# US 11,896,483 B2 · Transcatheter valve lead and valve element

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- Number: US 11,896,483 B2
- Document ID: US11896483B2
- Status: Granted
- Kind: B2
- Application number: 17/181,703
- Filed: 2021-02-22
- Published: 2021-08-26
- Granted: 2024-02-13
- Earliest claimed: 2020-02-20
- Applicants: Maurice Enriquez-Sarano
- Inventors: Maurice Enriquez-Sarano
- Web page: https://patentgrep.com/patent/US11896483B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2454: {Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61B 2017/00243: {cardiac}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/0649: {Coils or spirals}
- A61F 2220/00: Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0083: using hook and loop-type fasteners
- A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
- A61F 2230/0017: Angular shapes
- A61F 2230/0067: conical
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A cardiac valve delivery system includes a lead configured to be inserted through a venous system to a heart, the lead having a distal end with a myocardial attachment apparatus, and a transcatheter prosthesis element configured to be delivered along the lead. The transcatheter prosthesis is configured with an anchoring element located on the outside rim of the prosthesis, configured to fix the transcatheter prosthesis in place along the lead. The prosthesis is also movable along the lead and steerable towards the appropriate angulation with the lead.

## Claims

### Claim 1

A transcatheter delivery system, comprising:
a supporting and guiding lead configured to be inserted through a venous system leading to a heart and attached to the heart, with the supporting and guiding lead having a distal end;
a myocardial attachment system at the distal end of the supporting and guiding lead, the myocardial attachment system configured to be introduced intravenously with the supporting and guiding lead up to a right ventricle of the heart and implanted from a right side of the heart into a ventricular septum using an anchor; and
a transcatheter prosthesis element configured to be delivered crimped using guidance along the supporting and guiding lead, the transcatheter prosthesis element having a guiding system positioned on the outer rim of the transcatheter prosthesis element, the guiding system configured to allow steering of the prosthesis;
wherein the myocardial attachment system comprises a screw deployable at an angle of substantially 90 degrees from a longitudinal axis of the distal end;
wherein the myocardial attachment system further comprises a mesh deliverable from a distal end thereto, the mesh configured to anchor through heart tissue or by pressure on heart tissue;
wherein the transcatheter prosthesis comprises a prosthesis mesh crimpable to contain a crimped valve element deliverable along the supporting and guiding lead by the guiding system placed on the outer rim of the prosthesis;
wherein the prosthesis mesh is conical in shape when uncrimped, with a first opening at a ventricular opening, and a second opening, larger than the first opening, deployed to be intra-atrial at anchoring.

### Claim 2 (depends on 1)

The transcatheter delivery system of claim 1, wherein transcatheter prosthesis positioning is secured by an anchoring element configured to fix the transcatheter prosthesis in place along the supporting and guiding lead.

### Claim 3 (depends on 1)

The transcatheter delivery system of claim 1, wherein the myocardial attachment system further comprises at least one of hooks, rods, scallops, and struts deployable on a left side of the ventricular septum.

### Claim 4 (depends on 1)

The transcatheter delivery system of claim 1, wherein the supporting and guiding lead comprises a widened width along a part of its body to allow improved anchoring of the prosthesis to the supporting and guiding lead.

### Claim 5 (depends on 1)

The transcatheter delivery system of claim 1, wherein the anchoring element further comprises:
a central immobile element attached to the prosthesis mesh; and
a secondary element which is mobile and steerable with respect to the central immobile element.

### Claim 6

A transcatheter delivery system, comprising:
a supporting and guiding lead configured to be inserted through a venous system leading to a heart and attached to the heart, with the supporting and guiding lead having a distal end;
a myocardial attachment system at the distal end of the supporting and guiding lead, the myocardial attachment system configured to be introduced intravenously with the supporting and guiding lead up to a right ventricle of the heart and implanted from a right side of the heart into a ventricular septum using an anchor; and
a transcatheter prosthesis element configured to be delivered crimped using guidance along the supporting and guiding lead, the transcatheter prosthesis element having a guiding system positioned on the outer rim of the transcatheter prosthesis element, the guiding system configured to allow steering of the prosthesis;
wherein the transcatheter prosthesis comprises a prosthesis mesh crimpable to contain a crimped valve element deliverable along the supporting and guiding lead by the guiding system placed on the outer rim of the prosthesis; and
wherein the guiding system of the prosthesis comprises:
a central immobile element attached to the prosthesis mesh; and
a pair of articulated semi-cylindrical wings movably coupled to the central immobile element, the pair of wings movable between a delivery position in which the wings do not engage the supporting and guiding lead, and an anchoring position in which the wings are closed in embrace over the supporting and guiding lead to anchor the transcatheter prosthesis to the supporting and guiding lead.

### Claim 7 (depends on 6)

The transcatheter delivery system of claim 6, wherein the supporting and guiding lead is positionable perpendicular to the myocardial attachment system.

### Claim 8 (depends on 6)

The transcatheter delivery system of claim 6, wherein the myocardial attachment system comprises a screw deployable at an angle of substantially 90 degrees from a longitudinal axis of the distal end.

### Claim 9 (depends on 8)

The transcatheter delivery system of claim 8, wherein the myocardial attachment system further comprises a mesh deliverable from a distal end thereto, the mesh configured to anchor through heart tissue or by pressure on heart tissue.

### Claim 10 (depends on 9)

The transcatheter delivery system of claim 9, wherein the transcatheter prosthesis is configured to allow existing valvular tissue in the heart to rest on top of an external side of the prosthesis mesh.

### Claim 11

A transcatheter delivery system, comprising:
a supporting and guiding lead configured to be inserted through a venous system leading to a heart and attached to the heart, with the supporting and guiding lead having a distal end;
a myocardial attachment system at the distal end of the supporting and guiding lead, the myocardial attachment system configured to be introduced intravenously with the supporting and guiding lead up to a right ventricle of the heart and implanted from a right side of the heart into a ventricular septum using an anchor; and
a transcatheter prosthesis element configured to be delivered crimped using guidance along the supporting and guiding lead, the transcatheter prosthesis element having a guiding system positioned on the outer rim of the transcatheter prosthesis element, the guiding system configured to allow steering of the transcatheter prosthesis element with respect to the lead;
wherein the myocardial attachment system comprises a screw deployable at an angle of substantially 90 degrees from a longitudinal axis of the distal end;
wherein the myocardial attachment system further comprises a mesh deliverable from a distal end thereto, the mesh configured to anchor through heart tissue or by pressure on heart tissue;
wherein the transcatheter prosthesis comprises a prosthesis mesh crimpable to contain a crimped valve element deliverable along the supporting and guiding lead by the guiding system placed on the outer rim of the prosthesis; and
wherein the guiding system comprises:
a central immobile element attached to the prosthesis mesh; and
a ring attached to the prosthesis mesh and around the supporting and guiding lead.

### Claim 12 (depends on 11)

The transcatheter delivery system of claim 11, wherein the myocardial attachment system includes a secondary attachment point on an adjoining myocardium of the ventricular septum.

### Claim 13 (depends on 11)

The transcatheter delivery system of claim 11, wherein the myocardial attachment system includes a secondary attachment point on the left ventricle.

### Claim 14 (depends on 11)

The transcatheter delivery system of claim 11, wherein the myocardial attachment system comprises at least one of hooks, rods or struts placed in the septal myocardium and/or adjoining left ventricular myocardium.

### Claim 15

A transcatheter prosthesis, comprising:
a prosthesis mesh crimpable to contain a crimped valve element deliverable along a supporting and guiding lead; and
an anchoring element configured to fix the transcatheter prosthesis in place on the supporting and guiding lead and to allow steering of the prosthesis, the anchoring element including a rotating anchor system configured to allow steering of the valve element with respect to the lead;
wherein the transcatheter prosthesis is configurable to be delivered intravenously to a heart along the supporting and guiding lead by the anchoring element;
wherein the anchoring element further comprises:
a central immobile element attached to the prosthesis mesh;
a secondary element which is mobile and steerable; and
a pair of articulated semi-cylindrical wings movably coupled to the central immobile element, the pair of wings movable between a delivery position in which the wings do not engage the supporting and guiding lead, and an anchoring position in which the wings are closed in embrace over the supporting and guiding lead to anchor the transcatheter prosthesis to the supporting and guiding lead.

### Claim 16 (depends on 15)

The transcatheter prosthesis of claim 15, wherein anchoring element allows direction of the prosthesis towards a myocardial wall allowing improvement of a flow direction.
