Steerable percutaneous paddle stimulation lead

The present disclosure relates to a percutaneous paddle stimulation lead that can be steered during implantation. The percutaneous paddle stimulation lead that can be steered in a thickness plane of percutaneous paddle stimulation lead during implantation.

BACKGROUND

The medical device industry produces a wide variety of electronic and mechanical devices such as neurological stimulators, therapeutic substance infusion pumps, pacemakers, and defibrillators for treating patient medical conditions such as pain, movement disorders, functional disorders, spasticity, cancer, and cardiac disorders. Medical devices can be configured to be surgically implanted or connected externally to the patient receiving treatment and can be used either alone or in combination with pharmaceutical therapies and surgery to treat patient medical conditions. For certain medical conditions, medical devices provide the best and sometimes the only therapy to restore an individual to a more healthful condition and a fuller life. One type of medical device is an implantable neurological stimulation system typically includes a neurostimulator, an electrical stimulation lead, and an extension. An implantable neurological stimulation system delivers electrical signals to tissue such as neurological tissue or muscle to treat a medical condition.

Electrical stimulation leads can be configured as surgical leads that require an incision for implantation and as percutaneous leads that are implanted through a needle or introducer. Surgical leads are typically less constrained in their shape because the incision used for implantation can be easily varied according to the surgical lead shape. Percutaneous leads are often constrained in their shape because of the requirement to be inserted through a needle or introducer.

A paddle style or flat lead is generally a rectangular shaped flat paddle that is surgically implanted. To introduce a paddle style lead into the epidural space percutaneously using needle insertion, the paddle lead can be rolled to a circular shape to slide through the circular cross section needle. The method of rolling the paddle lead and inserting through a needle and unrolling the paddle style lead has not been perfected for use. Implanting a paddle style lead is accomplished by a surgical procedure known as a laminotomy, a laminectomy, or similar surgical procedure.

BRIEF SUMMARY

The present disclosure relates to a percutaneous paddle stimulation lead. In particular, the present disclosure relates to a percutaneous paddle stimulation lead that can be steered during implantation. In many embodiments the percutaneous paddle stimulation lead that can be steered in a thickness plane of percutaneous paddle stimulation lead during implantation.

In one illustrative embodiment, a percutaneous paddle stimulation lead includes a lead body defining a paddle structure. The lead body has two opposing major surfaces and extends between a proximal end and a distal end. A plurality of electrical contacts disposed on the lead body. A lumen extends through a length of the lead body from the proximal end to the distal end. The lumen is configured to receive a guide wire and allow the lead body to move along the guide wire.

In one illustrative method, a percutaneous paddle stimulation lead is steering by first placing a guidewire into a body. The guidewire extends between a distal end and a proximal end. The distal end is placed in a target area of the body. Then a percutaneous paddle stimulation lead is slid along the guidewire until at least a portion of the percutaneous paddle stimulation lead is placed in the target area of the body. The method then includes removing the guidewire from the body, and the percutaneous paddle stimulation lead remains in the target area of the body.

DETAILED DESCRIPTION

In the following description, reference is made to the accompanying set of drawings that form a part hereof and in which are shown by way of illustration several specific embodiments. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense.

As used herein, when an element, component or layer for example is described as being “on” “connected to”, “coupled with” or “in contact with” another element, component or layer, it can be directly on, directly connected to, directly coupled with, in direct contact with, or intervening elements, components or layers may be on, connected, coupled or in contact with the particular element, component or layer, for example. When an element, component or layer for example is referred to as begin “directly on”, “directly connected to”, “directly coupled with”, or “directly in contact with” another element, there are no intervening elements, components or layers for example.

The present disclosure relates to a percutaneous paddle stimulation lead. In particular, the present disclosure relates to a percutaneous paddle stimulation lead that can be steered during implantation. In many embodiments the percutaneous paddle stimulation lead that can be steered in a thickness plane of percutaneous paddle stimulation lead during implantation. While the present disclosure is not so limited, an appreciation of various aspects of the disclosure will be gained through a discussion of the examples provided below.

The teachings presented herein are applicable to any implantable medical device system employing lead for delivering electrical signals to a tissue of a patient. For example, the system may include a neurostimulator, such as a peripheral nerve stimulator, a spinal cord stimulator, or a deep brain stimulator; a cardiac pacemaker or defibrillator; a gastric stimulator; or the like. It will be understood that the systems and devices described herein may be readily applied to systems employing leads for purposes of screening, sensing, monitoring, recording, or the like.

FIG. 1shows an environment of an implantable neurological stimulation system20. The implantable neurological stimulation system20includes an implantable neurological stimulator22, and a stimulation lead23. The implantable neurological stimulator22provides a programmable stimulation signal that is delivered to a desired location or target to stimulate selected nerves or muscle tissue. The implantable neurological stimulator22can be implanted in a subcutaneous pocket around the upper buttocks, for example.

The neurological lead23is a medical wire with special insulation attached to a planar paddle having a plurality of electrodes (described in more detail below). The neurological paddle leads described herein are designed to be inserted into a patient percutaneously. The neurological lead23can be percutaneously implanted and positioned to stimulate a specific site or area of the patient nervous system. The implanted stimulator22can be any “active medical device” or “signal generator” as described above and can be placed external to or in any location within a body cavity or tissue within the body, or on the surface of a patient's skin, as desired.

FIG. 2AtoFIG. 2Care a schematic diagrams of an illustrative method of steering a percutaneous paddle stimulation lead70to a target area55in a body50.FIG. 2Aillustrates schematically a guidewire60placed into a body50I the direction of the arrow. The guidewire60extends between a distal end64and a proximal end62. The distal end64is placed in a target area64of the body50.

FIG. 2Billustrates schematically sliding a percutaneous paddle stimulation lead70along the guidewire60until at least a portion of the percutaneous paddle stimulation lead70is placed in the target area55of the body50. The percutaneous paddle stimulation lead70can be formed of materials that provide enough stiffness to the percutaneous paddle stimulation lead70so that the percutaneous paddle stimulation lead70can be pushed along the guidewire60. In other embodiments the percutaneous paddle stimulation lead70can be pushed along the guidewire60with the assistance of a stylet.

FIG. 2Cillustrates schematically removing the guidewire60from the body50. The percutaneous paddle stimulation lead70remains in the target area55of the body50. Once the guidewire60is removed from the body50, the percutaneous paddle stimulation lead70can be electrically connected to a neurostimulator.

FIG. 3Ais a schematic diagram top view of an illustrative percutaneous paddle stimulation lead70.FIG. 3Bis a schematic diagram cross-sectional view of the percutaneous paddle stimulation lead70ofFIG. 3Ataken along line3B-3B.FIG. 3Cis a schematic diagram cross-sectional view of another percutaneous paddle stimulation lead embodiment ofFIG. 3Ataken along line3B-3B.

The embodiment illustrated inFIG. 3Cincludes a second lumen78that terminates within the percutaneous paddle stimulation lead70includes a lead body74. The second lumen78can be configured to receive a stylet (not shown). The stylet can be utilized to “push” the percutaneous paddle stimulation lead70along the guidewire60. Once the percutaneous paddle stimulation lead70is placed in the target area, the stylet can be removed from the percutaneous paddle stimulation lead70.

The percutaneous paddle stimulation lead70includes a lead body74defining a paddle structure72. The paddle structure72having two opposing major surfaces73,79. The lead body74extending between a proximal end76and a distal end77. A plurality of electrical contacts75are disposed on the lead body74paddle structure72. In many embodiments the electrical contacts75are disposed on only one major surface73of the two opposing major surfaces73,79. While four electrical contacts75are illustrated, it is understood that the lead body74paddle structure72can have any useful number electrical contacts75disposed on the lead body74paddle structure72.

A lumen71extends through a length of the lead body74from the proximal end76to the distal end77. The lumen71is configured to receive a guidewire60and allow the lead body74to move along the guide wire60. Thus, the guidewire60can be placed and the percutaneous paddle stimulation lead70is then loaded onto the guidewire60and slid along the guidewire60in an “over-the-wire” manner.

In many embodiments the lead body paddle structure72has a width W value that is greater than a thickness value T of the lead body paddle structure72. In many embodiments the lead body paddle structure72has a width:thickness (W:T) aspect ratio of at least 2:1 or at least 3:1 or at least 4:1 or at least 5:1. The lead body74and in particular, the paddle structure72is configured to allow the lead body74and in particular, the paddle structure72to steer within a thickness plane T defined between the two opposing major surfaces73,79of the paddle structure72. In other words, the paddle structure72is configured to allow the lead body74and in particular, the paddle structure72(having a top surface73and an opposing bottom surface79) to steer in a lateral direction (or side surface direction).

FIG. 4Ais a schematic diagram top view of another illustrative percutaneous paddle stimulation lead.FIG. 4Bis a schematic diagram cross-sectional view of the percutaneous paddle stimulation lead ofFIG. 4Ataken along line4B-4B.

The percutaneous paddle stimulation lead includes a lead body174defining a paddle structure172. The paddle structure172having two opposing major surfaces173,179including a polymeric sheath150. The lead body174extending between a proximal end and a distal end. A plurality of electrical contacts175are disposed on the lead body174paddle structure172. In many embodiments the electrical contacts175are disposed on only one major surface173of the two opposing major surfaces173,179. While three electrical contacts175are illustrated, it is understood that the lead body174paddle structure172can have any useful number electrical contacts175disposed on the lead body174paddle structure172.

A lumen171extends through a length of the lead body174from the proximal end to the distal end (as described above). The lumen171is configured to receive a guidewire60and allow the lead body174to move along the guide wire60. Thus, the guidewire60can be placed and the percutaneous paddle stimulation lead is then loaded onto the guidewire60and slid along the guidewire60in an “over-the-wire” manner.

In many embodiments the lead body paddle structure172has a width W value that is greater than a thickness value T of the lead body paddle structure172. In many embodiments the lead body paddle structure172has a width:thickness (W:T) aspect ratio of at least 2:1 or at least 3:1 or at least 4:1 or at least 5:1. The lead body174and in particular, the paddle structure172is configured to allow the lead body174and in particular, the paddle structure172to steer within a thickness plane T defined between the two opposing major surfaces173,179of the paddle structure172.

The paddle structure172includes a plurality of fins120. fins disposed along the length of the lead body174. The fins120are configured to allow the lead body174to steer within a thickness plane T defined between the two opposing major surfaces173,179of the paddle structure172. The fins120are separated by lateral spaces to allow the fins to flex and steer the paddle structure172within a thickness plane T defined between the two opposing major surfaces173,179of the paddle structure172.

FIG. 5is a schematic diagram view of another illustrative percutaneous paddle stimulation lead200including paddle structure272. This embodiments is similar to the percutaneous paddle stimulation lead shown inFIG. 4AandFIG. 4Bexcept that the lead body274is formed of a plurality of stacked segments220that are able to move somewhat independently of each other. In many embodiments the plurality of stacked segments220are not fixed to one another. A polymeric sheath250is disposed about the plurality of stacked segments220. A lumen272is disposed within a notch of each segment220and extends along a length of the percutaneous paddle stimulation lead200. The lumen272includes a conductor coil assembly that is electrically connected to electrical contacts on the paddle structure as described above. The lumen272can be utilized to receive a guidewire as described above.

A first steering cable222and a second steering cable224are each extend along a length of the percutaneous paddle stimulation lead200and can extend through each of the plurality of stacked segments220. The lumen272can be disposed parallel with and between the first steering cable222and the second steering cable224as illustrated. The steering cables222,224, are fixed to or near a distal end of the percutaneous paddle stimulation lead200.

When the first steering cable222is pulled, the percutaneous paddle stimulation lead200is deflected in a first direction that can be within a thickness plane defined between the two opposing major surfaces of the paddle structure, as described above. When the second steering cable224is pulled, the percutaneous paddle stimulation lead200is deflected in a second direction that can be a direction opposing the first direction and that can be within a thickness plane defined between the two opposing major surfaces of the paddle structure, as described above.

The first and second steering cables222,224, can be utilized in all of the percutaneous paddle stimulation leads described herein either in addition to the guidewire or without the guidewire to steer the percutaneous paddle stimulation leads described herein.

Thus, embodiments of the STEERABLE PERCUTANEOUS PADDLE STIMULATION LEAD are disclosed. The implementations described above and other implementations are within the scope of the following claims. One skilled in the art will appreciate that the present disclosure can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the present invention is limited only by the claims that follow.