Expandable trans-septal sheath

• US 9,827,404 B2
• Filed: 11/15/2012
• Issued: 11/28/2017
• Est. Priority Date: 12/20/2006
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Nance, Edward J., Lenker, Jay, Kick, George F., Nguyen, Hyun T.
• Primary Examiner(s): Rodjom, Katherine
• Application Number:
  US13/678,422
• Publication Number:
  US 20130281978A1
• Time in Patent Office: 1,839 Days
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the performance of procedures in the left atrium. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Claims

1. A method of instrumenting the left atrium comprising the steps of:

routing a guidewire into the right atrium from a peripheral vein;

inserting a sheath into the patient over the guidewire;

the sheath having a pre-inserted dilator, a hub affixed to a proximal end of the sheath, and a hemostasis adapter having an adapter tubing with an enlargement that both pass through a valve of the hub;

said enlargement having a cylindrical shape and being beveled at a proximal end to a surface of the adapter tubing and beveled at a distal end of said enlargement to the surface of the adapter tubing;

advancing the sheath to a treatment or diagnostic site within the right atrium of the heart, wherein the sheath comprises a distal region which is collapsed in diameter;

performing a trans-septal puncture between the right and left atrium and advancing the collapsed sheath through the puncture into the left atrium;

dilating the distal region of the sheath so that the distal region of the sheath is expanded, wherein a full-size lumen exists within the sheath and extending from the proximal end to the distal end;

collapsing the dilator by an action applied at the proximal end of said dilator;

removing the dilator from the sheath;

inserting instrumentation through the lumen of the sheath into the left atrium;

performing therapy or diagnosis with the instrumentation; and

removing the sheath from the patient.

2. The method of claim 1 wherein the dilation step is performed by inflating a balloon on the dilator.

3. The method of claim 1 wherein the dilation step is performed by attaching a liquid-filled inflation device to a balloon inflation port at the distal end of the dilator and infusing liquid under pressure into the dilator.

4. The method of claim 1 wherein the step of collapsing the dilator comprises withdrawing a plunger on the inflation device to withdraw liquid from the dilator.

5. The method of claim 1 wherein the therapy comprises electrophysiology energy delivery.

6. The method of claim 1 wherein instrumentation comprises inserting two or more catheters through the sheath to perform the therapy.

7. The method of claim 1 wherein the therapy comprises delivering an implant into the left atrium.

8. The method of claim 1 wherein dilation of the sheath also comprises the step of dilating anchors within the atria.

9. The method of claim 1 wherein the full-size lumen created in the expandable region by the dilator is substantially larger than the lumen of the proximal non-expandable tubing.

10. The method of claim 1 wherein the full-size lumen created in the expandable region by the dilator is substantially smaller than that of the proximal sheath lumen.

11. The method of claim 1 wherein the full-size lumen created in the expandable region by the dilator is substantially the same size as that of the proximal sheath lumen.

12. The method of claim 1, further comprising the step of removing the guidewire and inserting a Brockenbrough needle through the central lumen of the sheath dilator.

13. The method of claim 1, further comprising the steps of advancing the guidewire, and subsequently the sheath, into the superior vena cava;

removing the guidewire;

inserting a Brockenbrough needle to just inside the distal end of the sheath dilator; and

withdrawing the sheath, pre-inserted dilator, and Brockenbrough needle assembly retrograde into the right atrium.