Method and apparatus for post-operative tuning of a spinal implant

• US 20040152972A1
• Filed: 04/25/2003
• Published: 08/05/2004
• Est. Priority Date: 01/30/2003
• Status: Active Grant

• Current Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Navigation Incorporated (Medtronic Plc)
• Inventors: Hunter, Mark
• Granted Patent: US 9,867,721 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/175 for preparing the femur for hip prosthesis insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 : using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3983 : Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 34/30 : Surgical robots
• CPC Class Codes: A61B 90/10 : for stereotaxic surgery, e.g. frame-based stereotaxis
• CPC Class Codes: A61F 2/32 : for the hip
• CPC Class Codes: A61F 2/34 : Acetabular cups
• CPC Class Codes: A61F 2/36 : Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4425 : made of articulated components
• CPC Class Codes: A61F 2/4607 : of hip femoral endoprostheses
• CPC Class Codes: A61F 2/4609 : of acetabular cups
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/48 : Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2002/30471 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30476 : locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30517 : using a locking plate
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/30548 : for adjusting fluid pressure
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30649 : Ball-and-socket joints
• CPC Class Codes: A61F 2002/30668 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2002/3067 : for data transfer
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3069 : Revision endoprostheses
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• CPC Class Codes: A61F 2002/4632 : using computer-controlled surgery, e.g. robotic surgery
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/4668 : for measuring angles
• CPC Class Codes: A61F 2002/467 : for measuring fluid pressure
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0002 : for data transfer
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0013 : for adjusting fluid pressure
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A tunable implant, system, and method enables a tunable implant to be adjusted within a patient. The tunable implant includes a securing mechanism to secure the implant in the patient, a actuation portion that enables the implant to move and an adjustment portion that permits adjustment of the implant after the implant has been positioned within the patient. The method of adjusting the tunable implant includes analyzing the operation of the implant, determining if any adjustments are necessary and adjusting the implant to improve implant performance. The implant system includes both the tunable implant and a telemetric system that is operable to telemetrically receive data from the tunable implant where the data is used to determine if adjustment of the tunable implant is necessary. The system also includes an instrument assembly that is used for performing spinal surgery where the instrument assembly includes a mounting platform and a jig.

Claims

1. A method for tuning an implant positioned within a patient, said method comprising:

analyzing an operation of the implant positioned within the patient;

determining if any adjustment of the implant is necessary; and

adjusting the implant while the implant is positioned within the patient, wherein upon adjusting the implant, the implant provides improved performance.

2. The method as defined in claim 1 wherein analyzing the operation of the implant includes conducting a post-operative exam of the implant positioned within the patient.

3. The method as defined in claim 2 wherein the post-operative exam includes a motion analysis on the operation of the implant positioned within the patient.

4. The method as defined in claim 3 wherein the motion analysis is an image-based motion analysis and includes capturing images of the implant positioned within the patient.

5. The method as defined in claim 4 wherein the images are captured during motion of the patient to observe the implant in operation.

6. The method as defined in claim 4 wherein the images are captured during a static condition of the patient to observe the implant in operation.

7. The method as defined in claim 3 wherein the motion analysis is a sensor-based study where various parameters are sensed at the implant site.

8. The method as defined in claim 7 wherein said parameters are selected from a group comprising temperature, pressure, stress, strain, loading force, tortional force, and frictional force.

9. The method as defined in claim 7 wherein said sensed parameters are sensed from at least one sensor positioned within the implant.

10. The method as defined in claim 4 wherein the motion analysis is both image-based and sensor-based where the sensor-based analysis includes obtaining at least one reading of a parameter at the implant site.

11. The method as defined in claim 3 wherein determining if any adjustment of the implant is necessary includes analyzing the motion analysis study.

12. The method as defined in claim 1 wherein adjusting the implant includes performing a minimally invasive adjustment.

13. The method as defined in claim 12 wherein the minimally invasive adjustment is performed by engaging an adjustment mechanism within the implant with an adjustment instrument.

14. The method as defined in claim 13 wherein the adjustment instrument actuates an adjustment portion within the implant to adjust the orientation of the implant within the patient.

15. The method as defined in claim 13 wherein the adjustment instrument engages the implant to at least deliver a fluid or release a fluid within the implant.

16. The method as defined in claim 1 wherein adjusting the implant includes adjusting the implant telemetrically in a non-surgical procedure.

17. The method as defined in claim 16 wherein the telemetric adjustment includes wirelessly actuating a driver within the implant to adjust performance of the implant positioned within the patient.

18. The method as defined in claim 17 wherein the wireless actuation of the driver further includes wirelessly activating at least one of a passive driver and an active driver positioned within the implant.

19. The method as defined in claim 1 wherein adjusting the implant is a real-time adaptive adjustment of the implant without any outside intervention.

20. The method as defined in claim 1 further comprising tuning a plurality of implants positioned within the patient.

21. The method as defined in claim 20 further comprising adaptively adjusting the plurality of implants with a single controller positioned within the patient.

22. The method as defined in claim 21 further comprising positioning the controller within one of the plurality of implants.

23. The method as defined in claim 20 further comprising providing communication between the plurality of implants.

24. The method as defined in claim 1 wherein said implant is a spinal disc implant.

25. The method as defined in claim 24 wherein said spinal disc implant is a cervical spinal disc implant.

26. The method as defined in claim 24 wherein said spinal disc implant includes an articulating ball and socket.

27. The method as defined in claim 24 wherein said spinal disc implant includes an adjustable bladder.

28. A tunable implant positioned within a patient, said tunable implant comprising:

a securing mechanism operable to secure said implant within the patient;

an actuation portion operable to permit said tunable implant to move; and

an adjustable portion operable to permit adjustment of said tunable implant after said tunable implant is positioned within the patient, wherein upon adjusting the implant, the implant provides improved performance.

29. The tunable implant as defined in claim 28 wherein said securing mechanism includes a flange operable to engage a bone of the patient.

30. The tunable implant as defined in claim 29 wherein said flange defines a passageway operable to receive a bone screw to secure the tunable implant to the bone.

31. The tunable implant as defined in claim 29 further comprising a pair of flanges operable to secure a first portion and a second portion of said tunable implant to a pair of articulating bones.

32. The tunable implant as defined in claim 28 wherein said actuation portion includes a first articulating surface and a second articulating surface, wherein said first articulating surface is operable to articulate with said second articulating surface.

33. The tunable implant as defined in claim 32 wherein said first articulating surface is a ball and said second articulating surface is a socket, wherein said ball articulates within said socket.

34. The tunable implant as defined in claim 28 wherein said actuation portion includes a bladder portion operable to permit said tunable implant to move relative to bone.

35. The tunable implant as defined in claim 34 wherein said bladder portion is filled with fluid.

36. The tunable implant as defined in claim 28 further comprising at least one sensor positioned within said implant and operable to sense a parameter.

37. The tunable implant as defined in claim 36 wherein said parameter is selected from a group comprising temperature, pressure, stress, strain, loading force, tortional force, and frictional force.

38. The tunable implant as defined in claim 36 further comprising a controller operable to receive sensed information from said at least one sensor, said controller positioned within said implant.

39. The tunable implant as defined in claim 28 wherein said actuation portion is a mechanical actuation portion operable to be actuated by an instrument during a minimally invasive procedure.

40. The tunable implant as defined in claim 28 wherein said actuation portion is an actuator operable to be actuated telemetrically in a non-surgical procedure.

41. The tunable implant as defined in claim 39 wherein said actuation portion includes a hinged region and an adjustable screw operable to be engaged by said instrument during the minimally invasive procedure.

42. The tunable implant as defined in claim 40 wherein said actuation portion includes a hinged region and an adjustable screw wherein said actuator is operable to telemetrically adjust said adjustable screw during the non-surgical procedure.

43. The tunable implant as defined in claim 34 wherein said bladder portion includes a plurality of bladders.

44. The tunable implant as defined in claim 43 wherein each bladder includes a sensor operable to sense a parameter within each bladder.

45. The tunable implant as defined in claim 44 wherein said actuation portion includes a bladder control system operable to adjust pressure within each of said plurality of bladders.

46. The tunable implant as defined in claim 45 wherein said bladder control system is further operable to receive sensor readings from each of said sensors.

47. The tunable implant as defined in claim 46 wherein said bladder control system is one of at least a passive control system and an active control system.

48. The tunable implant as defined in claim 47 wherein said bladder control system is operable to be controlled telemetrically in a non-surgical procedure.

49. The tunable implant as defined in claim 47 wherein said bladder control system adaptively controls pressure in each of said plurality of bladders.

50. The tunable implant as defined in claim 34 wherein the bladder includes at least one mechanical adjustment mechanism.

51. The tunable implant as defined in claim 50 further comprising at least one sensor operable to sense a parameter within said bladder.

52. The tunable implant as defined in claim 50 further comprising a force control system operable to control the mechanical adjustment mechanism within the said bladder.

53. The tunable implant as defined in claim 52 wherein said force control mechanism is one of at least a passive and an active control system.

54. The tunable implant as defined in claim 53 wherein said force control system is operable to be controlled telemetrically in a non-surgical procedure.

55. The tunable implant as defined in claim 28 further comprising a plurality of tunable implants, each including said securing mechanism, said actuation portion and said adjustment portion.

56. The tunable implant as defined in claim 55 further comprising at least one controller operable to control adjustment in each of said plurality of tunable implants.

57. The tunable implant as defined in claim 56 further comprising at least one sensor positioned in each implant operable to forward sensed information to said at least one controller.

58. The tunable implant as defined in claim 57 wherein said at least one controller is operable to adaptively control each of said plurality of implants.

59. The tunable implant as defined in claim 56 wherein said at least one controller is located within at least one implant.

60. The tunable implant as defined in claim 56 wherein said at least one controller is remote from each of said implants and positioned within the patient.

61. The tunable implant as defined in claim 56 wherein said at least one controller is operable to be controlled telemetrically.

62. The tunable implant as defined in claim 28 further comprising a segmented portion operable to enable said implant to be folded in a manner to make the implant substantially smaller than its unfolded state.

63. A tunable implant system for use in adjusting a tunable implant in a patient, said tunable implant system comprising:

a tunable implant having an adjustment portion operable to permit adjustment of said tunable implant after said tunable implant is positioned within the patient; and

a telemetric system operable to telemetrically receive data from said tunable implant, wherein said data is used to determine said adjustment of said tunable implant.

64. The tunable implant system as defined in claim 63 wherein said tunable implant further includes an actuation portion operable to permit said tunable implant to move.

65. The tunable implant system as defined in claim 64 wherein said tunable implant further includes at least one sensor operable to sense a parameter within said implant, said parameter being at least part of said data received by said telemetric system.

66. The tunable implant system as defined in claim 65 wherein said tunable implant further includes a controller operable to receive said sensed parameter information from said sensor and further operable to transmit said sensed information to said telemetric system.

67. The tunable implant system as defined in claim 66 wherein said controller is at least one of a passive and an active controller.

68. The tunable implant system as defined in claim 66 wherein said controller is further operable to actuate said adjustment portion to adjust said tunable implant.

69. The tunable implant system as defined in claim 66 wherein said telemetric system is operable to transmit and receive data from said controller.

70. The tunable implant system as defined in claim 69 wherein said telemetric system is further operable to charge a battery in said controller.

71. The tunable implant system as defined in claim 63 wherein said telemetric system further includes a controller operable to process said data received telemetrically by said telemetric system.

72. The telemetric implant system as defined in claim 71 wherein said controller is further operable to transmit said data to a remote site.

73. An instrument assembly for use in performing spinal surgery, said instrument assembly comprising:

a mounting platform operable to be positioned adjacent to a plurality of vertebrae; and

a jig operable to be removably attached to said mounting platform, said jig further operable to support an instrument used during the spinal surgery.

74. The instrument assembly as defined in claim 73 wherein said mounting platform is further operable to substantially rigidly secure said plurality of vertebrae.

75. The instrument assembly as defined in claim 73 wherein said jig is further operable to be selectively and removably attached to said mounting platform, along a plurality of positions defined on said mounting platform.

76. The instrument assembly as defined in claim 73 wherein said instrument is a robotically controlled instrument coupled to said jig.

77. The instrument assembly as defined in claim 73 wherein a location of said instrument is tracked utilizing a surgical navigation system.

78. The instrument assembly as defined in claim 77 further comprising a tracking device attached to said instrument assembly and operable to be tracked by said surgical navigation system.

81. The instrument assembly as defined in claim 73 further comprising a plurality of jigs operable to be removably attached to said mounting platform, each of said jigs providing a different orientation of a working platform.

82. The instrument assembly as defined in claim 81 wherein said jig further includes a working platform defining an opening for passing said instrument.

79. The instrument assembly as defined in claim 79 wherein said tracking device is attached to said jig.

80. The instrument assembly as defined in claim 79 wherein said tracking device is attached to said instrument attached to said jig.