System and method for correcting valve regurgitation

• US 10,342,958 B2
• Filed: 06/30/2017
• Issued: 07/09/2019
• Est. Priority Date: 06/30/2017
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wei, Michael F., Snell, Anna M., Mahmoud, Tamer M., Mosher, Scott C.
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Gabr, Mohamed G
• Application Number:
  US15/639,324
• Publication Number:
  US 20190001104A1
• Time in Patent Office: 739 Days
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method for improving function of a cardiac valve in a patient, the cardiac valve having at least one leaflet that is attached to a papillary muscle: Inserting a balloon, that is in a first uninflated condition and having a first diameter, within tissue that is part of to the papillary muscle, and thereby separating tissue that was previously connected together, by a maximum amount equal to the first diameter; inflating the balloon to a second inflated condition having a second diameter greater than the first diameter, thereby permanently stretching tissue in the papillary muscle and separating the tissue from the first diameter to a maximum amount equal to the second diameter; deflating the balloon to the first uninflated condition, and thereby returning the tissue to a separation of a maximum amount substantially equal to the first diameter; and then removing the balloon from the patient.

Claims

1. A method for improving function of a cardiac valve in a heart of a patient, the cardiac valve having at least one leaflet that is attached to a papillary muscle, the method comprising the steps of:

inserting an expandable device, that is in a first unexpanded condition and having a first diameter, within tissue that is part of the papillary muscle and thereby, separating tissue that was previously connected together, by a first distance;

expanding the expandable device to a second expanded condition having a second diameter greater than the first diameter, thereby permanently stretching tissue in the papillary muscle and separating the tissue that is part of the papillary muscle by a second distance greater than the first distance;

unexpanding the expandable device to the first unexpanded condition, and thereby returning the tissue that is part of a papillary muscle to a separation of a third distance substantially equal to the first distance; and

then removing the expandable device from the patient, without leaving any substance within the tissue that is part of the papillary muscle.

2. The method of claim 1, wherein inserting an expandable device includes inserting a balloon, and expanding the expandable device includes inflating the balloon.

3. The method of claim 1, wherein expanding the expandable device to a second expanded condition includes expanding the expandable device to the second diameter, and then leaving the expandable device for a period of time in the second expanded condition before unexpanding the expandable device.

4. The method of claim 1, wherein inserting an expandable device within tissue that is part of the papillary muscle includes inserting the expandable device from outside the heart, through a wall of the heart, and into the tissue.

5. The method of claim 4, wherein inserting an expandable device includes inserting the expandable device through the wall of the heart into a space defined by the left ventricle, and then into the papillary muscle.

6. The method of claim 1, wherein inserting an expandable device within tissue that is part of the papillary muscle includes inserting the expandable device via an aortic valve and then via a left ventricle before inserting the expandable device within the tissue.

7. The method of claim 1, further including re-expanding the expandable device after the unexpanding step, and before the removing step.

8. The method of claim 7, wherein re-expanding the expandable device includes taking measurements of a degree of coaptation being achieved by leaflets in the heart before the re-expanding step.

9. The method of claim 1, further including treating a surface of tissue that was previously connected to adjacent tissue with a scar inhibiting agent.

10. The method of claim 9, wherein treating a surface with a scar inhibiting agent includes treating the surface with Neosporin.

11. A method for improving function of a cardiac valve in a heart of a patient, the cardiac valve having at least one leaflet that is attached to a papillary muscle, the method comprising the steps of:

inserting an expandable device within tissue that is part of the papillary muscle;

expanding the expandable device and thereby permanently stretching tissue in the papillary muscle;

unexpanding the expandable device and thereby leaving within the tissue a void not previously present within the tissue; and

removing the expandable device from the patient without leaving any implant device in the papillary muscle.

12. The method of claim 11, wherein expanding the expandable device includes inflating a balloon.

13. The method of claim 11, after the expanding step, the expandable device is left expanded for a period of time before the unexpanding step.

14. The method of claim 11, wherein inserting an expandable device within tissue that is part of the papillary muscle includes inserting the expandable device from outside the heart, through a wall of the heart, and into the tissue.

15. The method of claim 14, wherein inserting an expandable device includes inserting the expandable device through the wall of the heart into a space defined by the left ventricle, and then into the papillary muscle.

16. The method of claim 11, wherein inserting an expandable device within tissue that is part of the papillary muscle includes inserting the expandable device via an aortic valve and then via a left ventricle before inserting the expandable device within the tissue.

17. The method of claim 11, further including re-expanding the expandable device after the unexpanding step, and before the removing step.

18. The method of claim 17, wherein re-expanding the expandable device includes taking measurements of a degree of coaptation being achieved by leaflets in the heart before the re-expanding step.

19. The method of claim 11, further including treating a surface of tissue that was previously connected to adjacent tissue with a scar inhibiting agent.

20. The method of claim 19, wherein treating a surface with a scar inhibiting agent includes treating the surface with Neosporin.