Apparatus and methods for transfemoral delivery of prosthetic mitral valve

• US 10,201,419 B2
• Filed: 07/22/2016
• Issued: 02/12/2019
• Est. Priority Date: 02/05/2014
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Vidlund, Robert M., Christianson, Mark, Kovalsky, Igor
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): Wei, Charles
• Application Number:
  US15/217,376
• Publication Number:
  US 20160324635A1
• Time in Patent Office: 935 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

Apparatus and methods are described herein for use in the transfemoral delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The delivery sheath is inserted into a femoral vein and moved through the femoral vein and a septum of a heart until a distal end of the delivery sheath is disposed in the left atrium of the heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.

Claims

1. A method, comprising:

inserting a leader tube through an access site at an apex of the heart of a patient and positioning a distal end portion of the leader tube in the left atrium of the heart;

inserting a snare device into an entry site of a femoral vein of the patient and into the left atrium of the heart;

capturing the leader tube with the snare device;

pulling the snare device and leader tube out of the femoral vein such that the leader tube extends between the apex of the heart and the entry site of the femoral vein;

inserting a delivery sheath through the entry site of the femoral vein of the patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart, the delivery sheath having a prosthetic mitral valve disposed in a collapsed configuration within a lumen of the delivery sheath;

moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve assumes a biased expanded configuration; and

positioning the prosthetic mitral valve within a mitral annulus of the heart.

2. The method of claim 1, further comprising:

inserting a valve leader member into the leader tube and moving the valve leader member through the leader tube until the valve leader member exits the leader tube outside of the apex of the heart, a proximal end of the valve leader member being coupled to a tether line coupled to the prosthetic mitral valve and disposed within the delivery sheath.

3. The method of claim 2, further comprising:

coupling an epicardial pad device to the tether line coupled to the prosthetic mitral valve; and

securing the epicardial pad device to the apex of the heart.

4. The method of claim 1, further comprising:

prior to inserting the delivery sheath into the femoral vein, inserting a balloon dilator device through the access site at the apex of the heart, through the heart, through the femoral vein and out the femoral entry site;

coupling a balloon member of the balloon dilator device to a distal end portion of the delivery sheath; and

inflating the balloon member.

5. A method, comprising:

inserting a leader tube through an apex of the heart and positioning a distal end portion of the leader tube in the left ventricle of the heart;

inserting a snare device into the femoral vein and into the left ventricle of the heart;

capturing the leader tube with the snare device;

pulling the snare device and leader tube out of the entry site of the femoral vein such that the leader tube extends between the access site at the apex of the heart and the entry site to the femoral vein;

inserting a prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed shape, the prosthetic valve having a tether coupled thereto;

inserting the delivery sheath through an entry site of a femoral vein of a patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart;

moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve is moved to a biased expanded shape;

positioning the prosthetic mitral valve within a mitral annulus of the heart;

coupling an epicardial pad device to the tether; and

securing the epicardial pad device to the apex of the heart.

6. The method of claim 5, further comprising:

inserting a valve leader member into the leader tube and moving the valve leader member through the leader tube until the valve leader member exits the leader tube outside of the apex of the heart, a proximal end of the valve leader member being coupled to the tether line coupled to the prosthetic mitral valve and disposed within the delivery sheath.

7. A method, comprising:

inserting a prosthetic mitral valve into a lumen of a delivery sheath;

inserting a balloon dilator device through an access site at the apex of the heart of a patient, through the heart, through a femoral vein and out a femoral entry site;

coupling a balloon member of the balloon dilator device to a distal end portion of the delivery sheath such that the balloon member is at least partially disposed outside the lumen of the delivery sheath;

inflating the balloon member;

inserting the delivery sheath through the entry site of the femoral vein of the patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart;

deflating the balloon and removing the balloon dilator device from the patient; and

moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve assumes a biased expanded shape; and

positioning the prosthetic mitral valve within a mitral annulus of the heart.

8. The method of claim 7, further comprising:

prior to inserting the delivery sheath, inserting a leader tube through an access site at an apex of the heart and positioning a distal end portion of the leader tube in the left atrium of the heart;

inserting a snare device into the femoral vein and into the left atrium of the heart;

capturing the leader tube with the snare device; and

pulling the snare device and leader tube out of the femoral vein such that the leader tube extends between the apex of the heart and the entry to the femoral vein.

9. The method of claim 8, further comprising:

inserting a valve leader member into the leader tube and moving the valve leader member through the leader tube until the valve leader member exits the leader tube outside of the apex of the heart, a proximal end of the valve leader member being coupled to a tether line coupled to the prosthetic mitral valve and disposed within the delivery sheath.

10. The method of claim 9, further comprising:

coupling an epicardial anchor device to the tether; and

securing the epicardial anchor device to the apex of the heart.

11. The method of claim 10, wherein the epicardial anchor device is an expandable epicardial anchor device.

12. The method of claim 7, further comprising:

prior to inserting the delivery sheath, inserting a leader tube through an apex of the heart and positioning a distal end portion of the leader tube in the left ventricle of the heart;

inserting a snare device into the femoral vein and into the left ventricle of the heart;

capturing the leader tube with the snare device; and

pulling the snare device and leader tube out of the entry site of the femoral vein such that the leader tube extends between the access site at the apex of the heart and the entry site to the femoral vein.

13. The method of claim 12, further comprising:

inserting a valve leader member into the leader tube and moving the valve leader member through the leader tube until the valve leader member exits the leader tube outside of the apex of the heart, a proximal end of the valve leader member being coupled to a tether line coupled to the prosthetic mitral valve and disposed within the delivery sheath.