# US 12,213,880 B2 · Expandable sheath and methods of using the same

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- Number: US 12,213,880 B2
- Document ID: US12213880B2
- Status: Granted
- Kind: B2
- Application number: 18/437,821
- Filed: 2024-02-09
- Published: 2024-06-06
- Granted: 2025-02-04
- Earliest claimed: 2017-06-21
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Thanh Huy Le; Tung T. Le; Sovanpheap Mak; Alpana Kiran Gowdar; Richard D. White; Sonny Tran
- Web page: https://patentgrep.com/patent/US12213880B2

## CPC

- A61F 2/2436: {Deployment by retracting a sheath}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/0662: {Guide tubes}
- B29C 65/00: Joining {or sealing} of preformed parts {, e.g. welding of plastics materials}; Apparatus therefor {(general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326)}
- B29D 23/00: Producing tubular articles (B29D24/00 takes precedence)
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M 2025/0024: {Expandable catheters or sheaths}
- A61M 2025/0098: {having a strain relief at the proximal end, e.g. sleeve}
- A61M 2039/0626: {used with other surgical instruments, e.g. endoscope, trocar}
- 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)}
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29D: PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE (making granules B29B9/00; making preforms B29B11/00)

## Abstract

Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for an implant, then return to a non-expanded state after the passage of the device. The sheath includes a foldable inner member having a detached flap structure at its distal tip that facilitates expansion of the sheath lumen to increased diameters, and an elastomeric distal end that reduces push and retrieval forces therethrough. The sheath can include a hemostasis seal on its proximal end to prevent the leakage of blood out of the sheath and prevent ballooning of outer layer of the sheath.

## Claims

### Claim 1

An expandable sheath comprising:
an elongated inner member movable between an unexpanded and an expanded configuration, the inner member including a first circumferential portion including first and second longitudinal edges, where in the unexpanded configuration the first and second longitudinal edges overlap, and movement of the inner member toward the unexpanded configuration reduces the circumferential overlap of the first and second longitudinal edges;
wherein the inner member includes a distal tip, the distal tip including a flap comprising:
a free edge formed by an axial slit extending proximally along a length of the inner member axially from a distal end of the inner member; and
a circumferential proximal edge formed by a circumferential slit extending around a portion of the inner member,
wherein the distal tip is movable between an unexpanded and an expanded configuration such that in the unexpanded configuration the flap extends circumferentially around and overlaps an adjacent portion of the inner member, and movement of the distal tip toward the unexpanded configuration moves the flap into a less overlapping configuration.

### Claim 2 (depends on 1)

The expandable sheath of claim 1, wherein the circumferential proximal edge of the flap is located along the inner member between a proximal end of the free edge of the flap and a distal end of the first circumferential portion of the inner member.

### Claim 3 (depends on 1)

The expandable sheath of claim 1, wherein a first end of the circumferential proximal edge of the flap aligns with a proximal end of the free edge of the flap.

### Claim 4 (depends on 1)

The expandable sheath of claim 1, wherein the circumferential slit extends from a proximal end of the axial slit.

### Claim 5 (depends on 1)

The expandable sheath of claim 1, wherein the circumferential slit extends around less than an entire circumference of the inner member.

### Claim 6 (depends on 1)

The expandable sheath of claim 1, wherein in a connected edge is formed between a first end of the circumferential slit and a second end of the circumferential slit such that the flap is attached to the first circumferential portion of the inner member.

### Claim 7 (depends on 1)

The expandable sheath of claim 1, wherein the distal tip has a diameter less than a diameter of the inner member, wherein the distal tip defines a decreasing tapered shape extending from the first circumferential portion of the inner member to the distal end of the inner member such that a proximal end of the distal tip has a diameter larger than a diameter of a distal end of the distal tip in the unexpanded configuration.

### Claim 8 (depends on 1)

The expandable sheath of claim 1, wherein the flap is configured to slide circumferentially over an underlying portion of the flap when the distal tip moves between the unexpanded and expanded configurations.

### Claim 9 (depends on 1)

The expandable sheath of claim 1, wherein the axial slit of the flap extends in a direction generally perpendicular to the circumferential slit of the flap.

### Claim 10 (depends on 1)

The expandable sheath of claim 1, wherein the flap further includes an overlap extension that extends circumferentially from the free edge of the flap.

### Claim 11 (depends on 1)

The expandable sheath of claim 1, wherein the distal tip further comprises an elastomeric end extending from a distal end of the elongated inner member.

### Claim 12 (depends on 11)

The expandable sheath of claim 11, wherein the elastomeric end has a distally tapering shape.

### Claim 13 (depends on 11)

The expandable sheath of claim 11, wherein the elastomeric end restricts free expansion of the flap relative to the remainder of the inner member.

### Claim 14 (depends on 11)

The expandable sheath of claim 11, wherein the elastomeric end is configured to expand and/or split upon movement of the distal tip from the unexpanded configuration toward the expanded configuration.

### Claim 15 (depends on 1)

The expandable sheath of claim 1, further comprising a marker embedded in the inner member proximate the distal tip.

### Claim 16 (depends on 15)

The expandable sheath of claim 15, wherein the marker is positioned proximate the free edge and/or the circumferential proximal edge of the flap.

### Claim 17 (depends on 15)

The expandable sheath of claim 15, wherein the marker is positioned proximate at least one of a proximal end of the free edge of the flap, or a first end of the circumferential proximal edge of the flap.

### Claim 18 (depends on 1)

The expandable sheath of claim 1, further comprising an outer elastomeric member extending at least partially over the inner member and configured to exert a compressive force onto the inner member to bias the inner member toward the unexpanded configuration.

### Claim 19 (depends on 1)

The expandable sheath of claim 1, further comprising a strain relief portion extending distally from the proximal end of the expandable sheath, the strain relief portion having a higher durometer than the elongated inner member.

### Claim 20 (depends on 1)

The expandable sheath of claim 1, wherein the inner member is configured to at least partially expand toward the expanded configuration for passage of an implant through a central lumen of the expandable sheath.