Methods and systems for accessing a pericardial space and preventing strokes arising from the left atrial appendage

• US 9,186,174 B2
• Filed: 08/22/2013
• Issued: 11/17/2015
• Est. Priority Date: 08/22/2012
• Status: Active Grant

• Current Assignee: Subramaniam Chitoor Krishnan
• Original Assignee: Subramaniam Chitoor Krishnan
• Inventors: Krishnan, Subramaniam Chitoor
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Vahdat, Khadijeh
• Application Number:
  US13/973,949
• Publication Number:
  US 20140058371A1
• Time in Patent Office: 817 Days
• Field of Search: 606/27, 606/33, 606/34, 606/41, 606/50, 604/96.01
• US Class Current: 1/1
• 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 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0495 Reinforcements for suture lines
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

The invention presents methods and systems for accessing a pericardial space and preventing strokes arising from a left atrial appendage (“LAA”) by achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium. A complete occlusion of the LAA is desired because bleeding arising from the LAA often leads to embolic strokes. Due to the peculiar anatomy of the LAA ostium, traditional LAA ligation techniques using sutures can lead to puckering, thus compromising the occlusion of the LAA. The invention achieves a complete occlusion and a more effective hemostatic seal with the use of inflatable balloons having electromagnetic coils internally, as well as hydrogels, sponges, and caliber tubes attached to the respective balloon'"'"'s exterior, anchoring balloons, a closure device having a suture looped through two semi-rigid hollow tube that can be coated with hydrogel or silicone, and locking mechanisms.

Claims

1. A method for accessing a pericardial cavity and preventing strokes arising from a left atrial appendage (LAA), said method comprising:

introducing a catheter into a body cavity, wherein the catheter comprises an inner sheath, an outer sheath, and an inner catheter;

advancing a distal end of the inner sheath to position the distal end of the inner sheath in an interior of the LAA;

inflating a first inflatable balloon, wherein the first inflatable balloon is on the distal end of the inner sheath, wherein the first inflatable balloon is non-compliant, and wherein the first balloon is inflated within the LAA interior adjacent to an ostium of the LAA;

pulling the inflated first balloon in a direction from within the LAA interior and towards the LAA ostium;

inflating a second inflatable balloon, wherein the second balloon is on the distal end of the inner sheath, wherein the second balloon is inflated within a distal portion of the LAA interior, and wherein upon inflation, the inflated second balloon pushes the inflated first balloon towards the LAA ostium;

advancing a distal end of the outer sheath to position the distal end of the outer sheath in a portion of the left atrium adjacent to the LAA ostium;

inflating a third inflatable balloon, wherein the third balloon is on the distal end of the outer sheath, and wherein the third balloon is inflated within a portion of the left atrium adjacent to the LAA ostium;

pushing the inflated third balloon in a direction from within the left atrium portion adjacent to the LAA ostium and towards the LAA ostium;

activating a locking mechanism to lock the outer sheath with the inner sheath, thereby rendering stationary the inflated balloons;

advancing a distal end of the inner catheter to position the distal end of the inner catheter within a distal portion of the LAA interior near an apex of the LAA;

puncturing a wall of the LAA interior near or at the LAA apex using a tissue-penetrating tip, wherein the tissue-penetrating tip is on the distal end of the inner catheter;

advancing the distal end of the inner catheter into and through the pericardial cavity to position the distal end of the inner catheter at a desired site of exteriorization;

puncturing a wall of the pericardial cavity at the desired site of exteriorization using the tissue-penetrating tip;

externalizing the inner catheter at the desired site of exteriorization;

advancing a proximal end of the inner catheter to the distal portion of the LAA near the LAA apex;

inflating a fourth inflatable balloon, wherein the fourth balloon is on the proximal end of the inner catheter, and wherein the fourth balloon is inflated within the distal portion of the LAA interior near the LAA apex;

pulling the inflated fourth balloon in a direction from within the distal portion of the LAA interior near the LAA apex and towards the pericardial cavity to anchor the LAA;

advancing a closure device towards the LAA ostium via the externalized inner catheter to position the closure device over the exterior of the LAA ostium; and

deploying the closure device over the exterior of the LAA ostium.

2. The method of claim 1, further comprising the step of:

injuring at least a portion of an interior surface of the LAA ostium.

3. The method of claim 2, wherein at the step of injuring at least the portion of the interior surface of the LAA ostium, the injuring is achieved by delivering a heated liquid through the first and third inflated balloons.

4. The method of claim 2, wherein at the step of injuring at least the portion of the interior surface of the LAA ostium, the injuring is achieved by delivering radiofrequency current through the first and third inflated balloons.

5. The method of claim 1, further comprising the steps of:

deflating the first inflated balloon;

deflating the second inflated balloon;

deflating the third inflated balloon;

deactivating the locking mechanism;

removing the outer sheath from the body cavity; and

removing the inner sheath from the body cavity.

6. The method of claim 1, wherein at the steps of inflating the first and the third inflatable balloons, the first inflatable balloon has a first set of electromagnetic coils located within the first balloon, the third inflatable balloon has a second set of electromagnetic coils located within the third balloon, and upon inflation of the first and third balloons, the respective set of electromagnetic coils also expands with the respective balloon.

7. The method of claim 1, wherein at the step of advancing the distal end of the inner catheter to the desired site of exteriorization, the desired site of exteriorization is near a base of a sternum so that the inner catheter follows a subxiphoid path.

8. The method of claim 1, wherein at the step of advancing the distal end of the inner catheter to the desired site of exteriorization, the desired site of exteriorization is a pectoral region.

9. The method of claim 1, wherein at the step of externalizing the inner catheter at the desired site of exteriorization, the inner catheter is externalized by applying a magnetic force to pull the distal end of the inner catheter through the pericardial cavity and outwardly through a punctured skin.

10. The method of claim 1, wherein at the step of deploying the closure device over the exterior of the LAA ostium, the closure device is a suture looped through a pair of semi-rigid hollow tubes, wherein upon the deployment of the closure device, the pair of semi-rigid hollow tubes are clamped along a short diameter of the exterior of the LAA ostium, and the suture is tightened.

11. The method of claim 1, further comprising the step of inflating a fifth inflatable balloon, wherein the fifth balloon is on the distal end of the outer sheath, and wherein the fifth balloon is inflated within a portion of the left atrium adjacent to an interatrial septum.