External adjustment device for distraction device

• US 10,729,470 B2
• Filed: 05/22/2018
• Issued: 08/04/2020
• Est. Priority Date: 11/10/2008
• Status: Active Grant

• Current Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Original Assignee: Nuvasive Specialized Orthopedics, Inc. (Nuvasive Incorporated)
• Inventors: Pool, Scott, Walker, Blair, Chang, Arvin
• Primary Examiner(s): Hammond, Ellen C
• Application Number:
  US15/986,496
• Publication Number:
  US 20180280060A1
• Time in Patent Office: 805 Days
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/7004 with a cross-section which varies along its length A61B17/7019 takes precedence
• CPC Class Codes: A61B 17/7011 Longitudinal element being non-straight, e.g. curved, angled or branched adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs
• CPC Class Codes: A61B 17/7016 electric or electromagnetic means
• CPC Class Codes: A61B 17/7216 for bone lengthening or compression A61B17/7258 takes precedence
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body

Abstract

A method of positioning an external adjustment device relative to a patient includes placing a magnetic viewing sheet adjacent to a patient and identifying the location of an implanted magnetic assembly using the magnetic viewing sheet by visualizing a magnetic image of the implanted magnetic assembly in the magnetic viewing sheet. The external adjustment device is placed on the patient adjacent to the location where the magnetic image was located.

Claims

1. An external adjustment device comprising:

at least one magnet configured to generate a changing magnetic field and rotatably housed within a housing;

a drive system;

a power source;

at least one directional control configured to effect a change in the changing magnetic field;

a display configured to communicate information to a user, wherein the display is configured to provide information feedback to the user at least one of prior to, during, or after a use of the external adjustment device.

2. The external adjustment device of claim 1, wherein the information communicated to the user comprises a current state of an implanted medical device.

3. The external adjustment device of claim 1, wherein the information communicated to the user comprises an amount of change in at least one of a dimension of and a force on an implanted medical device.

4. The external adjustment device of claim 1, wherein the information communicated to the user comprises a rate of change of at least one of a dimension of and a force on an implanted medical device.

5. The external adjustment device of claim 1, wherein the information communicated to the user comprises a rate of change of the changing magnetic field of the external adjustment device.

6. The external adjustment device of claim 1 wherein the information communicated to the user comprises at least one of an amount of adjustment desired for an implanted medical device and an amount of adjustment achieved by an implanted medical device.

7. The external adjustment device of claim 1, further comprising:

a microcontroller configured to communicate with at least one of the at least one magnet, the drive system, and the at least one directional control and thereby to cause the changing magnetic field to change, and wherein the microcontroller is also configured to prevent change the changing magnetic field in response to one or more pre-determined criteria being met.

9. The external adjustment device of claim 7, wherein the microcontroller is configured to prevent a change in a dimension of an implantable medical device beyond a pre-determined limit.

10. The external adjustment device of claim 7, wherein the microcontroller is configured to prevent a second change of the changing magnetic field prior to the passing of a pre-determined time since a first change of the changing magnetic field.

11. The external adjustment device of claim 7, wherein the microcontroller is configured to accept and store at least one pre-determined criteria of the one or more pre-determined criteria.

12. The external adjustment device of claim 7, further comprising a data connection configured to allow a transfer of information between the external adjustment device and a network.

13. The external adjustment device of claim 7, wherein the transfer of information comprises at least one of a transfer of the at least one pre-determined criteria of the one or more predetermined criteria from the network to the external adjustment device and a transfer of data corresponding to a use of the external adjustment device from the external adjustment device to the network.

14. The external adjustment device of claim 7, wherein the pre-determined criteria comprises a change in a dimension of an implantable medical device reaching a pre-set limit.

15. The external adjustment device of claim 7, wherein the microcontroller is configured to communicate at least one instruction regarding use of the external adjustment device to a user.

16. The external adjustment device of claim 7, wherein the microcontroller is configured to control at least one of a rate of change of the changing magnetic field of the external adjustment device and an amount of change of the changing magnetic field of the external adjustment device.

8. The external adjustment device of 7, further comprising a feedback system configured to provide a status of the external adjustment device to a user.

17. An external adjustment device, for non-invasively adjusting an adjustable implant, the external adjustment device comprising:

one or more rotatable magnets configured to generate a rotating magnetic field to non-invasively change a dimension of the adjustable implant;

a power source comprising at least one of an internal power source and an external power source;

a motor coupled to a drive system, wherein the drive system is operatively coupled to the one or more rotatable magnets, and wherein the drive system is configured to translate rotation of the motor into rotation of the one or more rotatable magnets; and

a distraction control and a retraction control, wherein the distraction control and the retraction control are configured such that activation of the distraction control causes the one or more rotatable magnets to rotate in at least one of a first direction and a second direction, and wherein the retraction control is configured such that activation of the retraction control causes the one or more rotatable magnets to rotate in the other of the first direction and the second direction.

18. The external adjustment device of claim 17, wherein the one or more rotatable magnets comprise at least two external magnets located on a side of the external adjustment device, coupled to least one plate, and rotatably housed within a cover, wherein the at least two magnets are configured to rotate in at least one of a first direction and a second direction and thereby to generate at least two rotating magnetic fields.

19. The external adjustment device of claim 17, wherein a first external magnet of the one or more rotatable magnets is configured to rotate at a first rotational velocity and a second external magnet of the one or more rotatable magnets is configured to rotate at a second rotational velocity, wherein the first rotational velocity is substantially equal to the second rotational velocity.

20. The external adjustment device of claim 17, wherein the activation of the distraction control causes the one or more rotatable magnets to rotate at a first rotational velocity and activation of the retraction control causes the one or more rotatable magnets to rotate at a second rotation velocity, wherein the second rotational velocity is greater than the first rotational velocity.