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Title:
VIBRATION AND COMPRESSION COUNTERMEASURE HARNESS AND BELT FOR BONE AND MUSCLE LOSS
Document Type and Number:
WIPO Patent Application WO/2006/110545
Kind Code:
A3
Abstract:
An apparatus for reducing bone and muscle loss. In an embodiment, the apparatus comprises an adjustable harness operable to be mounted on one or more body parts of a person. In addition, the apparatus comprises at least one vibration actuator coupled to the harness, wherein the at least one vibration actuator generates vibrations, and wherein the at least one vibration actuator is positioned between the person and the harness when the harness is mounted to the person.

Inventors:
LIEBSCHNER MICHAEL (US)
GIBSON CHRISTOPHER (US)
ROONEY THOMAS (US)
ROBB ROLAND (US)
METWALLI ZEYAD (US)
ELAM WILLIAM (US)
Application Number:
PCT/US2006/013066
Publication Date:
April 26, 2007
Filing Date:
April 07, 2006
Export Citation:
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Assignee:
UNIV RICE WILLIAM M (US)
LIEBSCHNER MICHAEL (US)
GIBSON CHRISTOPHER (US)
ROONEY THOMAS (US)
ROBB ROLAND (US)
METWALLI ZEYAD (US)
ELAM WILLIAM (US)
International Classes:
A61F5/00
Foreign References:
US3053250A1962-09-11
US6350249B12002-02-26
US6436062B12002-08-20
Attorney, Agent or Firm:
TUMEY, Tod, T. et al. (P.C. P.O. Box 326, Houston Texas, US)
Download PDF:
Claims:

CLAIMS

What is claimed is:

1. An apparatus comprising: an adjustable harness operable to be mounted on one or more body parts of a person; and at least one vibration actuator coupled to the harness, wherein the at least one vibration actuator generates vibrations, and wherein the at least one vibration actuator is positioned between the person and the harness when the harness is mounted to the person.

2. The apparatus of claim 1, wherein the at least one vibration actuator is removably and adjustably coupled to the harness.

3. The apparatus of claim 1, wherein the at least one vibration actuator comprises three vibration actuators, and wherein the three vibration actuators are coupled to the harness such that two vibration actuators are each proximal to a greater trochanter of the person and one vibration actuator is proximal a lower vertebrae of the person when the harness is mounted on the person.

4. The apparatus of claim 1, wherein the at least one vibration actuator generates vibrations having frequencies between 20 and 300 Hz.

5. The apparatus of claim 1, wherein, the at least one vibration actuator generates vibrations having amplitudes between 0.1 and 10 mm. l

6. The apparatus of claim 1, wherein each vibration actuator comprises a brushless DC motor with an offset weighted flywheel.

7. The apparatus of claim 1, further comprising a shoulder harness coupled to a shoulder of the person and the harness.

8. The apparatus of claim 7, wherein the shoulder harness comprises a collar and one or more loading members, wherein the collar is mounted on a shoulder of the person, wherein each loading member connects the collar to the harness, and wherein each loading member provides compression to a part of the person.

9. The apparatus of claim 1 further comprising a leg harness coupled to a foot of the person and the harness.

10. The apparatus of claim 9, wherein the leg harness comprises a knee coupling, a foot terminus, and one or more loading members, wherein the knee coupling is mounted about a knee of the person, wherein the one or more loading members connect the knee coupling to the harness, and wherein the one or more loading members connect the knee coupling to a foot of the person and to the harness, and further wherein each loading member provides compression to a part of the person.

11. The apparatus of claim 10 further comprising a shoulder harness coupled to a shoulder of the person and the harness, wherein the shoulder harness comprises a collar and one or more

loading members, and wherein the collar is mounted on a shoulder of the person, and further wherein each loading member connects the collar to the harness and provides compression to a part of the person.

12. An apparatus comprising: an adjustable harness operable to be mounted on one or more body parts of a person; a shoulder harness coupled to a shoulder of the person and the harness, wherein the shoulder harness comprises a collar and one or more loading members; wherein the collar is mounted on a shoulder of the person, and wherein each loading member connects the collar to the harness; and wherein each loading member provides compression to a part of the person.

13. The apparatus of claim 12, further comprising a leg harness coupled to a foot of the person and the harness. ,,.

14. The apparatus of claim 13, wherein the leg harness comprises a knee coupling, a foot terminus, and one or more loading members; wherein the knee coupling is mounted about a knee of the person; i, ' wherein one or more loading members connect the knee coupling to the harness; wherein one or more loading members connect the knee coupling to a foot of the person and to the harness; and wherein each loading member provides compression to a part of the person.

15. The apparatus of claim 12, further comprising at least one vibration actuator, wherein the at least one vibration actuator generates vibrations, and wherein the at least one vibration actuator is positioned between the person and harness when the harness is mounted to the person.

16. The apparatus of claim 15, wherein the at least one vibration actuator generates vibrations having frequencies between 20 and 300 Hz and amplitudes between 0.1mm and 10mm.

17. The apparatus of claim 15, wherein each vibration actuator comprises a brushless DC motor with an offset weighted flywheel.

18. An apparatus comprising: an adjustable harness operable to be mounted on one or more body parts of a person; a leg harness coupled to the harness and a foot of the person, wherein the leg harness comprises a knee coupling, a foot terminus, and one or more loading members; wherein the knee coupling is mounted about a knee of the person; wherein one or more loading members connect the knee coupling to the harness;

wherein one or more loading members connect the knee coupling to a foot of the person; and wherein each loading member provides compression to a part of the person. 19. The apparatus of claim 18, further comprising at least one vibration actuator, wherein the at least one vibration actuator generates vibrations, and wherein the at least one vibration actuator is positioned between the person and harness when the harness is mounted to the person. 20 The apparatus of claim 19, wherein the at least one vibration actuator generates vibrations having frequencies between 20 and 300 Hz and amplitudes between 0.1mm and 10mm.

21. The apparatus of claim 20, wherein each vibration actuator comprises a brushless DC motor with an offset weighted flywheel.

22. A system for reducing bone and muscle loss in a person comprising: an adjustable harness operable to be mounted on one or more body parts of a person; at least one vibration actuator that generates controlled vibrations that is coupled to the harness, wherein the at least one vibration actuator is operable to provide vibrations to the person when the harness is mounted on the person; a shoulder harness coupled to a shoulder of the.person and the harness; a leg harness coupled to a foot of the person and the harness; and wherein the shoulder harness and the leg harness each provide compression to a different part of the person.

23. The system of claim 22, wherein the shoulder harness comprises a collar and one or more loading members, wherein the collar is mounted on a shoulder of the person, and wherein each loading member connects the collar to the harness and provides compression to a part of the person.

24. The system of claim 22, wherein the leg harness comprises a knee coupling, a foot terminus, and one or more loading members, and wherein the knee coupling is mounted about a knee of the person, further wherein one or more loading members connect the knee coupling to the harness and connect the knee coupling to a foot of the person and to the harness, and wherein each loading member provides compression to a part of the person.

25. The apparatus of claim 22, wherein the at least one vibration actuator generates vibrations having a frequency between 20 and 300 Hz and an amplitude between 0.1 and 10 mm.

Description:

VIBRATION AND COMPRESSION COUNTERMEASURE HARNESS AND BELT FOR BONE AND MUSCLE LOSS

BACKGROUND

Field of the Invention

The present invention relates generally to devices and methods to reduce bone and muscle loss. More particularly, the present invention relates to non-invasive devices and methods to reduce bone and muscle loss by compressing regions of the body and actively inducing the propagation of vibrations through the bones, muscles and soft tissue of the body. Background of the Invention

Millions of people around the world will experience musculoskeletal problems over the next year. Among the common musculoskeletal problems are bone loss and muscle loss. Bone loss and muscle loss can lead to a variety of musculoskeletal injuries including fractured bones, since bones and muscles generally weaken as a result of bone loss and muscle loss. Bone loss, muscle loss, and associated musculoskeletal weakening may result from a variety of conditions such as natural aging, degenerative bone/muscle diseases, microgravity or low gravity environments, and lack of physical activity and loading of the musculoskeletal system. Osteoporosis ;is a relatively common degenerative bone disease in which the bone mineral density is reduced,, and the bone structure is disrupted, which may cause bone loss and bone weakening over time. In the United States, it is estimated that osteoporosis causes a predisposition to more than 250,000 hip fractures yearly.

In addition, bone and muscle loss and associated weakening of the musculoskeletal system are common in individuals and/or patients who are bedridden, elderly, paraplegic or otherwise unable or unwilling to load their bones and sufficiently utilize their muscles through normal activities. Normal daily activities such as walking, lifting objects, etc. repeatedly place loads on the bones and muscles, and also exercise the muscles, tending to maintain the strength of bones and muscles, reduce muscle atrophy, and in some cases even strengthen bones and muscles. However, for individuals unwilling or unable to load their bones and utilize their muscles through normal activities, bone and muscle weakening may significantly increase risks for musculoskeletal injuries including bone fractures.

Further, bone and muscle loss, as well as other detrimental physiological changes, may be induced by extended duration in low gravity and microgravity environments. Low gravity environments include environments in which the gravitational acceleration and resulting gravitational force is less than that at the earth's surface (e.g., in low-earth orbit or in outer space).

For example, it is estimated that astronauts may lose an average of more than 1% bone mass per month spent in space. Weakening of the bones and muscles resulting from the lack of loads (e.g., weight resulting from the effects of gravity) encountered in such environments increases the risks of musculoskeletal injuries and has raised serious concerns about the feasibility of long duration space missions. For instance, on a potential flight to Mars, each astronaut may lose more than 10% of their bone mass just traveling to Mars, and then lose another 10% returning from Mars, putting the astronaut at risk for musculoskeletal problems.

Research has indicated that the application of physical loads to bones and muscles may reduce bone and muscle loss. For instance, some conventional approaches to counter bone and muscle loss and associated musculoskeletal weakening rely on the motion of the patient to generate and transmit impact loads through the bones and muscles (e.g., exercise programs, strength training programs, etc.). However, such approaches may not be an option for individuals who are unwilling or unable to load their bones (e.g., bed-ridden individuals, paralyzed individuals, etc.). Further, such approaches may not provide sufficient loading of bones and muscles in low gravity or microgravity environments. In such an environment, the loads and forces transmitted to the bones and muscles by physical motion are greatly reduced due to the reduction in gravity.

In addition, research has indicated that the propagation of vibrations through bones for a short period of time (e.g., 15 minutes a day) may also help to reduce bone and muscle loss. For example, some conventional approaches may employ a relatively large vibrating platform. The patient suffering bone and muscle loss may be required to stand upright on the platform such that the patient's skeletal structure bears the full weight of the patient's body, compressing the skeleton so as to enhance the transmission of vibrations across joints and between bones. However, such a device may be impractical for use in space or at home. In addition, such a device may be inconvenient, requiring the individual to remain on the vibrating platform for a certain period of time, thereby limiting the mobility of the patient during such time period. Further, such a device may not be sufficient for use with individuals unable or unwilling to stand upright, nor sufficient for use in microgravity or low gravity situations where the weight of the body is significantly reduced and may not provide adequate compression of the skeleton to enhance vibration transmission. Still further, such devices may not permit for focused or localized vibration treatment, potentially resulting in damping of the vibrations before they reach particular regions of the body.

Consequently, there is a need for improved methods and devices to prevent or reduce bone and muscle loss in individuals suffering from degenerative conditions, individuals spending an extended period of time in microgravity and low gravity environments, and individuals who are unable or otherwise unwilling to physically load their bones and muscles by themselves. In addition, there is a need for improved methods and devices to counter bone and muscle loss that are

relatively small and portable, relatively lightweight, convenient, and wearable. Further, needs include improved methods and devices to counter bone and muscle loss that are capable of focused, localized application of vibrations to specific regions of the body and specific bones.

BRIEF SUMMARY OF SOME OF THE PREFERRED EMBODIMENTS

These and other needs in the art are addressed in one embodiment by an apparatus for reducing bone and muscle loss. In an embodiment, the apparatus comprises an adjustable harness operable to be mounted on one or more body parts of a person. In addition, the apparatus comprises at least one vibration actuator coupled to the harness, wherein the at least one vibration actuator generates vibrations, and wherein the at least one vibration actuator is positioned between the person and the harness when the harness is mounted to the person.

These and other needs in the art are addressed in another embodiment by an apparatus for reducing bone and muscle loss. In an embodiment, the apparatus comprises an adjustable harness operable to be mounted on one or more body parts of a person. In addition, the- apparatus comprises a shoulder harness coupled to a shoulder of the person and the harness, wherein the shoulder harness comprises a collar and one or more loading members, wherein the collar is mounted on a shoulder of the person, and wherein each loading member connects the collar to the harness, and wherein each loading member provides compression to a part of the person.

These and other needs in the art are addressed in another embodiment by an apparatus for reducing bone and muscle loss. In an embodiment, the apparatus comprises an adjustable harness operable to be mounted on one or more body parts of a person. In addition, the apparatus comprises a leg harness coupled to the harness and a foot of the person, wherein the leg harness comprises a knee coupling, a foot terminus, and one or more loading members, wherein the knee coupling is mounted about a knee of the person, wherein one or more loading members connect the knee coupling to the harness, wherein one or more loading members connect the knee coupling to a foot of the person, and wherein each loading member provides compression to a part of the person.

These and other needs in the art are addressed in another embodiment by a system for reducing bone and muscle loss in a person. In an embodiment, the system comprises an adjustable harness operable to be mounted on one or more body parts of a person. In addition, the system comprises at least one vibration actuator that generates controlled vibrations that is coupled to the harness, wherein the at least one vibration actuator is operable to provide vibrations to the person when the harness is mounted on the person. Further, the system comprises a shoulder harness coupled to a shoulder of the person and the harness. Still further, the system comprises a leg harness coupled to a foot of the person and the harness, wherein the shoulder harness and the leg harness each provide compression to a different part of the person.

The foregoing has outlined rather broadly the features and technical advantages of embodiments of the present invention in order that the detailed description that follows may be better understood. Additional features and advantages of embodiments of the invention will be described hereinafter that form the subject of the claims. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of embodiments of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of embodiments of the invention as set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a detailed description of the preferred embodiments of the invention, reference will now be made to the accompanying drawings in which:

Figure 1 illustrates an embodiment of a vibration application system;

Figure 2 illustrates a posterior view of the vibration application system of Figure 1 worn by an individual;

Figure 3 illustrates an enlarged view of an embodiment of a vibration actuator coupled to a support structure;

Figure 4 illustrates an embodiment of a compression application system that may be used with the vibration application system of Figure 1;

Figure 5 illustrates an anterior view of the compression application system of Figure 4 worn by an individual;

Figure 6 illustrates a posterior view of the compression application system of Figure 4 worn by an individual; and

Figure 7 illustrates an anterior view of an embodiment of a combined vibration application system and compression application system worn by an individual.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

Certain terms are used throughout the following description and claims to refer to particular system components. As one skilled in the art will appreciate, different persons may

refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function. The drawing figures are not necessarily to scale. Certain features of the invention may be shown exaggerated in scale or in somewhat schematic form and some details of conventional elements may not be shown in interest of clarity and conciseness.

In the following discussion and in the claims, the terms "including" and "comprising" are used in an open-ended fashion, and thus should be interpreted to mean "including, but not limited to... ." Also, the term "couple" or "couples" is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices and connections. Vibration Application System

Referring to Figures 1 and 2, an embodiment of a vibration application system 10 positioned on an individual 99 is illustrated. Vibration application system 10. includes a harness 20 and a plurality of vibration actuators 30 coupled to harness 20. Each vibration actuator 30 generates and transmits controlled vibrations to targeted bones, muscles, and tissues of individual 99, which may reduce bone and/or muscle loss. ■ ,

In the embodiment illustrated in Figure 2, vibration application system 10 is .configured such that each vibration actuator 30 is positioned on a first side 21 of harness 20, proximal individual 99, between individual 99 and harness 20. This configuration permits each vibration actuator 30 to be held in contact with individual 99 or close enough to individual 99 such that vibrations generated by each vibration actuator 30 may be propagated into soft tissue, bones, and muscles of individual 99. Without being limited by theory, by minimizing the distance between vibration actuators 30 and individual 99 such a configuration may enhance the transmission of vibrations into individual 99 by reducing the potential for damping. In addition, this configuration permits the pressure between each vibration actuator 30 and individual 99 to be adjusted by tightening or loosening harness 20. In different embodiments (not illustrated), one or more vibration actuators 30 may be positioned distal individual 99 relative to harness 20.

Referring to Figure 2, vibration application system 10 is positioned around the lower waist of individual 99. In this manner, the two outer lateral vibration actuators 30 shown in Figures 1 and 2 are positioned to provide vibrational stimulation to each greater trochanter, while the central vibration actuator 30 is positioned to provide vibrational stimulation to the lower lumbar vertebrae. Without being limited by theory, vibrations applied to each greater trochanter may propagate to other bones and muscles in the pelvic region and upper leg regions {e.g., femur). Further, without being limited by theory, vibrations applied to the lower lumbar vertebrae may propagate to other bones in the pelvic region, superior vertebrae, other bones

W

coupled to the vertebral column, and muscles coupled to the vertebral column. Targeting the pelvis may be advantageous since the pelvis is particularly susceptible to breaking as a result of weakening from bone loss. In addition, since the pelvic region and the vertebral column represent the core of the skeletal system, targeting these regions in particular may enhance the likelihood of propagation of vibrations throughout the skeletal system and the muscular system connected to the skeletal system.

Although the embodiment of the vibration application system 10 illustrated in Figures 1 and 2 shows three vibration actuators 30, intended to target each greater trochanter and the lower vertebrae, in general, vibration application system 10 may be positioned at any suitable location of individual 99, and more particularly one or more vibration actuators 30 may be positioned at any suitable location of individual 99 to provide controlled vibrations to specific, targeted bones, muscles, or tissues of individual 99 to reduce bone and/or muscle loss.

Referring specifically to Figure 1, harness 20 has a first side 21 and a second side 22. Further, harness 20 includes a first end 23 and a second end 24. A longitudinal axis 25 of harness 20 extends between first end 23 and second end 24. In addition, the length of harness 20 is the distance between first end 23 and second end 24.

Harness 20 further includes. an attachment mechanism 26 that enables first end 23 to be adjustably and releasably coupled to second end .24. In the embodiment illustrated in Figure 1, attachment mechanism 26 comprises a buckle 27 and mating holes 28. However, in different embodiments (not illustrated), attachment mechanism 26 may comprise any suitable means of adjustably and releasably coupling first end 23 to second end 24 to create an adjustable belt-like structure including without limitation, buckles, snaps, buttons, adjustable releasable clips, Velcro® (available from Velcro Industries), adjustable connectors, or combinations thereof. In this manner, first end 23 may be releasably coupled to second end 24 such that the diameter of harness 20 may be adjusted when it is positioned around individual 99, for instance as shown in Figure 3. Thus, the diameter of harness 20, when first end 23 is coupled to second end 24, may be adjusted for different sized individuals and/or for positioning at different locations of the body. In alternative embodiments (not illustrated), harness 20 takes the form of one continuous, closed, elastic belt that may be stretched to be put on and worn.

Still referring to Figure 1, harness 20 further includes a plurality of shoulder harness attachment members 61 positioned along and extending from the upper portion of harness 20, and a plurality of leg harness attachment members 81 positioned along and extending from the lower portion of harness 20. Shoulder harness attachment members 61 and leg harness attachment members 81 may be used to couple additional devices to harness 20, as will be described in more

detail below. In select embodiments (not illustrated), no shoulder harness attachment members 61 and/or no leg harness attachment members 81 are included on harness 20.

In general, the components (e.g., harness 20, vibration actuators 30, etc.) of vibration application system 10 may comprise any suitable materials and size. Preferably, the relative size of each component and mass of each component are selected such that vibration application system 10 may be relatively lightweight, sleek (i.e., not unduly bulky or large), and comfortable when mounted to individual 99. Although mass may not significantly affect the comfort of vibration application system 10 in low gravity situations, both the mass and the size of vibration application system 10 may impact its ability to be transported to space. For instance, payload restrictions may effectively place upper limits on the size and mass of vibration application system 10.

In particular, harness 20 may comprise any suitable material sufficiently flexible to enable harness 20 to conform substantially to the shape of individual 99 and sufficiently strong to support one or more vibration actuators 30. Examples of suitable materials include without limitation leather, fabric, mesh, webbed materials, natural fibers, plastic or combinations thereof. Further, harness 20 may be an elastic, stretchable material or an inelastic material. . Still further, attachment mechanism 26, shoulder harness attachment members 61 and leg harness attachment members 81 may -each comprise any suitable material(s) including without limitation metals (e.g., aluminum), non-metals (e.g., stainless steel, plastic, composites, ceramics, etc.) or combinations thereof.

As previously discussed, in the embodiments illustrated in Figures 1 and 2, three vibration actuators 30 are coupled to first side 21 of harness 20 between first end 23 and second end 24. One vibration actuator 30 is positioned about the middle of harness 20, corresponding to the lower lumbar region when harness 20 is positioned around the waist, for instance as shown in Figure 2, while the other two vibration actuators 30 are positioned laterally to the central vibration actuator 30, corresponding to the greater trochanter of each leg when harness 20 is positioned around the waist, for instance as shown in Figure 2. However, in general, vibration application system 10 may include any number of vibration actuators 30 and may be mounted to any body part to provide vibrational stimulation.

Figure 3 illustrates an enlarged view of one vibration actuator 30 coupled to first side 21 of harness 20 by straps 29. However, in general, a vibration actuator 30 may be coupled to harness 20 by any suitable means including without limitation, straps, Velcro®, pockets provided in harness 20, snaps, adhesive, or combinations thereof.

In particular, vibration actuator 30 is adjustably coupled to harness 20 by straps 29 having a strap first end 29a fixed to harness 20 and a strap second end 29b fixed to vibration actuator 30.

The ability to adjust the location of each vibration actuator 30 along harness 20 permits improved positioning of each vibration actuator 30 in order to better target specific bones and muscles, and also permits vibration application system 10 to be adjusted for positioning around different sized individuals and/or different body parts. In the embodiment illustrated in Figure 3, the position of vibration actuator 30 relative to harness 20 may be adjusted with a set of buckles, however, in general, vibration actuator 30 may be adjustably coupled to harness 20 by any suitable means that permits adjustment of vibration actuator 30 relative to harness 20.

In addition, vibration actuator 30 is releasably coupled to harness 20 such that vibration actuator 30 may be completely separated from harness 20. Vibration actuator 30 may be removed for a variety of reasons including without limitation, maintenance, repair, replacement, adjustment, vibration actuators 30 are not needed, or combinations thereof. In some embodiments (not illustrated), vibration actuator 30 may be fixed to harness 20 such that it cannot be easily removed or adjusted.

Still referring to Figure 3, vibration actuator 30 comprises a body 32 and two vibration transmitters 34. As previously discussed, each vibration actuator 30 generates vibrations that are transmitted non-invasively through the skin and soft tissue (e.g., muscles, fat, etc.) to one or more bones and/or muscles of individual 99. In particular, vibration transmitters 34 contact individual 99 (e.g., at the skin or through clothes) and serve as a point of contact for transmitting vibrations from vibration actuator 30 to individual 99. The semi-spherically shape of vibration transmitters 34 illustrated in Figure 3 also enhances the ability to focus and target the vibrations. For instance, to transmit vibrations to a particular bone or particular muscle just beneath the skin, a vibration transmitter 34 may be positioned proximal the particular bone or muscle. Vibration actuator 30 illustrated in Figure 3 has two vibration transmitters 34, however, in different embodiments, vibration actuator may have any suitable number of vibration transmitters 34. For instance, the two outermost vibration actuators 30 shown in Figure 1 each have one vibration transmitter 34.

The vibrations generated by each vibration actuator 30 are of controlled frequency and controlled amplitude. In some embodiments, the frequency and amplitude of one or more vibration actuators 30 is fixed, while in different embodiments, the frequency and amplitude of one or more vibration actuators 30 is variable. In embodiments in which the frequency and amplitude are variable, control of the frequency and amplitude may be accomplished by any suitable means including without limitation, by the individual 99 using the device, by a physical therapist or physician, by an electronic control system instructed by software run on a computer system, or combinations thereof. For example, the frequency and amplitude of one or more vibration actuators 30 may vary continuously as controlled by a control system and associated feedback system which senses the resonance frequency of the targeted bone, muscle, and/or tissue at period intervals (e.g.,

10 times a second). In some embodiments, preferably the frequency and amplitude of the vibrations are optimized to reduce bone loss and/or muscle loss.

The frequency range may be adjusted depending on the anatomical site (e.g., hip, lower back, upper back, etc.) and the tissue of interest (e.g., bone or soft tissue). In some embodiments, the frequencies of vibrations may be in the range from about 20 to about 300 Hz. In one embodiment, the vibration frequencies are between 20 to 50 Hz. Further, in another embodiment, the vibration frequencies may be set close to the resonance frequency of the body or anatomical area to which vibration application system 10 is attached. Still further, in another embodiment, the vibration frequency is between 100 to 200 Hz to stimulate muscles and soft tissues. The vibrational frequencies may differ between vibration actuators 30.

In general, the amplitude of vibrations may be set at any suitable level for a particular area of the body (e.g., certain bones, particular area of soft tissue, etc.). In some embodiments, the amplitude of vibrations are on the order of millimeters, generally between 0 and 10 millimeters. Further, the vibrational amplitudes may differ with time and/or between vibration actuators 30. The combination of the frequency and amplitude of vibrations may be controlled to define the acceleration of the vibrations. For instance, the frequency and amplitude of vibrations may be controlled to limit the acceleration of the vibrations to less than IG, where G is the gravitational constant.

In embodiments in which the frequency and amplitude of vibrations are adjustable, a control panel (not shown) is provided. The control panel may be mounted to vibration application system 10 or remote from vibration application system 10. Such a control panel may provide any suitable controls including without limitation, an on/off switch, a frequency adjustment, an amplitude adjustment, or combinations thereof. In addition, the control panel may communicate wirelessly or by hard wire to vibration application system 10.

Each vibration actuator 30 may comprise any suitable device capable of generating controlled vibrations including without limitation DC electric motors, AC electric motors, brushless electric motors, pneumatic devices, hydraulic devices, electromagnetic actuators, electromechanical actuators, piezo-electric actuators, or any means of generating an oscillating force. Vibration actuator 30 may be powered by any suitable means including without limitation, batteries, by electrical connection to a power source, a high pressure fluid source (e.g., a compressor), or combinations thereof. In select embodiments, vibration actuator 30 comprises a brushless DC electric motor with an offset weighted flywheel housed within body 32. In such embodiments, the amplitude of the vibrations may be controlled by changing the weighted flywheel and/or with an amplitude control mechanism (not shown) that adjusts the centrifugal forces of the weighted flywheel.

Referring again to Figure 2, vibration application system 10 may be worn by individual 99 to non-invasively provide vibrational stimulation to targeted bones and/or muscles of individual 99. In particular, vibration transmitters 34 of each vibration actuator 30 are positioned proximal targeted bones and/or muscles of individual 99 to provide vibrations of a desired frequency and amplitude to reduce bone and/or muscle loss. Although vibration actuators 30 may be positioned to target specific bones and/or muscles, other bones and muscles in contact with the targeted bones and muscles may also be vibrationally stimulated as the vibrations propagate through the musculoskeletal system. For instance, vibrational stimulation of the greater trochanter may travel across the hip joint to the pelvis.

Without being limited by theory, the propagation of vibrations between solid objects is improved as the contact surface area between the bodies is increased. Thus, the propagation of vibrations between different bones may be enhanced by increasing the contact surface area between such bones. Contact surface area between bones may be increased by loading the bones such that the connected ends of the bones are pushed towards each other {e.g., putting the bones in compression). For the human body, such advantageous loading and compression may be obtained by standing upright, allowing the full weight of the body to be borne by the skeletal system. In addition to standing upright or as an alternative to standing upright, a compression application system 100, as will be described in more detail below, may be employed to compress the skeletal structure of an individual to enhance the propagation of vibrations through the skeletal system.

Some embodiments of vibration application system 10 may also include monitoring and data collection means that track the treatment of individual 99 with vibration application system 10 by monitoring when vibration application system 10 is turned on/off, how long vibration application system 10 was used, and which individual used vibration application system 10. The ability to monitor and collect such data may be helpful to a physician, physical therapist, and/or individual to optimize treatments with vibration application system 10. The collected data may be transmitted wirelessly or by hard wire from vibration application system 10 to a remote system.

In the manner described, vibration application system 10 provides a non-invasive device and method to reduce bone and/or muscle loss. Vibration application system 10 may be worn and used by individuals suffering from osteoporosis, by individuals in microgravity or low gravity environments, and individuals who are unable or unwilling to sufficiently load their bones and muscles by physical activity {e.g., bed-ridden individuals, paraplegics, elderly, etc.). Select embodiments of vibration application system 10 may be adjusted and customized to fit different individuals and to target different bones and muscles. Further, some embodiments of vibration application system 10 permit targeting of specific bones and muscles without the need to load the musculoskeletal system. Such embodiments may be effectively used by individuals in microgravity

or low gravity environments and individuals unable or unwilling to load their bones and muscles by normal physical activities.

Further, due to the relative size, weight, wearability, and mobility of vibration application system 10, vibration application system 10 may provide improved convenience as compared to some conventional methods used to treat bone loss with vibrational stimulation. For instance, embodiments of vibration application system 10 may be used in bed (e.g., bed-ridden patients, quadriplegics, etc.), while sitting, at work or at home, or while performing tasks. Still further, due to the relative size, weight, wearability, and mobility of vibration application system 10, vibration application system 10 may be convenient enough to be used as a preventative measure prior to the onset of degenerative bone conditions to strengthen bones and proactively reduce the effects of degenerative bone conditions such as osteoporosis. Compression Application System

,<! Referring to Figures 4-6, an embodiment of a compression application system 100 worn by individual 99 is illustrated. When mounted to individual 99, compression application system 100 loads and compresses the musculoskeletal system of individual 99. Compression application system 100 includes a shoulder harness 130, a waist harness 120, and a leg harness 140. Shoulder harness 130 is coupled to the upper portion of waist harness 120 by shoulder harness attachment members 161. Leg harness 140 is coupled to the lower portion of waist harness 120 by leg* harness attachment members 181. In some embodiments, waist harness 120 may be substantially the same as harness 20.

Shoulder harness 130 comprises a collar 135, two front loading members 132, and two rear loading members 133. As best seen in Figures 4 and 5, each front loading member 132 has a first end 132a coupled to the front of collar 135 and a second end 132b coupled to shoulder harness attachment member 161 of waist harness 120. As best seen in Figure 6, each rear loading member 133 has a first end 133a coupled to collar 135 and a second end 133b coupled to leg harness attachment member 181. In some embodiments, one or more front loading members 132 and one or more rear loading members 133 are removably coupled to collar 135 and waist harness 120 such that each front loading member 132 and each rear loading member 133 may be removed, adjusted, and/or replaced.

When shoulder harness 130 is worn by individual 99, collar 135 is positioned over the shoulders on either side of the head, and waist harness 120 is positioned about the waist line of individual 99. Each front loading member 132 extends from the front of collar 135, lateral the head, generally downward across the chest to waist harness 120 as best seen in Figure 5. Rear loading members 133 extend from the rear/backside of collar 135 generally downward across the back to waist harness 120 as best seen in Figure 6. Although the embodiment of shoulder harness

130 illustrated in Figure 4 includes two front loading members 132 and two rear loading members 133, in general, shoulder harness 130 may include any number of loading members {e.g., front loading members 132, rear loading members 133, etc.). For example, in an embodiment (not illustrated), one loading member may be coupled to waist harness 120 anterior individual 99, pass over collar 135 lateral to the head and continue down the back and couple to waist harness 120 posterior individual 99.

Each front loading member 132 and each rear loading member 133 may comprise any suitable flexible material that acts like a spring when stretched, thereby generating a force opposite to the direction of stretching that seeks to return the material in its unstretched state. Examples of suitable materials include without limitation, rubber bands, elastic, TheraBand® available from Hygenic Corporation, or combinations thereof. Such a suitable material may have a constant spring coefficient or a variable spring coefficient. In other words, the relationship between the length of stretch and the resulting force may be constant (see Equation 1 below as an example), or the relationship between the length of stretch and the resulting force may not be constant (see Equation 2 below as an example).

Equation 1 : F{x) = K x x , where K is a constant spring coefficient, x is the stretch distance, and F(x) is the resulting force dependent on x.

Equation 2: F(x) = K{x) x x , where x is the stretch distance, K(x) is a spring coefficient dependent on x, and F(x) is the resulting force dependent on x.

Further, collar 135 may comprise any suitable material(s) that are relatively lightweight, formable to the profile of the shoulders and neck of an individual, and sufficiently strong to withstand any forces applied by the loading members {e.g., front loading members 132, rear loading members 133, etc.). Examples of suitable materials for collar 135 include without limitation, polymers, fabrics, plastics, composites {e.g., carbon fiber composites), or combinations thereof.

Shoulder harness 130 is configured such that each front loading member 132 and each rear loading member 133 may be stretched between collar 135 and waist harness 120 when collar 135 is placed over the shoulders and waist harness 120 is placed about the waist of individual 99. Such stretching of each front loading member 132 and each rear loading member 133 may result in forces exerted on the shoulders of individual 99 by collar 135 generally in the direction of arrows 151, and forces exerted about the waist of individual 99 by waist harness 120 generally in the direction of arrows 152. The combination of such forces may result in compression of the skeletal system of individual 99 between the shoulders and waist areas.

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The amount of stretching, and hence the force exerted by each front loading member 132 and each rear loading member 133, may be controlled by varying the length of each front loading member 132 and each rear loading member 133, as well as by varying the material of each front loading member 132 and each rear loading member 133. For example, a thicker loading member provides greater elastic force than a thinner loading member of the same material. In embodiments in which each front loading member 132 and each rear loading member 133 are removably coupled to collar 135 and waist harness 120, the materials and lengths of each front loading member 132 and each rear loading member 133 may be adjusted and customized to achieve the desired forces. Further, different loading members (e.g., front loading members 132, rear loading members 133, etc.) may each be a different length, a different material, generate a different force, or combinations thereof. For example, a shorter loading member stretched a given distance may generate a greater elastic force than a longer loading member of the same material stretched the same distance. As another example, front loading members 132 may be intentionally adjusted/customized to generate less compressional forces than rear loading members 133.

Leg harness 140 comprises upper loading members 142, knee couplings 145, lower loading members 146, and foot terminus 147. Each upper loading member 142 has a first end 142a coupled to the front of waist harness 120 and a second end 142b coupled to a knee coupling 145.. Each lower loading member 146 has a first end 146a coupled to knee coupling 145 and a second end 146b coupled to foot terminus 147. In some embodiments, one or more upper loading members 142 is removably coupled to a knee coupling 145 and waist harness 120 such that each upper loading member 142 may be removed, adjusted, and/or replaced. Further, in select embodiments, one or more lower loading member 146s is removably coupled to a knee coupling 145 and a foot terminus 147 such that each lower loading member 146 may be removed, adjusted, and/or replaced.

When leg harness 140 is worn by individual 99, as illustrated in Figures 5 and 6, each knee coupling 145 is positioned about the knee of individual 99. In the embodiment illustrated in Figures 4-6, each knee coupling 145 is similar to an elastic knee brace that is maintained in position about the knee by elastic compression around the knee area. However, in different embodiments, knee coupling 145 may comprise any suitable device that can maintain its position about the knee under loads from loading members, and serve as a coupling point for one or more loading members (e.g., upper loading members 142, lower loading members 146, etc.). Each upper loading member 142 extends from waist harness 120 generally down the leg to knee coupling 145. In addition, when leg harness 140 is worn by individual 99, as illustrated in Figures 5 and 6, each foot terminus 147 is coupled to a foot of individual 99. Each lower loading member 142 extends from waist harness 120 generally down the leg to a foot terminus 147. In the embodiments illustrated in Figures 4-7, each

upper loading member 142 is coupled to the same lateral side of waist harness 120 as the knee coupling to which it is coupled.

Although the embodiment of leg harness 130 illustrated in Figure 4 includes two upper loading members 142 and two lower loading members 146, in general, leg harness 140 may include any number of loading members (e.g., front loading members 132, rear loading members 133, etc.). For example, in an embodiment (not illustrated), one loading member may be coupled to waist harness 120 coupled to a knee coupling 145 and continue to a foot terminus 147.

Each upper loading member 142 and each lower loading member 146 may comprise any suitable flexible material that acts like a spring when stretched, thereby generating a force opposite to the direction of stretching that seeks to place the material in its unstretched state. Examples of suitable materials include without limitation, rubber bands, elastic, TheraBand® available from Hygenic Corporation, or combinations thereof. Such a suitable material may have a constant spring coefficient or a variable spring coefficient. Jn other words, the relationship between the length of stretch and the resulting force may be constant (e.g., Force = K x stretch distance, where K is a constant), or the relationship between the length of stretch and the resulting force may not be constant (e.g., Force = K x stretch distance, where K is variable).

Leg harness 140 is configured- such that each upper loading member 142 is stretched between a knee coupling 145 and waist harness 120 when the knee coupling 145 to which it is coupled is positioned about a knee of individual 99 and waist harness 120 is positioned about the waist of individual 99. Such stretching of upper loading members 142 will result in forces exerted on the upper portion of the leg of individual 99 by knee coupling 145 generally in the direction of arrows 157, and forces exerted about the waist of individual 99 by waist harness 120 generally in the direction of arrows 159. The combination of such forces results in compression of the musculoskeletal system of individual 99 between the waist and knee areas.

In addition, leg harness 140 is configured such that each lower loading member 146 is stretched between knee coupling 145 and foot terminus 147 when the knee coupling 145 and foot terminus to which it is attached are positioned about the knee and foot, respectively, of individual 99. Such stretching of lower loading members 146 will result in forces exerted on the lower portion of the leg of individual 99 by knee coupling 145 generally in the direction of arrows 158, and forces exerted about the foot of individual 99 generally in the direction of arrows 156. The combination of such forces results in compression of the musculoskeletal system of individual 99 between the knee and foot.

The amount of stretching, and hence the force exerted by each upper loading member 142 and each lower loading member 146, may be controlled by varying the length and/or material of each upper loading member 142 and each lower loading member 146. In embodiments in which

each upper loading member 142 is removably coupled to waist harness 120 and knee coupling 145, the materials and/or lengths of each upper loading member 142 may be adjusted and customized to achieve the desired forces along the upper portion of each leg of individual 99. In addition, in embodiments in which each lower loading member 146 is removably coupled to foot terminus 147 and knee coupling 145, the materials and/or lengths of each lower loading member 146 may be adjusted and customized to achieve the desired forces.

In the manner described, compression application system 100 may be employed to compress the musculoskeletal system of individual 99. In particular, shoulder harness 130 is employed to compress the musculoskeletal system between the shoulders and waist, while leg harness 140 is employed to compress the musculoskeletal system between the waist and feet.

In general, each component of compression application system 100 (e.g., collar 135, knee coupling 145, waist harness 120, loading members, etc.) may comprise any suitable material. However, in preferred embodiments, each component of compression application system 100 (e.g., collar 135, knee coupling 145, waist harness 120, loading members, etc.), and hence compression application system 100, is relatively lightweight and minimally bulky such that it may be used by relatively vulnerable individuals (e.g., very young patients, very old patients), individuals with weakened bones (e.g., geriatric patients), etc., in reasonable comfort and convenience. Further, due to payload restrictions, compression application system 100 is preferably relatively lightweight and minimally bulky such that it may be carried along on space missions and subsequently used in microgravity and low gravity environments experienced in space flight. In addition, the components of compression application system 100 and associated connections therebetween are preferably sufficiently strong to withstand the forces applied by the loading members 142, 146.

Without being limited by theory, the compression of the musculoskeletal system provided by compression application system 100 may provide benefits to individuals in microgravity or low gravity environments. In such environments, the bones of the musculoskeletal system may tend to move slightly apart since there are little or no loads applied to the musculoskeletal system. In addition, due to lack of loads applied to the muscles, such environments may also result in muscle atrophy. Without being limited by theory, extended duration stays under such conditions may result in weakening of the bones and muscles. Such detrimental effects may be countered by employing compression application system 100 in microgravity or lower gravity environments in an effort to partially simulate the effects of gravity, thereby preventing and/or reducing the tendency of bones to move apart, bone loss, muscle atrophy, and associated musculoskeletal problems in such environments.

In addition, the compression of the musculoskeletal system provided by compression application system 100 may also provide benefits to individuals suffering from osteoporosis,

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individuals unwilling or unable to load their bones by physical activity, and individuals suffering from degenerative bone conditions. Without being limited by theory, compression of the musculoskeletal system may reduce bone loss and enhance muscle activity.

Further, although the embodiments of compression application system 100 illustrated in Figures 4-7 each include a shoulder harness 130 and a leg harness 140, in different embodiments (not illustrated), shoulder harness 130 or leg harness 140 may be used individually. Moreover, in such embodiments, vibration actuators 30 may be included in waist harness 120.

Although embodiments of compression application system 100 illustrated in Figures 4-6 provide compression between the shoulders and waist and between the waist and feet, in general, compression application system 100 may be configured to provide compression to any suitable part of individual 99. For instance, compression application system 100 may be modified to provide compression of the arms between the shoulder and elbow and/or elbow and hands.

Further, compression application system 100 may be employed with vibration application system 10 as illustrated in Figure 7. In this embodiment, portions of the musculoskeletal system of individual 99 are compressed as vibrations are transmitted to targeted bones and/or muscles. As previously discussed, without being limited by theory, compression of the musculoskeletal system may enhance the propagation of vibrations. By enhancing the propagation of vibrations, bones and muscles other than those specifically targeted may enjoy the benefits of vibrational stimulation (e.g., reduction of bone loss, muscle stimulation, etc.). Such benefits of the combined use of vibration application system 10 and compression application system 100 may be beneficial to individuals suffering from osteoporosis, individuals in microgravity or low gravity environments, and individuals unable or unwilling to load their bones by physical activity (e.g., bed-ridden individuals).

Although embodiments of vibration application system 10 and compression application system 100 described above are designed to counter bone loss and/or muscle loss, embodiments of vibration application system 10, compression application system 100, both combined may be used by athletes or by physical therapy patients as a muscle development system. For instance embodiments of vibration application system 10 and/or compression application system 100 may be used as an exercise unit through muscle resistance training.

Thus, embodiments comprise a combination of features and advantages that enable it to overcome various problems of conventional devices and methods used to counter bone loss. For instance, certain embodiments may provide relatively lightweight devices and methods to counter bone and/or muscle loss. Such embodiments may be suitable for bed-ridden individuals, very young individuals, and suitable to be brought along on space missions. In addition, embodiments may provide mobile devices and methods that can be conveniently employed during normal daily

routines, used at home or at the office, or any other desired location. Further, some embodiments provide devices and methods that do not require an individual to stand upright to support his/her own weight in order to treat bone loss. Such embodiments are specifically suited for individuals unwilling or unable to load their bones and muscles by standing (e.g., bed-ridden individuals, paralyzed individuals, etc.) or other physical activity. Still further, select embodiments provide devices and methods to target specific bones and muscles for vibration treatment and enhance the propagation of vibrations to other bones and muscles of the interconnected musculoskeletal system.

In some embodiments, vibration application system 10, compression application 100, or both are used about 15 minutes per day, three days a week. However, in general, the duration and frequency of treatments may be vary depending on a variety of factors including without limitation, physician recommendations, patient comfort level, treatment application, or combinations thereof.

While preferred embodiments of this invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from/ the scope or teaching of this invention. The embodiments described herein are exemplary only and are not limiting. Many variations and modifications of the system and apparatus are possible and are within the scope of the invention. For example, the relative dimensions of various parts, the materials from which the various parts are made, and other parameters can be varied, so long as . the interstitial insulation retains the advantages discussed herein. Accordingly, the scope of protection is not limited to the embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims.