# US 10,864,308 B2 · Sensors for catheter pumps

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- Number: US 10,864,308 B2
- Document ID: US10864308B2
- Status: Granted
- Kind: B2
- Application number: 16/020,674
- Filed: 2018-06-27
- Published: 2018-11-15
- Granted: 2020-12-15
- Earliest claimed: 2014-04-15
- Assignees: Tc1 LLC
- Applicants: Tci LLC
- Inventors: Paul F. Muller; Keif M. Fitzgerald; Richard L. Keenan; Veronica J. Neiman
- Web page: https://patentgrep.com/patent/US10864308B2

## CPC

- A61M 60/857: Implantable blood tubes
- A61B 5/6852: {Catheters}
- A61M 60/13: by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
- A61M 60/174: discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
- A61M 60/216: including a rotating member acting on the blood, e.g. impeller
- A61M 60/411: generated by an electromotor
- A61M 60/554: of blood pressure
- A61M 60/808: specially adapted for deformable impellers, e.g. expandable impellers
- A61M 60/816: Sensors arranged on or in the housing, e.g. ultrasonic flow sensors
- A61M 60/825: Contact bearings, e.g. ball-and-cup or pivot bearings
- A61M 60/827: Sealings between moving parts
- A61M 60/867: using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
- A61M 60/211: using a jet, venturi or entrainment effect for pumping the blood
- A61M 60/414: transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
- A61M 60/577: High-frequency driving
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/32: with radio-opaque indicia
- A61M 2205/3306: Optical measuring means
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- 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

Sensors for catheter pumps are disclosed herein. The catheter pump can include a catheter assembly comprising a catheter and a cannula coupled to a distal portion of the catheter. The cannula can have a proximal port for permitting the flow of blood therethrough. The catheter assembly can include a sensor to be disposed near the proximal port. A processing unit can be programmed to process a signal detected by the sensor. The processing unit can comprise a computer-readable set of rules to evaluate the signal to determine a position of the cannula relative to an aortic valve of a patient.

## Claims

### Claim 1

A computer-implemented method for determining a position of a cannula relative to an anatomy of a patient, the method comprising:
receiving a proximal signal from a proximal sensor disposed near a proximal port of the cannula;
processing the proximal signal to determine a proximal fluid signature related to a first property of the fluid flowing through the proximal port;
comparing the proximal fluid signature with a proximal baseline signature, the proximal baseline signature associated with a proper position of the cannula during a treatment procedure;
determining the position of the cannula based at least in part on the comparison of the proximal fluid signature with the proximal baseline signature;
receiving a distal signal from a distal sensor disposed near a distal port of the cannula; and
determining a misalignment of the cannula based at least in part on a pressure difference between the proximal signal and the distal signal.

### Claim 2 (depends on 1)

The computer-implemented method of claim 1, further comprising determining the proximal baseline signature of fluid flowing through the proximal port when the cannula is in the proper position during the treatment procedure.

### Claim 3 (depends on 1)

The computer-implemented method of claim 1, further comprising determining whether the proximal port is disposed in close proximity to or overlying a cardiac valve of the patient.

### Claim 4 (depends on 1)

The computer-implemented method of claim 1, further comprising:
processing the distal signal to determine a distal fluid signature related to a second property of the fluid flowing through the distal port;
comparing the distal fluid signature with a distal baseline signature, the distal baseline signature associated with a proper position of the cannula during the treatment procedure; and
determining the position of the cannula based at least in part on the comparison of the distal fluid signature with the distal baseline signature.

### Claim 5 (depends on 4)

The computer-implemented method of claim 4, wherein the method further comprises determining whether the distal port is disposed in close proximity to or overlying a cardiac valve of the patient.

### Claim 6

A non-transitory computer-readable medium comprising instructions stored thereon that, when executed by a processor, perform a method comprising:
receiving a proximal signal from a proximal sensor disposed near a proximal port of a cannula;
processing the proximal signal to determine a proximal fluid signature related to a first property of fluid flowing through the proximal port;
comparing the proximal fluid signature with a proximal baseline signature, the proximal baseline signature associated with a proper position of the cannula during a treatment procedure; and
determining a position of the cannula relative to the proper position of the cannula based on the comparison of the proximal fluid signature with the proximal baseline signature.

### Claim 7 (depends on 6)

The non-transitory computer readable medium of claim 6, wherein the method comprises determining the proximal baseline signature of fluid flowing through the proximal port when the cannula is in the proper position during the treatment procedure.

### Claim 8 (depends on 6)

The non-transitory computer readable medium of claim 6, wherein the method comprises determining whether the proximal port is disposed in close proximity to or overlying a cardiac valve of the patient.

### Claim 9 (depends on 6)

The non-transitory computer readable medium of claim 6, wherein the method comprises:
receiving a distal signal from a distal sensor disposed near a distal port of the cannula;
processing the distal signal to determine a distal fluid signature related to a second property of the fluid flowing through the distal port;
comparing the distal fluid signature with a distal baseline signature, the distal baseline signature associated with a proper position of the cannula during the treatment procedure; and
determining the position of the cannula based at least in part on the comparison of the distal fluid signature with the distal baseline signature.

### Claim 10 (depends on 9)

The non-transitory computer readable medium of claim 9, wherein the method further comprises determining whether the distal port is disposed in close proximity to or overlying a cardiac valve of the patient.

### Claim 11

A processing system for a catheter system having a cannula coupled to a distal portion thereof and configured to be placed in a vasculature of a patient, comprising:
a proximal sensor disposed near a proximal port of the cannula and configured to detect a first property of a fluid flowing through the proximal port and transmit a proximal signal indicative of the first property; and
a computing device communicatively coupled to the proximal sensor comprising a processor and a memory, the memory comprising instructions that, when executed by the processor cause the computing device to:
receive the proximal signal from the proximal sensor;
process the proximal signal to determine a proximal fluid signature related to the first property of the fluid;
compare the proximal fluid signature with a proximal baseline signature, the proximal baseline signature associated with a proper position of the cannula during a treatment procedure; and
determine a position of the cannula relative to the proper position of the cannula based on the comparison of the proximal fluid signature with the proximal baseline signature.

### Claim 12 (depends on 11)

The processing system of claim 11, wherein the computing device is further configured to determine the proximal baseline signature of the fluid flowing through the proximal port when the cannula is in the proper position during the treatment procedure.

### Claim 13 (depends on 11)

The processing system of any of claim 11, wherein the computing device is further configured to determine whether the proximal port is disposed in close proximity to or overlying a cardiac valve of the patient.

### Claim 14 (depends on 11)

The processing system of claim 11 further comprising a distal sensor disposed near a distal port of the cannula and configured to detect a second property of the fluid flowing through the distal port and transmit a distal signal indicative of the property, and
wherein the computing device is further configured to:
receive the distal signal from the distal sensor;
process the distal signal to determine a distal fluid signature related to the second property of the fluid;
compare the distal fluid signature with a distal baseline signature, the distal baseline signature associated with a proper position of the cannula during the treatment procedure; and
determining the position of the cannula based at least in part on the comparison of the distal fluid signature with the distal baseline signature.

### Claim 15 (depends on 14)

The processing system of claim 14, wherein the computing device is further configured to determine whether the distal port is disposed in close proximity to or overlying a cardiac valve of the patient.

### Claim 16 (depends on 1)

The computer-implemented method of claim 1, wherein the first property of the fluid flowing through the proximal port is selected from the group consisting of pressure and flow rate, and wherein the determining evaluates the proximal fluid signature based at least in part on a rate of change of the pressure or the flow rate over time.

### Claim 17 (depends on 16)

The computer-implemented method of claim 16, wherein comparing the proximal fluid signature with the proximal baseline signature comprises comparing the proximal fluid signature to an array of values corresponding to the pressure, the flow rate, the rate of change of pressure, or the rate of change of flow rate.