Apparatus and methods to create and maintain an intra-atrial pressure relief opening

• US 8,882,697 B2
• Filed: 02/10/2012
• Issued: 11/11/2014
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: McNamara, Edward, Sutherland, Michael W., Sugimoto, Hiroatsu, Celermajer, David
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US13/370,913
• Publication Number:
  US 20120259263A1
• Time in Patent Office: 1,005 Days
• Field of Search: 604/8, 604/9, 604/500, 604/506, 604/507, 604/508, 604/509, 604/510, 604/20, 604/22, 604/164.01, 604/164.09, 604/164.1, 604/164.11, 604/164.13, 604/171, 600/101, 600/104, 600/184, 606/27, 606/28, 606/29, 606/30, 606/31, 606/32, 606/33, 606/45
• US Class Current: 604/8
• 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 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• 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 2017/00575 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0237 for heart surgery
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00351 : Heart
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/503 : for diagnosis of the heart
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 8/0883 : for diagnosis of the heart
• CPC Class Codes: A61F 2/06 : Blood vessels
• 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: A61F 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2475 : Venous valves
• CPC Class Codes: A61M 2025/0039 : characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09008 : having a balloon
• 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 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 : having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 27/002 : Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Claims

1. A method for normalizing elevated blood pressure in a heart chamber, the method comprising:

penetrating an atrial septum between a right atrium and a left atrium of a heart to create an opening in the atrial septum;

increasing the opening to a larger size to create an intra-atrial pressure relief opening;

after the increasing step, treating tissue near the intra-atrial pressure relief opening to slow a natural healing process of the tissue to maintain patency of the intra-atrial pressure relief opening without implanting a stent or valve in the intra-atrial pressure relief opening; and

permitting blood to flow from the left atrium to the right atrium through the intra-atrial pressure relief opening to reduce left atrial pressure.

2. The method according to claim 1, wherein the treating step comprises delivering energy to the tissue near the intra-atrial pressure relief opening.

3. The method according to claim 1, wherein the treating step comprises delivering medication or a combination of medications to the tissue near the intra-atrial pressure relief opening.

4. The method according to claim 1, wherein the treating step comprises delivering an anti-proliferative or immunosuppressive drug to the tissue near the intra-atrial pressure relief opening.

5. The method according to claim 1, wherein the treating step comprises ablating, heating or cooling the tissue near the intra-atrial pressure relief opening.

6. The method according to claim 1, wherein the treating step comprises providing radiation energy to the tissue near the intra-atrial pressure relief opening.

7. The method according to claim 1, wherein the treating step comprises exuding ethyl alcohol from a balloon catheter into the tissue near the intra-atrial pressure relief opening.

8. The method according to claim 1, wherein the increasing step comprises enlarging the opening with a balloon catheter or with a conical distal tip of a catheter.

9. The method of claim 1, wherein the increasing step comprises using RF ablation.

10. The method of claim 1, wherein the increasing step comprises creating an intra-atrial pressure relief opening having a diameter from about 5 mm to about 10 mm.

11. The method of claim 1, wherein the treating step comprises

preparing a balloon with a medication on an outer surface of the balloon;

deploying the balloon within the intra-atrial pressure relief opening using a sheath; and

inflating the balloon to apply the medication to an inner surface of the intra-atrial pressure relief opening.

12. The method of claim 1, wherein the treating step comprises applying an adhesive, a fixative or an adhesion prevention substance to the tissue near the intra-atrial pressure relief opening.

13. The method of claim 1 wherein the increasing step comprises removing tissue from the atrial septum.

14. The method of claim 1 wherein the increasing step comprises inserting a retracting device from the right atrium through the atrial septum into the left atrium and grasping tissue with the retracting device.

15. The method of claim 14, wherein the retracting device comprises a plurality of legs, each leg comprising at least two struts and one apex.

16. A method for normalizing elevated blood pressure in a heart chamber, the method comprising:

creating an intra-atrial pressure relief opening in an atrial septum between a right atrium and a left atrium, the intra-atrial pressure relief opening having a diameter from about 5 mm to about 10 mm;

treating tissue near the intra-atrial pressure relief opening to slow a natural healing process of the tissue to maintain patency of the intra-atrial pressure relief opening without implanting a stent or valve in the intra-atrial pressure relief opening; and

permitting blood to flow from the left atrium to the right atrium through the intra-atrial pressure relief opening to reduce left atrial pressure.

17. The method according to claim 16, wherein the treating step comprises delivering energy to the tissue near the intra-atrial pressure relief opening.

18. The method according to claim 16, wherein the treating step comprises delivering medication or a combination of medications to the tissue near the intra-atrial pressure relief opening.

19. The method according to claim 16, wherein the treating step comprises delivering an anti-proliferative or immunosuppressive drug to the tissue near the intra-atrial pressure relief opening.

20. The method according to claim 16, wherein the treating step comprises ablating, heating or cooling the tissue near the intra-atrial pressure relief opening.

21. The method according to claim 16, wherein the treating step comprises providing radiation energy to the tissue near the intra-atrial pressure relief opening.

22. The method according to claim 16, wherein the treating step comprises exuding ethyl alcohol from a balloon catheter into the tissue near the intra-atrial pressure relief opening.

23. The method of claim 16, wherein the treating step comprises applying an adhesive, a fixative or an adhesion prevention substance to the tissue near the intra-atrial pressure relief opening.

24. The method according to claim 16, wherein the creating step comprises inserting a balloon catheter or a conical distal tip of a catheter into the atrial septum.

25. The method of claim 16, wherein the creating step comprises using RF ablation.

26. The method of claim 16 wherein the creating step comprises removing tissue from the atrial septum.

27. The method of claim 16 wherein the creating step comprises inserting a retracting device from the right atrium through the atrial septum into the left atrium and grasping tissue with the retracting device.

28. The method of claim 27, wherein the retracting device comprises a plurality of legs, each leg comprising at least two struts and one apex.