BACKGROUND

Field

Certain embodiments disclosed herein related to steerable adapters for delivery devices implanting prostheses within a lumen or body cavity. In particular, the delivery devices relate in some embodiments to replacement heart valves, such as replacement mitral heart valves.

Description of the Related Art

Human heart valves, which include the aortic, pulmonary, mitral and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. The valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves' ability to control blood flow. Such impairments reduce the heart's blood-pumping efficiency and can be a debilitating and life threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, extensive efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.

Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. More recently, substantial effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is then delivered to the native valve's annulus.

Development of prostheses including but not limited to replacement heart valves that can be compacted for delivery and then controllably expanded for controlled placement has proven to be particularly challenging. An additional challenge relates to the ability of such prostheses to be secured relative to intralumenal tissue, e.g., tissue within any body lumen or cavity, in an atraumatic manner.

Delivering a prosthesis to a desired location in the human body, for example delivering a replacement heart valve to the mitral valve, can also be challenging. Obtaining access to perform procedures in the heart or in other anatomical locations may require delivery of devices percutaneously through tortuous vasculature or through open or semi-open surgical procedures. The ability to control the deployment of the prosthesis and to provide control of the delivery device at the desired location can also be challenging.

SUMMARY

Embodiments of the present disclosure are directed to delivery systems, devices and/or methods of use to deliver and/or controllably deploy a prosthesis, such as but not limited to a replacement heart valve, to a desired location within the body. In some embodiments, a replacement heart valve and methods for delivering a replacement heart valve to a native heart valve, such as a mitral valve, are provided.

The present disclosure includes, but is not limited to, the following numbered embodiments.

Embodiment 1

An adapter configured to manipulate the position of a delivery system, the adapter comprising a clamp configured to at least partially hold a handle of the delivery system, a first actuator configured to provide translational motion of the clamp along a longitudinal axis of the handle of the delivery system, a second actuator configured to provide rotational motion of the clamp along a first rotational axis, and a third actuator configured to provide rotational motion of the clamp along a second rotational axis, wherein the first rotational axis is generally perpendicular to the second rotational axis.

Embodiment 2

The adapter of Embodiment 1 further comprising a mating component configured to releasably mate with a component outside of the adapter.

Embodiment 3

The adapter of any one of Embodiments 1-2 wherein the first actuator, the second actuator, and the third actuators are knobs.

Embodiment 4

The adapter of any one of Embodiments 1-3 wherein the first actuator is a knob connected to a screw and the clamp is configured to translate along the screw.

Embodiment 5

The adapter of any one of Embodiments 1-3 wherein the second and third actuators are knobs in communication with gears configured to provide the rotational motion.

Embodiment 6

The adapter of any one of Embodiments 1-5 further comprising a pair of U-shaped members, each U-shaped member attached to one of the second or third actuators, wherein the U-shaped members are configured to rotate with respect to one another to provide the rotational motion to the clamp.

Embodiment 7

A method for manipulating the position of a delivery system, the method comprising clamping a handle of the delivery system, actuating a first knob to translate the handle along a longitudinal axis of the handle, actuating a second knob to rotate the handle of the delivery system around a first rotational axis, and actuating a third knob to rotate the handle of the delivery system around a second rotational axis, the second rotational axis being generally perpendicular to the first rotational axis.

Embodiment 8

An adapter for manipulating the position of a handle of a delivery system, the adapter comprising a clamp configured to receive and retain the handle, an h-shaped bracket connected to the clamp, the h-shaped bracket having at least one knob configured to translate the clamp along a screw extending across opposing legs on the h-shaped bracket, a first U-shaped member fixedly attached to the h-shaped bracket, a second U-shaped member rotatably connected to the first U-shaped member, the first U-shaped member and second U-shaped member configured to be rotated independently of one another, and an adapter located on the second U-shaped member, the adapter configured to connect to an outside component.

Embodiment 9

The adapter of Embodiment 8, further comprising a plurality of knobs configured to rotate the first U-shaped member and the second U-shaped member.

Embodiment 10

The adapter of any one of Embodiments 8-9, wherein the clamp is configured to translate and/or rotate in three dimensions.

Embodiment 11

The adapter of any one of Embodiments 8-10, further comprising an x-shaped member connecting opposite legs of the first U-shaped member and opposite legs of the second U-shaped member, the x-shaped member acting as a rotation axis for rotation of the first U-shaped member with respect to the second U-shaped member.

Embodiment 12

An adapter for manipulating the position of a handle of a delivery system, the adapter comprising a clamp configured to receive and retain the handle, a u-shaped bracket connected with the clamp, the u-shaped bracket having at least one knob configured to translate the clamp along a screw extending between opposite ends of the u-shaped bracket, a first gear attached to u-shaped bracket and configured to be rotated, a first support platform rotatably attached to the first gear, a second gear fixedly attached to the first support platform and configured to be rotated, a second support platform rotatably attached to the second gear, and an adapter located on the second support platform, the adapter configured to connect to an outside component.

Embodiment 13

The adapter of Embodiment 12, further comprising a plurality of knobs configured to rotate the first gear and the second gear.

Embodiment 14

The adapter of Embodiment 13, further comprising a first secondary gear mating with one of the plurality of knobs and the first gear and a second secondary gear mating with one of the plurality of knobs and the second gear.

Embodiment 15

The adapter of any one of Embodiments 12-14, wherein the first and second support platforms are generally l-shaped.

Embodiment 16

The adapter of any one of Embodiments 12-15, wherein the clamp is configured to translate and/or rotate in three dimensions.

Embodiment 17

The adapter of any one of Embodiments 12-16, wherein the first gear is configured to rotate the clamp on a plane perpendicular to the plane created by rotation of the second gear.

Embodiment 18

An adapter configured to manipulate the position of a delivery system, the adapter comprising a clamp configured to at least partially hold a handle of the delivery system, a first actuator configured to provide translational motion of the clamp along a longitudinal axis of the handle of the delivery system, a ball and socket joint, wherein the ball and socket joint allows for angular movement of the clamp, and a locking system configured to prevent motion of the ball and socket joint when activated.

Embodiment 19

The adapter of Embodiment 18, wherein the locking system is a spring loading locking system comprising a locking plate configured to retain a ball in the ball and socket joint in place.

Embodiment 20

The adapter of Embodiment 18, further comprising an adapter configured to connect to an outside component.

Embodiment 21

The adapter of Embodiment 18, further comprising a plurality of legs configured to act as a stand for the adapter.

Embodiment 22

The adapter of Embodiment 18, wherein the clamp is configured to translate and/or rotate in three dimensions.

Embodiment 23

The adapter of Embodiment 5, wherein a first and a second gear are configured to provide the rotational motion.

Embodiment 24

The adapter of any one of Embodiments 1-6, wherein the clamp is configured to translate and/or rotate in three dimensions.

Embodiment 25

The adapter of Embodiment 6, further comprising an x-shaped member connecting opposite legs of a first U-shaped member and opposite legs of a second U-shaped member, the x-shaped member acting as a rotation axis for rotation of the first U-shaped member with respect to the second U-shaped member.

