# US 10,245,167 B2 · Delivery device and method of delivery

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- Number: US 10,245,167 B2
- Document ID: US10245167B2
- Status: Granted
- Kind: B2
- Application number: 15/227,757
- Filed: 2016-08-03
- Published: 2017-01-05
- Granted: 2019-04-02
- Earliest claimed: 2015-01-29
- Assignees: Intact Vascular, Inc.
- Applicants: Intact Vascular, Inc.
- Inventors: Michael Longo
- Web page: https://patentgrep.com/patent/US10245167B2

## CPC

- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/10: for applying or removing wound clamps {, e.g. containing only one clamp or staple (A61B17/076 takes precedence; containing multiple wound clamps A61B17/068)}; Wound clamp magazines
- A61F 2/844: folded prior to deployment
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61F 2002/826: {more than one stent being applied sequentially}
- A61F 2002/91566: {connected trough to trough}
- A61F 2002/91583: {by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band}
- A61F 2002/9511: {the retaining means being filaments or wires}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A delivery device can provide sequential delivery of a plurality of intraluminal devices or tacks held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold a tack in a compressed position and be positioned between annular pusher bands that may also be radiopaque markers. The annular pusher bands can be made of wire or sections of material to increase flexibility while remaining radiopacity. A post deployment dilation device can be included. The post deployment dilation device can be a plurality of expansion filaments, a bellows, or a balloon. A tack deployment method can include allowing a self-expanding tack to expand, aligning the post deployment dilation device under the tack, and causing the post deployment dilation device to expand radial to push outward on the tack.

## Claims

### Claim 1

A delivery device comprising:
an inner shaft;
a distal annular band and a proximal annular band fixed to the inner shaft;
a delivery platform between the distal annular band and the proximal annular band, wherein the delivery platform is configured to receive a self-expanding intraluminal device for deployment from the delivery device into a vessel;
an outer sheath slidable over the inner shaft and the delivery platform, the outer sheath having a pre-deployment position covering the delivery platform, and at least one delivery position uncovering the delivery platform and at least one of the distal annular band and the proximal annular band; and
a post deployment dilation device comprising:
a deployment platform fixed with respect to the inner shaft;
a balloon fixed with respect to a longitudinal axis of the deployment platform, the balloon having a pre-actuated position having a pre-deployment diameter and an actuated position having a deployment diameter larger than the pre-deployment diameter;
at least one inflation fluid lumen in fluid communication with the balloon and extending along at least a portion of the inner shaft;
a filament lumen; and
a helical coil extendable from the filament lumen to trap the balloon in the pre-deployment position and retractable from the filament lumen to allow the balloon to be inflated to the actuated position;
wherein the post deployment dilation device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device to improve at least one of expansion of the self-expanding intraluminal device and seating of the self-expanding intraluminal device in the vessel.

### Claim 2 (depends on 1)

The delivery device of claim 1, wherein the helical coil comprises an elongate filament having a helical distal portion including a rounded or blunted distal tip and a straight proximal portion, the proximal portion extending to a proximal end of the delivery device.

### Claim 3 (depends on 1)

The delivery device of claim 1, wherein the helical coil comprises a flexible material configured to retain shape after deformation.

### Claim 4

A delivery device comprising:
an inner shaft configured to receive a self-expanding intraluminal device for deployment from the delivery device into a vessel;
an outer sheath disposed about at least a portion of the inner shaft and movable with respect to the inner shaft, the outer sheath having a pre-deployment position in which the self-expanding intraluminal device is at least partially covered and at least one delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device; and
a post deployment dilation device comprising:
a balloon attached to the inner shaft of the delivery device, the balloon having a pre-actuated configuration having a pre-deployment diameter and an actuated configuration having a deployment diameter larger than the pre-deployment diameter; and
a helical coil configured to trap the balloon in the pre-deployment position;
at least one inflation fluid lumen in fluid communication with the balloon and extending along at least a portion of the inner shaft;
wherein the post deployment dilation device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device to improve at least one of expansion of the self-expanding intraluminal device and seating of the self-expanding intraluminal device in the vessel.

### Claim 5 (depends on 4)

The delivery device of claim 4, wherein the self-expanding intraluminal device has a deployed diameter range of greater than about 3 mm.

### Claim 6 (depends on 4)

The delivery device of claim 4, wherein the balloon has a working diameter range of no less than about 3 mm.

### Claim 7 (depends on 4)

The delivery device of claim 4, wherein at least a portion of the outer sheath extends over the balloon when the outer sheath is in the pre-deployment position.

### Claim 8 (depends on 4)

The delivery device of claim 4, wherein the outer sheath and the inner tube are movable with respect to each other.

### Claim 9 (depends on 4)

The delivery device of claim 4, wherein a cross-sectional shape of the inner shaft and a cross-sectional shape of the outer sheath are similar.

### Claim 10 (depends on 4)

The delivery device of claim 4, further comprising a delivery platform between a distal pusher and a proximal pusher, wherein the delivery platform is configured to receive the self-expanding intraluminal device for deployment from the delivery device into the vessel.

### Claim 11 (depends on 4)

The delivery device of claim 4, wherein the inner shaft is configured to receive a plurality of intraluminal devices for deployment from the delivery device into the vessel.

### Claim 12 (depends on 4)

The delivery device of claim 4, wherein the helical coil comprises an elongate filament having a helical distal portion including a rounded or blunted distal tip and a straight proximal portion, the proximal portion extending to a proximal end of the delivery device.

### Claim 13 (depends on 4)

The delivery device of claim 4, further comprising filament lumen and a guidewire lumen, wherein the helical coil is configured to have a helical coil shape out of the filament lumen.

### Claim 14

An intraluminal device deployment method comprising:
advancing a delivery device with a self-expanding intraluminal device in a compressed state to a target volume, wherein the delivery device comprises:
an inner shaft configured to receive the self-expanding intraluminal device for deployment from the delivery device into the target volume;
an outer sheath disposed about at least a portion of the inner shaft and movable with respect to at least a portion of the inner shaft and having at least one delivery position in which the self-expanding intraluminal device is uncovered to release the self-expanding intraluminal device from the delivery device; and
a post deployment dilation device comprising a balloon attached to the inner shaft of the delivery device and a helical coil, the balloon configured to be radially expanded upon activation of the post deployment dilation device and to generate an outward radial force on an inner surface of the self-expanding intraluminal device after release and expansion of the self-expanding intraluminal device;
retracting the outer sheath with respect to the inner shaft to release the self-expanding intraluminal device;
expanding the self-expanding intraluminal device, wherein the expanding comprises one of allowing the self-expanding intraluminal device to expand and actively expanding the self-expanding intraluminal device;
moving the delivery device to position at least a portion of the post deployment dilation device within the expanded self-expanding intraluminal device;
activating the post deployment dilation device to cause at least a portion of the post deployment dilation device to radially expand and to generate an outward radial force on an inner surface of the expanded self-expanding intraluminal device; and
trapping the balloon in the helical coil.

### Claim 15 (depends on 14)

The method of claim 14, further comprising deactivating the post deployment dilation device to cause at least a portion of the post deployment dilation device to radially contract.

### Claim 16 (depends on 14)

The method of claim 14, further comprising retracting the delivery device from within the expanded self-expanding intraluminal device.

### Claim 17 (depends on 14)

The method of claim 14, wherein the delivery device is configured to hold and deliver a plurality of self-expanding intraluminal devices.

### Claim 18 (depends on 17)

The method of claim 17 further comprising:
repeating the retracting, expanding, moving and activating steps for each self-expanding intraluminal device of the plurality of self-expanding intraluminal devices released in the target volume; and
removing the delivery device from within the target volume.

### Claim 19 (depends on 14)

The method of claim 14, wherein activating the post deployment dilation device comprises adding fluid to the balloon.

### Claim 20 (depends on 14)

The method of claim 14, further comprising advancing the outer sheath to cover at least a portion of the balloon of the post deployment dilation device prior to removal of the delivery device from within the target volume.

### Claim 21 (depends on 14)

The method of claim 14, wherein trapping the post deployment dilation device in the helical coil is after activating the post deployment dilation device.

### Claim 22 (depends on 14)

The method of claim 14, wherein trapping the post deployment dilation device in the helical coil comprises confining the balloon.

### Claim 23 (depends on 14)

The method of claim 14, wherein trapping the post deployment dilation device in the helical coil comprises extending the helical coil out of a filament lumen.

### Claim 24 (depends on 23)

The method of claim 23, further comprising retracting the helical coil into the filament lumen.

### Claim 25 (depends on 23)

The method of claim 23, wherein the helical coil is configured to have a helical coil shape out of the filament lumen.

### Claim 26 (depends on 14)

The method of claim 14, wherein the helical coil comprises an elongate filament having a helical distal portion including a rounded or blunted distal tip and a straight proximal portion.
