Steerable medical probe with stylets

• US 5,409,453 A
• Filed: 08/19/1993
• Issued: 04/25/1995
• Est. Priority Date: 08/12/1992
• Status: Expired due to Term

• Current Assignee: Vidamed, Inc. (Medtronic Plc)
• Original Assignee: Vidamed, Inc. (Medtronic Plc)
• Inventors: Edwards, Stuart D., Lundquist, Ingemar H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/109,190
• Time in Patent Office: 614 Days
• Field of Search: 604/95, 604/182, 604/19-22, 604/164, 604/52, 604/53, 604/280, 606/33, 606/39, 606/41, 606/45, 607/101, 607/105, 607/99, 128/642, 128/736
• 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 10/0233 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 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 18/1442 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 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2017/00469 : for insertion of instruments, e.g. guide wire, optical fibre
• 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 2018/00101 : 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 2018/00982 : 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 2090/378 : 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: 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 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• 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 5/04 : Radiators for near-field treatment
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body

Abstract

A medical probe device for reducing tissue mass in a selected portion of the body comprises a torquable catheter having a control end and a probe end. The probe end includes a stylet guide means with a flexible tip and a tip directing means extending from the control end to the flexible tip for changing the orientation of the central axis of the stylet guide means for directing a flexible stylet outward through the stylet port and through intervening tissue to targeted tissues. A stylet is positioned in the said stylet guide means. The stylet can be an RF electrode, microwave antenna, biopsy means, fluid supply means or combination thereof. Preferably, the stylet is a non-conductive sleeve having an electrode lumen and a second lumen therein, the electrode lumen terminating at a distal port in the distal end of the non-conductive sleeve, a radiofrequency electrode being positioned in said electrode lumen for longitudinal movement therein through the distal port. The medical probe device is particularly useful for removing tissue mass from the prostate and can be used for treating BPH or benign or cancerous tumors of the prostate. The device of this invention can be used in combination with a viewing scope such as a cystoscope, endoscope, laproscope and the like, being sized to extend therethrough or it can include a viewing scope. In one construction, the flexible tip comprises a metal tube with parallel spaced-apart slots extending through the tube to a continuous longitudinal section and enclosed within a flexible sleeve, whereby the tip will preferentially bend in a plane through the axis of the tube and the continuous longitudinal section.

Claims

1. A medical probe for the treatment by radio frequency ablation of a target volume in 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 comprising an elongate probe member having proximal and distal extremities and being sized so that it can be introduced into the urethra, said elongate probe member having a passage extending from the proximal extremity to the distal extremities, first and second guide cannulas mounted side by side in the passage of the elongate probe member and having proximal and distal extremities with the distal extremity of the guide cannulas being in the vicinity of the distal extremity of the elongate probe member, each of said guide cannulas having a lumen extending therethrough from the proximal extremity to the distal extremity, a radio frequency conductive electrode disposed in each lumen, an insulating sleeve coaxially disposed on each of said radio frequency electrodes, a control handle secured to the proximal extremity of the elongate probe member and means carried by the control handle and secured to the radio frequency electrode and the insulating sleeve in each lumen whereby the radio frequency electrode and the insulating sleeve in each lumen can be advanced and retracted.

2. A probe as in claim 1 together with means carried by the handle for causing bending of the distal extremity of each of the first and second guide cannulas to thereby control the direction of penetration of the radio frequency electrode through the urethral wall and into the tissue of the prostate.

3. A probe as in claim 1 wherein the distal extremity of each of the guide cannula is provided with a cylindrical wall, said cylindrical wall having at least a portion thereof containing a plurality of longitudinally spaced apart circumferentially extending slots subtending less than 360 degrees formed therein, said slots facilitating bending of the guide cannula in said flexibe portion of the distal extremity of the guide cannula.

4. A probe as in claim 3 wherein said slots are circumferentially aligned to provide a backbone extending longitudinally of the flexible portion so as to permit bending in only a single direction.

5. A probe as in claim 3 wherein said flexible portion can be bent through an angle at least approximating 90 degrees.

6. A probe as in claim 1 together with means carded by the control handle for pre-adjusting on the control handle the maximum distance the radio frequency electrode in each of the lumens can be extended distally.

7. A probe as in claim 6 together with means carried by the control handle for pre-adjusting on the control handle the amount of extension of the insulating sleeve.

8. A probe as in claim 7 wherein said means carried by the handle for adjusting the position of the radio frequency electrode and the position of the insulating sleeve includes means for causing relative movement between the insulating sleeve and the radio frequency electrode in each lumen so that a preselected length of the radio frequency electrode in each lumen can be exposed in tissue of the prostate.

9. A probe as in claim 1 together with a cystoscope carried by the control handle and having a distal extremity in the vicinity of the distal extremity of the elongate probe member.

10. A medical probe for the treatment by radio frequency ablation of a target volume in 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 comprising an elongate probe member having proximal and distal extremities and being sized so that it can be introduced into the urethra, said elongate probe member having a passage extending from the proximal extremity to the distal extremity, a guide cannula mounted in the passage of the elongate probe member and having proximal and distal extremities with the distal extremity of the guide cannula being in the vicinity of the distal extremity of the elongate probe member, said guide cannula having a lumen extending therethrough from the proximal extremity to the distal extremity, a radio frequency conductive electrode disposed in said lumen, an insulating tube coaxially disposed on said radio frequency electrode, a control handle secured to the proximal extremity of the elongate probe member, means carried by the control handle and secured to the radio frequency electrode and the insulating sleeve in the lumen whereby the radio frequency electrode and the insulating sleeve thereon can be advanced and retracted, means for causing bending of the distal extremity of the guide cannula to thereby control the direction of penetration of the radio frequency electrode through the urethral wall and into tissue of the prostate, the distal extremity of the guide cannula being provided with a cylindrical wall, said cylindrical wall having at least a portion thereof containing a plurality of longitudinally spaced apart circumferentially extending slots subtending less than 360 degrees formed therein, said slots facilitating bending of the guide cannula in said portion of the distal extremity of the guide cannula.

11. A probe as in claim 10 wherein said slots are circumferentially aligned to provide a backbone extending longitudinally of the flexible portion so as to permit bending in only a single direction.

12. A medical device for the treatment by radio frequency ablation of a target volume in 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 comprising an elongate probe member having proximal and distal extremities and having a passage therein extending from the proximal extremity to the distal extremity, said elongate probe member being sized so that it can be introduced into the urethra, first and second guide cannulas mounted side by side in the passage of the elongate probe member and having proximal and distal extremities with portions between the proximal and distal extremities, means for fastening together said portions so that they are disposed side by side, each of said guide cannulas having a lumen extending therethrough from the proximal extremity to the distal extremity, a radio frequency conductive electrode disposed in each lumen, an insulating sleeve coaxially disposed on each of said radio frequency electrodes, a handle secured to the proximal extremities of the first and second guide cannulas and means carried by the handle and secured to the radio frequency electrode and the insulating sleeve in each lumen whereby the radio frequency electrode and the insulating sleeve in each lumen can be advanced and retracted with respect to the guide cannula.

13. A device as in claim 12 together with means carried by the handle for causing bending of the distal extremity of each of the first and second guide cannulas to thereby control the direction of penetration of the radio frequency electrode through the urethral wall and into the tissue of the prostate.

14. A device as in claim 13 wherein the distal extremity of each of the guide cannulas is provided with a cylindrical wall, said cylindrical wall having at least a portion thereof containing a plurality of longitudinally spaced apart circumferentially extending slots subtending less than 360 degrees formed therein to provide a flexible portion, said slots facilitating bending of the guide cannula in said flexible portion of the distal extremity of the guide cannula.

15. A device as in claim 14 wherein said slots are circumferentially aligned to provide a backbone extending longitudinally of the flexible portion so as to permit bending in only a single direction.