Epidural thermal posterior annuloplasty

• US 6,673,063 B2
• Filed: 04/10/2001
• Issued: 01/06/2004
• Est. Priority Date: 10/06/2000
• Status: Expired due to Fees

• Current Assignee: Expanding Concepts, LLC
• Original Assignee: Expanding Concepts, LLC
• Inventors: Brett, Darrell C.
• Primary Examiner(s): Shay, David M.
• Application Number:
  US09/832,642
• Publication Number:
  US 20030158591A1
• Time in Patent Office: 1,001 Days
• Field of Search: 606/3-7, 606/10-17, 606/40-52, 607/88, 607/89, 607/91-103, 607/108
• US Class Current: 606/10
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2018/00017 with gas
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2090/0436 Shielding
• CPC Class Codes: A61B 90/04 Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022

Abstract

An apparatus for thermally treating intervertebral discs includes an energy application head having an energy application region and a tissue protecting region. A control member operationally connected to the energy application head preferably controls the energy application head during treatment. The present invention also includes a method for thermally treating an intervertebral disc.

Claims

1. An apparatus for thermally treating at least one intervertebral disc, comprising:

(a) an energy application head having an energy application region and a tissue protecting region;

(b) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said at least one intervertebral disc; and

(c) said energy application head having a distance between said energy application region and said tissue protecting region wherein said distance is variable to protect tissue of said at least one intervertebral disc.

2. An apparatus for thermally treating at least one intervertebral disc, comprising:

(a) an energy application head having an energy application region and a tissue protecting region;

(b) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said at least one intervertebral disc; and

(c) said energy application head having a distance between said energy application region and said tissue protecting region wherein said distance automatically varies to protect tissue of said at least one intervertebral disc.

3. An apparatus for thermally treating at least one intervertebral disc, comprising:

(a) an energy application head having an energy application region and a tissue protecting region;

(b) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said at least one intervertebral disc; and

(c) said energy application head having a distance between said energy application region and said tissue protecting region wherein said distance is variable in proportion to an amount of energy being delivered to said at least one intervertebral disc.

4. An apparatus for thermally treating at least one intervertebral disc, comprising:

(a) an energy application head having an energy application region and a tissue protecting region;

(b) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said at least one intervertebral disc; and

(c) said energy application head having a distance between said energy application region and said tissue protecting region wherein said distance automatically varies in proportion to an amount of energy being delivered to said at least one intervertebral disc.

5. An apparatus for thermally treating at least one intervertebral disc, comprising:

(a) an energy application head having an energy application region and a tissue protecting region, said energy application head being wedge-shaped;

(b) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said at least one intervertebral disc; and

(c) said energy application head having a distance between said energy application region and said tissue protecting region wherein said distance automatically varies in proportion to an amount of energy being delivered to said at least one intervertebral disc.

6. The apparatus of claim 5, wherein said energy application head has a smooth surface suitable for gliding over surfaces of an annulus fibrosis without snagging other tissues.

7. The apparatus of claim 5, said energy application head further comprising at least one instrument selected from the group consisting of:

(a) a temperature measuring instrument;

(b) a tissue visualizing instrument

(c) an energy measuring instrument;

(d) a distance measuring instrument;

(e) an area measuring instrument;

(f) a pressure measuring instrument; and

(g) a volume measuring instrument.

8. The apparatus of claim 5, said energy application head further comprising at least one energy applicator selected from the group consisting of:

(a) a laser;

(b) a fiber-optic strand;

(c) a lens;

(d) an electrode;

(e) a wire;

(f) a light bulb;

(g) a heating element; and

(h) an ultrasound transducer.

9. The apparatus of claim 5, said control member further comprising at least one member selected from the group consisting of:

(a) a wire;

(b) a fiber-optic strand;

(c) one or more hollow tubes;

(d) a radio control mechanism;

(e) a moving mechanical link; and

(f) a beam of light;

(g) a lumen for adding and removing instruments;

(h) a lumen for adding and removing tissue; and

(i) a lumen for irrigating.

10. The apparatus of claim 5, wherein said energy application head applies energy selected from the group consisting of:

(a) electric current;

(b) radio frequency waves;

(c) microwaves;

(d) infrared waves;

(e) visible light waves;

(f) ultraviolet waves;

(g) ultrasonic sound waves; and

(h) conductive thermal energy.

11. The apparatus of claim 10, said energy further comprising energy in a form selected from the group consisting of:

(a) incoherent electromagnetic radiation;

(b) defocused laser energy; and

(c) collimated laser energy.

12. The apparatus of claim 5, said tissue protecting region further comprising at least one thermal protector for protecting vulnerable tissues from energy applied by said energy application head.

13. The apparatus of claim 12, wherein said at least one thermal protector is selected from the group consisting of:

(a) at least one layer of insulation;

(b) airflow coolant;

(c) liquid coolant;

(d) coolant from a refrigeration system;

(e) a thermocouple; and

(f) a heat-pipe.

14. An apparatus for thermally treating at least one intervertebral disc, comprising:

(a) an energy application head having an energy application region and a tissue protecting region;

(b) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said at least one intervertebral disc;

(c) said energy application head having a thin insertion edge sloped to a thick region for lifting vulnerable tissues away from a site of energy application to said at least one intervertebral disc; and

(d) said energy application head having a distance between said energy application region and said tissue protecting region wherein said distance automatically varies in proportion to an amount of energy being delivered to said at least one intervertebral disc.

15. The apparatus of claim 14, wherein said energy application head has a smooth surface suitable for gliding over surfaces of an annulus fibrosis without snagging other tissues.

16. The apparatus of claim 14, said energy application head further comprising at least one instrument selected from the group consisting of:

(a) a temperature measuring instrument;

(b) a tissue visualizing instrument

(c) an energy measuring instrument;

(d) a distance measuring instrument;

(e) an area measuring instrument;

(f) a pressure measuring instrument; and

(g) a volume measuring instrument.

17. The apparatus of claim 14, said energy application head further comprising at least one energy applicator selected from the group consisting of:

(a) a laser;

(b) a fiber-optic strand;

(c) a lens;

(d) an electrode;

(e) a wire;

(f) a light bulb;

(g) a heating element; and

(h) an ultrasound transducer.

18. The apparatus of claim 14, said control member further comprising at least one member selected from the group consisting of:

(a) a wire;

(b) a fiber-optic strand;

(c) one or more hollow tubes;

(d) a radio control mechanism;

(e) a moving mechanical link;

(f) a beam of light;

(g) a lumen for adding and removing instruments;

(h) a lumen for adding and removing tissue; and

(i) a lumen for irrigating.

19. The apparatus of claim 14, wherein said energy application head applies energy selected from the group consisting of:

(a) electric current;

(b) radio frequency waves;

(c) microwaves;

(d) infrared waves;

(e) visible light waves;

(f) ultraviolet waves;

(g) ultrasonic sound waves; and

(h) conductive thermal energy.

20. The apparatus of claim 19, said energy further comprising energy in a form selected from the group consisting of:

(a) incoherent electromagnetic radiation;

(b) defocused laser energy; and

(c) collimated laser energy.

21. The apparatus of claim 14, said tissue protecting region further comprising at least one thermal protector for protecting vulnerable tissues from energy applied by said energy application head.

22. The apparatus of claim 21, wherein said at least one thermal protector is selected from the group consisting of:

(a) at least one layer of insulation;

(b) airflow coolant;

(c) liquid coolant;

(d) coolant from a refrigeration system;

(e) a thermocouple; and

(f) a heat-pipe.

23. A method for epidurally treating at least one intervertebral disc using a disc refurbisher, said method comprising the steps of:

(a) gaining access to a vertebral column;

(b) epidurally approaching the posterior aspect of said at least one intervertebral disc;

(c) applying energy to a posterior aspect of said at least one intervertebral disc using said disc refurbisher, said disc refurbisher having an energy application head having an energy application head having an energy application region and a tissue protecting region, said energy application head having a distance between said energy application region and said tissue protecting region; and

(d) varying said distance between said energy application region and said tissue protecting region to protect vulnerable tissues associated with said at least one intervertebral disc from said energy.

24. The method of claim 23, further comprising at least one step selected from the group of steps consisting of:

(a) evaluating an extent of disc injury;

(b) calculating an amount of energy needed to thermally refurbish said at least one intervertebral disc;

(c) monitoring an amount of energy delivered and a temperature in vulnerable tissues around said at least one intervertebral disc;

(d) observing and evaluating an amount of shrinkage and strengthening of said at least one intervertebral disc to determine an intensity and duration of further energy delivery; and

(e) verifying that said shrinkage and strengthening of said at least one intervertebral disc is mechanically successful.

25. The method of claim 23, further comprising the step of maintaining a safe temperature in vulnerable tissues near said at least one intervertebral disc.

26. A method for thermally treating an intervertebral disc while thermally protecting vulnerable tissues, said method comprising the steps of:

(a) providing a disc refurbisher, said disc refurbisher comprising;

(i) an energy application head having an energy application region and a tissue protecting region, said energy application head having a distance between said energy application region and said tissue protecting region; and

(ii) a control member operationally connected to said energy application head, said control member suitable for controlling said energy application head during treatment of said intervertebral disc;

(b) gaining access to a vertebral column;

(c) epidurally approaching the posterior aspect of said at least one intervertebral disc using said control member to position said energy application head;

(d) evaluating an extent of disc injury and calculating an amount of energy needed to thermally refurbish said at least one intervertebral disc;

(e) applying energy using said disc refurbisher to a posterior aspect of said at least one intervertebral disc while maintaining a safe temperature in said vulnerable tissues near said at least one intervertebral disc;

(f) varying said distance between said energy application region and said tissue protecting region to protect vulnerable tissues associated with said at least one intervertebral disc from said energy;

(g) monitoring an amount of energy delivered and a temperature in said vulnerable tissues near said at least one intervertebral disc;

(h) observing and evaluating an amount of shrinkage and strengthening of said at least one intervertebral disc to determine an intensity and duration of further energy delivery; and

(j) verifying that said shrinkage and strengthening of said at least one intervertebral disc is mechanically successful.

27. The method of claim 26, further comprising the step of applying further energy to other posterior areas of said at least one intervertebral disc to reduce pain.

28. The method of claim 26, said step of applying energy to said posterior aspect of said at least one intervertebral disc further comprising a step selected from the group consisting of:

(a) applying electric current;

(b) applying radio frequency waves;

(c) applying microwaves;

(d) applying infrared waves;

(e) applying visible light waves;

(f) applying ultraviolet waves;

(g) applying ultrasonic sound waves; and

(h) applying conductive thermal energy.

29. The method of claim 26, said step of monitoring an amount of energy delivered further comprising a step selected from the group consisting of:

(a) monitoring using a thermometer;

(b) monitoring using a thermistor;

(c) monitoring using a thyristor;

(d) monitoring using phosphor-coated optic fibers;

(e) monitoring using temperature-sensitive crystals;

(f) monitoring a pressure change in bodily tissue; and

(g) monitoring a volume change in bodily tissue.

30. The method of claim 26, said step of observing and evaluating an amount of shrinkage and strengthening of said at least one intervertebral disc further comprising a step selected from the group consisting of:

(a) observing with unaided vision;

(b) observing with at least one camera;

(c) observing with at least one lens;

(d) observing with at least one mirror;

(e) observing with at least one fiber-optic device;

(f) observing with a mechanical probe; and

(g) observing with a pressure sensor.