# US 2023/0057579 A1 · Cardiovascular device and kit for the reduction of a cardiac cavity

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- Number: US 2023/0057579 A1
- Document ID: US20230057579A1
- Status: Published application
- Kind: A1
- Application number: 17/794,751
- Filed: 2021-01-25
- Published: 2023-02-23
- Earliest claimed: 2020-01-23
- Assignees: Eucardia S.R.L.
- Applicants: Eucardia S.R.L.
- Inventors: Roberto Parravicini; Marco Bottaro; James Leo Pokorney
- Web page: https://patentgrep.com/patent/US20230057579A1

## CPC

- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- A61M 60/17: inside a ventricle, e.g. intraventricular balloon pumps
- A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)}
- A61B 17/12136: {Balloons}
- A61M 60/295: Balloon pumps for circulatory assistance
- A61M 60/843: Balloon aspects, e.g. shapes or materials
- A61M 60/861: Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
- A61M 60/865: Devices for guiding or inserting pumps or pumping devices into the patient's body
- A61M 60/882: Devices powered by the patient, e.g. skeletal muscle powered devices
- A61M 60/89: Valves
- A61B 2017/1205: {Introduction devices}
- A61M 60/497: for balloon pumps for circulatory assistance
- 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)

## Abstract

The cardiovascular device (1) comprises a diaphragm assembly designed to be inserted into a ventricular cavity (VS) substantially transverse in order to reduce its volume, said diaphragm assembly having a peripheral edge (2B) that can be sealingly engaged on the walls (5) of the cavity 7 and being alternately driven between an active blood thrust position and an inactive position, said assembly being at least partially deformable in response to contractions of the walls (5) and comprising a balloon-shaped elastic body (2; 100; 200; 300; 400) which has an external surface (2A; 103) that defines and encloses an internal cavity (CI; CI2) and which can be configured between a gathered position of minimum bulk, an everted position of maximum bulk and vice-versa, at least one mobile portion (3; 3′) of the peripheral surface which is disposed transverse/diagonal and which is surrounded by the peripheral edge and at least one aperture (3A) for access from the outside to the internal cavity (CI; CI2).

## Claims

### Claim 1

A cardiovascular device (1) designed for a cardiac cavity (VS) which has a volume and wherein blood flows, which is bounded by walls (5) and which has a greater longitudinal dimension and a smaller transverse dimension, said device comprising:
a diaphragm assembly designed to be inserted into said cardiac cavity (VS) substantially transverse to said greater longitudinal dimension so as to reduce said volume, said diaphragm assembly having a peripheral edge (2B) sealingly engageable with said walls (5) and being alternately driven between an active blood thrust position and an inactive position, said diaphragm assembly that includes said peripheral edge (2B) being at least partially deformable in response to contractions of said walls (5);
characterized in that said diaphragm assembly comprises:
a balloon-shaped elastic body (2; 100, 200; 300, 400) which has an external surface (2A; 103) which defines and encloses an internal chamber (CI) and which is modifiable alternatively between a position of minimum bulk in said inactive position and an everted position of maximum bulk in said active position, and vice-versa;
at least one mobile portion (3; 3′) of said external surface (2A; 103) which is transverse/diagonal with respect to said greater longitudinal dimension and which is peripherally surrounded by said peripheral edge (2B);
at least one aperture (3A) for access from the outside to said internal chamber (CI).

### Claim 2 (depends on 1)

The device according to claim 1, wherein said balloon-shaped body (2; 100, 200; 300, 400) has stiffening zones (6) of said external surface (2A) alternatively disposed alternated with more flexible zones (7).

### Claim 3 (depends on 1)

The device according to claim 1, wherein said peripheral edge (2B) comprises a closed ring profile made of an elastically flexible material and everted with respect to said external surface (2A; 103).

### Claim 4 (depends on 1)

The device according to claim 1, wherein said balloon-shaped body (2; 100, 200; 300, 400) comprises a segment of duct (10) for connection between said internal chamber (CI) and the outside.

### Claim 5 (depends on 1)

The device according to claim 1, wherein said access aperture (3A) is equipped with valve control means (13), alternatively selectable in an open position or in a closed position.

### Claim 6

Kit for dividing a cardiac cavity (VS), characterized in that it comprises:
a cardiovascular device (1) which has a balloon-shaped elastic body (2; 100, 200; 300, 400) which has an external surface (2A; 103) which defines and encloses an internal chamber (CI) and which is mobile alternately between a folded position of minimum bulk and an everted position of maximum bulk, and vice-versa;
at least one mobile portion (3; 3′) of said external surface (2A; 103) which is transverse/diagonal with respect to said greater longitudinal dimension and which is peripherally surrounded by a peripheral edge (2B);
at least one aperture (3A) for access from the outside to said internal chamber (CI);
a catheter (9) which has a housing tip (15) for internally receiving said cardiovascular device (1) in a folded configuration for introduction into a cardiac cavity (VS) and a plunger (17) for expelling said cardiovascular device (1) from said housing tip (15);
a syringe (8) for injecting a volume of fluid into said internal chamber (CI).

### Claim 7 (depends on 6)

The kit according to claim 6, wherein it further comprises at least one split pin (11) which can be associated with said balloon-shaped elastic body (2; 100, 200; 300, 400) outside said cardiac cavity (VS).

### Claim 8

A balloon-shaped elastic body (2; 100, 200; 300; 400) intended for a cardiovascular device (1) able to be implanted in a cardiac cavity (VS) which has a volume and wherein blood flows, which is bounded by walls (5) and which has a greater longitudinal dimension and a smaller transverse dimension, said elastic body having an external surface (103) which defines and encloses an internal chamber (CI, CI2) and which is modifiable alternatively between a position of minimum bulk in said inactive position and an everted position of maximum bulk in said active position, and vice-versa, characterized in that said balloon-shaped elastic body comprises an internal core (101) which passes through said internal chamber (CI, CI2) in a hermetically sealed manner and extends between a distal end and an apical end and which has an axial length able to be modified elastically with modification means between a dilated position of said external surface (2A; 103) and a contracted position of said external surface (2A; 103).

### Claim 9 (depends on 8)

The balloon-shaped elastic body according to claim 8, wherein said modification means are selected from a spring element (106), a sinusoid conformation of said internal core (101).

### Claim 10 (depends on 8)

The balloon-shaped elastic body according to claim 8, wherein said central core (101) comprises a tubular body (105).

### Claim 11 (depends on 8)

The balloon-shaped elastic body according to claim 8, wherein it comprises a balloon-shaped body (100; 200; 300; 400) and a second balloon-shaped elastic body (301).

### Claim 12 (depends on 11)

The balloon-shaped elastic body according to claim 11, wherein said second balloon-shaped elastic body (301) is located internally or externally to said balloon-shaped elastic body (300).

### Claim 13 (depends on 8)

The balloon-shaped elastic body according to claim 8, wherein said internal chamber (CI) and second internal chamber (CI2) have volumes selected from equal volumes or different volumes.

### Claim 14 (depends on 10)

The balloon-shaped elastic body according to claim 10, wherein said tubular body (105) comprises at least two internal ducts (304, 305; 402, 403) equipped with apertures (302; 405, 406) for connection with said internal chamber (CI) and second internal chamber (CI2).