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EP-4736780-A1 - CATHETER DISTAL TIP FOR PERFORMING SENSOR ASSISTED NAVIGATION, CATHETER ASSEMBLY, AND ROBOTICALLY ASSISTED INTERVENTIONAL DEVICES

EP4736780A1EP 4736780 A1EP4736780 A1EP 4736780A1EP-4736780-A1

Abstract

The present disclosure relates to a steerable catheter distal tip for performing sensor assisted navigation, to a catheter assembly comprising a catheter distal capsule and tip, and to a robotically assisted interventional device. A steerable catheter distal tip for performing sensor assisted navigation comprises an ultrasonic transducer system (106) arranged to surround a circumference of the catheter distal tip (100), wherein the ultrasonic transducer system (106) is operable to generate distance signals indicative of distances between a plurality of sensing locations on the circumference of the catheter distal tip (106) from walls of a cavity in which the catheter distal tip (100) is located in operation; and a signal processing unit (112) comprising a controller, which is operable to cause the catheter distal tip (100) being steered along a defined navigation path based on the distance signals.

Inventors

  • HART, STEPHEN
  • MCDERMOTT, BERNARD
  • REGUS, Cristian S.
  • Wiseman, Stephen
  • GOESSERINGER, Peter
  • BETTS, Andrew

Assignees

  • Creganna Unlimited Company
  • Tyco Electronics UK Ltd.

Dates

Publication Date
20260506
Application Date
20241029

Claims (16)

  1. Catheter distal tip for performing sensor assisted navigation, the catheter distal tip (100) comprising: an ultrasonic transducer system (106) arranged to surround a circumference of the catheter distal tip (100), wherein the ultrasonic transducer system (106) is operable to generate distance signals indicative of distances between a plurality of sensing locations on the circumference of the catheter distal tip (106) from walls of a cavity in which the catheter distal tip (100) is located in operation; a signal processing unit (112) comprising a controller, which is operable to cause the catheter distal tip (100) being steered along a defined navigation path based on the distance signals.
  2. Catheter distal tip according to claim 1, wherein the ultrasonic transducer system (106) is operable to generate the distance signals based on time-of-flight measurements.
  3. Catheter distal tip according to claim 1 or 2, wherein the ultrasonic transducer system (106) comprises a plurality of piezoelectric MEMS ultrasonic transducers, PMUT.
  4. Catheter distal tip according to one of the preceding claims, wherein the ultrasonic transducer system (106) comprises a plurality of panel-shaped arrays (108) of sensor elements (124), the arrays (108) being mounted on a carrier substrate (110) encompassing the steerable catheter distal tip (100).
  5. Catheter distal tip according to claim 4, wherein the carrier substrate (110) has a polygonal cross-section across to a longitudinal axis of the steerable catheter distal tip (100).
  6. Catheter distal tip according to one of the preceding claims, further comprising a temperature sensor and/or a force sensor and/or a pressure sensor and/or a sensor determining acoustic properties of a medium inside the cavity (142).
  7. Catheter distal tip according to one of the preceding claims, further comprising an acoustic beamforming unit which is associated with the ultrasonic transducer system (106) to emit a plurality of ultrasonic beams from the sensing locations on the circumference of the catheter distal tip (100).
  8. Catheter distal tip according to claim 7, wherein the beamforming unit is operable to modify a signal amplitude and/or a time or phase delay characteristics and/or wherein the beamforming unit is operable to perform comparator based amplitude processing and/or analog/digital conversion.
  9. Catheter distal tip according to one of the preceding claims, wherein the signal processing unit (112) is operable to calculate the navigation path as a centroid of calculated wall positions derived from the distance signals.
  10. Catheter distal tip according to one of the preceding claims, further comprising a memory for storing calculated wall positions derived from the distance signals and wherein the signal processing unit (112) is operable to calculate a map of the cavity along the navigation path.
  11. Catheter assembly for performing sensor assisted navigation, the catheter assembly (200) comprising a catheter distal tip (100) according to the preceding claims.
  12. Catheter assembly according to claim 11, wherein the signal processing unit (112) is arranged within the steerable catheter distal tip (100) or wherein the signal processing unit (112) is arranged at a proximal end of the catheter assembly (200).
  13. Catheter assembly according to claim 11 or 12, wherein the controller is operable to generate a corrective action navigation vector signal for causing the steerable catheter distal tip (100) to correct its position with respect to a centroid of calculated wall positions.
  14. Catheter assembly according to one of the claims 11 to 13, wherein the controller is operable to use data from multiple surgical procedures and clinical outcomes, the data being stored and used as training data for signal processing to define an optimal navigation path in a current procedure.
  15. Interventional robotic system comprising a catheter assembly (200) according to one of the claims 11 to 14.
  16. Interventional robotic system according to claim 15, comprising further sensor elements arranged on an outer surface of a catheter.

Description

The present disclosure relates to a preferably steerable catheter distal tip for performing sensor assisted navigation, to a catheter assembly comprising a catheter distal capsule and tip, and to a robotically assisted interventional device. Minimally invasive intravascular procedures allow the performance of therapeutic treatments of locations within a patient's body while requiring only relatively small access incisions. An intravascular procedure may, for example, eliminate the need for open-heart surgery, reducing risks, costs, and time associated with an open-heart procedure. The intravascular procedure also enables faster recovery times with lower associated costs and risks of complication. An example of an intravascular procedure that significantly reduces procedure and recovery time and cost over conventional surgery is a heart valve replacement or repair procedure in which an artificial valve or valve repair device is guided to the heart through the patient's vasculature. For example, a Transcatheter Mitral Valve repair (TMVr) procedure generally requires a catheter device to be inserted femorally and tracked through the vasculature to the right atrium of the heart, then navigated through a puncture in the intra-atrial septum to the left atrium. An aortic valve replacement device typically enters the femoral artery and traverses around the aortic arch to the location of the aortic valve. The distal end of a transcatheter delivery device needs to be positioned precisely to ensure the optimal positioning of, for instance a prosthetic valve before deployment, valve repair devices, stents, electrophysiology devices or other diagnostic or therapeutic devices. Additionally, it is crucial that the inner walls of the vessels are not damaged by the advancing catheter distal tip. In particular, dislodged wall tissue or collagenous debris might cause arterial embolism. The principles according to the present disclosure can be used advantageously for performing a Transcatheter Aortic Valve Replacement procedure (TAVR). During this minimally invasive procedure a bioprosthetic valve is inserted inside the defective native valve. The procedure may also be called a Transcatheter Aortic Valve Implantation (TAVI). Furthermore, the present disclosure is also applicable to various other minimally invasive procedures in which a catheter needs to be moved within a cavity, while minimizing the potential damage to boundaries of the cavity. There exist different concepts for localizing parts of catheters in the body and to display the result to a physician. However, there is still a need for providing means to optimally navigate the tip of a catheter through cavities in the body whilst minimizing contact with the vessel walls. For instance, the walls (or boundaries) of the cavity may be the walls of blood vessels through which the catheter distal tip has to move. This object is solved by the subject matter of the independent claims. Advantageous examples of the present disclosure are the subject matter of several dependent claims. The present disclosure is based on the idea that by providing a smart catheter distal tip with ultrasonic transducer-based navigation, contact of the distal end of the catheter device with the vessel walls can be minimized leading to less traumatic navigation of the catheter through the vessels. Signal processing electronics and a vector navigation algorithm can be used to center the catheter distal tip e.g. in a blood vessel during a medical procedure. One possible procedure is TAVR but the technique is extensible to additional structural heart, lung, et. al. procedures conducted via arterial pathway, or other bodily vessels, and any navigation of a catheter or instrument. In particular, a catheter distal tip for performing sensor assisted navigation according to an aspect of the present disclosure comprises an ultrasonic transducer system, the ultrasonic transducer system being arranged to surround a circumference of the catheter distal tip, wherein the ultrasonic transducer system is operable to generate distance signals indicative of distances between a plurality of sensing locations on the circumference of the catheter distal tip from walls of a cavity in which the catheter distal tip is located. A signal processing unit is provided, comprising a controller, which is operable to cause the catheter distal tip being steered along a defined navigation path based on the distance signals. The catheter distal tip may be steerable or non-steerable. With the catheter distal tip according to the present disclosure, the achieved clinical outcomes may be improved significantly. The distal end of typical devices can have tapers, steps and raised edges and can be larger in diameter than the following body of the device. This makes the distal end more prone to damage of the vessels whilst making contact. Any complications induced by vascular injury may be reduced by minimizing contact and particulate gene