Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath
Inventors
Schreck, Stefan • Jimenez, Jr., Teodoro S. • Charlton, Eileen • Gould, William
Assignees
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Publication Number
US-12121461-B2
Publication Date
2024-10-22
Expiration Date
Abstract
The present disclosure relates to a delivery system, a catheter system and a method for the minimally invasive application of prostheses to an individual in need thereof and a method for loading a prosthesis onto a catheter system and/or a delivery system.
Core Innovation
The invention relates to a catheter system for delivering a prosthetic heart valve using a delivery catheter with a distal tip that includes a first sleeve and a second sleeve movable relative to each other in a proximal-distal direction. The second sleeve is proximal to the first sleeve, and the first sleeve has an open end facing in a proximal direction. A middle section of the tip is uncovered when the first sleeve is in a proximal-most position while the second sleeve is in a distal-most position, with a holder disposed in the second sleeve.
The system integrates a delivery catheter and a steering catheter with an integrated handle that includes a delivery handle portion and a steering handle portion comprising a housing sized and configured to receive the delivery handle portion. The integrated handle is configured to control movement of the delivery catheter and the steering catheter independently, and an actuator movably coupled to the delivery handle portion manipulates the first sleeve and the second sleeve relative to the holder while the delivery handle portion is received by the housing.
The steering catheter is fixedly connected to the steering handle portion and the delivery catheter is fixedly connected to the delivery handle portion, and the steering catheter and the delivery catheter are selectively coaxially and rotationally independently movable. In an introducer configuration, the system includes an introducer comprising a sheath, with a crimping section proximal to a sheath in which the inner diameter decreases in a distal direction.
The catheter system is configured so that the delivery catheter and the steering catheter are simultaneously introducible into the crimping section, while the steering catheter, the delivery catheter, and the sheath are rotationally independently movable when the steering catheter and the delivery catheter are simultaneously disposed in the sheath.
Claims Coverage
The partial document provides two independent claims. Each claim is centered on a sleeve-based prosthetic heart valve delivery tip combined with an integrated handle and actuator arrangement that enables independent coaxial and rotational movement; the second claim further includes simultaneous introducibility through a crimping section with rotational independence in a sheath.
Movable first and second sleeves with uncovered middle tip section
A delivery catheter configured to deliver a prosthetic heart valve, with a distal tip including a first sleeve and a second sleeve movable relative to each other in a proximal-distal direction, the second sleeve proximal to the first sleeve, the first sleeve having an open end facing in a proximal direction, and a middle section of the tip uncovered when the first sleeve is in a proximal-most position while the second sleeve is in a distal-most position, with a holder disposed in the second sleeve.
Steering catheter and integrated handle with independent control
An integrated handle comprising a delivery handle portion and a steering handle portion comprising a housing sized and configured to receive the delivery handle portion, the integrated handle configured to control movement of the delivery catheter and the steering catheter independently, with the steering catheter fixedly connected to the steering handle portion and the delivery catheter fixedly connected to the delivery handle portion, and the steering catheter and the delivery catheter selectively coaxially and rotationally independently movable.
Actuator manipulating sleeves relative to holder while handles cooperate
An actuator movably coupled to the delivery handle portion and configured to move with respect to the delivery handle portion to manipulate the first sleeve and the second sleeve relative to the holder while the delivery handle portion is received by the housing of the steering handle portion.
Crimping section with decreasing inner diameter and simultaneous introducibility
An introducer comprising a sheath and a crimping section proximal to the sheath, the crimping section having an inner diameter that decreases in a distal direction, with the delivery catheter and the steering catheter simultaneously introducible into the crimping section.
Rotationally independently movable steering catheter, delivery catheter, and sheath
The steering catheter, the delivery catheter, and the sheath are rotationally independently movable when the steering catheter and the delivery catheter are simultaneously disposed in the sheath.
Across the two independent claims, the main inventive concept combines a delivery catheter tip having a first and second sleeve arrangement that uncovers a middle section of the tip with an integrated handle and actuator configuration that independently controls delivery and steering. The second independent claim further specifies an introducer with a distal-decreasing crimping section and simultaneous introducibility of the delivery and steering catheters together, while maintaining rotational independence among the steering catheter, delivery catheter, and the sheath.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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