Patent Application
20230173289
The present disclosure generally relates to the field of spinal decompression therapy and in particular to a device for applying pulsed energy to the spine during spinal decompression therapy.
The mature human spine is made of 24 separate vertebral bones (5 lumbar, 12 thoracic, 7 cervical), separated by 23 cartilaginous intervertebral discs. Each intervertebral disc is a major load-bearing joint. Additionally, there are over 100 smaller cartilage-bearing facet joints arranged about the vertebral bones which provide structure and support for smooth spinal movements. The synovium and its associated products, e.g., synovial fluid, provide lubrication and cushioning for the joints of the spine. Over 100 muscles and 220 individual ligaments work with the spine during normal function.
As the health of the spine degrades, patients may initially experience back pain associated with movement. The pain generally follows execution of movement which had not previously caused back pain, e.g., lifting a child. This is sometimes broadly characterized as osteoarthritis (OA). Chronic injury to the spine results in degradation of cartilage, reduction of joint space, narrowing of passageways through which nerves transit, inflammation, pain, and loss of function. Eventually, little-to-no fluid or material, e.g., cartilage, separates the opposing faces of bone which grind upon each other during movement. In the final stages of chronic injury, the bones of the joint naturally fuse together, a process familiar to any reader who has experienced a broken bone.
Prior to natural bone fusion or total loss of joint function, the spine naturally attempts to restore homeostasis with the external environment through spinal remodeling. The human spine naturally maintains a homeostatic balance with the external environment through constant remodeling of its cartilage, bone and synovium either anabolically or catabolically. Anabolic remodeling is initiated in response to movement and increased load-bearing demands, synthesizing healthy new tissues and suppressing inflammatory processes. Catabolic remodeling is initiated in the absence of mechanical movement or stress, promoting inflammatory processes and wasting unnecessary tissue for reintegration or elimination from the body.
Anabolic and catabolic remodeling of the human body is a process all readers are familiar with. When an individual regularly performs healthy exercise, their body undergoes anabolic changes which include strengthening muscles, bones and joints. The increase in density and strength of muscle, bone and connective tissue is the result of anabolic growth, synthesis of new muscle/bone/connective tissue. When an individual rarely performs any exercise, their body undergoes catabolic changes which include wasting of muscle strength and size along with weakening of bones and joints. The decreases in the size and density of these tissues are the result of catabolic destruction of these tissues and the resorption into the body of their constituent components.
The ability of the spine to repair itself anabolically declines with age, in the absence of routine use, and due to injury. Routine load-bearing movements and exercise of the range-of-motion of the spine's intervertebral and facet joints, within healthy limits, encourages an anabolic environment and reduces the impacts of aging. Conversely, whether by age, disuse or injury, joint and bone tissues subjected to chronic catabolic and inflammatory exposure become incapable of supporting sufficient clearance for nerves to pass through the spine unimpinged, resulting in pain, loss-of-function and further inflammatory signaling. Additionally, they can become incapable of movement within their intended range-of-motion. Finally, they can become incapable of separating the faces of the bones of the joint from direct contact, resulting in gross damage and pain, and ultimately natural fusion of the bones.
Despite modern surgical and pharmacological interventions, debilitating low back pain (LBP) is reported at increasing rates per capita year-over-year, and not less. Whether surgical and pharmacological interventions can ever fully eliminate lower back pain is yet to be demonstrated.
According to one embodiment of the present disclosure, the disclosure relates to a pulsed electromagnetic field spinal decompression device. The device includes a generally-horizontal mattress having a first end and a second end. A generally-vertical decompression tower is disposed at the first end of the generally-horizontal mattress. A tension strap having a first end and second end, is operably connected to the decompression tower at its first end. A pelvic harness is operably connected to the second end of the tension strap. A pulsed electromagnetic field device is disposed in the generally-horizontal mattress.
The foregoing summary, as well as the following detailed description of certain embodiments of the present disclosure, will be better understood when read in conjunction with the appended drawings. Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of disclosed embodiments, along with accompanying drawing figures in which like numerals represent like components.
The foregoing disclosure will be best understood, and the advantages thereof made most clearly apparent, when consideration is given to the following detailed description in combination with the drawing figures presented. The detailed description makes reference to the following drawings:
For the purpose of illustrating the disclosure, certain embodiments are shown in the drawings and described herein. It should be understood, however, that the present disclosure is not strictly limited to the arrangements and instrumentalities shown in the attached drawings.
The following detailed description provides certain specific embodiments of the subject matter disclosed herein. Although each embodiment represents a single combination of elements, the subject matter disclosed herein should be understood to include sub-combinations of the disclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also intended to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed herein.
One embodiment of the present disclosure comprises a pulsed electromagnetic force (PEMF) device incorporated into the mattress of a supine-orientation-type spinal decompression device. The disclosure can be utilized for either PEMF or spinal decompression therapy, or both.
A pelvic harness 116 is shown, worn about the pelvis region of the patient. The harness, typically of textile construction, conforms to the lower torso and hips of the patient and is held tight by fasteners (e.g., straps and clips). Pelvic harness 116 is shown connected by multiple straps 118 to a ring 120, and the ring to a tension strap 122 which feeds into decompression tower 102. Tension strap 122 is shown raised at an angle 124 relative to the surface of the mattress, as is typical of targeted distractive forces utilized in spinal decompression therapy. A dashed arrow 126 is shown above the tension strap indicating the direction of the applied distractive force during a treatment session.
Spinal decompression/PEMF spinal therapy device 100 incorporates PEMF device 152 for application of one or more pulsed electromagnetic fields to the therapeutic region. PEMF device 152 is shown mounted to upper frame 154 and within the upper mattress section 110 of device 100. In this embodiment, the lumbar spine apex-of-lordosis 108 is located approximately over a twin-coil within PEMF device 152, as described in detail below. While spinal decompression tower 102 is pulling on tension strap 120 generating distractive force 126, PEMF device 152 is generating pulsed electromagnetic frequencies 156 which extend into, through and surrounding the lumbar spine. In this configuration, the patient may receive both spinal decompression and PEMF therapy simultaneously or sequentially.
“Traction” is the activity of mechanical unloading of the spine through constant, or steady-state, application of one or more opposing forces in communication with said spine. “Decompression” is the activity of the mechanical unloading of the spine, through cyclical application of one or more opposing forces in communication with said spine and which forces preferably affect an intended sub-region of the spine.
“Cyclical” as used in reference to “decompression” means to modulate the amplitude, or intensity, of forces distracting the spine, as used herein. Mechanical unloading, in either case, is intended to distract the vertebral bones and facet joints resulting in elongation of the spine, which in turn leads to induction of a negative pressure-gradient upon and within the region.
Elongation of the spine is intended generally to reduce or eliminate pain and loss-of-function from compression of intervertebral discs, facet joints, and nerves transiting the spine. Secondarily, the resultant pressure gradient about and within the elongated region is generally intended to: (a) facilitate rehydration of the spine, as the satisfaction of the pressure gradient is the exchange of nutrient-rich fluids from tissues adjacent to the region of the spine; and (b) facilitate movement of herniated materials back into the elongated region of the spine, which also satisfies the induced pressure gradient.
Especially mobilized via the negative pressure-gradient are those fluids, e.g., herniated spinal nucleus adjacent to the damaged annulus, in most direct communication with the elongated spine. Herniated nucleus is drawn back through the damaged annulus, reducing the size of the herniation and its impingement-effect zone. Reincorporation of herniated nucleus reduces strain and inflammatory signaling in the region of damaged annulus, facilitating normal closure there.
Typical presentation of back pain includes one or more regions of inflamed and compressed intervertebral disc and facet joint spaces. Compression may be gradual or from traumatic insult. Repeated mechanical unloading of the spine is intended to generally restore normal intervertebral disc and facet joint height, relative to the compressed state of the spine prior to any traction or decompression therapy.
“Decompression” is commonly differentiated from “traction” by two characteristics. First is that it is cyclic, as opposed to steady-state, mechanical unloading of the spine. Second is the incorporation of mechanical systems intended to apply decompressive force(s) which preferably target regions of the spine of pathological interest.
Cycling the intensity of the mechanically-distractive force(s) generates oscillating negative pressure gradients upon the cells of and within the spine. The ‘pumping action’ of the cyclical mechanical unloading employed by “decompression” therapy is intended to enhance nutrient-rich rehydration of the spine. For example, enhanced rehydration of intervertebral discs, during each decompression therapy session, reduces the overall time and number of treatments required to achieve intervertebral-disc height(s) sufficient to support acceptable patient outcomes.
Cycling the intensity of the mechanical unloading additionally creates a state of ‘muscle confusion’, preventing paraspinal muscle contraction triggered by prolonged or excessive elongation.
The degree to which the spine can be mobilized influences the ease with which an anabolic environment can be induced mechanically, either by “traction” or “decompression” therapy. This brings to light a third and perhaps most distinguishing attribute of “decompression” therapy (as compared to “traction”). Cycling the intensity of the forces applied to the spine generates flexion of both the facet and intervertebral joint spaces, all while in a continuously unloaded state, triggering upregulated anabolic signaling there. The importance of this should not be lost on the reader. In a majority of cases, movement of these joints is no longer possible in the normally loaded, compressed state of the spine of the patient.
Biochemically speaking, growth and repair of both cartilage, bone and synovial tissue begins with synthesis of their respective extracellular matrix (ECM). Generally, the ECM is a three-dimensional space which contains proteoglycans and other macromolecules which are the constituents of human tissues, including cartilage, bone, and synovial products. Synthesis of new ECM requires synthesis of new proteoglycans. These are molecules that (a) fill the spaces of the ECM between other macromolecules and particles therein, (b) other macromolecules adhere to and through which integrate into the ECM and (c) generate lubrication, dampening, and absorption associated with mechanical movement, shock and stress.
Cartilage is comprised primarily of proteoglycan and collagen fibers. Both proteoglycans and collagen derive from chondroblasts which generate the ECM of cartilage. Similarly, osteoblasts are responsible for the ECM of bone which is comprised of collagen, bone minerals and proteoglycans. In this respect, proteoglycan synthesis is one direct correlation to cartilage and bone repair. The body protects the process of proteoglycan synthesis through the production and release of anti-inflammatory cytokines.
Revisiting the discussion of anabolic and catabolic activities as they relate to the remodeling of the spine, anabolic activities that occur within and to the ECM include electrochemical signaling and subsequent release of anti-inflammatory cytokines, and transformation of human mesenchymal stem cells (MSCs) into chondroblasts and osteoblasts (among others) which then continue to differentiate under the (anabolic) conditions. The activity of chondroblasts and osteoblasts includes the build-up and strengthening of cartilage and bone and their ECM. The enhanced structural remodeling requires additional nutrients and fluid incorporation by and throughout the ECM at a rate increased by the anabolic environment. This is an intuitive, natural response to an increased requirement for structural support as would be the case for a weightlifter generally, or for an astronaut residing on a planet or moon more massive than the Earth, thus experiencing stronger gravity.
Catabolic activities that occur within and to the ECM include electrochemical signaling and subsequent release of pro-inflammatory cytokines, transformation of human mesenchymal stem cells (MSCs) into chondroclasts and osteoclasts (among others) which then continue to differentiate under the (catabolic) conditions. The activity of chondroclasts and osteoclasts includes the breakdown of cartilage and bone, respectively, and their ECM which is resorbed into the body. This is an intuitive, natural response to a reduced requirement for structural support, as would be the case for wheelchair-bound patients, or for an astronaut residing in zero-gravity space for prolonged periods of time.
Revisiting the definition of “decompression” from a spinal-remodeling perspective, “decompression” is the mechanical-induction of anabolic growth and reparative processes within areas of pathological interest of the spine via application of amplitude modulation of mechanically-distractive forces acting axially upon the spine which flex and extend the facet and intervertebral joints while continuously unloaded. This activity gives rise to multiple effects. First, it stimulates natural mechanical strain-associated cell-triggers within the ECM which electrochemically signal the generation and release of anti-inflammatory cytokines and growth factors associated with synthesis of new, healthy cartilage, bone and synovial tissues. Second, it effectuates a ‘pumping action’ in the region to enhance fluid and nutrient delivery required for cartilage and bone repair. Third, it acts to withdraw and recover herniated fluids into the spine, allowing damaged annulus tissue to heal. Fourth, it physically unloads pressure on the facet and intervertebral joint spaces, which in turn (a) relieves nerve impingement pain and restoring function, (b) opens joint space and (c) provides a mechanically-unloaded environment within which to heal.
The United States Food and Drug Administration has cleared several therapeutic “spinal decompression” medical devices for safe effective use by patients. 89 ITH is the Product Code assigned to modern (as of this writing) spinal decompression devices, which has the Classification Name: “Power Traction Equipment”. The Indications for Use for one such device reads as follows: “The DRX9000 True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.” (Source: FDA Online Access, FDA Clearance #K060735, Retrieved Oct. 25, 2021: https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060735.pdf)
According to the present disclosure, mechanical spinal decompression is combined with a pulsed electromagnetic field (PEMF) in order to enhance the effectiveness of the therapy.
Electrical power communicates with the twin-coil 300 as shown by the black arrows 314 and 316 in
Placement of the twin-coil within the upper-mattress section 110 and beneath the AoL 108 of the lumbar spine is intended to target the maximum pulsed electromagnetic field (PEMF) intensity 400 upon, within and surrounding the pathological region of interest 406.
The design of the coils suggested herein is given as a range of general characteristics currently found in technology in-use today. The design of the coils will be specific to each application's end-effecting apparatus, and specific desired clinical outcomes.
The use of a pulsed electromagnetic field is believed to generate mechanical strain upon the highly ionically-charged ECM of the skeletal tissue. Such electro-kinetic events may also generate electro-chemical cell signaling, leading to new tissue synthesis and release of anti-inflammatory cytokines. The use of PEMF is also believed to upregulate cartilage and bone synthesis in a variety of joint and bone presentations and locations, including the spine.
The pulsed electromagnetic field (PEMF) therapeutic device of the present disclosure generates a pulsing magnetic field extending invisibly into the body. Ionically-charged structures within tissues exposed to PEMF are physically deflected within the field according to its amplitude and rate-of-pulsation (a.k.a. its ‘frequency’). Within the pulsing magnetic field, this electrokinetic activity is translated into electro-chemical cell signals that trigger physiological modifications.
The term ‘pulsing’ used in reference to the PEMF means to cycle the intensity, or amplitude, of the magnetic field, as used herein unless otherwise described. Frequency modulation is also contemplated within the scope of this disclosure. The frequencies and amplitudes may vary by application. In certain embodiments, the device can create pulsing magnetic fields with one or more frequencies between 0.001 Hz and 100 Hz. In other embodiments, the device emits fields with frequencies up to 300 Hz. In certain embodiments, the device will scan through frequencies within the range of 0.01 Hz and up to 300 Hz. The device produces magnetic fields with intensities ranging from 70 uT to 1000 uT. In other embodiments the device produces field intensities up to 2.5 mT. In other embodiments, the device produces field intensities up to 12 mT.
Decompression therapy using cyclical (a.k.a. ‘amplitude modulated’) mechanical forces in combination with PEMF therapy, using pulsed (a.k.a. ‘amplitude modulated’) magnetic fields, both activate the anabolic signaling events which translate into reparative and restorative spinal remodeling.
Cell membrane adenosine receptors (ARs) are believed to be a target of PEMF excitation in inflammatory cells, but other mechanisms may also play a role. It is believed that there may be an increase in the density of two ARs, A2A and A3, on the cell membranes of human chondrocytes, synoviocytes and osteoblasts following PEMF exposure. In this way, PEMF may cause ‘agonist’ activity for the A2A and A3 AR pathways, acting to upregulate their activity. Upregulated A2A and A3 activity may inhibit the NF-κB pathway, which may in turn inhibit both matrix metalloproteinase synthesis and pro-inflammatory signaling.
Cartilage cells, in the presence of both a specific pharmacological A2A receptor agonist as well as PEMF stimulation, may produce increased anabolic products. A2A stimulation via agonist drugs may have a chondroprotective effect, reducing joint inflammation and cartilage damage in septic arthritis patients. Upregulated A2A and A3 activation may be expressed biomechanically through enhanced new synthesis of proteoglycans and ECM, differentiation of MSCs into chondroblasts and osteoblasts, and synthesis of new cartilage, bone, and synovial tissues and fluid. This activity may be protected through synthesis and release of anti-inflammatory cytokines.
The upper manifold 606 is composed of a non-metallic material, such as blue acetal copolymer, and may be machined, molded, 3D printed or otherwise constructed. In one embodiment, the upper manifold 606 is approximately 9.6W×5L×1.3T inches. It contains three holes drilled vertically therethrough all along the widthwise central axis as: a) central hole 610 1.5 inches in diameter, b) two side holes 612 and 614 each 2.5 inches in diameter and set 2.3 inches away from the central hole 610 on either side. Four counterbore screw clearance holes 616 for 5/16-18 socket cap head screws are drilled through at four corner locations set 8.6 by 4 inches apart. Four glass-filled nylon (non-metallic) 5/16-18 socket cap head screws 618 are shown fully-tightened and are of sufficient length to clamp section 602 (via four through holes 710) between the upper manifold 606 and the lower manifold 620 (via four holes 712 having at least partial 5/16-18 threading). A slot 714 is cut into the upper frame 154/section 620 approximately two inches wide and extending approximately to the intersection of the “keep away” region. Any structural integrity loss is accounted for by the clamping of 606 and 620.
Two non-metallic springs 624 and 626 with outer diameters of 2.4 inches, inner diameters of 2.0 inches, and uncompressed lengths of approximately 3.3 inches are shown in view 622. The compressed length of the springs is approximately 1.3 inches. In one preferred embodiment, the springs' ends are closed, squared and ground. The springs' bases are affixed to section 602 and at their other ends to twin coil support 628. In other embodiments the springs 624 and 626 are attached only to either 602 or 628 or are not attached to either. Springs of this type are in common use and are fabricated using plastic materials including polyetherimide (PEI), which are non-metallic and exhibit outstanding mechanical strength and thermal performance. The springs 624/626 in one embodiment have a minimum rate of 3 pounds per inch (lbs./in). In other embodiments, springs 624/626 have minimum rates ranging from 1 and up to 3 lbs./in, and in other embodiments from 3 and up 10 lbs/in.
The design of the compression rate (lbs./in) of the springs is sufficient to support the combined weight of twin-coil support 628, twin coil 300, PEMF cover 630, spacing spheres 632 and 634, A-side cooling hose & clamp 636, B-side cooling hose and clamp 638, A-side electric cable 640, B-side electric cable 642 and exhaust hose 644.
PEMF device 152 as shown in
Twin coil support 628 is composed of a non-metallic material, such as blue acetal copolymer, and may be machined, molded, 3D printed or otherwise constructed. In one embodiment, the twin coil support is molded as a single piece. It is organized as two vertical cylinders having outer diameters of 1.9″ and spaced at 2.3″ from center, which corresponds to the centers of holes 612/614 in the upper manifold 606, axes 304/312 of twin-coil 300, through-holes 702/704 in section 602, and through-holes 706/708 in the lower manifold 620, respectively.
As will be described, the two vertical cylinders capture springs 624/626 therethrough, and also against the underside of the upper portion of the twin coil support 628. Additionally, the diameter of holes 702/704 is 2.22 inches, which is sufficient to let the vertical towers of the twin-coil support 628 pass through but which stops the springs 624/626.
The springs allow restorative vertical displacements of the twin-coil support in response to the patient's weight from above the upper-mattress section 110. The two vertical cylinders of the twin-coil support move freely through the springs, the section 602 holes 702/704, and the lower manifold holes 706/708. In this manner, the location of the twin-coil is maintained with respect to both the level of the spine receiving PEMF (x and y axes of mattress), as well as to the vertical distance between the twin-coil and the patient's spine.
In
The PEMF cover 630 is a molded part which mates to the top of the twin coil support 628. The inner cavity of the PEMF-cover is a rounded, circular channel similar to that of twin coil support 628 and also contains spacing fins that preserve the positioning of twin-coil 300 and allow cooling air to flow above and around twin-coil 300. The cover is shown having two holes, centered above corresponding spacing spheres 632/634, allowing the spheres to pass through the cover approximately 0.5 inches above the top of the cover, and to spin freely within the hemispherical dugouts 646/648. In other embodiments, the PEMF cover 630 incorporates a molded or machined dome(s) directly into the part, eliminating the spacing spheres and hemispherical dugouts. At either end of the cover two upper half-ports 654/656 are formed which correspond to the lower half-ports 650/652, and over which the cooling hoses and clamps 636/638 are fit and clamped. The ports formed of the upper and lower half-ports are approximately 0.70 inches OD/0.60 inches ID. The cooling hoses are designed to fit appropriately.
In normal use, PEMF device 152 is generating a pulsing magnetic field through conversion of a portion of the electrical power, passed through twin-coil 300, into magnetic field energy. A portion of the electrical power is converted into heat and must be managed to ensure safe operation. Thermal management is accomplished through active air cooling in one embodiment of the present disclosure. Aside and B-side cooling hoses & clamps 636/638, constructed of non-metallic materials, are used to carry pressurized cooling air from the PEMF-module 604 into the space formed between the twin-coil support 628 and PEMF cover 630.
Pressurized air is brought in through both hoses 636/638 and is circulated over, under, and around both sides of twin-coil 300. Heat from twin-coil 300 is pumped out through the central exhaust port 718 and into exhaust hose 644. The exhaust hose 644 in one embodiment is secured via adhesive, clamping or other means to the port in the center of the twin-coil support 628. As shown in views 600/622, the hose extends downward into the central hole 610 of the upper manifold 606 where it can exhaust heated-air down into the lower-manifold 620 through hole 716.
Cooling hoses 636/638 also carry electrical power via electrical cables 640/642 which are run therethrough. In other embodiments, the electrical cables 640/642 are run outside of the cooling hoses. Both the cooling hoses 636/638 and electrical cables 640/642 are flexible and move smoothly throughout the full vertical range-of-motion of the twin-coil support 628 upon springs 624/626.
The air pumps 1108/1110 in one embodiment are used to affect airflow into cooling hoses 636/638. In this embodiment the air pumps intake fresh air from port 1006, above section 602, which is the upper frame 154. The air then circulates across twin-coil 300 exchanging heat which is then exhausted through central port 718, through exhaust hose 644 and out through exhaust pipe 808. The exhausted air 804 is let out underneath section 602, which is the upper frame 154. In this embodiment the intake and exhaust are separated from each other. In other embodiments, cooling air may be delivered by sources including fans, blowers, air compressor(s), and external connection to pressurized gas.
The device disclosed herein is advantageous for a number of reasons. Patients rarely have the opportunity to receive both spinal decompression and EMF treatment modalities, due partially to the economics involved for healthcare providers. Normally, PEMF therapy would need to be scheduled separately from spinal decompression therapy, and this assumes that the same location would have both device types available. Staff familiar with the operational characteristics of both devices would be required to administer the separate treatments. Economically speaking, the return on investment for providing both treatment modalities may not make an attractive proposition for all healthcare facilities. The device of the present disclosure addresses this problem by combining both therapies into a single treatment device. In some embodiments, the user interface of the spinal decompression device may incorporate all of the necessary interaction with and for the control and instruction of the PEMF-device.
Both the spinal decompression and PEMF modalities operate on similar electro-kinetic biological pathways, using different stimuli. Simultaneous exposure to both modalities encourages additional anabolic signaling. It is known that the region-of-effect is receiving an upregulated supply of nutrient-rich fluid while undergoing decompression which augments the amount of material affected by the PEMF stimulation.
The device of the present disclosure incorporates the PEMF device into a mattress, providing the patient with enhanced comfort while receiving therapy. Spinal decompression devices (e.g., supine-orientation type) also keep the patient isolated and not otherwise moving. The apex of lordosis is utilized as an index of reference for patient positioning on the table. In this way, the region of pathological interest is also in a known location relative to the spinal decompression device, and therefore the PEMF device can reliably treat at the same lumbar position at each treatment session.
Incorporating both modalities into a simultaneous treatment may yield less overall time spent by the patient at the healthcare facility, enhanced therapeutic action for the same time spent receiving treatment, higher patient compliance due to ease of obtaining both modalities, higher patient compliance due to increased actual (quantitative) improvement in clinical outcomes as compared to either treatment alone, and higher patient compliance due to increased perceived (qualitative) improvement in clinical outcomes as compared to either treatment alone.
Incorporating PEMF into the decompression device allows the device to be used for either treatment individually or both simultaneously. This allows the healthcare provider or owner more flexibility in scheduling patients. The result is improved patient access to treatment by improving clinic flow and operating costs, reduced healthcare spending, and through faster return on investment for the purchase of the device disclosed herein.
What has been described above includes examples of the claimed subject matter. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the claimed subject matter, but one of ordinary skill in the art may recognize that many further combinations and permutations of the claimed subject matter are possible. Accordingly, the claimed subject matter is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term “includes” is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term “comprising” as “comprising” is interpreted when employed as a transitional word in a claim.
It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification or claims refers to at least one of something selected from the group consisting of A, B, C . . . and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.
| Number | Date | Country | |
|---|---|---|---|
| 63277151 | Nov 2021 | US |
