COMBINATION ELECTRICAL STIMULATING AND INFUSION DEVICE AND METHOD

• US 20090099613A1
• Filed: 12/19/2008
• Published: 04/16/2009
• 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 8,195,307 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• 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. One embodiment utilizes a dissolvable matrix for infusion as opposed to remote delivery through an infusion pump.

Claims

1. A combined electrical and chemical stimulation device comprising:

a stimulation lead having an elongated, 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 second 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 chemical/nutrients from the second lumen to tissue located exterior of said stimulation lead, said plurality of first infusion ports not communicating with said second lumen and said plurality of second infusion ports not communicating with said first lumen; 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 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 a bent distal end thereof 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 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.

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

an inflatable member attached to said stimulation lead, said inflatable member communicating with a source of fluid for selectively inflating said inflatable member.

9. 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.

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

said inflatable member is attached to said lead near a distal end thereof.

10. A stimulation device, as claimed in claim 9, 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.

11. A stimulation device, as claimed in claim 9, 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.

12. A stimulation device, as claimed in claim 9, wherein:

said stimulation lead further includes an outer membrane formed thereover.

13. A stimulation device, as claimed in claim 9, wherein:

said membrane includes an osmotic membrane for controlling the rate at which said medication and nutrients are infused into the disc.

14. A device, as claimed in claim 9, wherein:

said matrix is formed in a desired shape to assist in steering of said stimulation lead when emplaced within the disc.

15. A device, as claimed in claim 9, wherein:

said medications and said nutrients are selected from the group consisting of glucose, glucosamine, chondroitin, oxygen, oxygenating agents, anti-oxidants, anti-glycosylating agents, pH buffers, anti-inflammatory agents, growth and differentiating factor-5 (GDF-5), transforming growth factor-beta (TGF-β

), insulin-like growth factor-1 (IGF-1), and basic fibroblasts growth factor (bFGF).

16. 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.

17. A method, as claimed in claim 16, 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.

18. A method, as claimed in claim 16, wherein:

said stimulation lead includes a body made of a dissolvable matrix, said dissolvable matrix becoming dissolved over time within the disc.

20. A method, as claimed in claim 16, wherein:

at least one lumen of said plurality of lumens has a progressively narrowing size as said lumen extends in a distal direction.

21. A method, as claimed in claim 16, 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.

19. A method, as claimed in claim 19, wherein:

each lumen of said plurality of lumens has a different diameter size.

22. 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.

23. A method, as claimed in claim 22, 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.

24. A method, as claimed in claim 22 wherein:

said stimulation lead includes a body made of a dissolvable matrix, said dissolvable matrix becoming dissolved over time within the disc.

25. A method, as claimed in claim 22, wherein:

each lumen of said plurality of lumens has a different diameter size.

26. A method, as claimed in claim 22, wherein:

at least one lumen of said plurality of lumens has a progressively narrowing size as said lumen extends in a distal direction.

27. A method, as claimed in claim 22, 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.

28. 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.

29. A stimulation device, as claimed in claim 28, 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.

30. A stimulation device, as claimed in claim 28, wherein:

said stimulation lead further includes an outer membrane formed thereover.

31. A stimulation device, as claimed in claim 30, wherein:

said membrane includes an osmotic membrane for controlling a rate at which said materials are infused in the disc.

32. 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.

33. A method, as claimed in claim 32, 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.

34. A method, as claimed in claim 32, 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.

35. A method, as claimed in claim 32, wherein:

said stimulation lead further includes an outer membrane formed thereover.

36. A method, as claimed in claim 35, wherein:

said membrane includes an osmotic membrane for controlling a rate at which the nutrients and medication are delivered to the target tissue.

37. 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.

38. A stimulation lead, as claimed in claim 35, wherein:

said stimulation lead has an elongate, substantially tubular configuration.