Thermal mapping catheter with ultrasound probe

• US 5,542,915 A
• Filed: 01/12/1994
• Issued: 08/06/1996
• 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:
  US08/180,511
• Time in Patent Office: 937 Days
• Field of Search: 604/19-22, 604/53, 604/164, 604/280, 606/39, 606/32, 606/45, 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 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 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• 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 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00106 : ultrasonic
• CPC Class Codes: A61B 2017/00123 : and automatic shutdown
• CPC Class Codes: A61B 2017/00181 : Means for setting or varying the pulse energy
• CPC Class Codes: A61B 2017/00194 : Means for setting or varying the repetition rate
• 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 2017/22038 : with a guide wire
• 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 2018/00041 : Heating, e.g. defrosting
• 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 2018/00101 : low, i.e. thermally insulating
• 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 2018/00761 : 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 2018/00886 : 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 2018/0097 : Cleaning probe surfaces
• 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 2018/1861 : 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 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3786 : receiver only
• 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: 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 2025/0096 : 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 3/0279 : Cannula; Nozzles; Tips; their connection means
• 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 apparatus comprising a catheter having a stylet guide housing with one or more stylet ports therein and stylet guides for directing one or more flexible stylets outward through respective stylet ports and through intervening tissue to target tissue. The active stylets emit radio frequency RF energy which establishes an RF current in the patient. The current, being densest at the stylet tips, causes heating of the surrounding tissue to initiate ablation of the target tissue. One aspect of the invention includes temperature sensing stylets at the location of the RF emitting stylets to monitor the temperature of the tissue being ablated. This allows the surgeon to have increased knowledge about the abating action under way in order to control the intensity of the applied RF current, or to adjust the amount of time the current is applied, or both. Further included herein is a plurality of temperature sensors mounted on an ultrasound probe to be used to monitor tissue temperature at the ultrasound probe while allowing the ultrasound device to monitor the position and orientation of the medical probe apparatus of the present invention.

Claims

1. A system for applying ablation power to a body organ comprising:

a catheter having a plurality of stylet ports toward the distal end thereof, a first set of stylets for delivering ablation power to target tissue, a second set of stylets for measuring the temperature of the target tissue, an ultrasound probe insertable into the body independently of the catheter for providing information relating to the position of the first and second sets of stylets when situated adjacent to the desired body organ, and a set of temperature sensors carried by the ultrasound probe for monitoring the temperature of body tissue adjacent to the ultrasound probe.

8. The system of claim 1 wherein the temperature sensors are mounted on a condom placed over the operating end of the ultrasound probe.

9. The system of claim 8 further including a second condom which is placed over the first named condom to protect the temperature sensors from accidental displacement during positioning of the ultrasound probe.

10. The system of claim 9 wherein the sensors are mounted on an adhesive backed flexible element which is affixed to the first named condom.

2. A catheter for use in applying ablation power to body tissue comprising:

a) a plurality of stylet ports toward the distal end of the catheter, a first set of stylets for delivering ablation power to target tissue and a second set of stylets for measuring the temperature of the target tissue;

b) a handle coupled to the catheter for gripping by an operator;

c) a first set of deployment members on the handle for selectively deploying the first set of stylets through the ports and into the target tissue; and

d) a second set of deployment members on the handle for selectively deploying the second set of stylets through the ports and into the target tissue.

3. The system of claim 2 further including:

an electromagnetic energy generator coupled to the first set of stylets; and

temperature display apparatus coupled to the second set of stylets to monitor and display the temperature sensed by the second set of stylets.

4. The system of claim 2 further including:

a manual switch for electively enabling the electromagnetic energy generator to deliver electromagnetic energy to the first set of stylets; and

a grounding plate coupled to the generator for providing a return path to the generator for the electromagnetic energy.

5. The system of in claim 2 wherein the stylets are flexible and electrically conductive;

and wherein the first set of deployment members are individually operable to position one or more of the first set of stylets in the target tissue; and

the second set of deployment members are individually operable to position one or more of the second set of stylets in the target tissue.

6. The system as set forth in claim 5 wherein the first set of deployment members comprises a plurality of sliders mounted on the handle and coupled to the first set of stylets for longitudinal movement in the handle and catheter to deploy a selected portion of the electrically conductive surface of each stylet in the target tissue;

and

wherein the second set of deployment members comprises a plurality of push-pull handles on respective sliders in operating relationship with the handle and coupled to the second set of stylets for longitudinal movement in the handle and catheter to deploy a selected position of each stylet in the target tissue.

7. The system of claim 6 further including a temperature sensor mounted on each of the stylets in the second set near the distal end thereof, and an insulating layer on each stylet for insulating the temperature sensor from the stylet.

11. The catheter of in claim 2 wherein

a) the first set of deployment members comprise a plurality of sliders mounted on the handle and coupled to the first set of stylets for longitudinal movement in the handle and catheter to deploy a selected portion of each stylet in the first set in the target tissue;

and wherein

b) the second set of deployment members comprise a plurality of push-pull handles on respective sliders in operating relationship with the handle and coupled to the second set of stylets for longitudinal movement in the handle and catheter to deploy a selected portion of each stylet in the second set in the target tissue.

12. The catheter of claim 11

further including a temperature sensor mounted on each of the stylets in the second set near the distal end thereof, and an insulating layer on each stylet for insulating the temperature sensor from the stylet.

13. A method of heat treatment of a target tissue without exposing tissue surrounding the target tissue to destructive temperatures, comprising the steps of:

a) introducing a catheter to a position adjacent to the target tissue and deploying a first flexible stylet out from the catheter into the target tissue;

b) delivering through the first flexible stylet electromagnetic energy to the target tissue;

c) maintaining the electromagnetic energy at an energy level and for a time sufficient to ablate the target tissue;

d) deploying a second flexible stylet out from the catheter independently of the first stylet and into the target tissue to monitor the temperature of the target tissue proximate to the second flexible stylet; and

e) controlling the application of electromagnetic energy to the first stylet in accordance with the monitored temperature.

14. A method of heat treatment of a target tissue without exposing tissue surrounding the target tissue to destructive temperatures, comprising the steps of:

a) introducing a catheter to a position adjacent to the target tissue and deploying a first flexible stylet out from the catheter into the target tissue;

b) delivering through the first flexible stylet electromagnetic energy to the target tissue;

c) maintaining the electromagnetic energy at an energy level and for a time sufficient to ablate the target tissue;

d) deploying a second flexible stylet out from the catheter into the target tissue to monitor the temperature of the target tissue proximate to the second flexible stylet;

e) utilizing the measured temperature to control the application of the electromagnetic energy to the first stylet; and

f) introducing an ultrasound probe into the body independently of the catheter for monitoring the location of the catheter.

15. The method of claim 14 wherein the ultrasonic probe is manipulated to a position adjacent the target tissue.

16. The method of claim 15 wherein the second flexible stylet deployed from the catheter carries a temperature sensor immediately rearward of its distal end stylet.

17. The method of claim 16 further including the step of monitoring temperature near the operating end of the ultrasound probe with temperature sensors in operating relationship with the probe to provide temperature information in the area Immediately proximate to the operating end of the probe.

18. The method of in claim 14 including the step of measuring the temperature in the area immediately adjacent to the distal end of the catheter with a sensor carried by the ultrasonic probe.