US 11,026,788 B2Granted

Loader and retriever for transcatheter heart valve, and methods of crimping transcatheter heart valve

AssigneeEdwards Lifesciences Corporation

InventorsAsher L. Metchik, Thanh V. Nguyen, Raz Biran, Arvin T. Chang, Tarannum Nagpurwala, Jeff Lindstrom

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Abstract

A loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

Claims20

Dependent claims

A loader assembly for loading a transcatheter heart valve into a delivery sheath for delivering the heart valve into a body of a patient, the loader assembly comprising:

a loader tube having a first end, a second end, and a central axis extending through the first and second ends, the loader tube comprising a tube wall defining a coaxial bore, wherein the tube wall has a first section at the first end with a first inner diameter, a second section connected to a distal end of the first section and having a second inner diameter smaller than the first inner diameter, and a third section connected to a distal end of the second section and having a third inner diameter greater than the second inner diameter;
a hub in direct contact with and attached to at least an outer surface portion of the first section of the loader tube;
a cap directly coupled to a proximal-most end of the hub;
and
at least one seal disposed in the cap and positioned proximal to the loader tube, the seal being configured to maintain hemostasis in the loader tube when the coaxial bore of the loader tube is in communication with a blood vessel of the patient;
wherein the tube wall has a first tapered section between the first section and the second section, wherein the first tapered section has an inner surface that tapers in a direction extending from the first end towards the second end of the loader tube;
wherein the tube wall has a second tapered section between the second section and the third section, wherein the second tapered section has an inner surface that tapers in a direction extending from the second end towards the first end of the loader tube, wherein the inner surface of the second tapered section progressively and continuously tapers from a proximal end of the third section to the distal end of the second section.

4 more elements

An assembly for transcatheter implantation of an implantable device into a body of a patient, the assembly comprising:

a loader device comprising a loader tube, a first hub, a cap, and a first seal disposed in the cap;
and
a delivery sheath device comprising a second hub, a sheath attached to a distal end of the second hub, and a second seal disposed in the second hub;
wherein the loader tube having a first end, a second end, and a central axis extending through the first and second ends, the loader tube comprising a tube wall defining a coaxial bore, wherein the tube wall has a first section at the first end with a first diameter, a second section connected to a distal end of the first section and having a second diameter smaller than the first diameter, and a third section connected to a distal end of the second section and having a third diameter greater than the second diameter;
wherein the first hub is in direct contact with and attached to at least an outer surface portion of the first section of the loader tube and the cap is directly coupled to a proximal-most end of the first hub;
wherein the first hub has an axial length that is substantially the same as an axial length of the first section of the loader tube;
wherein the first seal is configured to maintain hemostasis in the loader tube when the coaxial bore of the loader tube is in communication with a blood vessel of the patient, and the second seal member is configured to maintain hemostasis when the sheath is in communication with the blood vessel of the patient;
and
wherein the second hub of the delivery sheath device is configured to receive at least the third section of the loader tube.

6 more elements

Dependencies are inferred from the claim text.

Facts

Application: 15/238,605Filed 16 Aug 2016 · us provisional application
Priority: 20 Aug 2015
Published: US 2017/0049567 A123 Feb 2017
Granted: 8 Jun 2021
Term ends: Not estimatedThe source records don’t support an estimate.

Classification6 codes

A61F 2/2433
Deployment by mechanical expansion: using balloon catheter
A61F 2/0095
Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting…:…
A61F 2/2436
Devices for manipulating or deploying heart valves during implantation: deployment by retracting a sheath
A61F 2/9522
Instruments specially adapted for placement or removal of stents or stent-grafts: means for mounting a stent or stent-graft onto or into a…

Family

Application62/207,879Us provisional application · filed 20 Aug 2015
US 2017/0049567 A1Pre-grant publication · published 23 Feb 2017
US 11,026,788 B2This patent

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

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