METHODS FOR LOADING A PROSTHESIS

• US 20110295182A1
• Filed: 11/24/2010
• Published: 12/01/2011
• 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, Forcucci, Stephen J., Sugimoto, Hiroatsu
• Granted Patent: US 8,745,845 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• 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 mounting a prosthesis, the method comprising:

placing a lower portion of the prosthesis onto a bottom plate;

placing a top plate having a central geometrical shape onto the bottom plate, wherein protruding lower portions of the prosthesis are held onto the bottom plate with portions of the geometrical shape;

installing a lower disc between the top plate and an upper portion of the prosthesis;

installing an upper disc between the lower disc and the upper portion of the prosthesis, wherein the upper and lower portions of the prosthesis are separated by installing the upper and lower discs; and

removing the top and bottom plates to form a mounted prosthesis.

2. The method of claim 1, wherein the lower portion of the prosthesis has a plurality of legs and apices and the geometrical cutout has a general shape of a star with a same number of star points as the plurality of apices of the lower portion of the prosthesis.

3. The method of claim 1, further comprising forming each of the upper and lower discs in a plurality of portions, and wherein the steps of installing are performed by removably joining the plurality of portions.

4. The method of claim 1, further comprising forming each of the upper and lower discs in two portions and wherein the steps of installing are performed by removably joining the two portions.

5. The method of claim 1, wherein the prosthesis is a device for implantation into an atrial septum of a patient and the lower portion of the prosthesis is a right atrium flange.

6. The method of claim 1, further comprising placing the mounted prosthesis into a loading tool.

7. The method of claim 1, further comprising:

compressing a right atrium flange from an enlarged diameter to a smaller diameter;

connecting the prosthesis to a control wire; and

pulling the prosthesis into a sheath.

8. The method of claim 7, wherein the step of squeezing the right atrium flange is accomplished by a first step of closing first doors of the loading tool and a second step of closing second doors of the loading tool.

9. The method of claim 8, wherein the second step of closing is accomplished in a direction orthogonal to the first step of closing.

10. The method of claim 7, further comprising placing a compression device within the right atrium flange before completing the step of compressing.

11. A method of mounting a device for implantation into an atrial septum of a patient, the method comprising:

placing a right atrium flange of the device onto a bottom plate;

placing a top plate having a central geometrical cutout onto the bottom plate, wherein protruding portions of the right atrium flange are held onto the bottom plate with portions of the geometrical cutout;

installing a lower disc between the top plate and a left atrium flange of the prosthesis;

installing an upper disc between the lower disc and the left atrium flange of the prosthesis, wherein the right and left atrium flanges of the prosthesis are separated by installing the upper and lower discs; and

removing the top and bottom plates to form a mounted device for implantation.

12. The method of claim 11, further comprising:

compressing the right atrium flange from an enlarged diameter to a smaller diameter;

connecting the prosthesis to a control wire; and

pulling the prosthesis into a catheter.

13. The method of claim 12, further comprising placing a compression sphere within the right atrium flange.

14. The method of claim 11, further comprising placing the mounted device for implantation into a tool for loading the prosthesis into a delivery device.

15. The method of claim 14, wherein the step of placing the mounted device for implantation into the tool for loading is accomplished by placing the upper disc onto a loading mount of the loading tool.

16. The method of claim 12, further comprising connecting the control and wire and the catheter to a control device.

17. A method of mounting a prosthesis onto a delivery device, the method comprising:

mounting a lower disc between a top flange and a bottom flange of the prosthesis;

mounting an upper disc between the lower disc and the top flange of the prosthesis, wherein the top and bottom flanges of the prosthesis are separated by mounting the upper and lower discs onto the prosthesis;

placing the mounted prosthesis onto a loading tool;

compressing the top flange from an enlarged diameter to a smaller diameter;

connecting the prosthesis to a control wire; and

placing the prosthesis into the delivery device.

18. The method of claim 17, wherein the step of placing the prosthesis into the delivery device is accomplished by pulling the prosthesis into a sheath of a catheter or fitting the sheath over the prosthesis.

19. The method of claim 17, wherein the prosthesis is a device for implantation into an atrial septum of a patient, the device comprising a left atrium flange, and right atrium flange and a central septum.

20. The method of claim 17, wherein the top flange is compressed by raising doors on the loading tool.

21. The method of claim 17, further comprising closing a set of separating doors in place.

22. The method of claim 18, further comprising placing a reinforcing loading tube over the sheath before the step of connecting.

23. The method of claim 17, further comprising placing a compression sphere within the right atrium flange before the step of connecting.

24. A method of mounting and loading a prosthetic device, the method comprising:

furnishing a prosthetic device having a first flange and a second flange separated by a central area;

placing the prosthetic device on a moveable surface;

placing at least one device between the first flange and the second flange, separating the first and second flanges;

capturing one of the first flange and second flange between the moveable plate and the at least one device;

inserting a second device between the first flange and second flange; and

raising the second device to further separate the first and second flanges.

25. The method of claim 24, further comprising inserting at least a portion of a catheter through a central portion of the prosthetic device before the step of inserting.

26. The method of claim 24, wherein the moveable plate is a mounting plate.

27. The method of claim 24, wherein the at least one device is a cutout plate.

28. The method of claim 24, wherein the at least one device is at least one pair of sliding doors.

29. The method of claim 24, wherein the second device is an iris for separating the first and second flanges.

30. The method of claim 24, wherein the second device is at least one of a left atrium disc and a right atrium disc.

31. The method of claim 24, wherein the step of capturing is accomplished by firmly securing a cutout plate to the moveable disc.

32. The method of claim 24, further comprising raising the second device to close one of the first and second flanges around a right atrium ball.