Abstract: A medical system comprising a guiding catheter having an inflation lumen. The inflation lumen extends within a handle and a shaft of the guiding catheter. An inflatable sleeve has a proximal end and a distal end, with the ends attached to the guiding catheter. A sealed interior portion of the inflatable sleeve is bounded by the inflatable sleeve and the shaft of the guiding catheter, and in fluid communication with a distal port of the inflation lumen. The system further comprises a delivery catheter defining a delivery lumen and configured for sliding engagement within the guide lumen of the guiding catheter.

Abstract: A medical access tool includes a needle member extending along a longitudinal axis, and a coiled wire extending around the axis. An inner surface of the coiled wire, along a proximal segment thereof, is spaced radially apart from an outer surface of the needle member, and a distal segment of the coiled wire extends distally to a tissue-engaging tip of the coiled wire, a piercing distal tip of the needle member being recessed proximally from the tissue-engaging tip at a fixed distance. An operator may rotate the coiled wire to engage tissue, for example, that of a pericardial sac or a diaphragmatic attachment, which then travels proximally along the coiled wire and into contact with the needle member's distal tip, to be pierced through thereby. At least one lumen of the needle member provides a passageway through which the operator may advance a guide wire and/or inject a fluid.

Abstract: A medical system comprising a guiding catheter having an inflation lumen. The inflation lumen extends within a handle and a shaft of the guiding catheter. An inflatable sleeve has a proximal end and a distal end, with the ends attached to the guiding catheter. A sealed interior portion of the inflatable sleeve is bounded by the inflatable sleeve and the shaft of the guiding catheter, and in fluid communication with a distal port of the inflation lumen. The system further comprises a delivery catheter defining a delivery lumen and configured for sliding engagement within the guide lumen of the guiding catheter.

Abstract: An operator advances a delivery catheter through a guiding catheter, after positioning an inflatable sleeve of the guiding catheter in proximity to a target implant site on an epicardial surface. By inflating the positioned sleeve, the operator displaces the epicardial surface to create a gap that accommodates a reach of the delivery catheter. With the delivery catheter extending distally from the guiding catheter, the operator can activate the reach of the delivery catheter within the gap, and then advance the lead out through a distal-most opening of the delivery catheter. The reach may orient a fixation member of the advanced lead relative to the epicardial surface so the operator can secure the lead to the surface. The sleeve of the guiding catheter is preferably non-compliant and has a maximum diameter of at least twice the reach of the delivery catheter, when inflated.

Abstract: In one example, this disclosure is directed to a method for intravascular implantation of an implantable medical device comprising positioning a distal end of an elongated outer sheath forming an inner lumen adjacent a target site within a vasculature of a patient, and partially deploying an implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element. A portion of the expandable fixation element assumes an expanded position when the implantable medical device is partially deployed from the distal opening. The method including advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening, and monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when the size of the portion of the expandable fixation element corresponds to the size of the vasculature.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming a first inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath forming a second inner lumen. An outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen. The second inner lumen at a distal end of the inner sheath is configured to carry an implantable medical device. The inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath.

Abstract: An operator advances a delivery catheter through a guiding catheter, after positioning an inflatable sleeve of the guiding catheter in proximity to a target implant site on an epicardial surface. By inflating the positioned sleeve, the operator displaces the epicardial surface to create a gap that accommodates a reach of the delivery catheter. With the delivery catheter extending distally from the guiding catheter, the operator can activate the reach of the delivery catheter within the gap, and then advance the lead out through a distal-most opening of the delivery catheter. The reach may orient a fixation member of the advanced lead relative to the epicardial surface so the operator can secure the lead to the surface. The sleeve of the guiding catheter is preferably non-compliant and has a maximum diameter of at least twice the reach of the delivery catheter, when inflated.

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 medical access tool includes a needle member extending along a longitudinal axis, and a coiled wire extending around the axis. An inner surface of the coiled wire, along a proximal segment thereof, is spaced radially apart from an outer surface of the needle member, and a distal segment of the coiled wire extends distally to a tissue-engaging tip of the coiled wire, a piercing distal tip of the needle member being recessed proximally from the tissue-engaging tip at a fixed distance. An operator may rotate the coiled wire to engage tissue, for example, that of a pericardial sac or a diaphragmatic attachment, which then travels proximally along the coiled wire and into contact with the needle member's distal tip, to be pierced through thereby. At least one lumen of the needle member provides a passageway through which the operator may advance a guide wire and/or inject a fluid.

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 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 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: In one example, this disclosure is directed to a method for intravascular implantation of an implantable medical device comprising positioning a distal end of an elongated outer sheath forming an inner lumen adjacent a target site within a vasculature of a patient, and partially deploying an implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element. A portion of the expandable fixation element assumes an expanded position when the implantable medical device is partially deployed from the distal opening. The method including advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening, and monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when the size of the portion of the expandable fixation element corresponds to the size of the vasculature.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming a first inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath forming a second inner lumen. An outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen. The second inner lumen at a distal end of the inner sheath is configured to carry an implantable medical device. The inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath.