# US 2025/0144367 A1 · Expandable introducer

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- Number: US 2025/0144367 A1
- Document ID: US20250144367A1
- Status: Published application
- Kind: A1
- Application number: 18/832,570
- Filed: 2023-01-26
- Published: 2025-05-08
- Earliest claimed: 2022-01-27
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Marc A. Anderson; Timothy Desmond Farrell; Fionnuala Morelli; Maro J. Sciacchitano; Matthew P. Norgrove; Luke A. Clarke; Mark Desmond Reid; Laura Marie Coultry; Shridhar R. Sail; Alan Thomas McGuinn; Mark Casley; Susheel R. Deshmukh; Jacqueline Bernadette OGorman; Patricia McAfee; Chris Moran; Antonia Trotta
- Web page: https://patentgrep.com/patent/US20250144367A1

## CPC

- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/008: {Strength or flexibility characteristics of the catheter tip}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0662: {Guide tubes}
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 17/3439: {with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662)}
- A61M 2025/0024: {Expandable catheters or sheaths}
- A61M 2025/0047: {the inner layer having a higher lubricity}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An expandable introducer includes a hub and a tubular sheath (121) coupled thereto. The tubular sheath (121) defines a central lumen (103). A circumference of the tubular sheath includes a full thickness region (162) having a first wall thickness (T2) and a reduced thickness region (161) having a second wall thickness (T1) smaller than the first wall thickness (T2). The reduced thickness region (162) is configured to be folded such that the tubular sheath includes an unexpanded, folded state and is configured to expand to an expanded, unfolded state in response to a device passing though the central lumen (103). A first outer diameter of the tubular sheath in the unexpanded, folded state is smaller than a second outer diameter of the tubular sheath in the expanded, unfolded state.

## Claims

### Claim 1

An expandable introducer comprising:
a hub having a distal end and a proximal end; and
a tubular sheath coupled to the hub and extending distally therefrom, the tubular sheath defining a central lumen, wherein a circumference of the tubular sheath includes a thick wall region having a first wall thickness and a thin wall region having a second wall thickness smaller than the first wall thickness, wherein the thin wall region is configured to be folded such that the tubular sheath includes an unexpanded, folded state and is configured to expand to an expanded, unfolded state in response to a device passing though the central lumen, wherein a first outer diameter of the tubular sheath in the unexpanded, folded state is smaller than a second outer diameter of the tubular sheath in the expanded, unfolded state.

### Claim 2 (depends on 1)

The expandable introducer of claim 1, wherein the first wall thickness is about 0.4-0.7 mm.

### Claim 3 (depends on 2)

The expandable introducer of claim 2, wherein the second wall thickness is about 0.05-0.2 mm.

### Claim 4 (depends on 1)

The expandable introducer of claim 1, wherein:
the thick wall region of the tubular sheath includes an outer wall having a first layer and a second layer, and a liner coupled to an inner surface of the outer wall, the liner defining the central lumen of the tubular sheath; and
the thin wall region of the tubular sheath includes the liner and only the second layer of the outer wall.

### Claim 5 (depends on 4)

The expandable introducer of claim 4, wherein the second layer in the thick wall region has a third thickness, and the second layer in the thin wall region has a fourth thickness smaller than the third thickness.

### Claim 6 (depends on 1)

The expandable introducer of claim 1, wherein the tubular sheath comprises a proximal end, wherein the proximal end of the tubular sheath does not include an unexpanded, folded configuration.

### Claim 7 (depends on 1)

The expandable introducer of claim 1, further comprising a hemostatic jacket surrounding at least a proximal end of the tubular sheath, wherein the hemostatic jacket is configured to prevent blood flow from outside of the tubular sheath.

### Claim 8 (depends on 7)

The expandable introducer of claim 7, wherein the hemostatic jacket is radially expandable.

### Claim 9 (depends on 8)

The expandable introducer of claim 8, wherein the hemostatic jacket is about 10-12 cm in length.

### Claim 10 (depends on 8)

The expandable introducer of claim 8, wherein the hemostatic jacket is about 30-35 cm in length.

### Claim 11 (depends on 7)

The expandable introducer of claim 7, wherein the hemostatic jacket is heat bonded to the proximal end of the tubular sheath.

### Claim 12 (depends on 7)

The expandable introducer of claim 7, wherein the hemostatic jacket includes an angled tip.

### Claim 13 (depends on 7)

The expandable introducer of claim 7, wherein the hemostatic jacket is attached to only the thick wall region of the tubular sheath.

### Claim 14 (depends on 1)

The expandable introducer of claim 1, further comprising a tip coupled to a distal end of the tubular sheath and extending distally from the distal end of the tubular sheath.

### Claim 15 (depends on 14)

The expandable introducer of claim 14, wherein the tip comprises a weakened region configured to tear to allow the tip to radially expand in response to a device being advanced through the tip.

### Claim 16 (depends on 15)

The expandable introducer of claim 15, wherein the tip includes an axial slit, wherein circumferential edges at proximal and distal ends of the longitudinal are attached to each other, and wherein the weakened region comprises the axial slit between the proximal and distal attachments.

### Claim 17 (depends on 15)

The expandable introducer of claim 15, wherein the weakened region comprises a longitudinal perforation.

### Claim 18 (depends on 1)

The expandable introducer of claim 1, wherein the tubular sheath is shape set to return to the unexpanded, folded state after the device has passed through to the central lumen.

### Claim 19 (depends on 1)

The expandable introducer of claim 1, wherein the first outer diameter of the tubular sheath is about 5-7 mm.

### Claim 20 (depends on 19)

The expandable introducer of claim 19, wherein the second outer diameter of the tubular sheath is about 8-10 mm.

### Claim 21 (depends on 1)

The expandable introducer of claim 1, wherein the introducer hub comprises:
a hub body having a proximal end, a distal end, and a central lumen;
a seal section disposed within the central lumen of the hub body, the seal section including at least one seal; and
a sealcap coupled to the hub body and at least partially disposed within the central lumen, the sealcap having a distal end abutting the seal section, the sealcap including a locking mechanism on an internal surface thereof configured to interlock with a device to be inserted into the introducer hub.

### Claim at position 22

22-31. (canceled)