IP Library Granted Patent US 12,465,413
Granted Patent B2
US 12,465,413 · App. 18/171,696 · Granted Nov 11, 2025

Ablation monitoring system and method

Inventors: Mark Hunter (St. Louis, MO); Troy L. Holsing (Golden, CO)
Assignee: Veran Medical Technologies, Inc.
A61B18/02A61B8/12A61B18/1492A61B90/37A61B2018/00583A61B2018/00702A61B2018/00791A61B2018/0212A61B2090/378
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,465,413
App. No.
18/171,696
Granted
Nov 11, 2025
Kind
B2
Abstract

A system and method are presented for treating targeted tissue using cryoablation. An introducer canula and a cryoprobe are inserted the targeted tissue. The cryoprobe is cooled and an ice ball is formed. The cryoprobe is removed while the ice ball is still frozen, and an ultrasound catheter is inserted. Ultrasound generated within the ice ball is used to determine the distance from the ultrasound catheter to a perimeter of the ice ball. This is repeated at different angles to model a slice of the ice ball. The ultrasound catheter is moved radially, and the process is repeated to create a model of at least a portion of the ice ball. The ice ball model can be displayed on a registered set of images representing the targeted tissue to ensure that the tissue lies within the treatment zone of the ice ball.

Claims (42)

1 . A method for treating a patient comprising:

a) inserting a cryoprobe within an introducer canula into targeted tissue in the patient;

b) generating an ice ball by cooling the cryoprobe;

c) removing the cryoprobe from the introducer canula and inserting an ultrasound catheter within the introducer canula; and

d) using the ultrasound catheter to determine a distance between the ultrasound catheter and a periphery of the ice ball by generating ultrasound energy within the ice ball.

2 . The method of claim 1 , wherein the ultrasound energy within the ice ball is generated by transmitting, from the ultrasound catheter, a plurality of directional ultrasound pulses within the ice ball radially away from the ultrasound catheter.

3 . The method of claim 2 , wherein the distance between the ultrasound catheter and the periphery of the ice ball is determined by using a time between the transmitting and a receiving of each pulse, and by using a known speed of ultrasound transmission in the ice ball.

4 . The method of claim 2 , wherein the plurality of directional ultrasound pulses are transmitted from a plurality of different translational positions by physically moving the ultrasound catheter between the plurality of different translational positions.

5 . The method of claim 4 , wherein a model of a slice of the ice ball is calculated at each of the plurality of different translational positions.

6 . The method of claim 5 , further comprising using a computer to combine the slices into an ice ball model showing a size and a shape for at least a portion of the ice ball.

7 . The method of claim 2 , wherein an ice ball model is created by a computer using determined distances from the plurality of directional ultrasound pulses, further comprising using the computer to compare the ice ball model against a known size and shape for the targeted tissue to identify portions of the targeted tissue outside an effective treatment area for the ice ball.

8 . The method of claim 2 , wherein the ultrasound catheter is physically rotated to transmit the plurality of directional ultrasound pulses.

9 . The method of claim 2 , wherein the ultrasound catheter has a plurality of ultrasound transducer elements near a distal end of the ultrasound catheter; further wherein each ultrasound transducer element of the plurality of ultrasound transducer elements is of a type selected from a set consisting of PZT based-transducers, pMUT based-transducers, and cMUT based-transducers.

10 . The method of claim 9 , wherein a particular directional ultrasound pulse in the plurality of directional ultrasound pulses is created using a phased-array in which the plurality of ultrasound transducer elements work together to form a directional beam of ultrasonic energy in a single direction.

11 . The method of claim 10 , wherein the plurality of ultrasound transducer elements that work together to form the directional beam of ultrasonic energy in the single direction also receive energy previously transmitted by the particular directional ultrasound pulse, wherein the received energy is analyzed to maximize a signal received by the plurality of ultrasound transducer elements from the single direction.

12 . The method of claim 1 , wherein using the ultrasound catheter to determine the distance includes generating a model of an ice ball that has been formed within the patient, the generating the model comprising:

a) positioning the ultrasound catheter into an interior of the ice ball;

b) transmitting, from the ultrasound catheter, a plurality of directional ultrasound pulses within the ice ball radially away from the ultrasound catheter, wherein the plurality of directional ultrasound pulses:

i) are transmitted in a plurality of radial directions, and

ii) are transmitted from a plurality of different translational positions;

c) determining, using a computer, a plurality of distances from the ultrasound catheter to an edge of the ice ball by using a time between a transmission and a receiving of each ultrasound pulse and by using a known speed of ultrasound transmission in the ice ball; and

d) creating, using the computer, the model of the ice ball using the plurality of distances based on the radial direction and the translational position for each ultrasound pulse.

13 . The method of claim 12 , further comprising:

e) displaying, using the computer, the model of the ice ball on a three-dimensional image of the patient showing an area of targeted tissue.

14 . The method of claim 13 , further comprising:

f) comparing on the computer the model of the ice ball against a known size and shape for the area of the targeted tissue to identify portions of the targeted tissue outside an effective treatment area for the area of ablated tissue; and

g) displaying the identified portions of the targeted tissue using an identifiable distinguishing visual characteristic.

15 . The method of claim 14 , wherein a distal end of the ultrasound catheter further contains electromagnetic sensors that receive electromagnetic signals that locate the distal end in an electromagnetic field, and further comprising using the received electromagnetic signals to display the model of the ice ball on the three-dimensional image of the patient.

16 . The method of claim 12 , wherein the ultrasound catheter has a plurality of ultrasound transducers at a distal end, further wherein a subset less than all of the plurality of ultrasound transducers are used to produce each ultrasound pulse, further wherein the subset is chosen based on a particular radial direction of each ultrasound pulse.

17 . The method of claim 16 , wherein the plurality of ultrasound transducers are PZT based-transducers.

18 . The method of claim 16 , wherein the plurality of ultrasound transducers are pMUT based-transducers.

19 . The method of claim 16 , wherein the plurality of ultrasound transducers are cMUT based-transducers.

20 . The method of claim 1 , using the ultrasound catheter to determine the distance includes generating a model of an area of ablated tissue that has been formed within the patient, the generating the model comprising:

a) positioning the ultrasound catheter into an interior of the area of the ablated tissue;

b) transmitting, from the ultrasound catheter, a plurality of directional ultrasound pulses within the area of the ablated tissue radially away from the ultrasound catheter, wherein the plurality of directional ultrasound pulses:

i) are transmitted in a plurality of radial directions, and

ii) are transmitted from a plurality of different translational positions;

c) determining, using a computer, a plurality of distances from the ultrasound catheter to an edge of the area of the ablated tissue by using a time between a transmission and a receiving of each ultrasound pulse and by using a known speed of ultrasound transmission in the area of the ablated tissue;

d) creating, using the computer, the model of the area of the ablated tissue using the plurality of distances based on the radial direction and the translational position for each ultrasound pulse;

e) displaying, using the computer, the model of the area of the ablated tissue on a three-dimensional image of the patient showing an area of targeted tissue;

f) comparing on the computer the model of the area of the ablated tissue against a known size and shape for the area of the targeted tissue to identify portions of the targeted tissue outside an effective treatment area for the area of the ablated tissue; and

g) displaying the identified portions of the targeted tissue using an identifiable distinguishing visual characteristic.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 27, 2024
From: HUNTER, MARK; HOLSING, TROY
To: VERAN MEDICAL TECHNOLOGIES, INC.
Reel/Frame 066577/0260 →
Continuity (2)
Continuation 16546652 · Aug 21, 2019
Related Publication 20230200877A1 · Jun 29, 2023
References Cited (58)
US 5741248A · Stern et al. · 1998 [cited by applicant]
US 6179831B1 · Bliweis · 2001 [cited by applicant]
US 6905492B2 · Zvuloni et al. · 2005 [cited by applicant]
US 7402161B2 · Zvuloni et al. · 2008 [cited by applicant]
US 7937132B2 · Piron et al. · 2011 [cited by applicant]
US 8685014B2 · Babkin et al. · 2014 [cited by applicant]
US 8695549B2 · Richter · 2014 [cited by applicant]
US 9820798B2 · Schwartz · 2017 [cited by applicant]
US 9918792B1 · Boveja et al. · 2018 [cited by applicant]
US 10413185B1 · Boveja et al. · 2019 [cited by applicant]
US 11602388B2 · Holsing · 2023 [cited by examiner]
US 20060089636A1 · Christopherson et al. · 2006 [cited by applicant]
US 20060149226A1 · Mccullagh et al. · 2006 [cited by applicant]
US 20060178665A1 · Sloan et al. · 2006 [cited by applicant]
US 20070185554A1 · Appling · 2007 [cited by applicant]
US 20100305439A1 · Shai et al. · 2010 [cited by applicant]
US 20120172838A1 · Flaherty et al. · 2012 [cited by applicant]
US 20120310064A1 · Mcgee · 2012 [cited by applicant]
US 20140236207A1 · Makower et al. · 2014 [cited by applicant]
US 20140276052A1 · Rankin et al. · 2014 [cited by applicant]
US 20150087975A1 · Salcudean · 2015 [cited by applicant]
US 20170086899A1 · Nalipinski et al. · 2017 [cited by applicant]
US 20170119432A1 · Mckay · 2017 [cited by applicant]
US 20180204284A1 · Cerezo Sanchez · 2018 [cited by applicant]
US 20190142528A1 · Vertikov · 2019 [cited by applicant]
US 20210052314A1 · Holsing et al. · 2021 [cited by applicant]
CN 204121161 · 2015 [cited by applicant]
CN 106132330 · 2016 [cited by applicant]
CN 106163414 · 2016 [cited by applicant]
CN 109589168A · 2019 [cited by applicant]
CN 114502090A · 2022 [cited by applicant]
JP 2004159668 · 2004 [cited by applicant]
JP 7538214 · 2024 [cited by applicant]
WO WO2007009118A2 · 2007 [cited by examiner]
WO WO2017167762A1 · 2017 [cited by applicant]
WO WO2021034744A1 · 2021 [cited by applicant]
“U.S. Appl. No. 16/546,652, Notice of Allowance mailed Nov. 16, 2022”, 8 pgs. [cited by applicant]
“U.S. Appl. No. 16/546,652, Response filed Sep. 21, 2022 to Non Final Office Action mailed Jun. 21, 2022”, 11 pgs. [cited by applicant]
“Chinese Application Serial No. 202080069686.3, Office Action mailed Jun. 17, 2024”, W/English Translation, 10 pgs. [cited by applicant]
“European Application Serial No. 20855218.2, Extended European Search Report mailed Aug. 2, 2023”, 7 pgs. [cited by applicant]
“European Application Serial No. 20855218.2, Response filed Jul. 18, 2022 to Communication pursuant to Rules 161(2) and 162 EPC mailed Mar. 29, 2022”, 10 pgs. [cited by applicant]
“European Application Serial No. 20855218.2, Response filed Nov. 3, 2023 to Extended European Search Report mailed Aug. 2, 2023”, 12 pgs. [cited by applicant]
“International Application Serial No. PCT/US2020/046613, International Preliminary Report on Patentability mailed Mar. 3, 2022”, 7 pgs. [cited by applicant]
“International Application Serial No. PCT/US2020/046613, International Search Report mailed Jan. 12, 2021”, 2 pgs. [cited by applicant]
“International Application Serial No. PCT/US2020/046613, Invitation to Pay Additional Fees mailed Sep. 30, 2020”, 2 pgs. [cited by applicant]
“International Application Serial No. PCT/US2020/046613, Written Opinion mailed Jan. 12, 2021”, 5 pgs. [cited by applicant]
“Japanese Application Serial No. 2022-510970, Notification of Reasons for Refusal mailed Feb. 27, 2024”, w/ English Translation, 4 pgs. [cited by applicant]
“Japanese Application Serial No. 2022-510970, Response filed Apr. 25, 2024 to Notification of Reasons for Refusal mailed Feb. 27, 2024”, with machine translation, 11 pgs. [cited by applicant]
Image-guided Interventions, second ed. Matthew A Mauro et al., Expert radiology series ebook, published by Sauders/Elsevier, Philadelphia, PA. USA 2014. [cited by applicant]
Temperature Monitoring During Tissue Freezing Using Ultrasound Speed Measurements, by I. Jovanovic et al. vol. 7265, Proc. SPIE 7265, Medical Imaging 2009: Utrasonic Imaging and Signal Processing, edited by Stephen A. M… [cited by applicant]
In Vivo Results with a New Device for Ultrasonic Monitoring of Pig Skin Cryosurgery: The Echographic Cryoprobe by Pascal Laugier et al. Laboratoire d'Imagerie Parame trique, URA CNRS, Paris, France; 1998 La Motte d'Avei… [cited by applicant]
Cancer Cryotherapy: Evolution and Biology, by Dan Theodorescu, MD, PhD. Reviews in Urology 2004; 6(Supp4):S9-819 MedReviews LLC 2004. [cited by applicant]
Jun. 21, 2022 USPTO Office Action (U.S. Appl. No. 16/546,652)—Our Matter 5936. [cited by applicant]
U.S. Appl. No. 16/546,652 now U.S. Pat. No. 11,602,388, filed Aug. 21, 2019, Ablation Monitoring System and Method. [cited by applicant]
“Japanese Application Serial No. 2024-131742, Voluntary Amendment Filed Sep. 5, 2024”, W/ Machine English Translation 17 pgs. [cited by applicant]
“Chinese Application Serial No. 202080069686.3, Response filed Oct. 17, 2024 to Office Action mailed Jun. 17, 2024”, w claims, 16 pgs. [cited by applicant]
“Chinese Application Serial No. 202080069686.3, Office Action mailed Dec. 9, 2024”, w Machine English translation, 9 pgs. [cited by applicant]
“Chinese Application Serial No. 202080069686.3, Response filed Feb. 8, 2025 to Office Action mailed Dec. 9, 2024”, w english claims, 14 pgs. [cited by applicant]