MEDICAL LEADS WITH SEGMENTED ELECTRODES AND METHODS OF FABRICATION THEREOF

Abstract

A method for fabricating a neurostimulation stimulation lead includes providing a plurality of ring components and hypotubes. An insulative coating is disposed on at least one of (i) inner surfaces of the ring components or (ii) the hypotubes. The method includes welding the hypotubes to the inner surfaces of the ring components, and molding an insulative material to fill interstitial spaces between the ring components and the hypotubes that are welded to form a stimulation tip component of the stimulation lead. The method includes forming segmented electrodes from the ring components after performing the molding.

Claims

1. A method for fabricating a neurostimulation stimulation lead, the method comprising: providing a plurality of ring components and hypotubes, wherein an insulative coating is disposed on at least one of (i) inner surfaces of the ring components or (ii) the hypotubes; welding the hypotubes to the inner surfaces of the ring components; molding an insulative material to fill interstitial spaces between the ring components and the hypotubes that are welded to form a stimulation tip component of the stimulation lead; and forming segmented electrodes from the ring components after performing the molding.

2. The method of claim 1, wherein the insulative coating comprises one or more polyxylylene polymers.

3. The method of claim 1, wherein the insulative coating comprises parylene.

4. The method of claim 1, further comprising coating the insulative coating on at least one of the (i) inner surfaces of the ring components or (ii) the hypotubes prior to welding the hypotubes to the inner surfaces of the ring components.

5. The method of claim 1, wherein the welding comprises applying a first weld and a second weld to attach each hypotube of the hypotubes to a corresponding ring component of the ring components.

6. The method of claim 1, wherein the ring components include longitudinal grooves, and the segmented electrodes are formed by grinding areas of reduced wall thickness of the ring components that align with the longitudinal grooves.

7. The method of claim 1, wherein proximal segments of the hypotubes proximally extend from the stimulation tip component, and the method further comprises loading the proximal segments of the hypotubes into different corresponding channels of a gear component to facilitate connection with conductor wires of the stimulation lead, the channels of the gear component circumferentially spaced around a perimeter of the gear component.

8. The method of claim 7, further comprising welding distal ends of the conductor wires of the stimulation lead to proximal ends of the hypotubes within the channels of the gear component.

9. The method of claim 1, further comprising, prior to the molding, loading the hypotubes into different corresponding lumens of an annular frame structure, wherein the annular frame structure is located proximal to the ring components.

10. The method of claim 1, further comprising inserting conductor wires of a lead body component of the stimulation lead into the hypotubes after the stimulation tip component is formed.

11. The method of claim 10, further comprising welding the conductor wires to the hypotubes.

12. The method of claim 1, wherein at least some of the hypotubes have different lengths from one another and extend different distances from the insulative material of the stimulation tip component after the molding is performed to facilitate subsequent connection of the hypotubes to specific conductor wires of the stimulation lead.

13. A neurostimulation lead comprising: a lead body component comprising a plurality of conductor wires; and a stimulation tip component connected to the lead body component, the stimulation tip component comprising: a plurality of segmented electrodes; a plurality of hypotubes welded to inner surfaces of the segmented electrodes, wherein an insulative coating is disposed on at least one of (i) the inner surfaces of the segmented electrodes or (ii) the hypotubes; and an insulative material that fills interstitial spaces between the segmented electrodes and the hypotubes that are welded, wherein proximal segments of the hypotubes proximally extend from the insulative material of the stimulation tip component and are electrically connected to the conductor wires of the lead body component.

14. The neurostimulation lead of claim 13, wherein the plurality of segmented electrodes are disposed in multiple rows spaced apart along a length of the stimulation tip component, and each row of the multiple rows includes multiple segmented electrodes circumferentially spaced apart from one another.

15. The neurostimulation lead of claim 14, wherein each row of the multiple rows includes three segmented electrodes.

16. The neurostimulation lead of claim 13, wherein at least some of the proximal segments of the hypotubes extend different distances from the insulative material to facilitate subsequent connection of the hypotubes to specific conductor wires of the lead body component.

17. The neurostimulation lead of claim 13, wherein the stimulation tip component further comprises an annular frame structure that defines multiple lumens and is located proximal to the segmented electrodes, wherein the hypotubes are disposed within different corresponding lumens of the annular frame structure.

18. The neurostimulation lead of claim 13, wherein the insulative coating comprises one or more polyxylylene polymers.

19. The neurostimulation lead of claim 13, wherein the insulative coating comprises parylene.

20. The neurostimulation lead of claim 13, wherein the stimulation tip component further comprises a gear component that defines a plurality of channels circumferentially spaced apart around a perimeter of the gear component, wherein the proximal segments of the hypotubes that extend from the insulative material of the stimulation tip component are electrically connected to the conductor wires within different corresponding channels of the gear component.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIGS. 1A and 1B depict a stimulation tip component shown in respective views according to some representative embodiments.

[0020] FIGS. 2A and 2B depict a terminal end component according to respective views according to some representative embodiments.

[0021] FIGS. 3A-3C depict a lead body component according to some representative embodiments.

[0022] FIGS. 4A-4F depict respective components of a stimulation tip component according to some representative embodiments.

[0023] FIG. 5 depicts an additional view of a terminal end component according to some representative embodiments.

[0024] FIG. 6 depicts integration of a stimulation tip component with a lead body component according to some representative embodiments.

[0025] FIG. 7 depicts a finished stimulation lead within a neurostimulation or other active medical device system according to some embodiments.

[0026] FIG. 8 depicts a flowchart of operations for fabrication of a stimulation end component according to one representative embodiment.

[0027] FIG. 9 depicts a flowchart for operations for joining a stimulation end component to a lead body component according to one representative embodiment.

[0028] FIG. 10 depicts a plurality of different marker designs that permit the orientation of a stimulation lead with segmented electrodes to be determined post-implant.

[0029] FIG. 11 depicts the orientation of a lead with segmented electrodes and an orientation marker according to one representative embodiment matched against corresponding images of the lead.

[0030] FIG. 12 depicts further images of segmented leads with markers according to some representative embodiments.

DETAILED DESCRIPTION

[0031] The present application is generally related to a process for fabricating a stimulation lead comprising multiple segmented electrodes. In one preferred embodiment, the lead is adapted for deep brain stimulation (DBS). In other embodiments, the lead may be employed for any suitable therapy including spinal cord stimulation (SCS), peripheral nerve stimulation, peripheral nerve field stimulation, dorsal root or dorsal root ganglion stimulation, cortical stimulation, cardiac therapies, ablation therapies, etc.

[0032] In some representative embodiments, multiple components are fabricated and assembled to form a stimulation lead including segmented electrodes. Referring to FIGS. 1A and 1B, stimulation end component 100 is shown in respective views. In one embodiment, stimulation end component 100 is fabricated by molding the respective components using a suitable biocompatible polymer to form an integrated assembly. In one embodiment, injection molding is the process selected for fabrication of stimulation end component 100, although any suitable molding technique may be employed. The various components include a plurality of electrodes and hypotubes. The electrodes are connected to a plurality of hypotubes. The stimulation end component 100 may also include a radio-opaque marker to permit the orientation of the lead to be determined post-implant using suitable medical imaging. Stimulation end component 100 preferably includes a plurality of segmented electrodes. In one embodiment, a distal ring electrode, two rows of three segmented electrodes, and a proximal ring electrode are provided, although any suitable electrode configuration may be selected. One other possible electrode configuration includes two rows of four segmented electrodes. Another possible electrode configuration includes four rows of two segmented electrodes.

[0033] FIGS. 2A and 2B depict terminal end 200 according to respective views. Terminal end component 200 may be fabricated in a substantially similar manner to stimulation end component 100 using suitable molding techniques. Terminal end component 200 may preferably comprise ring contacts for placement within the header of an implantable pulse generator (IPG). Terminal end component 200 may also comprise a non-active contact ring for use with a set screw and/or contact with an initial seal element within the header of the IPG. Terminal end component 200 preferably comprises a stylet guide and central lumen for the stylet.

[0034] FIGS. 3A and 3B depict lead body component 300. In one embodiment, a multi-lumen component of insulative material is initially molded or otherwise suitably fabricated. Conductors are placed within the various lumens as shown in FIGS. 3A and 3B. The conductors may extend from the distal and proximal ends of the body of insulative material. A central lumen is also provided in lead body component 300 for use of the finished stimulation lead with a stylet. In some embodiments, after placement of the conductor wires, lead body component 300 is twisted one or more times and subjected to heating (as shown in FIG. 3C). By heat setting a twist configuration to the lead body component 300, transfer of bending at one end of lead body component 300 to the other end of lead body component 300 is prevented. Preventing bend and other deformation transfers from occurring may be helpful during handling of the finished lead during an implant procedure.

[0035] FIGS. 4A-4D depict components of stimulation end component 100 according to some embodiments. In FIG. 4D, ring component 450 is shown. Ring component 450 is a substantially annular structure of suitable conductive material. Ring component 450 includes one or more step-down regions 451 where the outer diameter is reduced. The step-down regions may permit ring component 450 to be more securely integrated within the body of the stimulation end component 100 in the molding process. That is, the step-down regions 451 may be disposed below the outer surface of the insulative material after molding occurs. Also, step-down regions 450 may be bead blasted to increase the roughness of the surface of the electrodes to improve bonding or adhesion to the insulative material. Also, the inner diameter (not shown) of ring component 450 may be similar processed. Other techniques for application of abrasive materials to roughen the respective surfaces may be alternatively applied. The increase in surface roughness may further secure the integration of the metal components with the insulative material provided during the molding process. Additionally, ring component 450 may comprise longitudinal grooves or cuts (shown in FIG. 4F) along the inner diameter of component 450 to facilitate separation of the component 450 into multiple segmented electrodes by a grinding process or other suitable processing. The reduced wall thickness along such grooves permits separation during grinding operations as detailed in U.S. patent Ser. No. 12/873,838, filed Sep. 1, 2010 (published as U.S. Patent Pub. No. 2011/0047795) which is incorporated herein by reference.

[0036] FIG. 4A depicts component 410 which includes the ring components 450 (before grinding operations), ring electrodes, and the hypotubes integrated using molded insulative material. Component 410 is subjected to suitable grinding operations to provide stimulation tip component 420 in which the grinding produces the segmented electrodes from ring components 450. Pre-molded frame 425 (shown individually in FIG. 4C) is placed over a portion of the hypotubes as shown in FIG. 4E to form stimulation end component 100. Frame 425 may provide stability to hypotubes within the interior of the finished stimulation lead and prevent hypotubes from migrating to the outer surface of the stimulation lead. Also, frame 425 may ensure that hypotubes are maintained in a regular angular pattern to facilitate connection with other portions of the stimulation lead. A portion of hypotubes may preferably remain exposed to facilitate subsequent lead fabrication operations. Also, the lengths of the hypotubes may be preferably staggered as shown in FIG. 4E. The difference in length of the respective hypotubes permits ready identification of the connection of a specific hypotube to a corresponding electrode to facilitate further integration operations for fabrication of the stimulation lead.

[0037] FIG. 5 depicts an additional view of terminal end component 500. As discussed previously, terminal end component 500 may be fabricated in substantially the same manner as stimulation end component 100. Terminal end component 500 may include a hypotube configuration (i.e., varied lengths of hypotubes) that mirrors the arrangement of hypotubes on stimulation end component 100 to facilitate the lead fabrication process. Terminal end component 500 may include a suitable frame component surrounding the hypotubes. Further, terminal end component 500 may include an additional contact which is not connected to a hypotube. The additional contact may be employed for use with a set-screw in the header of an extension and/or IPG.

[0038] FIG. 6 depicts integration of stimulation end component 100 with lead body component 300. Lead body component 300 is placed next to gear component 650. Gear component 650 may be fabricated from suitable biocompatible material such as PEEK or ETFE. Gear component 500 comprises a plurality of grooves or channels for the conductors of lead body component 300 and the hypotubes of stimulation end component 100. The conductors of lead body component 300 are placed within the hypotubes and suitable welding operations are performed (e.g., laser welding). Clamshell component 610 is preferably placed over the exposed connection region of conductors and hypotubes. Clamshell component 610 is preferably fabricated from a reflowable (e.g., a biocompatible polyurethane or thermoplastic polycarbonate urethane) insulative material. The material of component 610 is selected to possess a lower flow temperature than of gear component 650. When reflow operations occur, gear component 650 retains the hypotubes and/or conductors in place and prevents mutual contact between such conductive material. Thereby, shorting between such components is prevented.

[0039] Similar operations may occur to connect the other end of lead body component 300 to terminal end component 200 to form the stimulation lead.

[0040] FIG. 7 depicts a finished stimulation lead within a neurostimulation or other active medical device system according to some embodiments. Neurostimulation system 700 includes pulse generator 720 and one or more stimulation leads 701. Examples of commercially available pulse generator include the EON, EON MINI, LIBRA, and BRIO pulse generators available from St. Jude Medical, Inc. Other active medical devices could be employed such as pacemakers, implantable cardioverter defibrillator, gastric stimulators, functional motor stimulators, etc. Pulse generator 720 is typically implemented using a metallic housing that encloses circuitry for generating the electrical pulses for application to neural tissue of the patient. Control circuitry, communication circuitry, and a rechargeable battery (not shown) are also typically included within pulse generator 720. Pulse generator 720 is usually implanted within a subcutaneous pocket created under the skin by a physician.

[0041] As fabricated according to techniques described herein, lead 701 is electrically coupled to the circuitry within pulse generator 720 using header 710. Lead 701 includes terminals (not shown) that are adapted to electrically connect with electrical connectors (e.g., Bal-Seal connectors which are commercially available and widely known) disposed within header 710. The terminals are electrically coupled to conductors (not shown) within the lead body of lead 701. The conductors conduct pulses from the proximal end to the distal end of lead 701. The conductors are also electrically coupled to electrodes 705 to apply the pulses to tissue of the patient. Lead 701 can be utilized for any suitable stimulation therapy. For example, the distal end of lead 701 may be implanted within a deep brain location or a cortical location for stimulation of brain tissue. The distal end of lead 701 may be implanted in a subcutaneous location for stimulation of a peripheral nerve or peripheral nerve fibers. Alternatively, the distal end of lead 701 positioned within the epidural space of a patient. Although some embodiments are adapted for stimulation of neural tissue of the patient, other embodiments may stimulate any suitable tissue of a patient (such as cardiac tissue). An extension lead (not shown) may be utilized as an intermediate connector if deemed appropriate by the physician.

[0042] Electrodes 705 include multiple segmented electrodes. The use of segmented electrodes permits the clinician to more precisely control the electrical field generated by the stimulation pulses and, hence, to more precisely control the stimulation effect in surrounding tissue. Electrodes 705 may also include one or more ring electrodes and/or a tip electrode. Any of the electrode assemblies and segmented electrodes discussed herein can be used for the fabrication of electrodes 705. Electrodes 705 may be utilized to electrically stimulate any suitable tissue within the body including, but not limited to, brain tissue, tissue of the spinal cord, peripheral nerves or peripheral nerve fibers, digestive tissue, cardiac tissue, etc. Electrodes 705 may also be additionally or alternatively utilized to sense electrical potentials in any suitable tissue within a patient's body.

[0043] Pulse generator 720 preferably wirelessly communicates with programmer device 750. Programmer device 750 enables a clinician to control the pulse generating operations of pulse generator 720. The clinician can select electrode combinations, pulse amplitude, pulse width, frequency parameters, and/or the like using the user interface of programmer device 750. The parameters can be defined in terms of stim sets, stimulation programs, (which are known in the art) or any other suitable format. Programmer device 750 responds by communicating the parameters to pulse generator 720 and pulse generator 720 modifies its operations to generate stimulation pulses according to the communicated parameters.

[0044] FIG. 8 depicts a flowchart of operations for fabrication of a stimulation end component according to one representative embodiment. In 801, pre-cut hypotubes are welded to electrodes that include singulation (e.g., grooves) and retention features (step-down regions). In some embodiments, the hypotubes are coated with insulative material before being welded to the electrodes. In one embodiment, a suitable thin coat (e.g., approximately 12 m) of parylene is provided over each hypotube and the coated hypotubes are welded to the electrodes. The thin coating of parylene permits electrical isolation to be maintained between the various conductive components. The thin coating of parylene prevents shorting between respective hypotubes and other electrically conductive components. Further, it is has been determined by the present inventors that the thin coating of parylene does not affect the integrity of the subsequently created weld points between the hypotubes and other conductive components. In certain embodiments, the rings/electrode components may be additionally or alternatively coated with a thin layer of insulative material (e.g., parylene).

[0045] In some embodiments, multiple weld operations are provided for each hypotube. In one embodiment, a first weld is provided for each hypotube at the proximal end of its ring component and a second weld is provided for each hypotube at the distal end of its ring component. The first and second welds may improve the integrity of the connection between the hypotubes and the ring components. Pushing and pulling of the hypotubes may occur by the injection of insulative material during the molding process. This arrangement may cause the forces applied by the injection process to be placed on the first weld while maintaining the mechanical and electrical integrity of the second weld.

[0046] In 802, operations to load and shrink insulation onto hypotubes are performed. In 803, hypotubes are loaded into pre-molded frame component. The frame component may comprise an annular structure with multiple lumens to accommodate each hypotube. In 804, the subassembly and marker are loaded into a suitable mold and injection molding operations are performed to provide BIONATE or other suitable insulative material under the electrodes. After molding, the assembly is subjected to grinding to obtain the intended outer diameter size (805). In 806, annealing occurs. The terminal end component may be fabricated in a substantially similar manner.

[0047] FIG. 9 depicts a flowchart for operations for joining a stimulation end component to a lead body component according to one representative embodiment. In 901, conductor cable ends are ablated to expose conductive material from insulative sheaths about the conductors. In one embodiment, one or more of the conductors are coated with a suitable dye material or other colorant to facilitate identification of a specific channel in the finished stimulation tip component). In 902, the cables are strung through lumens of a lead body. In 903, a PEEK or other extrusion or molded component (see e.g., component 650 in FIG. 6) is inserted between the hypotubes to hold the hypotubes in place. In 904, cables are inserted into the hypotubes and laser welded. In 905, a clamshell of BIONATE (thermoplastic polycarbonate urethane) material or other reflowable insulative material is loaded over the joint between the components and reflow operations are performed. The reflow operations may include providing a FEP shrink wrap and applying sufficient heat as is known in the art of lead fabrication. The terminal end component may be joined to the lead body component in a substantially similar manner.

[0048] FIG. 10 depicts a plurality of different marker designs that permit the orientation of a stimulation lead with segmented electrodes to be determined post-implant. One marker may be provided at a distal or tip of the stimulation lead. Additionally or alternatively, another marker may be provided proximal to the electrodes of the stimulation lead about the outer surface of the lead body. FIG. 11 depicts the orientation of a lead with segmented electrodes and an orientation marker according to one representative embodiment matched against corresponding images of the lead. FIG. 12 depicts further images of segmented leads with markers according to some representative embodiments.

[0049] Although certain embodiments of this disclosure have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims.

[0050] When introducing elements of the present disclosure or the preferred embodiment(s) thereof, the articles a, an, the, and said are intended to mean that there are one or more of the elements. The terms comprising, including, and having are intended to be inclusive and mean that there may be additional elements other than the listed elements.

[0051] As various changes could be made in the above constructions without departing from the scope of the disclosure, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.