Cardiac Valve Loading Devices and Systems

Patent metadata

Field	Value
Publication number	US-2022039949-A1
Application number	US-202117505739-A
Country	US
Kind code	A1
Filing date	Oct 20, 2021
Priority date	Oct 25, 2018
Publication date	Feb 10, 2022
Grant date	—

Abstract

A loading device configured to radially collapse an expandable medical implant may include an operating handle having an opening therein extending along a longitudinal axis, a native sheath coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle parallel to the longitudinal axis, a removable sheath removably coupled to the native sheath, an actuation rod extending parallel to the longitudinal axis at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.

First claim

1 . (canceled)

2 . A loading device configured to radially collapse an expandable medical implant, the loading device comprising:
an operating handle having a proximal end, a distal end, a longitudinal axis and an opening extending along the longitudinal axis; a native sheath having a proximal end and a distal end, the proximal end of the native sheath being coupled to the distal end of the operating handle and partially extending into the opening of the operating handle, the native sheath being configured to translate relative to the operating handle parallel to the longitudinal axis; a removable sheath having a proximal end and a distal end, the proximal end of the removable sheath being removably coupled to the distal end of the native sheath; an actuation rod having a proximal end and a distal end, the actuation rod extending parallel to the longitudinal axis at least partially through the opening of the operating handle, a lumen of the native sheath, and a lumen of the removable sheath, the distal end of the actuation rod being configured to be removably coupled to the expandable medical implant; and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle in first and second longitudinal directions parallel to the longitudinal axis.

3 . The loading device of claim 2 , further comprising a threaded rod extending within the opening parallel to the longitudinal axis and affixed to the native sheath, wherein the first control element is a sheathing knob threadedly engaged with the threaded rod such that rotational movement of the sheathing knob causes the threaded rod, the native sheath, and the removable sheath to translate in one of the first or second longitudinal directions.

4 . The loading device of claim 2 , further comprising a second control element movable relative to the operating handle and coupled to the actuation rod, the second control element being configured to translate the actuation rod relative to the operating handle in the first and second longitudinal directions.

5 . The loading device of claim 4 , further comprising a threaded rod extending within the opening parallel to the longitudinal axis and affixed to the actuation rod, wherein the second control element is a retention mechanism knob threadedly engaged with the threaded rod, such that rotational motion of the retention mechanism knob causes the actuation rod to translate in one of the first or second longitudinal directions.

6 . The loading device of claim 5 , further comprising a ratchet and pawl mechanism that is coupled to the retention mechanism knob, the ratchet and pawl mechanism being configured to permit rotation of the retention mechanism knob only in a single rotational direction.

7 . The loading device of claim 2 , further comprising a coupling element extending around the proximal end of the removable sheath and the distal end of the native sheath, the coupling element removably coupling the removable sheath to the native sheath.

8 . The loading device of claim 2 , wherein the lumen of the removable sheath defines a funnel having a first diameter at the distal end of the removable sheath and a second diameter at the proximal end of the removable sheath, the first diameter being greater than the second diameter.

9 . The loading device of claim 8 , wherein the distal end of the removable sheath includes a flange having a distal-facing surface extending in a plane oriented substantially perpendicular to the longitudinal axis, the flange having a through-opening that defines the first diameter at the distal end of the removable sheath.

10 . The loading device of claim 2 , wherein the distal end of the actuation rod has a threaded feature configured to mate with a corresponding threaded feature of a retention mechanism coupled to the expandable medical implant.

11 . A medical combination, comprising the loading device of claim 2 , the expandable medical implant, and a retention mechanism removably coupling the expandable medical implant to the actuation rod of the loading device, the expandable medial implant being radially collapsed within the lumen of the removable sheath.

12 . A method of loading an expandable medical implant into a distal end of a delivery device, the method comprising:
inserting an outer sheath at the distal end of the delivery device into a lumen of a brace of a loading device; removably coupling a retention mechanism to an inner shaft extending along a longitudinal axis within the outer sheath of the delivery device, the retention mechanism coupling the expandable medical implant to the inner shaft; actuating a control element of the loading device to translate a packing rod of the loading device relative to the loading device in a longitudinal direction parallel to the longitudinal axis, the translation of the packing rod causing a distal end of the packing rod to press against a distal end of the retention mechanism and apply a force to the retention mechanism; and inserting the expandable medical implant into the outer sheath of the delivery device while the distal end of the packing rod and the outer sheath of the delivery device are positioned within the lumen of the brace of the loading device, the insertion of the expandable medical implant including further translating the packing rod relative to the loading device and the outer sheath of the delivery device in the longitudinal direction.

13 . The method of claim 12 , wherein the control element is an actuation knob threadedly engaged with a threaded rod affixed to the packing rod, and actuating the control element includes rotating the actuation knob.

14 . The method of claim 12 , wherein the lumen of the brace defines a funnel having a first diameter at a proximal end of the brace and a second diameter at a distal end of the brace, the first diameter being greater than the second diameter, and inserting the expandable medical implant into the outer sheath includes collapsing the expandable medical implant in a plurality of radial directions perpendicular to the longitudinal axis while at least a portion of the expandable medical implant is positioned within the lumen of the brace.

15 . The method of claim 12 , further comprising removing the outer sheath of the delivery device from the lumen of the brace, the expandable medical implant being disposed within the outer sheath in a collapsed state after the removing is completed.

Assignees

• Cephea Valve Tech Inc

Inventors

• Haynes Evelyn
• Chu Diana
• Gregg Peter
• Von Oepen Randolf

Classifications

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/24

  Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body} · CPC title