System and methods for diagnosis and treatment of discogenic lower back pain

• US 9,950,164 B2
• Filed: 11/18/2015
• Issued: 04/24/2018
• Est. Priority Date: 02/23/2011
• Status: Active Grant

• Current Assignee: John D. Lipani
• Original Assignee: John D. Lipani
• Inventors: Lipani, John D
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US14/944,488
• Publication Number:
  US 20160067494A1
• Time in Patent Office: 888 Days
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00047 using Peltier effect
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61H 2205/081 Back
• CPC Class Codes: A61H 23/02 with electric or magnetic drive
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 : Frequency
• CPC Class Codes: A61N 1/36178 : Burst or pulse train parameters
• CPC Class Codes: A61N 1/37205 : Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 : Means for communicating with stimulators
• CPC Class Codes: A61N 1/37223 : Circuits for electromagnetic coupling
• CPC Class Codes: A61N 5/0622 : Optical stimulation for exciting neural tissue

Abstract

Methods and devices to treat discogenic lumbar back pain are disclosed. Electrodes are implanted within the anterior epidural space of the patient. A pulse generator that is connected to the electrodes delivers electrical impulses to sympathetic nerves located within the posterior longitudinal ligament (PLL) of the lumbar spine and outer posterior annulus fibrosus of the intervertebral disc. In alternate embodiments, energy directed to nerves in the PLL may be from light or mechanical vibrations, or the nerves may be cooled. The electrodes may also be used diagnostically to correlate spontaneous nerve activity with spinal movement, fluctuations in autonomic tone and the patient'"'"'s experience of pain. The electrodes may also be used to generate diagnostic evoked potentials. The diagnostic data are used to devise parameters for the therapeutic nerve stimulation. Automatic analysis of the data may be incorporated into a closed-loop system that performs the nerve stimulation automatically.

Claims

1. A method of treating discogenic lumbar back pain in a patient comprising:

positioning a plurality of electrodes within an anterior epidural space of the patient to a position adjacent to a posterior longitudinal ligament and/or a posterior annulus fibrosus;

generating one or more electrical impulses with a pulse generator; and

transmitting the electrical impulses through said electrodes to one or more nerves in said posterior longitudinal ligament and/or said posterior annulus fibrosus;

wherein the electrical impulses are sufficient to cause one or more sympathetic nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus to inhibit an initiation and/or a transmission of an action potential in one or more nociceptive nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus;

wherein the electrical impulses promote the release of one or more molecules of norepinephrine from the sympathetic nerves, thereby promoting a binding of the norepinephrine molecules to an alpha-2 adrenoreceptor in the nociceptive nerves, whereby the initiation and/or the transmission of the action potential in the nociceptive nerves is inhibited; and

wherein the electrical impulses at least partially relieve the pain without producing irreversible damage in any tissue of the patient.

2. The method of claim 1 wherein a sympathetic tone in the patient and a level of pain in the patient are measured, and wherein said tone and said level are found to be negatively correlated prior to the transmitting step.

3. The method of claim 1 wherein the electrical impulses are transmitted preferentially to sympathetic nerves in a superficial layer of the posterior longitudinal ligament, in a deep layer of the posterior longitudinal ligament, or in a superficial layer of the posterior annulus fibrosus.

4. A method of treating discogenic lumbar back pain in a patient comprising:

positioning a plurality of electrodes within an anterior epidural space of the patient to a position adjacent to a posterior longitudinal ligament and/or a posterior annulus fibrosus;

generating one or more electrical impulses with a pulse generator; and

transmitting the electrical impulses through said electrodes to one or more nerves in said posterior longitudinal ligament and/or said posterior annulus fibrosus;

wherein the electrical impulses are sufficient to inhibit one or more sympathetic nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus from promoting an initiation and/or a transmission of an action potential in one or more nociceptive nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus;

wherein the electrical impulses inhibit the release of one or more molecules of norepinephrine from the sympathetic nerves, thereby inhibiting a binding of the norepinephrine molecules to an alpha-1 adrenoreceptor in the nociceptive nerves, whereby the initiation and/or the transmission of the action potential in the nociceptive nerves is inhibited; and

wherein the electrical impulses at least partially relieve the pain without producing irreversible damage in any tissue of the patient.

5. The method of claim 4 wherein a sympathetic tone in the patient and a level of pain in the patient are measured, wherein said tone and said level are found to be positively correlated prior to the transmitting step.

6. The method of claim 4 wherein the electrical impulses are transmitted preferentially to sympathetic nerves in a superficial layer of the posterior longitudinal ligament, in a deep layer of the posterior longitudinal ligament, or in a superficial layer of the posterior annulus fibrosus.

7. A device for treating discogenic lumbar back pain in a patient comprising:

a plurality of electrodes that is coupled to an electrical pulse generator;

wherein the plurality of electrodes is configured to be positioned within an anterior epidural space of the patient at a position adjacent to a posterior longitudinal ligament and/or a posterior annulus fibrosus;

wherein the pulse generator is configured to transmit electrical impulses through said electrodes to at least partially relieve the pain without producing irreversible damage in any tissue of the patient; and

wherein the electrical impulses exhibit at least two alternate, selectable waveform configurations, comprising at least a Waveform Configuration A and an alternate Waveform Configuration B;

wherein when Waveform Configuration A is selected, the electrical impulses cause one or more sympathetic nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus to inhibit an initiation and/or a transmission of an action potential in one or more nociceptive nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus;

wherein when Waveform Configuration A is selected, the electrical impulses promote the release of one or more molecules of norepinephrine from the sympathetic nerves, thereby promoting a binding of the norepinephrine molecules to an alpha-2 adrenoreceptor in the nociceptive nerves, whereby the initiation and/or the transmission of the action potential in the nociceptive nerves is inhibited; and

wherein when Waveform Configuration B is selected, the electrical impulses inhibit one or more sympathetic nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus from promoting an initiation and/or a transmission of an action potential in one or more nociceptive nerves in the posterior longitudinal ligament and/or in the posterior annulus fibrosus;

wherein when Waveform Configuration B is selected, the electrical impulses inhibit the release of one or more molecules of norepinephrine from the sympathetic nerves, thereby inhibiting a binding of the norepinephrine molecules to an alpha-1 adrenoreceptor in the nociceptive nerves, whereby the initiation and/or the transmission of the action potential in the nociceptive nerves is inhibited.

8. The device of claim 7 further comprising a flexible and/or elastic electrically insulating material having a first side and an opposing second side, wherein said electrodes are attached to said insulating material, and wherein said electrodes are disposed along the first side of said electrically insulating material.

9. The device of claim 8, wherein the electrical impulses are transmitted through said electrodes substantially in one direction.

10. The device of claim 9, wherein the electrodes are disposed substantially linearly along the electrically insulating material, and wherein the electrodes and the insulating material are configured to be inserted into the patient percutaneously through a neural foramen.

11. The device of claim 10 further comprising fins, wherein said fins are joined to the insulating material.

12. The device of claim 8 wherein the plurality of electrodes is disposed nonlinearly or linearly along the first side of the electrically insulating material, and wherein a length, and/or a width, and/or a perimeter of said insulating material is configured to fit within a selected dimension and/or a selected surface area of one or more lumbar discs of the patient and/or to fit within a selected dimension and/or a selected surface area of an intervening vertebral bodies of said discs of the patient, and/or to fit within a selected distance between two adjacent ipsilateral nerve roots of the patient.

13. The device of claim 12 wherein the length, and/or width, and/or perimeter of said insulating material is configured to fit within the selected dimension and/or surface area of a single intervertebral disc of the patient.

14. The device of claim 13 wherein the length, and/or width, and/or perimeter of said insulating material is configured to fit within the selected dimension and/or surface area of two or more intervertebral discs of the patient and/or of the selected dimension and/or surface area of the intervening vertebral bodies of said discs.

15. The device of claim 8 wherein the insulating material is connected to one or more anchoring tabs that are configured for the attachment of said tabs to a tissue of the patient.

16. The device of claim 7 wherein the plurality of electrodes is coupled to the electrical pulse generator with electrically conducting wires.

17. The device of claim 7 wherein the electrical pulse generator is configured to be implanted within the patient.

18. The device of claim 7 wherein power is supplied to the electrical pulse generator by batteries.

19. The device of claim 7 wherein power is supplied to the electrical pulse generator by a receiver that is inductively coupled by a receiving coil to a physically-unattached external transmitter.

20. The device of claim 7 wherein the electrical impulses comprise rectangular, biphasic, charge balanced pulses of adjustable rate, adjustable duration and adjustable amplitude for each electrode among the plurality of electrodes.

21. The device of claim 7 wherein each electrode among the plurality of electrodes is configured to be disconnectable from the pulse generator.

22. The device of claim 7 wherein an adjustment of each electrode'"'"'s electrical impulse rate, duration, amplitude and anode/cathode configuration, and of each electrode'"'"'s connection or disconnection to the pulse generator, is made by the pulse generator using control signals that are transmitted to the pulse generator by a programmer.

23. The device of claim 22 wherein the transmission of the control signals is to a receiver of the pulse generator, said receiver being inductively coupled by a receiving coil to a physically unattached external transmitter of the programmer.

24. The device of claim 7 wherein the electrical impulses comprise pulses having a frequency of between about 0.01 Hz and 10,000 Hz.

25. The device of claim 7 wherein the electrical impulses comprise pulses having a frequency of between about 20 Hz and 120 Hz.

26. The device of claim 7 wherein the electrical impulses comprise pulses having a width of between about 100 and 400 microseconds.

27. The device of claim 7 wherein the electrical impulses comprise pulses having an amplitude of between about 0.001 and 10 volts.

28. The device according to claim 7, and further comprising a trocar, or a guide wire, or a stylet, or an introducer cannula, or an obturator, or a lead blank;

wherein the trocar, or the guide wire, or the stylet, or the introducer cannula, or the obturator, or the lead blank is configured for the placement into the patient of the device according to claim 7.