Transapical valve replacement

• US 10,058,313 B2
• Filed: 05/12/2016
• Issued: 08/28/2018
• Est. Priority Date: 05/24/2011
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Manasse, Eric
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US15/153,475
• Publication Number:
  US 20160256143A1
• Time in Patent Office: 838 Days
• Field of Search: 606185, 623 211
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• 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: A61F 2/2436 Deployment by retracting a sheath

Abstract

Techniques for reaching the interior of the heart, such as for aortic valve replacement, can combine elements of percutaneous implantation methods and elements of surgical implantation methods. In some instances, aortic valve replacement may include a dual transapical approach in which a transfemoral approach is used to reach the apex of the patient'"'"'s heart from inside the left ventricle while a minimally invasive surgical procedure provides access to the exterior of the apex via an intercostal approach.

Claims

1. A transapical method of gaining access to an interior of a patient'"'"'s heart, the method comprising steps of:

advancing a first hollow needle into a patient'"'"'s chest through an intercostal space that is above the apex of the patient'"'"'s heart;

advancing a guidewire through the first hollow needle;

advancing an S-shaped catheter through the first hollow needle and over the guidewire such that the S-shaped catheter has a distal end positioned proximate the apex of the patient'"'"'s heart and exterior to the patient'"'"'s pericardial sac;

advancing a second hollow needle through the S-shaped catheter to a position exterior to the patient'"'"'s pericardial sac;

penetrating the pericardial sac with the second hollow needle;

penetrating the heart wall of the patient'"'"'s heart;

advancing a first catheter including a first inflatable balloon on a distal region of the first catheter through the second hollow needle and into the patient'"'"'s heart; and

inflating the first inflatable balloon to provide a first seal between the first catheter and the heart wall.

2. The method of claim 1, comprising pulling on the first catheter to lift the apex of the heart to a higher position proximate the intercostal space through which the first hollow needle was advanced.

3. The method of claim 1, comprising partially withdrawing the first catheter to lift the apex of the heart to a higher position proximate the intercostal space through which the first hollow needle was advanced.

4. The method of claim 1, wherein penetrating the heart wall of the patient'"'"'s heart comprises penetrating the heart wall of the patient'"'"'s heart with the second hollow needle.

5. The method of claim 1, wherein penetrating the heart wall of the patient'"'"'s heart comprises:

advancing a cutting catheter bearing a cutting blade through the second hollow needle; and

penetrating the heart wall with the cutting blade.

6. The method of claim 1, comprising:

advancing a second catheter including a second inflatable balloon on a distal region of the second catheter through the S-shaped catheter to outside the heart wall; and

inflating the second inflatable balloon to provide a second seal between the second catheter and the heart wall.

7. The method of claim 1, comprising advancing a port over the first catheter and into the patient'"'"'s heart to provide access for delivery of a replacement valve.

8. The method of claim 7, comprising deflating the first inflatable balloon prior to advancing the port over the first catheter.

9. The method of claim 7, comprising providing structure in the port to secure the port to the heart wall.

10. The method of claim 7, comprising providing an inner flange and an outer flange on the port to secure the port to the heart wall.

11. The method of claim 7, wherein the port includes an internal valve that permits deliveries through the internal valve while preventing fluids from leaking through the port.

12. A transapical method of gaining access to an interior of a patient'"'"'s heart, the method comprising steps of:

advancing a first hollow needle into a patient'"'"'s chest through an intercostal space that is above the apex of the patient'"'"'s heart;

advancing a guidewire through the first hollow needle;

advancing an S-shaped catheter through the first hollow needle and over the guidewire such that the S-shaped catheter has a distal end positioned proximate the apex of the patient'"'"'s heart and exterior to the patient'"'"'s pericardial sac;

advancing a second hollow needle through the S-shaped catheter to a position exterior to the patient'"'"'s pericardial sac;

penetrating the pericardial sac with the second hollow needle;

penetrating the heart wall of the patient'"'"'s heart via the second hollow needle; and

advancing a port into the patient'"'"'s heart through the penetration in the heart wall made via the second hollow needle to provide access for delivery of a replacement valve.

13. The method of claim 12, comprising:

advancing a catheter including an inflatable balloon on a distal region of the catheter through the second hollow needle and into the patient'"'"'s heart; and

inflating the inflatable balloon to provide a seal between the catheter and the heart wall.

14. The method of claim 13, wherein advancing a port into the patient'"'"'s heart comprises:

deflating the inflatable balloon; and

advancing the port over the catheter including the inflatable balloon.

15. The method of claim 12, comprising providing structure in the port to secure the port to the heart wall.

16. The method of claim 12, comprising providing an inner flange and an outer flange on the port to secure the port to the heart wall.

17. The method of claim 12, wherein the port includes an internal valve that permits deliveries through the internal valve and prevents fluids from leaking through the port.