U.S. patent application number 15/857246 was filed with the patent office on 2019-07-04 for systems and methods for decompression, elliptical traction, and linear traction of the occiput, cervical spine, and thoracic spi.
The applicant listed for this patent is Richard A. Graham. Invention is credited to Richard A. Graham.
Application Number | 20190201276 15/857246 |
Document ID | / |
Family ID | 67058764 |
Filed Date | 2019-07-04 |
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United States Patent
Application |
20190201276 |
Kind Code |
A1 |
Graham; Richard A. |
July 4, 2019 |
SYSTEMS AND METHODS FOR DECOMPRESSION, ELLIPTICAL TRACTION, AND
LINEAR TRACTION OF THE OCCIPUT, CERVICAL SPINE, AND THORACIC
SPINE
Abstract
A traction device comprises a frame, a first bladder portion, a
second bladder portion, and a third inflatable bladder portion. The
first bladder expands in an outward direction a distance greater
than in a transverse direction. The second bladder expands in a
first angular direction. The second bladder is positioned generally
inferior to and to the side of the first bladder. The third bladder
expands in a second angular direction. Upon expanding in the
outward direction, the first bladder bears against the back of the
user's neck. Upon expanding in the transverse direction, the first
bladder applies an angular traction to the cervical spine. Upon
expanding in the first angular direction, the second bladder bears
angularly against the back of the user's upper thoracic region.
Upon expanding in the third angular direction, the third bladder
bears angularly against the user's occiput.
Inventors: |
Graham; Richard A.; (Sunset
Beach, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Graham; Richard A. |
Sunset Beach |
CA |
US |
|
|
Family ID: |
67058764 |
Appl. No.: |
15/857246 |
Filed: |
December 28, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/055 20130101;
A61H 2201/1611 20130101; A61H 2201/165 20130101; A61H 2201/1645
20130101; A61H 9/0078 20130101; A61H 2201/1238 20130101 |
International
Class: |
A61H 9/00 20060101
A61H009/00; A61F 5/055 20060101 A61F005/055 |
Claims
1-13. (canceled)
14. A method of treating a spine, the method comprising steps of:
securing a traction device to a head of a user, the traction device
comprising a support frame having a transverse neck support
projecting upwardly from a base of the support frame and first and
second inflatable bladder portions coupled to the neck support,
wherein securing the traction device to the head comprises
positioning the traction device such that the first inflatable
bladder portion transverses a cervical spine of the user, and such
that the second inflatable bladder portion transverses an occiput
of the user; expanding the first inflatable bladder portion in a
direction outward from the neck support and toward and
substantially normal to the cervical spine to force the cervical
spine to curve forwardly; expanding the first inflatable bladder
portion in a transverse direction to apply an angular traction to
the cervical spine; and expanding the second inflatable bladder
portion in a direction toward the occiput to apply an angular
traction to the cervical spine.
15. The method of claim 14, comprising the step of alternately
inflating and deflating the first and second bladder portions.
16. The method of claim 15, comprising the step of repeating
inflation and deflation of the first and second bladder
portions.
17. The method of claim 14, wherein the second inflatable bladder
portion has a semi-ellipsoidal configuration upon inflation.
18. The method of claim 14, wherein the traction device comprises a
third inflatable bladder portion coupled to the neck support,
wherein securing the traction device to the head comprises
positioning the traction device such that the third inflatable
bladder portion transverses an upper thoracic spine of the
user.
19. (canceled)
20. The method of claim 14, wherein the traction device comprises a
valve positioned in communication with a pump system, the first
inflatable bladder portion, and the second inflatable bladder
portion, wherein the method further comprises directing flow from
the pump system through the valve to the first inflatable bladder
portion and the second inflatable bladder portion.
21-27. (canceled)
28. A traction device comprising: a frame having a base and a neck
support coupled to the base to support the neck of a user during
use; an inflatable bladder portion coupled to the neck support, the
inflatable bladder portion configured to expand in an angular
direction from the neck support; and wherein upon the inflatable
bladder portion expanding in the angular direction, the inflatable
bladder portion bears angularly against the back of the upper
thoracic region and the mid thoracic region of the user as the
inflatable bladder is inflated and forces the thoracic spine to
decompress and reduces hyper-kyphosis of the upper thoracic spine
and the mid thoracic spine.
29. The traction device of claim 28, wherein the inflatable bladder
portion is a first inflatable bladder portion, wherein the angular
direction is a first angular direction, the traction device further
comprising a second inflatable bladder portion coupled to the neck
support, the second inflatable bladder portion bladder portion
being expandable in a second angular direction from the neck
support toward a occiput of the user upon inflation, wherein upon
the second inflatable bladder portion expanding in the second
angular direction, the second inflatable bladder portion bears
angularly against the occiput of the user as the second inflatable
bladder is inflated and forces the occipital-cervical junction to
decompress.
30. The traction device of claim 29, further comprising a third
inflatable bladder portion coupled to the neck support, the third
inflatable bladder portion configured to expand in an outward
direction from the neck support toward the neck of the user and
expandable in a transverse direction substantially normal to the
outward direction upon inflation, wherein upon the third inflatable
bladder portion expanding in the outward direction, the third
inflatable bladder portion bears outwardly against the back of the
neck of the user as the third inflatable bladder is inflated and
forces the cervical spine to curve forwardly, and upon expanding in
the transverse direction, the third inflatable bladder portion
applies an angular traction to the cervical spine as the third
inflatable bladder is inflated.
31. The traction device of claim 28, wherein the inflatable bladder
portion is a first inflatable bladder portion, the traction device
further comprising a second inflatable bladder portion coupled to
the neck support, the second inflatable bladder portion configured
to expand in an outward direction from the neck support toward the
neck of the user and expandable in a transverse direction
substantially normal to the outward direction upon inflation,
wherein upon the second inflatable bladder portion expanding in the
outward direction, the second inflatable bladder portion bears
outwardly against the back of the neck of the user as the second
inflatable bladder is inflated and forces the cervical spine to
curve forwardly, and upon expanding in the transverse direction,
the second inflatable bladder portion applies an angular traction
to the cervical spine as the second inflatable bladder is
inflated.
32. The traction device of claim 28, further comprising a spacer
configured to be coupled between a portion of the frame and the
inflatable bladder portion to adjust the angulation of the
inflatable bladder portion during inflation.
33. The traction device of claim 32, wherein the spacer is a
wedge-shaped spacer.
34. The traction device of claim 32, wherein the spacer is
rotatable.
35. A method of treating a spine, the method comprising steps of:
securing a traction device to a head of a user, the traction device
comprising a support frame having a transverse neck support
projecting upwardly from a base of the support frame and first and
second inflatable bladder portions coupled to the neck support,
wherein securing the traction device to the head comprises
positioning the traction device such that the first inflatable
bladder portion transverses an upper thoracic spine of the user,
and such that the second inflatable bladder portion transverses an
occiput of the user; expanding the first inflatable bladder portion
in a direction toward the upper thoracic spine to force the
thoracic spine to decompress and reduce hyper-kyphosis of the upper
thoracic spine; and expanding the second inflatable bladder portion
in a direction toward the occiput to apply an angular traction to a
cervical spine of the user.
36. The method of claim 35, comprising the step of alternately
inflating and deflating the first and second bladder portions.
37. The method of claim 36, comprising the step of repeating
inflation and deflation of the first and second bladder
portions.
38. The method of claim 35, wherein the second inflatable bladder
portion has a semi-ellipsoidal configuration upon inflation.
39. The method of claim 35, wherein the traction device comprises a
third inflatable bladder portion coupled to the neck support,
wherein securing the traction device to the head comprises
positioning the traction device such that the third inflatable
bladder portion transverses a cervical spine of the user.
40. The method of claim 39, wherein the third inflatable bladder
portion is positioned between the first inflatable bladder portion
and the second inflatable bladder portion.
41. The method of claim 35, wherein the traction device comprises a
valve positioned in communication with a pump system, the first
inflatable bladder portion, and the second inflatable bladder
portion, wherein the method further comprises directing flow from
the pump system through the valve to the first inflatable bladder
portion and the second inflatable bladder portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application, are hereby incorporated by reference
under 37 CFR 1.57.
BACKGROUND
Field
[0002] Disclosed herein are spinal decompression and traction
systems and methods related to the field of spinal treatment. More
particularly, certain embodiments disclosed herein relate to
occipital, cervical and thoracic spinal decompression and traction
systems having a plurality of inflatable bladders and methods of
use that maintain, enhance and restore a normal lordotic curve and
counter hyper-kyphosis of the upper and mid thoracic spine.
Description of the Related Art
[0003] Cervical pain is one of the most common health-related
complaints. When there are no neurological deficits, symptomatic
relief of pain is often sought with either non-steroidal
analgesics, or various physical therapy modalities, including
cervical traction. Most traction has consisted of axial linear
distraction employing various head/chin straps and weights of 20 to
25 pounds. Such traction tends to straighten the cervical spine,
removing its normal curve and often results in TMJ pain.
[0004] The undamaged cervical spine normally defines a forward or
lordotic curve of about 43.degree. (measured from C2-C7) whereby
weight is distributed on hard individual bony articular surfaces in
the posterior and soft intervertebral discs to the anterior.
Without such a forward curve in the cervical spine, weight of the
head transfers forward onto the soft non-bony intervertebral discs
and vertebral bodies causing discs to dehydrate, wear, degenerate
and protrude into the anterior subarachnoid space. As vertebral
bodies bear uneven stress, spurs and osteophytes form.
Additionally, individuals with lost or reversed (buckled) cervical
spinal curves eventually exhibit a significant loss of natural
joint movement, further limiting the normal canaliculus seepage and
imbibition of adjacent fluids via vertebral end plates and annuli.
Without such nutrient rich fluids the discs continue to dehydrate,
further weakening the discs, resulting in a further loss of
mobility, degeneration and possible nerve damage. Active nutrient
transport is particularly important because the intervertebral
discs' indigenous vascular supply often disappears at approximately
20 years of age.
[0005] Further, as the cervical spine is forced into flexion and
the lordotic curve is reversed, the dura, cord and nerve-roots are
drawn out; the root-sleeves come into contact with the pedicles,
and the nerve roots with the inner surfaces of the sleeves. During
extension (lordotic curve recovery) the dura, cord and nerve-roots
in the cervical canal are slack; the root-sleeves have lost contact
with the pedicles and the nerve-roots with the inner surfaces of
the sleeves.
[0006] Axial/Linear/Longitudinal traction has long been employed to
decompress cervical joints of the spine. Typically the head is
pulled, pried, lifted or otherwise separated from the thorax along
the Y axis (+Y axis translation or elevation translation).
Ostensibly, to pry the joints apart at the posterior, forward
flexion (+X axis rotation) is often employed in conjunction with or
as an unavoidable component of linear traction. Linear traction or
elevation translation applied to a curved column decreases or
removes the curve. Likewise, adding the component of flexion or
+rotation about the X axis, would apply a buckling force to the
cervical spine and have the effect of reversing the curve (-Z axis
translation). These forces, powerful enough to separate the spinal
joints, are unfortunately antithetical to the natural geometry and
biomechanics of the human cervical spine. The anchor points
commonly used in Axial/Linear/Longitudinal traction are the head as
it is pulled away from the thorax and/or the trapezius muscles as
the thorax is pushed away from the restrained head. U.S. Pat. No.
4,805,603 to Cumberland describes a method where the head and
thorax are separated by two platforms with an expanding air chamber
between the two platforms. These methods, due to their linear
function reduce, remove or reverse the proper cervical curve. U.S.
Pat. No. 6,506,174 to Saunders also describes a linear traction
system.
[0007] Some alternatives to axial/linear/longitudinal traction for
disc, joint and nerve decompression seek to maintain a normal
lordotic curve. For example, U.S. Pat. Nos. 5,382,226; 5,569,176;
5,713,841; 5,906,586; 7,060,085; 8,029,453; and D508,5665 to
Graham, each of which is hereby incorporated by reference herein in
its entirety, disclose some embodiments of systems for
decompression. In two IRB approved studies utilizing multiple
MRI's, an embodiment of the disclosed systems showed a consistent
ability to draw bulging disc material back toward the disc proper
and away from the subarachnoid space and spinal cord while
simultaneously enhancing or restoring the cervical lordotic curve
during and after one 20 minute treatment. Patients reported
immediate symptomatic relief of cervical pain. However, there
exists a need for improved decompression systems that also address
hyper-kyphosis of the upper thoracic spine, mid thoracic spine and
compression of the occipital-cervical junction.
SUMMARY
[0008] Described herein are some embodiments of decompression and
traction systems that maintain, enhance and restore a normal
lordotic curve, counter hyper-kyphosis of the upper and mid
thoracic spine and decompress the occipital-cervical junction.
Methods of assembling and using the decompression and traction
systems described herein are also included. These decompression and
traction systems and related methods are described in greater
detail below.
[0009] One aspect of the present invention is the recognition that
traditionally available traction systems do not provide devices,
systems and methods that simultaneously address cervical lordotic
curve loss/reversal (hypolordosis/kyphosis), and the often
accompanying posterior (-Z) translation (hyper-kyphosis) of the
upper thoracic spine. Embodiments and methods described herein
preferably provide pneumatic radial decompression and traction
equipment for treatment of the cervical and thoracic spine
including a free-standing frame, first and second expandable
bladders, the first expandable bladder providing positive pressure
to support a cervical spinal portion in a normal lordotic curve
configuration, and the second expandable bladder providing positive
pressure to support a thoracic spinal portion in a normal curve
configuration to counter hyper-kyphosis of the upper thoracic
spine.
[0010] According to certain embodiments of the invention, devices,
systems and methods are described that simultaneously address
cervical lordotic curve loss/reversal (hypolordosis/kyphosis), and
the often accompanying posterior (-Z) translation (hyper-kyphosis)
of the upper thoracic spine.
[0011] In relation to the head and neck, -Z translation of the
upper thoracic spine is an integral part of anterior or "Forward
Head Carriage." As the head shifts forward and/or the upper
thoracic spine moves posterior, the weight of the head and neck,
approximately 15 pounds, creates a forward buckling force (-Y and
+Z combination) on the thoracic spine. This continuous forward and
downward force begets more forward head carriage and more
compressive action to the cervical and thoracic intervertebral
discs and bodies. Many are familiar with the term "Dowagers Hump"
where hyper kyphosis of the thoracic spine is so pronounced as to
be obvious with the naked eye. While approximately 30% of these
postural defects (especially in women) are said to be caused by
anterior thoracic vertebral body fractures due to osteoporosis,
most hyper-kyphotic postures are developed over time by continuous
anterior and downward force on the cervical and thoracic
intervertebral discs and vertebral bodies.
[0012] As people spend long hours crouched in front of computer
screens, wear heavy back packs, are involved whiplash type auto and
sports injuries, forward head posture with associated cervical
curve loss, and hyper thoracic kyphosis has become more prevalent.
Neck and back pain, muscle tension and spasm, headaches,
neuropathies and degenerative vertebral joint disease result from
continuous cervical-thoracic disc and joint compression. While
there have been elastic bands and braces applied to the spine to
pull or hold it upright in an attempt to ameliorate worsening
posture, results are mixed.
[0013] In some embodiments, the devices, systems and methods
described herein apply pneumatic forces directly to the offending
spinal apexes in opposing directions. With the simultaneous
application of two separate air cells or pneumatic air chambers the
cervical spine is locked and powerfully decompressed into its
proper lordotic or curved configuration (<{circumflex over (
)}>) with -Y+Z+Y force vectors while the hyper kyphotic area of
the upper thoracic spine is simultaneously decompressed with a
combination +Z/-Y force mid-vector. The cervical spine's lordotic
curve is powerfully decompressed and enhanced while the thoracic
hyper-kyphosis is simultaneously reduced. In some embodiments, a
two pump system can be employed to alternate or unevenly inflate
the pneumatic air chambers. In some embodiments, a complex multi
vectored pneumatic air chamber can be used in place of two
individual cells. In some embodiments, the devices, systems and
methods described herein use the entire cervical spine including
the occiput (base of skull) as a first anchor point and the upper
thoracic spine as a second point. The pneumatic air chambers can
directly contact the cervical spine/occiput and the upper 25% of
the thoracic spine.
[0014] According to one embodiment, a traction device comprises a
frame, a first bladder portion, a second bladder portion, a strap,
and a pump. The first bladder expands in an outward direction a
distance greater than in a transverse direction. The second bladder
expands in an angular direction. The second bladder is positioned
generally below and to the side of the first bladder. The frame is
secured to the user's head. Upon expanding in the outward
direction, the first bladder bears against the back of the user's
neck and forces the cervical spine to curve forwardly. Upon
expanding in the transverse direction, the first bladder applies an
angular traction to the cervical spine. Upon expanding in the
angular direction, the second bladder bears angularly against the
back of the user's upper thoracic region and forces the thoracic
spine to decompress and reduces hyper-kyphosis of the upper
thoracic spine.
[0015] In certain embodiments, a traction device for imparting a
forward curve to the cervical spine and reducing hyper-kyphosis of
the upper thoracic spine is provided. The device comprises a frame
adapted to be supported on a rigid support surface. The frame is
configured to be disposed about a user's head and neck and defines
contact surfaces for abutting the rigid support surface. The frame
has a neck support extending between first and second side portions
of the frame. A first inflatable elongated bladder is coupled to
the neck support and configured to be positioned below a neck of a
user during use. The first inflatable elongated bladder is
expandable in a first direction outwardly from the neck support
toward the neck of a user and expandable in a second direction
substantially normal to the first direction upon inflation. A
second inflatable elongated bladder is coupled to the neck support
and configured to be positioned below the upper thoracic region of
a user during use. The second inflatable elongated bladder is
expandable in a third direction angularly from the neck support
toward the upper thoracic spine of a user upon inflation. A
securing strap is coupled to the frame and configured to secure the
frame to the user's head such that the first inflatable elongated
bladder is disposed adjacent the back of the user's neck and
transverses the cervical spine such that the first direction of
expansion is toward and substantially normal to the cervical spine.
The second inflatable elongated bladder is disposed adjacent the
back of the user's upper thoracic region and transverses the upper
thoracic spine such that the third direction of expansion is toward
and substantially normal to the upper thoracic spine. A pump system
is provided for selectively inflating and deflating the first and
second inflatable elongated bladders. Upon the first inflatable
bladder expanding in the first direction, the first inflatable
bladder bears outwardly against the back of the user's neck and
forces the cervical spine to curve forwardly. Upon expanding in the
second direction, the first inflatable bladder applies an angular
traction to the cervical spine. Upon the second inflatable bladder
expanding in the third direction, the second inflatable bladder
bears angularly against the back of the user's upper thoracic
region and forces the thoracic spine to decompress and reduces
hyper-kyphosis of the upper thoracic spine.
[0016] In some embodiments, the traction device comprises a valve
positioned in communication with the pump system and the first and
second inflatable elongated bladders. The valve comprises varying
lumen diameters that direct flow between the pump system and the
first and second inflatable elongated bladders. The first
inflatable elongated bladder is pivotably coupled to the neck
support. A spacer is configured to be coupled between a portion of
the frame and the second inflatable elongated bladder to adjust the
angulation of the second inflatable elongated bladder during
inflation.
[0017] In other embodiments, a traction device is provided for
imparting a forward curve to the cervical spine and reducing
hyper-kyphosis of the upper thoracic spine. The device comprises a
frame having a transverse neck support projecting upwardly from
first and second side portions defining a base of the frame. A
first inflatable bladder portion is coupled to the neck support.
The first inflatable bladder portion is configured to expand in an
outward direction from the neck support a distance greater than the
expansion of the first inflatable bladder portion in a transverse
direction normal thereto. A second inflatable bladder portion is
coupled to the neck support. The second inflatable bladder portion
is configured to expand in an angular direction from the neck
support. The second inflatable bladder portion is positioned
generally below and to the side relative to the first inflatable
bladder portion. A strap is coupled to the frame and configured to
secure the frame to the user's head such that the first inflatable
bladder portion is disposed adjacent the back of the user's neck
and transverses the cervical spine such that the outward direction
of expansion is toward and substantially normal to the cervical
spine. The second inflatable bladder portion is disposed adjacent
the back of the user's upper thoracic region and transverses the
upper thoracic spine such that the angular direction of expansion
is toward and substantially normal to the upper thoracic spine. A
pump system is provided for inflating the first and second
inflatable bladder portions. Upon the first inflatable bladder
portion expanding in the outward direction, the first inflatable
bladder portion bears outwardly against the back of the user's neck
and forces the cervical spine to curve forwardly. Upon expanding in
the transverse direction, the first inflatable bladder portion
applies an angular traction to the cervical spine. Upon the second
inflatable bladder portion expanding in the angular direction, the
second inflatable bladder portion bears angularly against the back
of the user's upper thoracic region and forces the thoracic spine
to decompress and reduces hyper-kyphosis of the upper thoracic
spine.
[0018] In some embodiments, a method is provided for imparting a
forward curve to the cervical spine and reducing hyper-kyphosis of
the upper thoracic spine. The method comprises securing a traction
device to a user's head. The traction device comprises a support
frame having a transverse neck support projecting upwardly from a
base of the support frame and first and second inflatable bladder
portions coupled to the neck support. The traction device is
secured to the user's head includes positioning the traction device
such that the first inflatable bladder portion transverses the
cervical spine, and such that the second inflatable bladder portion
transverses the upper thoracic spine. The first inflatable bladder
portion is expanded in a direction outward from the neck support
and toward and substantially normal to the cervical spine to force
the cervical spine to curve forwardly. The first inflatable bladder
portion is expanded in a transverse direction to apply an angular
traction to the cervical spine. The second inflatable bladder
portion is expanded in a direction toward and substantially normal
to the upper thoracic spine to force the upper thoracic spine to
decompress and reduce hyper-kyphosis of the upper thoracic
spine.
[0019] In certain embodiments, methods may comprise alternately
inflating and deflating the first and second bladder portions.
Inflation and deflation of the first and second bladder portions
can be repeated. The first inflatable bladder portion can have a
semi-ellipsoidal configuration upon inflation. The second
inflatable bladder portion can have a semi-ellipsoidal
configuration upon inflation. During inflation or deflation, flow
can be directed between the pump system and the bladder portion
through a valve that comprises different lumen diameters to provide
particular flow to or from the first and second inflatable bladder
portions. Methods can include pivoting the first inflatable bladder
relative to the neck support and/or positioning a spacer between a
portion of the frame and the second inflatable bladder portion to
adjust the angulation of the second inflatable bladder portion
during inflation.
[0020] In some embodiments, a traction device is provided for
imparting a forward curve to the cervical spine and reducing
hyper-kyphosis of the upper thoracic spine. The device comprises a
frame adapted to be supported on a rigid support surface. The frame
is configured to be disposed about a user's head and neck and
defines contact surfaces for abutting the rigid support surface.
The frame has a neck support extending between first and second
side portions of the frame. A first inflatable elongated bladder is
coupled to the neck support and configured to be positioned below a
neck of a user during use. The first inflatable elongated bladder
is expandable in a first direction outwardly from the neck support
toward the neck of a user and expandable in a second direction
substantially normal to the first direction upon inflation. A
second inflatable elongated bladder is coupled to the neck support
and configured to be positioned below the upper thoracic region of
a user during use. The second inflatable elongated bladder is
expandable in a third direction angularly from the neck support
toward the upper thoracic spine of a user upon inflation. A spacer
is configured to be coupled between a portion of the frame and the
second inflatable elongated bladder to adjust the angulation of the
second inflatable elongated bladder during inflation. A pump system
is provided for selectively inflating and deflating the first and
second inflatable elongated bladders. Upon the first inflatable
bladder expanding in the first direction, the first inflatable
bladder bears outwardly against the back of the user's neck, and
upon expanding in the second direction, the first inflatable
bladder applies an angular traction to the cervical spine. Upon the
second inflatable bladder expanding in the third direction, the
second inflatable bladder bears angularly against the back of the
user's upper thoracic region.
[0021] In certain embodiments, a traction device for imparting a
forward curve to the cervical spine and reducing hyper-kyphosis of
the upper thoracic spine comprises a frame having a transverse neck
support projecting upwardly from first and second side portions
defining a base of the frame. A first inflatable bladder portion is
coupled to the neck support, the first inflatable bladder portion
is configured to expand in an outward direction from the neck
support a distance greater than the expansion of the first
inflatable bladder portion in a transverse direction normal
thereto. A second inflatable bladder portion is coupled to the neck
support. The second inflatable bladder portion is configured to
expand in an angular direction from the neck support. The second
inflatable bladder portion is positioned generally below and to the
side relative to the first inflatable bladder portion. A spacer is
configured to be coupled between a portion of the frame and the
second inflatable bladder portion to adjust the angulation of the
second inflatable bladder portion during inflation. A pump system
is provided for inflating the first and second inflatable bladder
portions. Upon the first inflatable bladder portion expanding in
the outward direction, the first inflatable bladder portion bears
outwardly against the back of the user's neck. Upon expanding in
the transverse direction, the first inflatable bladder portion
applies an angular traction to the cervical spine. Upon the second
inflatable bladder portion expanding in the angular direction, the
second inflatable bladder portion bears angularly against the back
of the user's upper thoracic region.
[0022] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the second inflatable bladder portion during
inflation to provide lateral flexion traction. Other spacer systems
are contemplated and can also be used. For example, any component
or device that can be selectively adjusted and can contact at least
a portion of the second inflatable bladder portion can be used to
impart lateral flexion traction. Additionally, in some cases a
component or device need not be adjustable, for example, a spacer
or other component could be provided on a traction device to cause
the second inflatable bladder portion to consistently provide for
lateral flexion traction on one side, while other systems can
provide for lateral flexion traction on the other side.
Additionally, while adjustments made with the spacer may be
rotational, other movements or adjustments can be made with other
mechanisms and arrangements, such as by sliding, for example.
[0023] According to another implementation, a method of imparting a
forward curve to the cervical spine and reducing hyper-kyphosis of
the upper thoracic spine is provided. A traction device is secured
to a user's head. The traction device comprises a support frame
having a transverse neck support projecting upwardly from a base of
the support frame and first and second inflatable bladder portions
coupled to the neck support and a spacer coupled between a portion
of the frame and the second inflatable bladder portion to adjust
the angulation of the second inflatable bladder portion during
inflation to provide lateral flexion traction. Securing the
traction device to the user's head includes positioning the
traction device such that the first inflatable bladder portion
transverses the cervical spine, and such that the second inflatable
bladder portion transverses the upper thoracic spine. The first
inflatable bladder portion is expanded in a direction outward from
the neck support and toward and substantially normal to the
cervical spine to force the cervical spine to curve forwardly. The
first inflatable bladder portion is expanded in a transverse
direction to apply an angular traction to the cervical spine. The
second inflatable bladder portion is expanded in a direction toward
the upper thoracic spine to provide lateral flexion traction. In
some embodiments, the spacer is rotated to adjust the angulation of
the second inflatable bladder portion.
[0024] According to certain embodiments of the invention, devices,
systems and methods are described that address compression of the
occipital-cervical junction. In some embodiments, the devices,
systems, and methods described herein apply pneumatic forces
directly to the occiput.
[0025] In certain embodiments of the invention, devices, systems
and methods are described that simultaneously address cervical
lordotic curve loss/reversal (hypolordosis/kyphosis), the often
accompanying posterior (-Z) translation (hyper-kyphosis) of the
upper thoracic spine, and compression of the occipital-cervical
junction. With the application of an air cell or pneumatic air
chamber, the occipital-cervical junction is decompressed by the
application of +Z/+Y force vectors.
[0026] In some embodiments, the devices, systems, and methods
described herein apply pneumatic forces directly to the offending
spinal apexes in opposing directions and to the occiput. With the
simultaneous application of three separate air cells or pneumatic
air chambers the cervical spine is locked and powerfully
decompressed into its proper lordotic or curved configuration
(<{circumflex over ( )}>) with -Y+Z+Y force vectors while the
hyper kyphotic area of the upper thoracic spine is simultaneously
decompressed with a combination +Z/-Y force mid-vector and +Z/+Y
force vectors are applied to the occiput to decompress the
occipital-cervical junction. The cervical spine's lordotic curve is
powerfully decompressed and enhanced while the thoracic
hyper-kyphosis is simultaneously reduced and the occipital-cervical
junction is decompressed. In some embodiments, a two pump system
can be employed to alternate or unevenly inflate the pneumatic air
chambers. In some embodiments, a three pump system can be employed
to alternate or unevenly inflate the pneumatic air chambers. In
some embodiments, a complex multi vectored pneumatic air chamber
can be used in place of three individual cells. In some
embodiments, the devices, systems and methods described herein use
the entire cervical spine as a first anchor point, the upper
thoracic spine as a second point, and the occiput as a third point.
The pneumatic air chambers can directly contact the cervical
spine/occiput and the upper 25%-40% of the thoracic spine.
[0027] In certain embodiments, a traction device is provided. The
device comprises a frame having a base and a neck support coupled
to the base to support the neck of a user during use, a first
inflatable bladder portion coupled to the neck support, a second
inflatable bladder portion coupled to the neck support, and a third
inflatable bladder portion coupled to the neck support. The first
inflatable bladder portion is configured to expand in an outward
direction from the neck support toward the neck of a user and to
expand in a transverse direction substantially normal to the
outward direction upon inflation. The second inflatable bladder
portion is configured to expand in a first angular direction from
the neck support and is positioned generally inferior to the first
inflatable bladder portion. The third inflatable bladder portion is
configured to expand in a second angular direction from the neck
support and is positioned generally superior to the first
inflatable bladder portion. Upon the first inflatable bladder
portion expanding in the outward direction, the first inflatable
bladder portion bears outwardly against the back of the neck of the
user as the first inflatable bladder is inflated and forces the
cervical spine to curve forwardly, and upon expanding in the
transverse direction, the first inflatable bladder portion applies
an angular traction to the cervical spine as the first inflatable
bladder is inflated. Upon the second inflatable bladder portion
expanding in the first angular direction, the second inflatable
bladder portion bears angularly against the back of the upper
thoracic region of the user as the second inflatable bladder is
inflated and forces the thoracic spine to decompress and reduces
hyper-kyphosis of the upper thoracic spine. Upon the third
inflatable bladder portion expanding in the second angular
direction, the third inflatable bladder portion bears angularly
against the occiput of the user as the third inflatable bladder is
inflated and forces the occipital-cervical junction to
decompress.
[0028] In certain embodiments, a spacer is configured to be coupled
between a portion of the frame and the second inflatable bladder
portion to adjust the angulation of the second inflatable bladder
portion during inflation. In certain embodiments, a spacer is
configured to be coupled between a portion of the frame and the
third inflatable bladder portion to adjust the angulation of the
third inflatable bladder portion during inflation. In certain
embodiments, a pump system is provided for inflating the first,
second, and third inflatable bladder portions. In certain
embodiments, a valve is positioned in communication with the pump
system and the first inflatable bladder portion, the second
inflatable bladder portion, and the third inflatable bladder
portion, wherein the valve comprises varying lumen diameters that
direct flow between the pump system and the first inflatable
bladder portion, the second inflatable bladder portion, and the
third inflatable bladder portion. In certain embodiments, upon
inflation, the third inflatable bladder portion can impart
15.degree. to 20.degree. of forward head flexion to the occiput of
the user.
[0029] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the second inflatable bladder portion during
inflation to provide lateral flexion traction. Other spacer systems
are contemplated and can also be used. For example, any component
or device that can be selectively adjusted and can contact at least
a portion of the second inflatable bladder portion can be used to
impart lateral flexion traction. Additionally, in some cases a
component or device need not be adjustable, for example, a spacer
or other component could be provided on a traction device to cause
the second inflatable bladder portion to consistently provide for
lateral flexion traction on one side, while other systems can
provide for lateral flexion traction on the other side.
Additionally, while adjustments made with the spacer may be
rotational, other movements or adjustments can be made with other
mechanisms and arrangements, such as by sliding, for example.
[0030] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the third inflatable bladder portion during inflation
to provide lateral flexion traction. Other spacer systems are
contemplated and can also be used. For example, any component or
device that can be selectively adjusted and can contact at least a
portion of the third inflatable bladder portion can be used to
impart lateral flexion traction. Additionally, in some cases a
component or device need not be adjustable, for example, a spacer
or other component could be provided on a traction device to cause
the second inflatable bladder portion to consistently provide for
lateral flexion traction on one side, while other systems can
provide for lateral flexion traction on the other side.
Additionally, while adjustments made with the spacer may be
rotational, other movements or adjustments can be made with other
mechanisms and arrangements, such as by sliding, for example.
[0031] In some embodiments, the devices, systems, and methods
described herein apply pneumatic forces directly to the cervical
spine and the occiput. With the simultaneous application of two
separate air cells or pneumatic air chambers the cervical spine is
locked and powerfully decompressed into its proper lordotic or
curved configuration (<{circumflex over ( )}>) with -Y+Z+Y
force vectors the occipital-cervical junction is simultaneously
decompressed with +Z/+Y force vectors. The cervical spine's
lordotic curve is powerfully decompressed and enhanced while the
occipital-cervical junction is decompressed. In some embodiments, a
two pump system can be employed to alternate or unevenly inflate
the pneumatic air chambers. In some embodiments, a complex multi
vectored pneumatic air chamber can be used in place of two
individual cells. In some embodiments, the devices, systems and
methods described herein use the entire cervical spine as a first
anchor point, and the occiput as a second point.
[0032] In certain embodiments, a traction device is provided. The
traction device comprises a frame having a base and a neck support
coupled to the base to support the neck of a user during use, a
first inflatable bladder portion coupled to the neck support, and a
second inflatable bladder portion coupled to the neck support. The
first inflatable bladder portion is configured to expand in an
outward direction from the neck support toward the neck of the user
and in a transverse direction substantially normal to the outward
direction upon inflation. The second inflatable bladder portion is
configured to be positioned superior to the first inflatable
bladder portion and is expandable in an angular direction from the
neck support toward an occiput of the user upon inflation. Upon the
first inflatable bladder portion expanding in the outward
direction, the first inflatable bladder portion bears outwardly
against the back of the neck of the user as the first inflatable
bladder is inflated and forces the cervical spine to curve
forwardly, and upon expanding in the transverse direction, the
first inflatable bladder portion applies an angular traction to the
cervical spine as the first inflatable bladder is inflated. Upon
the second inflatable bladder portion expanding in the angular
direction, the second inflatable bladder portion bears angularly
against the occiput of the user as the second inflatable bladder is
inflated and forces the occipital-cervical junction to
decompress.
[0033] In certain embodiments, a spacer is configured to be coupled
between a portion of the frame and the second inflatable bladder
portion to adjust the angulation of the second inflatable bladder
portion during inflation. In certain embodiments, a pump system is
provided for selectively inflating and deflating one or more of the
first and second inflatable bladder portions. In certain
embodiments, a valve is positioned in communication with the pump
system and the first and second inflatable bladder portions,
wherein the valve comprises varying lumen diameters that direct
flow between the pump system and the first and second inflatable
bladder portions.
[0034] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the second inflatable bladder portion during
inflation to provide lateral flexion traction. Other spacer systems
are contemplated and can also be used. For example, any component
or device that can be selectively adjusted and can contact at least
a portion of the second inflatable bladder portion can be used to
impart lateral flexion traction. Additionally, in some cases a
component or device need not be adjustable, for example, a spacer
or other component could be provided on a traction device to cause
the second inflatable bladder portion to consistently provide for
lateral flexion traction on one side, while other systems can
provide for lateral flexion traction on the other side.
Additionally, while adjustments made with the spacer may be
rotational, other movements or adjustments can be made with other
mechanisms and arrangements, such as by sliding, for example.
[0035] In certain embodiments, a method of imparting a forward
curve to the cervical spine and reducing hyper-kyphosis of the
upper thoracic spine is provided. The method comprises a step of
securing a traction device to a head of a user. The traction device
comprises a support frame having a transverse neck support
projecting upwardly from a base of the support frame and first and
second inflatable bladder portions coupled to the neck support.
Securing the traction device to the head comprises positioning the
traction device such that the first inflatable bladder portion
transverses the cervical spine, and such that the second inflatable
bladder portion transverses an occiput of the user. The method
further comprises a step of expanding the first inflatable bladder
portion in a direction outward from the neck support and toward and
substantially normal to the cervical spine to force the cervical
spine to curve forwardly. The method also comprises a step of
expanding the first inflatable bladder portion in a transverse
direction to apply an angular traction to the cervical spine. The
method further comprises a step of expanding the second inflatable
bladder portion in a direction toward the occiput to apply an
angular traction to the occipital-cervical junction.
[0036] In some embodiments, the method further comprising a step of
alternately inflating and deflating the first and second bladder
portions. In some embodiments, the method further comprises a step
of repeating inflation and deflation of the first and second
bladder portions. In some embodiments, the second inflatable
bladder portion has a semi-ellipsoidal configuration upon
inflation. In some embodiments, the traction device comprises a
third inflatable bladder portion coupled to the neck support. In
some embodiments, securing the traction device to the head
comprises positioning the traction device such that the third
inflatable bladder portion transverses the upper thoracic spine. In
some embodiments, the method further comprises a step of inflating
the third bladder portion in a direction toward the upper thoracic
spine to force the thoracic spine to decompress and reduce
hyper-kyphosis of the upper thoracic spine. In some embodiments,
the traction device comprises a valve positioned in communication
with a pump system and the first inflatable bladder portion, the
second inflatable bladder portion, and the third inflatable bladder
portion. In some embodiments, the method further comprises a step
of directing flow from the pump system through the valve to the
first inflatable bladder portion, the second inflatable bladder
portion, and the third inflatable bladder portion.
[0037] In some embodiments, the devices, systems, and methods
described herein apply pneumatic forces directly to the thoracic
spine and to the occiput. With the simultaneous application of two
separate air cells or pneumatic air chambers, the hyper kyphotic
area of the upper thoracic spine is simultaneously decompressed
with a combination +Z/-Y force mid-vector and the
occipital-cervical junction is decompressed with +Z/+Y force
vectors. The thoracic hyper-kyphosis is simultaneously reduced and
the occipital-cervical junction is decompressed. In some
embodiments, the simultaneous application of two separate air cells
or pneumatic air chambers, to the thoracic spine and the occiput
can impart linear traction. In some embodiments, a two pump system
can be employed to alternate or unevenly inflate the pneumatic air
chambers. In some embodiments, a complex multi vectored pneumatic
air chamber can be used in place of two individual cells. In some
embodiments, the devices, systems and methods described herein use
the upper thoracic spine as a first anchoring point and the occiput
as a second point. The pneumatic air chambers can directly contact
the cervical spine/occiput and the upper 25%-40% of the thoracic
spine.
[0038] In certain embodiments, a traction device is provided. The
traction device comprises a frame having a base and a neck support
coupled to the base to support the neck of a user during use, a
first inflatable bladder portion coupled to the neck support, and a
second inflatable bladder portion coupled to the neck support. The
first inflatable bladder portion is configured to expand a first
angular direction from the neck support. The second inflatable
bladder portion is configured to be positioned superior to the
first inflatable bladder portion and is expandable in a second
angular direction from the neck support toward an occiput of the
user upon inflation. Upon the first inflatable bladder portion
expanding in the first angular direction, the first inflatable
bladder portion bears angularly against the back of the upper
thoracic region of the user as the second inflatable bladder is
inflated and forces the thoracic spine to decompress and reduces
hyper-kyphosis of the upper thoracic spine. Upon the second
inflatable bladder portion expanding in the angular direction, the
second inflatable bladder portion bears angularly against the
occiput of the user as the second inflatable bladder is inflated
and forces the occipital-cervical junction to decompress.
[0039] In certain embodiments, a spacer is configured to be coupled
between a portion of the frame and the second inflatable bladder
portion to adjust the angulation of the second inflatable bladder
portion during inflation. In certain embodiments, a pump system is
provided for selectively inflating and deflating one or more of the
first and second inflatable bladder portions. In certain
embodiments, a valve is positioned in communication with the pump
system and the first and second inflatable bladder portions,
wherein the valve comprises varying lumen diameters that direct
flow between the pump system and the first and second inflatable
bladder portions.
[0040] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the first inflatable bladder portion during inflation
to provide lateral flexion traction. Other spacer systems are
contemplated and can also be used. For example, any component or
device that can be selectively adjusted and can contact at least a
portion of the first inflatable bladder portion can be used to
impart lateral flexion traction. Additionally, in some cases a
component or device need not be adjustable, for example, a spacer
or other component could be provided on a traction device to cause
the second inflatable bladder portion to consistently provide for
lateral flexion traction on one side, while other systems can
provide for lateral flexion traction on the other side.
Additionally, while adjustments made with the spacer may be
rotational, other movements or adjustments can be made with other
mechanisms and arrangements, such as by sliding, for example.
[0041] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the second inflatable bladder portion during
inflation to provide lateral flexion traction. Other spacer systems
are contemplated and can also be used. For example, any component
or device that can be selectively adjusted and can contact at least
a portion of the second inflatable bladder portion can be used to
impart lateral flexion traction. Additionally, in some cases a
component or device need not be adjustable, for example, a spacer
or other component could be provided on a traction device to cause
the second inflatable bladder portion to consistently provide for
lateral flexion traction on one side, while other systems can
provide for lateral flexion traction on the other side.
Additionally, while adjustments made with the spacer may be
rotational, other movements or adjustments can be made with other
mechanisms and arrangements, such as by sliding, for example.
[0042] In certain embodiments, a traction device is provided. The
traction device comprises a frame having a base and a neck support
coupled to the base to support the neck of a user during use and an
inflatable bladder portion coupled to the neck support. The
inflatable bladder portion is configured to expand in an angular
direction from the neck support. Upon the inflatable bladder
portion expanding in the angular direction, the inflatable bladder
portion bears angularly against the back of the upper thoracic
region and the mid thoracic region of the user as the inflatable
bladder is inflated and forces the thoracic spine to decompress and
reduces hyper-kyphosis of the upper thoracic spine and the mid
thoracic spine.
[0043] In certain embodiments, the inflatable bladder portion is a
first inflatable bladder portion and the angular direction is a
first angular direction. In certain embodiments, the traction
device further comprises a second inflatable bladder portion
coupled to the neck support, and the second inflatable bladder
portion bladder portion is expandable in a second angular direction
from the neck support toward a occiput of the user upon inflation.
In certain embodiments, upon the second inflatable bladder portion
expanding in the second angular direction, the second inflatable
bladder portion bears angularly against the occiput of the user as
the second inflatable bladder is inflated and forces the
occipital-cervical junction to decompress the occipital-cervical
junction. In certain embodiments, the traction device further
comprises a third inflatable bladder portion coupled to the neck
support, and the third inflatable bladder portion is configured to
expand in an outward direction from the neck support toward the
neck of the user and in a transverse direction substantially normal
to the outward direction upon inflation. In certain embodiments,
upon the third inflatable bladder portion expanding in the outward
direction, the third inflatable bladder portion bears outwardly
against the back of the neck of the user as the third inflatable
bladder is inflated and forces the cervical spine to curve
forwardly, and upon expanding in the transverse direction, the
third inflatable bladder portion applies an angular traction to the
cervical spine as the third inflatable bladder is inflated.
[0044] In certain embodiments, the inflatable bladder portion is a
first inflatable bladder portion, and the traction device further
comprises a second inflatable bladder portion coupled to the neck
support. In certain embodiments, the second inflatable bladder
portion is configured to expand in an outward direction from the
neck support toward the neck of the user and in a transverse
direction substantially normal to the outward direction upon
inflation. In certain embodiments, upon the second inflatable
bladder portion expanding in the outward direction, the second
inflatable bladder portion bears outwardly against the back of the
neck of the user as the second inflatable bladder is inflated and
forces the cervical spine to curve forwardly, and upon expanding in
the transverse direction, the second inflatable bladder portion
applies an angular traction to the cervical spine as the second
inflatable bladder is inflated.
[0045] In certain embodiments, a spacer is configured to be coupled
between a portion of the frame and the inflatable bladder portion
to adjust the angulation of the inflatable bladder portion during
inflation. In certain embodiments, a pump system is provided for
selectively inflating and deflating the inflatable bladder portion.
In certain embodiments, a valve is positioned in communication with
the pump system and the inflatable bladder portion, wherein the
valve comprises varying lumen diameters that direct flow between
the pump system and the inflatable bladder portion.
[0046] According to some implementations, additional features
include a wedge-shaped spacer, a rotatable spacer, and/or a spacer
in a horizontal position that is configured to adjust the
angulation of the inflatable bladder portion during inflation to
provide lateral flexion traction. Other spacer systems are
contemplated and can also be used. For example, any component or
device that can be selectively adjusted and can contact at least a
portion of the inflatable bladder portion can be used to impart
lateral flexion traction. Additionally, in some cases a component
or device need not be adjustable, for example, a spacer or other
component could be provided on a traction device to cause the
inflatable bladder portion to consistently provide for lateral
flexion traction on one side, while other systems can provide for
lateral flexion traction on the other side. Additionally, while
adjustments made with the spacer may be rotational, other movements
or adjustments can be made with other mechanisms and arrangements,
such as by sliding, for example.
[0047] These and other objects and advantages of the present
disclosure will become readily apparent from the following detailed
description taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] FIG. 1 is a perspective view of one embodiment of a
decompression and traction system.
[0049] FIG. 2 is a perspective view of a portion of the system
shown in FIG. 1.
[0050] FIG. 3 is a top view of a portion of the system shown in
FIG. 1.
[0051] FIG. 4 is a side view of a portion of the system shown in
FIG. 1.
[0052] FIG. 5 is a cross-sectional side view of a portion of the
system shown in FIG. 1.
[0053] FIG. 6 is a perspective view of a valve component shown in
the cross-sectional side view of FIG. 5.
[0054] FIG. 7 is a perspective view of a portion of the system
shown in FIG. 1, showing a second inflatable bladder in an
unassembled configuration.
[0055] FIG. 8 is a schematic view of another embodiment of a
decompression and traction system, showing mobile pneumatic air
chambers comprising a first inflatable bladder being pivotably
adjustable and showing a spacer component configured to be
selectively coupled to the frame to adjust a position of a second
inflatable bladder.
[0056] FIG. 9 is a perspective view of the spacer component shown
in FIG. 8.
[0057] FIGS. 10A-F are illustrative views of a patient's spine in
multiple configurations, including some embodiments of
decompression and traction systems in use in deflated and inflated
configurations.
[0058] FIG. 11 is a schematic top view of a patient positioned on
another embodiment of a decompression and traction system, showing
pneumatic air chambers comprising first and second inflatable
bladders and an adjustable spacer component configured to be
selectively coupled to the frame to adjust a position of the second
inflatable bladder, in the shown configuration the spacer component
adjusts the position of the second inflatable bladder to provide an
even distribution of force generally along a force vector in the -Y
and +Z plane.
[0059] FIG. 12 is a schematic top view of a patient and the
embodiment of FIG. 11, showing a configuration wherein the spacer
component is moved to adjust the position of the second inflatable
bladder to provide an uneven distribution of force on one side of
the patient in that a force vector is directed, for example, in a
-Y, +Z, and -X direction.
[0060] FIG. 13 is a bottom view of the embodiment of FIG. 11, in
the shown configuration the spacer component adjusts the position
of the second inflatable bladder to provide an even distribution of
force generally along a force vector in the -Y and +Z plane.
[0061] FIG. 14 is a bottom view of the embodiment of FIG. 11,
showing a configuration wherein the spacer component is moved to
adjust the position of the second inflatable bladder to provide an
uneven distribution of force to a patient in that a force vector is
directed, for example, in a -Y, +Z, and -X direction.
[0062] FIG. 15 is a perspective view of one embodiment of a
decompression and traction system.
[0063] FIG. 16 is a perspective view of a portion of the system
shown in FIG. 15.
[0064] FIG. 17 is a top view of a portion of the system shown in
FIG. 15.
[0065] FIG. 18 is a side view of a portion of the system shown in
FIG. 15.
[0066] FIG. 19 is a cross-sectional side view of a portion of the
system shown in FIG. 15.
[0067] FIG. 20 is a perspective view of a valve component shown in
the cross-sectional side view of FIG. 19.
[0068] FIG. 21 is a perspective view of a portion of the system
shown in FIG. 15, showing a third inflatable bladder in an
unassembled configuration.
[0069] FIG. 22 is a schematic view of another embodiment of a
decompression and traction system, showing mobile pneumatic air
chambers comprising a first inflatable bladder being pivotably
adjustable, showing a spacer component configured to be selectively
coupled to the frame to adjust a position of a second inflatable
bladder, and showing a spacer component configured to be
selectively coupled to the frame to adjust a position of a third
inflatable bladder.
[0070] FIGS. 23A-B are illustrative views of a patient's spine
including embodiments of decompression and traction systems in use
in inflated configurations.
[0071] FIG. 24 is a schematic top view of a patient positioned on
another embodiment of a decompression and traction system, showing
pneumatic air chambers comprising first, second, and third
inflatable bladders, a first adjustable spacer component configured
to be selectively coupled to the frame to adjust a position of the
second inflatable bladder, wherein in the shown configuration the
spacer component adjusts the position of the second inflatable
bladder to provide an even distribution of force generally along a
force vector in the -Y and +Z plane, and a second adjustable spacer
component configured to be selectively coupled to the frame to
adjust a position of the third inflatable bladder, wherein in the
shown configuration the spacer component adjusts the position of
the third inflatable bladder to provide an even distribution of
force generally along a force vector in the +Y and +Z plane
[0072] FIG. 25 is a schematic top view of a patient and the
embodiment of FIG. 24, showing a configuration wherein the first
spacer component is moved to adjust the position of the second
inflatable bladder to provide an uneven distribution of force on
one side of the patient in that a force vector is directed, for
example, in a -Y, +Z, and -X direction, and wherein the second
spacer component is moved to adjust the position of the third
inflatable bladder to provide an uneven distribution of force on
one side of the patient in that a force vector is directed, for
example, in a +Y, +Z, and -X direction.
[0073] FIG. 26 is a bottom view of the embodiment of FIG. 24, in
the shown configuration the first spacer component adjusts the
position of the second inflatable bladder to provide an even
distribution of force generally along a force vector in the -Y and
+Z plane and the second spacer component adjusts the position of
the second inflatable bladder to provide an even distribution of
force generally along a force vector in the +Y and +Z plane.
[0074] FIG. 27 is a bottom view of the embodiment of FIG. 24,
showing a configuration wherein the first spacer component is moved
to adjust the position of the second inflatable bladder to provide
an uneven distribution of force to a patient in that a force vector
is directed, for example, in a -Y, +Z, and -X direction and the
second spacer component is moved to adjust the position of the
third inflatable bladder to provide an uneven distribution of force
to a patient in that a force vector is directed, for example, in a
+Y, +Z, and -X direction.
[0075] FIG. 28 is a perspective view of one embodiment of a
decompression and traction system.
[0076] FIG. 29 is a perspective view of one embodiment of a
decompression and traction system.
[0077] FIG. 30 is an illustrative view of a patient's spine
including an embodiment of a decompression and traction systems in
use in an inflated configuration.
DETAILED DESCRIPTION
[0078] According to some preferred embodiments, the devices,
systems and methods described herein relate to a decompression and
traction system for imparting the desired lordotic shape into the
cervical region of the spine and counteracting hyper-kyphosis of
the area of the upper thoracic spine. Some systems can be used to
work the spine and surrounding tissue to promote fluid and cellular
exchange in and around the intervertebral discs.
[0079] In some embodiments, the device comprises a frame, a first
substantially ellipsoidal inflatable bladder transversely in a neck
support cradle carried by the frame, a second inflatable bladder
supported on the neck support cradle carried by the frame and
configured to provide a force vector against the upper thoracic
spine when inflated, one or more restraining straps for securing
the device to the user's head such that the first and second
bladders are disposed against the back of the neck under a stress
point in the cervical spine and against the hyper-kyphotic upper
thoracic spine, respectively. Controlled inflation of the bladders
by the user by a hand-held pump causes a controlled lifting and a
stretching of the cervical and thoracic spine. As the first bladder
is inflated, the configuration of the first bladder causes the
first bladder to expand vertically and, to a lesser extent,
transversely. The vertical expansion lifts the spine, creating a
spinal apex while the transverse expansion of the bladder applies
an angular traction to the neck on both sides of the apex. As the
second bladder is inflated, preferably simultaneously, the
configuration of the second bladder causes the second bladder to
expand vertically and transversely. The vertical and transverse
expansion lifts the spine and applies an angular traction to the
thoracic region.
[0080] By controlling the inflation of the bladders, the user can
control the lifting and stretching of the spine and incrementally
increase the magnitude of spinal arc and decompression of the
cervical and thoracic regions to his or her own tolerance. As the
bladders are repetitively inflated to the tolerance of the user and
deflated, the cervical spine is alternatively and actively forced
from a lesser arc to a greater or hyper-lordotic arc and the
hyper-kyphotic arc of the upper thoracic spine is simultaneously
reduced and decompressed, thereby promoting nutrient transport to
the intervertebral discs while simultaneously increasing the
cervical lordotic arc and decreasing the thoracic hyper-kyphosis.
These decompression and traction systems and related methods are
described in greater detail below.
[0081] Referring now to the drawings, as shown in FIGS. 1-5,
according to one embodiment, a traction device 110 comprises a
frame 112, openings or slots 114 configured to receive one or more
straps to restrain the forehead and/or chin of a user, a first
inflatable air bladder 116, a second inflatable air bladder 118,
and an air pump assembly 120.
[0082] The frame 112 is preferably molded of a durable plastic
material in a tubular configuration so as to define a pair of side
members 122 and 124 curved and meeting at an apex 126, and a
transverse neck support 128. The frame side members 122 and 124
preferably form a stable base. The neck support 128 preferably
comprises vertically extending portions 130 and 132 which project
upwardly from the side members 122 and 124 respectively and project
inwardly to define inwardly directed raised lateral portions 134
and 136. A neck cradle 138 extends transversely between portions
134 and 136, spanning frame side members 122 and 124. In some
embodiments, the frame can be provided with side members that are
not connected at an apex 126, such as in some embodiments where
side members are shorter.
[0083] The first and second air bladders 116 and 118 are preferably
configured for inflation and simultaneous application of force to
the cervical and thoracic spine, when the patient is in a treatment
position, to decompressed the spine into its proper lordotic or
curved configuration (<{circumflex over ( )}>) with -Y+Z+Y
force vectors being applied to the cervical spine while the
hyper-kyphotic area of the upper thoracic spine is simultaneously
decompressed with a combination +Z/-Y force mid-vector. The
cervical spine's lordotic curve is powerfully decompressed and
enhanced while the thoracic hyper-kyphosis is simultaneously
reduced. In some embodiments, the devices, systems and methods
described herein use the entire cervical spine including the
occiput (base of skull) as the first anchor point and the upper
thoracic spine as the second point. The pneumatic air chambers can
directly contact the cervical spine/occiput and the upper 25%-40%
of the thoracic spine. The first and second inflatable bladders
116, 118, are described in more detail below.
[0084] To provide selective inflation and deflation of the first
and second inflatable bladders 116, 118, a flexible air line 140 of
the air pump assembly 120 communicates the interior of the first
and second inflatable bladders 116, 118 with a hand-operated air
pump 142. In other embodiments an automated pump can be used. A
pressure relief valve 144 is preferably disposed between the air
line 140 and pump 142. Air line 140 preferably extends from the
relief valve 144 through an opening in the neck support 128 and
communicates with the first and second inflatable bladders 116,
118. In some embodiments, the air can be communicated through
openings formed in the underside or ends of the bladders. In some
embodiments, a valve 146, such as a multi-directional metering
valve, shown in FIGS. 5 and 6 for example, can be coupled with the
air line 140 and can direct air to the first and second inflatable
bladders 116, 118. In some embodiments the valve 146 comprises
different lumen diameters to vary the air flow directed to the
opposing traction pneumatic air chambers of the first and second
inflatable bladders 116, 118. Different valve components can be
used to adjust the amount or flow of air to the respective
pneumatic air chambers. While air is an example fluid used in the
pneumatic decompression described herein, other suitable fluids can
be used to increase or decrease the volume of the bladders,
including using liquids in some embodiments. In some embodiments, a
two pump system can be employed to alternate or unevenly inflate
the pneumatic air chambers. In some embodiments, a single complex
multi-vectored cell or bladder can be used in place of two
individual cells.
[0085] According to one embodiment, by way of example, a frame 112
of a traction device 110 defines a spacing of about nine inches
between the curved side members 122 and 124 at a wide portion with
the side members coming together at the apex 126 of the frame. The
frame 112 is preferably between about 11 to 17 inches in length in
some embodiments. The frame 112 preferably elevates the neck
support 128 about 0.5 to about 1. 5 inches above the floor or
surface. In such a configuration, the frame 112 preferably bears
against the floor or surface during use and reduces the tendency of
the frame to twist about its transverse axis. The cradle 138 in
neck support 128 preferably tapers from an elevation of about 3
inches above the floor proximate side members 122 and 124 to a
central elevation of about 2.5 inches.
[0086] The first expandable bladder 116 is preferably coupled to
and carried by the neck support 128 in the cradle 138 defined
therein. The first expandable bladder 116 is preferably secured in
place as will be described further herein. The lateral portions 134
and 136 of neck support 128 are preferably provided with oppositely
facing recesses formed therein adjacent the lateral ends of cradle
138 for receiving the extended ends of the first expandable bladder
116 to facilitate retention and alignment of the bladder on the
cradle 138.
[0087] According to some embodiments, the upper portion of the
first expandable bladder 116 is of a generally semi-ellipsoidal
configuration having relatively pointed ends similar to the upper
half of a football bladder. In one preferred bladder configuration,
the underside of the first expandable bladder 116 is formed with
undercut portions so as to define a central depending portion. At
least a portion of the cradle is preferably configured to receive
the underside of the first expandable bladder 116. Preferably, the
first expandable bladder 116, when inflated, will expand upwardly
from the cradle 138 to a slightly greater extent than in a
transverse direction. Additionally, in some embodiments, provision
of the depending portion on the underside of the bladder provides a
cushioning effect under the apex of the expanded bladder which
bears against the user's neck, making the device more comfortable
for the user. Thus, as the bladder is inflated under and against
the user's neck, it expands vertically and transversely, lifting
the spine to create a spinal apex and applying an angular traction
to the neck on both sides of the spinal apex. The amount of
traction exerted in the vertical direction, however, will be
somewhat greater than that exerted longitudinally to obtain the
vertical lift necessary to restore the normal lordotic shape to the
cervical region of the spine without overly tractioning the neck
longitudinally.
[0088] In some embodiments, the first inflatable bladder 116 is
constructed of an expandable material such as neoprene rubber,
defines a length of between about 8 to 10 inches, a height of about
3 to 4 inches in an uninflated state, and depending on the
configuration of the bladder a transverse width of about 3 inches.
In some embodiments, the bladder 116 is constructed of a material
that resists expansion. In some embodiments, the bladder 116 is
constructed of a heat-sealable urethane with 200 Denier nylon. The
bladder 116 can comprise a cover of any suitable material,
including, for example, a neoprene material. The semi-ellipsoidal
upper portion of the first inflatable bladder 116, when inflated,
defines a transverse arc of about 4 inches in length about the
center of the bladder. It is to be understood that these dimensions
are by way of example only and can be varied, as can the
configuration of the frame, straps, and first and second bladders
without departing from the spirit and scope of the invention. For
example, in some embodiments the bladder 116 can have a length of
between about 6 to 9 inches, a height of about 2 to 3 inches in a
deflated state, a height of about 3 to 4 inches in an inflated
state. In some embodiments a deflated circumference of the bladder
is about 4 inches and an inflated circumference of the bladder is
between about 7 and 8 inches. In an inflated configuration, the
bladder 116 can be taller than it is wide, for example, it can be
approximately 4 inches tall and approximately 3 inches wide when
inflated in some embodiments.
[0089] The second expandable bladder 118 is coupled to and carried
by the neck support 128. The second expandable bladder 118 is
preferably adjustable in some embodiments to accommodate patient
anatomy and align with desired force vector directions as will be
described further herein. The lateral portions 134 and 136 of neck
support 128 are preferably configured with recesses formed therein
for receiving the extended ends 148, shown in FIG. 7, of the second
expandable bladder 118 to facilitate retention and alignment of the
bladder on the neck support 128.
[0090] According to some embodiments, the second expandable bladder
118 is of a generally semi-ellipsoidal configuration having a
relatively curved portion upon inflation for engaging a portion of
the thoracic spine. Preferably, the second expandable bladder 118,
when inflated, will expand about the same amount transversely and
upwardly from the neck support 128. In some embodiments, the second
expandable bladder 118 when inflated expands more transversely than
upwardly. In some embodiments, the second expandable bladder 118
when inflated expands more upwardly than transversely. Thus, as the
second expandable bladder 118 is inflated under and against the
user's thoracic spine, it expands transversely and vertically,
lifting the spine to counter hyper-kyphosis and applying an angular
traction to the thoracic spine. The amount of traction exerted in
the longitudinal direction, preferably, will be similar to the
amount of lift exerted vertically to obtain the necessary
decompression and lift to restore the normal shape to the thoracic
region of the spine.
[0091] In some embodiments, the second inflatable bladder 118 is
constructed of an expandable material such as neoprene rubber,
defines a length of between about 8 to 10 inches, a height of about
3 to 4 inches in an uninflated state, and depending on the
configuration of the bladder a transverse width of about 3 inches.
In some embodiments, the bladder 118 is constructed of a material
that resists expansion. In some embodiments, the bladder 118 is
constructed of a heat-sealable urethane with 200 Denier nylon. The
bladder 118 can comprise a cover of any suitable material,
including, for example, a neoprene material. The second inflatable
bladder 118, when inflated, defines a transverse arc of about 4
inches in length about the center of the bladder. It is to be
understood that these dimensions are by way of example only and can
be varied without departing from the spirit and scope of the
invention. For example, in some embodiments the bladder 118 can
have a length of about 9 inches where it is coupled to the frame, a
length of between about 6 and 7 inches where the bladder 118
contacts the patient. The bladder 118 can have a height of about 3
to 4 inches. The bladder 118 can have a circumference of about 6 to
7 inches.
[0092] In some embodiments the bladders preferably have a finite
shape and expand while being filled until the bladders reach the
finite shape. Once the bladder has been filled to the finite shape,
the pressure release valve of the pump assembly allows for gas or
fluid to escape from the system to maintain a desired pressure
within the bladder. The pressure release valve is preferably an
automatic pressure release valve. The system preferably also
comprises a manual release valve, such as a push button release
valve. The desired pressure is preferably held at a proven clinical
level. In some embodiments the pressure release valve is configured
to maintain a pressure of about 8 psi. At a pressure of about 8 psi
the system preferably provides over 50 pounds of tractional force.
In some embodiments the tractional force preferably is between
about 50 and 60 pounds of tractional force.
[0093] While the above described bladder configurations are
preferred, it is to be understood that other configurations of
expandable bladders could be employed in the present invention,
either with or without an expansion controlling casing to provide
the desired lifting and traction of the user's neck and spine.
Moreover, in some embodiments, mechanically expandable components
can be used in place of the first and second bladders. Mechanically
expandable components can be coupled to the frame and selectively
expanded to apply force vectors to the cervical and thoracic spine
in a manner similar to those produced by the expandable bladders as
described herein. For example, in some embodiments an expanding
mechanical component within a cushioned cover can be selectively
actuated to provide the desired force distribution.
[0094] In some embodiments, one or more of the first and second
expandable bladders 116, 118 are of a tubular configuration and are
disposed in a non-expandable casing, preferably constructed of a
vinyl or other suitable material. The casing is preferably formed
in the above described generally ellipsoidal configurations. As the
tubular bladder expands upon inflation, the expansion is limited by
the configuration of the casing to provide the desired increase in
the vertical and transverse directions.
[0095] In some embodiments, as shown in FIG. 8, the first
expandable bladder 116 is preferably rotatably secured to the neck
support 128. The first expandable bladder 116 can be tilted in a
forward position, a backward position, or maintained in a central
position. In some embodiments, the bladder can be locked into a
desired position. Providing a rotatable first expandable bladder
116 preferably provides mobility for the pneumatic air chamber to
comfortably accommodate various spinal configurations. In some
embodiments, the second expandable bladder 118 can be rotatably
secured to the neck support 128.
[0096] In some embodiments, as shown in FIGS. 8 and 9, a spacer
component 150 is preferably configured to be selectively coupled to
the frame 112 to adjust a position of a second inflatable bladder
118. The spacer component can be attached to the frame and can
allow clinicians and users to increase the negative Y directional
component of the lower pneumatic air chamber. In one embodiment,
the spacer component comprises an pneumatic air chamber or bladder
engaging face 152, a notched connector portion 154 and opposing
side portions 156. Other spacer configurations can be used to
modify the directional component of the second inflatable bladder
118.
[0097] FIGS. 10A-F are illustrative views of a patient's spine in
multiple configurations, including some embodiments of
decompression and traction systems in use in deflated and inflated
configurations. FIG. 10A shows a patient with cervical curve loss,
forward head carriage, and disc compression. FIG. 10B shows a
patient with normal spinal curves. FIGS. 10C and 10D show a patient
and one embodiment of a decompression system 110 having a chin and
forehead restraint, wherein the views show the decompression system
110 in a deflated configuration and an inflated configuration,
respectively. FIGS. 10E and 10F show a patient and another
embodiment of a decompression system 110 having a forehead
restraint, wherein the views show the decompression system 110 in a
deflated configuration and an inflated configuration,
respectively.
[0098] As shown in FIGS. 10C-F, restraint straps 158 and/or 160 can
be secured at the ends thereof to one or more of slots 114. Straps
can be passed under the user's chin and over the user's forehead in
some embodiments. In other embodiments, a strap can be passed over
the user's forehead only. The straps can be secured and fastened in
any suitable manner. For example, interlocking hook and loop type
fasteners, snaps, buckles or other fasteners can be used. According
to some embodiments, the traction device 110 can be easily and
securely affixed to the user's head with a strap configuration such
that with the user lying flat on his or her back on a horizontal
surface, the frame 112 rests on the surface and the neck support
128 is disposed under the user's neck and tapered ends 162 of the
frame side members 122, 124 are substantially adjacent the user's
shoulders and generally near the upper thoracic region. The
tightness of the securement of the device 110 to the user's head
can be readily adjusted as needed by the securement straps 158,
160.
[0099] In some embodiments, the system preferably comprises a frame
made of virgin acrylonitrile butadiene styrene (ABS) plastic
material. ABS is an engineering thermoplastic that is advantageous
due to its strength, toughness, chemical resistance, and ability to
maintain necessary stiffness. The expandable pneumatic air chambers
are preferably made of heat-sealable urethane with 200 Denier
nylon. The expandable pneumatic air chambers preferably have a
neoprene cover. The facial straps are preferably made of a durable
and waterproof neoprene material. The hand pump and tubing are
preferably made of rubber/plastic. Other embodiments can include
different materials.
[0100] According to some embodiments, the system is lightweight
(for example, about 3 lbs), portable, easy to operate, requires no
assembly, no weights, cables or ropes to set-up, comes with choice
of ballistic nylon carrying case or educational box, instruction
page and instructional DVD. In one embodiment, the device comprises
a built-in frame, an expanding elliptical pneumatic air chamber
(with neoprene cover) that creates radial tractional force and
thoracic decompressive force, a patient-controlled pneumatic hand
pump with a push button release and automatic safety valve
connected to approximately 30 inches of tubing, and one dual action
head restraint designed for patients who suffer with TMJ (does not
aggravate temporomandibular joint), which comprises an adjustable
forehead strap, and a removable chin strap (which is optional in
some other embodiments).
[0101] Accordingly to one aspect disclosed herein, methods for
pneumatic radial traction can restore the cervical and thoracic
spine to the proper configuration. Pneumatic radial traction, also
known in some embodiments as expanding ellipsoidal decompression
(EED), is a process in which joints of the cervical spine are
pneumatically tractioned and simultaneously aligned into the
cervical spine's proper radial or curved configuration. A major
clinical difference between some embodiments of a pneumatic radial
traction device disclosed herein and some prior art devices is that
the prior art devices flatten or reverse the proper cervical curve
to attain joint separation. In some embodiments, a pneumatic radial
traction device enhances or maintains the proper cervical curve
while attaining over twice the joint separation as some prior art
devices.
[0102] With reference to FIGS. 10A and 10B, in the upright
position, the cervical "lordotic" curve is what allows the weight
of the head (10-15 lbs.) to be directed toward the hard boney
posterior articular surfaces of the neck rather than toward the
softer anterior discs as in the compressed neck. Through modern
healthcare imaging it can be seen that that loss of the normal
forward cervical curve (approx.43.degree.) and the resulting
anterior disc compression this causes, was a contributing factor in
osteophyte formation (Wolff's Law), posterior disc bulging, disc
herniation, disc degeneration, neck pain and loss in cervical range
of motion.
[0103] With reference to FIGS. 10C to 10F, pneumatic radial
traction separates and simultaneously aligns the spinal joints in a
curved or radial configuration. In some embodiments, an elliptical
pneumatic air chamber directs multi-vectored expansive forces from
within the posterior spinal concavity (back of neck), vertically
(+Z axis translation) and in both horizontal directions. The spine
is simultaneously tractioned in three main directions. The radial
configuration created by these multi-vectored forces produces high
level joint separation at the posterior, middle and anterior of the
disc while forcefully enhancing the cervical spine's proper curve,
rather than flattening or reversing the curve. Pneumatic radial
traction is preferably achieved when the joints are separated by a
vertical displacement greater than the horizontal displacement,
however, displacement of equal height and width is also
advantageous in some embodiments. An advantage of a pneumatic
radial traction device is that it does not flatten or reverse the
proper cervical curve while attaining joint separation. In some
embodiments, the system provides a traction device with multiple
fulcrums. For example, at least two fulcrums are provided to
provide treatment to the cervical and thoracic spine of the
patient.
[0104] As the head is stabilized in the cervical device, joints are
actively tractioned in 3 main directions instead of one or two. The
cervical spine is tractioned vertically along the +Z axis with a
pneumatic force of over 58 lbs. This force expands into and against
the posterior cervical concavity. Simultaneously the spine is
tractioned horizontally in the two traditional directions (+Y and
-Y) with a pneumatic force of over 40-lbs in each direction. These
forces expand against the occiput and against the upper thoracic
region. The combination of these simultaneously applied pneumatic
forces produce radial traction. When fully inflated the elliptical
pneumatic cell expands to a 7.5 inch radius, affecting the entire
cervical spine. High level joint traction occurs at the posterior,
center and anterior aspect of the vertebral bodies in a ratio
coinciding with the discs' natural wedged spacing. While the
pneumatic radial traction device separates the posterior of the
joints to a magnitude typical of traditional traction, it separates
the overall disc more than twice as much as linear traction.
[0105] With the simultaneous application of two separate pneumatic
air chambers the cervical spine is decompressed into its proper
lordotic or curved configuration (<{circumflex over ( )}>)
with -Y+Z+Y force vectors while the hyper kyphotic area of the
upper thoracic spine is simultaneously decompressed with a
combination +Z/-Y force mid-vector. The cervical spine's lordotic
curve is powerfully decompressed and enhanced while the thoracic
hyper-kyphosis is simultaneously reduced.
[0106] Continuous expansion and contraction of the pneumatic air
chambers can be employed to create alternating hydration and
milking of the intervertebral discs, activating their sponge-like
imbibition action. Holding the air pressure constant over a period
of 15 to 20 minutes has the effect of simultaneously molding the
spine into a curved or elliptical shape, decompressing discs and
relaxing the dura, cord and nerve-roots in the cervical canal.
[0107] Embodiments described herein are preferably prescribed for
patients with chronic neck pain due to a musculoskeletal or
neurological impairment. The system applies radial tractional force
to the cervical spine, enhancing the cervical lordotic curve while
achieving high level joint separation at the anterior, center and
posterior aspect of the vertebral bodies and discs in a ratio
corresponding with their natural wedged spacing, reducing disc
protrusions, compression and increasing range of motion. In some
applications, devices advantageously decrease pain in chronic neck
pain patients, decrease headaches and increase range of motion
while reducing the necessity for chronic pain medication and neck
surgery.
[0108] With continued reference to FIGS. 10A-10F, according to some
embodiments in use, the traction device 110 rests on a horizontal
surface such that the neck support 128 projects upwardly therefrom.
The user lies on the device in a prone position such that the back
of the neck rests on the deflated first expandable bladder 116
carried in the cradle 138 of the neck support 128. The deflated
second expandable bladder 118 is positioned between the neck
support 128 and portions of the thoracic spine of the user. The
chin and/or forehead restraining restraint straps are respectively
extended under the user's chin and/or about the user's forehead and
secured, thereby affixing the traction device 110 to the user such
that the neck and cervical spine extend over the neck support and
first expandable bladder 116 and the thoracic spine is adjacent the
second expandable bladder 118. According to one preferred
embodiment, the outward extension of the neck support 128 is
relatively slight so that when the bladder is in the deflated
position with the forehead and chin restraints secured, very little
or no force is exerted on the neck by the neck support. This is
achieved by elevating the neck support 128 above the frame such
that the neck cradle 138 formed therein is about 2 to 3 inches
above the floor or other horizontal surface on which the device 110
is used. The first expandable bladder 116 is sized such that upon
full inflation, the apex of the curved upper surface of the bladder
will extend about 5 inches above the floor or surface. The second
expandable bladder 118 is sized such that upon full inflation, a
surface of the second expandable bladder engaging the thoracic
spine will extend toward the thoracic spine about 2 to 3 inches in
the -Y/+Z direction.
[0109] In some embodiments, as the user slowly inflates the first
and second inflatable bladders 116, 118 using the air pump 142, the
first inflatable bladder 116 expands upwardly and, to a lesser
extent, transversely, thereby forcing the cervical spine forwardly
creating a spinal apex while concurrently stretching the spine
angularly along both sides of the formed spinal apex. The second
inflatable bladder 118 expands transversely in the -Y direction,
thereby forcing the thoracic spine forwardly to offset the effects
of hyper-khyphosis. The user then continues to inflate the first
and second bladders 116 and 118 until his or her individual
tolerance level is reached. The bladders are then deflated by use
of the one way valve 144. The process is preferably repeated
several times, slowly increasing the spinal arc in the cervical
region and placing pressure on the thoracic region as the level of
tolerance increases. In addition, the first and second bladders 116
and 118 can be held in an inflated state at or slightly below the
level of tolerance for varying periods of time up to ten to twenty
minutes. Through such repetition, the cervical spine, thoracic
spine and surrounding tissue receive a workout promoting cellular
exchange in and around the intervertebral disc and a forward curve
is reinstated into the cervical spine while achieving proper spine
configuration in the thoracic region. FIGS. 10A-10F illustrate the
effects of the traction and exercise devices 110 of some
embodiments on the cervical and thoracic spine.
[0110] With reference to FIGS. 11-14, an adjustable spacer
component 150 can be provided in some implementations of a traction
system 110 to provide for lateral flexion traction. For example,
FIG. 11 is a schematic top view of a patient positioned on another
embodiment of a decompression and traction system, showing
pneumatic air chambers comprising first and second inflatable
bladders 116, 118 and an adjustable wedge-shaped spacer component
150 configured to be selectively coupled to the frame to adjust a
position of the second inflatable bladder, in the shown
configuration the spacer component is in a vertical orientation and
adjusts the position of the second inflatable bladder to provide an
even distribution of force generally along a force vector in the -Y
and +Z plane without providing any lateral flexion traction to the
patient.
[0111] FIG. 12 shows a configuration wherein the spacer component
is moved to adjust the position of the second inflatable bladder to
provide an uneven distribution of force on one side of the patient
in that a force vector is directed, for example, in a -Y, +Z, and
-X direction. For example, the spacer component is turned or
rotated to a horizontal position, whereby the wedge shape of the
spacer contacts the second inflatable bladder and causes the
bladder to deflect in one lateral direction more than another
lateral direction. As shown, the spacer is placed in right
horizontal position and causes more deflection on the right side of
the patient. In other configurations, the spacer can be positioned
in a left horizontal position to cause more deflection on the left
side of the patient. Based on the positioning of the spacer, the
second bladder can expand in an angular direction. Turning the
spacer component sideways creates lateral flexion traction by
forcing the shoulder/trapezius down while the head is held in
traction.
[0112] FIG. 13 is a bottom view of the embodiment of FIG. 11 and
shows the spacer component in a vertical position that adjusts the
position of the second inflatable bladder to provide an even
distribution of force generally along a force vector in the -Y and
+Z plane, but does not direct force laterally in a -X or +X
direction. FIG. 14 is a bottom view of the embodiment of FIG. 11,
showing a configuration wherein the spacer component is moved to
adjust the position of the second inflatable bladder to provide an
uneven distribution of force to a patient in that a force vector is
directed, for example, in a -Y, +Z, and -X direction as described
in connection with FIG. 12. The lower linear displacement pneumatic
air chamber is adjusted with a rotating wedge shaped spacer
component, allowing clinicians to increase the angle and force of
the mid (-Y)/(+Z) vector of this pneumatic air chamber. When
adjusted to the right or left horizontal position, the rotating
wedge allows clinicians to unilaterally increase and rotate the
(-Y) directional component on either the right or left side (+/-X)
of the upper thoracic region, producing lateral flexion traction.
The rotating wedge shaped spacer component can be removed in some
implementations to accommodate extreme kyphotic thoracic
spines.
[0113] In some embodiments, the device comprises a frame, a first
substantially ellipsoidal inflatable bladder transversely in a neck
support cradle carried by the frame, a second inflatable bladder
supported on the neck support cradle carried by the frame and
configured to provide a force vector against the upper thoracic
spine when inflated, a third inflatable bladder supported on the
neck support cradle carried by the frame and configured to provide
a force vector against the occiput when inflated, one or more
restraining straps for securing the device to the user's head such
that the first and second bladders are disposed against the back of
the neck under a stress point in the cervical spine and against the
hyper-kyphotic upper thoracic spine, respectively. Controlled
inflation of the bladders by the user by a hand-held pump causes a
controlled lifting and a stretching of the cervical and thoracic
spine and decompression of the occipital-cervical junction. As the
first bladder is inflated, the configuration of the first bladder
causes the first bladder to expand vertically and, to a lesser
extent, transversely. The vertical expansion lifts the spine,
creating a spinal apex while the transverse expansion of the
bladder applies an angular traction to the neck on both sides of
the apex. As the second bladder is inflated, preferably
simultaneously, the configuration of the second bladder causes the
second bladder to expand vertically and transversely. The vertical
and transverse expansion lifts the spine and applies an angular
traction to the thoracic region. As the third bladder is inflated,
preferably simultaneously, the configuration of the third bladder
causes the third bladder to expand vertically and transversely. The
vertical and transverse expansion lifts the head and applies an
angular traction to the occiput.
[0114] By controlling the inflation of the bladders, the user can
control the lifting and stretching of the spine and incrementally
increase the magnitude of spinal arc and decompression of the
cervical region, thoracic region, and occipital-cervical junction
to his or her own tolerance. As the bladders are repetitively
inflated to the tolerance of the user and deflated, the cervical
spine is alternatively and actively forced from a lesser arc to a
greater or hyper-lordotic arc, the hyper-kyphotic arc of the upper
thoracic spine is simultaneously reduced and decompressed, and the
occipital-cervical junction is simultaneously decompressed, thereby
promoting nutrient transport to the intervertebral discs while
simultaneously increasing the cervical lordotic arc and decreasing
the thoracic hyper-kyphosis. These decompression and traction
systems and related methods are described in greater detail
below.
[0115] Referring now to the drawings, as shown in FIGS. 15-19,
according to one embodiment, a traction device 210 comprises the
frame 112, openings or slots 114 configured to receive one or more
straps to restrain the forehead and/or chin of a user, the first
inflatable air bladder 116, the second inflatable air bladder 118,
a third inflatable bladder 119, and an air pump assembly 120.
[0116] The frame 112 is preferably molded of a durable plastic
material in a tubular configuration so as to define a pair of side
members 122 and 124 curved and meeting at an apex 126, and a
transverse neck support 128. The frame side members 122 and 124
preferably form a stable base. The neck support 128 preferably
comprises vertically extending portions 130 and 132 which project
upwardly from the side members 122 and 124 respectively and project
inwardly to define inwardly directed raised lateral portions 134
and 136. A neck cradle 138 extends transversely between portions
134 and 136, spanning frame side members 122 and 124. In some
embodiments, the frame can be provided with side members that are
not connected at an apex 126, such as in some embodiments where
side members are shorter.
[0117] The first, second, and third air bladders 116, 118, and 119
are preferably configured for inflation and simultaneous
application of force to the cervical spine, the thoracic spine, and
the occiput, when the patient is in a treatment position, to
decompress the spine into its proper lordotic or curved
configuration (<{circumflex over ( )}>) with -Y+Z+Y force
vectors being applied to the cervical spine while the
hyper-kyphotic area of the upper thoracic spine is simultaneously
decompressed with a combination +Z/-Y force mid-vector and +Z/+Y
force vectors are applied to the occiput to decompress the
occipital-cervical junction. The cervical spine's lordotic curve is
powerfully decompressed and enhanced while the thoracic
hyper-kyphosis is simultaneously reduced. In some embodiments, the
devices, systems and methods described herein use the entire
cervical spine as a first anchor point, the upper thoracic spine as
a second point, and the occiput as a third anchor point. The
pneumatic air chambers can directly contact the cervical spine, the
upper 25%-40% of the thoracic spine, and the occiput. The first,
second, and third inflatable bladders 116, 118, and 119 are
described in more detail below.
[0118] To provide selective inflation and deflation of the first,
second, and third inflatable bladders 116, 118, and 119, a flexible
air line 140 of the air pump assembly 120 communicates the interior
of the first, second, and third inflatable bladders 116, 118, and
119 with a hand-operated air pump 142. In other embodiments an
automated pump or electronic pump can be used. The electronic pump
may be part of an electronic pump system. In certain embodiments,
the electronic pump system can include a processor configured to
execute one or more software applications that cause the electronic
pump to fill one or more of the first, second, and third inflatable
bladders 116, 118, and 119. In certain embodiments, the electronic
pump can be configured to inflate one or more of the first, second,
and third inflatable bladders 116, 118, and 119 to one or more
predefined or user selected inflation amounts. For example, in some
embodiments, the software applications allow for selective
inflation of one or more of the first, second, and third inflatable
bladders 116, 118, and 119 to low, medium, and/or high amounts of
inflation. In certain embodiments, the electronic pump system can
include a user interface that allows a user to select and/or
control one or more settings of the pump. For example, the user
interface can allow for a selection of one or more of the first,
second, and third inflatable bladders 116, 118, and 119 for
inflation. In some embodiments, the user interface can allow for a
selection of one or more inflation amounts for each inflatable
bladder. In certain embodiments, the user interface can be provided
on the electronic pump. In some embodiments, the user interface can
be provided on an external device.
[0119] A pressure relief valve 144 is preferably disposed between
the air line 140 and pump 142. Air line 140 preferably extends from
the relief valve 144 through an opening in the neck support 128 and
communicates with the first and second inflatable bladders 116,
118. In some embodiments, the air can be communicated through
openings formed in the underside or ends of the bladders. In some
embodiments, a valve 246, such as a multi-directional metering
valve, shown in FIGS. 19 and 20 for example, can be coupled with
the air line 140 and can direct air to the first, second, and third
inflatable bladders 116, 118, and 119. In some embodiments the
valve 246 comprises different lumen diameters to vary the air flow
directed to the opposing traction pneumatic air chambers of the
first, second, and third inflatable bladders 116, 118, and 119.
Different valve components can be used to adjust the amount or flow
of air to the respective pneumatic air chambers. While air is an
example fluid used in the pneumatic decompression described herein,
other suitable fluids can be used to increase or decrease the
volume of the bladders, including using liquids in some
embodiments. In some embodiments, a two pump system or a three pump
system can be employed to alternate or unevenly inflate the
pneumatic air chambers. For example, in some embodiments, a first
pump can be employed to inflate the first inflatable bladder 116
and a second pump can be employed to inflate the second and third
inflatable bladders 118 and 119. In some embodiments, a first pump
can be employed to inflate the first and second inflatable bladders
116 and 118 and a second pump can be employed to inflate the third
inflatable bladder 119. In some embodiments, a pump can be employed
to inflate the first and third inflatable bladders 116 and 119 and
a second pump can be employed to inflate the second inflatable
bladder 118. In some embodiments, a single complex multi-vectored
cell or bladder can be used in place of three individual cells. In
some embodiments, a single complex multi-vectored cell or bladder
can be used in place of two of three inflatable bladders 116, 118,
and 119. For example, in some embodiments, a single complex
multi-vectored cell or bladder can be used in place of the first
and second inflatable bladders 116 and 118. In some embodiments, a
single complex multi-vectored cell or bladder can be used in place
of the first and third inflatable bladders 116 and 119.
[0120] According to one embodiment, by way of example, a frame 112
of a traction device 110 defines a spacing of about nine inches
between the curved side members 122 and 124 at a wide portion with
the side members coming together at the apex 126 of the frame. The
frame 112 is preferably between about 11 to 17 inches in length in
some embodiments. The frame 112 preferably elevates the neck
support 128 about 0.5 to about 1. 5 inches above the floor or
surface. In such a configuration, the frame 112 preferably bears
against the floor or surface during use and reduces the tendency of
the frame to twist about its transverse axis. The cradle 138 in
neck support 128 preferably tapers from an elevation of about 3
inches above the floor proximate side members 122 and 124 to a
central elevation of about 2.5 inches.
[0121] The first expandable bladder 116 is preferably coupled to
and carried by the neck support 128 in the cradle 138 defined
therein. The first expandable bladder 116 is preferably secured in
place as will be described further herein. The lateral portions 134
and 136 of neck support 128 are preferably provided with oppositely
facing recesses formed therein adjacent the lateral ends of cradle
138 for receiving the extended ends of the first expandable bladder
116 to facilitate retention and alignment of the bladder on the
cradle 138.
[0122] According to some embodiments, the upper portion of the
first expandable bladder 116 is of a generally semi-ellipsoidal
configuration having relatively pointed ends similar to the upper
half of a football bladder. In one preferred bladder configuration,
the underside of the first expandable bladder 116 is formed with
undercut portions so as to define a central depending portion. At
least a portion of the cradle is preferably configured to receive
the underside of the first expandable bladder 116. Preferably, the
first expandable bladder 116, when inflated, will expand upwardly
from the cradle 138 to a slightly greater extent than in a
transverse direction. Additionally, in some embodiments, provision
of the depending portion on the underside of the bladder provides a
cushioning effect under the apex of the expanded bladder which
bears against the user's neck, making the device more comfortable
for the user. Thus, as the bladder is inflated under and against
the user's neck, it expands vertically and transversely, lifting
the spine to create a spinal apex and applying an angular traction
to the neck on both sides of the spinal apex. The amount of
traction exerted in the vertical direction, however, will be
somewhat greater than that exerted longitudinally to obtain the
vertical lift necessary to restore the normal lordotic shape to the
cervical region of the spine without overly tractioning the neck
longitudinally.
[0123] In some embodiments, the first inflatable bladder 116 is
constructed of an expandable material such as neoprene rubber,
defines a length of between about 8 to 10 inches, a height of about
3 to 4 inches in an uninflated state, and depending on the
configuration of the bladder a transverse width of about 3 inches.
In some embodiments, the bladder 116 is constructed of a material
that resists expansion. In some embodiments, the bladder 116 is
constructed of a heat-sealable urethane with 200 Denier nylon. The
bladder 116 can comprise a cover of any suitable material,
including, for example, a neoprene material. The semi-ellipsoidal
upper portion of the first inflatable bladder 116, when inflated,
defines a transverse arc of about 4 inches in length about the
center of the bladder. It is to be understood that these dimensions
are by way of example only and can be varied, as can the
configuration of the frame, straps, and first and second bladders
without departing from the spirit and scope of the invention. For
example, in some embodiments the bladder 116 can have a length of
between about 6 to 9 inches, a height of about 2 to 3 inches in a
deflated state, a height of about 3 to 4 inches in an inflated
state. In some embodiments a deflated circumference of the bladder
is about 4 inches and an inflated circumference of the bladder is
between about 7 and 8 inches. In an inflated configuration, the
bladder 116 can be taller than it is wide, for example, it can be
approximately 4 inches tall and approximately 3 inches wide when
inflated in some embodiments.
[0124] The second expandable bladder 118 is coupled to and carried
by the neck support 128. The second expandable bladder 118 is
preferably adjustable in some embodiments to accommodate patient
anatomy and align with desired force vector directions as will be
described further herein. The lateral portions 134 and 136 of neck
support 128 are preferably configured with recesses formed therein
for receiving the extended ends 148, for example, as described with
respect to FIG. 7, of the second expandable bladder 118 to
facilitate retention and alignment of the bladder on the neck
support 128.
[0125] According to some embodiments, the second expandable bladder
118 is of a generally semi-ellipsoidal configuration having a
relatively curved portion upon inflation for engaging a portion of
the thoracic spine. Preferably, the second expandable bladder 118,
when inflated, will expand about the same amount transversely and
upwardly from the neck support 128. In some embodiments, the second
expandable bladder 118 when inflated expands more transversely than
upwardly. In some embodiments, the second expandable bladder 118
when inflated expands more upwardly than transversely. Thus, as the
second expandable bladder 118 is inflated under and against the
user's thoracic spine, it expands transversely and vertically,
lifting the spine to counter hyper-kyphosis and applying an angular
traction to the thoracic spine. The amount of traction exerted in
the longitudinal direction, preferably, will be similar to the
amount of lift exerted vertically to obtain the necessary
decompression and lift to restore the normal shape to the thoracic
region of the spine.
[0126] In some embodiments, the second inflatable bladder 118 is
constructed of an expandable material such as neoprene rubber,
defines a length of between about 8 to 10 inches, a height of about
3 to 4 inches in an uninflated state, and depending on the
configuration of the bladder a transverse width of about 3 inches.
In some embodiments, the bladder 118 is constructed of a material
that resists expansion. In some embodiments, the bladder 118 is
constructed of a heat-sealable urethane with 200 Denier nylon. The
bladder 118 can comprise a cover of any suitable material,
including, for example, a neoprene material. The second inflatable
bladder 118, when inflated, defines a transverse arc of about 4
inches in length about the center of the bladder. It is to be
understood that these dimensions are by way of example only and can
be varied without departing from the spirit and scope of the
invention. For example, in some embodiments the bladder 118 can
have a length of about 9 inches where it is coupled to the frame, a
length of between about 6 and 7 inches where the bladder 118
contacts the patient. The bladder 118 can have a height of about 3
to 4 inches. The bladder 118 can have a circumference of about 6 to
7 inches.
[0127] The third expandable bladder 119 is coupled to and carried
by the neck support 128. The third expandable bladder 119 is
preferably adjustable in some embodiments to accommodate patient
anatomy and align with desired force vector directions as will be
described further herein. The lateral portions 134 and 136 of neck
support 128 are preferably configured with recesses formed therein
for receiving the extended ends 149, shown in FIG. 21, of the third
expandable bladder 119 to facilitate retention and alignment of the
bladder on the neck support 128.
[0128] According to some embodiments, the third expandable bladder
119 is of a generally semi-ellipsoidal configuration having a
relatively curved portion upon inflation for engaging a portion of
the thoracic spine. Preferably, the third expandable bladder 119,
when inflated, will expand about the same amount transversely and
upwardly from the neck support 128. In some embodiments, the third
expandable bladder 119 when inflated expands more transversely than
upwardly. In some embodiments, the third expandable bladder 119
when inflated expands more upwardly than transversely. Thus, as the
third expandable bladder 119 is inflated under and against the
user's occiput, it expands transversely and vertically, lifting the
occiput to apply an angular traction to the occiput. The amount of
traction exerted in the longitudinal direction, preferably, will be
similar to the amount of lift exerted vertically to decompress the
occipital-cervical junction.
[0129] In some embodiments, the third inflatable bladder 119 is
constructed of an expandable material such as neoprene rubber,
defines a length of between about 8 to 10 inches, a height of about
3 to 4 inches in an uninflated state, and depending on the
configuration of the bladder a transverse width of about 3 inches.
In some embodiments, the bladder 119 is constructed of a material
that resists expansion. In some embodiments, the bladder 119 is
constructed of a heat-sealable urethane with 200 Denier nylon. The
bladder 119 can comprise a cover of any suitable material,
including, for example, a neoprene material. The third inflatable
bladder 119, when inflated, defines a transverse arc of about 4
inches in length about the center of the bladder. It is to be
understood that these dimensions are by way of example only and can
be varied without departing from the spirit and scope of the
invention. For example, in some embodiments the bladder 119 can
have a length of about 9 inches where it is coupled to the frame, a
length of between about 6 and 7 inches where the bladder 119
contacts the patient. The bladder 119 can have a height of about 3
to 4 inches. The bladder 119 can have a circumference of about 6 to
7 inches.
[0130] In some embodiments the bladders preferably have a finite
shape and expand while being filled until the bladders reach the
finite shape. Once the bladder has been filled to the finite shape,
the pressure release valve of the pump assembly allows for gas or
fluid to escape from the system to maintain a desired pressure
within the bladder. The pressure release valve is preferably an
automatic pressure release valve. The system preferably also
comprises a manual release valve, such as a push button release
valve. The desired pressure is preferably held at a proven clinical
level. In some embodiments the pressure release valve is configured
to maintain a pressure of about 8 psi. At a pressure of about 8 psi
the system preferably provides over 50 pounds of tractional force.
In some embodiments the tractional force preferably is between
about 50 and 60 pounds of tractional force.
[0131] While the above described bladder configurations are
preferred, it is to be understood that other configurations of
expandable bladders could be employed in the present invention,
either with or without an expansion controlling casing to provide
the desired lifting and traction of the user's neck, spine, and
head. Moreover, in some embodiments, mechanically expandable
components can be used in place of the first, second, and/or third
bladders. Mechanically expandable components can be coupled to the
frame and selectively expanded to apply force vectors to the
cervical and thoracic spine in a manner similar to those produced
by the expandable bladders as described herein. For example, in
some embodiments an expanding mechanical component within a
cushioned cover can be selectively actuated to provide the desired
force distribution.
[0132] In some embodiments, one or more of the first, second, and
third expandable bladders 116, 118, and 119 are of a tubular
configuration and are disposed in a non-expandable casing,
preferably constructed of a vinyl or other suitable material. The
casing is preferably formed in the above described generally
ellipsoidal configurations. As the tubular bladder expands upon
inflation, the expansion is limited by the configuration of the
casing to provide the desired increase in the vertical and
transverse directions.
[0133] In some embodiments, as shown in FIG. 22, the first
expandable bladder 116 is preferably rotatably secured to the neck
support 128. The first expandable bladder 116 can be tilted in a
forward position, a backward position, or maintained in a central
position. In some embodiments, the bladder can be locked into a
desired position. Providing a rotatable first expandable bladder
116 preferably provides mobility for the pneumatic air chamber to
comfortably accommodate various spinal configurations. In some
embodiments, the second expandable bladder 118 can be rotatably
secured to the neck support 128. In some embodiments, the third
expandable bladder 119 can be rotatably secured to the neck support
128.
[0134] In some embodiments, as shown in FIG. 22, a first spacer
component 150A is preferably configured to be selectively coupled
to the frame 112 to adjust a position of a second inflatable
bladder 118. The spacer component can be attached to the frame and
can allow clinicians and users to increase the negative Y
directional component of the lower pneumatic air chamber. A second
spacer component 150B is preferably coupled to the frame 112 to
adjust a position of the third inflatable bladder 119. The spacer
component can be attached to the frame and can allow clinicians and
users to increase the positive Y direction of the upper pneumatic
air chamber. Each of the spacer components 150A and 150B can
include the same or generally similar features as the spacer
component 150 described with respect to FIGS. 8 and 9. For example,
in one embodiment, each spacer component comprises an pneumatic air
chamber or bladder engaging face 152, a notched connector portion
154 and opposing side portions 156. Other spacer configurations can
be used to modify the directional component of the second
inflatable bladder 118 and the third inflatable bladder 119.
[0135] FIGS. 23A and 23B show a patient and an embodiment of a
decompression and traction system 210 having a forehead restraint,
wherein the views show the decompression system 210 in an inflated
configuration, respectively.
[0136] As shown in FIGS. 23A and 23B, restraint straps 158 and/or
160 can be secured at the ends thereof to one or more of slots 114.
Straps can be passed under the user's chin and over the user's
forehead in some embodiments. In other embodiments, a strap can be
passed over the user's forehead only. The straps can be secured and
fastened in any suitable manner. For example, interlocking hook and
loop type fasteners, snaps, buckles or other fasteners can be used.
According to some embodiments, the traction device 210 can be
easily and securely affixed to the user's head with a strap
configuration such that with the user lying flat on his or her back
on a horizontal surface, the frame 112 rests on the surface and the
neck support 128 is disposed under the user's neck and tapered ends
162 of the frame side members 122, 124 are substantially adjacent
the user's shoulders and generally near the upper thoracic region.
The tightness of the securement of the device 110 to the user's
head can be readily adjusted as needed by the securement straps
158, 160.
[0137] In some embodiments, the system preferably comprises a frame
made of virgin acrylonitrile butadiene styrene (ABS) plastic
material. ABS is an engineering thermoplastic that is advantageous
due to its strength, toughness, chemical resistance, and ability to
maintain necessary stiffness. The expandable pneumatic air chambers
are preferably made of heat-sealable urethane with 200 Denier
nylon. The expandable pneumatic air chambers preferably have a
neoprene cover. The facial straps are preferably made of a durable
and waterproof neoprene material. The hand pump and tubing are
preferably made of rubber/plastic. Other embodiments can include
different materials.
[0138] According to some embodiments, the system is lightweight
(for example, about 3 lbs), portable, easy to operate, requires no
assembly, no weights, cables or ropes to set-up, comes with choice
of ballistic nylon carrying case or educational box, instruction
page and instructional DVD. In one embodiment, the device comprises
a built-in frame, an expanding elliptical pneumatic air chamber
(with neoprene cover) that creates radial tractional force and
thoracic decompressive force, a patient-controlled pneumatic hand
pump with a push button release and automatic safety valve
connected to approximately 30 inches of tubing, and one dual action
head restraint designed for patients who suffer with TMJ (does not
aggravate temporomandibular joint), which comprises an adjustable
forehead strap, and a removable chin strap (which is optional in
some other embodiments).
[0139] Accordingly to one aspect disclosed herein, methods for
pneumatic radial traction can restore the cervical and thoracic
spine to the proper configuration. Pneumatic radial traction, also
known in some embodiments as expanding ellipsoidal decompression
(EED), is a process in which joints of the cervical spine are
pneumatically tractioned and simultaneously aligned into the
cervical spine's proper radial or curved configuration. A major
clinical difference between some embodiments of a pneumatic radial
traction device disclosed herein and some prior art devices is that
the prior art devices flatten or reverse the proper cervical curve
to attain joint separation. In some embodiments, a pneumatic radial
traction device enhances or maintains the proper cervical curve
while attaining over twice the joint separation as some prior art
devices.
[0140] With reference to FIGS. 23A and 23B, pneumatic radial
traction separates and simultaneously aligns the spinal joints in a
curved or radial configuration. In some embodiments, an elliptical
pneumatic air chamber directs multi-vectored expansive forces from
within the posterior spinal concavity (back of neck), vertically
(+Z axis translation) and in both horizontal directions. The spine
is simultaneously tractioned in three main directions. The radial
configuration created by these multi-vectored forces produces high
level joint separation at the posterior, middle and anterior of the
disc while forcefully enhancing the cervical spine's proper curve,
rather than flattening or reversing the curve. Pneumatic radial
traction is preferably achieved when the joints are separated by a
vertical displacement greater than the horizontal displacement,
however, displacement of equal height and width is also
advantageous in some embodiments. An advantage of a pneumatic
radial traction device is that it does not flatten or reverse the
proper cervical curve while attaining joint separation. In some
embodiments, the system provides a traction device with multiple
fulcrums. For example, at least two fulcrums, and preferably three
fulcrums, are provided to provide treatment to the cervical spine,
thoracic spine, and occipital-cervical junction of the patient.
[0141] As the head is stabilized in the cervical device, joints are
actively tractioned in 3 main directions instead of one or two. The
cervical spine is tractioned vertically along the +Z axis with a
pneumatic force of over 58 lbs. This force expands into and against
the posterior cervical concavity. Simultaneously the spine is
tractioned horizontally in the two traditional directions (+Y and
-Y) with a pneumatic force of over 40-lbs in each direction. These
forces expand against the occiput and against the upper thoracic
region. The combination of these simultaneously applied pneumatic
forces produce radial traction. When fully inflated the elliptical
pneumatic cell expands to a 7.5 inch radius, affecting the entire
cervical spine. High level joint traction occurs at the posterior,
center and anterior aspect of the vertebral bodies in a ratio
coinciding with the discs' natural wedged spacing. While the
pneumatic radial traction device separates the posterior of the
joints to a magnitude typical of traditional traction, it separates
the overall disc more than twice as much as linear traction.
[0142] With the simultaneous application of three separate
pneumatic air chambers the cervical spine is decompressed into its
proper lordotic or curved configuration (<{circumflex over (
)}>) with -Y+Z+Y force vectors while the hyper kyphotic area of
the upper thoracic spine is simultaneously decompressed with a
combination +Z/-Y force mid-vector and the occipital-cervical
junction is simultaneously decompressed with +Z/+Y force vectors.
The cervical spine's lordotic curve is powerfully decompressed and
enhanced while the thoracic hyper-kyphosis is simultaneously
reduced and the occipital-cervical junction is decompressed. In
certain embodiments, 15.degree. to 20.degree. of forward head
flexion can be imparted by the application of +Z/+Y force vectors
to the occiput.
[0143] Continuous expansion and contraction of the pneumatic air
chambers can be employed to create alternating hydration and
milking of the intervertebral discs, activating their sponge-like
imbibition action. Holding the air pressure constant over a period
of 15 to 20 minutes has the effect of simultaneously molding the
spine into a curved or elliptical shape, decompressing discs and
relaxing the dura, cord and nerve-roots in the cervical canal.
[0144] Embodiments described herein are preferably prescribed for
patients with chronic neck pain due to a musculoskeletal or
neurological impairment. The system applies radial tractional force
to the cervical spine, enhancing the cervical lordotic curve while
achieving high level joint separation at the anterior, center and
posterior aspect of the vertebral bodies and discs in a ratio
corresponding with their natural wedged spacing, reducing disc
protrusions, compression and increasing range of motion. The system
further applies angular traction forces to the occiput, achieving
decompression of the occipital-cervical junction. In some
applications, devices advantageously decrease pain in chronic neck
pain patients, decrease headaches and increase range of motion
while reducing the necessity for chronic pain medication and neck
surgery.
[0145] With continued reference to FIGS. 23A and 23B, according to
some embodiments in use, the traction device 110 rests on a
horizontal surface such that the neck support 128 projects upwardly
therefrom. The user lies on the device in a prone position such
that the back of the neck rests on the deflated first expandable
bladder 116 carried in the cradle 138 of the neck support 128. The
deflated second expandable bladder 118 is positioned between the
neck support 128 and portions of the thoracic spine of the user.
The deflated third expandable bladder 119 is positioned between the
neck support 128 and the occiput of the user. The chin and/or
forehead restraining restraint straps are respectively extended
under the user's chin and/or about the user's forehead and secured,
thereby affixing the traction device 110 to the user such that the
neck and cervical spine extend over the neck support and first
expandable bladder 116, the thoracic spine is adjacent the second
expandable bladder 118, and the occiput is adjacent the third
expandable bladder 119. According to one preferred embodiment, the
outward extension of the neck support 128 is relatively slight so
that when the bladder is in the deflated position with the forehead
and chin restraints secured, very little or no force is exerted on
the neck by the neck support. This is achieved by elevating the
neck support 128 above the frame such that the neck cradle 138
formed therein is about 2 to 3 inches above the floor or other
horizontal surface on which the device 110 is used. The first
expandable bladder 116 is sized such that upon full inflation, the
apex of the curved upper surface of the bladder will extend about 5
inches above the floor or surface. The second expandable bladder
118 is sized such that upon full inflation, a surface of the second
expandable bladder engaging the thoracic spine will extend toward
the thoracic spine about 2 to 3 inches in the -Y/+Z direction. In
certain embodiments, the second expandable bladder 118 is sized
and/or positioned such that during inflation, a surface of the
second expandable bladder 118 engaging the thoracic spine will
impart a force to the thoracic spine in the -Y direction during a
first period of inflation and will impart a force to the thoracic
spine in the -Y/+Z direction during a second period of inflation
following the first period of inflation. In certain embodiments,
the expandable bladder 118 is sized and/or positioned such that
upon full inflation, a surface of the expandable bladder 118
engaging the thoracic spine will impart a force to the thoracic
spine in the -Y direction. The third expandable bladder 119 is
sized such that upon inflation, a surface of the third expandable
bladder engaging the occiput will extend toward the occiput about 2
to 3 inches in the +Y/+Z direction. Upon inflation, the third
expandable bladder 119 can impart 15.degree. to 20.degree. of
forward head flexion. In certain embodiments, the third expandable
bladder 119 is sized and/or positioned such that during inflation,
a surface of the third expandable bladder 119 engaging the occiput
will impart a force to the occiput in the +Y direction during a
first period of inflation and will impart a force to the occiput in
the +Y/+Z direction during a second period of inflation following
the first period of inflation. In certain embodiments, the
expandable bladder 119 is sized and/or positioned such that upon
full inflation, a surface of the expandable bladder 119 engaging
the occiput will impart a force to the thoracic spine in the +Y
direction.
[0146] In some embodiments, as the user slowly inflates the first,
second, and third inflatable bladders 116, 118, and 119 using the
air pump 142, the first inflatable bladder 116 expands upwardly
and, to a lesser extent, transversely, thereby forcing the cervical
spine forwardly creating a spinal apex while concurrently
stretching the spine angularly along both sides of the formed
spinal apex. The second inflatable bladder 118 expands transversely
in the -Y direction, thereby forcing the thoracic spine forwardly
to offset the effects of hyper-khyphosis. The third inflatable
platter expands transversely in the +Y direction, thereby forcing
the occiput forwardly and upwardly to create radial traction to
attain joint separation of the occipital-cervical junction. The
user then continues to inflate the first, second, and third
bladders 116, 118, and 119 until his or her individual tolerance
level is reached. The bladders are then deflated by use of the one
way valve 144. The process is preferably repeated several times,
slowly increasing the spinal arc in the cervical region and placing
pressure on the thoracic region as the level of tolerance
increases. In addition, the first, second, and third bladders 116,
118, and 119 can be held in an inflated state at or slightly below
the level of tolerance for varying periods of time up to ten to
twenty minutes. Through such repetition, the cervical spine,
thoracic spine and surrounding tissue receive a workout promoting
cellular exchange in and around the intervertebral disc and a
forward curve is reinstated into the cervical spine while achieving
proper spine configuration in the thoracic region. FIGS. 23A and
23B illustrate the effects of the traction and exercise devices 210
of some embodiments on the cervical and thoracic spine.
[0147] With reference to FIGS. 24-27, an adjustable spacer
component 150A and a spacer component 150B can be provided in some
implementations of a traction system 110 to provide for lateral
flexion traction. For example, FIG. 24 is a schematic top view of a
patient positioned on another embodiment of a decompression and
traction system, showing pneumatic air chambers comprising first,
second, and third inflatable bladders 116, 118, and 119, a first
adjustable wedge-shaped spacer component 150A configured to be
selectively coupled to the frame to adjust a position of the second
inflatable bladder, and a second adjustable wedge-shaped spacer
component 150B configured to be selectively coupled to the frame to
adjust a position of the third inflatable bladder. In the shown
configuration, the first spacer component 150A is in a vertical
orientation and adjusts the position of the second inflatable
bladder to provide an even distribution of force generally along a
force vector in the -Y and +Z plane without providing any lateral
flexion traction to the patient. In the shown configuration, the
second spacer component 150B is in a vertical orientation and
adjusts the position of the third inflatable bladder to provide an
even distribution of force generally along a force vector in the +Y
and +Z plane without providing any lateral flexion traction to the
patient.
[0148] FIG. 25 shows a configuration wherein the first spacer
component 150A is moved to adjust the position of the second
inflatable bladder to provide an uneven distribution of force on
one side of the patient in that a force vector is directed, for
example, in a -Y, +Z, and -X direction. For example, the spacer
component is turned or rotated to a horizontal position, whereby
the wedge shape of the spacer contacts the second inflatable
bladder and causes the bladder to deflect in one lateral direction
more than another lateral direction. As shown, the spacer is placed
in right horizontal position and causes more deflection on the
right side of the patient. In other configurations, the spacer can
be positioned in a left horizontal position to cause more
deflection on the left side of the patient. Based on the
positioning of the spacer, the second bladder can expand in an
angular direction. Turning the spacer component sideways creates
lateral flexion traction by forcing the shoulder/trapezius down
while the head is held in traction.
[0149] In the configuration shown in FIG. 25, the second spacer
component 150B is moved to adjust the position of the third
inflatable bladder to provide an uneven distribution of force on
one side of the patient in that a force vector is directed, for
example, in a +Y, +Z, and -X direction. For example, the spacer
component is turned or rotated to a horizontal position, whereby
the wedge shape of the spacer contacts the third inflatable bladder
and causes the bladder to deflect in one lateral direction more
than another lateral direction. As shown, the spacer is placed in
right horizontal position and causes more deflection on the right
side of the patient. In other configurations, the spacer can be
positioned in a left horizontal position to cause more deflection
on the left side of the patient. Based on the positioning of the
spacer, the third bladder can expand in an angular direction.
Turning the spacer component sideways creates lateral flexion
traction by forcing the head up while the shoulder/trapezius is
held in traction. In certain embodiments, the spacer component 150B
can be moved to adjust the position of the third inflatable bladder
to provide an uneven force distribution of force on one side of the
patient, as described herein, to treat a misalignment or deformity
of the spine which causes the cervical spine to angle or curve in
the +X or -X direction. For example, if the cervical spine of a
patient is angled or curved in the +X direction, a -X force can be
imparted to restore the cervical spine to its proper configuration.
If the cervical spine of a patient is angled or curved in the -X
direction, a +X force can be imparted to restore the cervical spine
to its proper configuration.
[0150] FIG. 26 is a bottom view of the embodiment of FIG. 24 and
shows the spacer component 150A in a vertical position that adjusts
the position of the second inflatable bladder to provide an even
distribution of force generally along a force vector in the -Y and
+Z plane, but does not direct force laterally in a -X or +X
direction. FIG. 26 shows the spacer component 150B in a vertical
position that adjusts the position of the third inflatable bladder
to provide an even distribution of force generally along a force
vector in the +Y and +Z plane, but does not direct force laterally
in a -X or +X direction. FIG. 27 is a bottom view of the embodiment
of FIG. 24, showing a configuration wherein the first spacer
component 150A is moved to adjust the position of the second
inflatable bladder to provide an uneven distribution of force to a
patient in that a force vector is directed, for example, in a -Y,
+Z, and -X direction as described in connection with FIG. 25. The
lower linear displacement pneumatic air chamber is adjusted with a
rotating wedge shaped spacer component, allowing clinicians to
increase the angle and force of the mid (-Y)/(+Z) vector of this
pneumatic air chamber. When adjusted to the right or left
horizontal position, the rotating wedge allows clinicians to
unilaterally increase and rotate the (-Y) directional component on
either the right or left side (+/-X) of the upper thoracic region,
producing lateral flexion traction. The rotating wedge shaped
spacer component can be removed in some implementations to
accommodate extreme kyphotic thoracic spines. In the configuration
of FIG. 27, the second spacer component 150B is moved to adjust the
position of the third inflatable bladder to provide an uneven
distribution of force to a patient in that a force vector is
directed, for example, in a +Y, _Z, and -X direction as described
in connection with FIG. 25. The upper linear displacement pneumatic
air chamber is adjusted with a rotating wedge shaped spacer
component allowing clinicians to increase the angle and force of
the mid (+Y)/(+Z) vector of this pneumatic air chamber. When
adjusted to the right or left horizontal position, the rotating
wedge allows clinicians to unilaterally increase and rotate the
(+Y) directional component on either the right or left side (+/-X)
of the occiput, producing lateral flexion traction. The rotating
wedge shaped spacer component can be removed in some
implementations.
[0151] While three expandable bladders 116, 118, and 119 are
described with respect to FIGS. 15-27, certain embodiments may
employ only two of the inflatable bladders 116, 118, and 119, as
shown in FIGS. 1-14, or only one of the inflatable bladders 116,
118, and 119. For example, in some embodiments, a decompression and
traction system 310 may include only the first inflatable bladder
116 and the third inflatable bladder 119 as shown in FIG. 28. Such
an embodiment may be less expensive to manufacture than an
embodiment having three inflatable bladders. As described herein,
the first inflatable bladder 116 and third inflatable bladder 119
can be employed to apply -Y+Z+Y force vectors to the cervical spine
while +Z/+Y force vectors are applied to the occiput. The cervical
spine's lordotic curve is powerfully decompressed and enhanced
while the occipital-cervical junction is decompressed. Such an
embodiment may be advantageous if treatment of the thoracic spine
is not desired. For example, in some embodiments, damage to the
thoracic spine or an obstruction, such as a tumor or implant, may
make the application of force to the thoracic spine undesirable.
The system 310 may be utilized to treat symptoms associated with
compression, damage, deformity, and/or misalignment of the cervical
spine and the occipital-cervical junction, including, for example,
headaches, neck pain, and arm pain, which may be caused by pinched
nerves. In certain embodiments, the decompression and traction
system 310 can include a spacer component 150B as described with
respect to the decompression and traction system 210 as shown in
FIGS. 15-27.
[0152] In some embodiments, a similar application of force can be
imparted by the system 210 through selective inflation of the
bladders 119 and 116 without inflation of the bladder 118 or with
minimal inflation of the bladder 118. As described herein, in some
embodiments, a two pump system or a three pump system can be
employed to alternate or unevenly inflate the pneumatic air
chambers. For example, in some embodiments, a first pump can be
employed to inflate the first and third inflatable bladders 116 and
119 and a second pump can be employed to inflate the second
inflatable bladder 118.
[0153] In some embodiments, a decompression and traction system 410
may include only the second inflatable bladder 118 and the third
inflatable bladder 119 as shown in FIG. 29. Such an embodiment may
be less expensive to manufacture than an embodiment having three
inflatable bladders. In some embodiments, the system 410 includes a
pad or cushion 436 configured to be positioned against the cervical
spine when the system 410 is secured to a user. As described
herein, the second bladder 118 and third inflatable bladder 119 can
be employed to decompress a hyper kyphotic area of the upper
thoracic spine with a combination +Z/-Y force mid-vector while
+Z/+Y force vectors are simultaneously applied to the occiput to
decompress the occipital-cervical junction. Thoracic hyper-kyphosis
is simultaneously reduced while the occipital-cervical junction is
decompressed. In certain embodiments, the second inflatable bladder
118 can be employed to apply a -Y force vector to the upper
thoracic spine, and the third inflatable bladder 119 can be
employed to apply a +Y force vector to the occipital-cervical
junction. In some embodiments, the system 310 can be used to impart
linear traction to the spine. In certain embodiments, the
decompression and traction system 410 can include a spacer
component 150A as described with respect to the decompression and
traction system 210 as shown in FIGS. 15-27. In certain
embodiments, the decompression and traction system 410 can include
a spacer component 150B as described with respect to the
decompression and traction system 210 as shown in FIGS. 15-27.
[0154] In some embodiments, a similar application of force can be
imparted by the system 210 through selective inflation of the
bladders 119 and 118 without inflation of the bladder 116 or with
minimal inflation of the bladder 116. As described herein, in some
embodiments, a two pump system or a three pump system can be
employed to alternate or unevenly inflate the pneumatic air
chambers. For example, in some embodiments, a first pump can be
employed to inflate the second and third inflatable bladders 118
and 119 and a second pump can be employed to inflate the first
inflatable bladder 116. By inflating the bladders 119 and 118
without inflating the bladder 116 or with minimal inflation of the
bladder 116, linear traction can be imparted to the spine.
[0155] FIG. 30 shows a patient and an embodiment of a decompression
and traction system 510 having an elongated inflatable bladder 518.
The elongated inflatable bladder 518 can extend from the neck
support to the mid-thoracic spine when the decompression and
traction system 510 is secured to the user. In some embodiments as
described herein, the mid-thoracic spine can include the T4-T9
vertebrae, the T5-T8 vertebrae, or the T6-T7 vertebrae. In addition
to the application of forces to the upper thoracic spine, as
described herein, the inflatable bladder 518 can be configured for
inflation and simultaneous application of force to the mid-thoracic
spine, when the patient is in a treatment position, to decompress
the spine into its proper curved configuration with a +Z force
vector, and in some embodiments, -Y and/or +Y for force vectors,
being applied to the mid-thoracic spine. The elongated inflatable
bladder 518 can apply pressure to the apex of the kyphosis of the
thoracic spine. In some embodiments, the thoracic hyper-kyphosis
can be further reduced by the application of force to the
mid-thoracic spine. The elongated bladder 518 can directly contact
the upper 25%-75% of the thoracic spine. In certain embodiments,
the elongated bladder 518 can directly contact the upper 25% to
45%, upper 25% to 50%, upper 25% to 55%, upper 25% to 60%, upper
25% to 65%, or upper 25% to 70% of the thoracic spine. In certain
embodiments, the elongated bladder 518 can directly contact the
upper 50% of the thoracic spine.
[0156] As described herein, the inflatable bladder 518 can be
inflated using a pump assembly. A pump for inflation of the
inflatable bladder 518 can be the same as or a separate pump from
one or more pumps used for inflation of the inflatable bladders 116
and 119. In some embodiments, two or more pumps can be employed to
alternate or unevenly inflate portions of the elongated inflatable
bladder 518. For example, in some embodiments, a first pump can be
employed to inflate a first portion of the elongated inflatable
bladder 518 positioned to apply a force to the upper thoracic spine
and a second pump can be employed to inflate a second portion of
the elongated inflatable bladder 518 positioned to apply a force to
the mid-thoracic spine. Although a single elongated inflatable
bladder 518 is shown in FIG. 30, in some embodiments, a separate
inflatable bladder may be employed to apply a force to the
mid-thoracic spine. In such embodiments, the separate inflatable
bladder configured to apply a force to the mid-thoracic spine can
be inflated using a pump that can be separate from or shared with
the inflatable bladder positioned to apply a force to the upper
thoracic spine.
[0157] In certain embodiments, the decompression and traction
system 510 can include one or more spacer components having the
same or similar features to spacer components 150, 150A, and 150B.
For example, in some embodiments, the decompression and traction
system 510 can include a spacer between a portion of the frame 112
and the elongated inflatable bladder 518. The spacer can be
employed to adjust the angulation of the inflatable bladder 518
during inflation. In certain embodiments, the decompression and
traction system 510 can include a spacer between a portion of the
frame 112 and the inflatable bladder 119. The spacer can be
employed to adjust the angulation of the inflatable bladder 119
during inflation. Spacers used in the decompression and traction
system 510 can include a wedge-shaped spacer, a rotatable spacer,
and/or a spacer in a horizontal position that is configured to
adjust the angulation of the inflatable bladder portion 119 or the
inflatable bladder portion 518 during inflation to provide lateral
flexion traction. Other spacer systems are contemplated and can
also be used. For example, any component or device that can be
selectively adjusted and can contact at least a portion of the
inflatable bladder portion 119 and/or the inflatable bladder
portion 518 can be used to impart lateral flexion traction.
Additionally, in some cases a component or device need not be
adjustable, for example, a spacer or other component could be
provided on a traction device to cause the inflatable bladder
portion 119 and/or the inflatable bladder portion 518 to
consistently provide for lateral flexion traction on one side,
while other systems can provide for lateral flexion traction on the
other side. Additionally, while adjustments made with the spacer
may be rotational, other movements or adjustments can be made with
other mechanisms and arrangements, such as by sliding, for
example.
[0158] While three expandable bladders 116, 518, and 119 are
described with respect to FIG. 30, certain embodiments may employ
only the elongated inflatable bladder portion 518 or only the
elongated inflatable bladder portion 518 and one of the inflatable
bladder portion 116 and the inflatable bladder portion 119.
[0159] The various devices, systems and methods described above
provide a number of ways to carry out some preferred embodiments of
the invention. Of course, it is to be understood that not
necessarily all objectives or advantages described may be achieved
in accordance with any particular embodiment described herein.
Thus, for example, those skilled in the art will recognize that the
devices and systems may be made and the methods may be performed in
a manner that achieves or optimizes one advantage or group of
advantages as taught herein without necessarily achieving other
objectives or advantages as may be taught or suggested herein.
[0160] Furthermore, the skilled artisan will recognize the
interchangeability of various features from different embodiments.
Similarly, the various components, features and steps discussed
above, as well as other known equivalents for each such component,
feature or step, can be mixed and matched by one of ordinary skill
in this art to make devices and systems and perform methods in
accordance with principles described herein.
[0161] Although the invention has been disclosed in the context of
some embodiments and examples, it will be understood by those
skilled in the art that the invention extends beyond these
specifically disclosed embodiments to other alternative embodiments
and/or uses and obvious modifications and equivalents thereof.
Accordingly, the invention is not intended to be limited by the
specific disclosures of preferred embodiments herein.
* * * * *