# US 2026/0061180 A1 · Heart failure assistance

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- Number: US 2026/0061180 A1
- Document ID: US20260061180A1
- Status: Published application
- Kind: A1
- Application number: 19/105,860
- Filed: 2023-08-24
- Published: 2026-03-05
- Earliest claimed: 2022-08-24
- Assignees: Sheba Impact Ltd.
- Applicants: Sheba Impact Ltd.
- Inventors: Leonid STERNIK
- Web page: https://patentgrep.com/patent/US20260061180A1

## CPC

- A61M 1/3659: {Cannulae pertaining to extracorporeal circulation}
- A61M 60/178: drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
- A61M 1/3666: {Cardiac or cardiopulmonary bypass, e.g. heart-lung machines}
- A61M 60/109: incorporated within extracorporeal blood circuits or systems
- A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines
- A61M 60/117: for assisting the heart, e.g. transcutaneous or external ventricular assist devices
- A61M 60/20: Type thereof
- A61M 60/232: Centrifugal pumps
- A61M 60/38: Blood oxygenation
- A61M 60/833: Occluders for preventing backflow
- A61M 60/857: Implantable blood tubes
- A61M 60/859: Connections therefor
- A61M 60/861: Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
- A61M 39/00: Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use (for respiratory devices, e.g. tracheal tubes, A61M16/00; artificial heart valves A61F2/24)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present disclosure provides a solution for assisting cardiac circulation of a subject. In one aspect of the present disclosure, the new solution replaces the common practice of implementing a cannula of left ventricular assist device (LVAD) to the left ventricle (LV) through a large opening made in the apex of the LV, which has some disadvantages such as requirement of sternotomy, making a hole in an already very weak left ventricle, requirement of cardiopulmonary bypass, etc. The solution of the present disclosure suggests introducing the inflow cannula, namely the cannula/tube that suctions blood from the heart, through an opening made in the left atrium appendage (LAA) and guiding it through the left atrium (LA) and the mitral valve (MV) into the LV to be positioned therein. The inflow cannula is designed to allow suction of blood along various portions of its length that are intended to be positioned within the heart, namely along portions that are positioned in the LV, LA and optionally the LAA. The blood that is suctioned by the inflow cannula flows into a mechanical circulatory support device to be pumped therefrom, via an outflow cannula and into the aorta, thereby allowing supply of oxygenated blood to the entire body. Optionally, the outflow cannula can be coupled to the descending aorta and not to the ascending aorta as commonly done in the cases of LVAD implementations. A second aspect of the present disclosure provides a new solution for overcoming right ventricle failure by withdrawing blood from a first portion of the pulmonary artery and streaming blood to a second portion of the pulmonary artery, the second portion is downstream the first portion, namely more proximal to the lungs. The two solutions may be carried out by a similar surgical procedure, such as left thoracotomy. If the two solutions of the present disclosure are used together, they form a total artificial heart solution.

## Claims

### Claim at position 1

1-37. (canceled)

### Claim 38

A method for assisting cardiac circulation of a subject, comprising:
introducing a distal end of a first inflow cannula into the left ventricle (LV) of the subject through the left atrial appendage (LAA), the left atrium (LA) and the mitral valve (MV), the first inflow cannula extending between said distal end and a proximal end being coupled to an inlet of a mechanical circulatory support (MCS) device to allow suction of blood from the LV and/or the LA, to the MCS device;
fluidically coupling a distal end of a first outflow cannula with the aorta, a proximal end of said first outflow cannula is coupled with an outlet of said MCS device to allow outflow of blood from the MCS towards the aorta.

### Claim 39 (depends on 38)

The method of claim 38, wherein said first or second MCS device is selected from any one of: a left ventricular assist device (LVAD), temporary ventricle assist device (VAD) and extracorporeal membrane oxygenation (ECMO).

### Claim 40 (depends on 38)

The method of claim 38, wherein said distal end of the first outflow cannula is coupled to the descending aorta.

### Claim 41 (depends on 38)

The method of claim 38, wherein a distal end portion of the first inflow cannula is formed with perforations;
wherein said introducing comprises maintaining said perforations blocked until the distal end portion is soaked with blood;
wherein said maintaining comprises inserting an internal sleeve to an internal lumen of the first inflow cannula to cover and block said perforations, wherein extraction of the internal sleeve causes unblockage of said perforations.

### Claim 42 (depends on 38)

The method of claim 38, comprising placing a pump element of the first MCS device in the left thorax.

### Claim 43 (depends on 38)

The method of claim 38, wherein a distal end portion of the first inflow cannula is tapered towards the distal end, defining a tapered end portion;
wherein said tapered end portion extends between the LAA and the LA.

### Claim 44 (depends on 38)

The method of claim 38, wherein the method further comprising sewing said first inflow cannula to the LAA defining LAA sewn portions.

### Claim 45 (depends on 44)

The method of claim 44, further comprising reinforcing said LAA sewn portions with rings;
wherein said sewn portions comprise tissue growth inducing material.

### Claim 46 (depends on 38)

The method of claim 38, wherein said introducing comprises either performing side-biting clamp of the LAA following by suturing the first inflow cannula to the LAA or performing purse-string suturing of the first inflow cannula to the LAA; and
wherein said fluidically coupling comprises either performing side-biting clamp of the aorta following by suturing the first outflow cannula to the aorta or performing purse-string suturing of the first outflow cannula to the aorta.

### Claim 47 (depends on 38)

The method of claim 38, comprising:
blocking blood flow in a selected blocking portion of the pulmonary artery (PA);
fluidically coupling a first end of a second inflow cannula to an upstream portion of the PA upstream said blocking portion and fluidically coupling a second end of the second inflow cannula to an inlet of a second mechanical circulatory support (MCS) device to allow suction of blood from the pulmonary artery to the second MCS device, resulting in a suction of blood from the right ventricle to the MCS device;
fluidically coupling a first end of a second outflow cannula to a downstream portion of the PA downstream said blocking portion and fluidically coupling a second end of the second outflow cannula to an outlet of said second MCS device, thereby allowing outflow of blood from the MCS towards the downstream portion of the PA.

### Claim 48 (depends on 47)

The method of claim 47, wherein said second MCS device is selected from any one of: a left ventricular assist device (LVAD), temporary ventricle assist device (VAD) and extracorporeal membrane oxygenation (ECMO).

### Claim 49 (depends on 48)

The method of claim 48, wherein the first MCS is the second MCS.

### Claim 50

A kit for assisting cardiac circulation of a subject, the kit comprising:
a first inflow cannula extending between an inflow cannula proximal end, configured to be coupled to an inlet of a first mechanical circulatory support (MCS) device, and an inflow cannula distal end, configured to be inserted through the left atrial appendage and the mitral valve to be placed in the left ventricle (LV) to allow suction of blood from the LV and/or the LA to the first MCS device;
a first outflow cannula extending between an outflow cannula proximal end, configured to be coupled to an outlet of the first MCS device, and an outflow cannula distal end configured to be coupled to or inserted into the descending aorta so as to allow outflow of blood from the first MCS device to the aorta.

### Claim 51 (depends on 50)

The kit of claim 50, wherein the kit is for use in a method for assisting cardiac circulation of the subject, wherein said method comprises:
introducing said first inflow cannula distal end into the left ventricle (LV) of the subject through the left atrial appendage (LAA), the left atrium (LA) and the mitral valve (MV),
fluidically coupling said first outflow cannula distal end with the aorta,
coupling said first inflow cannula proximal end to the inlet of the first MCS device, and
coupling said first outflow cannula proximal end to the outlet of the first MCS device;
wherein the method further comprises placing a pump element of the first MCS device in the left thorax.

### Claim 52 (depends on 50)

The kit of claim 50, comprising connectors for allowing said coupling of the first inflow cannula proximal end to the inlet of the first MCS device and the outflow cannula proximal end to the outlet of the first MCS device.

### Claim 53 (depends on 50)

The kit of claim 50, comprising said first MCS device;
wherein said first MCS device is selected from any one of: a left ventricular assist device (LVAD), temporary ventricle assist device (VAD) and extracorporeal membrane oxygenation (ECMO).

### Claim 54 (depends on 50)

The kit of claim 50, wherein a distal end portion of said first inflow cannula is formed with perforations;
the kit further comprises a sleeve element configured to be fitted within an internal lumen of the first inflow cannula to block said perforations;
wherein a distal end portion of the first inflow cannula is tapered towards the distal end, defining a tapered end portion.

### Claim 55 (depends on 50)

The kit of claim 50, comprising:
a second inflow cannula for fluidically coupling a first end thereof to an upstream portion of a pulmonary artery (PA) of the subject upstream a blocking portion of the PA in which flow of blood is blocked and for fluidically coupling a second end thereof to a second mechanical circulatory support (MCS) device to allow suction of blood from the pulmonary artery to the second MCS device, resulting in a suction from the right ventricle to the second MCS device;
a second outflow cannular for fluidically coupling a first end thereof to a downstream portion of the PA downstream said blocking portion and fluidically coupling a second end of thereof to an outlet of said second MCS device, thereby allowing outflow of blood from the MCS towards the downstream portion of the PA.

### Claim 56 (depends on 55)

The kit of claim 55, comprising said second MCS device;
wherein said second MCS device is selected from any one of: a left ventricular assist device (LVAD), temporary ventricle assist device (VAD) and extracorporeal membrane oxygenation (ECMO).

### Claim 57 (depends on 55)

The kit of claim 55, comprising a blocking element for blocking the blood flow in the PA in said selected blocking portion.
