Combination Electrical Stimulating And Infusion Medical Device and Method

• US 20070135881A1
• Filed: 02/23/2007
• Published: 06/14/2007
• Est. Priority Date: 01/11/2005
• Status: Active Grant

• Current Assignee: Bradley Vilims
• Original Assignee: Bradley Vilims
• Inventors: Vilims, Bradley
• Granted Patent: US 7,945,331 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• 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 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

A combined electrical and chemical stimulation lead is especially adapted for providing treatment to the spine and nervous system. 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 ablate or electrically stimulate the target tissue. Embodiments of the stimulation lead include single or multiple lead elements. The multiple lead element embodiments can be selectively deployed to cover a targeted area. The lead may also includes central infusion passageway(s) or lumen(s) 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. An electrical stimulation device especially adapted for treatment of an SI joint, said device comprising:

an introducer needle including a distal end, said distal end having a curved shape;

a stimulation lead placed in said introducer needle and having an elongate, tubular configuration;

a plurality of electrodes positioned on said stimulation lead, said electrodes communicating with a source of electrical energy for providing ablative heat or electrical stimulation of tissue adjacent said electrodes.

2. 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

3. 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.

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

said electrodes are arranged substantially linearly along one side of said stimulation lead.

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

said electrodes are arranged circumferentially around a portion of said distal end thereof.

6. A method of managing SI joint pain in a sacrum of a patient, said method comprising the steps of:

providing a stimulation lead having a plurality of electrodes, said electrodes being selectively spaced along a length of said stimulation lead;

providing an introducer needle having a curved distal end;

inserting the introducer needle along a path of insertion into a patient and placing the introducer needle in a position medial to an inferior aspect of the SI joint and directed towards an inferior lateral edge of the sacrum;

advancing the introducer needle along a curve of the sacrum in close proximity to a periosteum, lateral to a sacral foramen and medial to the SI joint until reaching a superior aspect of the sacrum;

inserting the stimulation lead in the introducer needle;

placing pressure on the stimulation lead to maintain the lead in a first position;

withdrawing the introducer needle along the path of insertion and along a selected length of the stimulation lead to expose a desired number of electrodes necessary to denervate targeted tissue;

activating said electrodes in order to denervate tissue surrounding the stimulation lead;

withdrawing the stimulation lead along the path of insertion to a second position within the introducer needle;

placing pressure on the stimulation lead to maintain the lead in the second position;

further withdrawing the introducer needle along the path of insertion thereby exposing a desired number of electrodes on the stimulation lead; and

further activating said electrodes in order to denervate tissue surrounding the stimulation lead.

7. A method, as claimed in claim 6, further including the step of:

infusing through said stimulation lead at least one chemical selected from the group consisting of an anesthetic, a neurolytic, a proliferant, and a nutrient.

8. An electrical stimulation device comprising:

an introducer needle including an open distal end;

a stimulation lead placed in said introducer needle and having an elongate, tubular configuration, said stimulation lead being curved along substantially a length thereof, said stimulation lead having a distal end with a bend incorporated thereon to assist in steering said stimulation lead; and

a plurality of electrodes positioned on said stimulation lead, said electrodes communicating with a source of electrical energy for providing ablative heat or electrical stimulation of tissue adjacent said electrodes.

9. An electrical stimulation device comprising:

an introducer needle including an open distal end;

a flexible stimulation lead placed in said introducer needle and having an elongate, straight, and tubular configuration, said lead having a central lumen extending therethrough;

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; and

a stylet placed through said central lumen of said stimulation lead, said stylet being shaped to impart a desired shape onto said stimulation lead for steering said stimulation lead.

10. An electrical stimulation device comprising:

an introducer needle including an open distal end;

a stimulation lead having a base forming a proximal end of said lead, said lead further having at least a pair of stimulation elements connected to said base and extending distally from said base, said lead being selectively placed between a stored position within said introducer needle and a deployed position wherein the base has at least a portion thereof remaining in said introducer needle and said stimulation elements extend distally beyond said introducer needle; and

at least one electrode integral with each stimulation element, said electrodes communicating with a source of electrical energy for providing ablative heat or electrical stimulation of tissue adjacent said electrodes.

11. A device, as claimed in claim 10, wherein:

said stimulation elements are tubular shaped

12. A device, as claimed in claim 10, wherein:

said stimulation elements are flat shaped.

13. A device, as claimed in claim 10, wherein:

said stimulation device further includes at least one spring element attached between said stimulation elements for selectively displacing said stimulation elements into a desired configuration when said stimulation lead is in the deployed position.

14. A device, as claimed in claim 13, wherein:

said at least one spring element comprises a pair of spring elements, one spring element positioned between proximal ends of said stimulation elements and another spring element positioned between distal ends of said stimulation elements.

15. A device, as claimed in claim 13, wherein:

said spring elements are configured as leaf springs.

16. A device, as claimed in claim 13, wherein:

said spring elements are made of metal.

17. A device, as claimed in claim 13, wherein:

said spring elements are made of a thermoplastic material.

18. A device, as claimed in claim 10, wherein:

said stimulation device further includes a stylet extending through said introducer needle.

19. A device, as claimed in claim 13, wherein:

said spring element expands to spread said stimulation elements when said stimulation lead is in the deployed position, and said spring element collapses when stimulation lead is placed in the stored position.

20. A device, as claimed in claim 10, wherein:

said stimulation lead is made of an elastomeric material and when said lead is placed in said deployed position, said stimulation elements spread apart from one another.

21. A device, as claimed in claim 10, wherein:

said at least a pair of stimulation elements include three stimulation elements.

22. A device, as claimed in claim 10, wherein:

when said lead is placed in the deployed position, said pair of stimulation elements spread apart from one another side by side and remain substantially planar with one another

23. A device, as claimed in claim 10, wherein:

said at least a pair of stimulation elements include three stimulation elements and when said lead is placed in the deployed position, said stimulation elements spread apart from one another into a triangular configuration.

24. A device, as claimed in claim 10, wherein:

said stimulation device further includes a tab connected to distal ends of the stimulation elements, and a tether extending through said introducer needle adjacent said stimulation element, said tether connected to said tab, and wherein when said stimulation lead is placed in the deployed position, said stimulation lead is held stationary and said tether is retracted causing said stimulation elements to spread apart.

25. A device, as claimed in claim 10, wherein:

when said stimulation lead is placed in the deployed position, said stimulation leads spread apart from one another beyond a diameter of said introducer needle.

26. A device, as claimed in claim 24, wherein:

said tab has a pointed tip.

27. A device, as claimed in claim 10, wherein:

said stimulation lead has a central lumen and a branch extending through each stimulation element, and fluid placed in said central lumen and said branches when said lead is placed in said deployed position, said fluid being under pressure to cause said stimulation leads to spread apart from one another.

28. An electrical stimulation device comprising:

an introducer needle including an open distal end;

a sheath placed in said introducer needle;

a stimulation lead having a base forming a proximal end of said lead, said lead further having at least a pair of stimulation elements connected to said base and extending distally from said base, said lead being selectively placed between a stored position within said sheath and a deployed position wherein the base has at least a portion thereof remaining in said sheath and said stimulation elements extend distally beyond said sheath and said introducer needle; and

at least one electrode integral with each stimulation element, said electrodes communicating with a source of electrical energy for providing ablative heat or electrical stimulation of tissue adjacent said electrodes.

29. An electrical stimulation device comprising:

a sheath having a central passageway and an end cap;

a stylet placed through said central passageway and through a slot formed in said distal end cap, said stylet extending beyond a distal end of said sheath;

a stimulation lead having a proximal end and a distal end, said proximal end of said lead connected to said end cap, and said distal end of said lead connected to said stylet, said lead having at least a pair of stimulation elements, said lead being selectively placed between a non-deployed position wherein the stimulation elements are collapsed against one another, and a deployed position wherein the stimulation elements are spread from one another by sliding said sheath in a distal direction along said stylet as said stylet is held stationary; and

at least one electrode integral with each stimulation element, said electrodes communicating with a source of electrical energy for providing ablative heat or electrical stimulation of tissue adjacent said electrodes.

30. A method of deploying an electrical stimulation device especially adapted for treatment of targeted tissue wherein deploying the stimulation lead optimizes ablative heat or orientation of an electric field with respect to the targeted tissue, said method comprising the steps of:

providing an electrical stimulation device comprising a stimulation lead having a base forming a proximal end of said lead, said lead further having at least a pair of stimulation elements connected to said base and extending distally from said base;

placing said lead in a stored position within at least one of a sheath and an introducer needle;

exposing said stimulation elements; and

deploying said stimulation elements by displacement of said stimulation elements in a configuration different from a configuration of said stimulation elements within said sheath or introducer needle.

31. A method, as claimed in claim 30, wherein:

said exposing step includes moving said stimulation elements beyond a distal end of said sheath or said introducer needle.

32. A method, as claimed in claim 30, wherein:

said exposing step includes withdrawing said sheath or said introducer needle to expose said stimulation elements.

33. A method, as claimed in claim 30, wherein:

said deploying step is achieved by said stimulation lead being made of an elastomeric material and exposing said stimulation elements causes them to displace.

34. A method, as claimed in claim 30, wherein:

said deploying step is achieved by at least one spring element attached between said stimulation elements, and said spring element being expanded as said stimulation elements are exposed.

35. A method, as claimed in claim 30, wherein:

said deploying step is achieved by hydraulic pressure of a fluid that fills a lumen extending through said base and branches communicating with said lumen extending through said stimulation elements.

36. A method, as claimed in claim 30, wherein:

said deploying step is achieved by distal ends of said stimulation elements being connected to one another, and providing a tether secured to said distal ends and extending proximally through said at least one sheath or introducer needle, and wherein said stimulation lead is held stationary, and said tether is withdrawn in a proximal direction causing said stimulation elements to spread apart from one another.

37. A method, as claimed in claim 30, wherein:

said deploying step is achieved by provision of a stylet connected to distal ends of said stimulation elements, said stylet extending through said at least one sheath or introducer needle, proximal ends of said stimulation elements being secured to an end cap of said sheath, wherein said stylet is held stationary, and said sheath is advanced distally over said stylet thereby causing said stimulation elements to spread apart from one another.

38. A method, as claimed in claim 30, wherein:

said deploying step is achieved by hydraulic pressure of a fluid that fills an interior of said stimulation lead, and said stimulation lead expands in size when said fluid fills the interior.

39. An electrical stimulation device comprising:

a stimulation lead having a base forming a proximal end of said lead, said lead further having at least one stimulation element connected to said base and extending distally from said base, said lead being selectively placed between a stored position and a deployed position, said stimulation lead being made of a flexible and elastomeric material; and

at least one electrode integral said at least one stimulation element, said electrode communicating with a source of electrical energy for providing ablative heat or electrical stimulation of tissue adjacent said at least one electrode.