Transcatheter balloon-assisted mitral valve navigation device and method

Patent metadata

Field	Value
Publication number	US-9364637-B2
Application number	US-201113225735-A
Country	US
Kind code	B2
Filing date	Sep 6, 2011
Priority date	Sep 6, 2011
Publication date	Jun 14, 2016
Grant date	Jun 14, 2016

Abstract

A method for positioning a centering introducer in a heart of a patient, which includes the steps of inserting an anchoring wire delivery catheter through a heart wall and to a treatment region of the heart, deploying at least one anchoring wire from the delivery catheter and into tissue in the treatment region of the heart, and removing the delivery catheter from the heart. A centering introducer can then be advanced along the anchoring wire to the treatment region, wherein the centering introducer includes an introducer element and at least one balloon. At least one of the balloons can then be inflated to reorient the introducer element in at least one direction relative to a longitudinal axis of the centering introducer.

First claim

What is claimed is:

1. A method of positioning a centering introducer in a heart of a patient, comprising the steps of:
inserting an anchoring wire delivery catheter through a heart wall and to a treatment region of the heart;
deploying an anchoring wire from the anchoring wire delivery catheter and into tissue in the treatment region of the heart to anchor the anchoring wire, wherein a distal end of the anchoring wire pierces the tissue and is anchored in the tissue;
removing the anchoring wire delivery catheter from the heart;
advancing a centering introducer along the anchoring wire to the treatment region, wherein the centering introducer comprises an introducer element and at least one balloon separate from the introducer element;
inflating the at least one balloon to contact an outer surface of the introducer element to reorient the introducer element in at least one direction relative to a longitudinal axis of the centering introducer and away from the anchoring wire.

2. The method of claim 1 , wherein the step of inserting an anchoring wire delivery catheter further comprises inserting a guidewire through the heart wall and to the treatment region of the heart, and then advancing the anchoring wire delivery catheter along the guidewire.

3. The method of claim 1 , wherein the treatment region of the heart comprises the annular region of a mitral valve.

4. The method of claim 1 , further comprising the step of introducing a treatment device through the introducer element and into the treatment region of the heart.

5. The method of claim 4 , wherein the treatment device comprises at least one of a clip, an anchor, and a replacement heart valve.

6. The method of claim 1 , wherein at least a portion of the anchoring wire comprises a shape memory material.

7. The method of claim 6 , wherein the step of deploying the anchoring wire comprises pressing a distal end of the anchoring wire delivery catheter against the tissue while the distal end of the anchoring wire is disposed within a lumen of the anchoring wire delivery catheter, and then pushing the anchoring wire distally out of the distal end of the anchoring wire delivery catheter so that the distal end of the anchoring wire extends from the anchoring wire delivery catheter to engage with the tissue in the treatment region.

8. The method of claim 1 , wherein the centering introducer further comprises an anchoring wire lumen and an inflation lumen that is in communication with an interior area of the at least one balloon.

9. The method of claim 8 , wherein the centering introducer further comprises a control device operatively connected to the anchoring wire and an injection port operatively connected to the at least one balloon.

10. The method of claim 1 , wherein the centering introducer comprises multiple regions along its length, each of which comprises a different flexibility than at least one other region.

11. The method of claim 1 , wherein the delivery system further comprises a sheath that is slideably positionable relative to the introducer element and balloon, and wherein the method further comprises sliding the sheath in a proximal direction to unsheath the introducer element and the at least one balloon.

12. The method of claim 11 , further comprising a step of sliding the sheath in a distal direction to surround at least a portion of the introducer element and the at least one balloon prior to a step of removing the delivery system from the heart of the patient.

13. The method of claim 1 , further comprising a step of rotating at least a portion of the centering introducer to move the introducer element to a desired location relative to the heart.

14. The method of claim 2 , wherein the step of inserting an anchoring wire delivery catheter through a heart wall comprises moving the guidewire to the right atrium through a femoral vein, then moving the guidewire into the left atrium through a trans-septal puncture, and then moving the guidewire into the left atrium and to a commissure region of the mitral valve.

15. The method of claim 1 , wherein the introducer element at least partially surrounds an introducer lumen, and wherein the at least one balloon does not surround the introducer lumen.

16. The method of claim 9 , wherein the control device comprises a valve.

17. The method of claim 1 , wherein the distal end of the anchoring wire is sharpened to pierce the tissue in the treatment region.

18. The method of claim 1 , wherein the distal end of the anchoring wire includes an anchor loop that anchors the distal end of the anchoring wire in the tissue.

19. The method of claim 18 , wherein the anchor loop is at least partially straightened and disposed within a lumen of the anchoring wire delivery catheter as the anchoring wire delivery catheter is advanced to the treatment region of the heart, and wherein the step of deploying the anchoring wire from the anchoring wire delivery catheter comprises pushing the anchoring wire out of a distal end of the lumen and into the tissue in the treatment region, wherein as the anchor loop is pushed out of the lumen the anchor loop regains its loop shape to anchor the distal end of the anchoring wire in the tissue.

Assignees

• Rothstein Paul
• Medtronic Inc

Inventors

• Rothstein Paul

Classifications

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61M2025/1047

  having centering means, e.g. balloons having an appropriate shape · CPC title

• A61M2025/09125

  Device for locking a guide wire in a fixed position with respect to the catheter or the human body · CPC title

• A61B2017/00783

  Valvuloplasty · CPC title

• A61M25/04 Primary

  in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)} · CPC title