IP Library Granted Patent US 9,393,068
Granted Patent B1
US 9,393,068 · App. 13/337,920 · Granted Jul 19, 2016

Method for predicting the probability of steam pop in RF ablation therapy

Inventors: Giovanni Leo (Cologny, CH); Hendrik Lambert (Geneva, CH)
Assignee: ST. JUDE MEDICAL INTERNATIONAL HOLDING S.À R.L.
A61B18/1492A61B2018/00839
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Quick Facts
Patent No.
US 9,393,068
App. No.
13/337,920
Granted
Jul 19, 2016
Kind
B1
Abstract

A method and apparatus that utilizes a force-time integral for real time estimation of steam pop in catheter-based ablation systems. The apparatus measures the force exerted by a contact ablation probe on a target tissue and an energization parameter delivered to the ablation probe. The exerted force and energization parameter can be utilized to provide an estimation of the probability of steam pop. In one embodiment, the force and energization metrics can be used as feedback to establish a desired contact force and energization level combination to prevent steam popping.

Claims (35)

1. A system for delivering energy to a target tissue during a medical procedure, the system comprising:

an elongate flexible catheter adapted to be introduced into a patient during said medical procedure, said catheter including a distal portion;

an ablation head disposed at said distal portion of said catheter and arranged to contact said target tissue during said medical procedure;

a force sensor operatively coupled with said ablation head for detection of a contact force exerted on said ablation head, said force sensor adapted to produce an output signal that correlates with said contact force;

a power source operatively coupled with said ablation head for energization of said ablation head; and

a control system including a processor and being operatively coupled to said force sensor and said power source, said control system adapted to deliver an energization parameter to said ablation head from said power source, said processor being connected to a storage medium that contains programming instructions to be carried out by the processor, said programming instructions comprising:

utilizing a zone of optimum combinations of said energization parameter and said output signal, wherein each energization parameter and output signal combination within said zone of optimum combinations (i) ensures that said ablation head is energized at a power sufficiently high to form a lesion on said target tissue and (ii) maintains said energization parameter relative to said contact force such that an estimated probability of steam pop remains no greater than an acceptable value.

2. The system of claim 1 , wherein said power source is configured to generate RF power to energize said ablation head.

3. The system of claim 1 , wherein said acceptable value of said probability of steam pop is zero.

4. The system of claim 1 , wherein said zone of optimum combinations is determined by said processor based on experimental data for said ablation head that is preloaded into said storage medium.

5. The system of claim 1 , wherein said zone of optimum combinations is determined by said processor based on data acquired directly from said medical procedure and stored in said storage medium.

6. The system of claim 1 , wherein said programming instructions are arranged to form said lesion on said target tissue by providing instructions and visualization to an operator of said ablation head.

7. The system of claim 1 , wherein said programming instructions are arranged to form said lesion on said target tissue by providing instructions to a robotic controller of said ablation head.

8. The system of claim 1 , wherein said power source is configured to generate electrical current to energize said ablation head.

9. A system for delivering energy to a target tissue with a low probability of steam pop during a medical procedure, the system comprising:

an elongate flexible catheter adapted to be introduced into a patient during said medical procedure, said catheter including a distal portion;

an ablation head disposed at said distal portion of said catheter and arranged to contact said target tissue during said medical procedure;

a force sensor operatively coupled with said ablation head for detection of a contact force exerted on said ablation head, said force sensor adapted to produce an output that correlates with said contact force;

means for energizing said ablation head based on an energization parameter;

means for estimating a probability of steam pop based on said energization parameter and said contact force; and

means for utilizing a zone of optimum combinations of said energization parameter and said contact force to create a lesion on the target tissue while maintaining said low probability of steam pop, wherein each energization parameter and contact force combination within said zone of optimum combinations (i) ensures that said ablation head is energized at a power sufficiently high to form the lesion on said target tissue and (ii) maintains said energization parameter relative to said contact force such that the estimated probability of steam pop remains no greater than an acceptable value.

10. The system of claim 9 , wherein said means for energizing is configured to generate RF power to energize said ablation head.

11. The system of claim 9 , wherein said acceptable value of said probability of steam pop is zero.

12. The system of claim 9 , further comprising means for determining said zone of optimum combinations based on experimental data for said ablation head that is provided to said means for utilizing said zone of optimum combinations.

13. The system of claim 9 , further comprising means for determining said zone of optimum combinations based on data acquired directly from said medical procedure that is provided to said means for utilizing said zone of optimum combinations.

14. The system of claim 9 , wherein means for utilizing said zone of optimum combinations forms said lesion on said target tissue by providing instructions and visualization to an operator of said ablation head.

15. The system of claim 9 , wherein said means for utilizing said zone of optimum combinations forms said lesion on said target tissue by providing instructions to a robotic controller of said ablation head.

16. The system of claim 9 , wherein said means for energizing is configured to generate electrical current to energize said ablation head.

17. A system for delivering energy to a target tissue during a medical procedure, the system comprising:

an elongate flexible catheter adapted to be introduced into a patient during said medical procedure, said catheter including a distal portion;

an ablation head disposed at said distal portion of said catheter and arranged to contact said target tissue during said medical procedure;

a force sensor operatively coupled with said ablation head for detection of a contact force exerted on said ablation head, said force sensor adapted to produce an output signal that correlates with said contact force;

a power source operatively coupled with said ablation head to deliver ablation power to said ablation head; and

a control system including a processor and being operatively coupled to said force sensor and said power source, said control system being adapted to control delivery of power by said power source to said ablation head, said processor connected to a storage medium storing programming instructions to be carried out by the processor, said programming instructions configured to ensure that said power delivered to said ablation head is set based at least in part on said contact force such that a corresponding probability of steam pop is estimated to be at or below an acceptable value and such that said delivered power is sufficiently high to form a lesion on said target tissue.

18. The system of claim 17 , wherein said power source is configured to deliver ablation power of between 20 and 30 watts, and wherein said control system is further adapted to command delivery of ablation power to said ablation head only when said contact force is between 10 and 30 gmf.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2016
From: ST. JUDE MEDICAL LUXEMBOURG HOLDING S.À R.L.
To: ST. JUDE MEDICAL INTERNATIONAL HOLDING S.À R.L.
Reel/Frame 038018/0069 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 2, 2014
From: ST. JUDE MEDICAL GVA S.À.R.L.
To: ST. JUDE MEDICAL LUXEMBOURG HOLDING S.À.R.L.
Reel/Frame 034511/0947 →
CHANGE OF NAME Recorded Oct 23, 2014
From: ENDOSENSE SA
To: ST. JUDE MEDICAL GVA SÀRL
Reel/Frame 034035/0311 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 8, 2012
From: LEO, GIOVANNI; LAMBERT, HENDRIK
To: ENDOSENSE SA
Reel/Frame 028346/0240 →
Continuity (5)
Continuation In Part 12776762 · May 10, 2010
Provisional Application 61176519 · May 8, 2009
Provisional Application 61176853 · May 8, 2009
Provisional Application 61177180 · Jun 10, 2009
Provisional Application 61427425 · Dec 27, 2010