US 2026/0060804 A1Published application

Rotational alignment of medical implant

AssigneeBoston Scientific Scimed, Inc.

InventorsRichard Kiely, David Bishop

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Abstract

A system for delivering a replacement heart valve implant may include the implant including an expandable framework and leaflets coupled to the framework, and a delivery device including a handle and an elongate catheter extending from the handle. The catheter includes an outer sheath and an inner shaft movably disposed within the outer sheath. The implant is releasably coupled to the inner shaft. The inner shaft includes an orientation lumen extending longitudinally within the inner shaft, the orientation lumen being offset from a central guidewire lumen of the inner shaft. The delivery device includes an orientation mandrel disposed within the orientation lumen, the orientation mandrel extending distally from the handle to a distal end proximate a closed distal end of the orientation lumen. The orientation mandrel is operably coupled to an orientation mechanism of the handle configured to apply compressive force or tensile force to the orientation mandrel.

Claims20

Dependent claims

A method of delivering and positioning a replacement heart valve implant within a native heart valve of a patient, comprising:

advancing a delivery system percutaneously through vasculature to a position adjacent the native heart valve, the delivery system comprising:
a replacement heart valve implant including an expandable framework and a plurality of leaflets coupled to the expandable framework at commissural posts of the expandable framework;
and
a delivery device including a proximal handle and an elongate catheter extending distally from the proximal handle, wherein the elongate catheter includes an outer sheath and an inner shaft movably disposed within a lumen of the outer sheath,
wherein the replacement heart valve implant is releasably coupled to a distal portion of the inner shaft in a delivery configuration;
wherein the inner shaft includes a central guidewire lumen extending longitudinally therethrough;
wherein the inner shaft includes an orientation lumen extending longitudinally within the inner shaft, the orientation lumen being laterally offset from the central guidewire lumen and having a closed distal end;
wherein the delivery device includes an orientation mandrel slidably disposed within the orientation lumen;
positioning the elongate catheter such that a distal portion thereof conforms to an aortic arch of the patient;
deploying the replacement heart valve implant within the native heart valve;
and
aligning the commissural posts of the replacement heart valve implant with commissures of the native heart valve by actuating the orientation mandrel to rotate the replacement heart valve implant relative to the outer sheath.

9 more elements

A method of rotationally aligning a replacement heart valve implant within a native heart valve of a patient, comprising:

percutaneously advancing a delivery system to a target location adjacent the native heart valve, the delivery system comprising:
a replacement heart valve implant including an expandable framework and a plurality of leaflets coupled to the expandable framework at commissural posts of the expandable framework;
and
a delivery device including a proximal handle and an elongate catheter extending distally from the proximal handle, wherein the elongate catheter includes an outer sheath and an inner shaft movably disposed within a lumen of the outer sheath;
wherein the replacement heart valve implant is releasably coupled to a distal portion of the inner shaft in a delivery configuration;
wherein the inner shaft includes a central guidewire lumen extending longitudinally therethrough;
wherein the delivery device includes a first orientation mandrel attached to an outside surface of the inner shaft;
deploying the replacement heart valve implant within the native heart valve;
determining rotational alignment between the commissural posts of the replacement heart valve implant and commissures of the native heart valve;
and
adjusting rotational alignment by applying force to the first orientation mandrel to rotate the replacement heart valve implant relative to the outer sheath.

8 more elements

Dependencies are inferred from the claim text.

Facts

Application: 19/383,090Filed 7 Nov 2025
Priority: 9 Apr 2021
Published: 5 Mar 2026
Term ends: Not estimatedThe source records don’t support an estimate.

Classification6 codes

A61F 2/2436
Devices for manipulating or deploying heart valves during implantation: deployment by retracting a sheath
A61F 2/2418
With soft flexible valve members, e.g. tissue valves shaped like natural valves: scaffolds therefor, e.g. support stents
A61F 2/9517
Instruments specially adapted for placement or removal of stents or stent-grafts: handle assemblies therefor
A61M 25/09
Introducing, guiding, advancing, emplacing or holding catheters: guide wires

Family

Application63/173,097Us provisional application · filed 9 Apr 2021
Application17/716,291Continuation · filed 8 Apr 2022
Application19/383,090Continuation
US 12,485,008 B2Related patent
US 2022/0323217 A1Published application
US 2026/0060804 A1This patent

From the US filing history. Foreign family members aren’t listed.

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