METHODS FOR DEPLOYING A PROSTHESIS

• US 20110071623A1
• Filed: 11/24/2010
• Published: 03/24/2011
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: Finch, Matthew J., McNamara, Edward
• Granted Patent: US 10,610,210 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 catheter, the method comprising:

attaching an inner control wire of the catheter to a first portion of a control device;

attaching an outer sheath of the catheter to a second portion of the control device;

advancing the catheter to a desired location adjacent to the atrial septum of the patient, such that a tip of the catheter is in the left atrium;

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

retracting the outer sheath a first instance of a fixed length by a first actuation of the control device and exposing a left atrium flange and legs of the implantable prosthesis.

2. The method of claim 1, further comprising retracting the outer sheath a second instance of the fixed length by a second actuation of the control device and exposing a right atrium flange of the implantable prosthesis.

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

4. The method of claim 1, wherein the fixed length is determined by a tab on the first portion of the control device and orifices on the second portion of the control device.

5. The method of claim 4, further comprising additional discrete steps of retracting the outer sheath to expose greater portions of the implantable prosthesis, wherein lengths of retracting the outer sheath in the additional steps are fixed but are not equal to the fixed length.

6. The method of claim 5, wherein the discrete steps are determined by spacing of the series of orifices on the second portion of the control device.

7. 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.

8. The method of claim 7, further comprising repositioning the catheter within the patient or removing the catheter from the patient.

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

10. The method of claim 1, further comprising flushing the catheter with sterile solution before the steps of attaching.

11. The method of claim 1, wherein the prosthesis is contained within a shipping sheath, and further comprising withdrawing the prosthesis from the shipping sheath and into the outer sheath before the steps of attaching.

12. A method of deploying an implantable prosthesis within a patient via a catheter, the method comprising:

attaching an inner control wire of the catheter to a first slider of a control device;

attaching an outer sheath of the catheter to a second slider of the control device;

advancing the catheter to a desired location adjacent or within an atrial septum of the patient;

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

retracting the outer sheath a first instance of a fixed length by a first movement between bores of the control device, exposing a left atrium flange of the implantable prosthesis.

13. The method of claim 12, further comprising securing a position of the second slider via a pin in a bore.

14. The method of claim 12, further comprising retracting the outer sheath a second instance of the fixed length by a second movement between the bores of the control device, exposing a right atrium flange of the implantable prosthesis.

15. The method of claim 12, further comprising verifying a location of the left atrium flange, and if the location is not desired, advancing the outer sheath to recover the left atrium flange.

16. The method of claim 15, further comprising repositioning the catheter within the patient or removing the catheter from the patient.

17. The method of claim 12, further comprising visually inspecting the prosthesis through a shipping sheath before the steps of attaching.

18. The method of claim 12, further comprising flushing the catheter with sterile solution before the steps of attaching.

19. The method of claim 12, wherein the prosthesis is contained within a shipping sheath, and further comprising withdrawing the prosthesis from the shipping sheath and into the outer sheath before the steps of attaching.

20. A method of deploying an implantable prosthesis in a patient via a catheter, the method comprising:

attaching an inner control wire of the catheter to a first portion of a control device;

attaching an outer sheath of the catheter to a second portion of the control device;

advancing the catheter to a desired location adjacent to the atrial septum of the patient, such that a tip of the catheter is 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 by a first actuation of the control device and exposing a left atrium flange and legs of the implantable prosthesis; and

retracting the outer sheath a second instance of a fixed length by a second actuation of the control device and exposing a right atrium flange and legs of the implantable prosthesis,

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

21. The method of claim 20, wherein the first and second fixed lengths are equal.

22. The method of claim 20, wherein the first length is at least 1 mm longer than the second length.