Medtronic, Inc.

Duane J Zytkovicz

Roger W Dahl

Kenneth C Gardeski

Stephen Kenneth Sundquist

Eugene A Dickhudt

Brad D Pedersen

Arnold W Thornton

Thomas M Soukup

Terry Corbin

An improved system and method for deploying medical electrical leads is disclosed. The system includes a guiding device such as a guidewire used to navigate the vascular system of a body. The guiding device includes a fixation member that can be deployed to maintain the guiding device at a desired location within the vascular system. The fixation member may be an inflatable device such as a balloon, or alternatively, may be an expandable device constructed of flexible fibers that has both an expanded and a contracted state. The system may further include a coupling member located adjacent to the guiding device. The coupling member may be a rail extending distally from a proximal end of the guiding device to a point proximal the fixation member. In an alternative embodiment of the invention, the coupling member is a channel included in the body of the guiding device adapted to slidably engage an electrode assembly. The coupling member is adapted to allow the electrode assembly to be slid to the distal end of the coupling member and deployed at a predetermined implant site. In one embodiment of the invention, the coupling member is movable with respect to the guiding device. This allows the coupling member to be re-positioned to multiple implant sites to deploy more than one electrode while the fixation mechanism remains stationary within a patient's vascular system. According to yet another aspect of the invention, the guiding device includes a lumen to delivery fluoro visible medium.

System and method for placing endocardial leads

An implantable device including an elastically compressible member coupled to a distal end of a lead and further coupled to at least one electrode. The compressible member is in a contracted state when the electrode is being delivered to an implant site. At the implant site, the compressible member is expanded to urge the electrode into contact with tissue. Compressible member further includes a keyed structure to engage a stiffening member such as a stylet. The stiffening member is used both to deliver the electrode to the implant site, and to rotate the compressible member, if necessary, so that the electrode contacts predetermined body tissue. According to one aspect of the invention, an introducer having an inner lumen with a diameter that is smaller than that of the compressible member may be used to disengage the stiffening member from the compressible member. In one embodiment, compressible member includes a conductor wound to form multiple turns that are aligned during electrode delivery, but which expand into a non-aligned configuration after deployment. In another embodiment, compressible member includes a spring clip that has a compressed profile during delivery, and an expanded profile after deployment.

Medical electrical lead having an expandable electrode assembly

An improved system and method that is capable of delivering multiple electrode assemblies to predetermined implant sites within a body is disclosed. The system includes an elongated member such as an introducer sheath. The introducer includes an elongated channel along at least a distal end portion of the introducer. The elongated channel opens to the exterior surface of the introducer through an elongated slot. One or more electrode assemblies may be retained within the elongated channel such that the leads exit the introducer via the elongated slot. The elongated introducer further includes a lumen that is in fluid communication with channel through openings, or gaps. The electrode assemblies are loaded within the channel at predetermined positions with respect to the openings. A distal end of a stiffening member such as a stylet may then be advanced within the lumen and through a selected one of the openings to engage an electrode assembly. The distal end of the stylet, along with the electrode assembly, is pushed in a distal direction within the channel until the electrode assembly exits the channel at a predetermined implant site. The stylet is then de-coupled from the electrode assembly, and the distal end is again retracted into the lumen. The distal end of the stiffening member may be re-directed into a different opening to engage a second electrode assembly. After the introducer is repositioned at a second implant site, the second electrode assembly may be deployed in a manner similar to that discussed above. The process may be repeated to deploy an array of electrodes. According to one aspect of the invention, the stylet distal end is canted to extend from the lumen of the introducer into the channel.

System and method for placing a medical electrical lead

A tool having a handle portion and a curved tongue extending from the handle. The curve of the tongue is sufficient that, when the distal end of the tongue is placed substantially parallel to the spinal cord within the epidural space, the proximal portion of the curve extends substantially parallel to the plane passing between spinal vertebrae. The tongue is formed of a pliant material having sufficient rigidity to separate epidural fat to form a pocket in the epidural space, but sufficiently pliant to prevent trauma to the dura and the spine upon contact. A circular disc, having a thickness and width substantially equal to the thickness and width of the electrode to be placed in the pocket, is formed in the distal end of the tongue to shape the pocket to the size of the electrode.

Tool for creating a pocket for a epidural electrode

A medical electrode placement system including a stylet insertable within an electrode carrying lead to provide stability to the lead during electrode placement within the body. The stylet includes a knob secured to one end thereof and a lead engagement device mechanically connected to the knob for imparting movement to a lead in accordance with manipulation of the knob. In a preferred embodiment, the lead engagement device is spaced from the knob to accommodate differences in length from lead to lead and may take the form of a clamp. The lead engagement device may be formed of a body member having a lead accepting groove therein, the groove being configured to compress a lead of desired cross section when placed within the groove. Finger(s) may be provided to project into the lead accepting groove to further enhance the engagement of the lead. In some instances, x-rays may be employed to provide a view of the lead placement. In such instances, the knob may be provided with an extension to remove the hand of the physician from the x-ray or fluoroscopy field.

Stylet retainer and extension

A lead is disclosed for being inserted within a human or animal body for applying electrical stimulation to the spinal cord of the recipient, whereby selected pain is effectively relieved by the application of an electrical signal of selected frequency, pulsewidth and amplitude to the lead. In particular, the lead comprises a spherically-shaped, distal electrode adapted to be disposed near a selected segment of the spinal cord whereby maximum stimulation may be applied to the afferent nerves passing therethrough, a first conductor taking the form of a helically-wound coil extending from the distal electrode to a first tubular contact, and a second conductor disposed axially of the first-mentioned coil and forming an extension extending beyond the first-mentioned contact and terminated in a second tubular contact.

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Minneapolis, MN, United States of America

Duane J Zytkovicz