Abstract: A medical device includes a handle having a first end and a second end, a mixer positioned within the handle and an adapter coupled to the second end of the handle. A delivery needle includes a distal end, a proximal end, and a lumen extending from the distal end to the proximal end. The proximal end of the delivery needle is coupled to the first end of the handle. A sensor cable includes a distal end and a proximal end, and the proximal end of the sensor cable is positioned within the handle, and the distal end extends distally through the lumen of the delivery needle.

Abstract: A system includes a medical device and computer-readable media storing instructions that, when executed by a processor, cause operations to be performed, including: receiving a three-dimensional (3D) image of anatomy, processing the 3D image to extract a 3D model identifying anatomical structures of interest, receiving images captured by an imaging device of the medical device as the medical device is navigated through a body lumen to a target site, including a current image of the target site, receiving medical device spatial information from a position sensing system including a transmitter/receiver in or on the medical device, processing the images and spatial information to generate a 3D surface map of the body lumen, registering the 3D model to the patient using the map and spatial information, and generating and displaying a graphical user interface overlaying a representation of a position/trajectory of the anatomical structures of interest on the current image.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example system includes an inner shaft having proximal and distal end regions and a first coupling member disposed along the distal end region, wherein the first coupling member includes a first projection and a first recess. The system also includes a support shaft having proximal and distal end regions and a second coupling member disposed along the proximal end region, wherein the second coupling member includes a second projection and a second recess. The system also includes a locking collar coupled to the inner shaft. Additionally, coupling the inner shaft to the support shaft includes placing at least a portion of the first projection into the second recess, placing at least a portion of the second projection into the first recess and positioning the locking collar along a portion of both the first and second coupling members.

Abstract: Medical imaging reconstruction of a subject's anatomy may include: monitoring first and second medical imaging data of the subject's anatomy, wherein: the first medical imaging data is captured from within the subject's anatomy by at least one first medical imaging device; the second medical imaging data is captured from outside of the subject's anatomy by at least one second medical imaging device; and at least one of the first medical imaging device or the second medical imaging device is operable to selectively target different regions of the subject's anatomy; and in response to detecting, based on the monitoring, a divergence in the first medical imaging data and the second medical imaging data above a predetermined threshold, updating a medical imaging reconstruction of the subject's anatomy that is based on the first medical imaging data and the second medical imaging data.

Abstract: A medical device is described that may include a handle and a needle extending distally from the handle. The needle may be configured to be at least partially inserted into a body, and may include a sheath and a core disposed in the sheath. The core may have a distal portion including a distal tip, and a proximal portion distinct from the distal portion. A proximal end of the distal portion may be coupled to a distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may further include a device of a position sensing system arranged in the cavity. The device may be a transmitter device or a receiver device. The position sensing system may be configured to determine a position or an orientation of the distal tip.

Abstract: Medical systems are described, including a medical system includes a first medical device and a second medical device. The first medical device includes a handle and an insertion portion with a first working channel. A distal portion of the insertion portion of the first medical device includes a first tracking element and at least one camera. The second medical device includes a handle and an insertion portion. A distal portion of the insertion portion of the second medical device includes a second tracking element. The first tracking element is configured to provide a signal that indicates a position or orientation of the distal portion of the first medical device. The second tracking element is configured to provide a signal that indicates a position or orientation of the distal portion of the second medical device.

Abstract: Disclosed herein is an implantable medical device including a housing, a header, a connector port, and a collet assembly. The header can be arranged with the housing. The connector port can be arranged within the header and configured to couple an implantable lead to the header. The collet assembly can be arranged within the connector port and configured to frictionally engage a portion of the implantable lead and to secure the implantable lead with the header in response to insertion of the portion of the implantable lead into the connector port.

Abstract: Medical device delivery systems and methods for making and using medical device delivery systems are disclosed. An example delivery system for an implantable medical device includes an implantable heart valve including an inner shaft having a proximal end region, a distal end region and a first engagement member disposed along a portion of the distal end region and a tip assembly configured to attach to the inner shaft. The tip assembly includes a nosecone having a distal end region and a proximal end region, a second engagement member disposed within at least a portion of the nosecone, the second engagement member including a first locking member, the first locking member configured to deflect from a first position to a second engaged position. Further, attaching the tip assembly to the inner shaft includes deflecting the first locking member such that the locking member is coupled to the first engagement member.

Abstract: Disclosed herein is an implantable medical device including a housing, a header, a connector port, and a collet assembly. The header can be arranged with the housing. The connector port can be arranged within the header and configured to couple an implantable lead to the header. The collet assembly can be arranged within the connector port and configured to frictionally engage a portion of the implantable lead and to secure the implantable lead with the header in response to insertion of the portion of the implantable lead into the connector port.

Abstract: A system for delivering an implantable medical device includes a handle housing. An outer sheath is coupler secured to a proximal end of an outer sheath that is configured to cover at least a portion of the implantable medical device. An outer sheath drive assembly is operably coupled to the outer sheath coupler and is configured to translate the outer sheath relative to the handle housing. An actuation shaft coupler is secured to a proximal end of an activation shaft. An actuation shaft drive assembly is operably coupled to the actuation shaft coupler and is configured to cause the actuation shaft to translate relative to the handle housing and shift the implantable medical device from a first position and a second position in which the implantable medical device is radially expanded relative to the first position.

Abstract: The disclosure relates to localizing medical devices within a body lumen, such as for identifying the location of, or navigating to, a target tissue. Embodiments include localizing a medical device extended out of a working channel of a delivery device. The medical device may include an imaging sensor, such as for mapping the body lumen. In many embodiments, a delivery device may include one or more sensors including a first sensor to interact with a tracking system to determine the location of the delivery device within a tracking volume and a second sensor to determine the location of the medical device relative to the delivery device. In many such embodiments, a controller may determine the location of the medical device in the tracking volume based on the location of the delivery device in the tracking volume and the location of the medical device with respect to the delivery device.

Abstract: A method of providing in vivo navigation of a medical device includes: receiving input medical imaging data of a patient's anatomy; receiving input non-optical in vivo image data from a sensor on a distal end of the device in the anatomy; using a trained model to locate the distal end in the input imaging data, wherein: the model is trained, based on (i) training medical imaging data and training non-optical in vivo image data of one or more individuals' anatomy and (ii) registration data associating the training image data with locations in the training imaging data as ground truth, to learn associations between the training image data and the training imaging data; determining an output location of the medical device using the learned associations and the input data; modifying the input imaging data to depict the determined location; and causing a display to output the modified input imaging data.

Abstract: A magnetic field sensor for a medical device, the magnetic sensor assembly comprising a substrate having a plurality of planar sections, wherein adjacent planar sections are joined by a transition section, and wherein the planar sections are arranged in a substantially C-shaped arrangement such that an inner surface of the magnetic field sensor is concave, and wherein the plurality of planar sections includes a first planar section oriented in a first plane and a second planar section oriented in a second plane orthogonal to the first plane. A first magneto-resistive (MR) sensor is mounted to the first planar section and defining a first axis of sensitivity, and a second MR sensor is mounted to the second planar section and defining a second axis of sensitivity that is orthogonal to the first axis of sensitivity.

Abstract: The present disclosure includes elongate members for positioning medical devices at a target site within a body lumen. In various embodiments, the elongate member may include one or more articulation joints for maneuvering, one or more transducers for localizing, and one or more lumens for delivering instruments to the target site. Some embodiments are particularly directed to a medical device that guides an operator to a target site, confirms the location of the target site, and enables a biopsy to be taken from and/or a therapy to be delivered to the target site. For example, a position tracking sensor may be utilized to guide the medical device to the target site, a phased array sensor may be utilized to confirming proper positioning at the target site, and a biopsy needle inserted through a lumen may be utilized to acquire a sample from the target site.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example system for delivering an implantable medical device includes an outer shaft and an inner catheter, each having a proximal end, a distal portion and a lumen extending therein, wherein the inner catheter extends within a portion of the outer shaft lumen. The system also includes an actuation shaft extending within a portion of the inner catheter lumen, wherein a distal end of the actuation shaft is coupled to the implantable medical device. The system also includes a guidewire shaft extending within a portion of the inner catheter lumen and a coupling component including a distal end region, a proximal end region and a length, wherein the actuation shaft and the guidewire shaft are coupled to the coupling component such that actuation of the coupling component translates the actuation shaft and the tubular guidewire shaft simultaneously.

Abstract: A system for delivering an implantable medical device includes an outer sheath drive assembly and an actuation shaft drive assembly. The outer sheath drive assembly is configured to cause an outer sheath to translate relative to a handle, and includes an outer sheath drive motor. The actuation shaft drive assembly is configured to cause an actuation shaft to translate relative to the handle, and includes an actuation shaft drive motor. The outer sheath drive motor and/or the actuation shaft drive motor may be removed from the system, and the outer sheath drive assembly and/or the actuation shaft drive assembly may instead be manually driven.

Abstract: An example system for delivering an implantable heart valve is disclosed. The system includes an inner shaft having a proximal end region, a distal end region and a first coupling member disposed along a portion of the distal end region, wherein the first coupling member includes a first aperture. The system also includes a support shaft having a proximal end region, a distal end region and a second coupling member disposed along a portion of the proximal end region, wherein the second coupling member includes a stem, wherein the stem includes a groove extending circumferentially around the stem. The system also includes a locking clip coupled to the inner shaft, wherein coupling the inner shaft to the support shaft includes extending at least a portion of the locking clip through the first aperture and into at least a portion of the groove.

Abstract: An example system for delivering an implantable heart valve is disclosed. The system includes a connection assembly including: an inner shaft having a proximal end region, a distal end region and a first coupling member disposed along a portion of the distal end region, wherein the first coupling member includes a plurality of apertures. The connection assembly also includes a support shaft and a second coupling member, wherein the second coupling member includes a stem, wherein the stem includes a groove extending circumferentially around the stem. The connection assembly also includes a plurality of bearings, wherein a portion of each bearing is disposed in a portion of the groove. The connection assembly also includes a locking cap coupled to the inner shaft, wherein a portion of the locking cap is configured to cover at least a portion of each of the plurality of bearings.

Abstract: An example system for delivering an implantable medical device is disclosed. The system includes a handle housing having a distal end region, a proximal end region and an inner cavity. The system also includes a power supply disposed within the handle, the power supply coupled to a first and second electric motors. The system also includes a first linear screw coupled to both the first electric motor and an actuation shaft. The system also includes a second linear screw coupled to both the second electric motor and an outer shaft. Further, the first electric motor is configured to be disengaged from first linear screw such that a first tool can be used to engage the first linear screw and the second electric motor is configured to be disengaged from second linear screw such that the first tool can be used to engage the second linear screw.

Abstract: A delivery system for an implantable medical device includes an outer shaft defining an outer shaft lumen and an inner shaft translatable within the outer shaft lumen, the inner shaft defining a lumen extending through the inner shaft. An actuation mechanism extends through the lumen and includes a coupler, a force translation rod that extends proximally from the coupler and a plurality of push pull rods that extend distally from the coupler and that releasably couple to the implantable medical device. The force translation rod includes a transition in electromagnetic permeability. The delivery system includes an inductive coil disposed relative to the force translation rod and positioned to detect a change in inductance resulting from the transition in electromagnetic permeability passing through the inductive coil.