SYSTEMS AND METHODS FOR DELIVERING AN INTRAVASCULAR DEVICE TO THE MITRAL ANNULUS

• US 20180028177A1
• Filed: 07/27/2017
• Published: 02/01/2018
• Est. Priority Date: 07/29/2016
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: van Oepen, Randolf, McNiven, Sean A., Valencia, Francisco
• Granted Patent: US 11,324,495 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present disclosure describes devices, systems, and methods for intravascularly delivering an implantable device at the mitral annulus. A delivery system includes a delivery member coupled to a handle assembly and extending distally from the handle assembly. The intravascular device is attached at the distal end of the delivery member, and is housed within a distal piece of an outer sheath. A steering catheter is nested within the outer sheath to bend the delivery member into position. A delivery catheter is configured to advance the intravascular device relative to the outer sheath, and a suture catheter includes sutures/tethers which may be coupled to the intravascular device prior to deployment.

Claims

1. A delivery system for delivering an implantable intravascular device to a targeted cardiac valve, the delivery system comprising:

a handle assembly;

an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to an intravascular device at the distal end, the delivery member further including;

an outer sheath having a distal piece configured to house the intravascular device in a pre-deployed configuration;

a steering component configured to curve the delivery member in a compound curve that enables intravascular delivery of the delivery member to the targeted cardiac valve;

a delivery catheter configured to longitudinally translate the intravascular device relative to the outer sheath; and

a suture catheter having one or more tethers configured to detachably couple to the intravascular device, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the one or more tethers.

2. The delivery system of claim 1, wherein the steering component is a steering catheter nested within the outer sheath.

3. The delivery system of claim 2, wherein the steering catheter includes a plurality of tension cables and corresponding tension cable lumen, the tension cables providing for steering of the steering catheter by adjusting tension in the tension cables.

4. The delivery system of claim 3, wherein each tension cable lumen includes a micro coil along at least a distal section of the steering catheter.

5. The delivery system of claim 2, wherein the steering catheter is formed as a hypotube, the hypotube having a cut pattern that increases the flexibility of the hypotube relative to an uncut section of hypotube.

6. The delivery system of claim 5, wherein the hypotube includes a distal section, an intermediate section, and a proximal section, the distal section having a cut pattern which enables a bend radius of about 5 to 15 mm, and wherein the intermediate section has a cut pattern which provides a larger bend radius than of the distal section.

7. The delivery system of claim 1, wherein the distal piece includes a plurality of microfabricated cuts along at least a proximal section of the distal piece, the microfabricated cuts being configured to provide bending in a single plane.

8. The delivery system of claim 1, wherein the outer sheath includes a coil and a braided sleeve.

9. The delivery system of claim 8, wherein the coil is formed from a coil wire having a “

D”

shaped cross section.

10. The delivery system of claim 8, wherein the outer sheath further includes a fluid impermeable flexible polymer cover disposed over the coil and braided sleeve.

11. The delivery system of claim 1, wherein the distal piece is rotationally decoupled from the remainder of the outer sheath.

12. The delivery system of claim 1, wherein the outer sheath is coupled to the handle assembly with a swivel connection that enables the outer sheath to rotationally swivel relative to the handle assembly.

13. The delivery system of claim 1, wherein the delivery catheter includes a compression coil at least at a distal section.

14. The delivery system of claim 2, wherein the handle assembly is supported by a fixture, the fixture including a plurality of supports which support the outer sheath, a steering catheter handle, a delivery catheter holder, and a suture catheter holder, the fixture including adjustable controls which enable movement of components of the delivery member relative to other components of the delivery member.

15. The delivery system of claim 14, wherein the fixture includes a delivery device adjustor for longitudinally translating the entire delivery device relative to a base.

16. The delivery system of claim 14, wherein the fixture includes an outer sheath adjustor for translating the outer sheath relative to other components of the delivery member.

17. The delivery system of claim 14, wherein the fixture includes a deployment adjustor for translating the delivery catheter, outer sheath, and suture catheter relative to the steering catheter.

18. The delivery system of claim 1, wherein the handle assembly includes a delivery catheter holder, a suture catheter holder, and a suture catheter adjustor, the suture catheter adjustor being coupled to the delivery catheter holder, and the suture catheter holder including threads which engage with corresponding threads of the suture catheter adjustor such that rotation of the suture catheter adjustor translates the suture catheter holder relative to the delivery catheter holder.

19. A delivery system for intravascularly delivering an implantable intravascular device to the mitral annulus, the delivery system comprising:

an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to an intravascular device at the distal end, the delivery member further including;

an outer sheath having a distal piece configured to constrain the intravascular device in a pre-deployed configuration;

a steering catheter configured to curve the delivery member in a compound curve that enables intravascular delivery of the delivery member to the targeted cardiac valve;

a delivery catheter configured to longitudinally translate the intravascular device relative to the outer sheath;

a suture catheter having one or more tethers configured to detachably couple to a proximal section of the intravascular device, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the one or more tethers; and

a guidewire tube extending through the delivery member and through the distal piece to an attached distal tip, the distal tip being configured to connect to or seat against a distal side of the distal piece; and

a handle assembly, the handle assembly including;

an outer sheath holder coupled to the outer sheath at the proximal end of the outer sheath;

a steering catheter handle disposed proximal of the outer sheath holder, a proximal end of the steering catheter being coupled to the steering catheter handle and the steering catheter extending distally therefrom into the outer sheath;

a delivery catheter handle disposed proximal of the steering catheter handle, a proximal end of the delivery catheter being coupled to the delivery catheter handle and the delivery catheter extending distally therefrom into the steering catheter; and

a suture catheter handle disposed proximal of the delivery catheter handle, a proximal end of the suture catheter being coupled to the delivery suture catheter handle and extending distally therefrom into the delivery catheter.

20. A delivery system for intravascularly delivering an implantable intravascular device to the mitral annulus, the delivery system comprising:

an elongated delivery member coupled to the handle assembly and extending distally from the handle assembly, the delivery member having a distal end and being configured to detachably couple to an intravascular device at the distal end, the delivery member further including;

an outer sheath having a distal piece configured to hold the intravascular device in a pre-deployed configuration;

a steering catheter configured to curve the delivery member in a compound curve that enables intravascular delivery of the delivery member to the targeted cardiac valve;

a delivery catheter configured to longitudinally translate the intravascular device relative to the outer sheath;

a suture catheter having one or more tethers configured to detachably couple to the intravascular device, the suture catheter being longitudinally translatable relative to the delivery catheter to enable adjustment of tension in the one or more tethers; and

a guidewire tube extending through the delivery member and through the distal piece to an attached distal tip, the distal tip being configured to connect to or seat against a distal side of the distal piece; and

a handle assembly, the handle assembly including an outer sheath holder, a steering catheter handle, a delivery catheter holder, and a suture catheter holder; and

a fixture configured to support the handle assembly, the fixture including;

a delivery device adjustor for longitudinally translating the entire delivery device relative to a base;

an outer sheath adjustor for translating the outer sheath relative to other components of the delivery member; and

a deployment adjustor for translating the delivery catheter, outer sheath, and suture catheter relative to the steering catheter.