Spinal implants including a sensor and methods of use

• US 20070191833A1
• Filed: 01/27/2006
• Published: 08/16/2007
• Est. Priority Date: 01/27/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Bruneau, Aurelien, Anderson, Kent, Lange, Eric
• Granted Patent: US 7,691,130 B2
• Time in Patent Office: Days
• US Class Current: 606/86.00A
• 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 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:

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; and

replacing said first spinal implant with said second spinal implant.

2. The method of claim 1 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.

3. The method of claim 1 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.

4. The method of claim 3 wherein said material property is a stiffness.

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

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

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

8. 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.

9. The method of claim 8 wherein said first spinal implant directly engages both of said superior and inferior spinous processes.

10. The method of claim 1 further comprising installing a receiver body between a superior spinous process and an inferior spinous process;

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

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.

11. 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;

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 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.

12. The method of claim 1:

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.

13. The method of claim 12 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.

14. 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; and

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

15. The method of claim 14 wherein said disposing a spinal stabilizer between the spinous processes comprises replacing said first interspinous implant with a second interspinous implant.

16. The method of claim 14 wherein said disposing a spinal stabilizer between the spinous processes comprises replacing a portion of said first interspinous implant.

17. The method of claim 14 wherein said inserting a first interspinous implant between the spinous processes comprises inserting said first spinal implant during a first surgical procedure;

and wherein said disposing a spinal stabilizer between the spinous processes comprises disposing said spinal stabilizer between the spinous processes during a subsequent surgical procedure.

18. The method of claim 14 wherein said generating measurement data comprises transmitting said measurement data from said first interspinous implant.

19. The method of claim 14 wherein said sensor is embedded in said first interspinous implant.

20. The method of claim 14 wherein said first interspinous implant comprises a superior saddle, an inferior saddle, and a compressible body therebetween;

said sensor disposed in said body.

21. The method of claim 20 wherein said inserting said first interspinous implant between the superior and inferior spinous processes comprises disposing said superior and inferior saddles proximate the superior and inferior spinous processes, respectively.

22. The method of claim 14 wherein said spinal stabilizer has a stiffness different than said first interspinous implant.

23. The method of claim 14 wherein said generating measurement data indicative of a mechanical environment for said first interspinous implant when installed comprises generating measurement data indicative of compressive strain experienced by said first interspinous implant.

24. The method of claim 14:

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

said sensor disposed in said body;

wherein said inserting a first-interspinous implant comprises -inserting-said first spinal implant between the spinous processes during a first surgical procedure 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 spinal stabilizer has a stiffness different than said first interspinous implant; and

wherein said disposing a spinal stabilizer between the spinous processes comprises replacing said first interspinous implant with a second interspinous implant during a subsequent surgical procedure.

25. The method of claim 14:

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.

26. The method of claim 25 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.

27. An interspinous implant, comprising:

a superior saddle adapted to accept a superior spinous process, an inferior saddle adapted to accept an inferior spinous process, and a compressible body therebetween;

a sensor disposed in said body;

said sensor adapted to generate measurement data indicative of at least one of forces acting on said implant and strain of said implant.

28. The interspinous implant of claim 27 wherein said sensor comprises a strain gage.

29. The interspinous implant of claim 27 further comprising a removable module disposed in said body;

said sensor disposed in said removable module.

30. An interspinous implant kit, comprising:

a first interspinous implant comprising;

a superior saddle adapted to accept a superior spinous process, an inferior saddle adapted to accept an inferior spinous process, and an intermediate section therebetween;

a sensor disposed in said intermediate section;

said sensor adapted to generate measurement data indicative of at least one of forces acting on said first interspinous implant and strain of said first interspinous implant;

a second interspinous implant having a superior saddle adapted to accept the superior spinous process, an inferior saddle adapted to accept the inferior spinous process, and a compressible body therebetween;

said second interspinous implant having a second mechanical material property;

a third interspinous implant having a superior saddle adapted to accept the superior spinous process, an inferior saddle adapted to accept the inferior spinous process, and a compressible body therebetween;

said third interspinous implant having a third mechanical material property of the same type, but different than, said second mechanical material property.

31. An interspinous implant kit, comprising:

a receiver body adapted to be implanted between a superior spinous process and an inferior spinous process;

said receiver body comprising a superior saddle adapted to accept the superior spinous process, an inferior saddle adapted to accept the inferior spinous process, and an intermediate section therebetween;

said intermediate section comprising a module-receiving bay;

first, second, and third modules configured to be interchangeably received in said module-receiving bay;

said first module having a sensor disposed therein;

said sensor adapted to generate measurement data indicative of at least one of forces acting on said receiver body and strain when mated to said receiver body;

said second module having a second mechanical material property; and

said third module having a third mechanical material property of the same type, but different than, said second mechanical material property.