Thermal treatment methods and apparatus with focused energy application

• US 7,083,614 B2
• Filed: 08/23/2002
• Issued: 08/01/2006
• Est. Priority Date: 07/13/2000
• Status: Expired due to Term

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: ProRhythm, Inc.
• Inventors: Fjield, Todd, Lopath, Patrick David, Acker, David E., Harhen, Edward Paul
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US10/227,092
• Publication Number:
  US 20030050632A1
• Time in Patent Office: 1,439 Days
• Field of Search: 606/41, 606/42, 606 45- 50, 606/27, 607/100, 607/101, 607/115, 607/116, 607/119, 607/96, 128/898
• US Class Current: 606/41
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22027 Features of transducers
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

A collapsible ultrasonic reflector incorporates a gas-filled reflector balloon, a liquid-filled structural balloon an ultrasonic transducer disposed within the structural balloon. Acoustic energy emitted by the transducer is reflected by a highly reflective interface between the balloons. In a cardiac ablation procedure, the ultrasonic energy is focused into an annular focal region to ablate cardiac tissue extending in an annular path along the wall. Devices for stabilizing the balloon structure and for facilitating collapse and withdrawal of the balloon structure are also disclosed.

Claims

1. A method of applying energy to the wall of an internal organ of a living subject comprising the steps of:

(a) positioning an expansible structure within the body of the subject in or adjacent to said organ and bringing said expansible structure to an expanded condition; and

(b) directing energy onto an active region of said expansible structure so that energy is reflected from said active region and directed from said active region onto the wall of the internal organ, said expansible structure focusing said energy in a focal region;

wherein said expansible structure includes a first balloon, said step of bringing said reflector structure to said expanded configuration including inflating said first balloon;

wherein said first balloon defines a transmissive wall, said positioning step including positioning said first balloon so that said transmissive wall lies adjacent the wall of the organ, and said energy is directed onto said active region from within said first balloon so that the energy is reflected at said active region through the interior of the first balloon and through the transmissive wall into said focal region;

wherein said step of directing energy includes directing ultrasonic energy towards said active region, said expansible structure includes a second balloon, and said step of expanding said expansible structure includes the step of inflating said first balloon with a first fluid having a first acoustic impedance and inflating said second balloon with a second fluid having a second acoustic impedance different from said first acoustic impedance to thereby form a first reflective interface at said active region.

2. A method as claimed in claim 1, wherein said energy reflection at said active region focuses said energy.

3. A method as claimed in claim 1, wherein the energy is directed onto said active region so that the energy is directed into a treatment region of the wall of said organ in the form of an elongated path extending along the wall of said organ.

4. A method as claimed in claim 1 wherein the energy is directed so that said focal region extends along said path within the organ wall at a depth from the surface of the organ wall.

5. A method as claimed in claim 1, wherein said positioning step includes positioning the first balloon so that the transmissive wall lies adjacent the wall of the organ.

6. A method as claimed in claim 5, wherein said positioning step includes positioning the first balloon so that the transmissive wall is spaced from the wall of the organ and maintaining a layer of liquid between the transmissive wall and the wall of the organ, whereby energy directed through the transmissive wall passes through the layer of liquid.

7. A method as claimed in claim 6, wherein said step of inflating said first balloon includes inflating said first balloon with a biocompatible inflation liquid and said step of maintaining a layer of liquid includes discharging the inflation liquid to the exterior of the first balloon so that at least some of the discharged inflation liquid passes between the transmissive wall and the wall of the organ.

8. A method as claimed in claim 1, wherein said first fluid has an acoustic impedance close to the acoustic impedance of tissue in said wall.

9. A method as claimed in claim 1, wherein said first fluid is a liquid and said second fluid is a gas.

10. A method as claimed in claim 9, further comprising the step of detecting the disposition of said reflector structure by imaging the subject using an imaging modality in which said gas-filled second balloon provides contrast.

11. A method as claimed in claim 1, wherein said reflector structure includes a third balloon, the method further comprising the steps of inflating said second balloon with a fluid having acoustic impedance substantially equal to said first acoustic impedance and inflating said third balloon with a fluid having acoustic impedance different from said first acoustic impedance to an interface at a second active region having reflectivity greater than the reflectivity of the interface at the first said active region, and directing the ultrasonic energy onto said second active region so that the ultrasonic energy is reflected from said second active region into a second focal region different from the first focal region.

12. A method as claimed in claim 1, wherein said positioning step is performed so as to position said first balloon within a chamber of the heart and said path along a wall of the heart, and wherein said energy ablates tissue in the wall of the heart so as to form a first conduction block extending along said elongated path.

13. A method as claimed in claim 12, wherein said positioning step is performed so as to position said first balloon within a chamber of the heart and said path extends along the wall of the heart and at least partially around a first ostium of a first blood vessel communicating with such chamber.

14. A method as claimed in claim 13, wherein said first blood vessel is a pulmonary vein, said first ostium being disposed adjacent an opening of an atrial appendage, the method further comprising forming a second conduction block extending at least partially around the opening of the atrial appendage so that first and second conduction blocks cooperatively encompass and isolate a region of the heart wall including said first ostium and said opening of said atrial appendage.

15. A method as claimed in claim 13, wherein said path is substantially in the form of a closed loop encircling said first ostium.

16. A method as claimed in claim 1, wherein said step of directing energy is performed so as to direct the energy into said focal region along substantially the entire elongated path simultaneously.

17. A method as claimed in claim 1, wherein said energy-directing step includes directing the energy through an inflatable lens and varying the configuration of said inflatable lens so as to vary the location of said focal region.

18. A method as claimed in claim 1, wherein said energy-directing step includes directing the energy from a source to said active region and varying the positional relationship between said source and said active region so as to vary the location of said focal region.