# US 10,478,542 B2 · Cannula having nitinol reinforced inflow region

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- Number: US 10,478,542 B2
- Document ID: US10478542B2
- Status: Granted
- Kind: B2
- Application number: 15/463,156
- Filed: 2017-03-20
- Published: 2018-09-20
- Granted: 2019-11-19
- Earliest claimed: 2017-03-20
- Assignees: ABIOMED, Inc.
- Applicants: Abiomed, Inc.
- Inventors: Emilia Jahangir
- Web page: https://patentgrep.com/patent/US10478542B2

## CPC

- A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/0015: {Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges}
- A61M 60/13: by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
- A61M 60/135: inside a blood vessel, e.g. using grafting
- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- A61M 60/216: including a rotating member acting on the blood, e.g. impeller
- A61M 60/408: the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
- A61M 60/414: transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
- A61M 60/857: Implantable blood tubes
- A61M 60/81: Pump housings
- 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

An intravascular heart pump assembly can include a rotor with at least one impeller blade, and a cannula. The present application describes various cannulas that can be manufactured from multiple layers of material to improve flexibility, manufacturability, and durability without increasing an outer diameter of the cannula. In one embodiment, the cannula includes an inflow section having a sheet formed of a shape memory material embedded within a polymer and having at least one lateral hole or aperture in the inflow section. The at least one lateral hole is defined by a first hole in the sheet and a second hole in the outer polymer layer of the cannula. The first hole and the second hole overlap so that blood can enter the cannula through the holes.

## Claims

### Claim 1

An intravascular heart pump assembly comprising:
an elongate catheter having a proximal end configured to be positioned outside of a patient's body and a distal end configured to be positioned in an artery proximate to a patient's heart;
a rotor having at least one impeller blade coupled to the distal end of the elongate catheter;
a motor operatively coupled to the rotor; and
a cannula having a proximal end and a distal end, the proximal end coupled to the distal end of the elongate catheter, the cannula comprising:
a cannula body having a proximal region and a distal region, the distal region having at least one lateral inflow hole, and the proximal region having at least one lateral outflow hole,
a sheet formed of a shape memory material and embedded within a polymer, the sheet and the polymer forming the cannula body, and
in the distal region, the at least one lateral inflow hole being defined by a first layer having a hole in the shape memory material sheet and by a second layer having a hole in the polymer, wherein the hole in the first layer and the hole in the second layer overlap along an external surface of the cannula.

### Claim 2 (depends on 1)

The heart pump assembly of claim 1, wherein an outer perimeter of the hole in the second layer is within an outer perimeter of the hole in the first layer.

### Claim 3 (depends on 2)

The heart pump assembly of claim 2, further comprising at least one slitted opening disposed in the sheet configured to allow the sheet to flex.

### Claim 4 (depends on 3)

The heart pump assembly of claim 3, wherein the cannula further comprises a coil formed of a shape memory material.

### Claim 5 (depends on 4)

The heart pump assembly of claim 4, wherein at least a portion of the coil is positioned proximal to the shape memory material sheet.

### Claim 6 (depends on 4)

The heart pump assembly of claim 4, wherein at least a portion of the coil is positioned distal of the shape memory material sheet.

### Claim 7 (depends on 4)

The heart pump assembly of claim 4, wherein the shape memory material is nitinol.

### Claim 8 (depends on 7)

The heart pump assembly of claim 7, wherein the cannula body is formed of two polymer layers having the shape memory material sheet embedded in between the two polymer layers.

### Claim 9 (depends on 1)

The heart pump assembly of claim 1, wherein the at least one lateral outflow hole is proximal to or aligned with the rotor.

### Claim 10 (depends on 9)

The heart pump assembly of claim 9, wherein the proximal region including the at least one lateral outflow hole comprises a non-memory alloy having a plurality of lateral outflow holes.

### Claim 11 (depends on 10)

The heart pump assembly of claim 10, wherein the proximal region including the at least one lateral outflow hole is formed from stainless steel.

### Claim 12 (depends on 1)

The heart pump assembly of claim 1, further comprising a flexible projection coupled to a distal end of the cannula.

### Claim 13 (depends on 1)

The heart pump assembly of claim 1, wherein the distal region includes a plurality of lateral inflow holes.

### Claim 14 (depends on 13)

The heart pump assembly of claim 13, wherein the distal region further comprises a second lateral inflow hole positioned proximal to the at least one lateral inflow hole.

### Claim 15 (depends on 1)

The heart pump assembly of claim 1, wherein the cannula body has an outer diameter of less than or equal to about 22 Fr.

### Claim 16 (depends on 1)

The heart pump assembly of claim 1, wherein the shape memory material sheet is less than or equal to 0.07 mm thick.
