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| United States Patent Application |
20080004555
|
| Kind Code
|
A1
|
|
Reis; Daniel
;   et al.
|
January 3, 2008
|
Immobilizing and Supporting Inflatable Splint Apparatus
Abstract
Disclosed is a medical device that operates as a supporting splint for the
limbs and other body parts necessary for the treatment of a variety of
medical and surgical conditions. Said device is an inflatable, flexible,
lightweight water-resistant splint whose measure of rigidity is easily
controlled by the fitter or user. According to the present invention
there are several embodiments of the splint, each suited to fit a
different body part such as the limbs, torso, chest, pelvis, and neck.
Said device, which is constructed of inflatable tubes, is made of two
nylon layers welded together and coated with polyurethane. The tubes may
be inflated by any means of supplying air pressure. The present invention
is especially designed to allow normal blood circulation to the treated
body part, provide ventilation to the area, enable easy inspection of an
injury, and allow partial movement of the treated part.
| Inventors: |
Reis; Daniel; (Haifa, IL)
; Zucker; Dalia; (Haifa, IL)
; Bin Nun; Asher; (Carmiel, IL)
|
| Correspondence Address:
|
NATH & ASSOCIATES
112 South West Street
Alexandria
VA
22314
US
|
| Assignee: |
R & D SUPPORTS
99 Hahistadrut Street,
Haifa
IL
31250
|
| Serial No.:
|
591956 |
| Series Code:
|
10
|
| Filed:
|
November 7, 2006 |
| PCT NO:
|
PCT/IL05/00269 |
| Current U.S. Class: |
602/13 |
| Class at Publication: |
602/013 |
| International Class: |
A61F 5/058 20060101 A61F005/058 |
Claims
1. A splint for immobilizing and supporting a limb or other body parts of
a human, wherein said splint is made of flexible material for covering
body parts and articulations from at least three sides and where said
splint includes: a. inflatable tubes interconnected by non-inflatable
parts for achieving variable degrees of support, stiffness and
restriction of movement; b. ventilation holes for skin ventilation,
contained in the non-inflatable parts; c. at least one gas pressure
source device connected to said splint; d. at least one adjustable strap
for connecting splint edges; wherein the inflated structure of the splint
fits the structure and anatomical shape of the appropriate body part for
the purpose of stabilizing and providing support to the patient's body
part and its articulations in varying degrees of rigidity and in
particular positions.
2. The splint of claim 1 for supporting limbs wherein a part of the limb
remains uncovered.
3. The splint according to claim 1, wherein the adjustable straps are made
of Velcro.
4. The splint according to claim 1, wherein said splint is designed to
wrap the torso, taking into account the structure of the body and its
anatomical shape for maximum compatibility.
5. The splint according to claim 1, wherein said splint is designed to
wrap to the neck, taking into account the neck's anatomical shape and
structure for maximum compatibility.
6. The splint according to claim 2, wherein said splint is designed to
wrap the leg, the foot, the ankle and the heel of the patient, taking
into account the leg's anatomical shape and structure for maximum
compatibility and preventing pressure on the heel.
7. The splint according to claim 2, wherein said splint is designed to
wrap the leg, the foot, the ankle, heel, knee and thigh of the patient,
talking into account the leg's anatomical shape and structure for maximum
compatibility and preventing pressure on the heel.
8. The splint according to claim 2, wherein said splint is designed to
wrap the arm, fit the shoulder structure, and support the palm, taking
into account the arm's anatomical shape and structure for maximum
compatibility and immobilizing the shoulder joints or upper and lower arm
in any desired position.
9. The splint according to claim 1, wherein said splint is designed to
wrap the rib cage, wherein the inflated tubes are arranged in segments
that can be inflated separately in order to exert selected pressure on
different areas of the chest wall according to necessity, taking into
account the curves and structure of the ribs for maximum compatibility.
10. The splint according to claim 1, wherein said splint is made of two
nylon layers joined together by soldering means.
11. The splint according to claim 1, wherein said splint is made of two
nylon layers which are coated with polyurethane.
12. The splint according to claim 1, wherein movement, rigidity, and
stabilization of said limb articulation are controlled by the degree of
air pressure in said splint.
13. The splint according to claim 1, wherein the pressure source device is
a mechanical pump.
14. The splint according to claim 1, wherein the pressure source device is
an electrical pump.
15. The splint according to claim 1, wherein the pressure source device is
a pressure canister.
16. The splint according to claim 1, wherein in the inflated state, the
splint takes up the shape of the body part for which it was designed.
17. The splint according to claim 1, wherein the tightness of the splint
on the body part is controlled by the fastening or loosening of straps.
18. The splint according to claim 1 further including a suspension strap.
19. The splint according to claim 1, wherein pressure within the splint is
controlled by a valve.
20. The splint according to claim 1, wherein the adjustable strap is
detachable.
21. The splint according to claim 1, wherein the degree of rigidity of the
splint on the body part enables partial movement of the wrapped joints.
22. The splint according to claim 1 further comprising at least one loop
connected to the edge of said splint for suspension purposes.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to the field of medical devices, and,
more particularly, it relates to inflatable, versatile/universal/multi
purpose splints.
BACKGROUND OF THE INVENTION
[0002] The traditional techniques of providing external support and
immobilization in orthopedic conditions revolves around three existing
types of devices: casts, which have application primarily in broken
limbs; splints, which are used to immobilize and stabilize the limbs and
the torso; and pressure bandages, which help control swelling and give a
degree of support.
[0003] Creative individuals have come up with a variety of departures from
these standard themes in order to achieve better patient treatment and
recovery. Inflatable pouches made from various materials exist, adapted
to be filled with either liquid or gas, and incorporating means for
securing these pouches to and tightening them around the injured part of
a human body. Splints of this kind effect the immobilization and
compression of a limb or other part of a human body.
[0004] One of the alternative devices is presented in U.S. Pat. No.
5,954,676. This device utilizes two sets of multi-layer deformable
materials, such as fiberglass shims located in pouches in first and
second members having re-sealable bladders of sheaths that provide
structural support on each side of the limb.
[0005] The main drawback of the device, which limits its application
considerably, relates to its fixed and inflexible shape that does not
take into consideration the three-dimensional form of the limbs, joints
and torso, for instance.
[0006] A different device is U.S. Pat. No. 5,288,286, which is an
adjustable pressure cast for orthopedic injuries. It is composed of three
sets of air chambers and is only designed for treating orthopedic leg
injuries such as fractures. As in the previous patent, this device
suffers from an inconvenient structure, which may only support the calf,
the ankle, and the foot of a patient without conforming to the shape of
these structures.
[0007] U.S. Pat. No. 6,719,711 describes a third type of device, an
inflatable splint with a series of modular sections that independently
wrap around an injured body part, each section forming a circular
structure that surrounds the injured limb. The device requires multiple
sections when encircling the joints or various bends of the injured limb,
as it is not designed to accommodate the three-dimensional shape of the
human body. Furthermore, the circular shape of the fastened splint leaves
no openings for inspection of the injured area.
[0008] There is a need for a method and a concept for a lightweight and
convenient splint which adjusts to the shape of the limb, joint, or other
body part, and which may also provide steady support to the trunk (i.e.
spine, ribs, neck etc.), while at the same time allowing free blood
circulation and ventilation, and enabling medical inspection of the
injured area.
[0009] Such a device should further allow for as much functionality as
possible and allow rigidity and flexibility to be adjusted as needed.
SUMMARY OF THE INVENTION
[0010] In accordance with the shortcomings of previous art, it is a
principal object of the present invention to provide a splint device
which will present a maximum adjustment range, so it can be easily and
securely fitted to the injured body part, without bringing about any
uncomfortable chafing and minimizing overall discomfort, that will also
allow for adequate blood circulation to the injured part, and will
support the joints, limbs and any other body parts in an optimal position
with a controllable measure of rigidity.
[0011] The present invention is aimed, in particular, at all those
conditions in which absolutely rigid support is not needed.
[0012] It is yet another object of the present invention to introduce a
multi purpose splint device that will be appropriate for the treatment of
a wide range of conditions such as fractures, sprains, and post-operative
support, that will prevent bedsores, and that will allow for the
inspection of various wounds. The present invention provides a handy
solution for the temporary support of an injured limb in field conditions
and while transporting a patient, and can also be used as a long-term
cast or bandage during the full course of treatment, including
postoperative support.
[0013] The said splint offers solutions for the setting and treatment of
various areas of the body, such as the neck, limbs, pelvis, spine, and
chest areas. This novel splint answers the basic need for a simple device
that is easy to use, handle, store, and transport.
[0014] It is yet another object of the present invention to offer a
practical solution to the needs of various medical teams such as hospital
staffs, EMS personnel, health care providers for the elderly, and army
and police emergency teams, as well as for use in private homes.
[0015] The invention describes a splint designed to allow for an
adjustable and comfortable fit to different parts of the body, which
achieves maximum comfort and facilitates the recuperation period. It is a
simply structured splint, which allows for uncomplicated assembly and
operation. The splint is designed to fit the shape of the body part in
need of treatment. It provides support and wrapping for the injured area
from three sides. The splint is made out of inflatable ribs. Using a hand
pump or an air pressure source tank, the ribs may be inflated to various
degrees that provide the optimum support and comfort required for the
particular conditions. Ventilation holes in the structure allow for
sufficient airing and circulation of the treated area. The splints are
secured into place by Velcro straps.
[0016] It is a further object of the present invention to allow the user
movement and function of the joint and limb or body part, even at the
site of the injury, to such a degree as is ordered by the treating
physician. This concept being in line with contemporary knowledge on the
healing of soft tissue wounds and bones. The quality of healing is
enhanced in certain phases of repair and healing when controlled
mechanical forces create a load on the healing tissues and enable
movement of the injured area.
[0017] The simplicity of the design in one single unit, and assembly
enables the medical or paramedical fitter or the patient himself to
apply, use, assemble, and adjust the splint with minimal or no
assistance.
[0018] The invention is the combination of inflated tubes with flexible
material between the tubes, so designed in specific shapes for various
bodies parts as to fit to the anatomical shape of the specific part when
wrapped around the part and held together by means of Velcro straps.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] These and further features and advantages of the invention will
more clearly understood in the light of the ensuing description of a
preferred embodiment thereof, given by way of example only, with
reference to the accompanying drawings, wherein--
[0020] FIG. 1 is a perspective view of a first embodiment of the invention
in an unassembled and un-inflated condition.
[0021] FIG. 2 illustrates the first embodiment of the invention assembled
on a leg.
[0022] FIG. 2a illustrates a further example of the first embodiment,
assembled on the whole length of a leg.
[0023] FIG. 2b illustrates one example of an optional outrigger that
prevents rotation of the limb and the splint.
[0024] FIG. 2c illustrates another optional outrigger that folds in the
middle to allow projection to one side only.
[0025] FIG. 3 illustrates a cross section of the splint as assembled on a
leg.
[0026] FIG. 4 illustrates perspective view of a second embodiment of the
invention in an unassembled and un-inflated condition.
[0027] FIG. 5 illustrates a cross sectional view (section A) of the second
embodiment as illustrated in FIG. 4.
[0028] FIG. 6 illustrates the second embodiment of the invention assembled
on an arm.
[0029] FIG. 7 illustrates a cross sectional view (section B) of the second
embodiment as illustrated in FIG. 6.
[0030] FIG. 8 illustrates another example of the present invention in the
form of a vest for the treatment of fractures of the ribs.
[0031] FIG. 8a is a side view of the same example of a vest for the
treatment of fractures of the ribs.
[0032] FIG. 9 illustrates an example of the present invention used for
shoulder, arm, and elbow support.
[0033] FIG. 9a is the same example seen from the side.
[0034] FIG. 10 illustrates an example of the present invention in the form
of a corset for compressing the pelvis in cases of pelvic ring fractures.
[0035] FIG. 10a shows a cross section of the above example.
[0036] FIG. 10b is a perspective view of the pelvic corset in an
unassembled condition
[0037] FIG. 11 is a further example of the present invention, for the
wrist.
[0038] FIG. 12 illustrates an example of the present invention for
supporting the neck.
[0039] FIG. 12a is a side view of the same example for supporting the
neck.
[0040] FIG. 12b is the rear view of the same example for supporting the
neck.
DETAILED DESCRIPTION OF THE INVENTION
[0041] The present invention is a new and simple medical device, aimed to
help treat variety of general medical and surgical conditions, including
orthopedic, rheumatic, and rehabilitative conditions, by supporting,
splinting, and partially immobilizing the injured body part in a desired
position. It is a comfortable-to-wear, lightweight device, which is
simple and easy to assemble, water-resistant, and demands very little
storage space. When deflated, the splint folds into a compact, flat
package. This multipurpose device facilitates emergency and long-term
treatments of different sorts of conditions, including support for
injuries, dislocations, fractures, post operative conditions, and variety
of diseases of the skeletal and local motor system
[0042] The preferred embodiments of the invention are inflatable and
adjustable, suited to fit different body parts including the limbs,
chest, torso, spine, pelvis, and neck. The measure of air pressure
inflating the device and the manner of fastening it around a body part
are controllable and may be adjusted to suit the specific needs of any
given condition. The device is made from a double layer of nylon coated
by polyurethane, a flexible and lightweight material that is also strong
and waterproof.
[0043] According to known in the art research, it is advisable to enable
the injured person some mobility and functionality within the splint as
it contributes to the healing process. The present invention provides the
patient with a supporting splint that is flexible enough to allow
movement of nearby joints and even the injured site itself.
[0044] FIG. 1 offers a general description of the first embodiment of the
invention, suited for foot & ankle injuries, in an unassembled condition.
The splint 10 is comprised of a main body 20 and two or more unattached
adjustable straps: a front upper strap 6 and a front lower strap 7. When
in use, parts 24, 25, 26a, and 26b wrap the leg from three sides: part 24
encompasses the left side of the leg and part 25 the right side, while
the back of the leg is wrapped by splint central part 26a and 26b.
Connecting Velcro surfaces 30 and 6 fasten the device around the calf,
leaving the anterior surface uncovered and visible in its whole length.
[0045] The lower right part 40a and left part 40b of the splint wraps
around the foot, while part 41 covers the sole of the foot. Attaching
Velcro straps 31 to strap 7 on top of the foot and strap 42a to 42b at
the sole fastens the lower part of the splint for supporting the lower
part of the foot. FIG. 2 illustrates the device as it is assembled on a
leg 59.
[0046] Both the lower and the upper part of the splint have ventilating
holes 52 to increase the comfort during long term use of the device, and
at the edge of parts 40a and 40b there are loops 50 which, if necessary,
allow for suspending the leg raised up on a hook 55 to prevent it from
swelling, as illustrated in FIG. 2.
[0047] Parts 24, 25, 26, 40, and 41 contain inflatable tubes. These tubes
are designed to wrap the leg, the foot, the ankle, and the heel of the
injured person, taking into account the leg's anatomical shape and
structure for maximum compatibility. The tubes in the splint may be
inflated using a hand pump 16 or other type of pump, which is connected
to the said tubes through pipe 5 and valve 17. Alternatively, an air
pressure source can be connected to valve 17 and used for the same
purpose. Once inflated, a valve 15 may be used to open the airways and
let the air out of the tubes. Combining the effect of hand pump 16 and
valve 15 allows for achieving the desired pressure in the tubes
resulting, in the required stiffness of splint 10 around the leg, so that
the needed support is maintained and the movement and flexibility of the
leg is controlled without causing unnecessary discomfort. The pressure
that the air tubes create on the leg does not obstruct blood flow to the
leg, and ventilation holes 52 allow for sufficient airing of the area.
When inflated, the splint takes up the shape of the part of the body for
which it was designed, as FIG. 3 illustrates. An optional monitor for
measuring the pressure in the splint may be added to the splint.
[0048] Control over the amount of pressure and the tightness of the splint
on the Leg is mainly achieved by tightening or loosening Velcro straps 6
and 7 to splint Velcro 30 and 31 respectively. In a different embodiment,
Velcro straps 6 and 7 are stitched to one of the sides of the splint body
20. As illustrated in FIG. 2, the patient can easily reach said straps,
which are located on the front side of the leg, and the patient has
convenient access to the pump in order to adjust the level and volume of
split air pressure with minimal or no assistance, to achieve optimal
results.
[0049] FIG. 2a shows a further example of the first embodiment of the
invention, which is a splint for the whole length of the leg up to below
the groin 106, with Velcro straps below the knee 107 and above the knee
108. The insert shows that the position of the straps can be adjusted at
will by sliding the straps along the tape at the back of the splint 109,
or the straps can be fixed to the body of the splint as in FIGS. 1 and 2,
or the straps can be free and separate from the splint. FIG. 2a also
illustrates the uncovered part of the leg along its entire anterior
surface which is an important principle of the invention when applied to
a limb, ensuring that the limb is never entirely encased in a circular
element which prevents inspection and creates the danger of embarrassing
the blood circulation
[0050] FIGS. 2b and 2c are optional outriggers for providing additional
support to the foot. FIG. 2b shows an outrigger 100 that can be attached
to the foot section of the splint 101 for the purpose of preventing
rotation of both the limb and splint 102, 103, and 104. Attachment is by
Velcro strips at the points of meeting with the splint under the heel and
below the suspension ears. Suspension, when desired, is by the reinforced
perforations 105. FIG. 2c shows an outrigger 100 that folds in the middle
110, as seen in the insert, to allow projection to one side only. This
embodiment is intended as a universal first aid splint and for suitable
conditions requiring support for the leg from the toes to above the knee.
The inner surface of the splint is so shaped as to avoid pressure on the
heel and malleoli. An outrigger can be used also in different embodiments
of the invention for correcting deformities and preventing pressure
sores, particularly for the neck femur bone.
[0051] FIG. 3 illustrates a cross section of the splint as it is assembled
on a leg 59. In this illustration, it is easy to see that the splint is
designed to adjust to and fit the structure of the body part (the leg 59,
in this example) and its joints, one limb surface remaining free with
only the Velcro straps traversing that surface.
[0052] The second embodiment of the invention is illustrated in FIGS. 4,
5, 6, and 7 and is designed to be assembled on an arm. The principles
guiding the structure of this embodiment are similar to those of the
first embodiment; it differs from the first only in that the second
embodiment is intended to fit the structure and the treatment of a human
arm.
[0053] FIG. 4 illustrates the second embodiment in an unassembled state.
The main body of the splint is divided into two main parts: for
supporting the upper part of the arm 61a between the shoulder and the
elbow, and the lower part of the arm 61b between the elbow and the
wrists. Enclosing the main body 61 are Velcro straps 62 and 63 that
connect to each other when the device is assemble on an arm. The main
part 61a contains an aperture for the shoulder 67 and the main part 61b
includes an aperture for the palm 66 and a supporting surface for the
palm 66 and hand 65.
[0054] Like the main body of the first embodiment, these two sections are
both comprised of inflatable tubes which, when assembled on the arm, are
designed to support the arm from three directions. FIG. 5 displays a
cross-section of the splint when it is inflated and unassembled. This
figure clearly shows the four tubes a, b, c, and d in the splint. Velcro
straps 62 and 63 connect when the splint is assembled.
[0055] Also seen in FIG. 4 are the ventilating holes 68, similar to the
ones on the first embodiment of this invention 52, and a support strap
clip 64. This clip enables the attachment of straps that transfer the
weight of the hand to the shoulders or to the waist. FIG. 6 illustrates
the splint assembled on an arm. The figure displays the two options of
attaching the supporting straps: a suspension strap 70 around the
patience's neck and a strap wrapped around the waist 71. The straps hook
to the splint via said clip 64.
[0056] FIG. 6 also clearly illustrates the function of the aperture of the
shoulder 67, the palm's aperture 66, and the supporting surface for the
palm 65. The structure of this embodiment of the splint is suited to hold
the arm in a comfortable 90-degree angle at the elbow. FIG. 7 illustrates
a cross section of the assembled splint. This figure shows that the
splint can provide support to the arm from up to four directions.
[0057] Another embodiment of the present invention, shown in FIGS. 8 and
8a, is a vest splint 150, designed for the treatment of fractures of the
ribs or to support the rib cage or both. The inflated tubes are arranged
in segments 152 that can be inflated separately in order to exert
selected pressure on different areas of the chest wall according to
necessity. The inflatable rib-tubes of the splint are aligned to follow
the inclination of the rib bones. The vest is wrapped around the chest,
leaving two apertures for the arms and is fastened in the front by Velcro
straps 153.
[0058] For further clarification of the use and versatility of the present
invention, FIGS. 9 through 12a provide additional examples of the various
configurations that are possible with the present invention.
[0059] FIG. 9 shows the present invention configured to provide shoulder
support 111, arm support 112, and elbow support 113, together with a
classic neck suspension 114, cross shoulder straps 115, and body straps
116. An optional inflated cushion 117 between the chest wall and the arm
prevents pressure and ventilates the armpit. Velcro straps 118 attach the
splint from the front of the arm and forearm. FIG. 9a shows the same
shoulder support seen from the side. The inflated tubes 119 and 120 can
be variously arranged in any direction-longitudinal 119 or transverse
120--in order to create a well-shaped housing fitted to the body part
when attached with the Velcro straps 118 that close around the front of
the arm and forearm.
[0060] FIG. 10 shows an example of a corset arrangement for compressing
the pelvis in cases of pelvic ring fractures. The uninflated corset is
tightly wrapped round the pelvis and Velcro straps 122 are firmly secured
over an inflatable abdominal pillow 123. Inflating the corset through
valve 124 exerts circular pressure to stabilize the pelvis and inflating
the abdominal pillow 123 through valve 125 pressurizes the abdominal
cavity to aid the cessation of bleeding. FIG. 10a is a cross-section of
FIG. 10 at A-A to show the wrap of the inflated tubes 126 around the
pelvis and the pressure of the pillow 123 on the abdominal cavity 127,
which can be adjusted by the tightness of the Velcro straps 122 and the
degree of inflation of the tubes of the corset. FIG. 10b describes the
pelvic corset, showing the longitudinal tubes 126 interspaced with
tubeless material 129 to allow the wrap around the pelvis and the
arrangement of straps 122 with their Velcro attachment areas 130.
[0061] FIG. 11 is a splint organized for the wrist with inflated tubes on
the forearm 131 and on the back of the hand 132, which allows movement at
the wrist. Attachment is by Velcro bands across the palm 133 and around
the forearm 134. The front of the palm, wrist, and forearm are visible
for inspection. A narrow sleeve, which has a hand section 135 and a
forearm section 136, is for the insertion of rod extensions of a
universal joint should it be desired to position the wrist in any special
configuration.
[0062] FIGS. 12, 12a, and 12b show the front, side and back of a model of
the present invention for supporting the neck. The inflatable tubes 140
are interspersed with non-tubed areas 141 to allow for wrapping the
splint around the neck. Fastening is at the front or side with Velcro. An
aperture 142 allows access to the trachea.
[0063] These unique designs for the splints, as described, allow for
setting and stabilizing the injured body part while providing a
controlled range of flexibility, ensuring the necessary support of the
injured area, and improving the course of treatment for better results.
[0064] While the above description contains many specifities, these should
not be construed as limitations on the scope of the invention, but rather
as exemplifications of the preferred embodiments. Those skilled in the
art will envision other possible variations that are within its scope.
Accordingly, the scope of the invention should be determined not by the
embodiment illustrated, but by the appended claims and their legal
equivalents.
* * * * *