Search

US-12622670-B2 - Integrated cardiac mapping and piezoelectric micromachined ultrasonic transducer (pMUT) ultrasonic imaging catheter system and method

US12622670B2US 12622670 B2US12622670 B2US 12622670B2US-12622670-B2

Abstract

An integrated cardiac mapping and Piezoelectric Micromachined Ultrasonic Transducer (pMUT) ultrasonic imaging system, is disclosed. The system comprising a pMUT imaging and mapping catheter having a longitudinal axis, a proximal end, and a distal end. A micro-electromechanical (MEMS) based pMUT or other transducer disposed within the distal end of the pMUT imaging and mapping catheter. A pMUT mapping array disposed within the distal end of the pMUT imaging and mapping catheter, wherein the mapping array comprises an expandable basket, grid, hoop, or other configuration with an electronic sensor array arranged on electronic flex circuits.

Inventors

  • Donald Masters
  • Jesus Andres Lopez
  • Eric Stoppenhagen

Assignees

  • BOSTON SCIENTIFIC SCIMED, INC.

Dates

Publication Date
20260512
Application Date
20230208

Claims (11)

  1. 1 . An integrated cardiac mapping and piezoelectric micromachined ultrasonic transducer (pMUT) ultrasonic imaging system comprising: a pMUT imaging and mapping catheter having a longitudinal axis, a proximal end, and a distal end the pMUT imaging and mapping catheter including a catheter shaft that slidably receives a control shaft; a first micro-electromechanical (MEMS) based pMUT array disposed at the distal end of the pMUT imaging and mapping catheter, wherein the first MEMS based pMUT array comprises a substrate and a plurality of pMUT array elements arranged on the substrate; a mapping array disposed at the distal end of the pMUT imaging and mapping catheter, wherein the mapping array comprises a plurality of support members with an electronic sensor array arranged on the plurality of support members, wherein a distal end of the plurality of support members is connected to the control shaft and a proximal end of the plurality of support members is connected to the catheter shaft; and a first ring positioned on the control shaft at the proximal end of the plurality of support members, wherein the proximal end of the plurality of support members is directly connected to the first ring and the first ring is configured to attach the proximal end of the plurality of support members to the catheter shaft; wherein the first MEMS based pMUT array is positioned on the first ring.
  2. 2 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein the catheter shaft is connected at one end to a handle assembly and at another end to the first MEMS based pMUT array and the mapping array.
  3. 3 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein the pMUT imaging and mapping catheter is coupled to a dongle, and the dongle is configured to communicate ultrasound transmit pulses and ultrasound receive waveforms between the first MEMS based pMUT array and a combined ultrasound and mapping computer system.
  4. 4 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein the pMUT imaging and mapping catheter is coupled to a dongle, and the dongle is configured to communicate electronic mapping data between the plurality of support members and a combined ultrasound and mapping computer system.
  5. 5 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein each of the plurality of pMUT array elements having transducer cells of multiple diameters, to achieve a wide bandwidth.
  6. 6 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein each of the plurality of pMUT array elements is a linear phased array.
  7. 7 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein each of the plurality of pMUT array elements is a pMUT circular array.
  8. 8 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein the electronic sensor array corresponds to mapping elements.
  9. 9 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein the plurality of support members is configured to be placed against an interior wall of a heart.
  10. 10 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , further comprising a second ring positioned on the control shaft at the distal end of the plurality of support members, wherein a second MEMS based pMUT array is positioned on the second ring.
  11. 11 . The integrated cardiac mapping and pMUT ultrasonic imaging system of claim 1 , wherein first MEMS based pMUT array is arranged in a linear fashion wherein each of the plurality of pMUT array elements is positioned longitudinally next to another pMUT array element and is oriented perpendicularly to the longitudinal axis of the pMUT imaging and mapping catheter.

Description

FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of cardiac mapping and ultrasonic imaging and mapping catheters. More particularly, embodiments relate to mapping catheters having a distal piezoelectric micromachined transducer for transmitting and receiving acoustic pulse information. BACKGROUND OF THE DISCLOSURE Use of catheter-based structural and electrophysiological procedures have recently expanded to more complex scenarios, in which an accurate definition of variable individual cardiac anatomy is a key to obtain optimal results. In electrophysiology procedures, piezoelectric micromachined ultrasonic transducer (pMUT) imaging allows integration of real-time images with mapping to guide transcatheter cardiac procedures. Cardiac mapping utilizes electrodes that measure the electrical activity of the cardiac tissue. This is transferred into mapping system software where a 3D model is created of the heart, a color-coded overlay showing the electrical waves generated during each heartbeat, the touch points where the tissue was mapped, and showing the location of the catheter inside the heart. Tissue identified as having unhealthy electrical activity that is cause an arrhythmia can then be ablated directly or isolated using an ablation catheter to cause small burns/scar tissue that block electrical signals. The pMUT imaging integration allows a real-time assessment of cardiac anatomy during interventional procedures and guides catheter manipulation in relation to the different anatomic structures. Therefore, there is a need for an improved mapping catheters that integrate ultrasonic pMUT imaging. Atrial Fibrillation (AF) is one of the most widespread and sustained cardiac arrhythmias and it affects more than 30 million people worldwide. While prevalence in developed nations tends to be small, nearly 1%-4%. The AF is steadily increasing, and it is well known that the AF is associated with an increased risk of all-cause mortality, heart failure, thromboembolism, and dementia. Catheter mapping is an alternative treatment option that is more effective than antiarrhythmic medications. Pulmonary vein isolation (PVI), which involves electrically isolating the pulmonary veins (PV) from the left atrium, remains the cornerstone of Atrial Fibrillation (AF) mapping. The catheter mapping is necessary to locate triggers and substrate so that an ablation strategy can be optimized. The most used cardiac mapping approach is isochronal or activation mapping, which aims to create a spatial model of electrical wavefront propagation. The catheter mapping increase ability to perform rapid simultaneous contact mapping of the chamber. Typically, modern mapping technologies which may improve the efficacy, safety, and efficiency of mapping for persistent AF. Further, current technology requires the use of a separate mapping, ablation catheter and an Intracardiac Echocardiography (ICE) pMUT imaging catheter. ICE has applications for structural heart pMUT imaging of the left atrial appendage (LAA), to aid in septal defect closures and visualizing the fossa ovalis and plays a role in transcatheter valve replacement. It also is used in EP procedures for ablation catheter guidance. ICE confirms the exact location of the catheter tip to aid with more accurate ablations. ICE also can help with safety monitoring of the pericardial space for tamponade or pericardial effusion caused in rare cases by either the transeptal puncture or the ablation. ICE is expected to become increasingly important to better guide an increasing number of transcatheter ablation procedures. Once transcatheter aortic and mitral valve heart valve replacement and LAA occlusion devices gain U.S. Food and Drug Administration (FDA) clearance, ICE is expected to see increased use for the accurate deployment of these devices. Further, the AF refers to a type of cardiac arrhythmia where there is disorganized electrical conduction in the atria causing rapid uncoordinated contractions that result in ineffective pumping of blood into the ventricle and a lack of synchrony. During AF, the atrioventricular node receives electrical impulses from numerous locations throughout the atria instead of only from the sinus node. This overwhelms the atrioventricular node into producing an irregular and rapid heartbeat. As a result, blood pools in the atria that increases a risk for blood clot formation. The major risk factors for atrial fibrillation include age, coronary artery disease, rheumatic heart disease, hypertension, diabetes, and thyrotoxicosis. The AF affects 7% of the population over age 65. Moreover, the AF treatment options are limited. Lifestyle change only assists individuals with lifestyle related AF. Medication therapy assists only in the management of AF symptoms, may present side effects more dangerous than atrial fibrillation, and fail to cure AF. Electrical cardioversion often restores sinus rhythm but has a high recurrence rate. In additio