WO2018122621A1

WO2018122621A1 - Micro-embolism umbrella balloon

Info

Publication number: WO2018122621A1
Application number: PCT/IB2017/050002
Authority: WO
Inventors: Ans GHAZI FAKIHA
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-01-02
Filing date: 2017-01-02
Publication date: 2018-07-05
Anticipated expiration: 2019-07-02

Abstract

Surgery to replace heart valves is done for valve stenosis or valve regurgitation. During these surgeries, the damaged valve is removed and replaced with an artificial valve. The valve replacement is typically an open-heart surgery. The artificial valve might be mechanical. Others are made out of animal tissue, often from a pig. The goal of the invention is to reduce blood contaminates such as embolized calcium and particulate matter from being released during heart valve surgery into the general circulatory system which can result in end organ infarction. The second goal is to provide a blood free surgical field by obstructing the blood inside the heart or suctioning the blood from the ventricles (venting the heart) to any suction source during heart valves surgery.

Description

MICRO-EMBOLISM UMBRELLA BALLOON

Description

Field of the Invention:

This invention relates generally to medical devices. More particularly, the present invention relates to surgical tool to prevent embolism caused by falling debris inside the heart during valve surgeries.

Background of the Invention:

Surgery to replace heart valves is done for valve stenosis or valve regurgitation. During these surgeries, the damaged valve is removed and replaced with an artificial valve. The valve replacement is typically an open-heart surgery. The artificial valve might be mechanical. Others are made out of animal tissue, often from a pig.

One of the most significant complications of cardiac surgery is the introduction of blood contaminates such as air emboli, atherosclerotic material, mural thrombi, and micro aggregates that either form or are dislodged into the general circulatory system during cardiac surgery. These blood contaminates typically cause the greatest damage if they migrate to the brain where blood contaminates can cause central nervous system complications that include stroke and subtle cognitive changes. Cognitive decline, evident in as many as three quarters of patients at the time of hospital discharge, was present in 30-45% of patients after five years in one longitudinal study.

For example, calcium embolization resulted from valve debridement is a recognized complication of aortic valve operations in patient with calcified aortic valve that may leads to devastating outcomes like brain stroke and end organ ischemia (kidney, heart). The true incidence of calcium embolization during open-heart surgery is unknown, since movement of emboli to areas other than the heart, brain, or kidneys is usually asymptomatic.

Central nervous system (CNS) impairment ranging from stroke or coma to cognitive deficits is a major cause of morbidity after successful heart surgery. The reported frequencies range between 1% and 4% in patients undergoing coronary artery bypass grafting (CABG). Similar rates were found for patients receiving heart valve replacement. Cognitive deficits after heart surgery have been observed in 33% to 83% of patients during the first weeks after surgery. Both stroke and cognitive disturbance are thought to be related to macro-embolism and micro- embolism during surgery.

The evidence of postoperative brain lesions using MRI before and after aortic valve replacement is considered high (38%). Problem:

Calcium embolization is a recognized complication of aortic valve operations. Careful suction and monitoring of debris by the surgeon's assistant is generally used to prevent such complications.

The challenge with this technique are:

1) Some micro particles cannot be visualized with bare eyes,

2) If a small particles felled down inside the heart, the visualization is limited to the small incision which resulted in blind suctioning inside the heart without knowing if succeed or not.

Alternatively, surgical gauze, irrigated with saline, is placed in the left ventricle after valve excision and before further removal of calcium from the aortic annulus.

The major limitations of this technique are:

1) It offers protection only during annulus debridement and not during the valve excision,

2) It requires removal of the gauze before the valve is seated,

3) It can hide small loose fragments that might embolize when the gauze is removed,

4) The gauze may obstruct both the field of vision and the actual removal of calcifications that extend into the base of the anterior mitral valve leaflet.

For those reasons I got motivated to develop such a tool that might lower the incidence of calcium or tissue embolism during open heart surgery.

Prior Art:

There are no inventions to solve this problem but following you can find some for the same problems.

1- US20100211094:

The present invention generally provides an embolic protection device used to collect emboli during the treatment of a stenotic lesion when deployed within the vasculature of a patient. The embolic protection device is relatively easy to deploy past the stenotic area and to be retrieved after the risk of releasing blood clots and thrombi within the vasculature has passed. The embolic protection device includes a core wire, a plurality of attachment cables and filter struts, and a filter member. The distal end of the attachment cables and the proximal end of the filter struts are coupled to the proximal end of the filter member. The proximal end of the attachment cables are coupled to the core wire, while the distal ends of the filter struts form a cage or basket structure. The distal end of the filter member is closed, thereby, forming an annular chamber useful for collecting emboli during treatment of the stenotic area. During treatment, the emboli are forced by the blood flow to move into the most distal part of the annulus chamber where it is caught or held.

2- US20140031857: This disclosure pertains to an embolic protection device comprising a conical filter element having a distal opening; an elongated filter wire disposed along a generatrix of the conical filter element; and a support structure fixedly attached to a distal end of the elongated filter wire and to the conical filter element at the distal opening thereof, wherein the support structure forms a partial circumferential arch along and attached to the distal opening, and further wherein the conical filter element includes a split distal region having an edge which together with the partial circumferential arch of the support structure defines a generally cylindrical passage through at least a portion of the conical filter element, said generally cylindrical passage lying parallel to a longitudinal axis of the conical filter element and along a wall of a vessel in which the embolic protection device is deployed.

Invention summary:

The goal of the invention is to reduce blood contaminates such as embolized calcium and particulate matter from being released during heart valve surgery into the general circulatory system which can result in end organ infarction. The second goal is to provide a blood free surgical field by obstructing the blood inside the heart or suctioning the blood from the ventricles (venting the heart) to any suction source during heart valves surgery.

I have invented a surgical tool (embolism umbrella balloon catheter) used during cardiac surgery for reducing the release of embolized particles from a heart into general body circulatory system.

Brief description of the drawings:

FIG. 1: umbrella shape with the tip pointing distally

FIG. 2: deflated umbrella balloon

FIG. 3: embolism umbrella balloon catheter in aortic valve

FIG. 4: inflated umbrella balloon under the aortic valve

FIG. 5: shapes of the occlusive umbrella balloon

Detailed description of the drawings:

The method uses a double lumen catheter that has an inflation lumen and a suction lumen. The inflation lumen has an occlusive balloon (umbrella shape with the tip pointing distally) connected to the distal end. (Figure- 1)

Figure- 1: the deflated umbrella balloon;

1) double lumen catheter,

2A) deflated umbrella balloon,

3) suction tip opening,

4) cross section of double lumen catheter,

5) balloon inflating lumen, 6) suctioning lumen

When the occlusive balloon is inflated, (Figure-2) the balloon occludes the ventricular outflow tract (in case of aortic/pulmonary valve surgery) or in the subvalvular apparatus (in case of mitral/tricuspid valves surgery). The suction lumen has distal small openings at the end for venting the heart (suctioning any blood coming from the heart to keep blood free surgical field) and a proximate end connected to a suction source (wall suction/ cardiopulmonary bypass machine). Note: this invention can be made without the suction features.

Figure-2: inflated umbrella balloon;

1) double lumen catheter,

2B) inflated umbrella balloon,

3) suction tip opening,

4) vertical view of the inflated umbrella balloon

The embolism umbrella balloon catheter is used in the following manner: after stopping the heart during heart surgery and exposing the diseased valve, the embolism umbrella shield is inserted under the valve (ventricular side) (Figure-3).

Figure-3: inserting the umbrella balloon under the aortic valve;

7) aorta,

8) mitral valve

9) aortic valve

10) deflated umbrella balloon catheter

11) left ventricle.

Then the occlusive balloon is inflated with air or fluid to prevent any falling particles from the valve entering the heart ventricles then into the general body circulatory system and venting the heart by sucking the blood inside the ventricle with suction part. (Figure-4)

Figure-4: inflating the umbrella balloon under the aortic valve

At this point, debridement, repair or replacement is performed on the valve. The umbrella shaped balloon will trap any dislodged particles during the procedure inside and will be trapped inside the umbrella after deflating it). After the surgery is completed and before closing the heart, the occlusive umbrella balloon is deflated and removed from the patient's body.

In a first embodiment of umbrella balloon catheter, the occlusive umbrella balloon is positioned as circular outer layer to the suction lumen distal end suction opening. When the occlusive umbrella balloon is inflated, the heart valve is separated from underlining ventricles so the suction opening at the tip communicates the ventricles and the suctioning source. It has oneway valve that allow surgeons to inflate and deflate the balloon with syringe. This embodiment is designed for use on any heart valve surgery. I refer to this embodiment as the occlusive umbrella balloon. This balloon diameter comes in deferent sizes and shapes (Figure-5). Sizes will be determent based on measuring the ventricles outflow tract diameter and subvalvular apparatus measured by echocardiography before the surgery.

In a second embodiment of my invention, the suction lumen of the catheter with distal end opening passes through a central umbrella balloon opening. The proximal end is connected to any suctioning source. This embodiment is designed for use in any heart valve surgery. I refer to this embodiment as the suctioning line. (Figure- 1)

All parts of the invention should be made out of silicon, polyvinyl chloride, polyurethane latex rubber, latex free rubber, polyethylene, Teflon or any safe, nontoxic, non allergic materials approved for medical uses to insure its safety on patient's health. Additionally, it should be flexible and ensure easy mobilization and fixation during the surgery as it should not obstruct the surgeons operative field.

Claims

MICRO-EMBOLISM UMBRELLA BALLOON Claims

1. An Micro-Embolism Umbrella Balloon composed of double lumen catheter 1, deflated umbrella balloon 2, suction tip opening 3, cross section of double lumen catheter 4

2. The method uses a double lumen catheter that has an inflation lumen and a suction lumen.

3. The inflation lumen has an occlusive balloon connected to the distal end.

4. According to claim 1, occlusive balloon can be inflated 2B.

5. According to claim 1, the suction lumen has distal small openings at the end for venting the heart and a proximate end connected to a suction source.

6. According to claim 4, the balloon diameter comes in deferent sizes and shapes 2C. Sizes will be determent based on measuring the ventricles outflow tract diameter and subvalvular apparatus measured by echocardiography before the surgery.

7. The suction lumen of the catheter can be with a distal end opening passes through a central umbrella balloon opening. The proximal end is connected to any suctioning source.