Method for the promotion of growth, ingrowth and healing of bone tissue and the prevention of osteopenia by mechanical loading of the bone tissue

• US 5,191,880 A
• Filed: 04/13/1992
• Issued: 03/09/1993
• Est. Priority Date: 07/31/1990
• Status: Expired due to Term

• Current Assignee: American Medical Innovations, LLC
• Original Assignee: Applied Epigenetics, Inc.
• Inventors: McLeod, Kenneth J., Rubin, Clinton T.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US07/865,148
• Time in Patent Office: 330 Days
• Field of Search: 128/419 F, 128/24 AA
• US Class Current: 601/2
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2002/286 Bone stimulation by mechanical vibrations for enhancing ossification
• CPC Class Codes: A61H 1/006 Apparatus for applying pressure or blows for compressive stressing of a part of the skeletal structure, e.g. for preventing or alleviating osteoporosis
• CPC Class Codes: A61H 2201/502 Card operated, e.g. pre-paid card, credit card or ID card
• CPC Class Codes: A61H 23/00 Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A method for preventing osteopenia, promoting bone tissue growth, ingrowth, and healing of bone tissue includes the step of applying a mechanical load to the bone tissue at a relatively low level on the order of between about 50 and about 500 microstrain, peak-to-peak, and at a relatively high frequency in the range of about 10 and about 50 hertz. Mechanical loading at such strain levels and such frequencies has been found to prevent bone loss and enhance new bone formation.

Claims

1. A method for preventing osteopenia, as well as for promoting growth, ingrowth and healing of bone tissue, which comprises the step of:

subjecting the bone tissue to a mechanical load sufficient to cause a strain in the bone tissue at a relatively low level of between about 10 and about 1000 microstrain, peak-to-peak, and at a relatively high frequency of between about 10 and about 100 hertz, said step being administered for a total of about 5 to about 60 minutes per day.

2. A method for preventing osteopenia, as well as for promoting bone tissue growth, ingrowth and healing of bone tissue, which comprises the step of:

subjecting the bone tissue to a mechanical load sufficient to cause a strain in the bone tissue at a relatively low level of substantially 500 microstrain, peak-to-peak, and at a relatively high frequency of substantially 15 hertz.

3. A method for preventing osteopenia, as well as for promoting bone tissue growth, ingrowth and healing of bone tissue, which comprises the step of:

subjecting the bone tissue to a mechanical load sufficient to cause a strain in the bone tissue at a relatively low level of between about 50 and about 500 microstrain, peak-to-peak, and at a relatively high frequency of between about 10 and about 50 hertz, said mechanical load being transcutaneously applied.

4. The method of claim 3, wherein transcutaneous application is via a vibrating floor plate.

5. The method of claim 3, wherein transcutaneous application is via a vibrating chair.

6. The method of claim 3, wherein transcutaneous application is via electrical stimulation of muscle tissue.

7. The method of claim 3, wherein transcutaneous application is via isometric exercise.

8. The method of claim 3, wherein transcutaneous application is via modulated ultrasound.

9. The method of claim 3, wherein transcutaneous application is via a transducer attached to the skin.

10. The method of claim 3, wherein transcutaneous application is via an external device that is fixedly attached to the bone.

11. A method of promoting osseointegration or bone ingrowth into a prosthetic implant, which comprises the step of:

subjecting the bone tissue to a mechanical load sufficient to cause a strain in the bone tissue at a relatively low level of between 10 and 1000 microstrain, peak-to-peak, and at a relatively high frequency of between about 10 and about 100 hertz.

12. A method of promoting osseointegration or bone ingrowth into a bone graft, which comprises the step of:

subjecting the bone tissue to a mechanical load sufficient to cause a strain in the bone tissue at a relatively low level of between 10 and 1000 microstrain, peak-to-peak, and at a relatively high frequency of between about 10 and about 100 hertz.

13. A method of promoting bone growth and/or healing of a bone fracture, which comprises the step of transcutaneously subjecting tissue of the fractured bone to a mechanical load sufficient to cause a strain in the bone tissue at a relatively low level of between about 50 and about 500 microstrain, peak-to-peak, and at a relatively high frequency of between about 10 and about 50 hertz, said step being performed by transcutaneously applied signals passed through a condyle of the fractured bone.