Balloon cover for delivery device for expandable artificial heart valve

Abstract

An improved balloon cover is provided to prevent rotation of the positioning device relative to the delivery device. [Solution] A balloon cover for a delivery device for an artificial valve is disclosed. In one embodiment, the balloon cover includes first and second shell members configured to interlock with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a greater width than the first portion. The first portion of the first and second shell members defines a first cavity configured to receive the distal end portion of the delivery device and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery device. The second portion of the first and second shell members defines a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery device proximal to the valve mounting portion of the distal end portion of the delivery device.

Claims

1. It is an assembly, A delivery device comprising a first shaft and a second shaft extending through the first shaft and having a distal end portion extending distally beyond the distal end portion of the first shaft, An inflatable balloon overlaps the valve mounting portion of the delivery device, which is coupled to the distal end portion of the first shaft and configured to receive the artificial valve in a radially compressed state, The distal end portion of the first shaft is connected to a positioning device coupled to the valve mounting portion proximal to the first shaft, It is a balloon cover, An assembly comprising a balloon cover, the balloon cover comprising a first shell member and a second shell member configured to interlock with each other around the balloon and the positioning device, each of the first shell member and the second shell member comprising a first shell portion and a second shell portion, wherein the first shell portion of the first shell member and the second shell member defines a first cavity configured to receive at least a portion of the balloon and the distal end portion of the second shaft, and the second shell portion of the first shell member and the second shell member defines a second cavity configured to receive the positioning device.

2. The assembly according to claim 1, wherein the width of the first shell portion of each of the first shell member and the second shell member is smaller than the width of the second shell portion of each of the first shell member and the second shell member, the width is defined in a direction perpendicular to the central longitudinal axis of the balloon cover, and the central longitudinal axis of the balloon cover is coaxial with the central longitudinal axis of the delivery device when the first shell member and the second shell member are engaged with each other around the delivery device.

3. The assembly according to claim 1 or 2, wherein each of the first shell member and the second shell member includes a planar meshing surface, and the planar meshing surface of the first shell member and the planar meshing surface of the second shell member are configured to mesh and engage with each other.

4. The assembly according to claim 3, wherein a portion of the planar meshing surface included in the second shell portion of the first shell member includes a first meshing element, and a portion of the planar meshing surface included in the second shell portion of the second shell member includes a second meshing element, and the first meshing element and the second meshing element are configured to mesh with each other, preventing the first shell member and the second shell member from sliding against each other.

5. The assembly according to any one of claims 1 to 4, wherein the first shell portion of the first shell member and the first shell portion of the second shell member each comprise an outer surface, an inner surface, and a pressing portion within the inner surface that is pressed toward the outer surface and extends along the length of the respective first shell portion, the length of which is defined in a direction parallel to the central longitudinal axis of the balloon cover, the inner surface of the first shell portion of the first shell member and the inner surface of the first shell portion of the second shell member are configured to interlock with each other, and the pressing portion of the first shell member and the pressing portion of the second shell member together form the first cavity.

6. The assembly according to claim 5, wherein each pressing portion comprises a distal section shaped to receive the distal end portion of the balloon that overlaps with the distal shoulder portion of the delivery device, and a proximal section shaped to receive the middle portion of the balloon that overlaps with the valve mounting portion of the delivery device.

7. The assembly according to claim 6, wherein the distal shoulder portion is connected to the distal end portion of the second shaft and includes a wide-mouth portion disposed adjacent to the valve mounting portion.

8. The assembly according to any one of claims 1 to 7, wherein the positioning device is disposed at the distal end of the positioning device and comprises a flange portion extending radially outward from the body of the positioning device, and the diameter of the second cavity is greater than the outer diameter of the flange portion of the positioning device.

9. The assembly according to claim 8, wherein the second shell portion of the first shell member comprises one or more protruding wall portions that protrude into the second cavity and form one or more cavities configured to receive and hold a portion of the flange portion of the positioning device, so as to prevent the positioning device and the balloon cover from rotating relative to each other.

10. The assembly according to any one of claims 1 to 9, further comprising a sleeve configured to be positioned around the first shell portion of the first shell member and the first shell portion of the second shell member such that the first shell member and the second shell member are held together by interlocking engagement.

11. The assembly according to any one of claims 1 to 10, further comprising a radiopaque marker disposed on the distal end portion of the delivery device.

12. The assembly according to claim 11, wherein the radiopaque marker is disposed on a distal shoulder portion coupled to the distal end portion of the second shaft, and the distal shoulder portion is disposed adjacent to the valve mounting portion.

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