Device and method for bone adjustment with anchoring function

• US 9,962,199 B2
• Filed: 10/29/2009
• Issued: 05/08/2018
• Est. Priority Date: 10/31/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Kirk Promotion Ltd.
• Inventors: Forsell, Peter
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Bray, Stuart S
• Application Number:
  US13/123,536
• Publication Number:
  US 20110196371A1
• Time in Patent Office: 3,113 Days
• Field of Search: 606 62- 68, 606 90, 606105
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• 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 17/7017 pneumatic or hydraulic means
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/7216 for bone lengthening or compression A61B17/7258 takes precedence
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length

Abstract

A method and a device for bone adjustment in a mammal is presented, wherein a device is implanted in the medullar cavity of a bone in the body of said mammal, said device being a device exerting a force to anchoring devices anchored ins aid bone. The method and device has utility in therapeutic and cosmetic bone adjustments, including the lengthening, reshaping and realigning of bones, for example in the correction of congenital deformations, restorative orthopedic surgery and the like.

Claims

1. A device for bone adjustment in a mammal, comprising two or more anchoring devices adapted to be attached to a bone in said mammal, and an adjustment device for exerting force on said anchoring devices adapted to adjust the distance between or orientation of at least two of said anchoring devices,

wherein said anchoring devices and said adjustment device are adapted to be implanted intramedullary in said mammal and wherein said adjustment device is constructed to postoperatively adjust said distance or orientation,

the device further comprising an operation device, wherein the adjustment device is operated by the operation device, which comprises a motor, wherein the motor comprises a motor or device positioning system, such as a tachometer or a sensor input to see the position of the adjustment device,

wherein the device further comprises a gearbox connected to the motor or a motor package, wherein an outgoing speed from the motor package is lower than the speed by the motor alone, accomplished by the gearbox, wherein the outgoing speed of the motor package is adapted to be decreased to less than 10 turn per second during normal operation,

wherein the device further comprises a control device, wherein the operation device is controlled by the control device comprising an internal control unit adapted to be programmable wirelessly from outside the patient'"'"'s body, and

programmed to regulate the device according to a pre-programmed time-schedule, and

programmed to regulate the device according to input from the sensor or another sensor or measuring device sensing any possible physical parameter of the patient or any functional parameter of the system.

2. The device according to claim 1, wherein the adjustment device comprises a hydraulic device for said bone adjustment, to control the amount of force exerted by the device onto said anchoring devices, wherein the hydraulic device is comprising at least one of:

a cylinder and piston,

a mechanical multi step locking mechanism, locking the hydraulic device in its new position after adjustment,

a mechanical multi step locking mechanism, locking the hydraulic device in its new position after adjustment, wherein the mechanical multi step locking mechanism comprises at least one of a sprint, a elongated structure using the principle of saw teeth, flanges, barbs or a bonnet band, a nut, a gearbox, or a spring loaded locking principle,

hydraulic fluid and a reservoir containing said fluid, adapted to move said fluid to said adjustment device,

hydraulic fluid and a reservoir containing said fluid, adapted to move said fluid to said adjustment device, wherein the hydraulic fluid is moved from said reservoir to said adjustment device by using a pre-pressurized reservoir or a pump,

a device positioning system such as a fluid volume or flow measurement or any other sensor input to see the position of the adjustment device.

3. The device according to claim 2, wherein the device comprises a control device.

4. The device according to claim 3, wherein said control device follows a program of incremental changes, set before the device is implanted.

5. The device according to claim 3, wherein said control device follows a program of incremental changes, communicated to the control device after implantation and/or during the treatment.

6. The device according to claim 3, wherein said control device comprises an external control unit and an implantable receiver suitable for wireless communication with said external control unit, having a transmitter located outside the body.

7. The device according to claim 1, wherein said two or more anchoring devices are adapted to at least one of:

engaging and stabilizing the anchoring device using a thread in relation to the bone,

engage and carry weight only on the outside of the bone,

engage and carry weight only on the inside of the bone, and

anchoring a relative rotation of the adjustment device including at least two parts adapted to rotate in relation to each other.

8. The device according to claim 7, wherein said at least two anchoring devices are chosen from a screw, an adhesive, a barb construction, a saw-tooth construction, an expandable element, combinations thereof or other mechanical connecting members.

9. The device according to claim 1, wherein said adjustment is the lengthening of a bone, the healing of a fracture, the changing of a bone angle, the reshaping of a bone, the compression of a bone, the torsion of a bone or a combination thereof.

10. The device according to claim 1, wherein the force exerted by the adjustment device is at least one of:

a longitudinal force, extending the length of the bone,

directed to the end portions of the medullar cavity,

a longitudinal force, adjusting the angle or curvature of the bone,

applies torque to the bone, adjusting the torsion of the bone along its longitudinal axis.

11. The device according to claim 1, wherein said device is flexible.

12. The device according to claim 1, wherein the control device at least one of:

follows a program of incremental changes, set before the device is implanted, and

follows a program of incremental changes, communicated to the control device after implantation and/or during the treatment.

13. The device according to claim 1, wherein said adjustment is adapted to perform:

the lengthening of a bone, the compression of a bone, the healing of a fracture, the changing of a bone angle, the reshaping of a bone, a correcting of a limb discrepancy caused by a congenital condition or deformation, correcting of a limb discrepancy caused by previous trauma, the changing of the curvature of a bone, the changing the torsion of a bone, the changing the angle between the diaphysis and the epiphysis, the changing the thickness of a bone, the changing of the curvature of the spine, the adjoining of vertebrae adapted to change the curvature of the spine, and the adjoining of vertebrae adapted to relieve a herniated lumbar disc or the like.

14. The device according to claim 1, wherein said adjustment device is, at least one of:

adapted to implement torsion of a bone,

adapted to change the angle of a bone,

adapted to have at least two parts to rotate in relation to each other, wherein said adjustment device comprises at least two parts, the relative rotation being anchored by at least two anchoring devices,

adapted to have at least two parts angled in relation to each other, wherein said adjustment device comprises at least two parts,

adapted to change the curvature of a bone,

adapted to change the curvature of the spine,

adapted to adjoining vertebrae, adapted to change at least one of, the curvature of the spine and to relieve a herniated lumbar disc or the like, and

adapted to non-adjoining vertebrae, adapted to change at least one of;

the curvature of the spine and to relieve a herniated lumbar disc or the like.

15. The device according claim 1, wherein the control device is adapted to, at least one of:

control incremental changes of the adjustment device, communicated to the receiver after implantation and/or during the treatment by using an comprised external control unit and an implantable receiver suitable for wireless communication with said external control unit, having a transmitter located outside the body,

regulate the device non-invasively by manually pressing at least one subcutaneous switch, whereby the operation of the device is switched on and off, further comprising an implantable internal energy source for powering implantable energy consuming components of the apparatus, and

regulate the device non-invasively by manually pressing at least one subcutaneous switch, wherein the switch sends information to the internal control unit to perform a certain predetermined performance.

16. The device according to claim 1, wherein the adjustment device comprising, at least one of:

a mechanical device for said bone adjustment,

a mechanical device for said bone adjustment comprising at least one nut and screw,

a mechanical device for said bone adjustment comprising at least one gearbox,

a mechanical device for said bone adjustment comprises a servo mechanism or mechanical amplifier,

a hydraulic or mechanical device for said bone adjustment, which comprising a mechanical multi step locking mechanism, locking the mechanical device in its new position after adjustment, and

a mechanical or hydraulic device for said bone adjustment, which comprising a mechanical multi step locking mechanism, locking the mechanical device in its new position after adjustment, comprising at least one of;

a sprint, a elongated structure using the principle of saw teeth, flanges, barbs or a bonnet band, a nut, a gearbox, or a spring loaded locking principle.

17. The device according to claim 1, wherein the operation device comprising, at least one of:

a motor operated as a three-phase motor,

a motor operated as a two or more phase motor,

an electric speed controller connected to the motor, a motor package, wherein the outgoing speed of the motor in said motor package is decreased by said electrical speed controller,

a rotational motor

a linear motor.

18. The device according to claim 1, wherein said device is, at least one of:

flexible to allow introduction into the medullar cavity,

at least partly elastic and flexible to allow introduction into the medullar cavity,

comprising a spring and is flexible to allow introduction into the medullar cavity,

regaining its shape after having been bent,

comprising a locking device, which allows extension of the device but substantially prevents contraction,

comprising a sensor direct or indirect sensing the position of the adjustment device.

19. The device according to claim 1, wherein the device comprising a sensor direct or indirect sensing the position of the adjustment device, the device comprising a feedback transmitter adapted to transmit information received direct or indirect from said sensor out from the human body, said transmitted information adapted to be received by a external control unit and relating to the position of the adjustment device.

20. The device according to claim 1, being part of a system, comprising at least one of:

a sensor or measuring device sensing or measuring a functional parameter correlated to the transfer of energy for charging an internal energy source, and a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related to the functional parameter sensed by the sensor or measured by the measuring device, further comprising an implantable internal energy source for powering implantable energy consuming components of the device, and an external energy source for transferring energy in a wireless mode, wherein the internal energy source is chargeable by the energy transferred in the wireless mode,

a feedback device for sending feedback information from inside the patient'"'"'s body to the outside thereof, the feedback information being related to at least one of a physical parameter of the patient and a functional parameter related to the apparatus,

a sensor and/or a measuring device and an implantable internal control unit for controlling the apparatus in response to information being related to at least one of a physical parameter of the patient sensed by the sensor or measured by the measuring device and a functional parameter related to the device sensed by the sensor or measured by the measuring device,

an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator feeds data related to the device or the patient to the external data communicator, the external data communicator feeds data to the internal data communicator, or the internal communicator feeds data related to the device or the patient to the external data communicator and the external data communicator feeds data to the internal data communicator.

21. The device according to claim 1 being part of a system, comprising at least one of:

at least one switch implantable in the patient for manually and non-invasively controlling the device,

a wireless remote control for non-invasively controlling the device,

a hydraulic device having an implantable hydraulic reservoir, which is hydraulically connected to the apparatus, wherein the device is adapted to be non-invasively regulated by manually pressing the hydraulic reservoir.

22. The device according to claim 1, being part of a system comprising at least one of:

a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the device with wireless energy,

an implantable internal energy source for powering implantable energy consuming components of the device, and

an external energy source for transferring energy in a wireless mode and an implantable internal energy source for powering implantable energy consuming components of the device, wherein the internal energy source is chargeable by the energy transferred in the wireless mode,

implantable electrical components including at least one voltage level guard and/or at least one constant current guard,

an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form of energy, wherein the second form energy is used at least partly to charge an accumulator

an operation device for operating the device, wherein the wireless energy is used in its wireless state to directly power the operation device to create kinetic energy for the operation of the device, as the wireless energy is being transmitted by the energy-transmission device, and

an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form of energy, wherein the energy-transforming device directly powers implantable energy consuming components of the device with the second form energy, as the energy-transforming device transforms the first form energy transmitted by the energy-transmission device into the second form energy.

23. The device according to claim 1, wherein the adjustment device comprises a hydraulic device for said bone adjustment, the hydraulic device is adapted to at least one of:

be stabilized when the bone adjustment is completed,

be filled with a material which stabilizes the position of the adjustment device and permanents the distance between the anchoring devices,

be stabilized when the bone adjustment is completed, wherein the material is chosen from a curable foam, a curable gel, a polymer or polymer mixture which solidifies, crosslinks or otherwise attains and retains a stable volume,

be stabilized when the bone adjustment is completed, wherein the hydraulic fluid used in said device is a material chosen from a curable foam, a curable gel, a polymer or polymer mixture which solidifies, crosslinks or otherwise attains and retains a stable volume when the curing, solidification, crosslinking or other reaction is initiated by the user, and

be stabilized when the bone adjustment is completed, wherein the material is chosen from a curable foam, a curable gel, a polymer or polymer mixture which solidifies, crosslinks or otherwise attains and retains a stable volume, is added to the device, partially or completely replacing the hydraulic fluid.

24. The device according to claim 1, wherein said two or more anchoring devices are adapted to engage and carry weight purely on the inside of the bone, wherein two or more anchoring devices are adapted to engage with and carrying weight to the bone without penetrating to the outside of the bone, from the intramedullary cavity of the bone.

25. The device according to claim 1, wherein at least one of the two or more anchoring devices comprises an expandable part adapted to expand at least partially perpendicular to the longitudinal extension of the elongated device for engaging and stabilizing the anchoring device in relation to the bone.

26. The device according to claim 1, wherein the motor is a rotational motor and the outgoing speed of the motor package is decreased to less than:

1 turn per second, or 10 turns per second.

27. The device according to claim 1, wherein the motor is a rotational motor and the outgoing speed of the motor package is decreased to less than:

0.1 turn per second, 0.01 turn per second, or 0.001 turn per second.

28. The device according to claim 1, adapted to be exerting an intermittent, oscillating force, or intermittent and oscillating force according to a preset program or according to instructions transmitted wirelessly to the device.

29. The device according to claim 1, wherein the intermittent, oscillating force, or intermittent and oscillating force comprises an implanted hydraulic device.

30. The device according to claim 1, adapted to be implanted intramedullary in a body of said mammal, wherein said device is a hydraulic device exerting a force to anchoring devices adapted to be anchored in said bone and further comprising a control device which controls the amount of force exerted by the device.

31. The device according to claim 1, wherein the adjustment device comprises an extension device, adapted to be capable of longitudinal movement and in particular capable of exerting a force longitudinally between two or more points, wherein the extension device can be a hydraulic device, an electronic device, a mechanical device, or a combination of two or more thereof.

32. The device according to claim 1, comprising a hydraulic device, adapted to bring longitudinal force on elements in the device, such as hydraulic cylinders and the like, transmitted by a hydraulic fluid bringing the longitudinal force.

33. The device according to claim 1, wherein the hydraulic device comprises a device positioning system such as a fluid volume or flow measurement or any other sensor input to see the position of the adjustment device.

34. The device according to claim 1, wherein the adjustment device adapted to exert force on said the two or more anchoring devices to adjust the distance between or orientation of at least two of said anchoring devices, wherein said anchoring devices and said adjustment device are implanted intramedullary in said mammal and wherein said adjustment device is constructed to postoperatively adjust said distance.

35. The device according to claim 1, comprising an electrical speed controller connected to the motor, a motor package, wherein the outgoing speed of the motor in said motor package is controlled by said electrical speed controller,

wherein the motor is a linear motor and the outgoing speed of the motor package is less than at least one of:

less than 1 mm per second,

less than 0.1 mm per second,

less than 0.01 mm per second,

less than 0.001 mm per second,

less than 0.0001 mm per second, and

less than 0.00001 mm per second.

36. The device according to claim 1, being part of a system, comprising a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the device with wireless energy, further comprising a control device for controlling the transmission of wireless energy from the energy-transmission device, and an implantable internal energy receiver for receiving the transmitted wireless energy, the internal energy receiver being connected to implantable energy consuming components of the apparatus for directly or indirectly supplying received energy thereto, the system further comprising a determination device adapted to determine an energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components of the device, wherein the control device controls the transmission of wireless energy from the external energy-transmission device, based on the energy balance determined by the determination device.

37. The device according to claim 1, being part of a system, comprising an implantable internal energy receiver for receiving wireless energy, the energy receiver having an internal first coil and a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil, wherein the external second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver, the system further comprising a feedback device for communicating out the amount of energy received in the first coil as a feedback information, and wherein the second electronic circuit includes a determination device for receiving the feedback information and for comparing the amount of transferred energy by the second coil with the feedback information related to the amount of energy received in the first coil to obtain the coupling factors between the first and second coils.