JP-7857464-B2 - Treatment of osteopenia and osteoporosis, and stimulation of bone growth.

Inventors

• ベルガラ，アレクサンダー
• バーネット，ダニエル・アール
• マングラム，シェーン
• ルキシオン，エヴァン・エス
• イー，アレックス

Assignees

• ボーン ヘルス テクノロジーズ，インコーポレーテッド

Dates

Publication Date

20260512

Application Date

20250326

Claims (15)

1. A vibration device configured to be wearable by a subject, A vibration motor configured to vibrate in contact with the area of the subject when the subject wears the vibration device, wherein the vibration device is portable while the vibration device is fixed to the subject, One or more motor sensors configured to receive motor feedback related to the vibration motor, One or more adaptive sensors configured to make contact with the subject and receive contact feedback correlated with the measurement of the placement or fixing of the vibration motor in the area of the subject , A control unit is configured to communicate with the vibration motor, one or more motor sensors, and one or more compatibility sensors, to activate a treatment timer, to operate the vibration motor at a predetermined frequency, and to receive contact feedback from one or more compatibility sensors , The control unit is further configured to warn the subject if the motor feedback is outside a predetermined window, which is a predetermined frequency away from a predetermined timer or counter . The control unit is further configured to adjust the predetermined frequency of the vibration motor in response to the contact feedback until the contact feedback is optimized within a predetermined range of the treatment , and to stop the vibration motor when the predetermined treatment time of the treatment timer is completed . Equipped with A vibration device characterized by the following features.
2. The vibration device according to claim 1, characterized in that the area of the subject includes an area that overlaps with and is in contact with the subject's buttocks or spine.
3. The vibration device according to claim 1, wherein one or more of the compatible sensors include a contact sensor configured to be attached to the vibration device via a fixing mechanism .
4. The vibration device according to claim 1, characterized in that one or more of the compatible sensors include a pressure sensor.
5. The vibration device according to claim 1, characterized in that one or more of the compatible sensors include strain gauges.
6. The vibration device according to claim 1, characterized in that one or more of the compatible sensors include an accelerometer.
7. The vibration device according to claim 1, characterized in that the control unit is configured to adjust the frequency of the vibration motor based on the motor feedback from one or more motor sensors or the contact feedback from one or more compatibility sensors .
8. The vibration device according to claim 1, further comprising an enclosure housing the vibration motor, one or more motor sensors, and the control unit.
9. The vibration device according to claim 1, further comprising a spacer positioned in close proximity to the vibration motor and in contact with the area of the subject to transmit vibration to the area of the subject.
10. The vibration device according to claim 1, characterized in that one or more of the motor sensors communicate with and are in close proximity to the vibration motor.
11. The vibration device according to claim 1, characterized in that the vibration motor is configured to transmit vibrations at a frequency of 1 to 100 Hz .
12. The vibration device according to claim 1, characterized in that the vibration motor is configured to transmit vibrations at a frequency of 25 to 35 Hz.
13. The vibration device according to claim 1, characterized in that the vibration motor is configured to transmit vibrations having an acceleration of 0.01 g to 10 g.
14. The vibration device according to claim 1, characterized in that the vibration motor is configured to transmit vibrations having an acceleration of 0.01 g to 4.0 g.
15. The vibration device according to claim 1, characterized in that the tactile feedback includes an auditory, visual, or tactile alarm configured to warn the subject to adjust the vibration device to the area.

Description

Devices for the treatment or prevention of osteopenia and osteoporosis, for stimulating bone growth, for maintaining or improving bone density, and for inhibiting lipogenesis. The present invention relates, in particular, to stimulating bone growth, healing bone tissue, and treating and preventing osteopenia, osteoporosis, and chronic back pain by repeated application of mechanical load to bone tissue, as well as preserving or improving bone density and suppressing fat formation. (References provided) All publications and patent applications referenced herein are incorporated herein by reference to the same extent as each of those individual publications or patent applications is specifically and individually indicated. Low bone density (BMD) and osteoporosis are significant problems faced by older adults, resulting in 1.5 million fractures in 2002 (Non-Patent Literature 1). Bisphosphonates, a class of compounds that typically inhibit bone digestion, have been used for over a decade to treat osteoporosis with considerable success. However, they have caused undesirable side effects, including jaw osteonecrosis, esophageal erosion, and atypical femoral fractures, leading to a reassessment of bisphosphonate therapy. One alternative treatment for osteoporosis is the use of whole-body vibration (WBV), which consists of repeated mechanical loading of bone tissue using a vibrator with relatively high frequencies (e.g., 15 to 90 Hz) and relatively low mechanical loads (e.g., loads of 0.1 to 1.5 g). Studies have shown that WBV can delay and/or halt the progression of osteoporosis (Non-Patent Literature 2). In another randomized study where vibration forces of 0.6 g or more were delivered to patients' feet, WBV demonstrated that it was effective in improving gluteal BMD outcomes compared to a control group that either did not exercise or was part of an exercise program (Non-Patent Literature 3). Related studies have demonstrated the ability of WBV to improve gluteal function and maintain spinal BMD in healthy cyclists, postmenopausal women, and children with disabilities (Non-Patent Literature 4). While the mechanism by which WBV affects BMD is a subject of debate, research suggests that shear stress in the bone marrow within the trabecular structure during high-frequency vibrations may provide mechanical signals to bone marrow cells that lead to ossinolysis (Non-Patent Literature 5). More specifically, shear stresses exceeding 0.5 Pa are mechanically stimulating to osteoblasts, osteoclasts, and mesenchymal stem cells (Non-Patent Literature 5). Many conventional methods for promoting bone tissue growth and bone maintenance through WBV application generally tend to apply relatively high frequencies (e.g., 15 to 90 Hz) and relatively low-intensity mechanical loads (e.g., loads of 0.1 to 1.5 g) to the limbs of the body, such as the use of a vibrating platform on which the user stands, repeatedly applying mechanical load to the user's feet. Current WBV vibrating platforms (e.g., Galileo 900/2000® from Novotec Medical GmbH in Pforzheim, Germany, or PowerPlate® in Amsterdam, Netherlands) and associated treatment regimens require the user to stand on the platform for up to 30 minutes a day, which is inconvenient for many users. Furthermore, applying vibration to the patient's feet is an inefficient method for mechanically loading the glutes, thighs, and spine, which are the target areas for WBV therapy for osteoporosis. Due to mechanical damping at the knees and ankles, up to 40% of the vibrational force is lost between the feet, buttocks, and spine (Non-Patent Literature 6). Another challenge with current WBV platforms is the directionality of the applied force. When standing on a vibrating platform, an individual receives WBV stimulation in a plane perpendicular to the elongated bones of the spine and hip. Studies have shown that vibrations applied in the vertical direction are misaligned with the direction of the main fiber trabeculae of the greater trochanter and femoral neck, resulting in reduced shear force. In contrast, the trabeculae of the lumbar spine are aligned with the direction of vibration and have higher permeability (Non-Patent Literature 5). A more efficient and user-friendly source of mechanical vibration is needed to deliver approximately 0.6g of force directly to the spine and buttocks. A more efficient method for delivering vibrational force would reduce the load on the patient, make the device easier to use, and maximize the therapeutic effect on osteoporosis by localizing the repeatedly delivered mechanical load to the buttocks and spine. Furthermore, the possibility of delivering WBV in a plane perpendicular to the direction of the long bones of the spine and buttocks may be more effective than traditional vibration plates on which a person stands. Furthermore, both portable and fixed-type devices are desirable. Finally, existing vibration platform technologies limit the application of WBV to specif