TAVI anchoring assist device

• US 10,285,809 B2
• Filed: 03/03/2016
• Issued: 05/14/2019
• Est. Priority Date: 03/06/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Folan, Martyn G., Granada, Juan F.
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US15/060,258
• Publication Number:
  US 20160256270A1
• Time in Patent Office: 1,167 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An implant system may include a delivery sheath having an actuator mechanism, an anchoring assistance device including an expandable scaffold including a mid-body section, a cusp interface section, and a crown end arrangement, and a replacement heart valve implant. The cusp interface section includes a plurality of loop portions arranged at radial intervals about the expandable scaffold. Each loop portion is circumferentially spaced apart from another loop portion by a region having a deployment ring, the region being configured to span a commissure of the aortic valve and extending distally a shorter distance from the distal end than the loop portions. An elongate deployment member is configured to releasably engage with the deployment rings to actuate the expandable scaffold from a delivery configuration to a deployed configuration. The replacement heart valve implant is configured to be at least partially disposed within the expandable scaffold in the deployed configuration.

Claims

1. An anchoring assistance device, comprising:

an expandable scaffold including a mid-body section defining a central longitudinal axis, the expandable scaffold having a cusp interface section extending axially from a distal end of the mid-body section, and a crown end arrangement extending axially from a proximal end of the mid-body section;

wherein the expandable scaffold is configured to expand radially outward from a delivery configuration to a deployed configuration;

wherein the cusp interface section includes a plurality of loop portions arranged at radial intervals about the central longitudinal axis of the expandable scaffold, each loop portion being configured to be positioned adjacent a leaflet of an aortic valve;

wherein each loop portion includes two cusp loops circumferentially offset from each other,

wherein each loop portion is circumferentially spaced apart from another loop portion by a region having disposed therein a deployment ring configured to be positioned over and downstream of a commissure of the aortic valve and extending distally a shorter distance from the distal end of the mid-body section than the plurality of loop portions.

2. The anchoring assistance device of claim 1, wherein each region includes a minor loop, each minor loop having the deployment ring coupled thereto.

3. The anchoring assistance device of claim 2, wherein the two cusp loops circumferentially overlap each other at a location distal of the minor loops in the deployed configuration.

4. The anchoring assistance device of claim 2, wherein the two cusp loops are circumferentially spaced apart from each other at a location distal of the minor loops in the deployed configuration.

5. The anchoring assistance device of claim 2, wherein each deployment ring is formed from a coiled loop portion of its minor loop.

6. The anchoring assistance device of claim 2, wherein each deployment ring is integrally formed with its minor loop.

7. The anchoring assistance device of claim 1, wherein each loop portion extends a longer circumferential distance around the central longitudinal axis than each region.

8. The anchoring assistance device of claim 1, wherein the anchoring assistance device includes an equal number of loop portions and regions.

9. An anchoring assistance device delivery system, comprising:

a delivery sheath having at least one lumen extending longitudinally therethrough and an actuator mechanism disposed at a proximal end of the delivery sheath;

an elongate deployment member extending from the actuator mechanism to an anchoring assistance device disposable within a distal portion of the delivery sheath, the anchoring assistance device comprising;

an expandable scaffold including a mid-body section defining a central longitudinal axis, the expandable scaffold having a cusp interface section extending axially from a distal end of the mid-body section, and a crown end arrangement extending axially from a proximal end of the mid-body section;

wherein the expandable scaffold is configured to expand radially outward from a delivery configuration to a deployed configuration;

wherein the cusp interface section includes a plurality of loop portions arranged at radial intervals about the central longitudinal axis of the expandable scaffold, each loop portion being configured to be positioned adjacent a leaflet of an aortic valve;

wherein each loop portion is circumferentially spaced apart from another loop portion by a region having disposed therein a deployment ring configured to be positioned over and downstream of a commissure of the aortic valve and extending distally a shorter distance from the distal end of the mid-body section than the plurality of loop portions;

wherein the elongate deployment member is configured to releasably engage with each deployment ring such that the elongate deployment member actuates the expandable scaffold from the delivery configuration to the deployed configuration in response to activation of the actuator mechanism,

wherein the elongate deployment member includes a plurality of deployment loops at a distal end thereof, each deployment loop being configured to releasably engage with one deployment ring,

wherein each deployment loop extends at least partially through one deployment ring,

wherein proximal withdrawal of the elongate deployment member creates an interference between each deployment loop and its corresponding deployment ring such that the expandable scaffold is actuated from the delivery configuration to the deployed configuration.

10. The anchoring assistance device delivery system of claim 9, wherein the actuator mechanism is configured to axially translate the elongate deployment member with respect to the delivery sheath.

11. The anchoring assistance device delivery system of claim 9, wherein after achieving the deployed configuration, further proximal withdrawal of the elongate deployment member pulls each deployment loop through its corresponding deployment ring to disengage the elongate deployment member from the expandable scaffold.

12. A medical implant system, comprising:

a delivery sheath having at least one lumen extending longitudinally therethrough and an actuator mechanism disposed at a proximal end of the delivery sheath;

an anchoring assistance device comprising an expandable scaffold including a mid-body section defining a central longitudinal axis, the expandable scaffold having a cusp interface section extending axially from a distal end of the mid-body section, and a crown end arrangement extending axially from a proximal end of the mid-body section; and

a replacement heart valve implant;

wherein the expandable scaffold is configured to expand radially outward from a delivery configuration to a deployed configuration;

wherein the cusp interface section includes a plurality of loop portions arranged at radial intervals about the central longitudinal axis of the expandable scaffold, each loop portion being configured to be positioned adjacent a leaflet of an aortic valve;

wherein each loop portion is circumferentially spaced apart from another loop portion by a region having disposed therein a deployment ring configured to be positioned over and downstream of a commissure of the aortic valve and extending distally a shorter distance from the distal end of the mid-body section than the plurality of loop portions;

wherein an elongate deployment member extends from the actuator mechanism to the anchoring assistance device, the anchoring assistance device being disposable within a distal portion of the delivery sheath;

wherein the elongate deployment member is configured to releasably engage with each deployment ring to actuate the expandable scaffold from the delivery configuration to the deployed configuration;

wherein the replacement heart valve implant is configured to be at least partially disposed within the expandable scaffold in the deployed configuration,

wherein the elongate deployment member includes a plurality of deployment loops at a distal end thereof, each deployment loop being configured to releasably engage with one deployment ring;

wherein proximal withdrawal of the elongate deployment member creates an interference between each deployment loop and its corresponding deployment ring such that the expandable scaffold is actuated from the delivery configuration to the deployed configuration.

13. The medical implant system of claim 12, wherein the replacement heart valve implant includes a transcatheter aortic valve implantation (TAVI) device or a transcatheter aortic valve replacement (TAVR) device.

14. The medical implant system of claim 12, wherein the replacement heart valve implant includes an anchor member expandable from a collapsed configuration to an installed configuration, the anchor member being configured to radially engage the expandable scaffold in the installed configuration.

15. The medical implant system of claim 14, wherein the anchoring assistance device prevents migration of the replacement heart valve implant when the anchor member is radially engaged with the expandable scaffold.