Medical ablation apparatus

• US 5,554,110 A
• Filed: 01/12/1994
• Issued: 09/10/1996
• 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., Baker, James A., Lundquist, Ingemar H.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/180,578
• Time in Patent Office: 972 Days
• Field of Search: 604/164, 604/19-22, 604/53, 604/280, 601/2, 606/39, 606/45, 606/32, 607/96, 607/113, 607/115, 607/116, 607/138, 607/156, 607/101, 607/102
• US Class Current: 604/22
• CPC Class Codes: A61B 1/00188 with focusing or zooming features
• 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 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0241 for prostate
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• 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 18/14 Probes or electrodes 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 2018/1425 : Needle
• 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: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61K 31/465 : Nicotine; Derivatives thereof
• 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 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• 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 medical probe device including a catheter having a stylet guide housing with one or more stylet ports in a side wall thereof and a for directing a flexible stylet outward through the stylet port and through intervening tissue at a preselected, adjustable angle to a target tissue. The total catheter assembly includes a stylet guide lumen communicating with the stylet port and a stylet positioned in said stylet guide lumen for longitudinal movement from the port through intervening tissue to a target tissue. The stylet can be an electrical conductor enclosed within a non-conductive layer, the electrical conductor being a radio frequency electrode. During the ablation operation, the tissue immediately adjacent the stylet can become desiccated, thereby necessitating an increase of current flow and a loss of ablation efficiency. A forward and reverse movement of the non-conductive sleeve on the stylet during an operation frees the stylet from sticking tissue and creates a space around the electrode to allow the tissue to rehydrate.

Claims

1. A method for the treatment of benign prostatic hypertrophy 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 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 the radio frequency electrode to penetrate the urethral wall and to extend into the tissue of the prostate so that a preselected length of the radio frequency 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, separating ablated tissue from the radio frequency electrode while the radio frequency electrode is within the prostate, continuing the ablation of the tissue in the selected target volume and thereafter withdrawing the radio frequency electrode from the tissue of the prostate and out of the urethra whereby the separation of the ablated tissue from the radio frequency electrode improves the efficiency of the treatment.

2. A method as in claim 1 further comprising the step of ceasing the supply of radio frequency energy to the radio frequency electrode prior to the separating step and wherein the continuing step includes resuming the supply of radio frequency energy to the radio frequency electrode after the separating step.

3. A method as in claim 1 further comprising the step of monitoring the flow of radio frequency energy from the radio frequency electrode.

4. A method as in claim 3 wherein the separating step includes separating ablated tissue from the radio frequency electrode when the flow of radio frequency energy from the radio frequency electrode drops.

5. A method for the treatment of benign prostatic hypertrophy 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 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 slidably mounted on the radio frequency electrode movable to expose a preselected length of the radio frequency electrode comprising the steps of 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 an 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 a preselected length of the radio frequency electrode extends beyond the urethral wall and is surrounded by a target volume of tissue and the sleeve extends through 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 raise the temperature of the tissue of the prostate in the target volume to cause ablation of the tissue in the target volume, moving the sleeve distally along at least a portion of the preselected length of the radio frequency electrode to free ablated tissue from the radio frequency electrode and continuing the ablation of the tissue in the target volume.

6. A method as in claim 5 wherein the moving step includes moving the sleeve distally and then proximally along at least a portion of the preselected length of the radio frequency electrode.

7. A method for treatment of a prostate of a 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 and having a flexible distal extremity, the stylet assembly including 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, and control means secured to the proximal extremity of the stylet assembly, the method comprising the steps of inserting the elongate member into the urethra until the distal extremity is in the proximity of the prostate, utilizing the control means 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 of the stylet assembly 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, supplying radio frequency energy to the conductive electrode for causing ablation of the tissue in the prostate, moving the insulating sleeve distally and then proximally along at least a portion of the conductive electrode being exposed in the tissue of the prostate to rehydrate ablated tissue in the vicinity of the conductive electrode, continuing the ablation of the tissue in the prostate and thereafter withdrawing the stylet assembly from the prostate and the urethral wall into the passageway and removing the elongate member from the urethra.

8. A method as in claim 7 further comprising the step of causing relative movement between the insulating sleeve and the conductive electrode to expose a desired length of the conductive electrode while having the insulating sleeve extend a sufficient distance beyond the urethral wall so that the urethral wall is protected by the insulating sleeve from radio frequency energy during the supply of radio frequency energy to the conductive electrode.

9. A method as in claim 7 further comprising the step of ceasing the supply of radio frequency energy to the conductive electrode prior to the moving step and wherein the continuing step includes resuming the supply of radio frequency energy to the conductive electrode after the moving step.

10. A method as in claim 7 further comprising the step of monitoring the flow of radio frequency energy from the conductive electrode.

11. A method as in claim 10 wherein the moving step includes rehydrating ablated tissue in the vicinity of the conductive electrode when the flow of radio frequency energy from the conductive electrode drops.

12. A medical probe device for medical treatment of tissue at a treatment site through a natural body opening defined by a wall comprising a guide housing having proximal and distal extremities and having a passageway extending from the proximal extremity to the distal extremity, a stylet slidably mounted in the passageway and including a flexible conductive electrode with a sharpened tip and an insulating sleeve slidably mounted on the electrode but exposing the sharpened tip, means carried by the distal extremity of the guide housing and in communication with the passageway for directing the electrode and the insulating sleeve sidewise of the guide housing, handle means mounted on the proximal extremity of the guide housing for introducing the distal extremity of the guide housing into the natural body opening to a position adjacent the treatment site, means mounted on the proximal extremity of the guide housing for advancing the stylet to cause the sharpened tip of the electrode to penetrate the wall and extend into the tissue at the treatment site with the insulating sleeve extending through the wall and means for supplying electrical energy to the electrode to cause a thermal effect in the tissue at the treatment site, the means for advancing the stylet including means for moving the insulating sleeve distally and then proximally along at least a portion of the electrode to free the electrode from ablated tissue which has adhered to the electrode.

13. A medical probe device as in claim 12 further comprising means for measuring the flow of electrical energy from the electrode.

14. A medical probe device as in claim 12 for the treatment by radio frequency ablation of a target volume in prostatic 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 further comprising an additional stylet slidably mounted in the passageway and of the same type as the first named stylet whereby the handle means introduces the distal extremity of the guide housing into the urethra to a position adjacent the prostate and the means mounted on the proximal extremity of the guide housing advances the stylets to cause the sharpened tip of the electrodes to penetrate the urethral wall and to extend into a selected target volume of the prostate with the insulating sleeves extending through the urethral wall and whereby the means for supplying electrical energy to the electrodes causes a thermal effect in the selected target volume of the prostate, the means for advancing the stylets including means for moving the insulating sleeves distally and then proximally along at least a portion of the electrodes to free the electrodes from ablated tissue which has adhered to the electrodes.