# US 10,369,033 B2 · Delivery system and method of use for deployment of self-expandable vascular device

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,369,033 B2
- Document ID: US10369033B2
- Status: Granted
- Kind: B2
- Application number: 14/971,630
- Filed: 2015-12-16
- Published: 2016-06-16
- Granted: 2019-08-06
- Earliest claimed: 2005-07-14
- Assignees: Merit Medical Ireland Limited
- Applicants: Merit Medical Ireland Limited
- Inventors: Menashe Yacoby; Ascher Shmulewitz; Raz Bar-On; Gil Naor; Damian Kelly; Michael Gilmore; Mark Steckel
- Web page: https://patentgrep.com/patent/US10369033B2

## CPC

- A61F 2/97: the outer sleeve being splittable
- A61F 2/844: folded prior to deployment
- A61F 2/88: the wire-like elements formed as helical or spiral coils
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/1034: {Joining of shaft and balloon}
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2002/821: {Ostial stents}
- A61F 2002/91525: {within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude}
- A61F 2002/91533: {characterised by the phase between adjacent bands}
- A61F 2002/91558: {connected peak to peak}
- A61F 2002/9583: {Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve}
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2250/0039: differing in diameter
- A61M 2025/1081: {having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths}
- Y10T 29/4987: Elastic joining of parts
- 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)
- 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)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A delivery system that includes a catheter, a balloon, a self-expanding prosthesis, and a sheath. The sheath including an opening in a wall of the sheath that initiates rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state. Additionally, a distal end portion of the balloon that is distal to a distal end of the sheath includes an enlarged diameter portion, the enlarged diameter portion having approximately the same outer diameter as an outer diameter of the sheath when the self-expanding prosthesis is in its compressed state, and the enlarged diameter portion being the maximum outer diameter of the balloon when the self-expanding prosthesis is in its compressed state.

## Claims

### Claim 1

A delivery system comprising:
a catheter having a distal portion and a proximal portion;
a balloon disposed on the distal portion of the catheter;
a self-expanding prosthesis disposed on at least a portion of the balloon, the self-expanding prosthesis having a compressed state and an expanded state; and
a sheath coupling the self-expanding prosthesis to the balloon when the self-expanding prosthesis is in its compressed state, wherein:
the sheath includes an opening in a wall of the sheath that initiates rupturing of the sheath so that the self-expanding prosthesis may move from its compressed state to its expanded state,
a distal end portion of the balloon that is distal to a distal end of the sheath includes an enlarged diameter portion, the enlarged diameter portion having approximately a same outer diameter as an outer diameter of the sheath when the self-expanding prosthesis is in its compressed state, and the enlarged diameter portion being the maximum outer diameter of the balloon when the self-expanding prosthesis is in its compressed state,
the opening is at the distal end of the sheath, and
the enlarged diameter portion having approximately the same outer diameter as the outer diameter of the sheath when the self-expanding prosthesis is in its compressed state ensures that inflation of the balloon initiates rupturing of the sheath at the opening.

### Claim 2 (depends on 1)

The delivery system according to claim 1, wherein a distal end of the balloon, distal of the enlarged diameter portion, tapers inward to an outer diameter of the catheter when the self-expanding prosthesis is in its compressed state.

### Claim 3 (depends on 1)

The delivery system according to claim 1, wherein the enlarged diameter portion provides a smooth transition to the distal end of the sheath when the self-expanding prosthesis is in its compressed state.

### Claim 4 (depends on 1)

The delivery system according to claim 1, wherein the opening in the wall of the sheath is a slit.

### Claim 5 (depends on 4)

The delivery system according to claim 4, wherein a length of the slit extends for not more than 5% a length of the sheath.

### Claim 6 (depends on 4)

The delivery system according to claim 4, wherein the slit includes a single slit on the sheath.

### Claim 7 (depends on 4)

The delivery system according to claim 4, wherein the slit includes a plurality of linearly arranged slits.

### Claim 8 (depends on 4)

The delivery system according to claim 4, wherein the slit includes a plurality of slits arranged circumferentially around a distal cross-section of the sheath.

### Claim 9 (depends on 4)

The delivery system according to claim 4, wherein the slit extends along a grain longitudinal direction of the sheath.

### Claim 10 (depends on 1)

The delivery system according to claim 1, wherein the delivery system has a first configuration for delivery to a target site within a vessel and a second configuration upon deployment of a prosthesis at the target site within the vessel,
the enlarged diameter portion having approximately the same outer diameter as the outer diameter of the sheath when the delivery system is in the first configuration, and the enlarged diameter portion being the maximum outer diameter of the balloon when the delivery system is in the first configuration.

### Claim 11 (depends on 1)

The delivery system according to claim 1, wherein the enlarged diameter portion of the balloon applies a radial force on the distal end of the sheath during inflation of the balloon.