# US 10,499,895 B2 · Elastic introducer sheath

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- Number: US 10,499,895 B2
- Document ID: US10499895B2
- Status: Granted
- Kind: B2
- Application number: 15/495,657
- Filed: 2017-04-24
- Published: 2018-10-25
- Granted: 2019-12-10
- Earliest claimed: 2017-04-24
- Assignees: Medtronic Vascular, Inc.
- Applicants: Medtronic Vascular, Inc.
- Inventors: Marc Anderson
- Web page: https://patentgrep.com/patent/US10499895B2

## CPC

- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61M 25/0662: {Guide tubes}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61B 2017/0225: {flexible, e.g. fabrics, meshes, or membranes}
- A61B 2017/0237: {for heart surgery}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 2025/0024: {Expandable catheters or sheaths}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

An introducer sheath system including an outer layer, an inner layer, and a dilator is disclosed. The outer layer is circumferentially extending between a first longitudinal edge and a second longitudinal edge. An expandable gap is defined between the first and second longitudinal edges. The inner layer is disposed within the outer layer. The inner layer is configured to be continuously circumferentially expandable. The inner layer includes a non-extended state having a circumferential portion extending circumferentially inside the outer layer and a fold portion extending into an interior cavity of the inner layer. The inner layer includes an extended state wherein the fold portion extends at least partially circumferentially between the first and second longitudinal edges. The dilator is extendable longitudinally within the inner layer. The dilator includes a recess configured to accommodate the fold portion of the inner layer.

## Claims

### Claim 1

An elastic surgical access system, comprising:
an outer layer comprising a circumferentially non-continuous layer extending between a first longitudinal edge and a second longitudinal edge, wherein the first and second longitudinal edge are non-overlapping;
an inner layer attached within the outer layer, the inner layer being circumferentially continuous, the inner layer including a circumferential portion extending circumferentially within the outer layer and a fold portion extendable within an interior lumen of the inner layer, the fold portion longitudinally aligned between the first and second longitudinal edges; and
a dilator insertable into the interior lumen of the inner layer, the dilator including a body including an axial lumen extending through the body and a recessed channel extending radially from an exterior surface of the dilator, the recessed channel configured to accommodate the fold portion; wherein the recessed channel is separated from the axial lumen by the body of the dilator.

### Claim 2 (depends on 1)

The elastic surgical access system of claim 1, wherein an expandable gap is defined between the first and second longitudinal edges.

### Claim 3 (depends on 1)

The elastic surgical access system of claim 1, wherein the inner layer is coupled to the outer layer at least along the first and second longitudinal edges.

### Claim 4 (depends on 1)

The elastic surgical access system of claim 1, wherein the circumferential portion of the inner layer is fully adhered to the outer layer and the fold portion is un-adhered.

### Claim 5 (depends on 1)

The elastic surgical access system of claim 1, wherein the outer layer includes a wire structure having a repeating longitudinal pattern.

### Claim 6

An introducer sheath system, comprising:
an outer layer including a circumferentially discontinuous layer and an elastic frame, wherein the outer layer is discontinuous between a first longitudinal edge and a second longitudinal edge, wherein the first and second longitudinal edges abut in a non-expanded state and wherein a gap is formed between the first and second longitudinal edges in an expanded state;
an inner layer disposed within the outer layer, the inner layer comprised of a circumferentially continuous membrane including a circumferential portion attached to the outer layer and a fold portion freely extendable into an interior lumen of the inner layer in the non-expanded state and circumferentially aligned with the circumferential portion in the expanded state; and
a dilator insertably extendable within the inner layer, the dilator including a body including an axial lumen extending through the body and a recessed channel extending radially from an exterior surface of the dilator, the recessed channel configured to accommodate the fold portion, the dilator configured to transition the outer and inner layers from the non-expanded state to the expanded state; wherein the recessed channel is separated from the axial lumen by the body of the dilator.

### Claim 7 (depends on 6)

The introducer sheath system of claim 6, wherein the elastic frame biases the outer layer toward the non-expanded state.

### Claim 8 (depends on 6)

The introducer sheath system of claim 6, wherein the first and second longitudinal edges are non-overlapping.

### Claim 9 (depends on 6)

The introducer sheath system of claim 6, wherein the elastic frame forms a longitudinally repeating pattern fully extending within the circumferentially discontinuous layer.

### Claim 10 (depends on 6)

The introducer sheath system of claim 6, wherein the recessed channel is radially extending from an outer surface of the dilator toward a central longitudinal axis and the fold portion radially projects into the recessed channel in the non-expanded state.

### Claim 11 (depends on 6)

The introducer sheath system of claim 6, wherein the fold portion is aligned with the first and second longitudinal edges.