MOUNTING TOOL FOR LOADING A PROSTHESIS

• US 20110295366A1
• Filed: 11/24/2010
• Published: 12/01/2011
• Est. Priority Date: 11/07/2007
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: Finch, Matthew J., McNamara, Edward, Sugimoto, Hiroatsu
• Granted Patent: US 8,752,258 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
• 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 mounting tool for a prosthesis, the mounting tool comprising:

a bottom plate having a central raised portion;

a top plate having a first surface with a central area in a geometrical shape, the central raised portion and the geometrical shape suitable for capturing legs of the prosthesis between a top surface of the central raised portion and a bottom surface of the geometrical shape;

a lower disc formed in a plurality of portions, the lower disc having a central bore, the plurality of lower disc portions joined by at least one of tabs, slots, magnets and magnetic materials; and

an upper disc formed in a plurality of portions and having a central bore, the plurality of upper disc portions joined by at least one of tabs, slots, magnets and magnetic material,

wherein the lower and upper discs are suitable for separate insertion between upper and lower portions of the prosthesis to separate the upper portion of the prosthesis from the lower portion of the prosthesis.

2. The mounting tool of claim 1, wherein the top plate comprises a plurality of polar magnets oriented with all poles selected from one of the group consisting of north poles and south poles oriented in an upward direction, and the bottom plate further comprises a plurality of polar magnets oriented with all poles selected from the other of the group consisting of north poles and south poles oriented in a downward direction.

3. The mounting tool of claim 1, further comprising a chamfer on an outer diameter of the lower and upper discs.

4. The mounting tool of claim 1, wherein the central raised portion comprises a generally cylindrically shaped lower portion with a first diameter and a generally cylindrically shaped upper portion with a second diameter less than the first diameter.

5. The mounting tool of claim 4, wherein the central bore of the lower and upper discs has a diameter intermediate between the first and second diameters.

6. The mounting tool of claim 1, wherein a second surface of the top plate further comprises a counterbore.

7. The mounting tool of claim 1, wherein the top and bottom plates further comprise joining features selected from the group consisting of:

magnets and materials attracted to magnets;

tabs and slots;

grooves and slots; and

mortise and tenon.

8. The mounting tool of claim 1, wherein the upper disc has a counterbore on a first upper face.

9. The mounting tool of claim 1, wherein the geometrical shape is a star, the star having a same number of points as a number of apices of a lower flange of the prosthesis.

10. The mounting tool of claim 1, wherein each of the upper disc and lower disc is formed as two portions in a general shape of a semicircle.

11. A mounting tool for a prosthesis, the mounting tool comprising:

a bottom plate having a central raised portion;

a top plate having a top surface with a central area in a geometrical shape, the central area and the geometrical shape suitable for capturing legs of the prosthesis between a top surface of the central raised portion and a bottom surface of the geometrical shape;

a lower disc formed in two portions, the lower disc having a central bore, the lower disc portions joined by at least one of tabs, slots and magnets; and

an upper disc formed in two portions and having a central bore, the upper disc portions joined by at least one of tabs, slots and magnets,

wherein the lower and upper discs are suitable for separate insertion between upper and lower portions of the prosthesis to separate the upper portion of the prosthesis from the lower portion of the prosthesis.

12. The mounting tool of claim 11, wherein the geometrical shape is a star having a plurality of points.

13. The mounting tool of claim 11, wherein the bottom plate, top plate, lower disc and upper disc are molded from a material selected from the group consisting of a fluoropolymer, fluorinated ethylene-propylene, PTFE, UHMWPE, acetal and polycarbonate.

14. The mounting tool of claim 11, wherein each half of the upper and lower discs further comprises two polar magnets oriented in a single orientation, such that one half of each of the upper and lower discs comprises outward-facing north poles and the other half of each of the upper and lower discs comprises outward-facing south poles.

15. The mounting tool of claim 14, wherein each half further comprises a tab having a shape of a dowel or a slot having a shape of a bore, such that one half of each of the upper and lower discs comprises a dowel and the other half of each of the upper and lower discs comprises a bore for accommodating the dowel.

16. The mounting tool of claim 15, wherein one half of the upper disc has a tab and two magnets with outward-facing poles selected from one of the group consisting of north poles and south poles, and wherein one half of the lower disc has a tab and two magnets with outward-facing poles selected from the other of the group consisting of north poles and south poles.

17. The mounting tool of claim 11, wherein the upper disc has a thickness greater than a thickness of the lower disc.

18. The mounting tool of claim 11, wherein the upper disc has a counterbore on a first upper face, the counter bore suitable for mounting on a loading tool.

19. A mounting tool for a prosthesis, the mounting tool comprising:

a bottom plate having a first central raised portion having a first diameter and a first height and also having a second central raised portion rising from the first central raised portion, the second central raised portion having a second diameter less than the first diameter and second height greater than the first height;

a top plate having a top surface with a central area in a geometrical shape, the first central raised portion and the geometrical shape suitable for capturing legs of the prosthesis between a top surface of the first central raised portion and a bottom surface of the geometrical shape;

a lower disc formed in two portions, the lower disc having a central bore, the lower disc portions joined by at least one of tabs, slots and magnets; and

an upper disc formed in two portions and having a central bore with a diameter about equal to a diameter of the central bore of the lower disc, the upper disc portions joined by at least one of tabs, slots and magnets,

wherein the lower and upper discs are suitable for separate insertion between upper and lower portions of the prosthesis to separate the upper portion of the prosthesis from the lower portion of the prosthesis.

20. The mounting tool of claim 19, wherein the geometric shape is a nine-pointed star.

21. A tool for loading an implantable device onto a catheter delivery system, the catheter delivery system comprising an inner wire and an outer sheath covering said inner wire, the tool comprising:

a first plate having a channel in a first side of said plate and a circular opening for accommodating the catheter delivery system and the implantable device;

an adjustable pressure plate fitting in said opening;

a mechanism comprising two sections forming a circular opening when said sections are in contact with one another; and

a second plate aligned vertically with and above the circular opening of the first plate, the second plate comprising a mechanism to adjustably close the opening,

wherein said pressure plate is configured for adjustment in a direction toward said second plate when the implantable device is placed thereon, and which causes said implantable device to come into contact with said second plate; and

wherein at least one of said first and second plates is adjustable in a direction away from the other of said first and second plates when said implantable device is in contact with said second plate and said pressure plate thereby causing said implantable device to be stretched into a loadable position.