Guide catheter extension system with a delivery micro-catheter configured to facilitate percutaneous coronary intervention
Inventors
Fischell, Tim A. • Saltiel, Frank S.
Assignees
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Publication Number
US-12194258-B2
Publication Date
2025-01-14
Expiration Date
Abstract
The subject guide catheter extension system with a micro-catheter delivery catheter includes an outer sheath, an inner member extending within the sheath, and a mechanism for engagement/disengagement of the inner member to/from the sheath. Several mechanisms of engagement/disengagement between the inner and outer members are provided including a friction mechanism, threaded mechanism, pull away sheath, and engagement/disengagement mechanism for pusher's handles. The sheath and the inner member are modified for different engagement/disengagement mechanisms operation. A micro-catheter delivery system provides for an improved atraumatic crossability to the treatment site in an expedited and simplified fashion. During a procedure, a guidewire along with a guide catheter are advanced to the vicinity of the treatment site within a blood vessel. Subsequent thereto, the subject guide catheter extension system is manipulated to advance the micro-catheter along the guidewire inside the guide catheter towards and beyond the site of interest. Once the micro-catheter is in place, the outer sheath slides along the micro-catheter until reaching the lesion, and then the inner member is removed from the sheath, and the sheath then is ready for passing the treatment catheter (stent/balloon) towards the lesion to be treated.
Core Innovation
The invention is an intravascular delivery system that includes an outer member with a lumen and a plurality of flexible ribs separated by inter-rib spaces, where the flexible ribs are located closer to the outer member proximal end than the outer member distal end. The system also includes an inner member with a tubular member and an interconnection unit disposed circumferentially around the tubular member. The interconnection unit has a cylindrical section with a second diameter greater than the first diameter of the tubular member, and an engagement feature extends beyond the outer surface of the interconnection unit with a third diameter greater than the second diameter and greater than the first diameter.
The engagement feature is configured to be inserted into the outer member proximal end such that the engagement feature moves past a flexible rib of the plurality of flexible ribs to an inter-rib space of the inter-rib spaces. The inner member and the outer member are placed in a locked configuration when the engagement feature reaches an end of the inter-rib space. In the locked configuration, the proximal end of the interconnection unit does not extend beyond the proximal end of the outer member, and the engagement feature is positioned closer to the proximal end of the outer member than the distal end of the outer member. The inner member extends distally from the outer member in the locked configuration.
In described embodiments, the inner member and the outer member are adapted for delivery beyond a coronary lesion, including a distal micro-catheter with a tip diameter of less than 1 mm. The distal interface is described as a substantially flush transition between an outer tip of the outer member and a distal tip of the inner member, including a chamfered interface. Additional structural and delivery-support features are described, including enhanced crossability via lubricity, a thin-walled guide extension sheath for subsequent balloon or stent delivery, and a removable coaxial arrangement in which the inner member is removed while the sheath remains.
Claims Coverage
The partial content provides one independent claim directed to an intravascular delivery system with an outer member having flexible ribs and an inner member with an interconnection unit whose engagement feature locks into an inter-rib space. Dependent refinements in the provided claim set further specify distal geometry/size constraints, flush transition limits, chamfer angle, an extension length constraint, and a helical coil feature.
Outer member with flexible ribs and inter-rib spaces for locking engagement
An outer member comprising a lumen, the outer member comprising a plurality of flexible ribs separated by respective inter-rib spaces, wherein the plurality of flexible ribs are located closer to the outer member proximal end than the outer member distal end.
Inner member with tubular member and circumferential interconnection unit
An inner member comprising a tubular member and an interconnection unit, wherein the tubular member extends distally from the interconnection unit and proximally from the interconnection unit, the tubular member has a first diameter, the interconnection unit comprises a cylindrical section having a second diameter greater than the first diameter, and the interconnection unit is disposed circumferentially around the tubular member.
Engagement feature that embraces inner member outer surface and locks into inter-rib space
An engagement feature of the interconnection unit extends beyond an outer surface of the interconnection unit, the engagement feature has a third diameter greater than the second diameter and greater than the first diameter, and the plurality of flexible ribs are configured to embrace the outer surface of the interconnection unit, wherein the interconnection unit is inserted into the outer member proximal end such that the engagement feature moves past a flexible rib to an inter-rib space.
Locked configuration with constrained interconnection unit placement and distal extension
The inner member and the outer member are placed in a locked configuration when the engagement feature reaches an end of the inter-rib space, wherein the proximal end of the interconnection unit does not extend beyond the proximal end of the outer member in the locked configuration, the engagement feature is positioned closer to the proximal end of the outer member than the distal end of the outer member in the locked configuration, and wherein the inner member extends distally from the outer member when the inner member and the outer member are placed in the locked configuration.
Sub-1 mm distal end diameter for inner member
The intravascular system wherein a diameter of a distal end of the inner member is less than 1 mm.
Substantially flush transition between outer tip and inner tip
The intravascular system configured so that a transition between an outer diameter of an outer tip of the outer member and an outer diameter of a distal tip of the inner member is equal to or less than 0.0006 inches to create a substantially flush transition.
Chamfered distal interface at approximately 45 degrees
The intravascular system wherein an interface between the outer tip of the outer member and the distal tip of the inner member is approximately 45° chamfer.
Inner member extends beyond outer member by predetermined length greater than 2 cm
The intravascular system wherein the inner member extends beyond an outer member by a predetermined length greater than 2 cm.
Helical coil as at least part of inner member or outer member
The intravascular system further includes a helical coil formed as at least part of either the inner member or the outer member.
Overall, the claim coverage centers on a locked coaxial intravascular delivery arrangement in which an engagement feature on an interconnection unit passes flexible ribs and locks in an inter-rib space while constraining proximal extension of the interconnection unit and allowing distal extension of the inner member; provided refinements further tighten distal size/transition/geometry, require a flush interface with chamfer, specify an extension length, and add a helical coil feature.
Stated Advantages
Enhanced crossability via lubricity.
A substantially flush transition between the outer tip of the outer member and the distal tip of the inner member.
A thin-walled guide extension sheath configured to remain after removal of the inner member for subsequent balloon or stent delivery.
Documented Applications
Percutaneous coronary intervention guide catheter extension using a removable tapered micro-catheter delivery catheter tracking over a guidewire, with subsequent balloon or stent delivery beyond a coronary lesion.
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