Abstract: The invention is directed to lead configurations for sensors that allow for less invasive sensor replacement procedures. In one configuration, a sensor lead assembly includes an outer lead body and an inner lead including a sensor such as an electrochemical glucose sensor. The inner lead can be positioned in an inner conduit of the outer lead body. The outer lead body may be substantially permanently implanted in the patient, and the inner lead can be implanted through the inner conduit of the outer lead body. Once the sensor of the inner lead has worn out or otherwise exhausted its useful life, the inner lead can be removed, and a new inner lead can be implanted in place of the old inner lead.

Abstract: A system for locating a target tissue site is described. The system includes a locating guide that frames an area of interest upon placement over skin of a patient, an electrode patch defining an aperture and including two or more electrodes for placement within the area of interest, and a medical imaging device that indicates a location of a target tissue site within the patient based on electrical signals generated by one or more of the electrodes. A clinician may guide an introducer needle into the aperture for implanting a medical lead proximate to the target tissue site.

Abstract: A locating guide for locating a target tissue site within a patient includes a body, a first substantially radiopaque reference marker on the body, and a second substantially radiopaque reference marker extending from a major surface of the body. The reference markers provide reference points that extend in at least two dimensions, and may be useful for registering a medical image of tissue with an actual location on or within the patient in order to more accurately and precisely locate a target tissue site within the patient. In some embodiments, the second reference marker is oriented at a predetermined angle relative to the major surface of the body, and provides a guide that a clinician may reference in order to orient a medical element introducer when introducing the introducer into the patient to access a particular target tissue site.

Abstract: The invention includes a implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion, wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration. Kits, and systems and methods of using the lead are also included.

Abstract: An implantable electrical lead for applying stimulation energy to bodily tissue, such as a patient's nervous system, from an external power source. The lead is defined by a distal section, an intermediate section and a proximal section, and includes a lead body, a plurality of insulated wires, and a plurality of connector elements. The lead body includes a plurality of electrodes and an anchoring device. The insulated wires are electrically coupled to the electrodes, respectively. A wire intermediate segment extends proximal the lead body and is characterized as having a non-coiled configuration, terminating at a respective connector element for coupling to an external power source. The wire intermediate segments are extendible through a patient's skin and are sealable relative to the skin. The lead is adapted for providing temporary electrical stimulation to a sacral nerve in a bipolar mode, with the anchoring device inhibiting electrode migration.

Abstract: A system for providing medical electrical stimulation including a lead assembly and a cannula. The lead assembly includes a lead body and a needle tip. The lead body has a distal section and a proximal section. The needle tip is formed of an electrically conductive material and is connected to the distal section of the lead body. The lead body is slidably disposed within a cannula lumen, with a distal end of the cannula being selectively connected to an abutment surface of the needle tip such that the needle tip extends distal the cannula to define a needle probe. With this construction, the lead assembly can be delivered to a desired implantation site via manipulation of the cannula and/or energization of the needle tip, and the cannula can be removed from the lead body without requiring movement of the needle tip.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one modifiable portion that exhibits a permanent configuration and a temporary configuration, wherein the temporary configuration exists only when the surrounding magnetic field is increased, wherein the permanent configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the temporary configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems, and methods of implanting the leads are also included in the invention.

Abstract: A device comprises a medical implant and an actively deployable clip attached to the medical implant that operates to restrict movement of the medical implant once the actively deployable clip is deployed within a body of a patient. In some embodiments, the medical implant is an electrical lead for electrical stimulation. The actively deployable clip is operable to fixate the medical implant to a body tissue once deployed, such that the actively deployable clip performs a similar function to a suture. In this manner, embodiments of the invention may provide a medical implant that requires few or even no sutures to properly fixate the implant within the patient.

Abstract: The invention includes an implantable medical electrical lead for electrical stimulation of body tissue that includes at least one modifiable portion that exhibits a first configuration when exposed to a first temperature and a second configuration when exposed to a second temperature, wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration, and the second temperature is higher than the first temperature; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems including leads of the invention and methods of implanting leads of the invention are also included.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems and kits as well as methods of utilizing the leads of the invention are also included.

Abstract: An implantable medical electrical lead for applying electrical stimulation energy from an external power source and adapted to be introduced through a small diameter needle. The lead includes a lead body and a fixation assembly. The lead body includes a wire and an electrically non-conductive material. The wire forms a wound coil along a distal portion thereof. The non-conductive material covers some of the wire coil, with an uncovered distal region of the wire serving as an electrode. The fixation assembly is coupled to the uncovered distal region and includes at least one fixation member. The fixation assembly is transitionable between a contracted state and an expanded state, with the fixation member extending outwardly relative to the coil to a greater extent in the expanded state. In the expanded state, the fixation assembly serves to inhibit axial migration of the lead body.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion wherein the at least one modifiable portion can exist in both a deflated configuration and an inflated configuration, and wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated configuration. Kits, systems, and methods of using the leads are also included.

Abstract: The invention includes an implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion that is coaxial with the lead body, wherein the at least one modifiable portion can exist in both a first configuration and a second configuration, wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration, and wherein the first configuration is exhibited when an external force is applied to the outer surface of the modifiable portion. Kits, systems and methods of implanting are also included in the invention.

Abstract: An implantable medical electrode lead for stimulation of bodily tissue. The lead is adapted for use with a needle lumen diameter of not greater than 0.05 inch, and includes a lead body and a tine assembly. The lead body has a distal section forming at least one exposed electrode surface. The tine assembly includes a plurality of tines each having a base end coupled to an exterior of the lead body immediately adjacent the exposed electrode surface and a free end that is movable relative to the lead body to inhibit axial migration of the lead body upon implantation into a patient. In one embodiment, the lead body is a PNE lead and provides two electrode surfaces for bipolar operation.

Abstract: Implantable medical devices with coatings formed by atomic layer deposition and methods of applying such coatings to implantable medical devices are disclosed. The medical devices may include electrical feedthroughs and media exposed integrated circuits and/or transducer systems, as well as others. The coatings may improve, among other things, hermeticity, biocompatibility, biostability, surface characteristics, and electrical properties.

Abstract: The invention is directed to lead configurations for sensors that allow for less invasive sensor replacement procedures. In one configuration, a sensor lead assembly includes an outer lead body and an inner lead including a sensor such as an electrochemical glucose sensor. The inner lead can be positioned in an inner conduit of the outer lead body. The outer lead body may be substantially permanently implanted in the patient, and the inner lead can be implanted through the inner conduit of the outer lead body. Once the sensor of the inner lead has worn out or otherwise exhausted its useful life, the inner lead can be removed, and a new inner lead can be implanted in place of the old inner lead.

Abstract: The disclosure is directed to a method and tool for implanting a stimulation lead or other medical device adjacent a pudendal nerve. The tool includes a shaped needle that enters a patient and passes through an obturator foramen passage in a pelvis. A physician places a tip of the tool at the pudendal nerve and performs test stimulation to confirm an effective stimulation location. A shape memory cannula initially covering the needle remains at the pudendal nerve when the physician removes the tool. The cannula deforms to follow the curve of the pudendal nerve once the needle is removed, and a lead is inserted into the cannula and secured at the pudendal nerve placement site. This method may provide an easier and more consistent procedure for implanting the stimulation lead near the pudendal nerve.

Abstract: An automated identification and configuration system for use with an implantable medical device (IMD) is disclosed. The system includes a first communication circuit that is attached to, or otherwise carried by, a detachable component associated with the IMD such as a medical lead. The communication circuit stores data such as model numbers, serial numbers, technical data, and/or calibration information that describes the additional component. This information may be transferred by the first communications circuit to a second communications circuit that is external to the additional component. This transferred data can be used to automatically configure the internal circuitry and connection functions of the IMD to properly interface with, and support, the additional component. For example, the data can be used to automatically adjust amplifier gains or other sensor circuitry, or to configure a connector block to properly couple to the component.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes a lead body extending between lead proximal and distal ends, at least one tine element that includes at least one flexible, pliant, tine, that is adapted to be folded inward and temporarily secured against the lead body using a temporary fixative, and at least one electrode, wherein the at least one electrode is distal of the at least one tine element on the lead body. A medical electrical stimulation system that includes an implantable pulse generator for providing medical electrical stimulation, and a medical electrical lead coupled to the implantable pulse generator for electrical stimulation of body tissue, the medical electrical lead including a lead body extending between lead proximal and distal ends.

Abstract: The invention includes a delivery device for introducing a prosthesis beneath a tissue surface that includes an elongate body having a proximal end and a distal end, an opening on the elongate body, which is at least partially covered by a mesh, and a deployment lumen extending through the body that has a longitudinal axis and a distal end, wherein the distal end of the deployment lumen is positioned proximal of the opening. Also included are delivery systems and kits that include delivery devices of the invention. Further, an overtube for receiving an endoscope, that includes an elongate, flexible tubular body, having a proximal end and a distal end and a longitudinal axis, at least one lumen extending therethrough for receiving an endoscope, an opening on the body, in communication with the lumen, and a tissue limiting surface within the body aligned with the opening, formed at least in part by a mesh. Methods of using the devices, and kits are also included in the invention.