SKELETAL MANIPULATION SYSTEM
A system for manipulating a portion of the skeletal system of a mammal includes an implant having a first portion and a second portion, the first portion configured for mounting at a first location of the skeletal system and the second portion configured for mounting at a second location of the skeletal system. The system further includes an adjustment device disposed on the implant and configured to apply a biasing force to the skeletal system, the adjustment device including a magnetic element configured for cyclic movement, the magnetic element being operatively coupled to a drive element configured to alter at least one of the distance or the force between the first location and the second location. The system includes an implantable feedback device operatively coupled to the implant that is configured to produce a response that is indicative of a condition of the implant which can be identified non-invasively.
1 . A system for manipulating a portion of the skeletal system in the body of a mammal comprising:
an implant having a first portion and a second portion, the first portion configured for mounting at a first location of the skeletal system and the second portion configured for mounting at a second location of the skeletal system;
an adjustment device disposed on the implant and configured to apply a biasing force to the skeletal system, the adjustment device comprising a magnetic element configured for cyclic movement, the magnetic element being operatively coupled to a drive element configured to alter at least one of the distance or the force between the first location and the second location; and
an implantable feedback device operatively coupled to the implant, the feedback device being configured to produce a response that is indicative of a condition of the implant which can be identified non-invasively.
2 . The system of claim 1 , wherein the condition comprises a distraction force.
3 . The system of claim 1 , wherein the condition comprises a distraction distance.
4 . The system of claim 1 , wherein the response comprises acoustic energy.
5 . The system of claim 1 , wherein the response comprises light energy.
6 . The system of claim 1 , wherein the implantable feedback device comprises a force transducer or strain gauge.
7 . The system of claim 1 , wherein the implantable feedback device comprises a first object that impacts a second object, wherein the impact creates an acoustic signal.
8 . The system of claim 7 , wherein the first object is magnetic.
9 . The system of claim 7 , further comprising a third object, wherein the first object impacts the second object when the adjustment device is being adjusted with an increasing distraction and the first object impacts the third object when the adjustment device is being adjusted with a decreasing distraction.
10 . The system of claim 5 , wherein the implantable feedback device comprises a reflective portion configured to reflect the light energy.
11 . The system of claim 5 , wherein the implantable feedback device comprises a translucent portion.
12 . The system of claim 1 , wherein the magnetic element comprises a permanent magnet.
13 . The system of claim 1 , wherein the magnetic element is cylindrical.
14 . The system of claim 1 , wherein the magnetic element is rotatably mounted within a housing.
15 . The system of claim 1 , further comprising an external adjustment device configured to magnetically couple to the adjustment device from a location external to the mammal.
16 . The system of claim 15 , wherein the external adjustment device automatically adjusts the implant based at least in part on the response generated by the feedback device.
17 . The system of claim 1 , wherein the feedback device produces a response that is indicative of the cyclic movement of the magnetic element.
18 . The system of claim 17 , wherein the feedback device produces a response at least once per cycle of the magnetic element.
19 . A system for manipulating a portion of the skeletal system in the body of a mammal comprising:
an implant having a first portion and a second portion, the first portion configured for mounting to a first location of the skeletal system and the second portion configured for mounting to a second location of the skeletal system;
an adjustment device configured to change at least one of the distance or the force between the first location and the second location; and
a clamp disposed on the first portion, the clamp comprising a magnetic element configured to allow for non-invasive activation of the clamp to fixedly mount the first portion to the first location.
20 . The system of claim 19 , further comprising an external device capable of non-invasively activating the clamp by engagement with the magnetic element.
21 . A system for manipulating a portion of the skeletal system in the body of a mammal comprising:
an implant having a first portion and a second portion, the first portion configured for coupling to a first location of the skeletal system and the second portion configured for coupling to a second location of the skeletal system;
an adjustment device operatively coupled to the implant and configured to change at least one of the distance or force between the first location and the second location, the adjustment device comprising a drive element configured to alter at least one of the distance or the force between the first location and the second location;
an external adjustment device configured to non-invasively couple to the adjustment device from a location external to the mammal, the external adjustment device configured to impart a driving torque to the drive element;
a slip clutch operatively coupled to the drive element and configured to selectively engage with the adjustment device, the slip clutch configured to disengage from the adjustment device when a threshold torque level is reached or exceeded.
22 . The system of claim 21 , wherein the adjustment device comprises a magnetic element configured for cyclic movement, the magnetic element being operatively coupled to the drive element.
23 . The system of claim 22 , wherein the external adjustment device comprises a first permanent magnet configured for cyclic movement.
24 . The system of claim 21 , wherein the threshold torque level corresponds to a maximum desired distraction force.
25 . The system of claim 21 , wherein the threshold torque level corresponds to an ideal distraction force.
26 . The system of claim 24 , wherein the maximum desired distraction force is 100 pounds or less.
27 . The system of claim 26 , wherein the maximum desired distraction force is 45 pounds or less.
28 . The system of claim 25 , wherein the ideal distraction force is 45 pounds or less.
29 . The system of claim 21 , wherein the threshold torque level is between 2 inch-ounces and 42 inch-ounces.
30 . The system of claim 29 , wherein the threshold torque level is between 2 inch-ounces and 19 inch-ounces.
31 . The system of claim 30 , wherein the threshold torque level is between 2 inch-ounces and 8.5 inch-ounces.
32 . A system for manipulating a portion of the skeletal system in the body of a mammal comprising:
an implant having a first portion and a second portion, the first portion configured for coupling to a first location of the skeletal system and the second portion configured for coupling to a second location of the skeletal system;
an adjustment device disposed on the implant and configured to change at least one of the distance or force between the first location and the second location, the adjustment device comprising a magnetic element configured for rotational movement, the magnetic element being operatively coupled to a drive element configured to alter at least one of the distance or the force between the first location and the second location;
an external adjustment device configured to magnetically couple to the adjustment device from a location external to the mammal, the external adjustment device comprising a first permanent magnet configured for rotation about an axis and a second permanent magnet configured for rotation about a second, separate axis; and
a feedback device operatively coupled to either the external adjustment device or the magnetic element, wherein the feedback device is configured to produce a response indicative of the extent of magnetic coupling between at least one of the first and second permanent magnets of the external adjustment device and the magnetic element of the adjustment device.
33 . The system of claim 32 , wherein the magnetic element comprises a permanent magnet.
34 . The system of claim 33 , wherein the magnetic element comprises a rare earth magnet.
35 . The system of claim 34 , wherein the magnetic element comprises Neodynium-Iron-Boron.
36 . The system of claim 35 , wherein the magnetic element is grade N30 or higher.
37 . The system of claim 36 , wherein the magnetic element is grade N48 or higher.
38 . The system of claim 32 , wherein the first and second permanent magnets of the external adjustment device comprise rare earth magnets.
39 . The system of claim 32 , wherein the magnetic element is cylindrical.
40 . The system of claim 32 , wherein the magnetic element is configured for rotation about an axis.
41 . The system of claim 32 , wherein the response is a current which varies in relation to a torque between the magnetic element and the at least one of the first and second permanent magnets.
42 . The system of claim 32 , wherein the feedback device is disposed on the external adjustment device.
43 . The system of claim 32 , wherein the feedback device is disposed on the implant.
44 . The system of claim 32 , wherein the external adjustment device automatically adjusts the implant at least in part on the response generated by the feedback device.
45 . A system for manipulating a portion of the skeletal system in the body of a mammal comprising:
an implant having a first portion and a second portion, the first portion configured for coupling to first location of the skeletal system and the second portion configured for coupling to a second location of the skeletal system;
an adjustment device configured to alter a distraction force between the first location and the second location, the adjustment device comprising a magnetic element configured for rotation about an axis of rotation, the magnetic element being operatively coupled to a drive element configured to alter the distraction force between the first location and the second location;
an external adjustment device configured to magnetically couple to the adjustment device from a location external to the mammal, the external adjustment device comprising at least one permanent magnet configured for rotation about an axis; and
wherein one of the first and second portions of the implant configured to couple the skeletal system comprises a connecting rod having a substantially 180° curve.