# US 10,478,324 B2 · Handle for medical device deployment

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- Number: US 10,478,324 B2
- Document ID: US10478324B2
- Status: Granted
- Kind: B2
- Application number: 14/822,870
- Filed: 2015-08-10
- Published: 2016-02-18
- Granted: 2019-11-19
- Earliest claimed: 2014-08-12
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Justin W. Sokel; Adam T. Storey; Jared L. Van Cleave
- Web page: https://patentgrep.com/patent/US10478324B2

## CPC

- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F 2/9517: {handle assemblies therefor}
- A61F 2002/9665: {with additional retaining means}
- 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 system for endoluminal delivery of an expandable device comprising a catheter having a proximal end and an opposite distal end configured to support an expandable device, a primary sheath having a delivery position in which the primary sheath constrains the expandable device toward a collapsed configuration suitable for endoluminal delivery, and a handle having an actuator for axially displacing the primary sheath from the delivery position, wherein the handle includes a knob for operating one or more functions of the handle which is initially hidden to prevent use by a user and then revealed as a result of displacement of the primary sheath from delivery position so as to allow subsequent actuation of the knob by the user.

## Claims

### Claim 1

A delivery system for endoluminal delivery of an expandable device, said delivery system comprising
a catheter having a proximal end and an opposite distal end, the distal end configured to support the expandable device;
a primary sheath having a delivery position in which the primary sheath constrains the expandable device toward a collapsed configuration suitable for endoluminal delivery;
a handle having a first actuator that is rotatable and non-translatable wherein rotation of the first actuator causes axial displacement of the primary sheath along the catheter from the delivery position, the handle having a second actuator for operating one or more functions of the handle, wherein the second actuator is initially hidden to prevent use by a user and then revealed as a result of the axial displacement of the primary sheath along the catheter from the delivery position so as to allow subsequent actuation of the second actuator by the user.

### Claim 2 (depends on 1)

The delivery system as set forth in claim 1 including a secondary sheath having a delivery position in which the secondary sheath limits expansion of the expandable device to an intermediate configuration larger than a constrained configuration and smaller than a fully deployed configuration.

### Claim 3 (depends on 2)

The delivery system as set forth in claim 2, wherein the one or more functions of the handle includes deployment of the secondary sheath to allow deployment of the expandable device from the intermediate configuration.

### Claim 4 (depends on 3)

The delivery system as set forth in claim 3, wherein an arm is coupled to the secondary sheath, wherein removal of the second actuator from the handle causes removal of the secondary sheath and, in turn, deployment of the expandable device toward the fully deployed configuration.

### Claim 5 (depends on 1)

The delivery system as set forth in claim 1, wherein the axial displacement of the primary sheath is axial displacement of the entire primary sheath.

### Claim 6 (depends on 1)

The delivery system as set forth in claim 1, wherein the second actuator includes a longitudinally extending arm for engaging the primary sheath, whereby the second actuator is displaced from an initially hidden position and revealed in response to the axial displacement of the primary sheath from the delivery position.

### Claim 7 (depends on 6)

The delivery system as set forth in claim 6 including a follower fixedly secured to the primary sheath for movement therewith.

### Claim 8 (depends on 7)

The delivery system as set forth in claim 7 including a receiver slidably coupled to the handle, and having a first end for engaging the follower as the primary sheath moves from the delivery position and an opposite second end for engaging an end of the arm.

### Claim 9 (depends on 8)

The delivery system as set forth in claim 8 wherein the receiver includes a pair of legs extending outwardly from the second end which are spaced apart to define a tapered recess that receives the end of the arm therein.

### Claim 10 (depends on 8)

The delivery system as set forth in claim 8, wherein the follower and the receiver are spaced apart when the primary sheath is in the delivery position, so that the second actuator is revealed after an initial delay following at least a partial deployment of the expandable device.

### Claim 11 (depends on 7)

The delivery system as set forth in claim 7, wherein the primary sheath is displaceable by actuation of a positioner mechanism, the positioner mechanism having a tubular wall having a longitudinal axis and an inner surface defining a lumen extending along the longitudinal axis, the lumen capable of receiving the primary sheath and the follower therethrough.

### Claim 12 (depends on 11)

The delivery system as set forth in claim 11, wherein the inner surface includes a helically extending slot for engaging the follower, wherein rotation of the tubular wall about the longitudinal axis causes axial displacement of the primary sheath and follower along the lumen.

### Claim 13 (depends on 1)

The delivery system as set forth in claim 1, wherein the second actuator includes a longitudinally extending arm for engaging the primary sheath, whereby the second actuator is displaced from an initially hidden position and revealed in response to the axial movement of the primary sheath from the delivery position.

### Claim 14 (depends on 13)

The delivery system as set forth in claim 13, wherein the primary sheath is displaceable by actuation of a positioner mechanism, the positioner mechanism having a tubular wall having a longitudinal axis and an inner surface defining a lumen extending along the longitudinal axis, the lumen capable of receiving the primary sheath and a follower therethrough.

### Claim 15 (depends on 14)

The delivery system as set forth in claim 14, wherein the inner surface of the positioner mechanism includes a helically extending slot for engaging the follower, wherein rotation of the tubular wall about the longitudinal axis causes axial displacement of the primary sheath and the follower along the lumen.

### Claim 16 (depends on 1)

The delivery system of claim 1, wherein the second actuator is a knob.

### Claim 17

A delivery system for endoluminal delivery of an expandable device, the delivery system comprising
a catheter having a proximal end and an opposite distal end, the distal end configured to support the expandable device;
a primary sheath having a delivery position in which the primary sheath constrains the expandable device toward a collapsed configuration suitable for endoluminal delivery; and
a handle having a first actuator that is rotatable and non-translatable wherein rotation of the first actuator causes axial displacement of the primary sheath from the delivery position, the handle having a second actuator for operating one or more functions of the handle, wherein the second actuator is initially hidden to prevent use by a user and then revealed as a result of the axial displacement of the primary sheath so as to allow subsequent actuation of the second actuator by the user,
wherein the second actuator is revealed after an initial delay following displacement of the primary sheath from the delivery position.

### Claim 18 (depends on 17)

The delivery system of claim 17, wherein the second actuator is a knob.

### Claim 19 (depends on 17)

The delivery system of claim 17, wherein the axial displacement of the primary sheath is axial displacement of the entire primary sheath.

### Claim 20

A delivery system for endoluminal delivery of an expandable device, said delivery system comprising
a catheter having a proximal end and an opposite distal end, the distal end configured to support the expandable device;
a follower fixedly secured to a primary sheath for movement therewith;
the primary sheath having a delivery position in which the primary sheath constrains the expandable device toward a collapsed configuration suitable for endoluminal delivery, wherein the primary sheath is displaceable by actuation of a positioner mechanism, the positioner mechanism having a tubular wall having a longitudinal axis and an inner surface defining a lumen extending along the longitudinal axis and including a helically extending slot for engaging the follower, the lumen capable of receiving the primary sheath and the follower therethrough such that a rotation of the tubular wall about the longitudinal axis causes axial displacement of the primary sheath and follower along the lumen; and
a handle having a first actuator for axially displacing the primary sheath from the delivery position, the handle having a second actuator for operating one or more functions of the handle, the second actuator including a longitudinally extending arm for engaging the primary sheath, wherein the second actuator is displaced from initially hidden to prevent use by a user and then revealed as a result of axial displacement of the primary sheath from the delivery position so as to allow subsequent actuation of the second actuator by the user.
