IP Library › Granted Patent US 12,295,839
Granted Patent B2
US 12,295,839 · App. 17/156,370 · Granted May 13, 2025

Motorized implant delivery system

Inventors: Matthew Michael Becerra (Lake Forest, CA); David Robert Landon (Costa Mesa, CA)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2427A61B90/06A61B90/37A61F2/9517G16H10/60G16H40/63A61B2090/065
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Quick Facts
Patent No.
US 12,295,839
App. No.
17/156,370
Granted
May 13, 2025
Kind
B2
Abstract

Systems, apparatuses, and methods disclosed herein are provided for a motorized implant delivery system. The delivery system may utilize a processor for control of at least one motor for actuating a delivery apparatus. The delivery system may include sensors configured sense one or more of a condition of the patient's body or a condition of the delivery apparatus. The processor may process the signals provided by the sensors, which may comprise feedback signals to the processor.

Claims (33)

1. A method of advancing a prosthetic replacement heart valve through a patient's vasculature in an atraumatic manner, the method comprising:

advancing a guide wire through the patient's vasculature and into a heart chamber;

advancing an elongate shaft of a catheter through the patient's vasculature over the guide wire to deliver the prosthetic replacement heart valve to a native heart valve, the prosthetic replacement heart valve being disposed along a distal end portion of the elongate shaft, the catheter including at least one motor for deflecting the distal end portion of the elongate shaft of the catheter within the patient's vasculature with one or more pull wires during advancement through the patient's vasculature for reducing contact with an inner wall of a blood vessel, wherein one or more proximity sensors are positioned along a nose cone for sensing a lateral distance between the nose cone and the inner wall of the blood vessel, wherein the nose cone has a tapered shape and is disposed distal to the elongate shaft during advancement;

providing, with a processor, control of the at least one motor to deflect the distal end portion of the elongate shaft of the catheter with the one or more pull wires while continuing to advance the elongate shaft through the patient's vasculature for steering the elongate shaft through the patient's vasculature in an atraumatic manner, wherein the at least one motor deflects the distal end portion with the one or more pull wires based on signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the blood vessel while the elongate shaft of the catheter continues to be advanced, the signals provided as feedback to the processor; and

radially expanding the prosthetic replacement heart valve within the native heart valve to deploy the prosthetic replacement heart valve to the native heart valve from the distal end portion of the elongate shaft of the catheter.

2. The method of claim 1 , wherein the processor provides an output that is provided as an indicator on an output device,

wherein the output device comprises one or more of a display screen, a light, a speaker, or a haptic device, and

wherein the indicator indicates a condition of the catheter or a condition of the patient's body.

3. The method of claim 1 , wherein the processor provides an output comprising a log of data for an implantation procedure with the catheter, and further comprising storing the log of data in a memory.

4. The method of claim 1 , wherein the catheter further comprises one or more sensors on the elongate shaft that sense a condition of the patient's body comprising one or more of a blood pressure within the patient's body or a blood flow within the patient's body, and

wherein the processor controls the at least one motor to deploy the prosthetic replacement heart valve to the native heart valve.

5. The method of claim 1 , wherein the catheter includes a handle coupled to a proximal end of the elongate shaft, and

wherein the catheter comprises a self-contained unit including the processor, the at least one motor, and a power source for providing power to the processor and the at least one motor.

6. The method of claim 1 , wherein the catheter autonomously delivers the prosthetic replacement heart valve to the native heart valve.

7. The method of claim 1 , further comprising:

providing an input with a control device to the processor to cause the processor to actuate at least a portion of the catheter; and

adjusting the input utilizing the processor to avoid or retract from the inner wall of the blood vessel based on the signals from the one or more proximity sensors of the lateral distance between the nose cone and the inner wall of the blood vessel.

8. The method of claim 1 , wherein the processor controls the at least one motor to deflect the distal end portion of the elongate shaft of the catheter with the one or more pull wires utilizing a machine learning algorithm utilizing data from past implantation procedures or from characteristics of the patient.

9. The method of claim 1 , wherein the native heart valve is the mitral heart valve, and advancing the elongate shaft of the catheter through the patient's vasculature includes passing the elongate shaft of the catheter through an atrial septum of the patient's heart.

10. The method of claim 1 , wherein the native heart valve is the aortic heart valve, and advancing the elongate shaft of the catheter through the patient's vasculature includes passing the elongate shaft of the catheter through an aortic arch of the patient's heart, and

wherein the processor controls the at least one motor to deflect the distal end portion of the elongate shaft of the catheter with the one or more pull wires within the aortic arch based on the signals from the one or more proximity sensors of the lateral distance between the nose cone and an inner wall of the aortic arch.

11. The method of claim 1 , wherein the one or more proximity sensors sense the lateral distance between the nose cone and the inner wall of the blood vessel utilizing ultrasound signals.

12. The method of claim 1 , wherein the one or more proximity sensors sense the lateral distance between the nose cone and the inner wall of the blood vessel utilizing echo signals.

13. The method of claim 1 , wherein the one or more proximity sensors sense the lateral distance between the nose cone and the inner wall of the blood vessel utilizing visual identification.

14. The method of claim 1 , wherein one or more imaging devices are located on the elongate shaft for imaging the patient's vasculature within the patient's vasculature.

15. The method of claim 1 , further comprising utilizing the one or more proximity sensors on the nose cone to sense a distance between the distal end portion of the elongate shaft and the native heart valve.

16. The method of claim 1 , further comprising utilizing the one or more proximity sensors on the nose cone to sense a distance between the distal end portion of the elongate shaft and the native heart valve while deploying the prosthetic replacement heart valve to the native heart valve from the distal end portion of the elongate shaft of the catheter.

17. The method of claim 1 , further comprising utilizing the one or more proximity sensors on the nose cone to sense a distance between the distal end portion of the elongate shaft and the native heart valve to align the distal end portion of the elongate shaft with an annulus of the native heart valve.

18. The method of claim 1 , further comprising gripping a handle coupled to a proximal end portion of the elongate shaft and manually advancing the elongate shaft of the catheter through the blood vessel.

19. The method of claim 18 , further comprising manually manipulating one or more control devices on the handle to deflect the distal end portion of the elongate shaft.

20. The method of claim 18 , wherein a power source is positioned within the handle.

21. The method of claim 1 , wherein the one or more proximity sensors are a first one or more proximity sensors, and a second one or more proximity sensors are positioned on a retractable capsule of the elongate shaft surrounding the prosthetic replacement heart valve, the second one or more proximity sensors for sensing a distance between the distal end portion of the elongate shaft and the inner wall of the patient's vasculature.

22. The method of claim 1 , wherein the prosthetic replacement heart valve comprises an expandable frame and a tissue-based valve body supported by the expandable frame, wherein the tissue-based valve body provides one-way blood flow for replacing a function of the native heart valve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 6, 2021
From: BECERRA, MATTHEW MICHAEL; LANDON, DAVID ROBERT
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 055843/0068 →
Continuity (3)
Continuation PCTUS2020029138 · Apr 21, 2020
Provisional Application 62837641 · Apr 23, 2019
Related Publication 20210145576A1 · May 20, 2021
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