US-12622784-B2 - Heart valve repair

US12622784B2US 12622784 B2US12622784 B2US 12622784B2US-12622784-B2

Abstract

A heart valve repair system includes an implantable device and a connector. The implantable device is configured to attach to at least two leaflets of a native heart valve of a patient and hold the at least two leaflets in a relatively fixed position. The connector is separate from the implantable device and includes first and second tissue anchors. The connector is configured to be attached to the at least two leaflets of the native valve when the at least two leaflets are held by the implantable device in the relatively fixed position. The implantable device is configured to be detached from the at least two leaflets and removed from the patient with the connector remaining attached to the at least two leaflets.

Inventors

Nima V. Nia
Hengchu Cao
Bingquan Su
Douglas Thomas Dominick
Sakyasingh Tripathy

Assignees

EDWARDS LIFESCIENCES CORPORATION

Dates

Publication Date: 20260512
Application Date: 20211021

Claims (20)

1 . A heart valve repair system comprising: an implantable device configured to attach to at least two leaflets of a native heart valve of a patient and hold the at least two leaflets in a relatively fixed position; and a connector that is separate from the implantable device, the connector including first and second tissue anchors and being configured to be attached to the at least two leaflets of the native heart valve of the patient when the at least two leaflets are held by the implantable device in the relatively fixed position; wherein the connector includes a wedge and a locking nut; the connector having angled engagement surfaces that are configured to engage the at least two leaflets of the native valve and having a base surface with a locking aperture; a first suture attached to the first anchor; a second suture attached to the second anchor; wherein the first suture and the second suture are received by the angled engagement surfaces, exit the wedge through the base surface and extend through an internal passage of the locking nut; wherein the locking nut is configured to be at least partially received in the locking aperture; wherein the locking nut is configured to capture the first suture and the second suture between the locking nut and the wedge; and the implantable device being configured to be detached from the at least two leaflets and removed from the patient with the connector remaining attached to the at least two leaflets.
2 . The heart valve repair system of claim 1 , wherein the implantable device is configured both to allow the implantable device to remain attached to the native heart valve after the connector is attached to the native heart valve and to allow the implantable device to be removed from the native heart valve after the connector is attached to the native heart valve.
3 . The heart valve repair system of claim 2 , wherein the implantable device includes a spacer element.
4 . The heart valve repair system of claim 1 , wherein the implantable device includes a plurality of paddles that each comprise an inner paddle portion and an outer paddle portion.
5 . The heart valve repair system of claim 1 , wherein the implantable device and the connector are configured to close a gap in the native heart valve of the patient when the valve repair system is attached to the native heart valve.
6 . The heart valve repair system of claim 1 , wherein the first anchor comprises a pledget.
7 . The heart valve repair system of claim 1 , wherein the implantable device includes a first anchor configured to embed into a first valve leaflet and a second anchor configured to embed into a second valve leaflet.
8 . The heart valve repair system of claim 1 , wherein the locking nut is configured to be threaded into the locking aperture until the first suture line and the second suture line are sandwiched between the locking nut and an interior surface of the wedge.
9 . The heart valve repair system of claim 1 , wherein the locking nut is sized such that the locking nut and the base surface form a step.
10 . The heart valve repair system of claim 1 , wherein the locking nut is sized such that the locking nut is spaced apart from the at least two leaflets of the native heart valve.
11 . A valve repair system comprising: an implantable device comprising: first and second paddles that are movable between an open position and a closed position; first and second tissue-gripping elements associated with the first and second paddles, respectively, each of the first and second tissue-gripping elements being configured to attach to a respective leaflet of a native heart valve of a patient; a connector configured to be implanted in first and second leaflets of the native heart valve of the patient when the implantable device is gripped to the first and second leaflets and to allow for the implantable device to be removed when the connector is implanted in the first and second leaflets, the connector comprising: a first anchor configured to engage a first valve leaflet of the native heart valve of the patient; a second anchor configured to engage a second valve leaflet of the native heart valve of the patient; a first suture attached to the first anchor; a second suture attached to the second anchor; wherein the first suture and the second suture extend between the first anchor and the second anchor; a wedge having angled engagement surfaces that are configured to engage the first valve leaflet and the second valve leaflet between the first anchor and the second anchor and having a base surface with a locking aperture; a locking nut at least partially received in the locking aperture; wherein the first suture and the second suture are received by the angled engagement surfaces, exit the wedge through the base surface, and extend through an internal passage of the locking nut; and wherein the locking nut is configured to capture the first suture and the second suture between the locking nut and the wedge.
12 . The valve repair system of claim 11 , wherein the implantable device is configured both to allow the implantable device to remain attached to the native heart valve after the connector is attached to the native heart valve and to allow the implantable device to be removed from the native heart valve after the connector is attached to the native heart valve.
13 . The valve repair system of claim 11 , wherein each of the first and second paddles comprise an inner paddle portion and an outer paddle portion.
14 . The valve repair system of claim 11 , wherein the connector is configured to keep a gap in the native heart valve of the patient closed after the implantable device is removed.
15 . The valve repair system of claim 11 , wherein the first anchor comprises a pledget.
16 . The valve repair system of claim 11 , wherein the first anchor is configured to embed into the first valve leaflet and the second anchor is configured to embed into the second valve leaflet.
17 . The valve repair system of claim 11 , wherein the locking nut is configured to be threaded into the lacking aperture until the first suture line and the second suture line are sandwiched between the locking nut and an interior surface of the wedge.
18 . The valve repair system of claim 11 , wherein the locking nut is sized such that the locking nut and the base surface form a step.
19 . The valve repair system of claim 11 , wherein the locking nut is sized such that the locking nut is spaced apart from the at least two leaflets of the native heart valve.
20 . A heart valve repair system comprising: an implantable device configured to attach to at least two leaflets of a native heart valve of a patient and hold the at least two leaflets in a relatively fixed position; and a connector that is separate from the implantable device, the connector including first and second tissue anchors and being configured to be attached to the at least two leaflets of the native heart valve of the patient when the at least two leaflets are held by the implantable device in the relatively fixed position; wherein the connector includes a wedge and a lock; the connector having angled engagement surfaces that are configured to engage the at least two leaflets of the native valve and having a base surface; a first suture attached to the first anchor; a second suture attached to the second anchor; wherein the first suture and the second suture are received by the angled engagement surfaces, exit the wedge through the base surface and extend through an internal passage of the lock; and the implantable device being configured to be detached from the at least two leaflets and removed from the patient with the connector remaining attached to the at least two leaflets.

Description

RELATED APPLICATION This application is a continuation of PCT application no. PCT/US2020/027789, filed on Apr. 10, 2020, which claims priority to U.S. Provisional Application No. 62/836,839, filed on Apr. 22, 2019, entitled HEART VALVE REPAIR SYSTEM, the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND Field The present disclosure generally relates to the field of medical devices and procedures. Description of Related Art The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) of the human heart aid in the circulation blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, or disease. SUMMARY The disclosure describes, in one aspect, an implantable valve repair system for repairing a native valve of a patient. The implantable valve repair system for repairing a native valve of a patient includes an implantable prosthetic device and a connector. The implantable prosthetic device is configured to attach to two leaflets of the native valve of the patient. The connector is separate from the implantable prosthetic device and is also configured to attach to the two leaflets of the native valve of the patient. The implantable prosthetic device is configured both to allow the implantable prosthetic device to remain attached to the native valve after the connector is attached to the native valve and to allow the implantable prosthetic device to be removed from the native valve after the connector is attached to the native valve. In some implementations, the present disclosure relates to a heart valve repair system comprising an implantable prosthetic device configured to attach to at least two leaflets of a native heart valve of a patient and hold the at least two leaflets in a relatively fixed position, and a connector that is separate from the implantable prosthetic device, the connector including first and second tissue anchors and being configured to be attached to the at least two leaflets of the native valve of the patient when the at least two leaflets are held by the implantable prosthetic device in the relatively fixed position, the implantable prosthetic device being configured to be detached from the at least two leaflets and removed from the patient with the connector remaining attached to the at least two leaflets. The implantable prosthetic device may include a plurality of paddles that each comprise an inner paddle portion and an outer paddle portion. In some embodiments, the implantable prosthetic device includes a coaption element. For example, the paddles can be connected to a distal end of the coaption element. The prosthetic device and the connector can be configured to close a gap in the native valve of the patient when the valve repair system is attached to the native valve. The connector can be configured to keep the gap in the native valve of the patient closed after the prosthetic device is removed. The heart valve repair system can further comprise one or more additional connectors. The connector can comprise a first anchor configured to be positioned on a ventricular side of a first leaflet of the at least two leaflets, a second anchor configured to be positioned on a ventricular side of a second leaflet of the at least two leaflets, and a connecting portion including one or more suture lines coupled to the first and second anchors and configured to extend through the first leaflet and the second leaflet. In some embodiments, the connecting portion comprises a first suture line extending from the first anchor through the first leaflet, a second suture line extending from the second anchor through the second leaflet, and a suture-locking device engaging both the first suture line and the second suture line to hold the first leaflet and the second leaflet together. For example, the suture-locking device can include a wedge and a locking nut. In some embodiments, nut is configured to threadably engage the wedge to capture the first suture line and the second suture line within the wedge. The wedge can include a first engagement surface configured to engage a first leaflet of the at least two leaflets and a second engagement surface configured to engage a second leaflet of the at least two leaflets. In some embodiments, the connector comprises a shape-memory alloy. In some embodiments, the connector is one of a pledgeted suture or a staple. In some embodiments, the implantable prosthetic device includes a first anchor configured to embed into a first valve leaflet and a second anchor configured to embed into a second valve leaflet. In some implementations, the present disclosure relates to a valve repair system comprising an implantable prosthetic device comprising a first and second paddles that are movable between an open position and a closed position, and a first and second tissue-gripping elements as