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Expandable trans-septal sheath

  • US 10,272,231 B2
  • Filed: 10/11/2013
  • Issued: 04/30/2019
  • Est. Priority Date: 09/09/2004
  • Status: Active Grant
First Claim
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1. A method of instrumenting a left atrium of a patient comprising the steps of:

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

    inserting a sheath with a distal region in a collapsed state and a pre-inserted dilator into the patient over the guidewire;

    the collapsed state of the distal region having a plurality of folded regions forming two outer fold edges that are oriented adjacent to each other, and forming two inner fold edges that are oriented apart and across from each other;

    advancing the sheath to a treatment or diagnostic site within the right atrium of the heart;

    performing a trans-septal puncture between the right and left atrium and advancing the distal region in the collapsed state through the puncture into the left atrium;

    dilating with a dilation balloon of the pre-inserted dilator the distal region of the sheath to an expanded state so that the distal region of the sheath is expanded to dilate the puncture and increase a diameter of a distal end of a lumen extending through the sheath;

    maintaining a position of the distal region of the sheath into the left atrium by inflating a distal balloon of the sheath in the left atrium and inflating a proximal balloon of the sheath in the right atrium, so as to engage the atrial septum,collapsing the dilator;

    removing the dilator from the sheath;

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

    said instrumentation being larger in diameter than said distal end of said lumen when said distal region of said sheath is in a collapsed state;

    performing therapy or diagnosis with the instrumentation; and

    removing the sheath from the patient.

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