Transcatheter delivery systems and delivery catheters for prosthetic mitral valve delivery, and methods for prosthetic mitral valve delivery using a retrograde approach

• US 10,716,667 B2
• Filed: 01/20/2017
• Issued: 07/21/2020
• Est. Priority Date: 01/20/2017
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: O'Connell, Barry, Griffin, Patrick, Bateman, Michael, Haynes, William
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/411,542
• Publication Number:
  US 20180206989A1
• Time in Patent Office: 1,278 Days
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Transcatheter delivery systems, delivery catheters and associated methods for percutaneous delivery of prosthetic mitral valves using a retrograde approach are disclosed herein. A heart valve delivery system configured in accordance herewith includes a delivery catheter having an elongated tubular component and an articulation assembly at a distal end thereof. The articulation assembly includes an arm portion coupled to the tubular component by an elbow or hinge portion. In a closed, delivery state, the elbow portion positions the arm portion generally parallel to the tubular component for delivery of the delivery catheter through the vasculature. In an open, deployed state, the elbow portion positions the arm portion in a non-axial direction with respect to a longitudinal axis of the tubular component for orienting and positioning a prosthetic valve device carried by the arm portion, e.g., within the native mitral valve region.

Claims

1. A heart valve prosthesis delivery system, comprising:

a delivery catheter comprising

an outer tubular component,

a distal tip,

an elongated tubular component,

an arm portion, and

an elbow portion coupling the arm portion to the elongated tubular component,

wherein the delivery catheter is in a delivery configuration when the elbow portion is in a state of flexion with an angle between the elongated tubular component and the arm portion being substantially 0 degrees, such that the arm portion is in a closed state in which the arm portion is laterally offset from, adjacent to, and substantially parallel with the elongated tubular component, and

wherein when the delivery catheter is in the delivery configuration a recessed segment defined between a distal end of the outer tubular component and the distal tip is configured to receive the arm portion in the closed state; and

a heart valve prosthesis releasably attached to the arm portion.

2. The delivery system of claim 1, wherein at least the elbow portion is configured to have a shape-memory to bias the arm portion from the state of flexion into an open state when the delivery catheter is in a deployed configuration in which the arm portion is angled away from a longitudinal axis of the elongated tubular component and in which an extension angle formed between the arm portion and the elongated tubular component is less than 90 degrees.

3. The delivery system of claim 1, wherein the elbow portion comprises a ball-and-socket hinge mechanism.

4. The delivery system of claim 1, wherein the elbow portion comprises a bellows connector having concertinaed sides.

5. The delivery system of claim 1, further comprising:

a tether device attached to the arm portion and configured to restrain the arm portion in the closed state, wherein the tether device comprises a tether line that extends through a hole in the elongated tubular component to an attachment point on the arm portion.

6. The delivery system of claim 1, further comprising:

a wire configured to push the arm portion to an outward open state when the delivery catheter is in a deployed configuration in which the arm portion is angled away from the longitudinal axis of the elongated tubular component.

7. The delivery system of claim 1, further comprising:

a cinch device configured to constrain the heart valve prosthesis in a compressed delivery configuration on the arm portion.

8. The delivery system of claim 7, wherein the outer tubular component has a distal end disposed proximal of the arm portion.

9. The delivery system of claim 1, further comprising:

a balloon attached to the arm portion of the delivery catheter, wherein the heart valve prosthesis is crimped onto the balloon, and wherein the delivery catheter further comprises an inflation lumen that provides fluid communication between the balloon and a source of inflation fluid.

10. The delivery system of claim 1, wherein the arm portion includes an outermost tubular member and a distal member that resides within the outermost tubular member, the distal member being configured to be longitudinally and/or rotatably translatable relative to the outermost tubular member to extend or contract a length of the arm portion and/or to rotate the heart valve prosthesis releasably attached to the arm portion.

11. The delivery system of claim 1, wherein the elongated tubular component is a first elongated tubular component, the delivery catheter further comprising a second elongated tubular component disposed adjacent to and parallel with the first elongated tubular component, wherein the second elongated tubular component defines a guidewire lumen.

12. A heart valve prosthesis delivery system, comprising:

a delivery catheter comprising

a first elongated tubular component,

a second elongated tubular component having a distal tip portion,

an arm portion, and

an elbow portion coupling the arm portion to the first elongated tubular component,

wherein when the elbow portion is in a state of flexion, the delivery catheter is in a delivery configuration with the arm portion in a closed state in which the arm portion is substantially parallel with the first elongated tubular component, and

wherein the distal tip portion of the second elongated tubular component comprises a proximal facing recess that is configured to receive the elbow portion therein to constrain the arm portion in the closed state when the delivery catheter is in the delivery configuration; and

a heart valve prosthesis releasably attached to the arm portion.

13. The delivery system of claim 12, wherein the distal tip portion of the second elongated tubular component is configured to be distally advanced relative to the elbow portion to release the arm portion such that the arm portion transitions to an open state when the delivery catheter is in a deployed configuration in which the arm portion is angled away from the longitudinal axis of the first elongated tubular component.

14. The delivery system of claim 12, wherein the second elongated tubular component comprises an inner tubular member that resides within an outer tubular member, the inner tubular member being configured to be longitudinally translatable relative to the outer tubular member to advance or retract the distal tip portion.

15. The delivery system of claim 14, wherein the inner tubular member defines a guidewire lumen.

16. A heart valve prosthesis delivery system, comprising:

a delivery catheter comprising

an elongated tubular component,

an arm portion,

an elbow portion coupling the arm portion to the elongated tubular component, and

a balloon attached to the arm portion,

wherein when the elbow portion is in a state of flexion, the delivery catheter is in a delivery configuration with the arm portion in a closed state in which the arm portion is substantially parallel with the elongated tubular component; and

a heart valve prosthesis crimped onto the balloon and releasably attached to the arm portion,

wherein the delivery catheter further comprises an inflation lumen that provides fluid communication between the balloon and a source of inflation fluid, and

wherein in response to an inflation fluid being directed into the balloon, the arm portion is biased into an open state and the delivery catheter is in at least a partially deployed configuration in which the arm portion is angled away from a longitudinal axis of the elongated tubular component and in which an extension angle formed between the arm portion and the elongated tubular component is less than 90 degrees.

17. The delivery system of claim 16, wherein the inflation fluid also expands the balloon component and thereby expands the heart valve prosthesis.

18. The delivery system of claim 17, wherein the arm portion includes an outermost tubular member and an inflation tubular member that resides within the outermost tubular member, the inflation tubular member being configured to be longitudinally and/or rotatably translatable relative to the outermost tubular member to extend or contract a length of the arm portion and/or to rotate the heart valve prosthesis releasably attached to the arm portion, and wherein the inflation tubular member defines the inflation lumen that provides fluid communication between the balloon and the source of inflation fluid.

19. The delivery system of claim 18, further comprising an innermost tubular member in the inflation tubular member, the innermost tubular member defining a guidewire lumen.

20. The delivery system of claim 17, wherein the arm portion includes a bellows connector configured to extend or contract a length of the arm portion, and wherein an increase in a partial pressure within the bellows connector extends the length.

21. A delivery catheter for intravascular delivery of a heart valve prosthesis to a heart valve of a patient, the delivery catheter comprising:

a first elongated tubular component having a distal segment and an articulation assembly at the distal segment, wherein the articulation assembly includes an arm portion coupled to the first elongated tubular component by an elbow portion; and

a second elongated tubular component disposed adjacent to and parallel with the first elongated tubular component, wherein the second elongated tubular component defines a guidewire lumen,

wherein in a state of flexion, the elbow portion positions the arm portion laterally offset from, adjacent to, and generally parallel to the first elongated tubular component for intravascular delivery of the distal segment of the delivery catheter, whereby an angle between the first elongated tubular component and the arm portion is substantially 0 degrees, and

wherein in a state of extension, the elbow portion positions the arm portion in an outwardly angled direction with respect to a longitudinal axis of the first elongated tubular component.

22. The delivery catheter of claim 21, wherein the arm portion is configured to carry the heart valve prosthesis in a compressed or delivery configuration.

23. The delivery catheter of claim 21, wherein in the state of extension, an extension angle formed between the arm portion and the first elongated tubular component is less than 90 degrees.

24. The delivery catheter of claim 21, further comprising:

a tether device having a tether line configured to restrain the elbow portion in the state of flexion, wherein advancement of the tether line relative to a remainder of the delivery catheter allows the elbow portion to transition between the state of flexion and the state of extension.

25. The delivery catheter of claim 21, wherein the elbow portion includes a bellows connector having concertinaed sides, and wherein the elbow portion transitions between the state of flexion and the state of extension hydraulically.

26. The delivery catheter of claim 21, wherein the elbow portion is a hinged joint, and wherein advancement of a wire relative to a remainder of the delivery catheter is configured to push the arm portion away from the first elongated tubular component and transition the elbow portion from the state of flexion to the state of extension.