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

• US 9,630,011 B2
• Filed: 11/18/2015
• Issued: 04/25/2017
• 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:
  US14/944,594
• Publication Number:
  US 20160074661A1
• Time in Patent Office: 524 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 reversible electroporation A61N1/327
• 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 an anatomical structure;

wherein said anatomical structure is a posterior longitudinal ligament alone, a posterior annulus fibrosus alone, or said posterior longitudinal ligament and said posterior annulus fibrosus taken together;

measuring an activity of one or more nerves in said anatomical structure with said electrodes, wherein said measuring comprises a recording of one or more local field potential;

generating energy impulses with a pulse generator; and

transmitting said energy impulses to within said anatomical structure or to a device positioned adjacent to said anatomical structure;

wherein the nerve activity measurement is used to devise said energy impulses; and

wherein the energy impulses are used to at least partially relieve the pain in the patient.

2. The method of claim 1 wherein the energy impulses comprise at least one of the following fifteen modes:

(1) A;

(2) B;

(3) A and B taken together;

(4) C;

(5) A and C taken together;

(6) B and C taken together;

(7) A and B and C taken together;

(8) D;

(9) A and D taken together;

(10) B and D taken together;

(11) A and B and D taken together;

(12) C and D taken together;

(13) A and C and D taken together;

(14) B and C and D taken together;

or (15) A and B and C and D taken together;

where A is electrical energy that is transmitted to said electrodes;

where B is light energy that is transmitted to said nerves;

where C is electrical energy that is transmitted to a mechanical vibrator; and

where D is electrical energy that is transmitted to a thermoelectric device.

3. The method of claim 2 wherein the thermoelectric device is in contact with a material, wherein said material is both a thermal conductor and an electrical insulator.

4. The method of claim 3 wherein the material comprises at least one of:

a polyborazine compound, a diamond powder, a beryllium oxide, or a boron nitride.

5. The method of claim 1 further comprising positioning within the anterior epidural space adjacent to said anatomical structure at least one of:

an accelerometer, a stress sensor, or a laser Doppler flowmeter sensor; and

measuring a location with said positioned accelerometer wherein said location is used to devise said energy impulses, measuring a stress with said positioned stress sensor wherein said stress is used to devise said energy impulses, or measuring a blood flow with said positioned laser Doppler flowmeter sensor wherein said blood flow measurement is used to devise said energy impulses.

6. The method of claim 1 further comprising measuring an attribute of the patient, wherein the measured attribute is at least one of:

a level of pain, an electroencephalogram, an evoked potential, an electrocardiogram, an electrodermal response, or an electromyogram;

wherein said measured attribute is used to devise said energy impulses.

7. The method of claim 1 wherein the measuring is a component of a feedback or feedforward loop.

8. The method of claim 7 wherein the feedback or feedforward loop comprises calculation involving at least one of:

a regression, a Kalman filter, a Fourier transform, a wavelet transform, a hidden Markov model, an artificial neural network, or a support vector machine.