IP Library › Granted Patent US 12702469
Granted Patent B2
US 12702469 · App. 18/335,932 · Granted Aug 11, 2026

Apparatus and method for transseptal puncture based on impedance

Inventors: Yitzhak Tzachi Levy (Irvine, CA); Vitaliy Putra (Irvine, CA); Kruti Shah (Mission Viejo, CA); Tonima R. Quabili (Laguna Hills, CA); Paul A Suárez (La Crescenta, CA); Maria Duarte (Chino, CA); Erica E. Lovejoy (La Puente, CA); Kokou A. Amefia (Aliso Viejo, CA); Debby E. Highsmith (Laguna Niguel, CA); Eajer Toh (Sugar Land, TX)
Assignee: Biosense Webster (Israel) Ltd.
A61B18/14A61B2018/00601A61B2018/00875A61B2018/1425
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Quick Facts
Patent No.
US 12702469
App. No.
18/335,932
Granted
Aug 11, 2026
Kind
B2
Abstract

A transseptal puncture system and method uses a guiding instrument, and an atraumatic puncture instrument longitudinally movable therein, with a first electrode configured for ablation and a second electrode electrically insulated from the first electrode. An impedance monitoring module is configured to measure at least an impedance at the second electrode, and an electrical generator is configured to selectively apply electrical energy to the first electrode based at least in part on the measured impedance at the second electrode. Moreover, impedance measurements at the first and second electrodes are used to determine relative positions of the instruments in the approach, contact, ablation and puncture of the septum.

Claims (42)

1 . A transseptal puncture system, comprising:

a guiding instrument configured with a lumen;

an elongated instrument configured to move longitudinally within the lumen, the elongated instrument having a distal end and including a distal electrode configured for ablation and a proximal electrode electrically insulated from the distal electrode;

an electrical generator configured to apply electrical energy to the distal electrode; and

an impedance monitoring module configured to:

measure a first distal impedance at the distal electrode to detect a first distal decrease indicative of the distal electrode being in contact with blood;

measure a second distal impedance at the distal electrode to detect a first distal increase indicative of the distal electrode being in contact with tissue;

measure a third distal impedance at the distal electrode when the application of electrical energy by the electrical generator begins;

measure a first proximal impedance at the proximal electrode to detect a first proximal increase indicative of the proximal electrode being in contact with tissue; and

after detecting the first proximal increase, measure a second proximal impedance at the proximal electrode to detect a first proximal decrease indicative of the proximal electrode being in contact with blood,

the electrical generator configured to suspend electrical energy to the distal electrode upon detection of the first proximal decrease.

2 . The system of claim 1 , wherein the guiding instrument includes a guiding sheath.

3 . The system of claim 1 , wherein the elongated instrument includes a needle instrument.

4 . The system of claim 1 , wherein the distal electrode is atraumatic, being devoid of a tissue-piercing distal end.

5 . The system of claim 1 , wherein the distal electrode is configured as a monopolar electrode for tissue ablation.

6 . The system of claim 1 , wherein the distal electrode is configured as a bipolar electrode for tissue ablation.

7 . The system of claim 1 , wherein the distal electrode and the proximal electrode are separated on the elongated instrument by a predetermined distance.

8 . The system of claim 1 , further including a return pad configured to be affixed to a patient's body to enable the impedance monitoring module to measure the impedance at the proximal electrode.

9 . The system of claim 8 , wherein electrical energy applied to the proximal electrode generates a current that is distributed through the patient's body to the return pad.

10 . A method of transseptal puncture, comprising:

positioning a guiding instrument near a septum with an atraumatic needle instrument slidably disposed in a lumen of the guiding instrument, the atraumatic needle instrument including a distal electrode and a proximal electrode;

deploying the atraumatic needle instrument from the lumen with distal advancement relative to the guiding instrument;

measuring a first distal impedance at the distal electrode to detect a first distal decrease indicative of the distal electrode being in contact with blood;

measuring a second distal impedance at the distal electrode to detect a first distal increase indicative of the distal electrode being in contact with the septum;

energizing the distal electrode to ablate the septum;

measuring a third distal impedance at the distal electrode when the energization of the distal electrode begins;

measuring a first proximal impedance at the proximal electrode to detect a first proximal increase indicative of the proximal electrode being in contact with the septum;

after detecting the first proximal increase, measuring a second proximal impedance at the proximal electrode to detect a first proximal decrease indicative of the proximal electrode being in contact with blood; and

suspending energization of the distal electrode upon detection of the first proximal decrease.

11 . The method of claim 10 , further comprising suspending distal advancement of the atraumatic needle instrument upon detection of the first proximal decrease.

12 . The method of claim 10 , wherein the proximal electrode is a nonablation electrode.

13 . A method of transseptal puncture, comprising:

positioning a guiding instrument near a septum with an atraumatic needle instrument slidably disposed in a lumen of the guiding instrument, the atraumatic needle instrument including a distal electrode and a proximal electrode;

providing a predetermined threshold impedance;

deploying the atraumatic needle instrument from the lumen with distal advancement relative to the guiding instrument;

measuring a first distal impedance at the distal electrode to detect a first distal decrease relative to the predetermined threshold impedance indicative of the distal electrode being in contact with blood;

measuring a second distal impedance at the distal electrode to detect a first distal increase relative to the predetermined threshold impedance indicative of the distal electrode being in contact with the septum;

energizing the distal electrode to ablate the septum;

measuring a third distal impedance at the distal electrode when the energization of the distal electrode begins and comparing the third distal impedance to the predetermined threshold impedance;

measuring a first proximal impedance at the proximal electrode to detect a first proximal increase relative to the predetermined threshold impedance indicative of the proximal electrode being in contact with the septum;

after detecting the first proximal increase, measuring a second proximal impedance at the proximal electrode to detect a first proximal decrease relative to the predetermined threshold impedance indicative of the proximal electrode being in contact with blood; and

suspending energization of the distal electrode upon detection of the first proximal decrease.