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1. (WO1994017856) TRANSURETHRAL NEEDLE ABLATION DEVICE AND METHOD
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WHAT IS CLAIMED IS:

1. A transurethral needle ablation device for the treatment of the prostate of a human male using radio frequency energy from a radio frequency power source, the human male having a bladder with a base, a prostate and a penis with a urethra therein formed by a urethral wall extending from the base of the bladder through the prostate and the penis along a longitudinal axis with the prostate having prostatic tissue surrounding the urethral wall near the base of the bladder comprising a sheath having proximal and distal extremities and having a lumen extending from the proximal extremity to the distal extremity, a guide tube assembly slidably mounted in the lumen in the sheath and having proximal and distal extremities and having a lumen extending from the proximal to the distal extremity and having a longitudinal axis, a needle electrode slidably mounted in the lumen in the guide tube assembly and having proximal and distal extremities, an insulation sleeve disposed about the needle electrode and having a distal extremity with the distal extremity of the insulation sleeve being positioned so that the distal extremity of the needle electrode is exposed, a handle adapted to be gripped by the human hand, means for mounting the proximal extremity of the sheath on the handle, means carried by the handle and coupled to the guide tube assembly for moving the distal extremity of the guide tube assembly from a retracted position with the distal extremity of the guide tube assembly within the distal extremity of the sheath and an extended position with the distal extremity of the guide tube assembly disposed distally of the sheath, means carried by the handle and coupled to the guide tube assembly for causing bending of the distal extremity of the guide tube assembly at an angle with respect to the longitudinal axis whereby the lumen in the guide tube assembly can be directed so that it faces the urethral wall, means connected to the needle electrode adapted to be coupled to the radio frequency power supply for supplying radio frequency energy to the needle electrode, means carried by the handle and coupled to the needle electrode and the insulating sleeve for advancing and retracting the needle electrode with respect to the guide tube whereby when the sheath is positioned in the urethra with its distal extremity in the vicinity of the prostate, the needle electrode can be advanced through the urethral wall and into the tissue of the prostate to permit the application of radio frequency energy to the tissue of the prostate surrounding the needle electrode to form a lesion in the prostate.

2. A device as in Claim 1 wherein said means carried by the handle and coupled to the needle electrode and the insulating sleeve includes means for causing relative slidable movement between the insulating sleeve and the needle electrode.

3. A device as in Claim 1 together with means carried by the handle to prevent bending of the distal extremity of the guide tube assembly until the distal extremity of the guide tube assembly extends distally of the distal extremity of the sheath.

4. A device as in Claim 1 wherein said means carried by the handle and coupled to the needle electrode and the insulation sleeve includes first and second slide members slidably mounted on the handle, means connecting the needle electrode to the first slide member, means connecting the insulation sleeve to the second slide member, said first and second slide members being movable between front and rear positions.

5. A device as in Claim 4 together with brake means coupled to the first slide member and engaging the handle to inhibit movement of the first slide member when the second slide member is retracted towards a rear position.

6. A device as in Claim 4 together with adjustable stop means carried by the handle adapted to be engaged by the first slide member to preset the maximum deployment of the needle electrode and additional adjustable stop means adapted to be engaged by the second slide member to preset the retraction distance for the insulating sleeve with respect to the needle electrode.

7. A device as in Claim 1 wherein said means for mounting the proximal extremity of the sheath on the handle includes a bridge secured to the proximal extremity of the sheath and secured to the handle and means connecting the handle to the bridge, said means connecting the handle to the bridge including cooperative mating means capable of assuming two different positions whereby in the first position, the distal extremity of the guide tube assembly is disposed within the distal extremity of the sheath and in the second position the distal extremity of the guide tube assembly is disposed distally of the distal extremity of the sheath.

8. A device as in Claim 7 wherein said cooperative mating means includes a cylindrical extension carried by the handle and wherein the bridge has a bore therein adapted to receive the cylindrical extension and cooperative latch means carried by the bridge and the cylindrical extension capable of latching said cylindrical extension in said bore in said two different positions.

9. A device as in Claim 8 wherein said cooperative latch means includes a member adapted to be engaged by the human hand to permit operation of the latch means to permit movement of the cooperative mating means from the first position to the second position.

10. A device as in Claim 7 together with safety means carried by the handle for preventing movement of the needle electrode and the insulating sheath until the cooperative mating means has assumed the second position.

11. A device as in Claim 10 wherein said safety means includes a release member carried by the handle and adapted to be operated when the cooperative mating means assumes the second position to permit the movement of the needle electrode and the insulation sleeve.

12. A device as in Claim 11 wherein said means for preventing movement of said needle electrode and said insulation sleeve includes cam members operatively coupled to said release member for preventing movement of the slide members.

13. A device as in Claim 1 together with an additional guide tube assembly slidably mounted in the lumen in the sheath and being movable in the same manner as the first named guide tube assembly to create a lesion in the prostate at a different location than the lesion for the first named guide tube assembly.

14. A device as in Claim 16 wherein said means for applying radio frequency energy to the needle electrode includes means for supplying radio frequency energy to the needle electrode of the additional guide tube assembly, said radio frequency energy being applied to the first named and additional needle electrodes having different frequencies which are not harmonics of each other.

15. In a method for the treatment of benign prostatic hyperplasia of the prostate of a human male having a bladder with a base, a prostate and a penis with a urethra formed by a urethral wall extending from the base of the bladder through the prostate and the penis along a longitudinal axis with the prostate having prostatic tissue surrounding the urethral wall by the use of a needle electrode having a distal extremity comprising the steps of introducing the needle electrode into the urethra and advancing the needle electrode along the longitudinal axis until the needle electrode is in the vicinity of the prostate, thereafter bending the distal extremity of the needle electrode in a direction at a substantial angle to the longitudinal axis of the urethra face the urethral wall, advancing the distal extremity of the needle electrode to penetrate the urethral wall and to extend into the tissue of the prostate, applying radio frequency energy to the electrode to cause a current to flow by conduction in the tissue of the prostate at a sufficient power level and for a sufficient period of time to raise the temperature of the tissue in the prostate in the vicinity of the needle electrode and in a defined area to cause a formation of a lesion in the tissue of the prostate which is spaced from the urethral wall and from the capsule of the prostate.

16. A method as in Claim 18 together with the step of withdrawing the needle electrode from the prostatic tissue and from the urethral wall, redirecting the needle electrode into a different position in the urethra and then advancing the needle electrode through the urethral wall into the prostate in the different position, applying radio frequency energy to the needle electrode to cause a current to pass by conduction through the tissue of the prostate to cause the formation of another lesion in the tissue of the prostate in the same manner.

17. A method as in Claim 18 together with the step of introducing an additional needle electrode into the tissue of the prostate with the same procedure and applying radio frequency energy at two different frequencies which are not harmonically related to cause a simultaneous formation of a lesions in the prostatic tissue of the prostate.

18. A method as in Claim 18 wherein the needle electrode is enclosed in a insulation sleeve and wherein the insulation sleeve and the needle electrode are movable with respect to each other including the steps of advancing the insulation sleeve with the needle electrode into the tissue of the prostate and then retracting the insulation sleeve while retaining the needle electrode in a predetermined position to expose the needle electrode but having the insulation sleeve extend beyond the urethral wall for a sufficient distance so that the urethral wall is protected during application of radio frequency energy during the application of the same to the needle electrode.

AMENDED CLAIMS
[received by the International Bureau on 28 July 1994 (28.07.94) original claims 1-18 replaced by amended claims 1-18 (8 pages)3
1. A transurethral needle ablation device for the treatment of the prostate of a human male using radio frequency energy from a radio frequency power source, the human male having a bladder with a base, a prostate and a penis with a urethra therein formed by a urethral wall extending from the base of the bladder through the prostate and the penis along a longitudinal axis with the prostate having prostatic tissue surrounding the urethral wall near the base of the bladder comprising a sheath having proximal and distal extremities and having a lumen extending from the proximal extremity to the distal extremity, a guide tube assembly slidably mounted in the lumen in the sheath and having proximal and distal extremities and having a lumen extending from the proximal to the distal extremity and having a longitudinal axis, a needle electrode slidably mounted in the lumen in the guide tube assembly and having proximal and distal extremities, an insulation sleeve disposed on the needle electrode, a handle adapted to be gripped by the human hand, means for mounting the proximal extremity of the guide tube assembly on the handle, means carried by the handle and coupled to the guide tube assembly for moving the distal extremity of the guide tube assembly from within the distal extremity of the sheath to an extended position distally of the sheath, means for causing bending of the distal extremity of the guide tube assembly at an angle with respect to the longitudinal axis whereby the lumen in the guide tube assembly can be directed so that it faces the urethral wall, means connected to the needle electrode adapted to be coupled to the radio frequency power source for supplying radio frequency energy to the needle electrode, and means carried by the handle and coupled to the needle electrode and the insulating sleeve for advancing and retracting the needle electrode and the insulating sleeve with respect to the guide tube whereby when the sheath is positioned in the urethra with its distal extremity in the vicinity of the prostate the needle electrode can be advanced through the urethral wall and into the tissue of the prostate and the insulating sleeve advanced through the urethral wall while leaving a preselected length of the needle electrode exposed in the tissue of the prostate so that upon the application of radio frequency energy to the needle electrode tissue of the prostate surrounding the needle electrode is ablated to form a lesion in the tissue of the prostate while the urethral wall is protected from the radio frequency energy supplied to the radio frequency electrode by the insulating sleeve.

2. A device as in Claim 1 wherein said insulating sleeve is slidably mounted on said needle electrode and wherein said means carried by the handle and coupled to the needle electrode and the insulating sleeve includes means for causing relative sliding movement between the insulating sleeve and the needle electrode.

3. A device as in Claim 1 wherein said means for causing bending of the distal extremity of the guide tube assembly includes means carried by the handle and coupled to the guide tube assembly, together with means carried by the handle to prevent bending of the distal extremity of the guide tube assembly until the distal extremity of the guide tube assembly extends distally of the distal extremity of the sheath.

4. A medical probe for use with the human hand for the treatment by radio frequency ablation of a target volume in the tissue of a prostate of a human male having a bladder with a base and a penis with a urethra therein formed by a urethral wall extending into the base of the bladder along a longitudinal axis with the tissue of the prostate surrounding the urethra near the base of the bladder comprising an elongate member having proximal and distal extremities and having a longitudinal axis and being sized to be able to enter the urethra and having a length so that when the distal extremity is disposed in the vicinity of the prostate, the proximal extremity is outside of the urethra, said elongate member having a sidewall defining a passageway extending along the longitudinal axis, said distal extremity having an outlet port in communication with the passageway, a radio frequency electrode of an electrically conductive material disposed in said passageway and having a sharpened tip, a sleeve formed of insulating material coaxially mounted on said radio frequency electrode and disposed in said passageway, said sleeve being disposed on said radio frequency electrode so that a preselected length of the radio frequency electrode can extend beyond the sleeve, a handle secured to the proximal extremity of the elongate member, means for moving said radio frequency electrode and said sleeve when the elongate member is disposed within the urethra out of the outlet port of the elongate member so that the preselected length of the radio frequency electrode is disposed in tissue within the target volume of the prostate and the sleeve extends through the urethral wall and means for supplying radio frequency energy to the radio frequency electrode to cause ablation of tissue in the target volume of the prostate while the urethral wall is protected from the radio frequency energy by the sleeve.

5. A probe as in Claim 4 together with an additional elongate member having proximal and distal extremities and being sized as the elongate member and being disposed substantially parallel therewith, said additional elongate member having a sidewall defining a passageway extending along the longitudinal axis, said additional elongate member having a distal extremity having an outlet port in communication with the passageway in the additional elongate member, a radio frequency electrode of electrically conductive material disposed in said passageway of said additional elongate member and having a sharpened tip, a sleeve formed of insulating material coaxially mounted on said radio frequency electrode in said additional elongate member and being disposed in the passageway in the additional elongate member, said sleeve on the radio frequency electrode in the additional elongate member being disposed on said radio frequency electrode in the additional elongate member so that a preselected length of the radio frequency electrode in the additional elongate member can extend beyond the sleeve and wherein said handle is secured to the proximal extremity of said additional elongate member, means for moving said radio frequency electrode in the additional elongate member in said sleeve when the additional elongate member is disposed within the urethra out of the outlet port of the additional elongate member so that the preselected length of the radio frequency electrode in the additional elongate member is disposed within the target volume and the sleeve extends through the urethral wall and means for supplying radio frequency energy to the radio frequency electrode in the additional elongate member to cause ablation of the tissue in the target volume while the urethral wall is protected from the radio frequency energy by the sleeve on the radio frequency electrode in the additional elongate member.

6. A probe as in Claim 4 together with means carried by the handle adapted to be engaged by the human hand to cause relative movement of the radio frequency electrode and the sleeve.

7. A probe as in Claim 4 wherein said sleeve is slidably movable with respect to said radio frequency electrode and wherein said means carried by the handle has first and second separate control members movably mounted thereon and secured respectively to the radio frequency electrode and to the sleeve to permit adjustment of the sleeve relative to the radio frequency electrode whereby the preselected length can be obtained by adjustment of the sleeve with respect to the radio frequency electrode.

8. A probe as in Claim 4 together with a cystoscope having proximal and distal extremities and means for mounting the cystoscope on the elongate member so that the distal extremity of the cystoscope is disposed in the vicinity of the distal extremity of the elongate member to thereby permit viewing through the cystoscope of the radio frequency electrode and the sleeve as they are advanced into the tissue of the prostate.

9. A probe as in Claim 8 wherein said means for mounting said cystoscope includes a rigid elongate sheath having proximal and distal extremities, said sheath being sized to be able to enter the urethra and having a length so that when the distal extremity is disposed in the vicinity of the prostate, the proximal extremity is outside the urethra, said sheath having a lumen extending from the proximal extremity to the distal extremity, said elongate element being disposed in the lumen in the sheath.

10. A probe as in Claim 9 wherein said cystoscope is disposed on the lumen in said sheath.

11. A device as in Claim 5 wherein said means for applying radio frequency energy to the needle electrode in the elongate member and to the needle electrode in the additional elongate member includes means for supplying radio frequency energy to the needle electrode in the elongate member of one frequency and to the needle electrode of the additional elongate member of another different frequency which is not a harmonic of the one frequency.

12. A probe as in Claim 10 together with means carried by the sheath for forming a liquid tight seal with respect to the cystoscope and the elongate member and means for supplying a liquid to the sheath for circulating a liquid through the lumen in the sheath to provide a clear field of view for the cystoscope.

13. In a method for the treatment of the prostate of a human male having a bladder with a base, a prostate and a penis with a urethra formed by a urethral wall extending from the base of the bladder through the prostate and the penis along a longitudinal axis with the prostate having prostatic tissue surrounding the urethral wall and a capsule enclosing the prostatic tissue by the use of a needle electrode having a distal extremity comprising the steps of introducing the needle electrode into the urethra and advancing the needle electrode along the longitudinal axis until the needle electrode is in the vicinity of the prostate, thereafter bending the distal extremity of the needle electrode in a direction at a substantial angle to the longitudinal axis of the urethra to face the urethral wall, advancing the distal extremity of the needle electrode to penetrate the urethral wall and to extend into the tissue of the prostate, applying radio frequency energy to the electrode to cause current to flow by conduction in the tissue of the prostate at a sufficient power level and for a sufficient period of time to raise the temperature of the tissue in the prostate in the vicinity of the needle electrode and in a defined area to cause ablation and formation of a lesion in the tissue of the prostate which is spaced from the urethral wall and from the capsule of the prostate.

14. A method as in Claim 13 together with the step of withdrawing the needle electrode from the tissue of the prostate and from the urethral wall, redirecting the needle electrode into a different position in the urethra and then advancing the needle electrode through the urethral wall into the prostate in a different position, applying radio frequency energy to the needle electrode to cause current to pass by conduction through the tissue of the prostate to cause the formation of another lesion in the tissue of the prostate whch is spaced from the urethral wall and from the capsule of the prostate.

15. A method as in Claim 14 together with the step of introducing an additional needle electrode into the tissue of the prostate and applying radio frequency energy at two different frequencies which are not harmonically related to cause simultaneous formation of lesions in the prostatic tissue of the prostate.

16. A method as in Claim 13 wherein the needle electrode is enclosed in an insulation sleeve and wherein the insulation sleeve and the needle electrode are movable with respect to each other including the steps of advancing the insulation sleeve with the needle electrode into the tissue of the prostate so that a preselected length of the needle electrode is disposed in the tissue of the prostate and the insulation sleeve extends beyond the urethral wall for a sufficient distance so that the urethral wall is protected by the insulation sleeve from radio frequency energy during application of radio frequency energy.

17. A method for the treatment of a prostate of the human male having a bladder with a base and a penis with a urethra therein formed by a urethral wall extending into the base of the bladder along a longitudinal axis with the prostate having tissue surrounding the urethra near the base of the bladder, comprising selecting a target volume of the tissue of the prostate beyond the urethral wall, introducing radiofrequency energy through the urethral wall into the target volume of the tissue of the prostate to cause ablation of tissue in the target volume of the tissue in the prostate and protecting the urethral wall from ablation by the radio frequency energy supplied to the target volume of tissue in the prostate.

18. A method as in Claim 17, together with a radio frequency electrode formed of an electrically conductive material having a length and a sleeve of insulating material slidably mounted on the radio frequency electrode, the method further comprising the steps of moving the radio frequency electrode and the sleeve through the urethra and through the urethral wall into the target volume of the tissue of the prostate so that a preselected length of the radio frequency electrode is exposed in the tissue of the target volume and so that the sleeve remains extending through the urethral wall and wherein the radio frequency energy is supplied to the radio frequency electrode while it is disposed in the tissue of the prostate to cause ablation of the tissue of the prostate in the target volume while the insulated sleeve protects the urethral wall from radio frequency energy supplied to the radio frequency electrode.