EP-4735086-A1 - EXPANDABLE INTRODUCER

Abstract

An expandable introducer (100) includes a hub (110) having a distal end (114) and a proximal end (112), and a sheath (120) coupled to the hub and extending distally therefrom, the sheath defining a central lumen (125). The sheath is configured to radially expand from a radially unexpanded, folded state having a first diameter and to a radially expanded, unfolded state having a second diameter larger than the first diameter in response to a device passing through the central lumen. A wall (150) of the sheath includes a thick wall region (146) having a first wall thickness and a thin wall region (144) having a second wall thickness smaller than the first wall thickness, wherein the thick wall region includes a coil (160) embedded within the wall of the sheath.

Inventors

• FARRELL, Timothy Desmond
• GRIFFIN, PATRICK
• MORAN, CHRIS
• ANDERSON, MARC A.
• MCAFEE, Patricia
• CLARKE, Luke A.
• TROTTA, Antonia
• MARTIN, Andrea Quero
• KITT, Tomas Patrick
• WILCOX, ROSS L.

Assignees

• Medtronic, Inc.

Dates

Publication Date

20260506

Application Date

20240620

Claims (20)

1. WHAT IS CLAIMED IS 1. An expandable introducer comprising: a hub having a distal end and a proximal end; and a sheath coupled to the hub and extending distally therefrom, the sheath defining a central lumen, the sheath configured to radially expand from a radially unexpanded, folded state having a first diameter and to a radially expanded, unfolded state having a second diameter larger than the first diameter in response to a device passing through the central lumen, wherein a wall of the 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 thick wall region includes a coil embedded within the wall of the sheath.
2. 2. The expandable introducer of claim 1, wherein the first wall thickness is about 0.4- 0.7mm.
3. 3. The expandable introducer of claim 1, wherein the second wall thickness is about 0.05-0.2mm.
4. 4. The expandable introducer of claim 1, wherein: the coil is a C-shaped coil including a plurality of circumferential portions coupled by bends.
5. 5. The expandable introducer of claim 4, wherein adjacent bends of the coil face opposite circumferential directions such that there is a circumferential gap between the bends facing opposite directions in the radially unexpanded, folded state.
6. 6. The expandable introducer of claim 1, wherein the coil is a shape memory material and is shape set to the radially unexpanded, folded state.
7. 7. The expandable introducer of claim 1, wherein the sheath comprises a proximal portion disposed within a lumen of the hub, an expanded portion distal of the proximal portion, a tapered portion distal of the expanded portion, an expandable coiled portion distal of the tapered portion, and an expandable non-coiled portion distal of the expandable coiled portion.
8. 8. The expandable introducer of claim 7, wherein the expanded portion is not foldable and is the second diameter.
9. 9. The expandable introducer of claim 7, wherein the tapered portion tapers in the distal direction such that in the radially unexpanded, folded state of the sheath, a proximal end of the tapered portion has the second diameter and a distal end of the tapered portion has the first diameter.
10. 10. The expandable introducer of claim 9, wherein in the radially expanded, unfolded state, both the proximal end and the distal end of the tapered portion have the second diameter.
11. 11. The expandable introducer of claim 7, wherein the expandable coiled portion has the first diameter in the radially unexpanded, folded state and the second diameter in the radially expanded unfolded state.
12. 12. The expandable introducer of claim 7, wherein the expandable non-coiled portion has the first diameter in the radially unexpanded, folded state and the second diameter in the radially expanded, unfolded state.
13. 13. The expandable introducer of claim 7, wherein the coil is embedded in the wall of the sheath along the expanded portion, the tapered portion, and the expandable coiled portion.
14. 14. The expandable introducer of claim 7, wherein the coil is not embedded in the wall of the sheath along the proximal portion and the expandable non-coiled portion.
15. 15. The expandable introducer of claim 7, wherein the coil is a shape memory material, and wherein an Active A(f) temperature of the coil is higher in a proximal region of the coil than in a distal region of the coil.
16. 16. The expandable introducer of claim 7, wherein the coil includes a proximal expanded region embedded in the expanded portion of the sheath, a tapered region embedded in the tapered portion of the sheath, and a distal expandable region embedded in the expandable coiled portion of the sheath.
17. 17. The expandable introducer of claim 16, wherein the proximal expanded region and the tapered region of the coil have a first Active A(f) temperature and the distal expandable region of the coil has a second Active A(f) temperature lower than the first Active A(f) temperature.
18. 18. The expandable introducer of claim 1, wherein the coil comprises a wire, wherein at least one end of the wire is formed into a pigtail.
19. 19. The expandable introducer of claim 1, wherein the coil comprises a wire, wherein at least one end of the wire is disposed closer to a central longitudinal axis of the sheath than a middle portion of the wire.
20. 20. The expandable introducer of claim 1, wherein the coil comprises a wire, wherein at least one end of the wire is laser cut such that the at least one end has a smooth profile.

Description

EXPANDABLE INTRODUCER CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/510,670, filed June 28, 2023, and U.S. Patent Application No. 18/615,140, filed March 25, 2024, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to an expandable introducer device for providing percutaneous access to a patient’s vasculature for a transcatheter device delivery system. BACKGROUND [0003] An introducer device is used to provide percutaneous access to the vascular system of a patient and functions to permit the introduction and positioning of various minimally invasive delivery devices within the patient’s vasculature. In general, making the smallest incision is the most desirable and leads to less complications, less trauma, and improved patient outcomes. Some delivery devices, however, are large and require large sheaths to accommodate and help deliver them to the desired site within the body. BRIEF SUMMARY OF THE INVENTION [0004] In accordance with an example hereof, an expandable introducer includes a hub having a distal end and a proximal end, and a sheath coupled to the hub and extending distally therefrom, the sheath defining a central lumen. The sheath is configured to radially expand from a radially unexpanded, folded state having a first diameter and to a radially expanded, unfolded state having a second diameter larger than the first diameter in response to a device passing through the central lumen. A wall of the 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 thick wall region includes a coil embedded within the wall of the sheath. [0005] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the first wall thickness is about 0.4-0.7mm. [0006] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the second wall thickness is about 0.05-0.2mm. [0007] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the coil is a C-shaped coil including a plurality of circumferential portions coupled by bends. [0008] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, adjacent bends of the coil face opposite circumferential directions such that there is a circumferential gap between the bends facing opposite directions in the radially unexpanded, folded state. [0009] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the coil is a shape memory material and is shape set to the radially unexpanded, folded state. [0010] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the sheath comprises a proximal portion disposed within a lumen of the hub, an expanded portion distal of the proximal portion, a tapered portion distal of the expanded portion, an expandable coiled portion distal of the tapered portion, and an expandable non-coiled portion distal of the expandable coiled portion. [0011] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the expanded portion is not foldable and is the second diameter. [0012] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the tapered portion tapers in the distal direction such that in the radially unexpanded, folded state of the sheath, a proximal end of the tapered portion has the second diameter and a distal end of the tapered portion has the first diameter. [0013] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, wherein in the radially expanded, unfolded state, both the proximal end and the distal end of the tapered portion have the second diameter. [0014] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the expandable coiled portion has the first diameter in the radially unexpanded, folded state and the second diameter in the radially expanded unfolded state. [0015] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the expandable non-coiled portion has the first diameter in the radially unexpanded, folded state and the second diameter in the radially expanded, unfolded state. [0016] In another example hereof, in the expandable introducer of any of the previous or subsequent examples herein, the coil is embedded in the wall of the sheath along the expanded portion, the tapered portion, and the expandable coiled portion. [0017] In another example hereof, in the expandable int