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

• US 9,789,313 B2
• Filed: 08/21/2014
• Issued: 10/17/2017
• 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:
  US14/465,822
• Publication Number:
  US 20150005680A1
• Time in Patent Office: 1,153 Days
• Field of Search: None
• 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 for treating a patient having a spine comprising an epidural space and a posterior longitudinal ligament, wherein the patient has a diseased vertebral disc, wherein the method includes:

implanting a neurostimulation lead within an anterior portion of the epidural space adjacent to the posterior longitudinal ligament, wherein the neurostimulation lead has a plurality of electrodes that are adjacent to the diseased vertebral disc, wherein the neurostimulation lead is a paddle lead and the plurality of electrodes are disposed on the same side of the paddle lead, wherein the paddle lead is implanted such that the electrodes face the posterior longitudinal ligament;

and wherein said treating is performed by a person who may select among treatment neurostimulations comprising;

(1) direct inhibition of initiation and/or propagation of an action potential in one or more afferent nociceptor nerves wherein said afferent nerves are caused to increase their mechanical force threshold above which said afferent nerves initiate and/or propagate an action potential;

(2) promotion of initiation and/or propagation of an action potential in one or more sympathetic nerves in said posterior longitudinal ligament, whereby initiation and/or propagation of an action potential in one or more afferent nociceptor nerves is caused to be secondarily inhibited; and

(3) inhibition of initiation and/or propagation of an action potential in one or more sympathetic nerves in said posterior longitudinal ligament, whereby said inhibited sympathetic nerve is hindered from secondarily promoting initiation and/or propagation of an action potential in one or more afferent nociceptive nerves.

2. A method for treating a patient having a spine comprising an epidural space and a posterior longitudinal ligament, wherein the patient has a diseased vertebral disc, wherein the method includes:

implanting a neurostimulation lead within an anterior portion of the epidural space adjacent to the posterior longitudinal ligament, wherein the neurostimulation lead has a plurality of electrodes that are adjacent to the diseased vertebral disc;

wherein the neurostimulation lead may be a percutaneous or paddle lead and the plurality of electrodes are disposed on the same side of the lead, wherein the lead is implanted such that the electrodes face the posterior longitudinal ligament;

and wherein said treating is performed by a person who may select among treatment neurostimulations comprising;

direct inhibition of initiation and/or propagation of an action potential in one or more afferent nociceptor nerves, wherein said afferent nerves are caused to increase their mechanical force threshold above which said afferent nerves initiate and/or propagate an action potential.