Medical probe device and method

• US 5,800,378 A
• Filed: 03/20/1996
• Issued: 09/01/1998
• 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): Bockelman, Mark
• Assistant Examiner(s): Sadula, Jennifer R.
• Application Number:
  US08/618,583
• Time in Patent Office: 895 Days
• Field of Search: 604/19-22, 604/53, 604/164, 604/280, 606/32, 606/33, 606/39, 606/41, 606/45, 607/101, 607/105, 607/96, 607/98, 607/99, 607/102, 607/104, 607/113, 607/115, 607/116, 607/154, 607/156, 601/2
• 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
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other
• 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 medical probe device comprises a catheter having a stylet guide housing with one or more stylet ports in a side wall thereof and a stylet guide 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 radiofrequency electrode. Preferably, the non-conductive layer is a sleeve which is axially moveable on the electrical conductor to expose a selected portion of the electrical conductor surface in the target tissue. The stylet can also be a microwave antenna. The stylet can also be a hollow tube for delivering treatment fluid to the target tissue. It can also include a fiber optic cable for laser treatment. The catheter can include one or more inflatable balloons located adjacent to the stylet port for anchoring the catheter or dilation. Ultrasound transponders and temperature sensors can be attached to the probe end and/or stylet. The stylet guide can define a stylet path from an axial orientation in the catheter through a curved portion to a lateral orientation at the stylet port.

Claims

1. A medical probe device for treating by radio frequency ablation a target volume in tissue of a prostate of a body 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 tissue of the prostate surrounding the urethra near the base of the bladder comprising an elongate probe member having proximal and distal extremities and having a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, the elongate probe member having a length so that when the distal extremity is disposed in the urethra in the vicinity of the prostate the proximal extremity is outside of the urethra, handle means coupled to the proximal extremity of the elongate probe member for introducing the distal extremity of the elongate probe member into the urethra, a stylet slidably mounted in the passageway in the elongate probe member and having a distal extremity, the distal extremity of the stylet being movable between a retracted position in which the distal extremity of the stylet is disposed within the passageway and an extended position disposed outwardly from the distal extremity of the elongate probe member, the stylet having a length so that the distal extremity of the stylet extends through the urethral wall into the tissue of the prostate when in the extended position, means including a radio frequency generator coupled to the stylet for supplying radio frequency energy to the stylet and a grounding plate in contact with the body and electrically coupled to the radio frequency generator, the stylet including a conductive radio frequency electrode and a layer of insulating material coaxially disposed on the conductive electrode so that a distal portion of the conductive electrode is free of insulation and exposed in the tissue of the prostate for causing ablation of tissue in the target volume of the prostate when radio frequency energy is supplied to the conductive electrode while the layer of insulating material extends through the urethral wall and protects the urethral wall from radio frequency energy supplied to the conductive electrode.

2. A device as in claim 1 wherein the layer of insulating material is slidably mounted on the conductive electrode, the handle means including means for causing relative movement between the layer of insulating material and the conductive electrode to expose the distal portion of the conductive electrode.

3. A device as in claim 1 wherein the conductive electrode is in the form of a tube having an axial lumen extending therethrough.

4. A device as in claim 1 together with ultrasound means carried by the distal extremity of the elongate probe member for providing an electrical signal for indicating the position of the device in the human male.

5. A device as in claim 4 wherein said ultrasound means is mounted on the layer of insulating material.

6. A device as in claim 1 together with temperature sensing means mounted on the layer of insulating material.

7. A device as in claim 1 together with an additional stylet slidably mounted in the passageway in the elongated probe member, the additional stylet being of the same type as the first named stylet, the distal extremity of the additional stylet being movable between a retracted position in which the distal extremity of the additional stylet is disposed within the passageway and an extended position disposed outwardly from the distal extremity of the elongate probe member, the additional stylet having a length so that the distal extremity of the additional stylet extends through the urethral wall into the tissue of the prostate when in the extended position.

8. A device as in claim 7 wherein the means for supplying radio frequency energy includes means for supplying radio frequency energy to the conductive electrode of the first named for passage through the tissue of the prostate to the conductive electrode of the additional stylet so as to cause ablation of the tissue disposed between the conductive electrodes of the first named and additional stylets.

9. A device as in claim 1 together with a guide housing carried by the distal extremity of the elongate probe member, the guide housing having a lumen for receiving the conductive electrode and a curved surface in the lumen for directing the conductive electrode sidewise of the longitudinal axis.

10. A device as in claim 1 wherein the conductive electrode is made from a shape memory alloy.

11. A medical device for treating by radio frequency ablation a target volume in tissue of a prostate of a body 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 tissue of the prostate surrounding the urethra near the base of the bladder comprising an elongate probe member having proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, the elongate probe member having a length so that when the distal extremity is disposed in the urethra in the vicinity of the prostate the proximal extremity is outside of the urethra, first and second radio frequency conductive electrodes slidably mounted in the passageway in the elongate probe member and each having a flexible distal extremity, a layer of insulating material disposed about each of the first and second conductive electrodes, control means secured to the first and second conductive electrodes for moving the distal extremities of the first and second conductive electrodes between retracted positions in which the distal extremities of the first and second conductive electrodes are disposed within the passageway and extended positions disposed outwardly from the distal extremity of the elongate probe member so that when the elongate probe member is disposed in the urethra with the distal extremity in proximity to the prostate the first and second conductive electrodes extend through the urethral wall when in the extended positions so as to be disposed in spaced apart positions in the tissue of the prostate and means including a radio frequency return coupled to the first and second conductive electrodes for supplying radio frequency energy to the first conductive electrode for passage through the tissue of the prostate to the second conductive electrode so as to cause ablation of tissue disposed between the first and second conductive electrodes in the target volume of the prostate.

12. A medical device as in claim 11 together with means carried by the distal extremity of the elongate probe member and cooperatively coupled into the passageway for directing the distal extremities of the first and second conductive electrodes through a curved path as the distal extremities of the first and second conductive electrodes are moved to their extended positions.

13. A medical device as in claim 12 wherein said means carried by the elongate probe member and cooperatively coupled into the passageway includes a guide housing carried by the distal extremity of the elongate probe member, the guide housing having first and second lumens for respectively receiving the first and second conductive electrodes and a curved surface in each lumen for directing the first and second conductive electrodes sidewise of the longitudinal axis.

14. A medical device as in claim 13 wherein the guide housing has an outer surface provided with first and second spaced-apart ports in communication with the first and second lumens.

15. A medical device as in claim 11 together with handle means coupled to the proximal extremity of the elongate probe member for introducing the distal extremity of the elongate probe member into the urethra.

16. A medical device as in claim 11 wherein each layer of insulating material is slidably mounted on the respective conductive electrode.

17. A medical probe device for treating by radio frequency ablation a target volume in tissue of a prostate of a body 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 tissue of the prostate surrounding the urethra near the base of the bladder comprising an elongate probe member having proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, the elongate probe member having a length so that when the distal extremity is disposed in the urethra in the vicinity of the prostate the proximal extremity is outside of the urethra, a stylet slidably mounted in the passageway in the elongate probe member and having a distal extremity movable between a retracted position in which the distal extremity of the stylet is disposed within the passageway and an extended position disposed outwardly from the distal extremity of the elongate probe member whereby the stylet can extend through the urethral wall into the tissue of the prostate, means including a radio frequency generator coupled to the stylet for supplying radio frequency energy to the stylet and a grounding plate in contact with the body and electrically coupled to the radio frequency generator, the stylet including a conductive radio frequency needle electrode and a layer of insulating material coaxially disposed on the conductive electrode so that a distal portion of the conductive electrode is free of insulation and exposed in the tissue of the prostate for causing ablation of tissue in the target volume of the prostate when radio frequency energy is supplied to the conductive electrode while the layer of insulating material extends through the urethral wall and protects the urethral wall from radio frequency energy supplied to the conductive electrode.

18. A device as in claim 17 together with a means carried by the elongate probe member and cooperatively coupled into the passageway for directing the distal extremity of the stylet through a curved path extending at an angle to the longitudinal axis.

19. A device as in claim 17 wherein the conductive electrode has a sharpened tip.

20. A device as in claim 17 wherein the conductive electrode is in the form of a tube having an axial lumen extending therethrough.

21. A device as in claim 17 wherein the conductive electrode has proximal and distal extremities and a length so that when the distal extremity of the conductive electrode is in the tissue of the prostate the proximal extremity of the conductive electrode is outside of the urethra.

22. A medical device for treating by radio frequency ablation a target volume in tissue of a prostate of a body 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 tissue of the prostate surrounding the urethra near the base of the bladder comprising an elongate probe member having proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, the elongate probe member having a length so that when the distal extremity is disposed in the urethra in the vicinity of the prostate the proximal extremity is outside of the urethra, a radio frequency needle electrode having a flexible distal extremity and a sharpened tip slidably mounted in the passageway in the elongate probe member, a layer of insulating material coaxially disposed about the needle electrode, control means secured to the needle electrode for moving the distal extremity of the needle electrode between a retracted position in which the distal extremity of the needle electrode is disposed within the passageway and an extended position disposed outwardly from the distal extremity of the elongate probe member, means carried by the elongate probe member and cooperatively coupled into the passageway for directing the distal extremity of the needle electrode through a curved path extending at an angle to the longitudinal axis as the needle electrode is moved to its extended position so that when the elongate probe member is disposed in the urethra with the distal extremity in proximity to the prostate the sharpened tip penetrates the urethral wall and the needle electrode extends through the urethral wall into the tissue of the prostate and means including a radio frequency return coupled to the needle electrode for supplying radio frequency energy to the needle electrode to ablate tissue in the target volume of the prostate, the distal extremity of the needle electrode having an axial lumen extending therethrough for permitting a liquid to be delivered into the tissue of the prostate.

23. A device as in claim 22 wherein the means including a radio frequency return includes a radio frequency generator and a grounding plate in contact with the body and electrically coupled to the radio frequency generator.

24. A medical probe device for the treatment of benign prostatic hypertrophy by radio frequency ablation of a target volume in tissue of a prostate of a body 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 probe 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 urethra in the vicinity of the prostate the proximal extremity is outside of the urethra, the elongate probe member having a sidewall with a passageway therein extending along the longitudinal axis to an opening in the distal extremity, a stylet slidably disposed in the passageway and including a radio frequency needle electrode having a distal extremity with a sharpened tip, the stylet movable between a retracted position in which the distal extremity of the stylet is disposed within the passageway and an extended position disposed outwardly of the opening in a direction away from the distal extremity, the radio frequency needle electrode having a length so that the distal extremity of the radio frequency needle electrode penetrates the urethral wall and extends into the tissue of the prostate when in the extended position, a layer of insulating material coaxially disposed on the radio frequency needle electrode so that a distal portion of the radio frequency needle electrode is free of insulation and exposed in the tissue of the prostate for causing ablation of tissue in the target volume of the prostate when radio frequency energy is supplied to the radio frequency needle electrode while the layer of insulating material extends through the urethral wall and protects the urethral wall from radio frequency energy supplied to the radio frequency needle electrode.

25. A device as in claim 24 further comprising means carried by the proximal extremity of the elongate probe member for causing relative movement between the layer of insulating material and the radio frequency needle electrode to expose the distal portion of the radio frequency needle electrode.

26. A medical device for treating by radio frequency ablation a target volume in tissue of a prostate of a body 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 tissue of the prostate surrounding the urethra near the base of the bladder comprising an elongate probe member having proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, the elongate probe member having a length so that when the distal extremity is disposed in the urethra in the vicinity of the prostate the proximal extremity is outside of the urethra, first and second radio frequency needle electrodes slidably mounted in the passageway in the elongate probe member and each having a distal extremity, a layer of insulating material coaxially disposed about each of the first and second needle electrodes, control means secured to the first and second needle electrodes for moving the distal extremities of the first and second needle electrodes between retracted positions in which the distal extremities of the first and second needle electrodes are disposed within the passageway and extended positions disposed outwardly from the distal extremity so that when the elongate probe member is disposed in the urethra with the distal extremity in proximity to the prostate the first and second needle electrodes extend through the urethral wall when in the extended position so as to be disposed in spaced apart positions in the tissue of the prostate and means including a radio frequency return coupled to the first and second needle electrodes for supplying radio frequency energy to the first needle electrode for passage through the tissue of the prostate to the second needle electrode so as to cause ablation of tissue disposed between the first and second needle electrodes in the target volume of the prostate.