Medical probe device and method

• US 5,964,727 A
• Filed: 12/24/1997
• Issued: 10/12/1999
• 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): SADULA, JENNIFER R
• Assistant Examiner(s): Mendez, Manuel
• Application Number:
  US08/998,044
• Time in Patent Office: 657 Days
• Field of Search: 604/22, 604/19-21, 604/164, 604/53, 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 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 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 device for medical treatment of tissue at a treatment site beyond a wall defining a natural body cavity accessible from outside a body by a natural body opening comprising an elongate probe member having proximal and distal extremities and having a longitudinal axis, a stylet carried by the distal extremity of the elongate probe member, handle means coupled to the proximal extremity of the elongate probe member for advancing the distal extremity of the elongate probe member into the natural body opening so that the stylet is disposed in the natural body cavity adjacent the treatment site, a radio frequency generator coupled to the stylet for supplying radio frequency energy to the stylet, a grounding plate electrically coupled to the radio frequency generator and in contact with the body, the stylet including a conductive radio frequency electrode and a layer of insulating material disposed around the conductive radio frequency electrode but exposing a distal portion of the conductive radio frequency electrode which is exposed in the tissue at the treatment site to form a lesion in the tissue at the treatment site when radio frequency energy is supplied to the conductive radio frequency electrode while the layer of insulating material extends through the wall and protects the wall from radio frequency energy supplied to the conductive radio frequency electrode.

2. A device as in claim 1 further comprising a temperature sensor mounted on the layer of insulating material.

3. A device as in claim 2 wherein the layer of insulating material has a distal extremity, the temperature sensor mounted on the distal extremity of the layer of insulating material.

4. A device as in claim 1 further comprising an optical viewing device mounted in the elongate probe member and having a distal extremity positioned in the distal extremity of the elongate probe member.

5. A device as in claim 1 wherein the conductive radio frequency electrode has an axial lumen extending therethrough and an opening in the distal portion in communication with the axial lumen for permitting a liquid to be introduced through the opening into the tissue at the treatment site.

6. A device as in claim 1 wherein the elongate probe member has a passageway extending from the proximal extremity to the distal extremity, the stylet slidably mounted in the passageway and actuation means carried by the handle means for advancing the stylet from the passageway through the wall into the tissue at the treatment site.

7. A device as in claim 6 wherein the distal extremity of the elongate probe member is flexible to facilitate introduction of the elongate probe member into the natural body cavity.

8. A device as in claim 1 wherein the layer of insulating material and the conductive radio frequency electrode are longitudinally movable relative to each other, the handle means including actuation means for causing relative longitudinal movement between the layer of insulating material and the conductive radio frequency electrode to expose the distal portion of the conductive radio frequency electrode.

9. A device as in claim 1 further comprising an additional stylet carried by the distal extremity of the elongate probe member, the additional stylet including a conductive radio frequency electrode and a layer of insulating material disposed around the conductive radio frequency electrode but exposing a distal portion of the conductive radio frequency electrode, the radio frequency generator supplying radio frequency energy to the conductive radio frequency electrode of the first-named stylet through tissue of the treatment site to the conductive radio frequency electrode of the additional stylet so as to cause ablation of the tissue disposed between the conductive radio frequency electrodes of the first-named and additional stylets.

10. A medical device for medical treatment of tissue at a treatment site beyond a wall defining a natural body cavity accessible from outside a body by a natural body opening comprising an elongate probe member having proximal and distal extremities and a longitudinal axis, a stylet carried by the distal extremity of the elongate probe member, handle means coupled to the proximal extremity of the elongate probe member for advancing the distal extremity of the elongate probe member into the natural body opening so that the stylet is disposed in the natural body cavity adjacent the treatment site, a radio frequency generator coupled to the stylet for supplying radio frequency energy to the stylet, a grounding plate electrically coupled to the radio frequency generator and in contact with the body, the stylet including a radio frequency needle electrode of a conductive material and a layer of insulating material disposed around the radio frequency needle electrode but exposing a distal portion of the radio frequency needle electrode, the stylet being relatively rigid and the radio frequency needle electrode having a sharpened tip for puncturing the wall so as to permit the distal portion of the radio frequency needle electrode to be exposed in the tissue at the treatment site to form a lesion in the tissue at the treatment site when radio frequency energy is supplied to the radio frequency needle electrode while the layer of insulating material extends through the wall and protects the wall from radio frequency energy supplied to the radio frequency needle electrode.

11. A device as in claim 10 wherein the layer of insulating material has a distal extremity, a temperature sensor mounted on the distal extremity of the layer of insulating material.

12. A device as in claim 11 wherein the radio frequency needle electrode has an axial lumen extending therethrough and an opening in the distal portion in communication with the axial lumen for permitting a liquid to be introduced through the opening into the tissue at the treatment site.

13. A medical device for medical treatment of tissue at a treatment site beyond a wall defining a natural body cavity accessible from outside a body by a natural body opening comprising an elongate probe member having proximal and distal extremities and a longitudinal axis, a stylet carried by the distal extremity of the elongate probe member, handle means coupled to the proximal extremity of the elongate probe member for advancing the distal extremity of the elongate probe member into the natural body opening so that the stylet is disposed in the natural body cavity adjacent the treatment site, a radio frequency generator coupled to the stylet for supplying radio frequency energy to the stylet, a return electrode electrically coupled to the radio frequency generator and in contact with the body, the stylet including a conductive radio frequency electrode and a layer of insulating material disposed around the conductive radio frequency electrode but exposing a distal portion of the conductive radio frequency electrode which is exposed in the tissue at the treatment site to form a lesion in the tissue at the treatment site when radio frequency energy is supplied to the conductive radio frequency electrode while the layer of insulating material extends through the wall and protects the wall from radio frequency energy supplied to the conductive radio frequency electrode.

14. A device as in claim 13 further comprising an additional stylet carried by the distal extremity of the elongate probe member, the additional stylet including a conductive radio frequency electrode serving as the return electrode and a layer of insulating material disposed around the conductive radio frequency electrode but exposing a distal portion of the conductive radio frequency electrode, the radio frequency generator supplying radio frequency energy to the conductive radio frequency electrode of the first-named stylet through tissue of the treatment site to the conductive radio frequency electrode of the additional stylet so as to cause ablation of the tissue disposed between the conductive radio frequency electrodes of the first-named and additional stylets.

15. A device as in claim 13 wherein the return electrode is a grounding plate.

16. A method for treating tissue in a target volume at a treatment site in a body accessible through a natural body cavity defined by a wall and accessible from outside the body by a natural body opening by the use of a radio frequency electrode formed of an electrically conductive material and being relatively rigid so as to serve as a stylet and having a sharpened distal extremity serving as a tissue puncturing tip and a layer of insulating material disposed around the radio frequency electrode but exposing a distal portion of the radio frequency electrode comprising the steps of introducing the radio frequency electrode and the layer of insulating material through the natural body opening into the natural body cavity and advancing the radio frequency electrode and the layer of insulating material until the tip is in the vicinity of the treatment site, thereafter advancing the radio frequency electrode to cause the tip to penetrate the wall and to extend into the tissue of the treatment site so that the distal portion of the radio frequency electrode is surrounded by the target volume of tissue and the layer of insulating material extends through the wall so that radio frequency energy can be supplied to the target volume but not to the wall and supplying radio frequency energy to the radio frequency electrode at a sufficient power level and for a sufficient period of time to cause ablation of tissue in the target volume so as to shrink the target volume while inhibiting ablation of the wall.

17. A method as in claim 16 wherein the layer of insulating material is slidably mounted on the radio frequency electrode.

18. A method as in claim 16 further comprising supplying a liquid through the radio frequency electrode into the tissue of the treatment site.

19. A method for treating tissue in a target volume at a treatment site in a body accessible through a natural body cavity defined by a wall and opening outside the body to provide a natural body opening by use of a radio frequency electrode formed of an electrically conductive material comprising selecting a target volume of the tissue of the treatment site beyond the wall, advancing the radio frequency electrode through the wall into the target volume of the tissue of the treatment site, supplying radio frequency energy to the radio frequency electrode to cause ablation of tissue in the target volume so as to shrink the target volume of tissue of the treatment site and protecting the wall from ablation by the radio frequency energy supplied to the target volume of tissue of the treatment site.

20. A method as in claim 19 together with a sleeve of insulating material mounted on the radio frequency electrode, the protecting step including the step of introducing the sleeve of insulating material into the target volume of the tissue of the treatment site so that a length of the radio frequency electrode corresponding to the size of the target volume is exposed and the sleeve of insulating material extends through the wall.

21. A method as in claim 20 further comprising the step of causing relative sliding movement between the radio frequency electrode and the sleeve of insulating material.

22. A method as in claim 19 further comprising the step of providing a grounding plate in contact with the body for serving as a return electrode.

23. A method as in claim 19 further comprising the step of advancing an additional radio frequency electrode through the wall into the tissue of the treatment site for serving as a return electrode.

24. A method as in claim 19 further comprising the step of measuring the temperature of the tissue of the treatment site in the vicinity of the radio frequency electrode.

25. A method as in claim 19 further comprising the step of measuring the impedance of the tissue of the treatment site while it is being ablated and controlling the radio frequency ablation in response to the measured impedance.