Delivery devices and methods for heart valve repair
Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.
1. A catheter assembly comprising:
a guide sheath having a guide sheath axis and a distal end, wherein the guide sheath is configured to position the distal end in a subannular space;
an elongate device slidably extendable within the guide sheath, the elongate device having an elongate device axis, a distal portion, a distal end, and a plurality of openings corresponding to a plurality of distinct anchor delivery sites located along the distal portion;
the guide sheath comprising a sheath orientation portion having a pre-shaped non-linear configuration; and
the elongate device comprising a device orientation portion having a pre-shaped non-linear configuration that corresponds with the pre-shaped non-linear configuration of the sheath orientation portion and located proximal to the distal portion, wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion are determined prior to positioning the guide sheath in the subannular space;
wherein registration of the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion axially and rotationally aligns the guide sheath and the elongate device such that the distal end of the elongate device is at a selected orientation.
2. The catheter assembly according to claim 1 wherein at least one of the guide sheath and elongate device is steerable.
3. The catheter assembly according to claim 2 wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion each comprise a first curved portion in a first plane and a second curved portion in a second plane, said first and second planes being different planes.
4. The catheter assembly according to claim 1 wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion each comprise a first curved portion in a first plane and a second curved portion in a second plane, said first and second planes being different planes.
5. The catheter assembly according to claim 1 wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion are configured to cause the sheath orientation portion and device orientation portion to form a complementary interfit when the sheath orientation portion and device orientation portion are axially and rotationally aligned.
6. A method for orienting a catheter assembly comprising:
selecting a catheter assembly comprising:
selecting a guide sheath having a guide sheath axis and a distal end, wherein the guide sheath is configured to position the distal end in a subannular space;
selecting an elongate device slidably extendable within the guide sheath, the elongate device having an elongate device axis, a distal portion, a distal end, and a plurality of openings corresponding to a plurality of distinct anchor delivery sites located along the distal portion;
wherein the guide sheath comprises a sheath orientation portion, the sheath orientation portion having a pre-shaped non-linear configuration; and
the elongate device comprises a device orientation portion, the device orientation portion having a pre-shaped non-linear configuration that corresponds with the pre-shaped non-linear configuration of the sheath orientation portion and located proximal to the distal portion, and wherein the pre-shaped non-linear configuration of the sheath orientation portion and the pre-shaped non-linear configuration of the device orientation portion are determined prior to positioning the guide sheath at a chosen location;
placing the distal end of the guide sheath at the chosen location; and
registering the sheath orientation portion and the device orientation portion so that the guide sheath and elongate device are axially and rotationally aligned such that the distal end of the elongate device is at a selected orientation.