DEVICES FOR RETRIEVING A PROSTHESIS

• US 20110071624A1
• 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 9,456,812 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 retrieval device, comprising:

an outer sheath;

a basket contained within the outer sheath for deployment outside the outer sheath;

an inner sheath contained within the outer sheath, the inner sheath having an outer diameter smaller than an inner diameter of the outer sheath; and

a grasper contained within the inner sheath for deployment outside the inner sheath to retrieve an implanted atrial septum valve,

wherein the grasper and the basket are controlled for separate deployment from the inner and outer sheaths to retrieve the implanted atrial septum valve.

2. The retrieval device according to claim 1, wherein the basket is made from shape-memory wire.

3. The retrieval device according to claim 1, wherein the basket comprises at least one layer of shape-memory material mesh.

4. The retrieval device according to claim 1, wherein the retrieval device is configured for recovering an atrial septum valve having at least one feature selected from the group consisting of a retrieval wire or suture, a retrieval crimp tube with a retrieval wire or suture, a longer leg with a retrieval orifice and an apex with a retrieval orifice.

5. The retrieval device according to claim 1, wherein the grasper comprises at least one protruding tab for insertion into an orifice of the implanted device.

6. A retrieval device, comprising:

an outer sheath;

a nitinol basket contained within the outer sheath, the basket configured for recovering an implanted atrial septum;

a control wire attached to the nitinol basket;

a grasper contained within the outer sheath; and

a control wire attached to the grasper,

wherein the control wire attached to the nitinol basket is controlled independently from the control wire attached to the grasper, and wherein the nitinol basket and the grasper are controlled for separate deployment to retrieve the implanted atrial septum valve.

7. The retrieval device according to claim 6, further comprising an inner sheath within the outer sheath, the inner sheath containing the grasper.

8. The retrieval device according to claim 6, further comprising non-invasive imaging markers on at least one component selected from the group consisting of the grasper, the nitinol basket, and the outer sheath.

9. The retrieval device according to claim 6, wherein the basket comprises wire having a diameter in the range from about 0.003 inches (about 0.08 mm) to about 0.020 inches (about 0.51 mm).

10. The retrieval device according to claim 6, further comprising a second grasper and a third control wire attached to the second grasper.

11. A retrieval device, comprising:

an outer sheath;

a device tip distal to the outer sheath;

an expanding device within the outer sheath; and

at least one control wire attached to the outer sheath, the device tip or the expanding device,

wherein extension of the device tip and expansion of the expanding device creates a space for retrieval of a deployed atrial septum valve.

12. The retrieval device according to claim 11, wherein the expanding device comprises a balloon.

13. The retrieval device according to claim 11, wherein the retrieval device further comprises a forceps and a capture basket, the forceps and the capture basket each comprising a control wire for controlling advancement and retraction of the forceps and the capture basket.

14. A method of retrieving an atrial septum valve implanted within a mammal, the method comprising:

furnishing a retrieval device for retrieving the atrial septum valve;

advancing the retrieval device within the mammal to a location proximate the atrial septum valve;

checking a location of the atrial septum valve and the retrieval device by a non-invasive imaging technique;

advancing a grasper and grasping the atrial septum valve;

advancing a metal mesh basket near the grasper and the atrial septum valve;

retracting the grasper and the atrial septum valve into an outer sheath of the retrieval device; and

withdrawing the retrieval device and the implanted atrial septum valve from the mammal.

15. The method of claim 14, further comprising making a space near the atrial septum valve.

16. The method of claim 15, wherein making the space is accomplished by inflating a balloon.

17. The method of claim 14, further comprising exchanging an inflation balloon with a grasper and basket before the steps of advancing the grasper and advancing the basket.

18. The method of claim 14, wherein the atrial septum valve has at least one feature selected from the group consisting of a retrieval wire or suture, a retrieval crimp tube with a retrieval wire or suture, a longer leg with a retrieval orifice and an apex with a retrieval orifice.

19. A method of retrieving an atrial septum valve implanted within a mammal, the method comprising:

furnishing a retrieval device for retrieving the implanted atrial septum valve;

advancing the retrieval device within the mammal to a location proximate the implanted atrial septum valve;

checking a location of the implanted atrial septum valve and the retrieval device by a non-invasive technique;

advancing a grasper to the implanted atrial septum valve and grasping the implanted atrium septum valve via a feature selected from the group consisting of a retrieval wire or suture, a retrieval crimp tube with a retrieval wire or suture, a longer leg with a retrieval orifice and an apex with a retrieval orifice;

advancing a basket near the grasper and the implanted atrial septum valve;

retracting the grasper and the implanted atrial septum valve into an outer sheath of the retrieval device; and

withdrawing the retrieval device and the implanted atrial septum valve from the mammal.

20. The method of claim 19, further comprising placing the retrieval device onto a guidewire previously placed into the mammal for implanting the atrial septum valve.

21. The method of claim 19, wherein the grasper is contained within an inner sheath, and further comprising a step of advancing the grasper within the inner sheath before the step of advancing the grasper.

22. The method of claim 19, wherein the step of checking comprises checking via a technique selected from the group consisting of x-raying the mammal, checking via an echographic image on the mammal, and fluoroscoping the mammal.