Medical probe device and method

• US 5,536,240 A
• Filed: 09/27/1994
• Issued: 07/16/1996
• Est. Priority Date: 08/12/1992
• Status: Expired due to Term

• Current Assignee: Vidamed, Inc. (Medtronic Plc)
• Original Assignee: Vidamed, Inc. (Medtronic Plc)
• Inventors: Sharkey, Hugh R., Edwards, Stuart D., Lax, Ronald G., Lundquist, Ingemar H.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/313,719
• Time in Patent Office: 658 Days
• Field of Search: 604/19-22, 604/53, 604/164, 604/280, 601/2, 606/39, 606/45, 606/32, 606/47, 606/48, 607/96, 607/113, 607/115, 607/116, 607/138, 607/186, 607/101, 607/102
• US Class Current: 604/22
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0241 for prostate
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 : after introduction of a substance
• CPC Class Codes: A61B 2017/248 : Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61B 2017/2939 : Details of linkages or pivot points
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00005 : Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00011 : with fluids
• CPC Class Codes: A61B 2018/00083 : low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00095 : high, i.e. heat conducting
• CPC Class Codes: A61B 2018/00196 : reciprocating lengthwise
• CPC Class Codes: A61B 2018/0022 : Balloons
• CPC Class Codes: A61B 2018/00547 : Prostate
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/0075 : Phase
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/00946 : slidable
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/128 : generating two or more frequencies
• CPC Class Codes: A61B 2018/1412 : Blade
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2018/2238 : with means for selectively laterally deflecting the tip of the fibre
• CPC Class Codes: A61B 2090/0814 : Preventing re-use
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3925 : ultrasonic
• CPC Class Codes: A61F 2007/0054 : with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61M 2025/0086 : the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 : Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0089 : Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/009 : the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/018 : Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 : Tip not integral with tube
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/02 : using microwaves
• CPC Class Codes: A61N 5/04 : Radiators for near-field treatment
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body

Abstract

A method for the treatment of benign prostatic hypertrophy in the 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 urethral near the base of the bladder comprising selecting a target volume of the tissue of the prostate beyond the urethral wall, introducing radio frequency 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.

Claims

1. A method for the treatment of benign prostatic hypertrophy of the 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 by the use of a radio frequency electrode formed of an electrically conductive material and being relatively rigid so that it can serve as a stylet and having a sharpened distal extremity serving as a tissue puncturing tip comprising the steps of introducing the radio frequency electrode into the urethra and advancing it longitudinally of the urethra along the longitudinal axis until the tip is in the vicinity of the prostate, thereafter advancing the radio frequency electrode in a direction at an angle to the longitudinal axis of the urethra to cause it to penetrate the urethral wall and to extend into the tissue of the prostate so that a preselected length of the radiofrequency electrode including the tip is exposed to tissue in the prostate to thereby select a target volume of the tissue in the prostate surrounding the exposed length of the radio frequency electrode to be exposed to radio frequency energy, supplying radio frequency energy to the radio frequency electrode so that radio frequency energy is supplied to the selected target volume of the prostate surrounding the exposed length of the radio frequency electrode at a sufficient power level and for a sufficient period of time to raise the temperature of the tissue of the prostate in the selected target volume to cause ablation of the tissue in the selected target volume and thereafter withdrawing the radio frequency electrode from the tissue of the prostate through the urethral wall and out of the urethra.

2. A method for the treatment of benign prostatic hypotrophy of the 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 by the use of a radio frequency electrode formed of an electrically conductive material and being relatively rigid so that it can serve as a stylet and having a sharpened distal extremity serving as a tissue puncturing tip and a sleeve of insulating material slidably mounted on the radio frequency electrode movable to expose a preselected length of the radio frequency electrode comprising the steps of selecting a target volume of the tissue of the prostate to be ablated by the use of radio frequency energy, introducing the radio frequency electrode with the sleeve thereon into the urethra and advancing the radio frequency electrode longitudinally of the urethra until the tip is in the vicinity of the prostate, advancing the tip of the radio frequency electrode in a direction at a substantial angle to the longitudinal axis of the urethra to cause the tip of the radio frequency electrode to penetrate the urethral wall and to extend into the target volume of the tissue of the prostate so that the target volume of the tissue of the prostate surrounds the radio frequency electrode, moving the sleeve so that it extends through the urethral wall to expose a preselected length of the radio frequency electrode extending beyond the urethral wall so that radio frequency energy can be supplied to the target volume but not to the urethral wall, supplying radio frequency energy to the radio frequency electrode at a sufficient power level and for a sufficient period of time to cause the temperature of the tissue of the prostate in the target volume to cause ablation of the tissue in the target volume while inhibiting ablation of the urethral wall.

3. A method for the treatment of the benign prostatic hypertrophy in the 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 radio frequency 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.

4. A method as in claim 3, 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 and further comprising the steps of introducing the radio frequency electrode into the target volume of the tissue of the prostate and causing relative sliding movement between the radio frequency electrode and the sleeve to expose a preselected length of the radio frequency electrode corresponding to the size of the target volume while retaining the sleeve in a position so that it continues to extend through the urethral wall, said radio frequency energy being supplied to the radio frequency electrode.

5. 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 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 an 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 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.

6. A method as in claim 5 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 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 by the insulation sleeve from radio frequency energy during the application of radio frequency energy to the needle electrode.

7. A method for medical treatment of the prostate through the urethra formed by a urethral wall by the use of a catheter having a distal extremity and having a flexible radio frequency electrode with a sharpened tip and an insulating sleeve mounted on and surrounding the flexible radio frequency electrode, said radio frequency electrode and said insulating sleeve being slidably mounted on the catheter and being movable through the distal extremity of the catheter, the flexible radio frequency electrode and the insulating sleeve being movable relative to each other, comprising introducing the catheter through the urethra to a region adjacent the prostate, advancing the flexible radio frequency electrode and the insulating sleeve using the sharpened tip to penetrate the urethral wall and pass through the urethral wall into the prostate establishing a relationship between the flexible radio frequency electrode and the insulating sleeve so that a predetermined length of the flexible radio frequency electrode extends out of the insulating sleeve and is exposed in the prostate, passing sufficient radio frequency energy through the electrode to raise the temperature of the prostate adjacent the predetermined length of electrode to a temperature causing destruction of cells by ablation in the prostate while protecting the urethral wall by the insulating sleeve from the radio frequency energy.

8. A method for ablating tissue in the prostate of a human male having a bladder with a base and a penis with a urethral formed by a urethral wall extending into the base of the bladder with the prostate having tissue surrounding the urethra near the base of the bladder by the use of a medical probe having an elongate member with proximal and distal extremities and a passageway therein extending from the proximal and distal extremities, first and second flexible stylets disposed in said passageway and movable between extended and retracted positions, the flexible stylets including conductive electrodes surrounded by insulating material and having a sharpened tip adapted to be free of insulating material, the method comprising introducing the distal extremity of the elongate member into the urethra until the distal extremity is near the prostate, advancing the first and second stylets into their extended positions by advancing the stylets through the urethral wall and into the tissue of the prostate so that the sharp tip is disposed in the tissue of the prostate and the insulating material extends through the urethral wall and means for supplying radio frequency energy to the conductive electrode of the stylets for causing ablation of the tissue of the prostate while protecting the urethral wall from the radio frequency energy.

9. A method as in claim 8 together with the step of advancing the stylets into the prostate at an angle with respect to each other of less than 110 degrees.

10. A method as in claim 8 wherein the radio frequency energy is supplied simultaneously to the electrodes of the stylets.

11. 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 and a capsule enclosing the prostatic tissue 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 an 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 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 formation of a lesion in the tissue of the prostate which is spaced from the urethral wall and from the capsule of the prostate.

12. A method as in claim 11 wherein the needle electrode is enclosed in an insulation sleeve and wherein the insulation sleeve and the needle electrode are slidably 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 causing relative movement between the insulation sleeve and the needle electrode to expose a desired length of the needle electrode while having the insulation sleeve extend beyond the urethral wall for a sufficient distance so that the urethral wall is protected by the insulation sleeve from radio frequency energy during the application of radio frequency energy to the needle electrode.

13. A method for treatment of the prostate of the human male having a bladder with a base with a urethra formed by a urethral wall extending into the base of the bladder with the prostate having tissue surrounding the urethra near the base of the bladder by use of a medical probe device having an elongate member with proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, a flexible stylet assembly slidably mounted in the passageway in the elongate member having a flexible distal extremity, said stylet assembly including a conductive electrode, a sleeve of insulating material surrounding the conductive electrode and permitting a predetermined portion of the conductive electrode to be exposed and control means secured to the proximal extremity of the stylet assembly, the method comprising inserting the elongate element into the urethra until the distal extremity is in the proximity of the prostate, utilizing the control assembly to advance the distal extremity of the stylet assembly from a position within the passageway of the elongate member to a position outside of the passageway permitting the distal extremity to move outwardly in a direction which is at an angle with respect to the longitudinal axis so that the stylet assembly passes through the urethral wall and into the prostate with the conductive electrode being exposed in the tissue of the prostate and supplying radio frequency energy to the conductive electrode for causing ablation of the tissue in the prostate, and thereafter withdrawing the stylet assembly from the prostate and from the urethral wall and into the passageway and withdrawing the elongate member from the urethra.

14. A method for treatment of the prostate of the human male having a bladder with a base with a urethra formed by a urethral wall extending into the base of the bladder with the prostate having tissue surrounding the urethra near the base of the bladder by use of a medical probe device having an elongate member with proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, first and second stylet assemblies slidably mounted in the passageway in the elongate member, each having a flexible distal extremity, each of the stylet assemblies comprising a conductive electrode and a sleeve of insulating material surrounding the conductive electrode and permitting a predetermined portion of the conductive electrode to be exposed, the method comprising inserting the elongate element into the urethra until the distal extremity of the elongate element is in proximity to the prostate with the first and second stylet assemblies being disposed within the passageway, moving the first and second stylet assemblies so that their distal extremities extend out of the passageway and in an outward direction at an angle with respect to the longitudinal axis permitting the distal extremities of the stylet assemblies to extend through the urethral wall and into the prostate with the conductive electrodes of the first and second stylet assemblies being disposed in the tissue of the prostate, supplying radio frequency energy to the conductive electrodes for causing ablation of tissue in the prostate, withdrawing the first and second stylet assemblies from the prostate and from the urethral wall into the passageway in the elongate member and withdrawing the elongate member from the urethra.

15. A method as in claim 14 wherein said first and second stylet assemblies are moved simultaneously into the prostate.

16. A method as in claim 14 together with the step of measuring the temperature of the urethral wall in the vicinity of the distal extremity of the elongate element.

17. A method as in claim 14 together with the step of measuring the impedance of the prostate tissue while it is being ablated and controlling the radio frequency ablation in response to the measured impedance.

18. A method for treatment of the prostate of the human male having a bladder with a base and a penis with a urethra 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 by use of first and second radio frequency electrodes formed of an electrically conductive material and being relatively rigid so that they can serve as stylets and having sharpened distal extremities serving as tissue puncturing tips comprising the steps of selecting a target volume of tissue of the prostate to be ablated by the use of radio frequency energy, introducing the first and second radio frequency electrodes into the urethra and longitudinally of the urethra until the tips are in the vicinity of the prostate, advancing the tips of the first and second radio frequency electrodes in a direction at an angle to the longitudinal axis of the urethra to cause the tips of the radio frequency electrodes to penetrate the urethral wall and to extend into the target volume of the tissue of the prostate so that the tips of the first and second radio frequency electrodes are disposed in spaced-apart positions with the tissue of the prostate between the electrodes being in the target volume of tissue in the prostate and supplying radio frequency energy to the first and second radio frequency electrodes so that the radio frequency energy passes between the first and second electrodes to cause ablation of the tissue disposed between the first and second electrodes.

19. A method as in claim 18 wherein each of said radio frequency electrodes includes a sleeve of insulating material slidably mounted on the respective radio frequency electrode and being movable to expose a preselected length of the respective radio frequency electrode and further including the steps of advancing the sleeve of insulating material on each of the first and second radio frequency electrodes through the urethral wall and causing relative movement between the sleeves of insulating material and the radio frequency electrodes so that lengths of the radio frequency electrodes are exposed in the tissue of the prostate while the sleeves of insulating material remain extending through the urethral wall so that the urethral wall is protected from radio frequency energy during the time that radio frequency energy is being supplied to the first and second radio frequency electrodes.