# US 12,005,177 B2 · Self-sealing cannula

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- Number: US 12,005,177 B2
- Document ID: US12005177B2
- Status: Granted
- Kind: B2
- Application number: 16/891,655
- Filed: 2020-06-03
- Published: 2020-12-31
- Granted: 2024-06-11
- Earliest claimed: 2014-11-14
- Assignees: University of Maryland, Baltimore
- Applicants: University of Maryland, Baltimore
- Inventors: Zhongjun Wu; Bartley P. Griffith; Keshava Rajagopal
- Web page: https://patentgrep.com/patent/US12005177B2

## CPC

- A61M 1/3659: {Cannulae pertaining to extracorporeal circulation}
- A61M 60/109: incorporated within extracorporeal blood circuits or systems
- 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)}
- A61B 17/3421: {Cannulas}
- A61B 17/3439: {with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662)}
- A61M 60/117: for assisting the heart, e.g. transcutaneous or external ventricular assist devices
- 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 60/216: including a rotating member acting on the blood, e.g. impeller
- A61M 60/253: including a displacement member directly acting on the blood
- A61M 60/38: Blood oxygenation
- A61M 60/857: Implantable blood tubes
- 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
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/3419: {Sealing means between cannula and body}
- A61B 2017/3425: {for internal organs, e.g. heart ports}
- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- 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 present invention discloses a self-sealing cannula and methods of its use. The self-sealing cannula can be minimally invasively placed into the heart for drawing and/or returning blood with a self-sealing function at the interface of the blood access site. The disclosed cannula can be implemented as a single lumen cannula or a double lumen cannula, which can be used with ventricular assist devices for heart support or pump-oxygenators for ECMO and respiratory support. Through a self-sealing mechanism fixed on the ventricular wall or atrial wall, a cannula body is attached to the self-sealing fixture and blood is drawn into the lumen via an external pump and returned to the circulation system through a separate cannula. In the case of the double lumen cannula embodiment, the blood will be drawn into the drainage lumen of the double lumen cannula and returned through an infusion lumen at the desired location. The present invention achieves minimally invasive insertion without surgical sutures to the heart, and allows for optimal drainage of the blood from the heart. With use of the double lumen cannula, it prevents need for multiple cannulation sites, and greatly reduces the blood recirculation. Removal of the cannula is simplified without need for suturing or insertion of a plugging member.

## Claims

### Claim 1

A self-sealing cannula system, comprising:
an elongated first cannula; and
a flexible, self-sealing closure attached to said first cannula, said closure comprising a hollow, elongate structure defining an open interior and a first connector on an interior of said open interior, said first cannula having a second connector configured for removable attachment to said first connector, and wherein said closure further comprises an integrally-formed self-sealing shutter;
wherein said self-sealing closure is configured to expand radially from a compressed state to an uncompressed state, wherein in said uncompressed state said self-sealing closure is configured to seal against an interior surface and an exterior surface of an insertion site of said first cannula; and
wherein said self-sealing shutter is further configured to close a central hole of the shutter when the first cannula is not inserted therein, and is expandable to open when the first cannula is inserted therein.

### Claim 2 (depends on 1)

The self-sealing cannula system of claim 1, wherein said first connecting member and said second connecting member comprise a mating threaded connection.

### Claim 3 (depends on 1)

The self-sealing cannula system of claim 1, further comprising a removable sheath encasing said self-sealing closure and at least a portion of said first cannula.

### Claim 4 (depends on 3)

The self-sealing cannula system of claim 3, wherein said removable sheath compresses said self-sealing closure into said compressed state, and wherein said self-sealing closure is further configured to automatically expand from said compressed state to said uncompressed state upon removal of said sheath within a patient's body.

### Claim 5 (depends on 4)

The self-sealing cannula system of claim 4, wherein said self-sealing closure is temperature-responsive and further configured to expand from said compressed state to said uncompressed state in response to a patient's body temperature.

### Claim 6 (depends on 1)

The self-sealing cannula system of claim 1, wherein said self-sealing closure further comprises a self-closing iris at an end of said self-sealing closure.

### Claim 7 (depends on 6)

The self-sealing cannula system of claim 6, wherein said iris is configured to automatically close said end of said self-sealing closure upon removal of said first cannula from said self-sealing closure.

### Claim 8 (depends on 1)

The self-sealing cannula system of claim 1, further comprising:
a second cannula positioned within said first cannula and extendable from said first cannula.

### Claim 9 (depends on 8)

The self-sealing cannula system of claim 8, said second cannula having an end formed of an expandable wire frame.

### Claim 10 (depends on 9)

The self-sealing cannula system of claim 9, wherein said expandable wire frame of said second cannula is temperature responsive and configured to expand in response to a patient's body temperature.

### Claim 11 (depends on 8)

The self-sealing cannula system of claim 8, further comprising a blood pump attached to said first cannula, and a blood oxygenator attached to said second cannula.

### Claim 12 (depends on 1)

The self-sealing cannula system of claim 1, wherein said self-sealing closure is formed of temperature responsive wire mesh.

### Claim 13 (depends on 12)

The self-sealing cannula system of claim 12, wherein said wire mesh further comprises a superelastic Nitinol alloy.

### Claim 14 (depends on 1)

The self-sealing cannula system of claim 1, wherein said self-sealing shutter is affixed to a bottom end of a wall of said hollow, elongate structure of said self-sealing closure.

### Claim 15

A self-sealing cannula system, comprising:
an elongated first cannula; and
a flexible, self-sealing closure attached to said first cannula, said closure comprising a hollow, elongate structure defining an open interior, wherein said first cannula is removably attached to said interior of said closure, and wherein said closure further comprises an integrally-formed self-sealing shutter;
wherein said self-sealing closure is configured to expand radially from a compressed state to an uncompressed state, wherein in said uncompressed state said self-sealing closure is configured to seal against an interior surface and an exterior surface of an insertion site of said first cannula; and
a second cannula positioned within said first cannula and extendable from said first cannula.

### Claim 16 (depends on 15)

The self-sealing cannula system of claim 15, said second cannula having an end formed of an expandable wire frame.

### Claim 17 (depends on 16)

The self-sealing cannula system of claim 16, wherein said expandable wire frame of said second cannula is temperature responsive and configured to expand in response to a patient's body temperature.

### Claim 18 (depends on 15)

The self-sealing cannula system of claim 15, further comprising a blood pump attached to said first cannula, and a blood oxygenator attached to said second cannula.

### Claim 19 (depends on 15)

The self-sealing cannula system of claim 15, wherein said self-sealing closure further comprises a self-closing iris at an end of said self-sealing closure, wherein said iris is configured to automatically close said end of said self-sealing closure upon removal of said first cannula from said self-sealing closure.
