FULLY COMPLIANT LARGE BORE EXPANDABLE SHEATH

• US 20160213882A1
• Filed: 01/20/2016
• Published: 07/28/2016
• Est. Priority Date: 01/22/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Fitterer, Mimi Trinh, Escalona, Floriza Q., Ino, Takashi H., Gamarra, Randy S.
• Granted Patent: US 10,918,829 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B29C 53/08 of tubes or other profiled members
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 66/522 Joining tubular articles B29C66/53241 takes precedence
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

An expandable sheath may include an inelastic compliant membrane having a lumen therethrough, and a discontinuous outer member bonded to the membrane. The membrane may include one or more folds formed therein. At least a portion of the outer member may extend continuously around a circumference of the membrane in a first configuration. The outer member may be configured to separate to a second configuration when subjected to a radially outward force from within the membrane. The outer member may taper from a first diameter adjacent a proximal hub to a second smaller diameter at a distal end. A method of manufacturing an expandable sheath may include forming one or more folds in a compliant membrane, cutting a plurality of apertures through a wall of an outer covering; and laminating the outer covering onto the membrane, wherein the plurality of apertures is disposed over the one or more folds.

Claims

1. An expandable sheath, comprising:

a compliant membrane having a lumen extending therethrough; and

a discontinuous outer member bonded to the membrane;

wherein at least a portion of the outer member extends continuously around a circumference of the membrane in a first configuration;

wherein the outer member is configured to separate to a second configuration when subjected to a radially outward force from within the membrane.

2. The expandable sheath of claim 1, wherein the membrane is inelastic.

3. The expandable sheath of claim 1, wherein the membrane includes one or more folds disposed radially inward of the outer member.

4. The expandable sheath of claim 3, wherein the one or more folds each form a wave shape.

5. The expandable sheath of claim 3, wherein the one or more folds each form a T-shape.

6. The expandable sheath of claim 1, wherein a maximum inner diameter of the lumen increases when the outer member separates.

7. The expandable sheath of claim 1, further comprising an elongate introducer member having a maximum outer diameter less than or equal to a maximum inner diameter of the membrane when the outer member is in the first configuration, the introducer member being configured for insertion into the lumen without separating the outer member.

8. The expandable sheath of claim 1, further comprising an elongate dilator having a maximum outer diameter greater than a maximum inner diameter of the membrane when the outer member is in the first configuration and less than or equal to a maximum inner diameter of the lumen, the dilator being configured to pass through the lumen.

9. The expandable sheath of claim 1, wherein the outer member is configured to separate from the first configuration to the second configuration upon passage of a medical device through the lumen of the membrane.

10. The expandable sheath of claim 1, wherein the membrane is non-self-supporting.

11. An expandable sheath, comprising:

an inelastic compliant inner membrane laminated to an outer tear-away covering, the inner membrane defining a lumen therethrough having an inner diameter; and

a proximal hub;

wherein the outer tear-away covering tapers from a first diameter adjacent the proximal hub to a second smaller diameter at a distal end.

12. The expandable sheath of claim 11, wherein the inner membrane includes one or more folds disposed radially inward of the outer tear-away covering.

13. The expandable sheath of claim 12, wherein the outer tear-away covering includes a plurality of weakening features disposed over the one or more folds.

14. The expandable sheath of claim 13, wherein the plurality of weakening features is configured to separate when subjected to a radially outward force from within the lumen, thereby permitting the one or more folds to unfold and increase the inner diameter of the lumen.

15. The expandable sheath of claim 11, further comprising an elongate introducer member having a maximum outer diameter less than or equal to the inner diameter of the membrane at a location within the outer tear-away covering where the outer tear-away covering is at the first diameter, the introducer member being configured for insertion into the lumen without separating the outer tear-away covering.

16. A method of manufacturing an expandable sheath, comprising:

forming one or more folds in a compliant tubular membrane, thereby reducing an inner diameter of the membrane, wherein the membrane includes a plurality of longitudinal corrugations along an inner surface thereof;

cutting a plurality of apertures through a wall of a tubular outer covering; and

laminating the outer covering onto the membrane, wherein the plurality of apertures is disposed over the one or more folds.

17. The method of claim 16, wherein the membrane is inelastic.

18. The method of claim 16, wherein the outer covering is configured to separate along the plurality of apertures upon passage of an apparatus having an outer diameter greater than the reduced inner diameter through the membrane.

19. The method of claim 18, wherein the membrane is incapable of maintaining an increased inner diameter on its own after removal of the apparatus therefrom.

20. The method of claim 16, further including:

after laminating the outer covering onto the membrane, attaching a proximal hub to the membrane, the proximal hub including a port in fluid communication with a lumen of the membrane and a hemostatic seal therein.