COMBINATION ELECTRICAL STIMULATING AND INFUSION MEDICAL DEVICE AND METHOD

• US 20080200972A1
• Filed: 02/19/2008
• Published: 08/21/2008
• Est. Priority Date: 01/11/2005
• Status: Active Grant

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Original Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Inventors: Vilims, Bradley D., Rittman, William J.
• Granted Patent: US 8,066,702 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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: Y10T 29/49208 by assembling plural parts

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. The invention also includes a method of activating electrodes in the electrical stimulation lead whereby an ablative lesion can be formed in a desired shape and size. The invention further includes a method of managing pain in a sacrum of a patient, and a method of assembling an electrical stimulation device.

Claims

1. An electrical treatment device comprising:

a handle having proximal and distal ends, said proximal end of said handle including an electrical receptacle formed therein communicating with a source of RF energy said handle having a pair of notches formed on opposite sides of said handle for facilitating grasping by the user;

a stimulation lead extending from said distal end of said handle, said stimulation lead having a curvature along substantially a length of said stimulation lead, said stimulation lead having a plurality of electrodes spaced along said stimulation lead, said electrodes communicating with said receptacle whereby RF energy is selectively conducted to said electrodes;

a temperature-sensing element associated with each of said electrodes for measuring temperatures at said electrodes; and

said distal end of said stimulation lead incorporating a sharpened tip for penetrating tissue of a patient.

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

a plug connected to said electrical receptacle, said plug communicating with a conductor for electrically coupling said treatment device with an RF generator.

3. A method of activating electrodes in an electrical stimulation lead that transmits RF energy to tissue surrounding the lead thereby ablating the tissue, said method comprising:

providing a stimulation lead having a plurality of electrodes spaced longitudinally along the stimulation lead, said plurality of stimulation leads including at least a distal electrode, a proximal electrode, and an intermediate electrode positioned between, and electrically isolated from the proximal end distal electrodes;

providing a plurality of electrical conductors to interconnect said plurality of electrodes to an RF generator;

providing a temperature-sensing element adjacent each of said plurality of electrodes for sensing a temperature at respective locations of the electrodes;

sequentially energizing the plurality of electrodes in a mono-polar configuration to generate a generally spherical shaped lesion surrounding each of the electrodes, thereby producing corresponding proximal, intermediate and distal lesions;

energizing the intermediate and distal electrode in a bipolar configuration thereby generating a fourth lesion which fills in a space that may be present between the distal lesion and the intermediate lesion; and

energizing the proximal electrode and intermediate electrode in a bipolar configuration thereby generating a fifth lesion that fills in another space between said proximal lesion and said intermediate lesion, wherein collectively said lesions produce a substantially cylindrical lesion of a selected length and diameter.

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

said substantially cylindrical lesion is formed without having to move the stimulation lead and thus, said stimulation lead remains stationary during said energizing steps.

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

providing a stimulation device including a handle and a stimulation lead extending from the handle, said stimulation lead having a curvature substantially along a length thereof, said stimulation lead having a plurality of electrodes selectively spaced along the stimulation lead;

inserting the stimulation lead along a path insertion into a patient and placing the stimulation lead in a position medial to an inferior aspect of the SI joint directed toward an inferior lateral edge of the sacrum wherein the stimulation lead is captured under a corresponding iliac crest;

first activating said plurality of electrodes in a sequential pattern and in a mono-polar configuration to delivery RF energy to tissue surrounding the stimulation lead to create a first group of ablations;

next activating the electrodes in a bipolar configuration wherein ablation of surrounding tissues occurs in gaps between said first group of ablations, wherein a final ablative pattern produced by said next activation step results in creation of a substantially cylindrical shaped ablation surrounding said stimulation lead.

6. A method of assembling an electrical stimulation device, said method comprising:

providing a cylindrical mandrel, and positioning a plurality of electrode assemblies over the mandrel, each of said electrode assemblies comprising an electrode sleeve placed concentrically over the mandrel, and a plurality of electrode elements extending away from the electrode sleeve;

applying a non-conductive coating to cover said mandrel and each of said electrode sleeves, wherein said plurality of electrode elements remain exposed;

removing the mandrel thereby leaving the electrodes embedded in the coating wherein the non-conductive material has a cylindrical shape thereby forming a sheath;

providing an electrical stimulation lead having a plurality of electrode members spaced along a length thereof, said electrode members being spaced from one another to match a spacing of the electrode assemblies secured to said sheath; and

inserting the stimulation lead within the sheath such that respective electrode members of said stimulation lead contact corresponding electrode sleeves exposed within said sheath.

7. An electrical treatment device comprising:

a sheath having a pointed distal tip and an internal passageway extending therethrough, said sheath having a plurality of electrodes spaced along the length thereof, said electrodes having an electrode sleeve imbedded within said sheath, and a plurality of electrode elements extending away from said sheath for contact with tissue of the patient; and

a stimulation lead placed within said sheath, said stimulation lead having a plurality of electrode members spaced along the length thereof, said electrode members being aligned with the spacing of the electrodes on said sheath such that when said stimulation lead is placed within said sheath, said electrodes of said stimulation lead electrically contact inner exposed surfaces of the electrode sleeves.

8. A device, as claimed in claim 7, wherein:

said electrode elements of said sheath extend longitudinally along corresponding electrode sleeves and the electrode elements are spaced circumferentially around the corresponding sleeves and extend radially away from the corresponding sleeves.

9. An electrical treatment device comprising:

an outer sheath formed in a cylindrical shape and having an internal passageway extending therethrough, said sheath having groups of perforations spaced along a length of said sheath, each said group having a plurality of perforations that extend circumferentially around the sheath;

a stimulation lead inserted through said sheath, said stimulation lead having a plurality of electrodes, said electrodes being spaced along a length of the stimulation lead, a spacing of the electrodes substantially matching a spacing of the perforation groups such that when said stimulation lead is placed within the sheath, each of said groups of perforations align with respective electrodes.

10. An electrical treatment device comprising:

an outer sheath formed in a cylindrical shape and having an internal passageway extending therethrough, said sheath having groups of perforations spaced along a length of said sheath, each said group having a plurality of perforations that extend circumferentially around the sheath, said groups of perforations being made of a conductive material and said groups of perforations separated from one another by non-conductive sections;

a stimulation lead inserted through said sheath, said stimulation lead having a plurality of electrodes, said electrodes being spaced along a length of the stimulation lead, wherein a spacing of the electrodes is different from a spacing of the groups of perforations such that when the stimulation lead is placed within the sheath, the groups of perforations are misaligned with respect to the underlying electrodes of the stimulation lead thereby changing an ablation pattern when activating the stimulation lead as compared to an ablation pattern if the outer sheath is not used with the stimulation lead.

11. A method of assembling an electrical stimulation lead, said method comprising:

providing a plurality of stimulation lead sections, at least one of said plurality of sections being a non-conductive section, and at least one other of said segments being a conductive section;

providing a mating connection between adjacent sections of said plurality of segments; and

locking adjacent sections to one another by engagement of the sections with one another.

12. A method, as claimed in claim 11, wherein:

a first section has a key formed at an end thereof, and an adjacent section has a keyway for receiving the key, thereby providing locking engagement between the sections.

13. A method, as claimed in claim 11, wherein:

a first section has a plurality of splines extending therefrom, and an adjacent section has an opening for receiving the splines thereby providing locking engagement between the sections.

14. A method, as claimed in claim 11, wherein:

a first section has a conductive extension extending from one end thereof, and an adjacent section has an opening for receiving the conductive extension therein thereby providing engagement between the sections.

15. A method as claimed in claim 11, wherein:

a first section has a threaded conductive extension extending from one end thereof, and an adjacent section has a threaded opening for receiving the threaded conductive extension, thereby providing locking engagement between the sections.

16. A method, as claimed in claim 11, wherein:

a first section has an opening extending therethrough, and an adjacent section has an opening extending therethrough, and an interconnecting peg is placed within the openings of the adjacent sections to interconnect the adjacent sections thereby providing locking engagement between the sections.

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

a sharpened distal tip integral with a most distal section and wherein said most distal segment is conductive.

18. A method of manufacturing an electrical stimulation device, said method comprising the steps of:

providing a blank having a cylindrical shape and a lumen extending therethrough, said lumen including a plurality of gaps extending radially away from a longitudinal axis of the blank;

removing a first selected length of material from an exterior surface of said blank thereby exposing the plurality of gaps and forming a plurality of longitudinally extending legs spaced circumferentially around the blank;

removing a second selected length of material from the exterior surface of said blank, said selected second length being spaced longitudinally from said first selected length, wherein material removed from the second selected length thereby further exposes the plurality of gaps and forms first additional longitudinally extending legs spaced circumferentially around the blank;

removing a third selected length of material spaced longitudinally from the second length of material, thereby further exposing the plurality of gaps and forming second additional longitudinally extending legs spaced circumferentially around the blank;

applying a conductive material over selected portions of the removed material in said first, second and third lengths, said conductive material forming electrodes of the sheath; and

inserting a stimulation lead within the sheath, said stimulation lead having a plurality of electrode elements that align with respective electrodes of the sheath such that electrical contact is made between respective electrodes of the sheath and the electrode elements of the stimulation lead.

19. An electrical treatment device comprising:

A sheath including a plurality of electrodes spaced along the length thereof, said sheath including a plurality of non-conductive legs extending longitudinally along the sheath and spaced circumferentially from one another along the sheath, a corresponding electrode covering corresponding portions of the legs, and said electrode further including a plurality of radial conductors extending from an exterior surface of the corresponding electrode radially inward to an interior of the sheath; and

a stimulation lead placed within said sheath, said stimulation lead having a plurality of electrode elements that make contact with the corresponding plurality of electrodes on said sheath and wherein the plurality electrodes are electrically isolated from one another by nonconductive sections of said sheath.

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

said stimulation lead has a central portion, and a plurality of circumferentially spaced keys extending radially away from said central portion, said keys being received in corresponding keyways of said sheath formed adjacent said radial conductors.

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

said stimulation lead has a distal conductive strip, said distal conductive strip having a conductive extension extending proximally along a length of said stimulation lead; and

said stimulation lead having at least one proximal conductive strip, said proximal conductive strip having a conductive extension extending proximally along a length of said stimulation lead, wherein said conductive extensions are electrically isolated from one another and from a non-corresponding conductive strip wherein breaks are formed in said at least one proximal conductive strip to prevent electrical contact between said conductive extensions and said at least one proximal conductive strip, thereby enabling independent and selective activation of the plurality of electrodes of the sheath when energy is conducted along said conductive extensions to said conductive strips.