Systems and methods for accessing a site within the body

Patent metadata

Field	Value
Publication number	US-2022008707-A1
Application number	US-201917413318-A
Country	US
Kind code	A1
Filing date	Dec 11, 2019
Priority date	Dec 11, 2018
Publication date	Jan 13, 2022
Grant date	—

Abstract

In one embodiment, an expandable access sheath including a planar sheet of material that is configured to be rolled up around an inflatable balloon, the sheet comprising an inner surface, an outer surface, a leading edge, a trailing edge, a proximal edge, and a distal edge, the sheet further including at least one locking tab that extends from either the inner surface or the outer surface of the sheet, wherein the leading edge of the sheet is configured to interface with the locking tab to lock the access sheath in a predetermined configuration in which the access sheath forms an inner working channel having a predetermined cross-sectional dimension after the access sheath has been expanded by the inflatable balloon.

First claim

Claimed are:

1 . An access assembly comprising:
an inflatable balloon having a first internal passage configured to receive a guidewire; a dilation tip mounted to the inflatable balloon, the dilation tip having a second internal passage aligned with the first passage that is also configured to receive a guidewire; and an expandable access sheath wrapped around the inflatable balloon; wherein the access sheath is configured to expand when the balloon is inflated so as to form an inner working channel through which a surgical procedure can be performed.

2 . The assembly of claim 1 , wherein the expandable access sheath comprises a flexible planar sheet of material that is rolled up to form a cylindrical tube, the sheet comprising an inner surface and an outer surface.

3 . The assembly of claim 2 , wherein the sheet further comprises at least one locking tab that extends from the inner side or the outer side of the sheet that is configured to interface with a leading edge of the sheet to lock the access sheath in a predetermined configuration in which the working channel has a predetermined cross-sectional dimension.

4 . The assembly of claim 3 , wherein the locking tab extends from the inner side of the sheet.

5 . The assembly of claim 3 , wherein the locking tab extends from the outer side of the sheet.

6 . The assembly of claim 3 , wherein the leading edge comprises a beveled portion that is configured to mate with the locking tab.

7 . The assembly of claim 6 , wherein the leading edge further comprises a bulbous portion inward of the beveled portion, the bulbous portion being configured to form a smooth transition between the locking tab and the surface of the sheet.

8 . The assembly of claim 3 , wherein the sheet comprises multiple locking tabs positioned at discrete positions along the inner or outer surface of the sheet so as to be configured to lock the access sheath in multiple predetermined configurations, each forming an inner working channel having a predetermined cross-sectional dimension.

9 . The assembly of claim 3 , wherein the locking tab comprises multiple spaced locking tab segments that are linearly aligned with each other so as to form the locking tab.

10 . The assembly of claim 2 , further comprising an elastic outer casing wrapped around the expandable access sheath.

11 . An expandable access sheath comprising:
a flexible planar sheet of material that is configured to be rolled up around an inflatable balloon, the sheet comprising an inner surface, an outer surface, a leading edge, a trailing edge, a proximal edge, and a distal edge, the sheet further comprising at least one locking tab that extends from either the inner surface or the outer surface of the sheet, wherein the leading edge of the sheet is configured to interface with the locking tab to lock the access sheath in a predetermined configuration in which the access sheath forms an inner working channel having a predetermined cross-sectional dimension after the access sheath has been expanded by the inflatable balloon.

12 . The access sheath of claim 11 , wherein the locking tab extends from the inner side of the sheet.

13 . The access sheath of claim 11 , wherein the locking tab extends from the outer side of the sheet.

14 . The access sheath of claim 11 , wherein the leading edge comprises a beveled portion that is configured to mate with the locking tab.

15 . The access sheath of claim 14 , wherein the leading edge further comprises a bulbous portion inward of the beveled portion, the bulbous portion being configured to form a smooth transition between the locking tab and the surface of the sheet.

16 . The access sheath of claim 11 , wherein the sheet comprises multiple locking tabs positioned at discrete positions along the inner or outer surface of the sheet so as to be configured to lock the access sheath in multiple predetermined configurations, each forming an inner working channel having a predetermined cross-sectional dimension.

17 . The access sheath of claim 11 , wherein the locking tab comprises multiple spaced locking tab segments that are linearly aligned with each other so as to form the locking tab.

18 . The access sheath of claim 11 , wherein the leading edge is parallel with the trailing edge but the distal edge is angled relative to the proximal edge such that the access sheath forms a conical distal end when the access sheet is rolled up.

19 . A method for performing a surgical procedure, the method comprising:
forming a passage through soft tissues of a subject to a site of interest at which the surgical procedure is to be performed; passing a guidewire through the passage; passing an access assembly over the guidewire and into the passage; inflating an inner inflatable balloon of the access assembly to cause an expandable access sheath surrounding the balloon to expand; locking the access sheath with locking elements of the access sheath in a predetermined configuration such that the access sheath forms an inner working channel having a predetermined cross-sectional dimension; deflating and removing the balloon from the working channel; and performing the surgical procedure at the site of interest with surgical instruments that are passed through the working channel.

20 . The method of claim 19 , wherein the access sheath comprises a flexible sheet of material that is rolled up around the inflatable balloon and wherein the sheet unrolls as the balloon is inflated to form the working channel, wherein the locking elements comprise at least one locking tab that extends from a side of the sheet and a leading edge of the sheet that is configured to mate with the locking tab.

Assignees

• Univ California

Inventors

• Metzler Ian
• Chi Thomas
• Nedelec Pierre
• Kim Woojoo
• Gupta Anshal

Classifications

• A61M25/0662

  Guide tubes · CPC title

• A61M2025/1081

  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 · CPC title

• A61M2025/0687

  having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths · CPC title

• A61M29/02

  Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} · CPC title

• A61M2025/0024

  Expandable catheters or sheaths · CPC title