Delivery systems for implantable medical devices, and associated tethering assemblies and methods

A method for tethering a relatively compact implantable medical device to a delivery system, the method comprising:

• engaging a second segment of an elongate tethering member of the delivery system with a holding member of the medical device, wherein the delivery system comprises:
• an elongate inner shaft
• an elongate outer shaft in sliding engagement around the inner shaft
• a handle coupled to the elongate inner shaft and elongate outer shaft, the handle including a proximal port at a proximal end of the handle, the inner shaft including a first lumen and a second lumen, both lumens extending longitudinally along a length of the inner shaft from proximal openings thereof to distal openings thereof, one or both of the proximal openings being in fluid communication with the proximal port, the distal openings being located at a distal end of the inner shaft, and the outer shaft including a distal-most portion sized to contain the medical device therein;
• an elongate tool extending within the first lumen of the inner shaft and being in sliding engagement therein, the elongate tool including a proximal end accessible in proximity to the proximal port, and a distal end protruding from the distal end of the inner shaft, the distal end of the tool including a coupling feature;
• and
• the elongate tethering member including a first end, a second end, a first segment, the second segment, and a retainer, the first segment extending within the second lumen of the inner shaft from the first end to the second segment, the second segment extending from the first segment to the second end and distally from the distal end of the inner shaft, the first end protruding from the proximal port and being joined to the retainer proximal to the proximal port of the handle, and the second segment being configured to engage with the holding member of the medical device;
• and
• wherein the coupling feature of the tool is configured to couple with the second segment of the tethering member and to transfer a pull force thereto, when the pull force is applied to the proximal end of the tool, the pull force drawing the coupled second segment of the tethering member into the first lumen of the inner shaft, through the distal opening thereof;
• coupling the distal end of the elongate tool to the engaged second segment of the tethering member;
• applying the pull force to the coupled tool until the coupled segment of the tethering member is drawn into the first lumen of the system inner shaft and the device abuts the distal end of the inner shaft;
• and
• securing the elongate tool in position after applying the pull force.

A method for tethering a relatively compact implantable medical device to a delivery system, the method comprising:

• engaging a second segment of an elongate tethering member of the delivery system with a holding member of the medical device:
• an elongate inner shaft
• an elongate outer shaft in sliding engagement around the inner shaft
• a handle coupled to the elongate inner shaft and elongate outer shaft, the handle including a proximal port at a proximal end of the handle, the inner shaft including a first lumen and a second lumen, both lumens extending longitudinally along a length of the inner shaft from proximal openings thereof to distal openings thereof, one or both of the proximal openings being in fluid communication with the proximal port, the distal openings being located at a distal end of the inner shaft, and the outer shaft including a distal-most portion sized to contain the medical device therein;
• an elongate tool extending within the first lumen of the inner shaft and being in sliding engagement therein, the elongate tool including a proximal end accessible in proximity to the proximal port, and a distal end protruding from the distal end of the inner shaft, the distal end of the tool including a coupling feature;
• and
• the elongate tethering member including a first end, a second end, a first segment, the second segment, and a retainer, the first segment extending within the second lumen of the inner shaft from the first end to the second segment, the second segment extending from the first segment to the second end and distally from the distal end of the inner shaft, the first end protruding from the proximal port and being joined to the retainer proximal to the proximal port of the handle, and the second segment being configured to engage with the holding member of the medical device;
• and
• wherein the coupling feature of the tool is configured to couple with the second segment of the tethering member and to transfer a pull force thereto, when the pull force is applied to the proximal end of the tool, the pull force drawing the coupled second segment of the tethering member into the first lumen of the inner shaft, through the distal opening thereof;
• coupling the distal end of the elongate tool to the engaged second segment of the tethering member;
• applying the pull force to the coupled tool until the coupled segment of the tethering member is drawn through the first lumen of the system inner shaft and the second end of the tethering member protrudes from a proximal port of the system;
• uncoupling the tool distal end from the engaged second segment of the tethering member when the second end of the tethering member protrudes from the proximal port of the system;
• and
• attaching the second end of the tethering member that protrudes from the system proximal port to the retainer of the tethering member.