Methods for delivery of prosthetic mitral valves

• US 10,327,894 B2
• Filed: 09/14/2016
• Issued: 06/25/2019
• Est. Priority Date: 09/18/2015
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Vidlund, Robert M., Kovalsky, Igor
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US15/265,221
• Publication Number:
  US 20170079790A1
• Time in Patent Office: 1,014 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• 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 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts

Abstract

In some embodiments, a method for delivery and deployment of a prosthetic mitral valve into a heart includes inserting an introducer sheath having a prosthetic mitral valve disposed therein in a collapsed configuration into the left atrium of a patient'"'"'s heart, through a gap between the native mitral valve leaflets, the left ventricle and apex of the heart. An epicardial pad device coupled to the prosthetic valve via a tether is moved distally out of the sheath. The introducer sheath is withdrawn into the left atrium of the heart. An inner delivery sheath is extended distally from within the introducer sheath and disposed within the left atrium. The prosthetic mitral valve is moved distally out of the inner delivery sheath and assumes a biased expanded configuration. The valve is positioned within the mitral annulus of the heart, and secured in place via the tether and epicardial pad device.

Claims

1. A method, comprising:

inverting an outer frame of a prosthetic mitral valve relative to an inner frame of the prosthetic mitral valve when the prosthetic mitral valve is in a biased expanded configuration, wherein leaflets are attached to the inner frame, the prosthetic mitral valve being formed with a shape-memory material, an open end of the outer frame being disposed distally of an open end of the inner frame when inverted;

after the inverting, inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed configuration, while remaining inverted;

inserting the delivery sheath through a trans-atrial entry site directly into a left atrium of a heart of a patient;

moving the prosthetic mitral valve distally out of the lumen of the delivery sheath such that the inverted outer frame of the prosthetic mitral valve reverts and the prosthetic mitral valve assumes its biased expanded configuration, the open end of the outer frame being disposed proximally of the open end of the inner frame when reverted and the prosthetic mitral valve is in the 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 catheter through an opening in an apex of the heart and positioning a distal end portion of the catheter in a left ventricle of the heart;

inserting a snare device through the catheter and into the left ventricle; and

prior to the moving the prosthetic valve distally out of the lumen of the delivery sheath, capturing a distal portion of a tether coupled to the prosthetic valve with the snare device and pulling the portion of the tether through the catheter and outside of the heart.

3. The method of claim 2, further comprising:

coupling an epicardial pad device to the tether 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 through the trans-atrial entry site, disposing a dilator and guidewire within a lumen of the delivery sheath such that a portion of the dilator and a portion of the guidewire extend distally from the delivery sheath;

prior to the moving the prosthetic valve distally out of the delivery sheath, moving the distal end of the delivery sheath through the left atrium, through the left ventricle and out through an opening in an apex of the heart; and

withdrawing the dilator and guidewire from the delivery sheath.

5. The method of claim 4, further comprising:

after the withdrawing the dilator and guidewire, moving the delivery sheath such that a distal end portion of the delivery sheath is disposed in the left atrium of the heart.

6. The method of claim 4, further comprising:

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

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

7. The method of claim 1, further comprising:

coupling an epicardial pad device to a tether coupled to and extending from the prosthetic mitral valve; and

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

8. A method, comprising:

inverting an outer frame of a prosthetic mitral valve relative to an inner frame of the prosthetic mitral valve when the prosthetic mitral valve is in a biased expanded configuration, wherein leaflets are attached to the inner frame, the prosthetic mitral valve being formed with a shape-memory material, an open end of the outer frame being disposed distally of an open end of the inner frame when inverted;

after the inverting, inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed configuration, while remaining inverted;

inserting the delivery sheath through a puncture site in a jugular vein of a patient, through the superior vena cava of the patient, and through the atrial septum wall of a heart of the patient and into a left atrium of the heart;

moving the prosthetic mitral valve distally out of the lumen of the delivery sheath such that the inverted outer frame of the prosthetic mitral valve reverts and the prosthetic mitral valve assumes its biased expanded configuration, the open end of the outer frame being disposed proximally of the open end of the inner frame when reverted and the prosthetic mitral valve is in the biased expanded configuration; and

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

9. The method of claim 8, further comprising:

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

inserting a snare device through the catheter and into the left ventricle; and

prior to the moving the prosthetic valve distally out of the lumen of the delivery sheath, capturing a distal portion of a tether coupled to the prosthetic valve with the snare device and pulling the portion of the tether through the catheter and outside of the heart.

10. The method of claim 9, further comprising:

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

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

11. The method of claim 8, further comprising:

prior to inserting the delivery sheath through the puncture site in the jugular vein, disposing a dilator and guidewire within the lumen of the delivery sheath such that a portion of the dilator and a portion of the guidewire extend distally from the delivery sheath;

prior to the moving the prosthetic valve distally out of the delivery sheath, moving the distal end of the delivery sheath through the left atrium, through the left ventricle and out through an opening in an apex of the heart; and

withdrawing the dilator and guidewire from the delivery sheath.

12. The method of claim 11, further comprising:

after the withdrawing the dilator and guidewire, moving the delivery sheath such that a distal end portion of the delivery sheath is disposed in the left atrium of the heart.

13. The method of claim 11, further comprising:

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

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

14. The method of claim 11, wherein an epicardial pad device is coupled to a distal end of the guide wire and the tether is movably coupled to the prosthetic valve, the method further comprising:

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

15. The method of claim 14, further comprising:

after securing the epicardial pad device to the apex of the heart, securing the tether to the prosthetic valve;

cutting the tether at a location within the left atrium; and

removing a proximal portion of the tether through the entry site at the jugular vein.

16. The method of claim 8, further comprising:

coupling an epicardial pad device to a tether coupled to and extending from the prosthetic mitral valve; and

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

17. A method, comprising:

inverting an outer frame of a prosthetic mitral valve when the prosthetic mitral valve is in a biased expanded configuration, the prosthetic mitral valve being formed with a shape-memory material;

after the inverting, inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed configuration, while remaining inverted;

inserting the delivery sheath through a trans-atrial entry site directly into a left atrium of a heart of a patient;

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

inserting a snare device through the catheter and into the left ventricle;

capturing a distal portion of a tether coupled to the prosthetic valve with the snare device and pulling the portion of the tether through the catheter and outside of the heart;

after the capturing, moving the prosthetic mitral valve distally out of the lumen of the delivery sheath such that the inverted outer frame of the prosthetic mitral valve reverts and the prosthetic mitral valve assumes its biased expanded configuration; and

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

18. A method, comprising:

inverting an outer frame of a prosthetic mitral valve when the prosthetic mitral valve is in a biased expanded configuration, the prosthetic mitral valve being formed with a shape-memory material;

after the inverting, inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed configuration, while remaining inverted;

disposing a dilator and guidewire within a lumen of the delivery sheath such that a portion of the dilator and a portion of the guidewire extend distally from the delivery sheath;

after the disposing, inserting the delivery sheath through a trans-atrial entry site directly into a left atrium of a heart of a patient;

moving the distal end of the delivery sheath through the left atrium, through the left ventricle of the heart and out through an opening in an apex of the heart;

after the moving, moving the prosthetic mitral valve distally out of the lumen of the delivery sheath such that the inverted outer frame of the prosthetic mitral valve reverts and the prosthetic mitral valve assumes its biased expanded configuration;

withdrawing the dilator and guidewire from the delivery sheath; and

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

19. A method, comprising:

inverting an outer frame of a prosthetic mitral valve when the prosthetic mitral valve is in a biased expanded configuration, the prosthetic mitral valve being formed with a shape-memory material;

after the inverting, inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed configuration, while remaining inverted;

inserting the delivery sheath through a puncture site in a jugular vein of a patient, through the superior vena cava of the patient, and through the atrial septum wall of a heart of the patient and into the left atrium of the heart;

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

inserting a snare device through the catheter and into the left ventricle

capturing a distal portion of a tether coupled to the prosthetic valve with the snare device and pulling the portion of the tether through the catheter and outside of the heart;

after the capturing, moving the prosthetic mitral valve distally out of the lumen of the delivery sheath such that the inverted outer frame of the prosthetic mitral valve reverts and the prosthetic mitral valve assumes its biased expanded configuration; and

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

20. A method, comprising:

inverting an outer frame of a prosthetic mitral valve when the prosthetic mitral valve is in a biased expanded configuration, the prosthetic mitral valve being formed with a shape-memory material;

after the inverting, inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed configuration, while remaining inverted;

disposing a dilator and guidewire within a lumen of the delivery sheath such that a portion of the dilator and a portion of the guidewire extend distally from the delivery sheath;

after the disposing, inserting the delivery sheath through a puncture site in a jugular vein of a patient, through the superior vena cava of the patient, and through the atrial septum wall of a heart of the patient and into a left atrium of the heart;

moving the distal end of the delivery sheath through the left atrium, through the left ventricle of the heart and out through an opening in an apex of the heart;

withdrawing the dilator and guidewire from the delivery sheath;

after the moving, moving the prosthetic mitral valve distally out of the lumen of the delivery sheath such that the inverted outer frame of the prosthetic mitral valve reverts and the prosthetic mitral valve assumes its biased expanded configuration; and

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