# US 10,478,295 B2 · Actively controllable stent, stent graft, heart valve and method of controlling same

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- Number: US 10,478,295 B2
- Document ID: US10478295B2
- Status: Granted
- Kind: B2
- Application number: 15/918,987
- Filed: 2018-03-12
- Published: 2018-07-19
- Granted: 2019-11-19
- Earliest claimed: 2011-10-21
- Assignees: Edwards Lifesciences CardiAQ LLC
- Applicants: Edwards Lifesciences CardiAQ LLC
- Inventors: Richard George Cartledge; Kevin W. Smith; Thomas O. Bales, Jr.; Max Pierre Mendez; Korey Kline; Matthew A. Palmer; Michael Walter Kirk; Carlos Rivera; Derek Dee Deville
- Web page: https://patentgrep.com/patent/US10478295B2

## CPC

- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F 2/07: Stent-grafts
- A61F 2/9517: {handle assemblies therefor}
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2002/061: {provided with means for allowing access to secondary lumens}
- A61F 2002/075: {the stent being loosely attached to the graft material, e.g. by stitching}
- A61F 2002/077: {having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve}
- A61F 2002/8483: {Barbs}
- A61F 2002/8486: {provided on at least one of the ends}
- A61F 2002/9505: {having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument}
- A61F 2002/9534: {for repositioning of stents}
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/0033: made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2220/0091: connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
- A61F 2230/0054: V-shaped
- A61F 2250/0006: for adjusting angular orientation
- A61F 2250/0007: for adjusting length
- A61F 2250/001: for adjusting a diameter
- A61F 2250/006: modular
- 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)

## Abstract

A delivery apparatus can include a handle portion and at least one rotatable drive shaft. The handle portion can have an actuation mechanism with a motor. The rotatable drive shaft can have a proximal end portion and a distal end portion. The proximal end portion of the rotatable drive shaft can be coupled to the motor, and the distal end portion of the rotatable drive shaft can be configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism can be configured to control and monitor expansion of the prosthetic heart valve and to control and monitor torque of the motor.

## Claims

### Claim 1

A delivery apparatus, comprising:
a handle portion having an actuation mechanism and a user interface, wherein the actuation mechanism includes a motor, and wherein the user interface includes a display and a plurality of input elements; and
at least one rotatable drive shaft having a proximal end portion and a distal end portion, wherein the proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve,
wherein the actuation mechanism is configured to expand and contract of the prosthetic heart valve via the drive shaft,
wherein the display of the user interface is configured to display data about the prosthetic heart valve, and
wherein the input elements of the user interface are configured to actuate the actuation mechanism.

### Claim 2 (depends on 1)

The delivery apparatus of claim 1, wherein the input elements include a first input element configured to actuate the actuation mechanism such that the prosthetic heart valve expands from a fully contracted diameter to a pre-defined diameter and stops expanding at the pre-defined diameter.

### Claim 3 (depends on 2)

The delivery apparatus of claim 2, wherein the pre-defined diameter of the prosthetic heart valve is less than a fully expanded diameter of the prosthetic heart valve.

### Claim 4 (depends on 2)

The delivery apparatus of claim 2, wherein the input elements include a second input element configured to actuate the actuation mechanism such that the prosthetic heart valve expands incrementally from the pre-defined diameter to the fully expanded diameter.

### Claim 5 (depends on 4)

The delivery apparatus of claim 4, wherein the actuation mechanism is configured to expand the prosthetic heart valve in 1 mm increments upon actuation of the second input element.

### Claim 6 (depends on 1)

The delivery apparatus of claim 1, wherein the input elements include first and second input elements, wherein the first input element is configured to actuate the actuation mechanism such that the prosthetic heart valve expands, and wherein the second input element is configured to actuate the actuation mechanism such that the prosthetic heart valve contracts.

### Claim 7 (depends on 6)

The delivery apparatus of claim 6, wherein the actuation mechanism is configured such that actuating the first input element results in the prosthetic heart valve expanding in 1 mm increments, and wherein the actuation mechanism is configured such that actuating the second input element results in the prosthetic heart valve contracting in 1 mm increments.

### Claim 8 (depends on 1)

The delivery apparatus of claim 1, wherein the input elements include buttons, switches, levers, or toggles.

### Claim 9 (depends on 1)

The delivery apparatus of claim 1, wherein the data includes a diameter of the prosthetic heart valve.

### Claim 10 (depends on 1)

The delivery apparatus of claim 1, wherein the data includes a radial force imparted to native heart valve tissue by the prosthetic heart valve.

### Claim 11 (depends on 1)

The delivery apparatus of claim 1, wherein the actuation mechanism further comprises a torque limiting member configured to limit an electrical current of the motor.

### Claim 12 (depends on 1)

The delivery apparatus of claim 1, wherein the actuation mechanism further comprises a clutch mechanism configured to limit the torque transmitted to the drive shaft from the motor.

### Claim 13 (depends on 1)

The delivery apparatus of claim 1, wherein the actuation mechanism further comprises a gear assembly coupled to the motor and the drive shaft and configured to transfer rotational movement of the motor to the drive shaft.

### Claim 14 (depends on 1)

The delivery apparatus of claim 1, wherein the handle portion includes software configured for controlling and monitoring expansion of the prosthetic heart valve by limiting current to the motor.

### Claim 15

A delivery apparatus, comprising:
a handle portion having an actuation mechanism and a display, wherein the actuation mechanism includes a motor and one or more actuators; and
at least one rotatable drive shaft having a proximal end portion and a distal end portion, wherein the proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve,
wherein the actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve, and
wherein the display is configured to display one or more parameters of the prosthetic heart valve.

### Claim 16

A delivery apparatus, comprising:
a handle portion having an actuation mechanism, wherein the actuation mechanism includes a motor,
a control system connected to the handle and having a display and a plurality of controls; and
at least one rotatable drive shaft having a proximal end portion and a distal end portion, wherein the proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve,
wherein the actuation mechanism is configured to expand and contract the prosthetic heart valve by the drive shaft,
wherein the display of the control system is configured to display data about the prosthetic heart valve, and
wherein the controls of the control system are configured to actuate the actuation mechanism.

### Claim 17 (depends on 16)

The delivery apparatus of claim 16, wherein the control system is integrally formed with the handle portion.

### Claim 18 (depends on 16)

The delivery apparatus of claim 16, wherein the control system is connected to the handle portion with a cord.

### Claim 19 (depends on 16)

The delivery apparatus of claim 16, wherein the control system is wirelessly connected to the handle portion.

### Claim 20 (depends on 16)

The delivery apparatus of claim 16, wherein the controls of the control system include a first control configured for actuating coarse expansion of the prosthetic heart valve, and a second control configured for actuating fine expansion of the prosthetic heart valve.

### Claim 21 (depends on 20)

The delivery apparatus of claim 20, wherein the coarse expansion is expansion of the prosthetic heart valve that is less than or equal to 1 mm, and wherein the fine expansion is expansion of the prosthetic heart valve that is greater than 1 mm.
