A leadless biostimulator, such as a leadless cardiac pacemaker, having a header assembly is described. The header assembly includes a helix mount mounted on a flange. An inner surface of the helix mount conforms to an outer surface of the flange, and the outer surface has a non-circular profile such that the conforming surfaces interfere with rotation of the helix mount relative to the flange. The non-circular profile includes a linear segment, such as a radial segment, that resists rotational movement of the helix mount. The helix mount has a protrusion that extends into a recess of the flange to interfere with longitudinal movement between the helix mount and the flange. The protrusion is formed before or after mounting the helix mount on the flange. The interfering surfaces threadlessly interconnect the header assembly components. Other embodiments are also described and claimed.

The present invention changes the magnet-mode of an active implantable medical device (AIMD) such that repeated application of a clinical magnet in a predetermined and deliberate time sequence will induce the AIMD to enter into its designed magnet-mode. In one embodiment, a clinical magnet is applied close to and over the AIMD and removed a specified number of times within a specified timing sequence. In another embodiment, the clinical magnet is applied close to and over the AIMD and flipped a specified number of times within a specified timing sequence. This makes it highly unlikely that the magnet in a portable electronic device, children's toy, and the like can inadvertently and dangerously induce AIMD magnet-mode.

A system for delivery of a leadless pacemaker. The system includes a catheter with an elongate flexible tubular body with a proximal end and a distal end, wherein the distal end of the tubular body includes a delivery cup with an external surface having an inflatable compliant balloon; and a pacing capsule of the leadless pacemaker releasably retained in the delivery cup. The pacing capsule includes an arrangement of tines configured to deploy and pierce a target tissue at a desired pacing capsule implant site in a coronary sinus of a patient. The balloon, when at least partially inflated, is configured to urge the delivery cup against the target tissue during deployment of the pacing capsule.

Brugada syndrome and related forms of ion channelopathies, including ventricular asynchrony of contraction, originate in the region near the His bundle or para-Hisian regions of the heart. Manifestations of Brugada syndrome can be corrected by delivering endocardial electrical stimulation coincident to the activation wave front propagated from the atrioventricular (AV) node. By performing the start of the activation of the HIS bundle or para-Hisian region early enough, electrical stimulation can be delivered fast enough to compensate for the conduction problems that start in those region, such that the activation wave front, as stimulated, transitions from the AV node to the His bundle in a normal, albeit electrically-supplemented, fashion. This stimulation not only helps resolve the conditions that trigger Brugada syndrome, but also resolves the asynchrony of the contraction of the heart.

Nonwoven resorbable pouches that at least partially enclose implantable medical devices and improved methods for producing the implantable medical device pouches are described. The nonwoven pouches may comprise one or more drugs. Implantable medical devices that are placed in the pouches prior to implantation are prevented from migrating from the site of implantation by tissue ingrowth into the pouch. Antibiotics may be incorporated into the pouches to prevent post-operative infections. The pouches may be formed in fewer steps than conventional pouches, and without polymer coatings. Nonwoven pouches can be formed in one step by dry spinning instead of using multiple processing steps. In embodiments, the nonwoven pouches are smoother on the inside than the outside to tightly fit the implantable medical devices internally while encouraging external tissue ingrowth. In embodiments, the nonwoven pouches eliminate the use of knitted or woven multifilament fibers that can trap bacteria and result in post-operative infection.

One aspect is a system for reception or emission of an electrical signal from or into the human or animal body, comprising at least one insulated electrical conductor; a sleeve-shaped electrode that is electrically connected to the electrical conductor and includes an internal side, an external side, and a channel, wherein the channel defines a longitudinal axis along which the conductor is arranged. According to one embodiment, the conductor extends without interruption along the entire area of the electrode, and the electrode further includes a slit that extends from the internal side to the external side of the electrode and in which the conductor is appropriately arranged in the slit such that the electrode forms a direct durable mechanical and electrical connection to the conductor.

A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

A fastening system for an electrical stimulation generator, with a generator and an electrode, has a casing for containing the generator that presents identical first and second openings, disposed on opposite sides; means for the connection of the electrode to the first or second opening in the casing formed by a first pass-through connector for the electrode, with a sealing element; an airtight closing element disposed at the opening of the casing opposite the one presenting the means for the connection of the electrode; a device for securing the electrode to the skin; and means for fastening the casing to the body of the patient.

A leadless biostimulator, such as a leadless pacemaker, including a header assembly having a monolithic controlled release device (MCRD) for therapeutic agent elution, is described. The MCRD is in fluid communication with a space between an insulator and an electrode of the header assembly to elute therapeutic agent into the space when the leadless biostimulator is implanted. The therapeutic agent can elute through the space around the electrode to provide controlled elution of the therapeutic agent to a surrounding environment. The electrode can extend longitudinally through the insulator cavity to a distal tip that provides a stable surface area and controlled impedance for pacing a target tissue. Other embodiments are also described and claimed.

Synchronized stimulation of cardiac tissue can be implemented by implanting two or more rectifier-based AM receivers into different positions within a subject's heart. Each receiver is tuned to a different frequency, and generates an output signal that is capable of stimulating cardiac tissue when a signal at the corresponding tuned frequency arrives at the receiver. An AM transmitter can activate any given one of the receivers by transmitting a signal into the subject's body at the proper frequency. A controller controls the transmitter by commanding the transmitter to transmit pulses of AC at different frequencies at different times, so that when those pulses are received by the correspondingly-tuned receivers, each of the receivers will generate respective output signals that stimulate respective parts of the heart at respective times to promote improved cardiac performance.