# US 10,946,127 B2 · Devices and methods for assisting cardiac function

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- Number: US 10,946,127 B2
- Document ID: US10946127B2
- Status: Granted
- Kind: B2
- Application number: 16/182,272
- Filed: 2018-11-06
- Published: 2019-06-27
- Granted: 2021-03-16
- Earliest claimed: 2013-02-26
- Assignees: 3DT Holdings, LLC
- Applicants: CVDevices, LLC
- Inventors: Ghassan S. Kassab; Jose A. Navia, Sr.
- Web page: https://patentgrep.com/patent/US10946127B2

## CPC

- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 60/191: mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
- A61M 60/289: Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
- A61M 60/468: the force acting on the actuation means being hydraulic or pneumatic
- A61M 60/508: Electronic control means, e.g. for feedback regulation
- A61M 60/865: Devices for guiding or inserting pumps or pumping devices into the patient's body
- 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)}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/003: {Steerable}
- A61B 2017/00584: {Clips}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00601: {Implements entirely comprised between the two sides of the opening}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/00628: {T-shaped occluders}
- A61B 2017/306: {holding by means of suction}
- A61B 2017/308: {with suction cups}
- A61B 2018/00392: {Transmyocardial revascularisation}
- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61M 25/003: {characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves (catheter tips A61M25/0067)}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/0084: {being one or more injection needles}
- A61M 25/0136: {Handles therefor}
- A61M 25/0141: {having flexible regions as a result of using materials with different mechanical properties}
- A61M 25/06: Body-piercing guide needles or the like
- A61M 2025/0036: {with more than four lumina}
- A61M 2025/0039: {characterized by lumina being arranged coaxially}
- A61M 2025/004: {characterized by lumina being arranged circumferentially}
- A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip}
- A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres}
- A61M 2025/015: {Details of the distal fixation of the movable mechanical means}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2205/32: with radio-opaque indicia
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3303: Using a biosensor
- A61M 2205/3331: Pressure; Flow
- A61M 2210/122: Pericardium
- A61M 2210/125: Heart
- A61M 2230/005: Parameter used as control input for the apparatus
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Devices and methods for assisting cardiac function. In an exemplary embodiment of a device for assisting heart function of the present disclosure, the device includes a first plate and an opposing second plate, each plate having an inner surface, a cardiac processor coupled to at least one of the first plate and the second plate, a bladder having an inner chamber and disposed between the inner surfaces, and a first catheter having a proximal end in communication with the inner chamber of the bladder and a distal end having a first pericardial balloon coupled thereto, wherein a gas and/or a liquid within the inner chamber of the bladder can be injected into the first pericardial balloon upon compression of the first plate relative to the second plate, and wherein the gas and/or the liquid can be removed from the first pericardial balloon upon retraction of the first plate relative to the second plate.

## Claims

### Claim 1

A method of assisting heart function, the method comprising the step of:
introducing at least part of a device for assisting heart function into a pericardial space surrounding a heart, the device comprising:
a first catheter having a proximal end in communication with the source of the gas and/or the liquid and a distal end having a first pericardial balloon coupled thereto, and
a second catheter having a proximal end in communication with a portion of the device and a distal end having a second pericardial balloon coupled thereto;
wherein the introducing step is performed to position at least one of the first pericardial balloon and/or the second pericardial balloon into the pericardial space.

### Claim 2 (depends on 1)

The method of claim 1, wherein the introducing step is performed to position the first pericardial balloon into the pericardial space at or near a first heart chamber, and wherein the method further comprises the step of:
introducing a gas and/or a liquid into the first pericardial balloon so that the first pericardial balloon exerts pressure upon the first heart chamber when the first pericardial balloon is at least partially inflated.

### Claim 3 (depends on 2)

The method of claim 2, wherein the method further comprises the step of:
removing the gas and/or the liquid from the first pericardial balloon so to relieve pressure from the first heart chamber when the first pericardial balloon is at least partially deflated.

### Claim 4 (depends on 3)

The method of claim 3, wherein the introducing step is performed to position the second pericardial balloon into the pericardial space at or near a second heart chamber, and wherein the method further comprises the step of:
introducing a gas and/or a liquid into the second pericardial balloon so that the second pericardial balloon exerts pressure upon the second heart chamber when the second pericardial balloon is at least partially inflated.

### Claim 5 (depends on 4)

The method of claim 4, wherein the step of introducing the gas and/or the liquid into the first pericardial balloon is performed to create a counterpulsation by at least partially inflating the first pericardial balloon while at least partially deflating the second pericardial balloon.

### Claim 6 (depends on 4)

The method of claim 4, wherein the step of introducing the gas and/or the liquid into the first pericardial balloon is performed while the heart is in systole.

### Claim 7 (depends on 1)

The method of claim 1, wherein the introducing step is performed to position the second pericardial balloon into the pericardial space at or near a second heart chamber, and wherein the method further comprises the step of:
introducing a gas and/or a liquid into the second pericardial balloon so that the second pericardial balloon exerts pressure upon the second heart chamber when the second pericardial balloon is at least partially inflated.

### Claim 8 (depends on 7)

The method of claim 7, wherein the method further comprises the step of:
removing the gas and/or the liquid from the second pericardial balloon so to relieve pressure from the second heart chamber when the second pericardial balloon is at least partially deflated.

### Claim 9 (depends on 1)

The method of claim 1, wherein the device is operably coupled to a source of a gas and/or a liquid, and wherein the method further comprises the step of:
introducing gas and/or liquid into the first balloon from the source of the gas and/or the liquid.

### Claim 10 (depends on 1)

The method of claim 1, wherein the introducing step is performed to position the first pericardial balloon within the pericardial space at or near a first heart chamber and to position the second pericardial balloon within the pericardial space at or near a second heart chamber, and wherein the method further comprises the alternating steps of:
(a) injecting a gas and/or a liquid into the first pericardial balloon, causing at least partial expansion of the first pericardial balloon, which causes pressure to be applied to the first heart chamber, and to remove the gas and/or the liquid from the second pericardial balloon, causing at least partial deflation of the second pericardial balloon, which relieves pressure from the second heart chamber; and
(b) remove the gas and/or the liquid from the first pericardial balloon, causing at least partial deflation of the first pericardial balloon, which relieves pressure from the first heart chamber, and to inject the gas and/or the liquid into the second pericardial balloon, causing at least partial expansion of the second pericardial balloon, which causes pressure to be applied to the second heart chamber.