SKELETAL MANIPULATION METHOD

• US 20090112207A1
• Filed: 05/15/2008
• Published: 04/30/2009
• Est. Priority Date: 10/30/2007
• Status: Active Grant

• Current Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Original Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Inventors: Chang, Arvin, McCoy, Jay R., Pool, Scott, Walker, Blair, Lembo, Nicholas J.
• Granted Patent: US 8,057,472 B2
• Time in Patent Office: Days
• US Class Current: 606/57
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/7016 electric or electromagnetic means
• CPC Class Codes: A61B 17/7044 also having plates, staples or washers bearing on the vertebrae
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/707 Devices acting on, or attached to, a transverse process or rib; Tools therefor
• CPC Class Codes: A61B 17/7216 for bone lengthening or compression A61B17/7258 takes precedence
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/8004 with means for distracting or compressing the bone or bones
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61B 2017/681 Alignment, compression, or distraction mechanisms

Abstract

A method of treating scoliosis in a subject includes securing a scoliosis treatment device to first and second locations on the subject'"'"'s skeletal system, the scoliosis treatment device including a first portion, a second portion moveably mounted relative to the first portion, and an adjustment device disposed on the device and configured to change a distraction force between the first location and the second location, the adjustment device including a rotationally mounted magnetic element configured to move the second portion relative to the first portion in response to rotation of the magnetic element. An external adjustment device is provided external to the subject and is able to adjust the distraction force between the first location and second location.

Claims

1. A method of treating scoliosis in a subject comprising:

securing a scoliosis treatment device to first and second locations on the subject'"'"'s skeletal system, the scoliosis treatment device comprising a first portion, a second portion moveably mounted relative to the first portion, and an adjustment device disposed on the device and configured to change a distraction force between the first location and the second location, the adjustment device comprising a rotationally mounted magnetic element configured to move the second portion relative to the first portion in response to rotation of the magnetic element;

providing an external adjustment device external to the subject, the external adjustment device comprising a first rotating magnet adapted to rotate about a first axis and a second rotating magnet spaced apart from the first rotating magnet and adapted to rotate about a second, separate axis; and

non-invasively adjusting the implant by moving the first and second rotating magnets of the external adjustment device so as to increase the distraction force between the first location and second location.

2. The method of claim 1, wherein movement of the first and second rotating magnetic comprises rotational movement.

3. The method of claim 1, wherein the operation of securing the scoliosis treatment device comprises inserting the device through an incision formed in the subject.

4. The method of claim 3, wherein the incision is less than 15 cm in length.

5. The method of claim 4, wherein the incision is less than 7.5 cm in length.

6. The method of claim 1, wherein the first and second rotating magnets of the external adjustment device comprise permanent magnets.

7. The method of claim 1, wherein opposing poles of the first and second rotating magnets of the external adjustment device are angularly synchronized during rotation.

8. The method of claim 1, wherein the non-invasive adjustment of the implant is performed a plurality of times.

9. The method of claim 8, wherein the plurality of times occur over a span of more than one week.

10. The method of claim 1, further comprising reducing the distraction force between the first location and second location and subsequently removing the implant from the body of the mammal.

11. The method of claim 1, further comprising reducing the distraction force between the first location and second location and leaving the implant in the body of the mammal.

12. The method of claim 1, further comprising subsequently removing the treatment device from the body of the mammal.

13. A method of treating scoliosis comprising:

securing a scoliosis treatment device to first and second locations on the subject'"'"'s skeletal system, the scoliosis treatment device comprising a first portion, a second portion moveably mounted relative to the first portion, and an adjustment device disposed on the device and configured to change a distraction force between the first location and the second location, the adjustment device comprising a rotationally mounted magnetic element;

providing an external adjustment device external to the subject, the external adjustment device comprising first and second rotating magnetic fields rotating about separate axes, the first and second rotating magnetic fields being disposed on the same side of the subject'"'"'s body; and

non-invasively adjusting the implant by rotating the first and second magnetic fields of the external adjustment device so as to increase the distraction force between the first location and second location.

14. The method of claim 13, wherein the first and second rotating magnetic fields emanate from first and second permanent magnets.

15. The method of claim 13, wherein the operation of securing the scoliosis treatment device comprises inserting the device through an incision formed in the subject.

16. The method of claim 15, wherein the incision is less than 15 cm in length.

17. The method of claim 16, wherein the incision is less than 7.5 cm in length.

18. The method of claim 14, wherein opposing poles of the first and second rotating magnets of the external adjustment device are angularly synchronized during rotation.

19. The method of claim 13, wherein the non-invasive adjustment of the implant is performed a plurality of times.

20. The method of claim 19, wherein the plurality of times occur over a span of more than one week.

21. The method of claim 13, further comprising reducing the distraction force between the first location and second location and subsequently removing the treatment device from the skeletal system.

22. The method of claim 13, further comprising reducing the distraction force between the first location and second location and leaving the treatment device secured to the skeletal system.

23. The method of claim 13, further comprising subsequently removing the treatment device from the body of the mammal.

24. A method of treating scoliosis in a subject comprising:

identifying a genetic susceptibility of a subject having a Cobb angle of less than or equal to 30°

to develop a Cobb angle of greater than or equal to 40°

;

securing a scoliosis treatment device to first and second locations on the subject'"'"'s skeletal system, the scoliosis treatment device comprising a first portion, a second portion moveably mounted relative to the first portion, and an adjustment device disposed on the device and configured to change a distraction force between the first location and the second location, the adjustment device comprising a magnetic element configured for at least partial rotation about a first axis;

providing an external adjustment device external to the subject, the external adjustment device comprising at least one magnet configured for at least partial rotation about a second axis;

non-invasively adjusting the implant by rotating, at least partially, the at least one magnet of the external adjustment device.

25. The method of claim 24, wherein the scoliosis treatment device is delivered and removed from the subject via an incision.

26. The method of claim 25, wherein the incision is less than 15 cm in length.

27. The method of claim 26, wherein the incision is less than 7.5 cm in length.

28. The method of claim 24, wherein the at least one magnet in the external adjustment device comprises a permanent magnet.

29. The method of claim 24, further comprising performing the non-invasive adjustment a plurality times.

30. The method of claim 29, wherein the plurality of times occur over a span of more than one week.

31. The method of claim 24, further comprising reducing the distraction force between the first location and second location and subsequently removing the treatment device from the skeletal system.

32. The method of claim 24, further comprising reducing the distraction force between the first location and second location and leaving the treatment device secured to the skeletal system.

33. The method of claim 24, further comprising subsequently removing the treatment device from the body of the mammal.

41. The method of claim 24, wherein the at least partial rotational movement of the at least one magnet of the external adjustment device comprises cyclic movement.

42. The method of claim 24, wherein the at least partial rotational movement of the at least one magnet of the external adjustment device comprises rotational movement through at least a full rotation.

43. The method of claim 24, wherein the at least partial rotational movement of the magnetic element of the adjustment device comprises cyclic movement.

44. The method of claim 24, wherein the at least partial rotational movement of the magnetic element of the adjustment device comprises rotational movement through at least a full rotation.

34. A method of non-invasively adjusting a magnetically-driven device implanted within a subject comprising:

locating the subject within a magnetic field created by a magnetic resonant imaging instrument; and

rotating the subject about an axis of rotation.

35. The method of claim 34, wherein rotation of the subject about an axis in a first direction adjusts the magnetically-driven device in a first direction and wherein rotation of the subject about an axis in a second direction adjusts the magnetically-driven device in a second, opposing direction.

36. The method of claim 34, wherein the magnetically-driven device is selected from the group consisting of a distraction device, a restriction device, and a valve.

37. A method of treating scoliosis in a skeletally mature subject having an initial Cobb angle of more than 40°

comprising;

securing a scoliosis treatment device to first and second locations on the subject'"'"'s skeletal system, the scoliosis treatment device comprising a first portion, a second portion moveably mounted relative to the first portion, and an adjustment device disposed on the device and configured to change a distraction force between the first location and the second location, the adjustment device comprising a rotationally mounted magnetic element;

providing an external adjustment device external to the subject, the external adjustment device comprising at least one rotating magnet adapted to rotate about an axis;

periodically adjusting the implant in a non-invasive manner by rotating the at least one rotating magnet of the external adjustment device so as to reduce the Cobb angle of the subject from the initial Cobb angle.

38. The method of claim 37, wherein the initial Cobb angle is more than 100°

.

39. The method of claim 37, wherein the Cobb angle reduction of a single non-invasive adjustment is less than 50% of the original Cobb angle at surgery.

40. The method of claim 39, wherein the Cobb angle reduction of a single non-invasive adjustment is less than 15% of the original Cobb angle at surgery.