Combination electrical stimulating and infusion medical device and method

Abstract

A combined electrical and chemical stimulation lead is especially adapted for providing treatment to intervertebral discs. The combination lead may be placed proximate to intervertebral disc cellular matrix and nucleus pulposus tissue to promote tissue regeneration and repair, as well as nociceptor and neural tissue modulation. The stimulation lead includes electrodes that may be selectively positioned along various portions of the stimulation lead in order to precisely direct electrical energy to stimulate the target tissue. The lead also includes a central infusion passageway or lumen that communicates with various infusion ports spaced at selected locations along the lead to thereby direct the infusion of nutrients/chemicals to the target tissue. One embodiment utilizes a dissolvable matrix for infusion as opposed to remote delivery through an infusion pump.

1 . A combined electrical and chemical stimulation device especially adapted for inserting within an intervertebral disc for treatment of target tissue therein, said device comprising: 
 a stimulation lead having an elongate, tubular configuration, and a first lumen extending therethrough;    a plurality of first infusion ports communicating with said first lumen, said first infusion ports enabling infusion of chemicals/nutrients from the first lumen to tissue located exterior of said stimulation lead;    a second lumen extending through said stimulation lead and spaced from said first lumen, said second lumen terminating at a location on said stimulation lead between a proximal and a distal end of said stimulation lead, said first lumen extending beyond said first lumen toward said distal end of said stimulation lead;    a plurality of second infusion ports communicating with said second lumen, said second infusion port enabling infusion of chemicals/nutrients from the second lumen to tissue located exterior of said stimulation lead; and    a plurality of electrodes positioned on said stimulation lead and between said first and second infusion ports, said electrodes communicating with a source of electrical energy for providing electrical stimulation of tissue adjacent said electrodes.    
   
   
       2 . A device, as claimed in  claim 1 , wherein: 
 said first and second infusion ports are spaced between said electrodes longitudinally along a length of said stimulation lead.    
   
   
       3 . A device, as claimed in  claim 1 , wherein: 
 said stimulation lead is semi-rigid so that said bent distal end remains in a bent position as said stimulation lead traverses through the disc.    
   
   
       4 . A device, as claimed in  claim 1 , wherein: 
 said stimulation lead has a diameter that progressively narrows from a proximal end of said lead towards said distal end thereof.    
   
   
       5 . A device, as claimed in  claim 1 , wherein: 
 said electrodes extend circumferentially around said stimulation lead, and are spaced from one another longitudinally along a length of said stimulation lead.    
   
   
       6 . A device, as claimed in  claim 1 , wherein: 
 said electrodes are arranged substantially linearly along one side of said stimulation lead, and said plurality of infusion ports are interspersed between said electrodes.    
   
   
       7 . A device, as claimed in  claim 1 , wherein: 
 said electrodes are arranged circumferentially around a portion of said distal end thereof.    
   
   
       8 . A device, as claimed in  claim 1 , wherein:  
     said first and second infusion ports are selectively spaced along said stimulation lead in order to treat designated first and second treatment areas within the disc.  
   
   
       9 . A combined electrical and chemical stimulation device especially adapted for inserting within an intervertebral disc for treatment of target tissue therein, said device comprising: 
 a stimulation lead having an elongate, tubular configuration, and a central lumen extending therethrough;    a plurality of infusion ports communicating with said central lumen, said infusion ports enabling infusion of chemicals/nutrients from the central lumen to tissue located exterior of said stimulation lead;    a plurality of electrodes positioned on said stimulation lead and spaced between said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical stimulation of tissue adjacent said electrodes; and    an inflatable member attached to said stimulation lead, said inflatable member communicating with a source of fluid for selectively inflating said inflatable member.    
   
   
       10 . A device, as claimed in  claim 9 , wherein: 
 said inflatable member is attached to said lead near a distal end thereof.    
   
   
       11 . A device, as claimed in  claim 9 , wherein: 
 said inflatable member is attached to said lead near a proximal end thereof.    
   
   
       12 . A stimulation device especially adapted for inserting within an intervertebral disc for treatment of target tissue therein, said device comprising: 
 a stimulation lead having an elongate, substantially tubular configuration, wherein said stimulation lead is made of a matrix material including nutrients and medications intermixed therewith, said matrix being dissolvable within the intervertebral disc to deliver the medication and nutrients to the patient.    
   
   
       13 . A stimulation device, as claimed in  claim 12 , wherein: 
 said stimulation lead further includes a central lumen extending therethrough, and a stylet inserted within said lumen for assisting in steering of the stimulation lead when emplaced.    
   
   
       14 . A stimulation device, as claimed in  claim 12 , wherein: 
 said stimulation lead further includes a plurality of electrodes positioned on said stimulation lead, said electrodes communicating with a source of energy for providing electrical stimulation of tissue adjacent said electrodes.    
   
   
       15 . A stimulation device, as claimed in  claim 12 , wherein: 
 said stimulation lead further includes an outer membrane formed thereover.    
   
   
       16 . A stimulation device, as claimed in  claim 12 , wherein: 
 said membrane includes an osmotic membrane for controlling the rate at which said medication and nutrients are infused into the disc.    
   
   
       17 . A device, as claimed in  claim 12 , wherein: 
 said matrix is formed in a desired shape to assist in steering of said stimulation lead when emplaced within the disc.    
   
   
       18 . A device, as claimed in  claim 12 , wherein:  
     said medications and said nutrients are selected from the group consisting of glucose, glucosemine, chondroitin, sulphate, oxygen, oxygenating agents, anti-oxidants, anti-glycosilating agents, pH buffers, anti-inflammatory agents, growth and differentiating factor-5, transforming growth factor-beta, insulin-like growth factor-1, and basic fibroblasts growth factor.  
   
   
       19 . A method of managing intervertebral disc pain, said method comprising the steps of: 
 providing a stimulation lead having a plurality of electrodes and a plurality of infusion ports, said electrodes and said infusion ports being selectively spaced and arranged with one another, said plurality of infusion ports communicating with a plurality of lumens extending through said stimulation lead, each lumen of said plurality of lumens capable of delivering a selected chemical therethrough;    implanting the stimulation lead in the disc so that the plurality of electrodes and the plurality of infusion ports lie adjacent to a targeted area within the disc;    delivering electrical energy from the electrodes to the disc;    delivering at least one chemical through the infusion ports into the disc; and    wherein the electrical energy and chemical are especially selected to remediate the type of pain being experienced.    
   
   
       20 . A method, as claimed in  claim 19 , wherein: 
 said plurality of electrodes include at least two electrodes that can be separately energized by a source of electrical energy selectively applied to the two electrodes.    
   
   
       21 . A method, as claimed in  claim 19 , wherein: 
 said stimulation lead includes a body made of a dissolvable matrix, said dissolvable matrix becoming dissolved over time within the disc.    
   
   
       22 . A method, as claimed in  claim 19 , wherein: 
 each lumen of said plurality of lumens has a different diameter size.    
   
   
       23 . A method, as claimed in  claim 19 , wherein: 
 at least one lumen of said plurality of lumens has a progressively narrowing size as said lumen extends in a distal direction.    
   
   
       24 . A method, as claimed in  claim 19 , wherein: 
 said implanting step further includes the step of imparting a bend angle on a distal end of the stimulation lead in order to assist in implanting the stimulation lead within the targeted area within the disc.    
   
   
       25 . A method of stimulating a healing response from a damaged intervertebral disc, said method comprising the steps of: 
 providing a stimulation lead having a plurality of electrodes and a plurality of infusion ports, said electrodes and said infusion ports being selectively spaced and arranged with one another, said plurality of infusion ports communicating with a plurality of lumens extending through said stimulation lead, each lumen of said plurality of lumens capable of delivering a selected chemical therethrough;    implanting the stimulation lead in the disc so that the plurality of electrodes and the plurality of infusion ports lie adjacent to a targeted area within the disc;    delivering electrical energy from the electrodes to the disc;    delivering at least one chemical through the infusion ports into the disc; and    wherein the electrical energy and chemical are especially selected to remediate the type of pain being experienced.    
   
   
       26 . A method, as claimed in  claim 25 , wherein: 
 said plurality of electrodes include at least two electrodes that can be separately energized by a source of electrical energy selectively applied to the two electrodes.    
   
   
       27 . A method, as claimed in  claim 25 , wherein: 
 said stimulation lead includes a body made of a dissolvable matrix, said dissolvable matrix becoming dissolved over time within the disc.    
   
   
       28 . A method, as claimed in  claim 25 , wherein: 
 each lumen of said plurality of lumens has a different diameter size.    
   
   
       29 . A method, as claimed in  claim 25 , wherein: 
 at least one lumen of said plurality of lumens has a progressively narrowing size as said lumen extends in a distal direction.    
   
   
       30 . A method, as claimed in  claim 25 , wherein: 
 said implanting step further includes the step of imparting a bend angle on a distal end of the stimulation lead in order to assist in implanting the stimulation lead within the targeted area within the disc.    
   
   
       31 . A stimulation device especially adapted for placement within an intervertebral disc for treatment of target tissue therein, said device comprising: 
 a stimulation lead having an elongate configuration, said stimulation lead being made of a dissolvable matrix material that dissolves over a period of time when the stimulation lead is implanted within an intervertebral disc, and wherein the dissolvable matrix is composed of materials selected from the group consisting of nutrients and medications.    
   
   
       32 . A stimulation device, as claimed in  claim 31 , wherein: 
 said stimulation lead further includes a plurality of electrodes positioned on said stimulation lead, said electrodes communicating with a source of energy for providing electrical stimulation of tissue adjacent said electrodes.    
   
   
       33 . A stimulation device, as claimed in  claim 31 , wherein: 
 said stimulation lead further includes an outer membrane formed thereover.    
   
   
       34 . A stimulation device, as claimed in  claim 33 , wherein: 
 said membrane includes an osmotic membrane for controlling a rate at which said materials are infused in the disc.    
   
   
       35 . A method of providing selected nutrients and medications to targeted tissue in the body, said method comprising the steps of: 
 providing a stimulation lead composed of a dissolvable matrix, said matrix including materials selected from the group consisting of nutrients and medications;    implanting the stimulation lead in the body so that the stimulation lead lies adjacent to the targeted tissue; and    leaving the stimulation lead implanted within the body to enable the dissolvable matrix to dissolve and thereby deliver the selected nutrients and medications to the tissue.    
   
   
       36 . A method, as claimed in  claim 35 , wherein: 
 said stimulation lead further includes a central lumen extending therethrough, and a stilet inserted within said lumen for assisting in steering of the stimulation lead when implanted.    
   
   
       37 . A method, as claimed in  claim 35 , wherein: 
 said stimulation lead further includes a plurality of electrodes positioned on said stimulation lead, said electrodes communicating with a source of electrical energy for providing electrical stimulation of tissue adjacent said electrodes.    
   
   
       38 . A method, as claimed in  claim 35 , wherein: 
 said stimulation lead further includes an outer membrane formed thereover.    
   
   
       39 . A method, as claimed in  claim 38 , wherein: 
 said membrane includes an osmotic membrane for controlling a rate at which the nutrients and medication are delivered to the target tissue.    
   
   
       40 . A method, as claimed in  claim 35 , wherein: 
 said stimulation lead is formed in a desired shape to assist in steering of said stimulation lead when implaced within the body.    
   
   
       41 . A stimulation lead, as claimed in  claim 35 , wherein: 
 said stimulation lead has an elongate, substantially tubular configuration.