ABLATION DEVICE WITH OPTIMIZED INPUT POWER PROFILE AND METHOD OF USING THE SAME

Abstract

Ablation device including a probe structure 10 having a proximal end 12 and a distal end 14. Probe structure 10 includes a tubular first catheter 16, a tubular second catheter 18 surrounding the first catheter and a tubular guide catheter extending within the first catheter 16. The first catheter 16 carries a cylindrical ultrasonic transducer 20 adjacent its distal end. The transducer 20 is connected to a source of electrical excitation. The ultrasonic waves emitted by the transducer 20 are directed at the heart wall tissue. Once the tissue reaches the target temperature, the electrical excitation is turned on and off to maintain the tissue at the largest temperature. Alternatively, the transducer 20 is subjected to continuous excitation at one power level and upon the tissue reaching the target temperature, the power level of the continuous excitation is switched to a second lower power level.

Claims

1. An apparatus for applying energy intraluminally to a target tissue, the apparatus comprising: a catheter having a distal region adapted for placement adjacent to the target tissue; an ultrasound transducer disposed at the distal region of the catheter; a balloon disposed at the distal region of the catheter, wherein the ultrasound transducer is disposed within the balloon; an energy emission source configured to provide electrical energy to the ultrasound transducer, the energy emission source configured to cause the ultrasound transducer to emit energy at an initial level for a first time duration sufficient to necrose at least a portion of the target tissue so as to create an initial lesion that forms a protective barrier to obstruct subsequently emitted energy traveling toward collateral anatomical structures distal to the initial lesion, the energy emission source further configured to, upon completion of the first time duration, cause the ultrasound transducer to emit modulated energy by cycling between a first power level and a second power level to deliver energy to the protective barrier and target tissue for a second time duration to completely necrose the entire volume of target tissue, wherein the protective barrier reduces damage to untargeted tissue distal to the target tissue, and wherein the energy emission source causes the ultrasound transducer to emit modulated energy based on an empirical determination without monitoring temperature.

2. The apparatus of claim 1, further comprising a reflector at the distal region of the catheter, the reflector having an active region to redirect energy from the ultrasound transducer, wherein the active region defines a focal region comprising a volume of the target tissue.

3. The apparatus of claim 2, wherein the reflector is positioned within the balloon.

4. The apparatus of claim 2, wherein the reflector comprises a collapsible balloon positioned within the balloon.

5. The apparatus of claim 2, wherein the reflector is parabolic in shape and causes the active region to define a circular focal region.

6. The apparatus of claim 1, wherein the distal region of the catheter is adapted for placement within a blood vessel.

7. The apparatus of claim 1, wherein the first power level is greater than the second power level.

8. The apparatus of claim 1, wherein the initial power level is greater than the first power level.

9. The apparatus of claim 1, wherein no energy is delivered at the second power level.

10. An apparatus for applying energy intraluminally to a target tissue, the apparatus comprising: a catheter having a distal region adapted for placement adjacent to the target tissue; and an ultrasound transducer disposed at the distal region of the catheter, the ultrasound transducer configured to emit energy at an initial level for a first time duration sufficient to necrose at least a portion of the target tissue so as to create an initial lesion that forms a protective barrier to obstruct subsequently emitted energy traveling toward collateral anatomical structures distal to the initial lesion, the ultrasound transducer further configured to, upon completion of the first time duration, emit modulated energy by cycling between a first power level and a second power level to deliver energy to the protective barrier and the target tissue for a second time duration to necrose the target tissue.

11. The apparatus of claim 10, wherein the target tissue comprises a transmural area of an organ or a blood vessel.

12. The apparatus of claim 10, wherein the distal region of the catheter is adapted for placement within a blood vessel.

13. The apparatus of claim 10, wherein the initial power level is greater than the first power level.

14. The apparatus of claim 10, wherein no energy is delivered at the second power level.

15. The apparatus of claim 10, wherein the ultrasound transducer is configured to emit modulated energy based on an empirical determination without monitoring temperature.

16. The apparatus of claim 10, wherein the protective barrier reduces damage to untargeted tissue distal to the target tissue during the second time duration.

17. The apparatus of claim 10, further comprising an energy emission source configured to provide electrical energy to the ultrasound transducer.

18. The apparatus of claim 10, further comprising a balloon disposed at the distal region of the catheter, wherein the ultrasound transducer is disposed within the balloon.

19. The apparatus of claim 10, further comprising a reflector at the distal region of the catheter, the reflector having an active region to redirect energy from the ultrasound transducer, wherein the active region defines a focal region comprising a volume of the target tissue.

20. The apparatus of claim 19, wherein the reflector is parabolic in shape and causes the active region to define a circular focal region.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a diagrammatic view of apparatus in accordance with one embodiment of the invention in conjunction with a portion of a heart and pulmonary vein.

[0015] FIG. 2 is a diagrammatic sectional view taken along line 2-2 in FIG. 1.

[0016] FIG. 3 is a fragmentary diagrammatic view depicting certain geometrical relationships in the apparatus of FIG. 1.

[0017] FIG. 4 is an example of input power profile for the apparatus of FIG. 1.

[0018] FIG. 5 is a graph of temperature (at the phrenic nerve) versus time measured during animal experiments.

DETAILED DESCRIPTION

[0019] FIG. 1 shows one embodiment of ablation device of the invention. Many more embodiments of ablation device are disclosed in commonly assigned U.S. Pat. No. 6,635,054. Each of these embodiments can be used with the invention described herein. A portion of a probe structure 10 between proximal and distal ends 12 and 14 respectively is omitted in FIG. 1 for clarity of illustration. The probe structure includes a tubular first catheter 16 and a tubular second catheter 18 surrounding first catheter 16.

[0020] First catheter 16 and a cylindrical transducer 20 define a central axis 24 adjacent the distal end of the probe structure. First catheter 16 has a distal tip 26 projecting distally beyond transducer 20. A first balloon 28, also referred to herein as a structural balloon, is mounted to first catheter at the distal end thereof. First balloon 28 includes an active wall 32 formed from film which is flexible but which can form a substantially noncompliant balloon structure when inflated. A forward wall 30 may be generally conical or dome-shaped and may project forwardly from its juncture with active wall 32. For example, forward wall 30 may be conical, with an included angle of about 120 degrees. Forward wall 30 joins the wall of first catheter 16 at distal tip 26 thereof, whereas active wall 32 joins the wall of catheter 16 proximally of transducer 20. Thus, transducer 20 is disposed inside of first balloon 28.

[0021] The shape of active wall region 32 depicted in FIG. may be that of a surface of revolution about central axis 24 formed by rotation of a generatrix or curve 38 (FIG. 3) which is a portion of a parabola 40 having its principal axis 42 transverse to and desirably perpendicular to central axis 24. Focus 44 of the parabolic generatrix is slightly forward or distal of forward wall 30 when the balloon is in the inflated condition.

[0022] A second balloon 50, also referred to herein as the reflector balloon, is carried on the distal end of second catheter 18. When both first and second balloons 28 and 50, respectively, are in a deflated position, second balloon 50 is collapsed inwardly, toward central axis 24 so that second balloon in deflated condition 50 closely overlies deflated first balloon 28.

[0023] In use, the probe structure, with first balloon 28 and second balloon 50 deflated, is threaded through the subject's circulatory system. Thereafter, upon inflation of first balloon 28 and second balloon 50, forward wall 30 of first balloon 28 bears on the interior surface of the heart wall at an ostium or opening 74 at which pulmonary vein 72 communicates with heart chamber 70.

[0024] Transducer 20 is connected to a source 78 of electrical excitation signals through connector 22. Source 78 is adapted to provide continuous and intermittent electrical excitation. Thus, Source 76 can provide continuous excitation for a predetermined period of time and then turn the electrical excitation on and off for a predetermined period of time. For example, after providing continuous excitation for between 5 and 30 seconds, source 78 may turn the electrical excitation off for a one second and then turn it on for one second and repeat the on-off cycle for a predetermined period of time. The electrical excitation actuates transducer 20 to produce ultrasonic waves. The ultrasonic waves propagate substantially radially outwardly as indicated by arrows 80 in FIGS. 1 and 3. Stated another way, cylindrical transducer 20 produces substantially cylindrical wave fronts which propagate generally radially outwardly. These waves are reflected by the interface at active region 32. Because the interface has a parabolic shape, the waves striking any region of the interface will be reflected substantially to focus 44 defined by the surface of revolution, i.e., into a substantially annular or ring-like focal region at focus 44. As best seen in FIG. 2, this ring-like focus surrounds central axis 24 and surrounds ostium 74 of the pulmonary vein. This focal region is slightly forward of forward wall 30 and hence within the heart tissue, near the surface of the heart wall. For example, the focal region may be disposed at a depth equal to about one-half of the thickness of the heart wall as, for example, about 2-4 mm from the surface of the wall.

[0025] The heart wall tissue located at focus 44 is heated rapidly. The initial CW power delivery Is performed with high power output to quickly create the initial lesion which creates an absorptive barrier for ultrasound and therewith protects distal collateral structures. It is believed that the lesion will mostly grow towards the source. The temperature of the tissue depends upon several factors including the output power of transducer 20 and the time for which the tissue is exposed to the output of transducer 20. Upon the target tissue being exposed to the ultrasonic output of transducer 20 for a predetermined time, the target tissue reaches the target temperature, i.e., the temperature that would result in necrosis_ The target temperature may be in the range 55-80 degrees centigrade, preferably in the range 55-60 degrees centigrade. The continuous excitation is maintained for a first duration sufficient for the target tissue to reach the target temperature. At the end of the first duration, the electrical excitation is turned on and off to maintain the target tissue at the target temperature. The rapid heating of the target tissue to the target temperature effectively ablates or kills the tissue at the focal region so that a wall of non-conductive scar tissue forms in the focal region and in neighboring tissue. However, by turning the electrical excitation on and off and thereby maintaining the target tissue at the target temperature, the amount of neighboring tissue that is killed is minimized. This is in contrast to keeping the electrical excitation on continuously for the entire duration of time necessary to ablate the target tissue. If the electrical excitation is kept on for the entire duration of time necessary to ablate the target tissue, the temperature of the target tissue keeps rising for the entire duration and exceeds the temperature necessary for tissue necrosis. This results in necrosis of greater amount of neighboring tissue as compared to when the electrical excitation is turned on and off during the ablation cycle. For a particular ablation apparatus using particular transducer, the time it takes for the target tissue to reach the target temperature may be determined via theoretical models or experimentally or by a combination of these techniques. For a given ablation apparatus, experiments may be carried out wherein the cardiac tissue is ablated and temperature of the tissue at different time measured by known techniques such as use of thermocouples or imaging. Based upon these experiments, a recommendation for duration of operation of the ablation apparatus in the continuous mode and duration of operation in the on-off mode would be provided to the physicians. The process will have to be repeated for an ablation apparatus of a different design.

[0026] FIG. 4 shows the input power profile for electrical excitation of transducer 20. At the beginning of the ablation cycle, transducer 20 is supplied with 100 watt electrical excitation signal. The excitation of transducer 20 is continuous for approximately 11 seconds. However, the continuous excitation mode may range from 5 seconds to 30 seconds or for the duration necessary for the target tissue to reach the target temperature. Once the target tissue has reached the target temperature the input power is cycled off and on as shown in FIG. 4. The power is off for roughly 25 percent of the time and the power is on for roughly 75 percent of the time. To put it another way, once the target tissue has reached the target temperature, the power is off for roughly 1 second and then it is on for roughly 3 seconds with the on-off cycle continuing for the duration of the ablation cycle. The power is turned off at the end of the ablation cycle and the temperature of the target tissue drops rapidly thereafter. It should be noted that the power on-off cycle can be varied, for example, similar results may be obtained with the power being off for one second and on for one second following the continuous excitation mode. Alternatively, the entire power input profile may consist of continuous excitation at one power level and upon reaching of the target temperature switching to continuous excitation at a second lower power level.

[0027] FIG. 5 shows plots of temperature measured at a fixed distance from the target tissue during animal experiments. A 20 mm HIFU Ablation Catheter made by Prorhythm, inc., was used. The Ablation catheter was supplied with 100 watt electrical excitation signal, and the HIFU output was 32 watts acoustic. A 20 mm ablation device kills tissue in the shape of a ring of 20 mm diameter. Several embodiments of ablation devices that can cause necrosis of tissue in shape of a ring are disclosed in U.S. Pat. No. 6,635,054 and U.S. Patent Application Publication No. US 2004/0176757. As seen in FIG. 5, plot A, the temperature at the fixed distance from the target tissue keeps rising for the entire duration of the ablation cycle when the electrical excitation is kept on for the entire duration of the ablation cycle. On the other hand, as seen in FIG. 5, plot B, when the electrical excitation is turned on and off during a portion of the ablation cycle, the temperature at the fixed distance from the target tissue rises during the continuous excitation mode and then remains substantially constant at that level during the on-off mode. This results in reduction or elimination of collateral tissue damage.

[0028] Some of the ultrasonic energy is absorbed between the surface of the wall and the focal region, and at locations deeper within the wall than the focal region. To provide a complete conduction block, tissue should be ablated through the entire thickness of the wall, so as to form a transmural lesion. With a transducer capable of emitting about 15 Watts of acoustic energy, an ablated region extending entirely through the heart wall can be formed within a few minutes of actuation. Higher power levels as, for example, above 30 Watts of acoustic energy and desirably about 45 Watts are preferred because such power levels will provide shorter lesion formation time (under one minute). Because the sonic energy is directed simultaneously into the entire loop-like path surrounding the pulmonary vein, the PV isolation can be performed ideally without repositioning the probe. However, several applications may be required due to non circular, irregular anatomy.

[0029] The positioning of the ablation device within the heart desirably includes selectively controlling the disposition of the forward-to-rearward axis 24 of the device relative to the patient's heart. That is, the position of the forward-to-rearward axis desirably can be controlled by the physician to at least some degree. To that end, the assembly can be provided with one or more devices for selectively bending the ablation device. Various embodiments of the ablation device that lend themselves to allow disposition of the ablation device to be selectively controlled are disclosed in commonly assigned Patent Application No. US 2004/0176757. Each of these embodiments may be used in conjunction with the input power profile disclosed herein. Although the invention has been described with the aid of an ablation device using HIFU, any form of output power for ablating the tissue may be used in the on-off mode as described herein to realize the benefit of the invention. Non limiting examples of the other forms of output power are RF and heat.

[0030] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

INDUSTRIAL APPLICABILITY

[0031] This application relates to the medical device industry.