Abstract: An implantable device comprises a polymer structure having an outer surface facing a surrounding tissue when the implantable device is implanted in a subject body. At least a portion of the surface of the structure has a semi-random pattern of extending micropillars. The semi-random pattern of micropillars on the surface contributes to advantageous surface characteristics of the implantable device in terms of reducing adhesion viable cells to the implantable device as compared to regular patterns of micropillars.

Abstract: A device for brain stimulation includes a lead body having a longitudinal surface and a distal end. The device further includes at least one ring array. The at least one ring array includes a plurality of split ring electrodes disposed on the distal end of the lead body. Each of the plurality of split ring electrodes includes a stimulating portion and a base portion coupled to the stimulating portion. The split ring electrodes of the at least one ring array are arranged about the circumference of the lead body. At least a portion of the base portion of at least one of the plurality of split ring electrodes is disposed below, and insulated from, at least a portion of the stimulating portion of another of the plurality of split electrodes.

Abstract: Implantable devices containing extracellular matrix and methods of using the devices are provided.

Abstract: MR conditional needle and surface electrode assemblies. The surface electrode utilizes a disc or cone-shaped structure with a bore with a concave bottom surface for receiving a conductive gel and an insulated wire with a connector for an EEG. The needle electrode assembly utilizes a cylindrical-shaped structure and is constructed of an MR conditional material having a needle and an insulated lead wire structure with a connector for an EEG.

Abstract: An improved electrical neurological stimulation paddle lead is described. The paddle lead comprises two flexible concave paddle bodies that are joined together at their opposing convex surfaces. The first paddle body contains a series of electrodes that are embedded on the concave surface that expand to fit the contours of the dura mater. The second paddle body consists of a concave surface that is pressed against the bone of the spinal column to act as a fixation mechanism to keep the paddle assembly in place.

Abstract: The present invention is a flexible circuit electrode array for improved layer adhesions where the metal conductors overlap the polymer insulator. The steps to build the flexible circuit are as follows. Deposit a base polymer layer. Deposit a conductive trace over the base polymer layer. Deposit a top polymer layer over the trace and prepare a void in the top polymer layer smaller than the surface of the trace. Deposit an electrode on the trace through the void with a periphery larger than, and overlapping the void.

Abstract: A releasable contact connection arrangement for electrodes on an electromedical device, in particular for electrodes of active implants, such as neurostimulator devices, includes a contact end, which is provided on the electrode and comprises at least one electrical contact, a device-side connector head on the electromedical device, a connector opening on the connector head for anchoring the contact end of the electrode so as to produce an electrical contact connection and releasable mechanical fixing, and an anti-kink device at the exit of the contact end from the connector opening, wherein the anti-kink device includes a flexible anti-kink sleeve sitting on the contact end of the electrode before the at least one electrical contact, said anti-kink sleeve being slid via its fixing end facing the connector head into a receiving recess that is enlarged compared to the connector opening and being fastened therein.

Abstract: Methods and devices for stimulating nerves are disclosed. In one embodiment adapted for stimulating excitable tissue, the invention includes drive circuitry, an acoustic transducer and a pair of electrodes.

Abstract: A neuromodulation catheter positionable within a blood vessel for transvascular nerve stimulation includes a catheter body and an electrically insulative substrate carried at a distal end of the catheter body. A distal end of the substrate includes a plurality of laterally spaced-apart fingers. The substrate includes a first face and a second face on an opposite side of the substrate from the first face. A plurality of electrodes are disposed on the first face of the substrate such that each of the fingers has a plurality of the electrodes longitudinally spaced thereon. A support at the distal end of the catheter is expandable within the blood vessel to bias the first faces of the fingers against the wall of a blood vessel so as to bias at least a portion of the electrodes in contact with the wall.

Abstract: Single-use electrical leads for a nerve stimulator are disclosed. The nerve stimulator has a “test mode” that determines a current value for treatment, and a “therapy mode” that administers treatment with the chosen current value. Preferably the fuse is electrically isolated from the leads that contact the patient.

Abstract: The invention provides an implant, system and method for electrically stimulating a target tissue to either activate or block neural impulses. The implant provides a conductive pathway for a portion of electrical current flowing between surface electrodes positioned on the skin and transmits that current to the target tissue. The implant has a passive electrical conductor of sufficient length to extend from subcutaneous tissue located below a surface cathodic electrode to the target tissue. The conductor has a pick-up end which forms an electrical termination having a sufficient surface area to allow a sufficient portion of the electrical current to flow through the conductor, in preference to flowing through body tissue between the surface electrodes, such that the target tissue is stimulated to either activate or block neural impulses. The conductor also has a stimulating end which forms an electrical termination for delivering the current to the target body tissue.

Abstract: Various embodiments of this disclosure concern assembly of a lead having one or two modular lead ends. A modular lead end can be made by aligning a plurality of wires exposed on an end of a main lead body with a plurality of conductors exposed on an end of a lead end. The lead end may comprise a spine, the plurality of conductors circumferentially arrayed about the spine, and an outer surface comprising a plurality of exposed electrical elements and polymer material, the plurality of electrical elements arrayed on the spine and electrically connected with the plurality of conductors. The assembly can further include making electrical connections between the plurality of electrical wires and the plurality of conductors and insulating the plurality of wires and the plurality of conductors.

Abstract: An electrode device having an insertion part (12) adapted to be inserted into the suprachoroidal space of an eye so as to reach a service position, and an handling part (14) for manipulation of the electrode device, said electrode device comprising: —a support (25) having a distal part (31); —a set of wires (20) supported by said support and mobile between a retracted position in which said wires substantially extend along the support, and a deployed position in which respective parts of said wires, called “outside parts”, project from said distal part (31) of the support; —an electrically conductive element forming at least a portion of a said outside part or supported by a said outside part; —an electrical conductor (60) enabling, in said deployed position, an electrical connection between said electrically conductive element and an electrical generator; and —an actuator (16, 60) adapted for an operator to move the set of wires from said retracted position to said deployed position in said service position.

Abstract: A device according to some embodiments may include an implant unit which may include a flexible carrier, an antenna arranged on the flexible carrier, at least one pair of modulation electrodes on the flexible carrier, at least one implantable circuit electrically connected to the at least one pair of modulation electrodes and the antenna; and at least one pair of suture holes passing through the flexible carrier. The at least one pair of suture holes may be arranged on the flexible carrier such that the flexible carrier may be configured to conform to tissue in a subject's body, and such that each suture hole of the at least one pair of suture holes may be positioned to allow suturing to tissue adjacent to the suture holes.

Abstract: A method of manufacturing a device for brain stimulation includes forming a lead body having a distal end section and coupling at least one pre-electrode to the distal end section of the lead body. The pre-electrode defines a divider with a plurality of partitioning arms, and has a plurality of fixing lumens. A portion of the pre-electrode aligned with the portioning arms is removed to divide the pre-electrode into a plurality of segmented electrodes. Each of the plurality of segmented electrodes defines at least one of the plurality of fixing lumens at least partially disposed through the segmented electrode. A material is introduced through the at least one fixing lumen to couple the plurality of segmented electrodes to the lead body.

Abstract: A medical device for placing a medical lead in the human body using minimally invasive techniques is described. One lead includes a lead body connected to a lead head having an aperture for providing fiber optic access to the interior of a helical electrode. The fiber optic shaft may be disposed within or along-side a drive shaft releasably coupled to the lead head to rotate the head. The drive shaft and lead body may be delivered using a delivery catheter. The delivery catheter can be advanced though a small incision to the target tissue site, and the site remotely visualized through the fiber optic scope extending through the lead head aperture. The lead head can be rotated, rotating the helical electrode into the tissue, and the catheter, drive shaft, and fiber optic probe removed.

Abstract: A temporary implantable medical device lead includes a connector configured to connect the lead to an external control module, a helically coiled conductor including a plurality of insulated filars and having a proximal end mechanically and electrically connected to the connector, and one or more electrodes defined by uninsulated portions of the helically coiled conductor. The temporary implantable medical device lead also includes one or more tine assemblies proximal to the one or more electrodes and configured to inhibit axial migration of the temporary implantable medical device lead, each tine assembly including a base and a plurality of tines extending from the base.

Abstract: A medical electrical lead may include a lead body having a proximal end and a distal end, a conductive electrode shaft located near the distal end within the lead body, a coiled conductor extending within the lead body from the proximal end and coupled to a first end of the conductive electrode shaft, and an electrode located near the distal end of the lead body and coupled to an opposite end of the conductive electrode shaft as the coiled conductor. The lead may also include an energy dissipating structure located near the distal end of the lead body and formed from a conductive material that defines a lumen through which a portion of the coiled conductor extends. The portion of the coiled conductor extending through the lumen defined by the energy dissipating structure is formed to provide an interference contact with the energy dissipating structure.

Abstract: An implantable electrical stimulation lead includes a plurality of conductors that extend along a lead body and that electrically couple electrodes to terminals. A first tissue coupler is electrically coupled to a first conductor of the plurality of conductors. The first tissue coupler includes a conductive first inner member, a non-conductive member disposed adjacent to at least a portion of the first inner member, and a conductive outer member disposed adjacent to at least a portion of the non-conductive member such that at least a portion of the non-conductive member is sandwiched between the first inner member and the outer member. The first inner member is electrically coupled to the first conductor. The outer member is disposed along a portion of an outer surface of the lead body such that the conductive outer member is exposed to patient tissue when the lead is implanted in a patient.

Abstract: The invention provides an implantable multi-electrode device (300) and related methods and apparatuses. In one embodiment, the invention includes an implantable device (300) comprising: an assembly block (320); and a plurality of leads (340 . . . 348) radiating from the assembly block (320), each of the plurality of leads (340 . . . 348) containing at least one electrode (342A), such that the electrodes are distributed within a three-dimensional space, wherein the assembly block (320) includes a barb (350) for anchoring the assembly block (320) within implanted tissue.

Abstract: The present invention is an improved method of electrically stimulating percepts in a patient with a visual prosthesis, to induce a more controlled perception of light. In particular, the present invention is an improved electrode array to maximize retinal response. The array of the present invention is an array with a center section with no electrode, surrounded by a ring of small high density electrodes. Electrodes beyond to ring are gradually larger and more widely spaced.

Abstract: Various embodiments of this disclosure concern a lead end containing a slotted member. A slotted member can have a plurality of slots extending along at least a portion of the length of the slotted member, each of the slots having a respective positioning feature, the plurality of slots having a plurality of positioning features at different longitudinal positions along the length of the slotted member. The lead end can further include a plurality of conductors at least partially within the plurality of slots, each slot of the plurality of slots containing at least a respective one of the plurality of conductors, the plurality of conductors electrically connecting exposed electrical elements of both ends of the lead.

Abstract: An intracerebral electrode (11) which includes a narrow elongated body (1) for being implanted in a patient's brain. The body has contact pads (2) that are electrically connected to a measuring apparatus, and a mounting member (4) for attachment to the body to the patient's head. The electrode body has a closed distal end (5) and is hollow for receiving a treatment instrument (6). The intracerebral electrode (11) comprises a closed inner fluid flow circuit (20) formed inside the body (1) of the electrode to an area adjacent the closed distal end (5), and a connection mechanism (7) located outside the body which connects the closed inner fluid flow circuit to an outer fluid flow circuit so that fluid, flowing through the outer fluid flow circuit, flows into the electrode through the inner fluid flow circuit and controls the temperature of the electrode (11).

Abstract: An implantable electrode for electrical stimulation of a body, for example, being a component of an implantable medical electrical lead, is preferably in the form of a coiled conductor wire, wherein the wire is formed by a tantalum (Ta) core directly overlaid with a platinum-iridium (Pt—Ir) cladding. When a maximum thickness of the Pt—Ir cladding defines a cladded zone between an outer, exposed surface of the electrode and the Ta core, a surface of the Ta core encroaches into the cladded zone by no more than approximately 50 micro-inches. The tantalum core may be cold worked to improve surface quality or formed from a sintered and, preferably, grain stabilized tantalum.

Abstract: Apparatus (20) is provided, including a bifurcation stent (50) comprising one or more electrodes (32), the stent (50) configured to be placed in a primary passage (52) and a secondary passage (54) of a blood vessel (30), and a control unit (34), configured to drive the electrodes (32) to apply a signal to a wall (36) of the blood vessel (30), and to configure the signal to increase nitric oxide (NO) secretion by the wall (36). Other embodiments are also described.

Abstract: One embodiment is a method of making a stimulation lead that includes providing a pre-electrode assembly comprising a plurality of segmented electrodes and a plurality of raised connectors. Each of the segmented electrodes is coupled to at least one other of the segmented electrodes by at least one of the raised connectors. The method further includes forming the pre-electrode assembly into a tube with the tube defining a longitudinal axis. Each of the raised connectors is disposed at a radius with respect to the longitudinal axis that is greater than a radius of any of the segmented electrodes with respect to the longitudinal axis. The method also includes forming at least a portion of a lead body around the segmented electrodes of the pre-electrode assembly; and grinding the tube comprising the pre-electrode assembly and portion of the lead body to remove the plurality of raised connectors leaving the plurality of segmented electrodes and the portion of the lead body.

Abstract: A nerve stimulation system includes a pulse generator and implantable lead. The pulse generator includes a sensing module and a pace circuit. The lead has an electrode array near the distal end and a connector at the proximal end for connection to the pulse generator. Conductors in the lead electrically connect the electrode array with the sensing module and pace circuit. The electrode array includes a first pair of small electrodes and a large electrode close to each other. The small electrodes and large electrode are physically separated from each other by insulative spaces extending generally transversely to a longitudinal axis of the lead. When the conductors are in electrical communication with the sensing module and pace circuit, the first pair of small electrodes are in electrical communication with both the sensing module and the pace circuit and the large electrode is in electrical communication with the pace circuit only.

Abstract: Described herein are microelectrode array devices, and methods of fabrication and use of the same, to provide highly localized and efficient electrical stimulation of a neurological target. The device includes multiple microelectrode elements arranged along an elongated probe shaft. The microelectrode elements are dimensioned and shaped so as to target individual neurons, groups of neurons, and neural tissue as may be located in an animal nervous system, such as deep within a human brain. Beneficially, the neurological probe can be used to facilitate location of the neurological target and remain implanted for long-term monitoring and/or stimulation.

Abstract: A contacting device for electrical connections to flexible electrode lines insertable or implantable into a patient body, includes a line coil with a plurality of coradially bundled coil wires, an inner fixing sleeve for a partial bundle of the coil wires, the fixing sleeve has a through-slit running in the axial direction for the partial bundle of the coil wires, and a winding groove running in the peripheral direction for the partial bundle led through, an outer electrode sleeve sitting on the inner fixing sleeve and electrically contacted with the partial bundle, and a strain-resistant fixing between the fixing sleeve and the partial bundle guided through the through-slit via an application of force on the partial bundle by pressing the fixing sleeve onto the line coil to produce plastic deformation and by looping the led-out partial bundle around the fixing sleeve in the winding groove by a minimum looping angle.

Abstract: Systems for treating premature ejaculation include an electrical pulse generator and electrical leads in communication with sympathetic nerves serving ejaculatory structures. The system inhibits sympathetic nerve input to the ejaculatory structure with electrical impulses from the electrical pulse generator. The duration of inhibition may be predetermined or selectable. The system may be operated with user-actuated controls, a sensor and a timer, or combinations of these elements.

Abstract: An MRI compatible electrode circuit construct is provided. The construct includes at least two filter components constructed from an electrode wire. One filter component may be a resonant LC filter at or near an electrode/wire interface that resolves the issue of insufficient attenuation by effectively blocking the RF induced current on the wire from exiting the wire through the electrode. The second filter component may include one or more non-resonant filter(s) positioned along the length of the electrode wire that resolve(s) the issue of excessive heating of the resonant LC filter by significantly attenuating the current induced on the wire before it reaches the resonant LC filter. The non-resonant filter(s) may also attenuate the RF current reflected from the resonant LC filter thereby resolving the issue of the strong reflected power from the resonant filter and the associated dielectric heating.

Abstract: The embodiments herein relate to a conductor cable for use in a lead and more specifically to methods and devices related to laser consolidation of the cable. The various conductor cable embodiments and methods provide for at least one end of the cable having a weld mass created by a laser welding process.

Abstract: In a femoral head cap implant having a cup-shaped cap component and a pin fixed to its concave inner surface, a pick-up coil is arranged in the latter, each respective terminal of the same being connected to a tissue electrode. One tissue electrode comprises a cap component, the other an electrode provided insulated on the pin or on at least one part of the pin which is electrically insulated from the cap component. By inducing a low-frequency alternating current in the pick-up coil by means of an external coil, this low-frequency alternating current flows from the two tissue electrodes through the femoral head bone provided with the implant, thereby promoting the maintenance of its vitality.

Abstract: A system for treating chronic inflammation may include an implantable microstimulator, a wearable charger, and optionally an external controller. The implantable microstimulator may be implemented as a leadless neurostimulator implantable in communication with a cervical region of a vagus nerve. The microstimulator can address several types of stimulation including regular dose delivery. The wearable charger may be worn around the subject's neck to rapidly (<10 minutes per week) charge an implanted microstimulator. The external controller may be configured as a prescription pad that controls the dosing and activity of the microstimulator.

Abstract: An implantable electrical stimulation lead includes a tip electrode disposed on a distal tip of the lead body. One tip electrode has a base and a separate plug attached to the base. The base defines an interior lumen closed at one end by the plug. Another tip electrode has an electrode body, a stem extending from the electrode body, and shaped retention features extending from the stem. Yet another tip electrode has an electrode body, a stem extending from the electrode body, and a flange disposed on the stem opposite the electrode body. A further tip electrode has an electrode body defining an interior lumen and a plurality of protrusions extending into the interior lumen. Another tip electrode has an electrode body and arms extending from the electrode body. The electrode body defines an interior lumen and the arms extend over an opening to the interior lumen.

Abstract: A medical lead includes a coiled conductor portion that defines at least part of an outer surface of the lead and an expandable coiled fixation element that defines at least a part of the outer surface of the lead. The expandable coiled fixation element is configured to expand from a first dimension in a first state to a second dimension in a second state in a direction away from the coiled conductor portion. In some examples, the expandable coiled fixation element comprises a shape memory material.

Abstract: The neural interface system of the preferred embodiments includes an electrode array having a plurality of electrode sites and a carrier that supports the electrode array. The electrode array is coupled to the carrier such that the electrode sites are arranged both circumferentially around the carrier and axially along the carrier. A group of the electrode sites may be simultaneously activated to create an activation pattern. The system of the preferred embodiment is preferably designed for deep brain stimulation, and, more specifically, for deep brain stimulation with fine electrode site positioning, selectivity, tunability, and precise activation patterning. The system of the preferred embodiments, however, may be alternatively used in any suitable environment (such as the spinal cord, peripheral nerve, muscle, or any other suitable anatomical location) and for any suitable reason.

Abstract: A shielded component or network for an active medical device (AMD) implantable lead includes an implantable lead having a length extending from a proximal end to a distal end, all external of an AMD housing, a passive component or network disposed somewhere along the length of the implantable lead, the passive component or network including at least one inductive component having a first inductive value, and an electromagnetic shield substantially surrounding the inductive component or the passive network. The first inductive value of the inductive component is adjusted to account for a shift in its inductance to a second inductive value when shielded.

Abstract: A lead extending exteriorly from an active implantable medical device (AIMD) is at least partially ensheathed within an electromagnetic interference (EMI) shield. The AIMD has a conductive equipotential surface to which the EMI shield may be conductively coupled. An impeding circuit may be provided for raising the high frequency impedance of the lead. An energy diversion circuit may also be provided for conductively coupling the lead to the EMI shield.

Abstract: An integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Abstract: Strain relief loops are forced by being formed into medical leads such that a body of the lead imposes a force to regain the loop if the loop has been disturbed. Because the strain relief loop is forced, the surgeon implanting the medical lead is not required to create the strain relief loop as a step in the implantation procedure. Forcing the strain relief loop ensures that the strain relief is achieved. The forced strain relief loop also ensures that the loop is present to reduce heating at the electrodes of the medical caused by exposure to excessive radiofrequency energy. The forced strain relief loop may be created by heating the lead body while held in the loop configuration by a mold to cause the loop configuration to persist once the medical lead is removed from the mold.

Abstract: An implantable connector for use with a neurological device and a lead extension includes a male connector having a plurality of electrical contacts axially arranged along the connector, insulated from each other. The connector also includes a female connector having one or more channels axially disposed therein and a plurality of conductors axially arranged on the female connector. The plurality of conductors are electrically insulated from each other, and at least one indexing element is disposed adjacent to one or more of the channels. The indexing element allows the male connector to be received into the one or more channels in a defined orientation relative to the channel, thereby forming at least two electrical connections along two or more axial positions. Often the neurological device is a brain stimulating and recording lead. The male and female connectors are often fastened together with a screw or by twist-locking the two members together.

Abstract: An implantable paddle lead includes a paddle body coupled to a distal end of an elongated lead body. A plurality of contacts are disposed on a front surface of the paddle body. At least one manually bendable shape-retaining member is interconnected with the paddle body. The at least one shape-retaining member is formed from a deformable material that is stiff enough to maintain a given shape for at least one day. The at least one bendable shape-retaining member is interconnected with the paddle body such that bending the at least one shape-retaining member causes a corresponding bend of at least a portion of the paddle body in proximity to the at least one shape-retaining member.

Abstract: A paddle lead assembly for providing electrical stimulation of patient tissue includes a paddle body having a plurality of electrodes. At least one of the plurality of electrodes defines a removed center portion. At least one lead body is coupled to the paddle body. At least one terminal is disposed on each of the at least one lead bodies.

Abstract: An anchor sleeve for securing a therapy delivery element, such as a stimulation lead or catheter, within a living body, that includes an inner sleeve with pre-formed locations of weakness that facilitate localized deformation. The anchor includes a deformable outer sleeve with a primary lumen extending along an axis. The outer surface of the outer sleeve includes a plurality of suture grooves oriented generally concentric to the axis. The inner sleeve includes a plurality of beams connected at deflection regions arranged around a secondary lumen. The inner sleeve is located in the primary lumen adjacent to the suture grooves so that the secondary lumen is generally concentric with the primary lumen. A plurality of locations of weakness are preformed in each of the beams to facilitate localized deformation in response to a radially inward force applied around the suture grooves by a suture material.

Abstract: An implantable device (100) having an electronic component (110) and a biologic materials component (130). The biologic materials component has target cells in a matrix that interfaces the electronic component with the surrounding environment.

Abstract: Subdural arrays transmit electrocorticogram recordings wirelessly, across the patient's skull, allowing the craniotomy used for surgical placement of the arrays to be completely closed. In various embodiments, the arrays also respond to commands, applying signal patterns to the patient's brain for diagnostic and treatment purposes.

Abstract: A method of implanting an electrical stimulation lead to stimulate a dorsal root ganglion includes providing an electrical stimulation lead having a distal end, a proximal end, a longitudinal length, electrodes disposed along the distal end of the lead, terminals disposed on the proximal end of the body, a plurality of conductors electrically coupling the electrodes to the terminals. The method further includes sequentially inserting a series of hollow introducers into the back of a patient to open a passage to the dorsal root ganglion. Each introducer in the series has an inner diameter larger than an inner diameter of a preceding introducer in the series. The method also includes implanting the electrical stimulation lead through the passage formed using the series of hollow introducers. Upon implantation of the electrical stimulation lead, at least one of the plurality of electrodes is adjacent the dorsal root ganglion.

Abstract: Systems and methods for implantable medical devices and headers are described. In an example, an implantable medical device includes a device container including an electronic module within the device container. A header core includes a bore hole portion and at least two electronic connection features disposed within the bore hole portion. The bore hole portion includes at least one cavity configured to allow placement of at least one of the electronic connection features within the bore hole portion. The at least two electronic connection features are electrically coupled to the electronic module within the device container. The header core is configured to allow location of the at least two electronic connection features in a selected configuration within the bore hole portion. A header shell is disposed around the header core and attached to the device container.

Abstract: A medical lead is configured to be implanted into a patient's body and comprises a lead body, and an electrode coupled to the lead body. The electrode comprises a first section configured to contact the patient's body, and a second section capacitively coupled to the first section and configured to be electrically coupled to the patient's body.