# US 11,896,486 B2 · Delivery system for transcatheter prosthetic heart valves

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- Number: US 11,896,486 B2
- Document ID: US11896486B2
- Status: Granted
- Kind: B2
- Application number: 16/490,640
- Filed: 2018-03-01
- Published: 2020-01-02
- Granted: 2024-02-13
- Earliest claimed: 2017-03-08
- Assignees: Epygon
- Applicants: Epygon
- Inventors: Enrico Pasquino; Marcio Scorsin; Andrea Marchisio; Lorenzo Valerio; Stefano Pasquino
- Web page: https://patentgrep.com/patent/US11896486B2

## CPC

- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2433: {using balloon catheter}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61B 2017/00243: {cardiac}
- A61F 2/9517: {handle assemblies therefor}
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2/9525: {using a funnel}
- A61F 2/962: having an outer sleeve
- A61F 2002/9505: {having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument}
- 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

Transcatheter delivery system for a self-expandable heart valve prosthesis (29) comprising a handle (17, 17′), a hollow shaft (6) a distal tip (1, 1″, 1′″) and an actuation mechanism for moving a valve prosthesis (29) towards said distal tip (1, 1″, 1′″) or said handle (17, 17′), said hollow shaft (6) being adapted to slidingly receive a compressed valve prosthesis (29); the system being characterized by the fact that it includes a valve prosthesis crimping tool that comprises a hollow conical element (21), a detachable transfer tube (24) and a pulling device (26); said conical element (21) being adapted to let a valve prosthesis (29) in an expanded state enter the conical element (21) through its basis and enter said transfer tube (24) in a compressed state, said valve prosthesis (29) being pulled by said pulling device (26) when crossing said conical element (21) and entering said transfer tube (24), said transferring tube (24) being adapted to be temporarily connected to said conical element (21).

## Claims

### Claim 1

A transcatheter delivery system comprising: a handle; a hollow shaft; a distal tip, a self-expandable heart valve prosthesis;
an actuation mechanism for moving the hollow shaft towards the distal tip or the handle, the hollow shaft configured to slidingly receive the self-expandable valve prosthesis in a compressed state; and
a valve prosthesis crimping tool including a hollow conical element; a detachable transfer tube; and a pulling device,
wherein the hollow conical element is configured to allow the self-expandable valve prosthesis to enter in an expanded state through a base of the hollow conical element, and enter the transfer tube in the compressed state, wherein the valve prosthesis comprises a valve prosthesis anchoring system and the hollow conical element comprising at least one longitudinal groove for accommodating the valve prosthesis anchoring system, wherein the at least one longitudinal groove has an open end at an extremity of the conical element, wherein the longitudinal groove starts at a terminal face of an open end of the hollow conical element, and
wherein the self-expandable valve prosthesis is configured to be pulled by the pulling device when crossing the hollow conical element and entering the detachable transfer tube, the detachable transfer tube configured to be temporarily connected to the hollow conical element.

### Claim 2 (depends on 1)

The delivery system according to claim 1, wherein the conical element has a non-circular cross section at a first extremity.

### Claim 3 (depends on 2)

The delivery system according to claim 2, wherein the conical element has a substantially circular cross section at a second extremity.

### Claim 4 (depends on 1)

The delivery system according to claim 1, wherein the pulling device is configured to capture a valve holder already fixed to the valve prosthesis.

### Claim 5 (depends on 1)

The delivery system according to claim 1, wherein the at least one longitudinal groove comprises a closed outer wall.

### Claim 6 (depends on 1)

The delivery device according to claim 1, wherein the number of grooves is selected from the group comprising: at least two longitudinal grooves, at least three longitudinal grooves, at least four longitudinal grooves.

### Claim 7 (depends on 1)

The delivery system according to claim 1, further comprising: a transfer tube secure cap configured to be temporarily connected to the detachable transfer tube.

### Claim 8 (depends on 1)

The delivery system according to claim 1, further comprising: a stopper that is configured to hold the self-expandable valve prosthesis within the hollow shaft.

### Claim 9 (depends on 1)

The delivery system according to claim 1, further comprising: a valve-cover that is located between the hollow shaft and the distal tip.

### Claim 10 (depends on 1)

The delivery system according to claim 1, wherein the actuation mechanism includes a mechanical or electric or hydraulic actuation device.

### Claim 11

A transcatheter delivery system for a self-expandable heart valve prosthesis comprising: a handle; a hollow shaft; a distal tip;
an actuation mechanism for moving the hollow shaft towards the distal tip or the handle, the hollow shaft configured to slidingly receive the self-expandable valve prosthesis in a compressed state; and
a valve prosthesis crimping tool including, a hollow conical element; a detachable transfer tube; and a pulling device,
wherein the hollow conical element is configured to allow the self-expandable valve prosthesis to enter in an expanded state through a base of the hollow conical element, and enter the transfer tube in the compressed state,
wherein the pulling device is configured to capture a valve holder already fixed to the valve prosthesis,
wherein the delivery system comprises a transfer tube secure cap configured to be temporarily connected to the hollow conical element at a proximal longitudinal side of the transfer tube on an opposing side with respect to an open end of the hollow conical element, and
wherein the self-expandable valve prosthesis is configured to be pulled by the pulling device when crossing the hollow conical element and entering the detachable transfer tube until reaching the transfer tube secure cap, the detachable transfer tube configured to be temporarily connected to the hollow conical element.

### Claim 12 (depends on 11)

The delivery system according to claim 11, wherein the pulling device is configured to capture the valve holder already fixed to the atrial side of the valve prosthesis.

### Claim 13 (depends on 11)

The delivery system according to claim 11, wherein the pulling device is configured to capture the valve holder, the valve holder already fixed to the valve prosthesis by means of yarn.

### Claim 14 (depends on 11)

The delivery system according to claim 11, wherein the pulling device is configured to capture the valve holder, the valve holder already fixed to the valve prosthesis by means of rigid elements.

### Claim 15 (depends on 11)

The delivery system according to claim 11, wherein the conical element has a non-circular cross-section at a first extremity and a substantially circular cross-section at a second extremity.

### Claim 16 (depends on 11)

The delivery system according to claim 11, wherein the conical element has at least one longitudinal groove for accommodating an anchoring system of a valve prosthesis, further wherein the at least one longitudinal groove has a closed outer wall.

### Claim 17 (depends on 11)

The delivery system according to claim 11, further comprising: a valve-cover that is located between the hollow shaft and the distal tip.

### Claim 18 (depends on 11)

The delivery system according to claim 11, further comprising: a stopper that is configured to hold the self-expandable valve prosthesis within the hollow shaft.

### Claim 19 (depends on 11)

The delivery system according to claim 11, wherein the actuation mechanism includes a mechanical or electric or hydraulic actuation device.
