IP Library Granted Patent US 12,471,925
Granted Patent B2
US 12,471,925 · App. 18/752,221 · Granted Nov 18, 2025

Systems and methods for mechanical displacement of an esophagus

Inventors: Emile Daoud (Chagrin Falls, OH); William Fuller (Chagrin Falls, OH)
Assignees: Ohio State Innovation Foundation; S4 Medical Corp
A61B17/12104A61B17/00234A61B17/0218A61B17/12136A61B17/3431A61B34/70A61B2017/00243A61B2017/00292A61B2017/003A61B2017/00336A61B2017/345A61B2017/348A61B2017/3488A61B2090/0427A61B2217/005
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 12,471,925
App. No.
18/752,221
Granted
Nov 18, 2025
Kind
B2
Abstract

An assembly for use with a vacuum system and an esophageal positioning device esophageal positioning device includes an introducer, in which the esophageal positioning device includes a first segment and a second segment. The second segment is pivotally connected to the first segment. A gap portion of an outer tube of the introducer is defined along a longitudinal axis between a tube tip of the introducer and the distal end of the second segment of the esophageal positioning device when the esophageal positioning device is disposed within the introducer. The gap portion defines one or more radial vacuum holes.

Claims (25)

1 . A method of using a mechanical esophageal displacement system, the method comprising:

inserting an assembly into an esophagus of a patient via a mouth or nasal passage, wherein the assembly includes:

an introducer comprising:

an articulatable esophageal positioning device including a first segment coupled to a second segment via a pivotal connection, wherein the first segment has a central axis, wherein the second segment has a proximal end pivotally connected to the first segment and a distal end opposite and spaced apart from the proximal end, the second segment being pivotable about the first segment between a first position and a second position upon articulation, wherein the distal end of the second segment is disposed along the central axis in the first position and the distal end of the second segment is displaced from the central axis in the second position, wherein the distal end of the second segment remains a same distance from the proximal end of the second segment in the first position and the second position; and

a soft outer tube sized to pass through the mouth or nasal passage into the esophagus, the soft outer tube defining a longitudinal axis, a tube distal end, and a tube proximal end, the soft outer tube including a body, the body defining

an end portion between the pivotal connection and the tube distal end,

a gap portion between the distal end of the second segment and the tube distal end, and

radial vacuum holes positioned in the gap portion and spaced circumferentially around the longitudinal axis,

a tube tip coupled to the tube distal end and

a vacuum port comprising a vacuum port body, a vacuum line hook up, and a vacuum port cap; and

coupling a vacuum system to the vacuum line hook up of the introducer;

advancing the articulatable esophageal positioning device through the soft outer tube of the introducer;

engaging the vacuum system to adhere a portion of the soft outer tube to an esophageal wall; and

articulating the second segment about the first segment at a selected angle from the first position to the second position.

2 . The method of claim 1 , wherein the gap portion defines a higher density of the radial vacuum holes than any other portion of the body of the soft outer tube introducer.

3 . The method of claim 1 , wherein a density of the radial vacuum holes is highest adjacent the tube distal end of the soft outer tube, and the density of the radial vacuum holes gradually decreases along the longitudinal axis in a direction from the tube distal end of the soft outer tube toward the tube proximal end of the soft outer tube.

4 . The method of claim 1 , wherein a length of the gap portion of the soft outer tube as measured along the longitudinal axis is from 10 mm to 30 mm.

5 . The method of claim 4 , wherein the length of the gap portion of the soft outer tube as measured along the longitudinal axis is 28 mm.

6 . The method of claim 4 , wherein a length of the second segment is 40 mm or more.

7 . The method of claim 1 , wherein the introducer further comprises eyelets extending radially outward from the soft outer tube, wherein each of the eyelets defines an eyelet opening and the eyelet openings of each of the eyelets are axially aligned with each other along the soft outer tube.

8 . The method of claim 1 , wherein the introducer further comprises one or more occlusion balloons extending radially outward from the soft outer tube, the one or more occlusion balloons being inflatable.

9 . The method of claim 8 , wherein the one or more occlusion balloons include a first occlusion balloon and a second occlusion balloon, the first occlusion balloon being disposed at the tube distal end of the soft outer tube and the second occlusion balloon being disposed at a portion of the soft outer tube that is adjacent the pivotal connection between the first segment and the second segment of the articulatable esophageal positioning device when the articulatable esophageal positioning device is disposed within the introducer.

10 . The method of claim 1 , wherein the radial vacuum holes are also positioned in the end portion outside the gap portion, and wherein the gap portion defines a higher density of the radial vacuum holes than the end portion.

11 . The method of claim 1 , wherein a density of the radial vacuum holes is highest adjacent the tube distal end, and the density of the radial vacuum holes gradually decreases along the longitudinal axis in a direction from the tube distal end toward the tube proximal end.

12 . The method of claim 1 , wherein only the end portion defines the radial vacuum holes.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2024
From: FULLER, WILLIAM
To: S4 MEDICAL CORP
Reel/Frame 067929/0411 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2024
From: DAOUD, EMILE
To: OHIO STATE INNOVATION FOUNDATION
Reel/Frame 067929/0419 →
Continuity (3)
Division 17859694 · Jul 7, 2022
Division 16847958 · Apr 14, 2020
Related Publication 20240341767A1 · Oct 17, 2024
References Cited (45)
US 11382631B2 · Daoud · 2022 [cited by examiner]
US 20070010782A1 · Doty et al. · 2007 [cited by applicant]
US 20070215162A1 · Glassenberg et al. · 2007 [cited by applicant]
US 20080004598A1 · Gilbert · 2008 [cited by applicant]
US 20080033415A1 · Rieker et al. · 2008 [cited by applicant]
US 20140188080A1 · Besser et al. · 2014 [cited by applicant]
US 20170252027A1 · Kasic · 2017 [cited by applicant]
US 20170360503A1 · Miller · 2017 [cited by applicant]
US 20180200416A1 · Oza · 2018 [cited by examiner]
US 20180317943A1 · Razavi et al. · 2018 [cited by applicant]
US 20190223734A1 · Lakkireddy et al. · 2019 [cited by applicant]
US 20190269834A1 · Oza et al. · 2019 [cited by applicant]
CN 110392555A · 2019 [cited by applicant]
Japanese Patent Office. Office Action issued in JP Application No. JP 2022-562699. Nov. 21, 2024. 24 pages. [cited by applicant]
International Search Report and Written Opinion issued for Application No. PCT/US2021/027113, dated Aug. 2, 2021. [cited by applicant]
European Patent Office. Extended European Search Report. Issued in EP Application No. 21789123.3. Apr. 15, 2024. 12 pages. [cited by applicant]
Arbelo E, Brugada J, Lundqvist CB, Laroche C, Kautzner J, Pokushalov E, Raatikainen P, Efremidis M, Hindricks G, Barrera A, Maggioni A, Tavazzi L, Dagres N. Contemporary management of patients undergoing atrial fibrilla… [cited by applicant]
Aryana A, Arthur A, O'Neill PG, D'Avila A. Catastrophic manifestations of air embolism in a patient with atrio-esophageal fistula following minimally invasive surgical ablation of atrial fibrillation. J Cardiovasc Elect… [cited by applicant]
Bhardwaj R,Naniwadekar A, Whang W, Mittnacht AJ, Palaniswamy C, Koruth JS, Joshi K, Sofi A, Miller M, Choudry S, Dukkipati SR, Reddy VY: Esophageal deviation during atrial fibrillation ablation J Am Coll Cardiol EP 2018… [cited by applicant]
Black-Maier E, Pokorney SD, Barnett AS, Zeitler EP, Sun AY, Jackson KP, Bahnson TD, Daubert JP, Piccini JP: Risk of atrioesophageal fistula formation with contact force-sensing catheters. Heart Rhythm 2017;14:1328-1333. [cited by applicant]
Borchert B, Lawrenz T, Hansky B, Stellbrink C. Lethal atrio-esophageal fistula after pulmonary vein isolation using high-intensity focused ultrasound (HIFU). Heart Rhythm 2008;5:145-148. [cited by applicant]
Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for … [cited by applicant]
Cummings JE, Schweikert RA, Saliba WI, Burkhardt JD, Brachmann J, Gunther J,Schibgilla V, Verma A, Dery M, Drago JL, Kilicaslan F, Natale A. Assessment of temperature, proximity, and course of the esophagus during radio… [cited by applicant]
Cummings JE, Schweikert RA, Saliba WI, et al. Brief communication: atrial-esophageal fistulas after radiofrequency ablation. Ann Intern Med 2006;144: 572-574. [cited by applicant]
Giacomino BD, Worden N, Marchigiani R, Keech J, Giudici MC. Pericardial-esophageal fistula complicating cryoballoon ablation for refractory atrial fibrillation. Heart Rhythm Case Rep. 2017. [cited by applicant]
Halbfass P, Müller P, Nentwich K, Krug J, Roos M, Hamm K, Barth S, Szöllösi A,Mügge A, Schieffer B, Deneke T. Incidence of asymptomatic oesophageal lesions after atrial fibrillation ablation using an oesophageal tempera… [cited by applicant]
Halbfass P, Pavlov B, Müller P, Nentwich K, Sonne K, Barth S, Hamm K, Fochler F, Mügge A, Lüsebrink U, Kuhn R, Deneke T. Progression From esophageal thermal asymptomatic Lesion to perforation complicating atrial fibrill… [cited by applicant]
Herweg B, Johnson N, Postler G, Curtis AB, Barold SS, Ilercil A. Mechanical esophageal deflection during ablation of atrial fibrillation. Pacing Clin Electrophysiol. 2006;29(9):957-61. [cited by applicant]
Knopp H, Halm U, Lamberts R, Knigge I, Zachäus M, Sommer P, Richter, S,Bollmann A, Hindricks G, Husser D. Incidental and ablation-induced findings during upper gastrointestinal endoscopy in patients after ablation of at… [cited by applicant]
Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; Fire and Ice Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fi… [cited by applicant]
Mateos JC, Mateos EI, Peña TG, Lobo TJ, Mateos JC, Vargas RN, Pachón CT,Acosta JC. Simplified method for esophagus protection during radiofrequency catheter ablation of atrial fibrillation—prospective study of 704 cases… [cited by applicant]
Metzner A, Burchard A, Wohlmuth P, Rausch P, Bardyszewski A, Gienapp C, Tilz RR, Rillig A, Mathew S, Deiss S, Makimoto H, Ouyang F, Kuck KH, Wissner E. Increased incidence of esophageal thermal lesions using the second-… [cited by applicant]
Müller P, Dietrich JW, Halbfass P, Abouarab A, Fochler F, Szöllösi A, Nentwich K, Roos M, Krug J, Schade A, Mügge A, Deneke T. Higher incidence of esophageallesions after ablation of atrial fibrillation related to the u… [cited by applicant]
Nakagawa H, Seres KA, Jackman WM. Limitations of esophageal temperature monitoring to prevent esophageal injury during atrial fibrillation ablation. Circ Arrhythm Electrophysiol. 2008;1(3):150-2. [cited by applicant]
Palaniswamy C, Koruth JS, Mittnacht AJ, Miller MA, Choudry S, Bhardwaj R, Sharma D, Willner JM, Balulad SS, Verghese E, Syros G, Singh A, Dukkipati SR, Reddy VY: The extent of mechanical esophageal deviation to avoid es… [cited by applicant]
Pappone C, Oral H, Santinelli V, et al. Atrio-esophageal fistula as a complication of percutaneous transcatheter ablation of atrial fibrillation. Circulation 2004;109:2724-2726. [cited by applicant]
Parikh V, Swarup V, Hantla J, Vuddanda V, Dar T, Yarlagadda B, Biase LD, Al-Ahmad A, Natale A, Lakkireddy D: Feasibility, safety and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the … [cited by applicant]
Rillig A, Meyerfeldt U, Birkemeyer R, Wiest S, Sauer BM, Staritz M, Jung W.Oesophageal temperature monitoring and incidence of oesophageal lesions after pulmonary vein isolation using a remote robotic navigation system.… [cited by applicant]
Sánchez-Quintana D, Cabrera JA, Climent V, Farré J, Mendonça MC, Ho SY. Anatomic relations between the esophagus and left atrium and relevance for ablation of atrial fibrillation. Circulation. 2005;112(10):1400-5. [cited by applicant]
Schmidt M, Nölker G, Marschang H, Gutleben KJ, Schibgilla V, Rittger H, Sinha AM, Ritscher G, Mayer D, Brachmann J, Marrouche NF: Incidence of oesophageal wall injury post-pulmonary vein antrum isolation for treatment o… [cited by applicant]
Sohara H, Satake S, Takeda H, Yamaguchi Y, Nagasu N. Prevalence of esophageal ulceration after atrial fibrillation ablation with the hot balloon ablation catheter: what is the value of esophageal cooling? J Cardiovasc E… [cited by applicant]
Sommer P, Hindricks G. Prevention of oesophageal injury during catheter ablation of atrial fibrillation: is monitoring of oesophageal temperature the solution? Europace. 2010;12(7):911-2. [cited by applicant]
Stockigt F, Schrickel JW, Andrie R, Lickfett L. Atrio-esophageal fistula after cryoballoon pulmonary vein isolation. J Cardiovasc Electrophysiol 2012;12:1254-1257. [cited by applicant]
Israeli Patent Office. Office Action issued in IL Application No. 297204. 6 pages. [cited by applicant]
English translation of Office Action for Chinese Application No. 202180042233.6 dated Mar. 19, 2025, 9 pages. [cited by applicant]