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Methods of Placement of Neurostimulation Lead, Infusion Catheter, and/or Sensor via Peripheral Vasculature Disclosure Number: IPCOM000012136D
Publication Date: 2003-Apr-10
Document File: 7 page(s) / 633K

Publishing Venue

The Prior Art Database


The present invention provides a method for delivery of medical devices such as leads, catheters, and/or sensors via the vasculature to peripheral target sites, such as the limbs. The methods of the present invention provide less invasive and less cumbersome procedures for patients and physicians than traditional procedures. More specifically, the present invention provides methods for placing a lead(s) for neurostimulation of peripheral nerves, via the vasculature. The present invention also provides methods for placing an infusion catheter(s) via the vasculature to facilitate targeted application of drugs to peripheral nerves. The present invention also provides methods for placing a sensor(s) via the vasculature near peripheral nerves for detection of electrical, chemical, or other activity.

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Methods of Placement of Neurostimulation Lead, Infusion Catheter, and/or Sensor via Peripheral Vasculature

Background and Summary

        � � � � � � � � � � � Current implantable neurostimulation devices (e.g., spinal cord stimulators, deep brain stimulators) typically use leads to deliver an electrical stimulus from an implantable pulse generator (IPG) at the proximal end of a lead to an electrode(s) at the distal end of the lead.� In peripheral nerve stimulation (PNS), the lead typically contains an electrode array.� PNS electrode arrays are typically placed by exposing the peripheral nerve of interest; properly placing the electrodes next to or around the nerve of interest; stabilizing electrode placement through the use of tethers on surrounding tissue (not the nerve); forming a strain relief bend and loop in the lead; loosely attaching the strain relief loop/bend to adjacent fascia through the use of tie-downs; routing the connector end of the lead to the site of the implanted device, using tunneling tools if necessary; connecting the lead to the device; testing stimulation; and closing surgical incisions.

        � � � � � � � � � � � Pacemaker and implantable cardiac defibrillator leads are usually placed through a vascular approach to the cardiac tissue, rather than a direct approach that penetrates through the bone and tissue of the thoracic cavity.� In such a procedure, access to the vasculature may be gained through a major vessel, e.g., the femoral vein or artery or the subclavian vein or artery.� Typically, a flexible lead bolstered by a rigid stylet allows the electrodes to be snaked through the vasculature to the appropriate location, e.g., an atrium or ventricle.

        � � � � � � � � � � � U.S. Patent No. 6,006,134 to Hill, et al. discloses several aspects of a system for regulating the heartbeat where an intravenous lead stimulates nerve fibers of the heart, and electrodes and catheters are delivered intravenously.� The ‘134 patent teaches delivering a lead with electrodes through the vascular system to vascular sites where the electrodes may stimulate neighboring vagus, hypoglossal, phrenic, parasympathetic, and sympathetic nerve fibers.� The area of vagus nerve fibers intended to be stimulated in the ‘134 patent is below the cranium.� Further, the ‘134 patent teaches positioning of leads with electrodes within an azygous vein, a hemizygous vein, and an internal jugular vein below the cranium.� The use of these veins and stimulation of these nerve fibers in the ‘134 patent are intended to control the beating of a heart.� The ‘134 patent does not teach deliver of leads or catheters through or to the vasculature of limbs.

        � � � � � � � � � � � U.S. Patent No. 5,755,766 to Chastain, et al. discloses an open-ended intravenous cardiac lead that follows the path of a guidewire, upon which the lead is threaded through the cardiac vasculature.� The ‘766 patent does not teach delivery of leads or catheters through the vasculature to peripher...