METHOD AND APPARATUS FOR REPAIR OF INTERVERTEBRAL DISCS

• US 20080221490A1
• Filed: 03/06/2008
• Published: 09/11/2008
• Est. Priority Date: 03/06/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Zahos, Peter A.
• Granted Patent: US 8,088,084 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61H 2205/081 Back
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method of repairing an intervertebral disc of a patient'"'"'s body includes identifying a target area of the intervertebral disc. An ultrasound generator is placed proximate the target area and outside the patient'"'"'s body. An area temperature at the target area is monitored. Ultrasonic energy is generated with the ultrasound generator within a predetermined energy range. The ultrasonic energy is adjusted in response to the area temperature exceeding a predetermined temperature range. An apparatus for repairing an intervertebral disc of a patient'"'"'s body is also provided.

Claims

1. A method of repairing an intervertebral disc of a patient'"'"'s body, the method comprising the steps of:

identifying a target area of the intervertebral disc;

placing an ultrasound generator proximate the target area and outside the patient'"'"'s body;

monitoring an area temperature at the target area;

generating ultrasonic energy with the ultrasound generator within a predetermined energy range; and

adjusting the ultrasonic energy in response to the area temperature exceeding a predetermined temperature range.

2. The method of claim 1, wherein the step of generating ultrasonic energy with the ultrasound generator within a predetermined energy range includes the step of generating pulsed low intensity ultrasonic energy with a pulse width of 10-20000 μ

s, repetition rate of 100-1000 Hz, operation frequency of 1.3-2 MHz, and temporal average intensities less than 100 mW/cm².

3. The method of claim 2, wherein the step of generating pulsed low intensity ultrasonic energy with a pulse width of 10-20000 μ

s, repetition rate of 100-1000 Hz, operation frequency of 1.3-2 MHz, and temporal average intensities less than 100 mW/cm² includes the step of generating pulsed low intensity ultrasonic energy with a pulse width of 200 μ

s, repetition rate of 1 KHz, operation frequency of 1.5 MHz, and temporal average intensities of 30 mW/cm².

4. The method of claim 1, wherein the step of adjusting the ultrasonic energy in response to the area temperature exceeding a predetermined temperature range includes the step of discontinuing the ultrasonic energy.

5. The method of claim 1, including the steps of:

providing a pharmaceutical agent to the target area; and

enhancing at least one disc-healing quality of the pharmaceutical agent with the ultrasonic energy.

6. The method of claim 1, including the steps of:

providing at least one chondrocyte to the target area; and

enhancing at least one disc-healing quality of the at least one chondrocyte with the ultrasonic energy.

7. The method of claim 1, wherein the step of monitoring an area temperature at the target area includes the step of inserting a temperature sensor into the patient'"'"'s body.

8. The method of claim 1, including the step of regenerating at least one cell in the target area using the ultrasonic energy.

9. The method of claim 1, wherein the step of placing an ultrasound generator proximate the target area and outside the patient'"'"'s body includes the step of attaching a portable ultrasound generator to the patient'"'"'s body.

10. A method of treating degenerative disc disease of an intervertebral disc of a patient'"'"'s body, the method comprising the steps of:

identifying a target area of the intervertebral disc, the target area including at least a portion of the intervertebral disc which has deteriorated due to degenerative disc disease;

placing an ultrasound generator proximate the target area and outside the patient'"'"'s body;

monitoring an area temperature at the target area;

generating ultrasonic energy with the ultrasound generator within a predetermined energy range;

regenerating at least one cell in the target area using the ultrasonic energy; and

adjusting the ultrasonic energy in response to the area temperature exceeding a predetermined temperature range.

11. The method of claim 10, wherein the step of generating ultrasonic energy with the ultrasound generator within a predetermined energy range includes the step of generating pulsed low intensity ultrasonic energy with a pulse width of 200 μ

s, repetition rate of 1 KHz, operation frequency of 1.5 MHz, and temporal average intensities of 30 mW/cm².

12. The method of claim 10, including the steps of:

providing a pharmaceutical agent to the target area; and

enhancing at least one disc-healing quality of the pharmaceutical agent with the ultrasonic energy.

13. The method of claim 10, including the steps of:

providing at least one chondrocyte to the target area; and

enhancing at least one disc-healing quality of the at least one chondrocyte with the ultrasonic energy.

14. The method of claim 10, wherein the step of placing an ultrasound generator proximate the target area and outside the patient'"'"'s body includes the step of attaching a portable ultrasound generator to the patient'"'"'s body.

15. An apparatus for repairing an intervertebral disc of a patient'"'"'s body, comprising:

an ultrasound generator for providing ultrasonic energy to a target area of the intervertebral disc, the ultrasound generator being adapted for placement proximate the target area and outside the patient'"'"'s body, the ultrasonic energy generated by the ultrasound generator being within a predetermined energy range;

a temperature monitor for sensing an area temperature at the target area; and

a controller adapted to control the generation of ultrasonic energy by the ultrasound generator;

wherein the controller adjusts the ultrasonic energy responsive to the area temperature exceeding a predetermined temperature range.

16. The apparatus of claim 15, wherein the intervertebral disc has deteriorated due to degenerative disc disease.

17. The apparatus of claim 15, wherein the ultrasonic energy within the predetermined energy range is pulsed low intensity ultrasonic energy with a pulse width of 10-20000 μ

s, repetition rate of 100-1000 Hz, operation frequency of 1.3-2 MHz, and temporal average intensities less than 100 mW/cm².

18. The apparatus of claim 17, wherein the ultrasonic energy within the predetermined energy range is pulsed low intensity ultrasonic energy with a pulse width of 200 μ

s, repetition rate of 1 KHz, operation frequency of 1.5 MHz, and temporal average intensities of 30 mW/cm².

19. The apparatus of claim 15, wherein the controller controls the ultrasonic generator to discontinue generation of the ultrasonic energy responsive to the area temperature exceeding the predetermined temperature range.

20. The apparatus of claim 15, wherein a pharmaceutical agent is provided to the target area and the ultrasonic energy enhances at least one disc-healing quality of the pharmaceutical agent.

21. The apparatus of claim 15, wherein at least one chondrocyte is provided to the target area and the ultrasonic energy enhances at least one disc-healing quality of the at least one chondrocyte.

22. The apparatus of claim 15, wherein the temperature monitor is inserted into the patient'"'"'s body.

23. The apparatus of claim 15, wherein the ultrasonic energy is operative to at least partially regenerate at least one cell in the target area.

24. The apparatus of claim 15, wherein the ultrasonic generator is a portable ultrasonic generator, the apparatus including a patient harness adapted for attachment to the patient'"'"'s body and operative to maintain the portable ultrasound generator in a desired position proximate the target area during generation of ultrasonic energy.