Combination electrical stimulating and infusion medical device

• US 20060155342A1
• Filed: 01/11/2005
• Published: 07/13/2006
• Est. Priority Date: 01/11/2005
• Status: Active Grant

• Current Assignee: Bradley D. Vilims
• Original Assignee: Bradley D. Vilims
• Inventors: Vilims, Bradley D.
• Granted Patent: US 7,386,350 B2
• Time in Patent Office: Days
• US Class Current: 607/43
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke

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.

Claims

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 central lumen extending therethrough;

a plurality of infusion ports communicating with said central lumen, said infusion ports enabling infusion of chemical/nutrients from the central lumen to tissue located exterior of said stimulation lead;

a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical stimulation of tissue adjacent said electrodes; and

wherein said stimulation lead has a distal end bent at a desired angle enabling said stimulation lead to traverse in an arcuate path through said disc.

2. A device, as claimed in claim 1, wherein:

said 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.

11. A device, as claimed in claim 1, further including:

a stiffening member incorporated in said lead for increasing strength of said lead.

8. A combined electrical and chemical stimulation lead especially adapted for inserting within an intervertebral disc for treatment of target tissue therein, said device comprising:

an introducer needle having a proximal portion extending along a longitudinal axis, and a distal portion bent at a desired angle with respect to said longitudinal axis, said introducer needle having a central passageway formed therethrough;

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 chemical/nutrients from the central lumen to tissue located exterior of said stimulation lead;

a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical/thermal stimulation of tissue adjacent said electrodes; and

wherein said stimulation lead has a distal end bent at a desired angle enabling said stimulation lead to traverse in an arcuate path through said disc.

9. A stimulation system for stimulating target tissue within an intervertebral disc of a patient, said system comprising:

an introducer needle extending into the disc;

a stimulation lead having an elongate, tubular configuration, and a central lumen extending therethrough, said stimulation lead extending through the introducer needle and into the disc;

a plurality of infusion ports formed on said stimulation lead and communicating with said central lumen, said infusion ports enabling infusion of chemical/nutrients from the central lumen to tissue located exterior of said stimulation lead;

a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical/thermal stimulation of tissue adjacent said electrodes, wherein said stimulation lead has a distal end bent at a desired angle enabling said stimulation lead to traverse in an arcuate path through said disc;

an electrical stimulation source for generating electrical/thermal stimulation pulses for transmission through said stimulation lead to said electrodes to cause the electrodes to deliver electrical/thermal stimulation pulses to the target tissue; and

a chemical stimulation source for supplying chemicals/nutrients through said stimulation lead and through said infusion ports for delivery of the chemical/nutrients to the target tissue.

10. A method for treating intervertebral disc ailments, said method comprising the steps of:

inserting an introducer needle into the disc to be treated;

introducing a combined electrical and chemical stimulation device through said introducer needle and into the disc, said device comprising;

a stimulation lead having an elongate, tubular configuration, and a central lumen extending therethrough;

a plurality of infusion ports formed on said stimulation lead and communicating with said central lumen, said infusion ports enabling infusion of chemical/nutrients from the central lumen to tissue located exterior of said stimulation lead;

a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical/thermal stimulation of tissue adjacent said electrodes wherein said stimulation lead has a distal end bent at a desired angle;

maneuvering the stimulation lead through the disc in an arcuate pattern wherein the distal portion of said stimulation lead is placed adjacent the tissue to be treated;

inserting an electrical stimulation source into the patient, the electrical stimulation source communicating with said stimulation lead to generate electrical pulses for energizing said electrodes and to deliver electrical/thermal energy to target tissue; and

inserting a chemical stimulation source into the patient, said chemical stimulation source communicating with said stimulation lead to provide chemical/nutrients through said central lumen and through said infusion ports thereby delivering chemical/nutrients to the target tissue.

12. 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 infusion ports being selectively spaced and arranged with one another;

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; and

delivering electrical energy from the electrodes to the disc;

delivering at least one chemical through the infusion ports into the disc.

13. A method, as claimed in claim 12, 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.

14. 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 selectievely spaced and arranged with one another;

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; and

delivering at least one chemical through the infusion ports into the disc.