# US 10,945,869 B2 · Low profile stent delivery system and method

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- Number: US 10,945,869 B2
- Document ID: US10945869B2
- Status: Granted
- Kind: B2
- Application number: 15/911,596
- Filed: 2018-03-05
- Published: 2018-09-13
- Granted: 2021-03-16
- Earliest claimed: 2017-03-09
- Assignees: Cook Medical Technologies LLC
- Applicants: Cook Medical Technologies LLC
- Inventors: Ruth Osbrink; Ralf Spindler
- Web page: https://patentgrep.com/patent/US10945869B2

## CPC

- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2/962: having an outer sleeve
- A61F 2002/9583: {Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve}
- 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 low profiled stent delivery system includes a balloon catheter with a balloon mounted at a first location, and a balloon expandable stent crimped about the balloon catheter at a second location. The stent expands from a crimped state to a less than fully expanded state responsive to movement of an auxiliary expander from a first configuration to a second configuration. An inner diameter of the stent in the less than fully expanded state is greater than an outer diameter of the balloon in a deflated state. After repositioning the balloon within the less than fully expanded state, the balloon is inflated to fully expand the stent.

## Claims

### Claim 1

A low profile stent delivery system comprising:
a balloon catheter that includes a catheter and a balloon mounted about the catheter at a first location along a length of the catheter;
a balloon expandable stent crimped about the catheter at a second location that is separated from the first location in a first arrangement;
an auxiliary expander that is movable with respect to the stent between a first configuration and a second configuration;
wherein the stent expands from a crimped state to a less than fully expanded state responsive to movement of the auxiliary expander from the first configuration to the second configuration;
wherein an inner diameter of the stent in the less than fully expanded state is greater than an outer diameter of the balloon in a deflated state; and
wherein the stent expands from the less than fully expanded state to a fully expanded state responsive to inflation of the balloon from the deflated state to an inflated state in a second arrangement;
wherein the outer diameter of the balloon in the inflated state is greater than a diameter of the auxiliary expander in the second configuration;
a sheath that is seven French or less; and
wherein the balloon catheter and the auxiliary expander are sized to be slidably received through the sheath.

### Claim 2 (depends on 1)

The low profile stent delivery system of claim 1 wherein the second location is distal to the first location; and
a stent securement mechanism mounted to the catheter and being movable from an inactive configuration at which the stent securement mechanism is within an outer diameter that is less than an outer diameter of the stent in the crimped state, to an active configuration at which the stent securement mechanism is positioned to contact a distal end of the stent when the stent is in the less than fully expanded state.

### Claim 3 (depends on 2)

The low profile stent delivery system of claim 2 including a deployment actuator in contact with the stent securement mechanism, and being movable from a first position to a second position; and
the stent securement mechanism moving from the inactive configuration to the active configuration responsive to movement of the deployment actuator from the first position to the second position.

### Claim 4 (depends on 3)

The low profile stent delivery system of claim 3 wherein the stent securement mechanism includes a plurality of stent securement arms that are parallel to a longitudinal axis of the catheter in the inactive configuration.

### Claim 5 (depends on 1)

The low profile stent delivery system of claim 1 wherein the auxiliary expander includes a wedge positioned inside the catheter and being movable from a first position that is one of proximal and distal to the second location, to a second position that is the other one of proximal and distal to the second location.

### Claim 6 (depends on 5)

The low profile stent delivery system of claim 5 wherein the wedge is positioned in an inflation lumen fluidly connected to the balloon.

### Claim 7

A low profile stent delivery system comprising:
a balloon catheter that includes a catheter and a balloon mounted about the catheter at a first location along a length of the catheter;
a balloon expandable stent crimped about the catheter at a second location that is separated from the first location;
an auxiliary expander that is movable with respect to the stent between a first configuration and a second configuration;
wherein the stent expands from a crimped state to a less than fully expanded state responsive to movement of the auxiliary expander from the first configuration to the second configuration;
wherein an inner diameter of the stent in the less than fully expanded state is greater than an outer diameter of the balloon in a deflated state;
wherein the balloon is a main balloon;
the auxiliary expander includes an auxiliary balloon mounted about the catheter at the second location, and being deflated in the first configuration and inflated in the second configuration;
wherein the auxiliary balloon and the main balloon share a common inflation lumen that is defined by the catheter;
an outer diameter of the main balloon in an inflated state is greater than an outer diameter of the auxiliary balloon in an inflated state;
a rupture disk blocking the inflation lumen between the first location and the second location;
the auxiliary balloon moves from the first configuration to the second configuration responsive to a first inflation pressure in the inflation lumen;
the rupture disk ruptures at a rupture pressure that is greater than the first inflation pressure; and
the main balloon is moved to the inflated state responsive to a second inflation pressure that is equal to or greater than the rupture pressure.

### Claim 8 (depends on 7)

The low profile stent delivery system of claim 7 including a sheath that is seven French or less; and
wherein the balloon catheter and the auxiliary expander are sized to be slidably received through the sheath.

### Claim 9 (depends on 7)

The low profile stent delivery system of claim 7 wherein the catheter defines a wire guide lumen that opens through a distal end of the catheter.

### Claim 10 (depends on 7)

The low profile stent delivery system of claim 7 wherein the main balloon is positioned distally from the auxiliary balloon.

### Claim 11

A low profile stent delivery system comprising:
a sheath that is seven French or less;
a balloon catheter that is slidably received in the sheath, and includes a catheter and a balloon mounted about the catheter at a first location along a length of the catheter;
a balloon expandable stent;
the low profile stent delivery system has a first configuration characterized by the balloon expandable stent being crimped about the catheter at a second location that is proximal to, and separated from, the first location;
the low profile stent delivery system has a second configuration characterized by the balloon expandable stent being in a less than fully expanded state at the second location, and wherein an inner diameter of the stent in the less than fully expanded state is greater than an outer diameter of the balloon in a deflated state;
the low profile stent delivery system has a third configuration characterized by the balloon expandable stent being in the less than fully expanded state at the first location;
the low profile stent delivery system has a fourth configuration characterized by the balloon expandable stent being in a fully expanded state at the first location in contact with the balloon; and
wherein a change from the first configuration to the second configuration is responsive to movement of an auxiliary expander within and with respect to the stent.

### Claim 12 (depends on 11)

The low profile stent delivery system of claim 11 including the auxiliary expander coupled to the catheter;
is responsive to movement of the auxiliary expander within and with respect to
wherein a change from the second configuration to the third configuration is responsive to movement of the balloon with respect to the stent along an axis of the catheter; and
wherein a change from the third configuration to the fourth configuration is responsive to inflation of the balloon.

### Claim 13 (depends on 12)

The low profile stent delivery system of claim 12 wherein the balloon is a main balloon; and
the auxiliary expander includes an auxiliary balloon mounted about the catheter at the second location.

### Claim 14 (depends on 12)

The low profile stent delivery system of claim 12 wherein the auxiliary expander includes a wedge positioned inside the catheter and being movable from a first position that is one of proximal and distal to the second location, to a second position that is the other one of proximal and distal to the second location.

### Claim 15

A low profile stent delivery system comprising:
a balloon catheter that includes a catheter and a balloon mounted about the catheter at a first location along a length of the catheter;
a balloon expandable stent crimped about the catheter at a second location that is separated from the first location in a first arrangement;
an auxiliary expander that is movable with respect to the stent between a first configuration and a second configuration;
wherein the stent expands from a crimped state to a less than fully expanded state responsive to movement of the auxiliary expander from the first configuration to the second configuration;
wherein an inner diameter of the stent in the less than fully expanded state is greater than an outer diameter of the balloon in a deflated state; and
wherein the stent expands from the less than fully expanded state to a fully expanded state responsive to inflation of the balloon from the deflated state to an inflated state in a second arrangement;
wherein the balloon is a main balloon;
the auxiliary expander includes an auxiliary balloon mounted about the catheter at the second location, and being deflated in the first configuration and inflated in the second configuration;
an outer diameter of the main balloon in the inflated state is greater than an outer diameter of the auxiliary balloon in an inflated state;
the catheter defines a wire guide lumen that opens through a distal end of the catheter;
wherein the auxiliary balloon and the main balloon share a common inflation lumen that is defined by the catheter;
a rupture disk blocking the inflation lumen between the first location and the second location;
the auxiliary balloon moves from the first configuration to the second configuration responsive to a first inflation pressure in the inflation lumen;
the rupture disk ruptures at a rupture pressure that is greater than the first inflation pressure; and
the main balloon is moved to the inflated state responsive to a second inflation pressure that is equal to or greater than the rupture pressure.