EXPANDABLE INTRODUCER SHEATH AND METHOD

• US 20160128723A1
• Filed: 11/06/2015
• Published: 05/12/2016
• Est. Priority Date: 11/10/2011
• Status: Active Grant

• Current Assignee: Transaortic Medical, Inc
• Original Assignee: Transaortic Medical, Inc
• Inventors: Ginn, Richard S., Carley, Michael T.
• Granted Patent: US 11,213,318 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2039/0626 used with other surgical instruments, e.g. endoscope, trocar
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

One embodiment is directed to a system for deploying a device to a distal location across a vessel, comprising an elongate introducer sheath tubing member comprising open-cell fibrous wall material defining a lumen therethrough, wherein in a collapsed configuration the sheath has a first cross-sectional outer diameter and a first lumen inner diameter, and in an expanded configuration, the sheath has a second cross-sectional outer diameter and a second lumen inner diameter; and a substantially non-porous expandable layer coupled to a proximal portion of sheath and configured to prevent fluids present in the lumen from crossing the fibrous wall material. Also disclosed is a delivery assembly comprising an obturator which releasably captures the distal portion of an introducer sheath which obturator can be removed after the sheath is deployed to a desired location.

Claims

1. An expandable sheath assembly comprising:

an introducer sheath comprising a relatively flexible distal portion and a relatively stiff proximal portion, said distal portion comprising a mesh, said introducer sheath having a lumen extending therethough,

a dilator assembly comprising a dilator shaft, a dilator tip extending distally from said dilator shaft, and a dilator sheath having a lumen through which said dilator shaft extends, said dilator shaft having a lumen which extends therethrough, said dilator tip having a lumen which extends therethrough and which communicates with the lumen in the dilator shaft, said dilator tip being affixed to said dilator shaft,

the proximal region of said dilator tip having an internal beveled wall and the distal region of said dilator sheath having an external beveled wall, said beveled walls being complementary,

the distal region of said distal portion of said introducer sheath extending over said external beveled wall of said dilator sheath and within said internal beveled wall of said dilator tip such that said distal region of said introducer sheath is gripped between said beveled walls,

said dilator shaft being axially slidable within said dilator sheath.

2. The expandable sheath assembly of claim 1 wherein said mesh is in a slack state when said dilator shaft is displaced proximally and in a tensioned state when said dilator shaft is displaced distally.

3. The expandable sheath assembly of claim 1 wherein the distal portion of said introducer sheath is expandable.

4. The expandable sheath assembly of claim 1 wherein the proximal portion of said introducer sheath is expandable.

5. The expandable sheath assembly of claim 1 wherein both the proximal and distal portions of said introducer sheath are expandable.

6. The assembly of claim 1 wherein the proximal end of said introducer sheath is coupled to a hub.

7. The assembly of claim 6 wherein said dilator shaft is slidable within said hub.

8. The assembly of claim 6 wherein said dilator sheath is slidable within said hub.

9. The assembly of claim 6 wherein said dilator shaft and said dilator sheath are slidable within said hub and a clip is removeably coupled to the hub.

10. The assembly of claim 9 wherein the proximal end of said dilator shaft is coupled to a luer lock.

11. The assembly of claim 10 wherein said clip comprises a housing compartment through which said dilator sheath and shaft extend.

12. The assembly of claim 11 wherein said housing comprises a luer lock constraint distal to said luer lock.

13. The assembly of claim 12 wherein said luer lock restraint prevents distal displacement of said dilator shaft when said luer lock abuts said restraint.

14. The assembly of claim 13 wherein said compartment comprises a dilator sheath restraint distal to said luer lock restraint and which abuts the proximal end of said dilator sheath.

15. The assembly of claim 14 wherein said dilator sheath restraint limits the range of axial displacement of said dilator sheath.

16. The assembly of claim 9 wherein said clip is provided with a handle on its external wall.

17. The assembly of claim 1 wherein said proximal portion of said introducer sheath comprises a reinforcing element which increases the rigidity of said proximal portion.

18. The assembly of claim 1 wherein said proximal portion of said introducer sheath is fabricated from a material which is more rigid than said distal portion.

19. The assembly of claim 6 wherein said hub is provided with a hemostasis valve.

20. The method of deploying a device in a blood vessel comprising the steps of:

introducing the expandable sheath assembly of claim 15 into the vasculature,

advancing said assembly until its distal portion is at a desired location,

removing said clip from said hub,

advancing said dilator shaft distally to disengage said dilator tip from said dilator sheath and allowing the distal portion of said introducer sheath to be free of constraint such that said dilator assembly can be withdrawn from said introducer sheath,

displacing said dilator shaft proximally until said dilator tip and said dilator sheath are withdrawn from said introducer sheath,

introducing a device to be deployed into the proximal end of said introducer sheath and advancing said device until it is delivered at the desired location, and

withdrawing said introducer sheath from the vasculature.