Guide flex system for delivery handle for prosthetic valve delivery systems

A system that delivers an expandable medical device to a treatment site, the system comprising:

• a flexible catheter;
• and
• a delivery handle arrangement;
• said delivery handle arrangement comprising:
• a housing having an inner core that at least partially extends linearly between a proximal end and a distal end of said housing;
• a flex adjustment mechanism that is configured to controllably bend a distal region said flexible catheter;
• said flex adjustment mechanism includes:
• a flex knob that is movably connected to said housing;
• said flex knob includes a body portion that is at least partially positioned in said inner core of said housing;
• a flex insert and/or flex actuator that is at least partially positioned in said inner core of said housing;
• said flex insert and/or flex actuator is configured to move within said housing during movement of said flex knob;
• and
• a wire member;
• said wire member is coupled at a proximal end to said flex insert and/or flex actuator and a distal region of said flexible catheter;
• and
• wherein said flexible catheter that is connected to said housing;
• and
• wherein said distal region of said flexible catheter is caused to controllably bend during movement of said flex knob;
• and
• wherein movement of said flex knob in a first direction causes said flex insert and/or flex actuator to translate linearly along a longitudinal axis of said housing to cause movement of said wire member to cause said flexible catheter to controllably bend said flexible catheter.

A flexible catheter that includes a catheter cavity that is configured to receive at least a balloon catheter and wherein the balloon catheter is movable along a longitudinal length of said catheter cavity and is rotatable about a longitudinal axis of said catheter cavity;

• said catheter cavity runs along a central longitudinal axis of said flexible catheter and along 80-100% of a longitudinal length of said flexible catheter;
• said flexible catheter includes a) an outer layer, and wherein said outer layer forms an outer surface of said flexible catheter along 50-100% of said longitudinal length of said flexible catheter, and wherein said outer layer runs along a central longitudinal axis of said flexible catheter and along 80-100% of a longitudinal length of said flexible catheter;
• b) and inner layer, and wherein said inner layer runs along a central longitudinal axis of said flexible catheter and along 80-100% of a longitudinal length of said flexible catheter;
• c) a flexible inner layer that includes a wire cavity, and wherein said flexible inner layer is positioned between said inner layer and said outer layer, and wherein said flexible inner layer is spaced from a distal end of said flexible catheter, and wherein at least a portion of said flexible inner layer is located at a distal region of said flexible catheter;
• d) a flexible hypotube, and wherein said flexible hypotube is located between said inner layer and said outer layer, and wherein said flexible hypotube is positioned in said distal region of said flexible catheter, and wherein at least a portion of said flexible hypotube is positioned distal to said flexible inner layer;
• e) a pull ring that is positioned at a distal region of said flexible catheter, and wherein said pull ring is positioned at or distal to a distal end of said flexible inner layer, and wherein said pull ring is positioned at a distal location to said flexible inner layer, and wherein said flexible hypotube is positioned at or spaced proximal to said pull ring;
• and f) a wire member, and wherein said wire member extends along at least a portion of said longitudinal length of said flexible catheter, and wherein said wire member is at least partially positioned in said wire cavity of said flexible inner layer and is moveable within said wire cavity, and wherein a distal end of said wire member is connected to said pull ring;
• and wherein movement of said wire member toward a proximal end of said flexible catheter causes said flexible hypotube of bend and cause a distal region of said flexible catheter to bend.