Sensors for catheter pumps

• US 10,029,037 B2
• Filed: 04/15/2015
• Issued: 07/24/2018
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Inventors: Muller, Paul F., Fitzgerald, Keif M., Keenan, Richard L., Neiman, Veronica J.
• Primary Examiner(s): Voorhees, Catherine
• Application Number:
  US14/687,493
• Publication Number:
  US 20150290372A1
• Time in Patent Office: 1,196 Days
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• CPC Class Codes: A61M 60/211 using a jet, venturi or entrainment effect for pumping the blood
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/411 generated by an electromotor
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/577 High-frequency driving
• CPC Class Codes: A61M 60/808 specially adapted for deformable impellers, e.g. expandable impellers
• CPC Class Codes: A61M 60/816 Sensors arranged on or in the housing, e.g. ultrasound flow sensors
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/827 : Sealings between moving parts
• CPC Class Codes: A61M 60/857 : Implantable blood tubes
• CPC Class Codes: A61M 60/867 : using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter

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

1. A catheter assembly comprising:

a catheter body;

a cannula coupled to a distal portion of the catheter body, the cannula having a proximal port and a distal port to enable a flow of blood through the cannula from the distal port to the proximal port;

an impeller disposed in the cannula between the proximal port and the distal port and configured to generate the flow of blood through the cannula;

a sensor assembly configured to measure a fluid property of the flow of blood through the cannula, wherein the sensor assembly comprises an elongate connector and at least one of;

(a) a proximal sensor coupled with the catheter body and having a distal portion near the proximal port, and (b) a distal sensor coupled with the cannula and having a distal portion near the distal port, the catheter body configured to receive the elongate connector through a sensor lumen from outside a patient to a location near the proximal port; and

a bearing housing disposed within the cannula, the bearing housing comprising a trough sized and shaped to receive the elongate connector between the bearing housing and the cannula.

2. The catheter assembly of claim 1, wherein the sensor assembly comprises the distal sensor.

3. The catheter assembly of claim 1, wherein the sensor assembly comprises a pressure sensor configured to measure a pressure of the flow of blood through the cannula and generate a signal related to the pressure.

4. The catheter assembly of claim 3, wherein the pressure sensor comprises a fiber optic sensor.

5. The catheter assembly of claim 4, wherein the fiber optic sensor comprises an elongate optical fiber and a sensor tip coupled to a distal end of the elongate optical fiber, the catheter body configured to receive the elongate optical fiber from outside a patient to a location near the proximal port or the distal port to provide optical communication between the sensor tip and a processing unit.

6. The catheter assembly of claim 1, wherein the sensor assembly further comprises a sensor tip at a distal end of the elongate connector.

7. The catheter assembly of claim 6, wherein the cannula comprises a tubular portion coupled to the distal portion of the catheter body, and wherein the tubular portion is configured to receive the elongate connector along an inner wall of the tubular portion.

8. The catheter assembly of claim 1, wherein the sensor assembly comprises the distal sensor disposed near the distal port, the distal sensor comprising an elongate connector extending from a proximal portion of the catheter assembly and a sensor tip disposed at a distal end of the elongate connector.

9. The catheter assembly of claim 8, wherein the distal sensor is disposed on or within an outer wall of the cannula and the elongate connector extends about a circumference of the cannula.

10. The catheter assembly of claim 8, further comprising a protective lumen coupled to a wall of the cannula, wherein the distal sensor is configured to pass through the protective lumen to position the sensor tip near the distal port.

11. The catheter assembly of claim 8, further comprising a central lumen disposed in the cannula, the distal sensor configured to pass through the central lumen to position the sensor tip near a sensing zone formed through the central lumen.

12. The catheter assembly of claim 11, further comprising an impeller disposed in the cannula and a tip member at a distal end of the cannula, wherein the central lumen passes between the impeller and the tip member.

13. A catheter assembly comprising:

a catheter body;

a cannula coupled to a distal portion of the catheter assembly, the cannula having a proximal port to enable a flow of blood through the cannula and exiting the proximal port;

an impeller disposed in the cannula distal the proximal port and configured to generate the flow of blood through the cannula;

a sensor assembly comprising an elongate connector and a sensor to be disposed near the proximal port, the catheter body configured to receive the elongate connector through a sensor lumen from outside a patient to a location near the proximal port;

a bearing housing disposed within the cannula, the bearing housing comprising a trough sized and shaped to receive the elongate connector between the bearing housing and the cannula; and

a processing unit programmed to process a signal generated by the sensor, the processing unit configured to execute a computer-readable set of rules to evaluate the signal to determine a position of the cannula relative to a cardiac valve of a patient during a treatment procedure.

14. The catheter assembly of claim 13, wherein the computer-readable set of rules evaluates the signal based at least in part on a rate of change of pressure or flow rate over time.

15. The catheter assembly of claim 14, wherein the processing unit comprises a look-up table (LUT) comprising an array of values corresponding to pressure, flow rate, rate of change of pressure, or rate of change of flow rate.

16. The catheter assembly of claim 13, wherein the computer-readable set of rules evaluates the signal based at least in part on a recognition of a pattern in a waveform of the signal.

17. The catheter assembly of claim 13, wherein the sensor comprises a pressure sensor, and wherein the signal is related to a pressure of a fluid flowing through the proximal port.

18. The catheter assembly of claim 17, wherein the pressure sensor comprises a fiber optic sensor.

19. The catheter assembly of claim 18, wherein the fiber optic sensor comprises an elongate optical fiber and a sensor tip coupled to a distal end of the elongate fiber, the catheter configured to receive the elongate optical fiber from outside a patient to a location near the proximal port to provide optical communication between the sensor tip and the processing unit.

20. The catheter assembly of claim 17, wherein the computer-readable set of rules includes a baseline rule for determining a baseline pressure signature from the signal, wherein the baseline pressure signal indicates proper placement of the cannula relative to the cardiac valve.

21. The catheter assembly of claim 20, wherein the baseline pressure signature indicates that the proximal port of the cannula is disposed proximal the cardiac valve.

22. The catheter assembly of claim 21, the assembly further comprising a distal sensor near a distal port of the cannula, wherein the computer-readable set of rules includes a baseline rule for determining a distal baseline pressure signature from a distal signal received from the distal sensor, wherein the distal baseline pressure signature indicates that the distal port of the cannula is disposed distal the cardiac valve.

23. The catheter assembly of claim 22, wherein the computer-readable set of rules includes a rule for determining whether the distal port is in close proximity to or overlying the cardiac valve.

24. The catheter assembly of claim 20, wherein the computer-readable set of rules includes a disturbance rule for determining a disturbance pressure signature from the pressure signal, wherein the disturbance pressure signature represents improper placement of the cannula relative to the cardiac valve.

25. The catheter assembly of claim 24, wherein the disturbance rule comprises a rule for determining a difference between a mean baseline pressure of a baseline pressure signature and a mean disturbance pressure of a disturbance pressure signature.

26. The catheter assembly of claim 24, wherein the disturbance rule comprises a rule for determining whether the proximal port is in close proximity to or overlying the cardiac valve.