Ambulatory spinal unloading method and apparatus
An ambulatory spinal unloading method and apparatus are implemented to achieve a desired minimum level of residual cushioning in response to a biasing force applied to the associated apparatus tensioning and/or compression mechanism(s). The ambulatory spinal unloading apparatus may further include a treatment system to provide desired levels of nerve and/or muscle stimulation in addition to hot and/or cold elements to provide further therapeutic effects as desired or necessary.
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This application is a Continuation of U.S. patent application Ser. No. 11/094,862, which is a Continuation-in-Part of U.S. patent application Ser. No. 11/035,485, and further claims priority under 35 U.S.C. § 119(e) (1) of U.S. Provisional Application Ser. No. 60/640,479.
BACKGROUND OF THE INVENTION1. Field of the Invention
This invention relates generally to methods and apparatus that may employ electrical stimulation and/or hot/cold compresses, among other things, for alleviating pain due to abnormalities associated with, but not limited to, body weight, internal organs, muscles and various spinal infractions, and more particularly, to a method and apparatus for implementing ambulatory spinal unloading.
2. Description of the Prior Art
Traction has long been the treatment of choice for alleviating pain due to certain bodily abnormalities associated with, but not necessarily limited to, internal organs, muscles, body and various spinal infractions. U.S. Pat. No. 6,749,579 B1, entitled Traction Garment, issued Jun. 15, 2004 to Schroder, for example, discloses a nonstationary or ambulatory traction garment that includes a plurality of tension spreaders to provide injury-specific traction while restricting unwanted and potentially injurious motions.
Other U.S. patents, e.g. U.S. Pat. No. 5,704,904, issued Jan. 6, 1998 to Dunfee; U.S. Pat. No. 5,724,993, issued Mar. 10, 1998; and U.S. Pat. No. 5,950,628, issued Sep. 14, 1999 to Dunfee, the inventor of the present invention, each disclose use of an ambulatory, wearable support for applying an extending force or traction to a portion of the human anatomy while being worn. These wearable supports employ a plurality of extender sets having at least one selectively inflatable bladder.
U.S. Pat. No. 6,689,082 B2, and U.S. Pat. No. 6,776,767 B2, issued Feb. 10, 2004 and Aug. 17, 2004 respectively to Reinecke et al., disclose an ambulatory traction device that employs one or more lifting mechanisms configured to apply a decompressive force to a portion of a user's body when positioned around the user's body.
A flexible fluidic force generator capable of applying both an extending (traction) force and a compressive force to a portion of the human anatomy while being worn is disclosed in U.S. Pat. No. 6,237,602 B1, entitled Flexible Fluidic Force Generator, issued May 29, 2001, to Nickels et al.
While all of the devices described herein above have provided some advances in the field of ambulatory traction devices, they remain deficient in providing an effective residual spinal cushioning or spinal unloading condition, in the absence of a biased tensioning and/or compressive force.
In view of the foregoing, it would be desirable and advantageous in the art to provide a method and apparatus for implementing ambulatory spinal unloading, even in the absence of a biased tensile or traction force to those areas to relieve a portion of the compressive load on the spine to alleviate pain, and to optionally allow proper healing of bodily injuries. It would be further advantageous if the method and apparatus could employ embedded electrodes to deliver electrical stimulation in like fashion to known transcutaneous electrical nerve stimulation (TENS) that are readily available in the market place.
SUMMARY OF THE INVENTIONThe present invention is directed to an ambulatory spinal unloading method and apparatus that are implemented by defining a set of desired human characteristics and/or parameters and then implementing an ambulatory traction and cushioning apparatus structure based on the set of human characteristics/parameters to achieve a desired minimum level of residual cushioning, upon deactivating the bias applied to the associated apparatus tensioning and/or compression mechanism(s). The method and apparatus eliminate the absolute necessity for trial and error testing by an end user, and further allow the ambulatory spinal unloading apparatus to be optimized to the desired human characteristic(s) and/or parameter(s). A substantial benefit provided by this optimized apparatus is the avoidance of further inadvertent injuries experienced by an end user due to undesirable trial and error techniques such as those generally associated with apparatus that are already known in the related art. Further, the optimized apparatus will allow an end user in many instances, to wear the apparatus for much longer periods of time than that achievable using known apparatus, without experiencing fatigue. This feature is particularly desirable since it will decrease the level of discomfort generally associated with bodily injuries and thereby benefit a user who is wearing the optimized spinal unloading apparatus. This method and apparatus therefore importantly allows a doctor to prescribe both a tension time period and a compression (non-biased) time period, to yield long term spinal relief. A period of therapeutic electrical stimulation and/or hot/cold pack treatment is desirably prescribed concurrent with for subsequent to the foregoing tension and compression time periods. The desired human characteristics and/or parameters may include, but are not limited to, height, weight, percent of body fat, a plurality of desired circumferential measurements, relative location of human anomaly(s), period of time in traction, amount or percent of body weight, desired traction level(s), length of time and percent of body weight to be subjected to spinal cushioning apparatus, a desired therapeutic application and so on.
In one aspect of the invention, an ambulatory spinal unloading apparatus absorbs undesirable pressure caused by degenerative disc or nerve faucets, using both compression and expansion features provided via a lifter assembly or mechanism.
In another aspect of the invention, an ambulatory spinal unloading apparatus eliminates the necessity to develop time tables and data necessary to formulate correct orthotic belts.
In yet another aspect of the invention, an ambulatory spinal unloading apparatus provides flexible stabilizing effects to yield a desired level of user comfort, even in the absence of activation or biasing of any lifter mechanism(s).
One embodiment of the invention provides a spinal unloading apparatus having an upper or thoracic belt and a lower or lumbar belt in which the thoracic belt and the lumbar belt are separated via a single posterior lifting mechanism. The single posterior lifting mechanism can be formulated, for example, via a single fluidic i.e. piston driven pneumatic chamber in combination with a residual cushioning mechanism such as one or more gel-filled chambers to provide a desired level of residual cushioning upon the removal of fluidic pressure from the fluidic chamber. The single posterior lifting mechanism may optionally be formulated via a mechanically actuated or electro-mechanically actuated device. The mechanically actuated device can be implemented, for example, via a spring structure that may be compressed and released via one or more cam mechanisms. The electro-mechanically actuated device can be implemented, for example, via one or more stepper motors configured to selectively adjust one or more extension means, i.e. rods. The electro-mechanically actuated device could optionally be implemented, for example, via one or more motor actuated worm gears, belts, or pulley mechanisms, turning one or more threaded extension rods. Regardless, the electro-mechanically actuated device(s) are energy efficient such that the desired lifting effect(s) can be achieved using a portable battery pack that may be rechargeable or a portable power pack that may, for example, receive its primary source of power from an automotive accessory outlet. The thoracic belt and the lumbar belt are sufficiently rigid such that a desired spinal lifting effect can be achieved from the single posterior lifting mechanism. Further, the thoracic belt and the lumbar belt may each comprise one or more internal fluidic chambers strategically located to provide a desired level of user comfort and to prevent restrictive binding of the user's thoracic region. These internal fluidic chambers can be replaced instead by one or more pockets configured to receive hot and/or cold compresses. Additional lifting and/or residual cushioning mechanisms can optionally be positioned between the thoracic and lumbar belts at desired locations to provide a desired lifting and/or residual cushioning effect to the user's anterior region subsequent to attaching the spinal unloading apparatus. These additional lifting and/or residual cushioning mechanisms most preferably are implemented via non-fluidic means whenever the posterior lifting mechanism employs fluidic means, and implemented via fluidic means whenever the posterior lifting mechanism employs non-fluidic means, such that the spinal unloading apparatus never employs more than a single fluidic lifting mechanism.
The orthotic belts comprising the spinal unloading apparatus can optionally be implemented with integral electrodes that are positioned such that a desired level of muscular and/or nerve stimulation can be achieved while a user is wearing the spinal unloading apparatus. Most preferably, these integral electrodes are activated/energized via the portable battery pack or power pack that also provides power to the electro-mechanical lifting mechanism(s). Such muscle and/or nerve stimulation can accelerate the spinal healing process due to a reduction in the level of discomfort/pain associated with spinal unloading that may be experienced by the end user.
The upper, or thoracic, belt, which may have the shape of a vest or shirt, may further have shoulder straps configured to ease user fitting and removal.
Other aspects, features and advantages of the present invention will be readily appreciated as the invention becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawing figures wherein:
While the above-identified drawing figures set forth particular embodiments, other embodiments of the present invention are also contemplated, as noted in the discussion. In all cases, this disclosure presents illustrated embodiments of the present invention by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of this invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTSAn ambulatory spinal unloading method and apparatus are implemented, as stated herein before, by defining a set of desired human characteristics and/or parameters and then implementing an ambulatory traction and cushioning apparatus structure based on the set of human characteristics/parameters to achieve a desire minimum level of residual cushioning, upon deactivating the associated apparatus biasing mechanism(s). These desired human characteristics/parameters may include, but are not limited to, height, weight, percent of body fat, a plurality of desired circumferential measurements, relative location of human anomaly/anomalies, period of time in traction, amount or percent of body weight to be subjected to spinal cushioning apparatus, desired traction levels, and so on. The ambulatory spinal unloading apparatus is configured to absorb an intermittent and/or unexpected shock and/or vibration using compression and expansion features provided via a lifter assembly such as described herein below with reference to
Looking first at
Advantages and features of the present invention will become more readily apparent in view of the known art that generally employs a plurality of lifters/lifter assemblies which result in undesirable rigid traction in the absence of lifter mechanism biasing/activation. With continued reference now to
The embodiments described herein with reference to the figures were found by the present inventors to eliminate the necessity to develop time tables and data necessary to formulate acceptable known orthotic belts. Modern ambulatory traction apparatus and devices, for example, are most often designed and manufactured using rigid and narrow semi-circular belts which results in too much pressure on any one point of a person's body, and also do not allow enough material area to dissipate large amounts of a person's body weight.
It is noteworthy that, unlike known ambulatory spinal traction/support devices, structures implemented in accordance with the principles described herein make use of mathematical computations associated with human characteristics and/or parameters that may include, for example, but are not limited to, percent of body fat to determine structural related data such as strength, size and length of lift required. This technique then allows for a “one size fits all” lifter structure that may, for example, utilize a single pneumatic biasing mechanism.
Unlike common modern ambulatory traction devices that use various rigid lifter(s) such as assemblies that employ pneumatic pistons, which when unbiased, maintain a rigid device around a person's thoracic region which makes the device difficult to wear when not biased, the embodiments described herein deliver a desired residual amount of cushioning, as stated herein before, upon deactivation of the lifter(s)/lifter assemblies. Values associated with percent of residual cushioning will, of course, depend upon the specific abnormality, but, as discovered by the present inventors, could be as low as about 5 percent of a person's body weight.
Upper and lower orthotic belts 102, 104, as stated herein before, can optionally be formulated to selectively integrate fluidic chambers such as air pockets that function to eliminate restrictive binding of a user's thoracic region when the assembly 100 is worn by the user. These air pockets could instead be replaced with pockets configured to selectively receive hot and/or cold packs. Orthotic belts 102, 104, further may be formulated with a desired quantity of accessory pockets configured to accept inflatable cushions or gel-filled packs that may optionally be temperature controlled to provide a residual cushioning effect in combination with a cold or hot compress effect upon insertion of the gel-filled pack(s) into one or more pockets.
With continued reference now to
The cushioned lifter mechanism(s), assemblies and devices described herein with reference to the figures can employ numerous structural materials, such as, but not limited to, metals, plastics, gels and rubbers, to provide a lifter embodiment having both compressive and expansion characteristics such that the inventive ambulatory spinal unloading method and apparatus will provide a flexible stabilizing effect that yields a desired level of user comfort, even when the cushioned lifter mechanism(s) is not activated or biased. Although particular embodiments are described herein using fluidic devices, mechanical devices, and electro-mechanical devices, the present invention is not so limited, and it shall be understood that the desired residual cushioning could just as easily be implemented using particular materials that are commonly employed by those skilled in the mechanical engineering arts and versed in the structural, shock and vibration arts to implement elastomeric damping structures. Such materials may include, but are not limited to, gels, natural rubbers, synthetic resins such as polyvinyl chlorides, polyurethanes, polyamides, polystyrenes, copolymerized polyvinyl chlorides, polyolefin synthetic rubbers, as well as urethanes, EPDM, styrene-butadiene rubbers, nitrites, isoprene, chloroprenes, polypropylene, and silicones.
Moving now to
In summary explanation, an ambulatory spinal unloading method and apparatus are implemented by defining a set of desired human characteristics and/or parameters and then implementing an ambulatory traction and cushioning apparatus structure based on the set of human characteristics/parameters to achieve a desired minimum level of residual cushioning, even in the absence of any bias applied to the associated apparatus tensioning and/or compression mechanism(s). This technique eliminates the need for trial and error testing by an end user, and further allows the ambulatory spinal unloading apparatus to be optimized to the desired human characteristic(s) and/or parameter(s). A substantial benefit provided by this optimized apparatus is the avoidance of further inadvertent injuries experienced by an end user due to undesirable trial and error methods associated with apparatus that is already known in the related art. Further, the optimized apparatus will allow an end user in many instances, to wear the apparatus for much longer periods of time than that achievable using known apparatus, without experiencing fatigue. This feature is particularly desirable since it will enhance the healing time associated with bodily injuries that will benefit from wearing the optimized spinal unloading apparatus, especially when the spinal unloading is combined with therapeutic electrical nerve and/or muscle stimulation and/or application of hot and/or cold compresses. The desired human characteristics and/or parameters may include, but are not limited to, height, weight, percent of body fat, a plurality of desired circumferential measurements, relative location of human anomaly(s), period of time in traction, amount or percent of body weight, desired traction level(s), length of time and percent of body weight to be subjected to spinal cushioning apparatus and/or therapeutic treatment, and so on.
Claims
1. An ambulatory spinal unloading apparatus configured to provide a desired amount of traction force to a spine of a patient and to absorb an intermittent and/or unexpected shock and/or vibration, with the traction force provided via a plurality of lifter assemblies, comprising:
- an upper orthotic belt;
- a lower orthotic belt;
- a residual cushioning device; and
- the plurality of lifter assemblies;
- wherein the plurality of lifter assemblies each independently expands or retracts to control distance between the orthotic belts to provide the traction force to a spine of a patient, and each of the lifter assemblies further comprises a residual cushioning device that independently provides a desired residual cushioning effect by compression of a spring and/or damper to thereby absorb an intermittent and/or unexpected shock and/or vibration, wherein the spring and/or damper is effective to provide the residual cushioning for the lifting assembly in a deactivated state.
2. The apparatus of claim 1 with the lifter assemblies each comprising a worm gear turning a threaded rod or a piston actuated fluidic lifting device.
3. The apparatus of claim 2, with at least one of the lifter assemblies comprising a piston actuated fluidic lifting device.
4. The apparatus of claim 3 wherein the piston actuated fluidic lifting device comprises a pneumatically operated piston.
5. The apparatus of claim 3 wherein the piston actuated fluidic lifting device comprises a pair of pistons connected by a piston rod, and with each piston fitting a pneumatic cylinder.
6. The apparatus of claim 5 further comprising a gel-filled chamber that provides the residual cushioning.
7. The spinal unloading apparatus according to claim 1, wherein at least one orthotic belt comprises integrated electrodes selectively positioned to provide a desired level of muscle or nerve stimulation in response to a desired electrical bias.
8. The apparatus of claim 1 further comprising a plurality of contact electrodes to deliver transcutaneous electrical nerve stimulation.
9. The apparatus of claim 1 wherein the upper orthotic belt and/or the lower orthotic belt comprises a plurality of contact electrodes to deliver transcutaneous electrical nerve stimulation.
10. The apparatus of claim 1 further comprising a lumbar pad assembly that comprises a plurality of contact electrodes to deliver transcutaneous electrical nerve stimulation.
11. The spinal unloading apparatus according to claim 1, wherein the residual cushioning device comprises a gel-filled chamber.
12. The spinal unloading apparatus according to claim 1, wherein the residual cushioning device comprises the spring.
13. The spinal unloading apparatus according to claim 1, wherein the residual cushioning device comprises the damper.
14. The spinal unloading apparatus according to claim 1, wherein each of the plurality of lifter assemblies comprises no more than one fluidic chamber.
15. The spinal unloading apparatus according to claim 1, wherein the plurality of lifter assemblies each comprise at least one electric motor configured in combination with a mechanical extension shaft assembly to selectively control the distance.
16. The spinal unloading apparatus according to claim 15, wherein the mechanical extension shaft assembly comprises at least one element selected from the group consisting of belts, pulleys, cables, threaded shafts, and gears.
17. The spinal unloading apparatus according to claim 1, further comprising a lumbar support apparatus selectively positioned between the upper and lower belts.
18. The spinal unloading apparatus according to claim 17, wherein the lumbar support comprises a hot pack.
19. The spinal unloading apparatus according to claim 1, further comprising a recording apparatus operational to selectively record desired information associated with at least one parameter selected from the list consisting of traction, spinal unloading, stimulation, and/or therapeutic parameters.
20. A method of spinal unloading comprising:
- providing an ambulatory spinal unloading apparatus that comprises a first orthotic belt, a second orthotic belt, and a plurality of lifter assemblies configured to selectively vary a distance between the orthotic belts a residual cushioning device that provides a desired residual cushioning effect achieved by compression of a spring and/or damper to thereby absorb an intermittent and/or unexpected shock and/or vibration for the threaded rod or for the piston actuated fluidic lifting device in a deactivated state.
21. The method of claim 20 further comprising providing transcutaneous electrical nerve stimulation through a plurality of contact electrodes.
22. The method of claim 20 further comprising providing transcutaneous electrical nerve stimulation through a plurality of contact electrodes located on the upper belt, the lower belt, and/or a lumbar belt.
23. The method of claim 22 further comprising providing a heat source in combination with the transcutaneous electrical nerve stimulation.
24. The method of claim 23 comprising providing a pocket for a hot pack at or near the plurality of contact electrodes.
25. The method of claim 20, with at least one of the lifter assemblies comprising a piston actuated fluidic lifting device that comprises a pneumatically operated piston.
26. The method of claim 20 wherein the piston actuated fluidic lifting device comprises a pair of pistons connected by a piston rod, with each piston fitting a pneumatic cylinder, and further comprising supplying a gas to one of the cylinders for moving the piston rod.
Type: Application
Filed: Sep 23, 2008
Publication Date: Feb 5, 2009
Applicant:
Inventors: Matthew J. Dunfee (Belle Plaine, MN), Susan J. Dunfee (Belle Plaine, MN)
Application Number: 12/284,555
International Classification: A61B 17/00 (20060101); A61F 5/00 (20060101);