-tight locking means 30, in the form of a groove locking 
device such as may be found on a conventional plastic bag of the type used 
for storing food and sold under the brand name "ZIP-LOC.RTM.", is engaged. 
Support ring 103 can be placed in the support rod 100 (see also FIGS. 13A 
and 13B) and secured to a stationary support. 
An irrigation port 22 is used to exchange sterile fluid. In the preferred 
embodiment a plurality of ports 22 are incorporated into the flexible 
container 10. The irrigation ports 21 can be attached to devices which 
monitor and purify the fluid. In the preferred embodiment the fluid is 
saline, however, electrolytes and drugs can be added. The fluid can be 
processed by devices external to the cephalic expansion apparatus. For 
example the pH can be adjusted or the fluid can be cooled. 
Another enhancement to the cephalic expansion apparatus 9 is shown in FIG. 
12. Here a plurality of cortical electrodes 107 are placed in reinforced 
rings 110. The leads 119 from the surface electrode grid 116 can be 
connected to a pre-amp and amplifier for surface EEG and evoked potential 
recordings. 
In the preferred embodiment the cephalic expansion apparatus 9 holds 
approximately 7-9 liters of fluid. The fluid is preferably cooled, pH 
adjusted, filtered saline. 
FIG. 13 shows a patient intubated in bed 124 with the cephalic expansion 
apparatus 9 attached. The patient's head is supported by a support means 
indicated generally in FIGS. 13 and 13B at reference numeral 125, and is 
elevated. In the treatment of severe head injury the head is elevated from 
about 30.degree. to about 45.degree.. In the preferred embodiment the head 
is elevated at about 45.degree.. The cerebral expansion apparatus 9 is 
supported by support rod 100, which in turn supports the semi-circular 
rods 103. The surface electrodes 107 are made stationery by locking arms 
128. The surface electrode grid wires 131 are secured by multi-pin sockets 
133 and are channeled to a data acquisition area. One skilled in the art 
will recognize that a number of patient monitoring, and treatment devices 
can be attached to the patient and the cephalic expansion apparatus. 
One embodiment of the cephalic expansion apparatus for the treatment of 
brain trauma comprises a flexible container for holding sterile fluid and 
allowing a swollen brain to expand. The flexible container can include a 
circumferential expansion flap for increasing the volume of flexible 
container. The external, inferior surface of the flexible container 
includes an adhesion means. The adhesion means, includes a biological 
adhesive for forming a water-tight bonding of the container to the skin. 
For example, alpha-cyanoacrylates can be used. A water-tight locking means 
is used for sealing the container. In the preferred embodiment the 
container is sterile when sealed. In the preferred embodiment a groove 
locking device is used. A support means for supporting the container and a 
port for access to the sealed container are also included. 
Specific embodiments of the device in the preferred mode include a 
plurality of ports on the device for the irrigation of the chamber and for 
the insertion of monitor means for monitoring the brain. For example, 
cortical electrodes can be inserted into the device for monitoring brain 
surface electrical activity. The plurality of ports can have support rings 
attached to prevent inadvertent tube and probe movement and cortical 
injury. The ports are of a sufficient size to allow the attachment and 
insertion of tubes for the irrigation of the brain and to allow the 
attachment and insertion of monitor means. Furthermore, the ports can be 
connected to devices for monitoring, as well as, for exchanging the fluid 
in the brain. One skilled in the art will recognize that a variety of 
devices can be used to reduce the temperature, to adjust the pH, to filter 
the fluid and to add substances such as electrolytes and drugs for the 
treatment of infections or other medical, physical and chemical problems 
of the patient. 
The cortical electrodes are moveable over the cortical surface and include 
surface attachments connected to a pre-amp. A locking means is used to 
prevent inadvertent electrode movement and cortical injury. 
The cephalic expansion apparatus can be used to treat head injury. This 
method of treatment includes the attachment of the cephalic expansion 
apparatus to the scalp. In the preferred embodiment the shaved head of the 
patient receives a ten minute surgical scrub to minimize infection. The 
head is then aseptically prepared with an antiseptic solution and 90% 
alcohol. One skilled in the art will recognize that a variety of scrubbing 
and surgical preparation procedures are available. The preferred 
embodiment for scrubbing and sterilizing employees betadine and alcohol. 
The liquid alpha-cyanocrylate is spread on the alcohol prepared scalp in a 
thin layer. Strips of plastic polymer sheeting, for example polyethylene, 
are applied along the sagittal suture from the nasion to the inion and 
from midway between the coronal and lambdoidal sutures to the level of 
both tragi. After these strips adhere, the cephalic expansion apparatus is 
attached to the strips and scalp. The bonding of the cephalic expansion 
apparatus to the strips and scalp with a topical biological adhesive forms 
a water-tight seal between scalp and the cephalic expansion apparatus. The 
external, inferior surface of the cephalic expansion apparatus is applied 
with sufficient force to spread the liquid in a thin layer between the 
scalp and the flexible container. Usually about one drop of adhesive per 
square inch of skin is sufficient to cause adhesion in seconds. Sixty 
percent of the final bond strength occurs within 10 minutes. A standard 
craniotomy is then performed. The bone flaps are removed and preserved for 
replacement after the treatment of the brain injury. In the preferred 
embodiment the bone flaps are kept sterile and frozen at about 4.5.degree. 
C. The cephalic expansion apparatus is sealed by closing the water-tight 
locking means. The closed cephalic expansion apparatus is then filled with 
pH adjusted fluid. The fluid is cooled with a temperature regulating 
means. The lower temperature facilitates recovery. In the preferred 
embodiment the electrical, physical and chemical parameters of the brain 
and the surrounding fluid are monitored. Additionally, the fluid can be 
modified, purified and recycled. When the patient has improved 
sufficiently such that the danger of brain swelling has subsided, usually 
in about 72 hours, the device is removed and the bone flaps are replaced. 
In addition to treating brain injury from trauma, one skilled in the art 
will readily recognize that other brain injuries and/or diseases which 
require continual and/or repeated access to the brain can be treated with 
the cephalic expansion apparatus. 
One skilled in the art will readily appreciate that the present invention 
is well adapted to carry out the objects and obtain the ends and 
advantages mentioned as well as those inherent therein. The methods, 
procedures, techniques, devices and apparatuses described herein are 
presently representative of the preferred embodiments and are intended to 
be exemplary and not intended as limitations on the scope. Changes therein 
and other uses which are encompassed within the spirit of the invention or 
defined by the scope of the appended claims will occur to those skilled in 
the art.