Medical probe device and method

• US 6,129,726 A
• Filed: 03/17/1999
• Issued: 10/10/2000
• 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): PEFFLEY, MICHAEL F
• Application Number:
  US09/270,946
• Time in Patent Office: 573 Days
• Field of Search: 606/41, 606/46, 606/48-50, 607/101, 607/102, 604/22
• US Class Current: 606/41
• 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 stylet assembly for use in electrosurgical ablation procedures, said stylet assembly comprising a needle electrode having a body including a sharpened tip for penetrating target and intervening tissues and an insulating sleeve disposed around a predetermined portion of said body of said needle electrode and having a size and shape for penetrating said intervening tissues whereby said insulating sleeve provides insulation between a portion of said body of said needle electrode and said intervening tissues when an electrical stimulus is applied to said needle electrode, said insulating sleeve being movable relative to said body of said needle electrode such that movement of said insulating sleeve may be used to vary a length of said needle electrode which is exposed to said target tissue.

2. The stylet of claim 1, wherein said body of said needle electrode has a hollow central lumen for fluid passage.

3. A radio frequency electrode assembly comprising a housing having a guide tube with a hollow lumen provided therein, said guide tube having a distal end that is bent at an angle with respect to a central axis of said housing, a stylet assembly disposed within said hollow lumen of said guide tube, said stylet assembly comprising a needle electrode having a body including a sharpened tip and an insulating sleeve surrounding a predetermined portion of said body, said stylet assembly being movable within said guide tube such that a distal end of said stylet assembly may be advanced outward of said distal end of said guide tube through an intervening tissue layer and into a target tissue to expose a portion of said needle electrode within said target tissue, and an actuator mechanism for controlling advancement and retraction of said stylet assembly within said guide tube.

4. The electrode assembly of claim 3, wherein said insulating sleeve is movable with respect to said needle electrode, and wherein said electrode assembly further comprises an actuator mechanism for controlling said movement of said insulating sleeve.

5. A radio frequency electrode comprising a housing having a guide tube with a hollow lumen provided therein, a stylet assembly disposed within said hollow lumen of said guide tube, said stylet assembly comprising a needle electrode having a body including a sharpened tip and an insulating sleeve surrounding a predetermined portion of said body, said stylet assembly being movable within said guide tube such that a distal end of said stylet assembly may be advanced outward of a distal end of said guide tube through an intervening tissue layer and into a target tissue to expose a portion of said needle electrode within said target tissue and said insulating sleeve being movable with respect to said body of said needle electrode to allow adjustment of said exposure of said needle electrode within said target tissue.

6. The electrode assembly of claim 5 further comprising a first actuator mechanism for controlling advancement and retraction of said stylet assembly within said guide tube and a second actuator mechanism for controlling movement of said insulating sleeve with respect to said body of said needle electrode.

7. A method for delivering radio frequency energy to a target tissue within a body for causing ablation of said target tissue, said method comprising the steps of advancing a stylet assembly including a needle electrode and an insulating sleeve through an intervening tissue layer and into said target tissue, moving said insulating sleeve along a predetermined portion of said needle electrode to expose a predetermined length of said needle electrode within said target tissue and applying radio frequency energy to said needle electrode.

8. The method of claim 7 further comprising the step of supplying a liquid through the needle electrode into the target tissue.

9. The method of claim 7 further comprising the step of measuring the temperature of the target tissue in the vicinity of the needle electrode.

10. The method of claim 7 further comprising the step of measuring the impedance of the target tissue while it is being ablated and controlling the radio frequency energy in response to the measured impedance.

11. The method of claim 7 further comprising the step of advancing an additional needle electrode into the target tissue for serving as a return electrode.

12. The method of claim 7 further comprising the step of advancing an additional needle electrode into the target tissue, wherein the radio frequency energy is supplied to the first-named needle electrode and the additional needle electrode so as to cause ablation of the target tissue disposed between the first-named needle electrode and the additional needle electrode.

17. The method of claim 8 further comprising the step of measuring the temperature of the target tissue in the vicinity of the needle electrode.

13. A method for delivering radio frequency energy to a target tissue within a body for causing ablation of said target tissue, said method comprising the steps of advancing a tubular member providing a housing for a stylet assembly into a body lumen until said stylet assembly reaches a predetermined location within said body lumen, said stylet assembly comprising a needle electrode having a body including a sharpened tip and having an insulating sleeve covering a predetermined portion of said body of said needle electrode, advancing said stylet assembly outward of said tubular member at an angle relative to a central axis of said body lumen, through an intervening tissue layer and into a target tissue to thereby expose at least said tip of said needle electrode within said target tissue, while insulating said intervening tissue from said body of said needle electrode and applying radio frequency energy to said needle electrode to cause ablation of said target tissue.

14. The method of claim 13, wherein said insulating sleeve is movable relative to said body of said needle electrode for exposing a predetermined length of said body of said needle electrode within said target tissue.

15. The method of claim 13, wherein said body lumen comprises a urethra of a patient, said intervening tissue comprises a wall of said urethra and said target tissue comprises prostatic tissue.

16. The method of claim 13 further comprising the step of supplying a liquid through the needle electrode into the target tissue.

18. The method of claim 13 further comprising the step of measuring the impedance of the target tissue while it is being ablated and controlling the radio frequency energy in response to the measured impedance.

19. The method of claim 13 further comprising the step of advancing an additional needle electrode into the target tissue for serving as a return electrode.

20. The method of claim 13 further comprising the step of advancing an additional needle electrode into the target tissue, wherein the radio frequency energy is supplied to the first-named needle electrode and the additional needle electrode so as to cause ablation of the target tissue disposed between the first-named needle electrode and the additional needle electrode.