Spinal implants including a sensor and methods of use

• US 7,691,130 B2
• Filed: 01/27/2006
• Issued: 04/06/2010
• Est. Priority Date: 01/27/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Bruneau, Aurelien, Lange, Eric C., Anderson, Kent M.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HAMMOND, ELLEN CHRISTINA
• Application Number:
  US11/340,974
• Publication Number:
  US 20070191833A1
• Time in Patent Office: 1,530 Days
• Field of Search: 600/594, 623 1711- 1716, 606/90, 606/248, 606/279, 606/24
• US Class Current: 606/249
• 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 2090/064 for measuring force, pressure or mechanical tension

Abstract

A method of spacing spinal elements includes installing a first spinal implant having a sensor associated therewith; selecting a second spinal implant based on measurement data provided by the sensor; and replacing the first spinal implant with the second spinal implant. The first and second implants may be installed in separate surgical procedures, or during the same surgical procedure, and the implants may be positioned between a superior spinous process and an inferior spinous process and advantageously directly engage the same. The selection of the second implant may be based on the data provided by the sensor and a material property of the second spinal implant, such as its stiffness. The measurement data may correspond to strain or force data. The sensor may be, but is not required to be, embedded in the first spinal implant. A corresponding apparatus is described.

Claims

1. A method of spacing spinal elements, comprising:

creating a first incision in a human body during a first surgical procedure;

installing a first spinal implant having a sensor associated therewith during the first surgical procedure;

closing the first incision;

generating measurement data, by said sensor, indicative of at least one mechanical property of the spine with said first spinal implant installed;

selecting a second spinal implant based on said measurement data and a material property of the second spinal implant;

thereafter, creating a second incision in the human body during a second surgical procedure;

replacing said first spinal implant with said second spinal implant during the subsequent second surgical procedure;

wherein said replacing the first spinal implant with the second spinal implant comprises replacing a first insert with a second insert by removing the first insert from a receiver body and joining a second insert to the receiver body;

thereafter, closing the second incision.

2. The method of claim 1 further comprising transmitting said measurement data from said sensor prior to said replacing.

3. The method of claim 1 wherein said measurement data corresponds to strain data.

4. The method of claim 1 wherein said sensor is embedded in said first spinal implant.

5. The method of claim 1 wherein said installing said first spinal implant comprises installing said first spinal implant between a superior spinous process and an inferior spinous process.

6. The method of claim 5 wherein said first spinal implant directly engages both of said superior and inferior spinous processes.

7. The method of claim 1:

wherein said sensor is affixed to said first spinal implant;

wherein said installing said first spinal implant comprises installing said first spinal implant between a superior spinous process and an inferior spinous process such that said first spinal implant directly engages both of said superior and inferior spinous processes;

further comprising transmitting said measurement data from said sensor prior to said replacing.

8. A method of spacing spinal elements, comprising:

installing a receiver body between a superior spinous process and an inferior spinous process;

installing a first spinal implant having a sensor associated therewith;

generating measurement data, by said sensor, indicative of at least one mechanical property of the spine with said first spinal implant installed;

selecting a second spinal implant based on said measurement data;

replacing said first spinal implant with said second spinal implant;

wherein said installing said first spinal implant comprises joining said first spinal implant to said receiver body; and

wherein replacing said first spinal implant with said second spinal implant comprises removing said first spinal implant from said receiver body and joining said second spinal implant to said receiver body.

9. A method of spacing spinal elements, comprising:

installing a first spinal implant having a sensor associated therewith

generating measurement data, by said sensor, indicative of at least one mechanical property of the spine with said first spinal implant installed;

selecting a second spinal implant based on said measurement data;

replacing said first spinal implant with said second spinal implant;

wherein said sensor is embedded in said first spinal implant;

wherein said installing said first spinal implant comprises installing a receiver body between a superior spinous process and an inferior spinous process such that said receiver body directly engages both of said spinous processes, and joining said first spinal implant to said receiver body;

further comprising transmitting said measurement data from said sensor prior to said replacing;

wherein said selecting said second spinal implant comprises selecting said second spinal implant based on said measurement data and a material property of said second spinal implant; and

wherein replacing said first spinal implant with said second spinal implant comprises removing said first spinal implant from said receiver body and joining said second spinal implant to said receiver body.

10. The method of claim 9 wherein said installing said first spinal implant comprises installing said first spinal implant during a first surgical procedure;

and wherein said replacing said first spinal implant with said second spinal implant comprises replacing said first spinal implant with said second spinal implant during a subsequent surgical procedure.

11. A method of spacing a superior spinous process relative to an inferior spinous process, comprising:

inserting a first interspinous implant between the spinous processes;

said first implant having a sensor associated therewith;

thereafter, generating measurement data indicative of a mechanical environment for said first interspinous implant when installed;

disposing a spinal stabilizer, having a mechanical property based on said measurement data, between the spinous processes;

wherein said first interspinous implant comprises a receiver body having a superior saddle, an inferior saddle, and a compressible body therebetween;

said sensor disposed in a sensor module mated to said body;

wherein said inserting a first interspinous implant comprises inserting said first spinal implant between the spinous processes such that said superior and inferior saddles engage the superior and inferior spinous processes, respectively;

wherein said generating measurement data comprises generating measurement data indicative of strain experienced by said first interspinous implant and transmitting said measurement data from said first interspinous implant;

wherein said disposing a spinal stabilizer between the spinous processes comprises unmating said sensor module from said receiver body and mating a second module to said receiver body; and

wherein said spinal stabilizer has a stiffness different than said first interspinous implant.

12. The method of claim 11 wherein said disposing a spinal stabilizer between the spinous processes comprises unmating said sensor module from said receiver body and mating a second module to said receiver body during a subsequent surgical procedure.

13. A method of spacing an upper spinous process relative to a lower spinous process, comprising:

creating a first incision in a human body during a first surgical procedure;

inserting a first implant between the spinous processes during the first surgical procedure;

wherein the first implant comprises an upper saddle, a lower saddle, and a sensor disposed between the upper and lower saddles;

wherein inserting the first implant comprises inserting the first implant between the spinous processes such that the upper saddle receives the upper spinous process, the lower saddle receives the lower spinous process, and the sensor is disposed between the upper and lower spinous processes;

closing the first incision;

generating measurement data with the sensor indicative of a mechanical strain applied by the spinous processes and transmitting the measurement data from the first implant while the first implant is disposed between the spinous processes;

thereafter, creating a second incision in the human body during a subsequent second surgical procedure;

removing a first insert from a receiver body of the first implant during the subsequent second surgical procedure;

selecting a second insert based on the measurement data;

inserting the second insert in the receiver body so as to be disposed between the spinous processes during the subsequent second surgical procedure;

thereafter, closing the second incision.

14. The method of claim 13 wherein selecting said second insert comprises selecting said second insert based on said measurement data and a material property of said second insert.

15. The method of claim 14 wherein the material property of the second spinal implant is a stiffness thereof.

16. The method of claim 14 wherein the material property of the second implant is a flexural modulus thereof.

17. The method of claim 13 wherein inserting the first implant comprises inserting the first implant such that the sensor extends through a sagittal plane defined by the spinous processes.