Methods for deploying a prosthesis

• US 10,610,210 B2
• Filed: 11/24/2010
• Issued: 04/07/2020
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Finch, Matthew J., McNamara, Edward
• Primary Examiner(s): David, Shaun L
• Application Number:
  US12/954,529
• Publication Number:
  US 20110071623A1
• Time in Patent Office: 3,422 Days
• Field of Search: 606213, 606153, 128831, 623 111, 623 211
• 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 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/4423 related to hygiene or sterilisation
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49005 Acoustic transducer
• CPC Class Codes: Y10T 29/53843 Tube, sleeve, or ferrule inserting or removing
• CPC Class Codes: Y10T 29/53909 Means comprising hand manipulatable tool
• CPC Class Codes: Y10T 29/53913 Aligner or center

Abstract

The present disclosure relates to devices and methods for implanting a prosthesis into a heart of a mammal, such as a person. The disclosure includes a prosthesis that acts as a pressure vent between the left and right atria of the heart. The disclosure also includes a mounting tool for mounting the prosthesis onto a loading tool, the loading tool useful for loading the prosthesis onto a device for delivering the prosthesis into the patient'"'"'s heart. Control devices and methods for using these devices are also disclosed. The intracardiac pressure vents disclosed allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms. The devices also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombi or other embolic material from entering arterial circulation.

Claims

1. A method of deploying an implantable prosthesis in a patient via a placement catheter, wherein the placement catheter comprises an inner control wire and an outer sheath slidably disposed over the inner control wire, the method comprising:

folding a left atrium flange and a right atrium flange of the implantable prosthesis away from each other with distal ends of flange segments of the right atrium flange aligning with a first position of the inner control wire;

stowing the outer sheath onto the folded implantable prosthesis;

advancing both the inner control wire and the outer sheath to a desired location adjacent to the atrial septum of the patient, such that distal ends of both the inner control wire and the outer sheath are in the left atrium;

verifying the desired location via a non-invasive imaging technique;

retracting the outer sheath a first instance of a fixed length proximally by a first actuation of a slider of a control device while maintaining the distal end of the inner control wire within the left atrium, and exposing a left atrium flange and legs of the implantable prosthesis in the left atrium, wherein a proximal end of the inner control wire is attached to a first portion of the control device; and

while keeping the aligning between the distal ends of flange segments of the right atrium flange and the first position of the inner control wire, retracting the placement catheter and partially exposed implantable prosthesis toward a right atrium until the left atrium flange is in contact with a left atrial side of the atrial septum;

retracting the outer sheath a second instance of a fixed length proximally by a second actuation of the slider of the control device while maintaining the distal end of the inner control wire within the left atrium, and exposing the right atrium flange of the implantable prosthesis in the right atrium, wherein a proximal end of the outer sheath is attached to a second portion of the control device,

wherein the first and second fixed lengths are determined by fixed lengths of a track in the control device.

2. The method of claim 1, wherein the first and second actuations comprise movement of a slider controlled by first and second lengths of the track molded into a control handle.

3. The method of claim 1, further comprising verifying a location of the left atrium flange, and if the location is not desired, advancing the sheath or retracting the inner control wire to recover the left atrium flange.

4. The method of claim 3, further comprising repositioning the catheter within the patient or removing the catheter from the patient.

5. The method of claim 1, further comprising visually inspecting the prosthesis through a shipping sheath before the steps of attaching.

6. The method of claim 1, wherein the first and second fixed lengths are equal.

7. The method of claim 1, wherein the first length is at least 1 mm longer than the second length.

8. The method of claim 1, further comprising flushing the catheter with sterile solution, wherein the steps of attaching are accomplished after the step of flushing.

9. The method of claim 1, further comprising adjusting a position of the implantable prosthesis by moving the inner control wire.

10. The method of claim 1, further comprising adjusting a position of the implantable prosthesis by rotary actuation of a wheel connected to a moveable retainer.

11. The method of claim 1, wherein the control device comprises a hollow cylindrical body.