Combination electrical stimulating and infusion medical device

• US 7,660,634 B2
• Filed: 01/19/2007
• Issued: 02/09/2010
• Est. Priority Date: 01/11/2005
• Status: Active Grant

• Current Assignee: Bradley D. Vilims
• Original Assignee: Bradley D. Vilims
• Inventors: Vilims, Bradley D.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Lee; Yun Haeng
• Application Number:
  US11/625,186
• Publication Number:
  US 20070179536A1
• Time in Patent Office: 1,117 Days
• Field of Search: 607/117, 607/120, 607/125
• US Class Current: 607/117
• 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 method for treating intervertebral disc ailments, said method comprising:

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, at least one of said infusion ports being located between two adjacent electrodes of said plurality of electrodes, and wherein said stimulation lead has a bend incorporated adjacent a distal end thereof;

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.

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

Said stimulation lead has a straight first portion with at least some of said infusion ports and said electrodes positioned thereon, and a curved shape incorporated at said distal end.

3. A method, as claimed in claim 1, wherein:

said stimulation lead further includes a stiffening member incorporated in said lead for increasing strength of said lead, said stiffening member extending within and substantially along a length of said stimulation lead and not within said central lumen.

4. A method of managing intervertebral disc pain, said method comprising:

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;

said stimulation lead has a diameter that narrows from a proximal end of said lead toward said distal end thereof, and wherein at least some of said infusion ports and said electrodes are positioned between said proximal end and said distal end.

5. A method, as claimed in claim 4, 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.

6. A method, as claimed in claim 4, wherein:

said stimulation lead has a straight first portion with at least some of said infusion ports and said electrodes positioned thereon, and a curved shape incorporated at said distal end.

7. A method, as claimed in claim 4, wherein:

said stimulation lead further includes a stiffening member incorporated in said lead for increasing strength of said lead, said stiffening member extending within and substantially along a length of said stimulation lead and not within said central lumen.

8. A method of stimulating a healing response from a damaged intervertebral disc, said method comprising:

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;

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; and

said stimulation lead has a diameter that progressively narrows from a proximal end of said lead toward said distal end thereof, and wherein at least some of said infusion ports and said electrodes are positioned between said proximal end and said distal end.

9. A method, as claimed in claim 8, wherein:

said stimulation lead has a straight first portion with at least some of said infusion ports and said electrodes positioned thereon, and a curved shape incorporated at said distal end.

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

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 and wherein said stimulation lead has a bend incorporated adjacent a distal end thereof;

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;

said stimulation lead has a straight first portion with at least some of said infusion ports and said electrodes positioned thereon, and a curved shape incorporated at said distal end; and

said stimulation lead has a diameter that narrows from a proximal end of said lead toward said distal end thereof, and wherein at least some of said infusion ports and said electrodes are positioned between said proximal end and said distal end.

11. A method of stimulating a healing response from a damaged intervertebral disc, said method comprising:

providing a stimulating 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, at least one of said infusion ports being located between two adjacent electrodes of said plurality of electrodes;

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;

said stimulation lead further includes a stiffening member incorporated in said lead for increasing strength of said lead, said stiffening member extending within and substantially along a length of said stimulation lead and not within said central lumen.

12. A method of stimulating a healing response from a damaged intervertebral disc, said method comprising:

providing a stimulating 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, at least one of said infusion ports being located proximally of at least two adjacent electrodes of said plurality of electrodes, and another one of said infusion ports being located distally of said at least two adjacent electrodes;

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.

13. A method for treating intervertebral disc ailments, said method comprising:

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 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 chemicals 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, at least one of said infusion ports being located between two adjacent electrodes of said plurality of electrodes;

maneuvering the stimulation lead through the 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 chemicals through said central lumen and through said infusion ports thereby delivering chemicals to the target tissue.