Pacesetter Patente

Leadless pacemakers (LPs) and systems for use therewith are disclosed. During a first period of time, during which an LP (102a, 102b) receives event messages from a second LP (102b, 102a), the LP (102a, 102b) times its pacing of a first cardiac chamber based on the event messages received from the second LP (102b, 102a) so that AV synchrony is maintained, and the LP (102a, 102b) determines and stores count value(s). Based on at least one of the count value(s), the LP (102a, 102b) determines a compensation offset indicative of a drift between timing circuitry (160) of the LP (102a, 102b) and timing circuitry (160) of the second LP (102b, 102a). During a second period of time, during which the LP (102a, 102b) does not receive event messages from the second LP (102b, 102a), the LP (102a, 102b) times its pacing of the first cardiac chamber based on the compensation offset to thereby compensate for the drift so that the AV synchrony is also maintained during the second period of time.

A biostimulator (100) includes a housing (302) having a longitudinal axis (304) and containing an electronics compartment (306). The biostimulator (100) includes a fixation element mount (307) mounted on the housing (302). The biostimulator (100) includes a fixation element (106) mounted on the fixation element mount (307). The fixation element (106) includes a helical wire (320) extending helically about the longitudinal axis (304). The helical wire (304) tapers inward from a proximal turn (402) to a distal tip (322).

A biostimulator (100) includes a housing (302) having a longitudinal axis (304) and containing an electronics compartment (306). A fixation element mount (311) is mounted on the housing (302) and a fixation element (106) is mounted on the fixation element mount (311). The fixation element (106) extends helically about the longitudinal axis (304) and has an outer dimension (902). The outer dimension (902) increases in a distal direction (408) over a proximal section (904) of the fixation element (106), and the outer dimension (902) decreases in the distal direction (408) over a distal section (906) of the fixation element (106).

Described herein is a multi-chamber implantable LP system (100) comprising at least a first LP (102a, 102b) configured to be implanted in or on a first cardiac chamber, and a second LP (102b, 102a) configured to be implanted in or on a second cardiac chamber. For each cardiac event, of a plurality of cardiac events associated with the first cardiac chamber, the first LP (102a, 102b) is configured to determine for the cardiac event whether at least one of a plurality of predetermined conditions is satisfied. Additionally, the first LP (102a, 102b) is configured to abstain from transmitting a cardiac event message indicative of the cardiac event to the second LP (102b, 102a), or transmit the cardiac event message indicative of the cardiac event to the second LP (102b, 102a), based on whether there is a determination that at least one of the plurality of predetermined conditions is satisfied. Methods for use with such a multi-chamber implantable LP system (100) are also described herein.

A biostimulator transport system (300) includes a catheter shaft (402) having a catheter lumen (502) extending longitudinally to a distal catheter end (404). The biostimulator transport system (300) includes a docking cap (320) coupled to the catheter shaft (402) and having a docking cavity (512). A drive shaft (503) extends through the catheter lumen (502) to a distal shaft end (504). The biostimulator transport system (300) includes a motion converter (506) coupling the drive shaft (503) to the docking cap (320). The motion converter (506) converts longitudinal motion of the drive shaft (503) into rotational motion of the docking cap (320).

Disclosed herein is an implantable medical device (IMD) (100), and system (5) for denoising biological signals. The IMD (100) generates a biological signal representative of a physiologic parameter of a patient (3) and normally analyzes the biological signal to detect a characteristic of interest (COI) indicative of a pathophysiologic condition of the patient (3). The present technology denoises, when the IMD (100) is exposed to a noise causing condition, noisy biological signal segments of the biological signal generated while the IMD (100) is exposed to the noise causing condition using a denoising prediction model (400) to obtain denoised biological signal segments. The denoising prediction model (400) is trained to predict a denoised biological signal segment from a noisy biological signal segment. The denoised biological signal segments can then be analyzed to detect the COI indicative of the pathophysiologic condition of the patient (3).

A biostimulator transport system (302) includes a sheath (312) having a distal sheath end (314). The biostimulator transport system (302) includes a deployment tube (316) extending from the distal sheath end (314) to a distal tube end (318). The biostimulator transport system (302) includes an expandable structure (700) having a ventricle-shaped envelope (904) surrounding the deployment tube (316). The ventricle-shaped envelope (904) includes a front boundary (702) coupled to the distal tube end (318) and a rear boundary (704) coupled to the distal sheath end (314). The front boundary (702) and the rear boundary (704) are joined along one or more of a bottom edge (710) and lateral edges (802, 804).

An implantable biostimulator (104, 200, 302) has a housing (106, 212, 402, 502, 602), one or more fixation elements (210, 304, 418, 510, 610) at a distal end of the housing (106, 212, 402, 502, 602), and one or more electrode probes (208, 306, 406, 506). The housing (106, 212, 402, 502, 602)includes an electronics compartment containing pacing circuitry. The one or more electrode probes (208, 306, 406, 506)are coupled to the pacing circuitry. The one or more electrode probes (208, 306, 406, 506)are extendable from the distal end of the housing (106, 212, 402, 502, 602). The one or more electrode probes (208, 306, 406, 506) have depth control to a controlled depth of extension.

Devices (106, 109) and methods for improving conductive communication are described herein. One of the devices (106, 109) involved in the conductive communication can be an external device while the other device is an IMD, or both of the devices can be IMDs. In certain embodiments, conductive communication is performed using a first timing scheme that specifies when conductive communication pulses are transmitted relative to one or more cardiac events. A quality metric of the conductive communication is monitored, when the first timing scheme is being used to perform the conductive communication. In response to detecting the quality metric being below a corresponding threshold, when the first timing scheme is being used to perform the conductive communication, the invention changes to using a second timing scheme to perform the conductive communication.

An apparatus comprises an accelerometer (125) and at least one processor (104). The accelerometer (125), alone or in combination with the at least one processor (104), used to determine an activity level of a patient and a posture of the patient. The at least one processor (104) configured to classify the patient as being asleep in response to both (i) the posture of the patient being recumbent or reclined for at least a sleep latency duration, and (ii) the activity level of the patient not exceeding an activity threshold for at least the sleep latency duration. The at least one processor (104) is also configured to, after the patient has been classified as being asleep, classify the patient as being awake in response to at least one of (iii) the posture of the patient being upright for at least an awake latency duration, or (iv) the activity level of the patient exceeding the activity threshold for at least the awake latency duration.

A biostimulator transport system (202) comprises a catheter, a universal joint (2102) having a ball and socket type mechanism (2302) including a ball (2104) mounted within a socket (2106) at a distal tip of the catheter, wherein the ball (2104) includes a central channel, and a central shaft (2202) extending through the central channel to a biostimulator coupling (410).

A method comprises a first implantable medical device, IMD1, (102a, 102b, 104, 106) generating a first series of bits that are to be communicated from the IMD1 (102a, 102b, 104, 106) to a second implantable medical device, IMD2 (102a, 102b, 104, 106). The IMD1 (102a, 102b, 104, 106) encodes each bit of the first series of bits as either a first pseudo noise pulse sequence corresponding to a first bit value of the first series, or a second pseudo noise pulse sequence corresponding to a second bit value of the first series, to thereby produce an encoded series of bits. The first pseudo noise pulse sequence and the second pseudo noise pulse sequence are orthogonal to one another. The IMD1 (102a, 102b, 104, 106) transmits the encoded series of bits using conductive communication.

An implantable medical device (IMD) (200) is provided that can include electronic circuitry (212), a first sensor (270) configured to detect a magnetic field in an environment of the IMD (200), and a second sensor (110, 112, 114, 234) configured to obtain environmental data. The IMD (200) includes one or more processors (264), and a memory (252) coupled to the one or more processors (264). The memory (252) stores program instructions, wherein the program instructions are executable by the one or more processors (264) to discriminate between a first magnet mode and a second magnet mode based on the environmental data and switch the mode of operation with the electronic circuitry (212) based on discriminating between the first magnet mode and the second magnet mode.

An implantable lead (400) is described that includes a header coupling (200), a helix shaft (302), and a fixation helix (106). The header coupling (200) extends from a proximal end (204) to a distal end (206) thereof, and defines a central lumen (208) from the proximal end (204) to the distal end (206). The header coupling (200) includes a base section (212) and a distal tube section (214) extending from the base section (212) to the distal end (206). The helix shaft (302) includes a proximal shank (306) that extends into the central lumen (208) of the header coupling (200) through a distal opening (210) of the distal tube section (214). The fixation helix (106) is mounted to a distal segment (304) of the helix shaft (302) and is configured to penetrate tissue of a patient. A surface (222) of the header coupling (200) directly engages and is fixedly secured to a surface (312) of the helix shaft (302), forming a sealed joint (308) that seals the central lumen (208) of the header coupling (200) and prevents fluid from migrating past the distal end (206).

A system (100) and computer readable medium for use during an implant procedure during which a delivery system (100) is being used to implant a leadless pacemaker (LP) (102a, 102b) within a patient may, while the delivery system (100) is being used to position the LP (102a, 102b) at a potential implant site within the patient: receive, from the LP (102a, 102b), data comprising one or more pacing impedance measurements and at least one measurement obtained by the LP (102a, 102b) other than pacing impedance; provide the data to a model (950) that is produced prior to the implant procedure based on data collected from other LPs implanted in other patients; and use the model (950) to output an indication of whether the LP (102a, 102b) should be chronically implanted at the potential implant site.

An attachment device (250) for coupling a biostimulator (200) to a delivery system (100) includes a case (502), a tether dock (504), and a filament (506). The case (502) has a wall (516), a first end (512), and a second end (514) opposite the first end (512). The wall (516) defines a passage (508) and a slot (510). The passage (508) extends between the first end (512) and the second end (514). The slot (510) extends through the wall (516) such that the passage (508) is accessible through the slot (510). The tether dock (504) extends from second end (514) of the case (502). The tether dock (504) defines a groove (524) extending therethrough. The filament (506) has a fixed end (526) and free end (528). The fixed end (526) is attached to the first end (521) of the case (502). The free end (528) includes a bulb (530) that is selectively receivable in the passage (508) of the case (502) through the slot (510).

A biostimulator (100) includes a housing (302) having a longitudinal axis (304) and containing an electronics compartment (306). A pacing element (108) is coupled to the housing (302). The pacing element (108) includes a flexible conductor (410) extending along the longitudinal axis (304). A fixation element mount (311) is mounted on the housing (302). The fixation element mount (311) includes a distal mount end (430). A fixation element (106) is mounted on the fixation element mount (311). The fixation element (106) extends about the longitudinal axis (304). A radiopaque marker (502) has a distal marker end (504) longitudinally aligned with the distal mount end (430) of the fixation element mount (311). Other embodiments are also described and claimed.

A biostimulator (100) includes a housing (302) having a longitudinal axis (304) and containing an electronics compartment (306). The biostimulator (100) includes a fixation element (106) coupled to the housing (302). The fixation element (106) extends about the longitudinal axis (304). The biostimulator (100) includes a pacing element (108) coupled to the housing (302). The pacing element (108) includes a flexible conductor (502) extending along the longitudinal axis (304) and a stiffening strand (503) extending beside the flexible conductor (502). A bending stiffness of the stiffening strand (503) is greater than a bending stiffness of the flexible conductor (502). Other embodiments are also described and claimed.

An implantable medical device (IMD) (101, 501) is described herein. The IMD (101, 501) includes sense circuitry (116, 544, 550) configured to produce a differential signal indicative of a voltage potential difference between first and second electrodes (112, 114). The IMD (101, 501) additionally includes disturbance detection circuitry (210) configured to detect a non-biological disturbance based at least in part on a slew rate of the differential signal exceeding a slew rate threshold. The IMD (101, 501) includes a controller (120, 520) communicatively coupled to the sense circuitry (116, 544, 550) and the disturbance detection circuitry (210) and configured to detect based on the differential signal an episode of asystole, an episode sinus pause, a premature ventricular contraction, or premature atrial contraction, and classify, as a false positive, a detection of the episode of asystole, the episode sinus pause, the premature ventricular contraction, or the premature atrial contraction, when the non-biological disturbance detected by the disturbance detection circuitry (210) at least partially coincides with the detection of the episode of asystole, the episode sinus pause, the premature ventricular contraction, or the premature atrial contraction.

Dual chamber leadless pacemaker systems comprising an atrial leadless pacemaker (aLP) (102) and a ventricular leadless pacemaker (vLP) (104) are disclosed. Such systems can detect and terminate pacemaker mediated tachycardia (PMT) even when the implant-to-implant (i2i) communication from the vLP (104) to aLP (102) (V2A) is compromised. The vLP (104) monitors for PMT in response to reception of an i2i communication from the aLP (102) indicating compromised V2A i2i communication and initiates, following detection of a PMT, initiate a PMT PV interval in response to reception of an i2i communication from the aLP (102) indicating an atrial sensed event. The PMT PV interval is shorter than a PV interval that the vLP (104) would otherwise use for ventricular pacing if PMT was not detected. The vLP (104) also delivers a ventricular pacing pulse to the ventricular cardiac chamber in response to the PMT PV interval expiring without an intrinsic ventricular event being detected during the PMT PV interval.

A biostimulator (100) includes a housing (202) having a longitudinal axis (204) and containing an electronics compartment (206). The biostimulator (100) includes a fixation element mount (402) coupled to the housing (202) and a helical fixation element (106, 602) coupled to the housing (202). The helical fixation element (106, 602) has several turns and extends about the longitudinal axis (204). The helical fixation element (106, 602) has a proximal turn (910) encased by a wall of the fixation element mount (402).

Described herein are leadless pacemakers (LPs) and methods for use therewith. In certain embodiments an LP stores a polarization artifacts template or a capture plus polarization artifacts template in memory of the LP. The LP uses the stored template when performing autocapture and/or other types of capture detection to mitigate adverse effects of electrode polarization. Such embodiments are especially useful where the LP is an atrial LP, but can also be used to other types of LPs, such as a ventricular LP.

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A biostimulator (200) includes a housing (302), an electrode extension (206), and an expandable frame (320). The housing (302) has a longitudinal axis (304) and an electronics compartment (306) containing pacing circuitry. The electrode extension (206) extends distally between the housing (302) and an electrode (212). The biostimulator (200) includes an expandable frame (320) including several struts (322) disposed about the longitudinal axis (304). Other embodiments are also described and claimed.

A biostimulator system includes a biostimulator (100) having a header module (150) and a housing module (152). The header module (150) includes a fixation element (106), a pacing electrode (108), and an electrical pin (304). The housing module (152) includes pacing circuitry that is electrically connected to a power source (206), and an electrical socket (306) to receive and electrically connect the electrical pin (304) to the pacing circuitry. The biostimulator system includes a biostimulator transport system (503) to deliver the header module (150) to an interventricular septal wall (104) and to deliver the housing module (152) to a ventricular chamber. The modules (150, 152) are then electrically connected within the ventricular chamber. Other embodiments are also described and claimed.

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