Method and apparatus for placing a catheter within a vasculature
Inventors
Farhangnia, Mehrdad • Miller, John • Taber, Mark • Yang, Mark C.
Assignees
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Publication Number
US-10130385-B2
Publication Date
2018-11-20
Expiration Date
Abstract
A catheter for insertion into vasculature of a patient to a target area in the vasculature includes a hollow inner shaft, a non-occluding self-expandable scaffold coupled to the distal end of the inner shaft and disposed at the distal end of the inner shaft, and a hollow outer shaft. The outer shaft is slidable over the inner shaft and scaffold such that the scaffold is in a non-expanded state when the outer shaft is around the scaffold. The outer shaft has a state where the distal end of the outer shaft remains near the target area without the inner shaft and the scaffold being within the outer shaft. The inner shaft and the scaffold are removable through the proximal end of the outer shaft while the distal end of the outer shaft remains near the target area.
Core Innovation
The invention describes a catheter apparatus and method for crossing a target area in a vessel of a patient while providing support for a medical device. The catheter includes a hollow shaft having a distal end and a proximal end, and a non-occluding self-expandable scaffold disposed at the distal end. A portion of the distal end is disposed at least in part inside the scaffold, and the scaffold is configured to be coupled to the distal end of the catheter.
The catheter further includes a sheath with a central lumen, a distal end having a distal opening, and a proximal end having a proximal opening, where the sheath is slidable along the hollow shaft. The scaffold is in an un-expanded state when covered by the sheath. The method includes withdrawing the sheath to expand the self-expandable scaffold and moving the sheath and scaffold relative to each other to position the sheath at least partially over the scaffold so the scaffold returns to the un-expanded state.
After expansion and optional return to the un-expanded state, the method includes withdrawing the hollow shaft and the scaffold through the proximal opening of the sheath. The sheath is adapted to remain in the vessel as a support catheter such that a medical device may be passed through the proximal opening of the sheath and advanced through the sheath to the target area near the distal end of the sheath. The disclosed system is particularly directed to crossing chronic total occlusion (CTO) conditions using a non-occluding scaffold configured to allow blood flow.
Claims Coverage
The independent claim broadly covers a method using a catheter that transitions a non-occluding self-expandable distal scaffold between un-expanded and expanded states using a slidable sheath, and then leaves the sheath behind as a support catheter for medical device delivery to the target area. The inventive features include the hollow shaft, the non-occluding self-expandable scaffold coupled to the distal end, and the sheath sliding relationship that enables scaffold expansion and subsequent resheathing/un-expansion before withdrawing the hollow shaft/scaffold while retaining the sheath for support.
Hollow shaft coupled with a non-occluding self-expandable scaffold
A hollow shaft with a distal end and a proximal end, and a non-occluding self-expandable scaffold disposed at the distal end of the catheter, where a portion of the distal end of the catheter is disposed at least in part inside the scaffold.
Slidable sheath with central lumen positioned over the scaffold
A sheath with a central lumen, a distal end having a distal opening, and a proximal end having a proximal opening, the sheath being slidable along the shaft.
Un-expanded scaffold under sheath and expansion by withdrawing the sheath
The scaffold is configured to be coupled to the distal end of the catheter, wherein the scaffold is in an un-expanded state when covered by the sheath, and withdrawing the sheath to expand the self-expandable scaffold.
Resheathing to return scaffold to un-expanded state
Moving the sheath and the scaffold relative to each other to position the sheath at least partially over the scaffold such that the scaffold returns to the un-expanded state.
Leaving the sheath as a support catheter after withdrawing scaffold and hollow shaft
Withdrawing the hollow shaft and the scaffold through the proximal opening of the sheath, the sheath being adapted to remain in the vessel as a support catheter such that a medical device may be passed through the proximal opening of the sheath and advanced through the sheath to the target area near the distal end of the sheath.
Overall, claim coverage is anchored in using a slidable sheath to control the un-expanded/expanded state of a non-occluding self-expandable distal scaffold coupled to a hollow shaft, and then removing the hollow shaft and scaffold while leaving the sheath in place to provide support for advancing a medical device to the target area near the sheath distal end.
Stated Advantages
Allows advancement of a medical device through a sheath that remains in the vessel as a support catheter after withdrawing the hollow shaft and scaffold.
Uses a non-occluding scaffold configured to allow blood flow.
Documented Applications
Crossing a target area in a vessel, including chronic total occlusion (CTO) contexts in a coronary artery, using the described catheter and distal non-occluding scaffold while providing support for a medical device.
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