A system for monitoring and/or affecting parameters of a patient's body and more particularly to such a system comprised of a system control unit (SCU) and one or more other devices, preferably battery-powered, implanted in the patient's body, i.e., within the envelope defined by the patient's skin. Each such implanted device is configured to be monitored and/or controlled by the SCU via a wireless communication channel. In accordance with the invention, the SCU comprises a programmable unit capable of (1) transmitting commands to at least some of a plurality of implanted devices and (2) receiving data signal from at least some of those implanted devices. In accordance with a preferred embodiment, the system operates in closed loop fashion whereby the commands transmitted by the SCU are dependent, in part, on the content of the data signals received by the SCU. In accordance with the invention, a preferred SCU is similarly implemented as a device capable of being implanted beneath a patient's skin, preferably having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm. Wireless communication between the SCU and the implanted devices is preferably implemented via a modulated sound signal, AC magnetic field, RF signal, or electric conduction.

System of implantable devices for monitoring and/or affecting body parameters

A single trigger system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device configured to deploy and implant anchor devices for such purposes.

Multi-actuating trigger anchor delivery system

An implantable medical device, such as an implantable pulse generator (IPG) used with a spinal cord stimulation (SCS) system, includes a rechargeable lithiumion battery having an anode electrode with a substrate made substantially from titanium. Such battery construction allows the rechargeable battery to be discharged down to zero volts without damage to the battery. The implantable medical device includes battery charging and protection circuitry that controls the charging of the battery so as to assure its reliable and safe operation. A multi-rate charge algorithm is employed that minimizes charging time while ensuring the battery cell is safely charged. Fast charging occurs at safer lower battery voltages (e.g., battery voltage above about 2.5 V), and slower charging occurs when the battery nears full charge higher battery voltages (e.g., above about 4.0 V). When potentially less-than-safe very low voltages are encountered (e.g., less than 2.5 V), then very slow (trickle) charging occurs to bring the battery voltage back up to the safer voltage levels where more rapid charging can safely occur. The battery charging and protection circuitry also continuously monitors the battery voltage and current. If the battery operates outside of a predetermined range of voltage or current, the battery protection circuitry disconnects the battery from the particular fault, i.e. charging circuitry or load circuits.

Implantable Pulse Generators Using Rechargeable Zero-Volt Technology Lithium-Ion Batteries

A method of treating cardiovascular disease in a medical patient is provided. The method includes the steps of generating a sensor signal indicative of a fluid pressure within the left atrium of the patient's heart, and delivering an electrical stimulus to a location in the heart. The electrical stimulus is delivered based at least in part on the sensor signal. The method also includes the steps of generating a processor output indicative of a treatment to a signaling device. The processor output is based at least in part on the sensor signal. At least two treatment signals are provided to the medical patient. The treatment signals are distinguishable from one another by the patient, and are indicative of a therapeutic treatment. The treatment signals are based at least in part on the processor output.

System for detecting, diagnosing, and treating cardiovascular disease

Systems including an implantable receiver-stimulator and an implantable controller-transmitter are used for leadless electrical stimulation of body tissues. Cardiac pacing and arrhythmia control is accomplished with one or more implantable receiver-stimulators and an external or implantable controller-transmitter. Systems are implanted by testing external or implantable devices at different tissue sites, observing physiologic and device responses, and selecting sites with preferred performance for implanting the systems. In these systems, a controller-transmitter is activated at a remote tissue location to transmit/deliver acoustic energy through the body to a receiver-stimulator at a target tissue location. The receiver-stimulator converts the acoustic energy to electrical energy for electrical stimulation of the body tissue. The tissue locations(s) can be optimized by moving either or both of the controller-transmitter and the receiver-stimulator to determine the best patient and device responses.

Leadless tissue stimulation systems and methods

An energy transmission system for transmitting energy non-invasively from an external unit to an implanted medical device to recharge a battery in the medical device. An alternating magnetic field is generated by the external charging unit and a piezoelectric device in the implanted medical device vibrates in response to the magnetic flux to generate a voltage. The voltage is rectified and regulated to provide charging current to a rechargeable battery in the medical device. A series of piezoelectric devices may be connected in series to produce a larger voltage than can be produced by any one piezoelectric device. Acoustic waves generated by the external charging unit alternatively can be used to vibrate the piezoelectric device instead of a changing magnetic flux. The acoustic waves are generated by an external source coupled to a piezoelectric transducer.

Transcutaneous energy coupling using piezoelectric device

A lead assembly (10) includes a proximal end (14) that has a connector (16) for electrical connection to a cardiac stimulator (18), such as a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The lead assembly includes an elongated proximal tubular portion (20) that extends distally from the connector. The distal end of the proximal tubular portion is provided with a branch assembly (22) that is joined distally to two elongated distal lead branches (23a, 23b). The distal branches are provided, respectively, with lead tips (24a, 24b) that each function as electrodes for transferring electrical signals from and/or to the myocardium. The branch assembly includes structure for enabling a surgeon to selectively manipulate the distal branches using a single stylet passed through a single lumen in the proximal tubular portion.

Endocardial lead with multiple branches

A cardiac lead is provided that is capable of deforming in situ to accommodate difficult myocardial structures. The lead includes a connector for coupling to a cardiac stimulator and a flexible tubular sleeve coupled to the connector. The sleeve is composed of a thermally-sensitive shape-memory polymeric material and is deformable in situ into a permanent shape. An electrode is coupled to the sleeve and a conductor wire is coupled to the connector and to the first electrode.

Implantable cardiac lead with multiple shape memory polymer structures

A cardiac stimulator lead is provided that includes a lead body that has a connector for coupling to a cardiac stimulator and a flexible insulating sleeve that has a first outer diameter. An electrode is coupled to the insulating sleeve. A conductor wire is coupled between the connector and the electrode. An annular seal is coupled to the lead body and is composed of a thermally-sensitive shape-memory polymeric material whereby the seal is deformable in situ from a temporary shape with a second outer diameter to a permanent shape with a third outer diameter that is greater than the second outer diameter. A shape-memory polymeric suture sleeve may be included that can tightly clamp the lead sleeve in situ.

Cardiac lead with shape-memory structure

A lead assembly (10) adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body (12) that has a proximal end provided with a connector (16) for electrical connection to a cardiac stimulator (18). The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing (22). The lead body (12) consists of a noncoiled conductor cable (24) surrounded by a coextensive insulating sleeve (26). In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires or an internal lumen. Manipulation of the lead body is via an external guide tube. Lead body diameters of 0.25 mm or smaller are possible.

Paul R. Spehr

Papers

Transcutaneous energy coupling using piezoelectric device

Endocardial lead with multiple branches

Implantable cardiac lead with multiple shape memory polymer structures

Cardiac lead with shape-memory structure

Small cable endocardial lead with exposed guide tube