Abstract: The present disclosure is directed to a shuttle apparatus for detachably joining a catheter to a guidewire so that the joined catheter, extending alongside the guidewire, is in sliding engagement with the guidewire without extending around the guidewire. The apparatus comprises a collar member sized for mounting in sliding engagement around a length of the guidewire, the collar member having a longitudinal axis that approximately aligns along the length, when mounted thereabout, the length being defined between a proximal-most point of the guidewire and a distal point of the guidewire, the distal point being offset proximally from a distal-most point of the guidewire. The apparatus further comprises a plug member coupled to the collar member, the plug member having a longitudinal axis, and the plug member being sized to fit within an opening of the catheter for detachable engagement therewith.

Abstract: A high contrast instrument, such as a radiopaque portion, can be captured and/or viewed in an image that is acquired with an imaging system, such as with a fluoroscopic imaging system. A statistical model can be used to assist in identifying a possible or probable location of a target. A user may move the instrument coil to the statistically probable location of the target to, for example, perform a procedure or carry out a task.

Abstract: An apparatus for forming a passageway through tissue includes a dilator mounted to a shaft, wherein the dilator includes a first portion, which has an increasing taper from a first outer diameter to a larger second outer diameter, and a second portion, which has a decreasing taper from the first portion to a distal end of the dilator, and which includes an external non-cutting thread formed along the decreasing taper. Lumens of the dilator and shaft provide a conduit for means to pierce through the tissue, for example, an elongate wire that includes a piercing tip. In some cases, the dilator first portion is expandable to, and contractible from, the larger second outer diameter, wherein the apparatus may include a spreading member configured to slide between the shaft and the first portion. The apparatus may be included in a system with an introducer sheath.

Abstract: A catheter assembly includes a pull wire and a control member subassembly, wherein the pull wire is secured to a post of the subassembly that may extend through a slot of a handle, and an engagement feature of the subassembly, being supported by an elastically deformable support of the subassembly resting on a railway of the handle, confronts a mating feature of the handle to interlock therewith, responsive to the support being un-deformed. The post, engagement feature, and support may be integrally formed together in a single-piece component, wherein the engagement feature may be one or two rows of teeth formed in a surface of an upper portion of the component, and the support may be a pair of flexible cantilever beam members of a lower portion of the component. Furthermore, the mating surface and railway may be integrally formed in an inner surface of a shell of the handle.

Abstract: A catheter for delivering a medical device to an implant site within a receptacle of a distal-most portion thereof, includes a coiled spring member, which has one or more proximal turns, secured to a shaft proximal portion, one or more distal turns, secured to the distal-most portion, and a plurality of open-pitch turns that extend between the proximal and distal turns and are, preferably, pre-loaded by longitudinal compression prior to forming a sheath thereover. A deflection assembly pull wire extends through a lumen of the shaft proximal portion and alongside the plurality of open-pitched turns of the spring member, wherein a pull wire proximal end extends proximally out from a proximal opening of the lumen of the proximal portion and into a handle of the catheter, for coupling to a control member subassembly, and a pull wire distal end is secured to the shaft distal-most portion.

Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: A catheter proximal section is preferably formed from a relatively soft part and a relatively rigid part, and includes a proximal terminal end that defines a perimeter of an opening into a lumen of the catheter. The proximal section may further include a feature for interlocking engagement with an accessory tool. An inner surface of each of the relatively soft and rigid parts may be located opposite one another, on either side of the catheter lumen. The relatively soft and rigid parts may be included in a sealing assembly that further includes an attachment feature for removable connection of the assembly to the proximal section catheter.

Abstract: This disclosure describes various examples of multi-purpose tools and associated methods for safely gaining access to extravascular spaces. The multi-purpose tools described herein are particularly suited for safely gaining access to the sub-sternal space underneath the sternum/ribcage as well as tunneling subcutaneously above the ribcage for the purpose of positioning of a medical electrical lead. This eliminates the need for separate tools for tunneling in different extravascular spaces by providing a single tool capable of the multiple uses.

Abstract: This disclosure describes various tools and associated methods suitable for gaining access to extravascular spaces. The various tools and associated methods utilize a boring tip that may rotate to aid in safely and effectively crossing diaphragmatic attachments. The boring tip may, in some instances not have any sharp edge. For example, the boring tip may have a dome shape but including at least one surface recessed and offset from a summit of the dome shape. Various mechanisms may be used to control rotation of the boring tip as described herein.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: A catheter assembly includes a pull wire and a control member subassembly, wherein the pull wire is secured to a post of the subassembly that may extend through a slot of a handle, and an engagement feature of the subassembly, being supported by an elastically deformable support of the subassembly resting on a railway of the handle, confronts a mating feature of the handle to interlock therewith, responsive to the support being un-deformed. The post, engagement feature, and support may be integrally formed together in a single-piece component, wherein the engagement feature may be one or two rows of teeth formed in a surface of an upper portion of the component, and the support may be a pair of flexible cantilever beam members of a lower portion of the component. Furthermore, the mating surface and railway may be integrally formed in an inner surface of a shell of the handle.

Abstract: A catheter for delivering a medical device to an implant site within a receptacle of a distal-most portion thereof, includes a coiled spring member, which has one or more proximal turns, secured to a shaft proximal portion, one or more distal turns, secured to the distal-most portion, and a plurality of open-pitch turns that extend between the proximal and distal turns and are, preferably, pre-loaded by longitudinal compression prior to forming a sheath thereover. A deflection assembly pull wire extends through a lumen of the shaft proximal portion and alongside the plurality of open-pitched turns of the spring member, wherein a pull wire proximal end extends proximally out from a proximal opening of the lumen of the proximal portion and into a handle of the catheter, for coupling to a control member subassembly, and a pull wire distal end is secured to the shaft distal-most portion.

Abstract: A catheter has a shaft that defines a delivery lumen, for example, to deliver an elongate medical device therethrough; a proximal section of the catheter includes a seal zone portion, a handle portion and a proximal port portion. A relatively thin wall section of the proximal port portion extends between the seal zone portion and a proximal edge that defines part of a perimeter of a proximal opening of the delivery lumen. The handle portion projects laterally from the seal zone portion, generally opposite the relatively thin wall section. An inflation subassembly of the catheter includes a compliant sleeve member and an inflation lumen extending from the sleeve member, proximally along the shaft, and into a connector port formed in the handle portion. The inflation lumen may be formed by fusing a section of a tube to the shaft and molding the handle portion around another section of the tube.

Abstract: A catheter proximal section is preferably formed from a relatively soft part and a relatively rigid part, and includes a proximal terminal end that defines a perimeter of an opening into a lumen of the catheter. The proximal section may further include a feature for interlocking engagement with an accessory tool. An inner surface of each of the relatively soft and rigid parts may be located opposite one another, on either side of the catheter lumen. The relatively soft and rigid parts may be included in a sealing assembly that further includes an attachment feature for removable connection of the assembly to the proximal section catheter.

Abstract: Extravascular implant tools that utilize a bore-in mechanism to safely access extravascular locations and implant techniques utilizing these tools are described. The bore-in mechanism may include a handle and a helix extending from the handle. The bore-in mechanism is used, for example, in conjunction with a tunneling tool to traverse the diaphragmatic attachments to access a substernal location. The tunneling tool may be an open channel tunneling tool or a conventional tunneling tool (e.g., metal rod).

Abstract: This disclosure provides various embodiments of implant tools and implant techniques utilizing those tools to implant components within extravascular locations. In one example, an implant tool for implanting a component within an extravascular location of a patient comprise a handle and a shaft adjacent the handle. The shaft has a proximal end, a distal end, and a body formed to define an open channel that extends from near the proximal end to the distal end. The open channel has a first width. The body has at least one flexible portion that defines an opening via which the open channel is accessed. The opening has a second width that is less than the first width. In another example, a sheath with an opening having the second width may be placed on the shaft of the implant tool instead of the implant tool having the at least one flexible portion.

Abstract: A catheter proximal section is preferably formed from a relatively soft part and a relatively rigid part, and includes a proximal terminal end that defines a perimeter of an opening into a lumen of the catheter. The proximal section may further include a feature for interlocking engagement with an accessory tool. An inner surface of each of the relatively soft and rigid parts may be located opposite one another, on either side of the catheter lumen. The relatively soft and rigid parts may be included in a sealing assembly that further includes an attachment feature for removable connection of the assembly to the proximal section catheter.

Abstract: A catheter has a shaft that defines a delivery lumen, for example, to deliver an elongate medical device therethrough; a proximal section of the catheter includes a seal zone portion, a handle portion and a proximal port portion. A relatively thin wall section of the proximal port portion extends between the seal zone portion and a proximal edge that defines part of a perimeter of a proximal opening of the delivery lumen. The handle portion projects laterally from the seal zone portion, generally opposite the relatively thin wall section. An inflation subassembly of the catheter includes a compliant sleeve member and an inflation lumen extending from the sleeve member, proximally along the shaft, and into a connector port formed in the handle portion. The inflation lumen may be formed by fusing a section of a tube to the shaft and molding the handle portion around another section of the tube.

Abstract: A high contrast instrument, such as a radiopaque portion, can be captured and/or viewed in an image that is acquired with an imaging system, such as with a fluoroscopic imaging system. A statistical model can be used to assist in identifying a possible or probable location of a target. A user may move the instrument coil to the statistically probable location of the target to, for example, perform a procedure or carry out a task.

Abstract: A catheter has a shaft that defines a delivery lumen, for example, to deliver an elongate medical device therethrough; a proximal section of the catheter includes a seal zone portion, a handle portion and a proximal port portion. A relatively thin wall section of the proximal port portion extends between the seal zone portion and a proximal edge that defines part of a perimeter of a proximal opening of the delivery lumen. The handle portion projects laterally from the seal zone portion, generally opposite the relatively thin wall section. An inflation subassembly of the catheter includes a compliant sleeve member and an inflation lumen extending from the sleeve member, proximally along the shaft, and into a connector port formed in the handle portion. The inflation lumen may be formed by fusing a section of a tube to the shaft and molding the handle portion around another section of the tube.