Medical probe device and method

• US 5,672,153 A
• Filed: 09/26/1994
• Issued: 09/30/1997
• Est. Priority Date: 08/12/1992
• Status: Expired due to Term

• Current Assignee: Vidamed, Inc. (Medtronic Plc)
• Original Assignee: Vidamed, Inc. (Medtronic Plc)
• Inventors: Lax, Ronald G., Baker, James A.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/311,814
• Time in Patent Office: 1,100 Days
• Field of Search: 604/19-22, 604/53, 604/164, 604/280, 606/39, 606/32, 606/45, 606/96, 606/113, 606/115, 606/116, 606/138, 606/156, 606/101, 606/102
• 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 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 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/1425 : 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 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• 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 2025/0096 : 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 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• 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 method and device for medical treatment of a tissue mass. The method comprises introducing a catheter along a body duct to a zone adjacent to the target tissue to be treated. A flexible stylet comprising a radiofrequency electrode partially enclosed within a non-conductive sleeve is moved from the catheter through a catheter port in the side wall of the catheter and through surrounding tissue into a target tissue to be treated. An outward force is exerted on the wall of the body duct by means of an inflatable balloon attached to the catheter and heat is generated in the target tissue by passing electrode current from the exposed area of the electrode into the target tissue.

Claims

1. A medical probe device for medical treatment of tissue at a treatment site through a natural body opening defined by a wall, comprising an elongate guide housing having proximal and distal extremities and having a passageway therein extending from the proximal extremity to the distal extremity along a longitudinal axis, a stylet mounted in the guide housing and having proximal and distal extremities, a handle mounted on the proximal extremity of the guide housing, means mounted on the proximal extremity of the guide housing and connected to the stylet for causing advancement of the stylet through the passageway, the distal extremity of the guide housing being in communication with the passageway and permitting the distal extremity of the stylet to be advanced out of the passageway sidewise at an angle with respect to the longitudinal axis into the tissue, the stylet including a conductive radio frequency electrode and a layer of insulating material coaxially disposed on the conductive radio frequency electrode so that a predetermined portion of the conductive radio frequency electrode is exposed in the tissue and the layer of insulating material protects the wall and expandable balloon means mounted on the guide housing for engaging the wall.

2. A medical probe of claim 1 wherein the balloon means includes at least one dilation balloon and wherein the guide housing is provided with a fluid delivery lumen extending from the proximal extremity to the distal extremity of the guide housing so as to be in communication with the dilation balloon whereby the dilation balloon expands outwardly from the distal extremity of the guide housing when fluid is supplied from the fluid delivery lumen to the dilation balloon.

3. A medical probe of claim 1 wherein the guide housing is provided with a lumen extending in a direction parallel to the longitudinal axis, the lumen having a proximal opening for receiving a scope and a distal viewing port.

4. A medical probe of claim 3 wherein the scope includes viewing fibers, light fibers and a liquid supply connector for supplying a flushing liquid to the distal extremity of the guide housing.

5. A medical probe of claim 1 wherein the stylet comprises a tube having an axial lumen extending longitudinally therethrough.

6. A medical probe of claim 5 wherein the tube is made of nickel-titanium.

7. A medical probe of claim 5 wherein a temperature sensor is slidably disposed in the axial lumen.

8. A medical probe of claim 1 including a temperature sensor mounted on the balloon means for measuring the temperature adjacent the balloon means.

9. A medical probe of claim 1 including a temperature sensor carried by the layer of insulating material.

10. A medical probe of claim 1 together with an additional stylet mounted in the guide housing.

11. A medical probe of claim 10 wherein the guide housing includes two stylet ports positioned approximately in a plane perpendicular to the longitudinal axis.

12. A medical probe of claim 1 together with ultrasound imaging means carried by the distal extremity of the guide housing.

13. A medical probe of claim 1 together with a stylet guide means carried by the distal extremity of the guide housing for directing the stylet sidewise at an angle with respect to the longitudinal axis, the stylet guide means defining a stylet path from an axial orientation in the guide housing through a curved portion to a lateral orientation.

14. A medical probe of claim 13 wherein the curved portion has a radius which is sufficient to permit sliding deployment of the stylet in the stylet path.

15. A medical probe of claim 14 wherein the stylet guide means defines a stylet path terminating at a stylet port, the stylet path having a first curved portion which curves away from the stylet port and a second curved portion continuing from the first curved portion which curves towards the stylet port.

16. A medical probe of claim 13 wherein the stylet guide means defines at least two non-intersecting stylet paths from parallel axial orientations in the guide housing through curved portions to lateral orientations at respective stylet ports, the central axes of the stylet paths at the stylet ports forming an angle of up to 180°

to one other and wherein a stylet is slidably disposed in each of the stylet paths.

17. A medical probe of claim 16 wherein the angle between the axes of the stylet paths at the stylet ports is less than 90°

.

18. A medical probe of claim 16 wherein the angle between the axes of the stylet paths at the stylet ports is 60°

.

19. A medical probe of claim 13 wherein the stylet guide means is made from a polycarbonate.

20. A medical probe of claim 1 in combination with at least one grounding plate, the grounding plate adapted to draw electrical energy passing from the conductive radio frequency electrode through target tissue to be ablated.

21. A medical probe of claim 1 wherein the stylet has a sharpened tip.

22. A medical probe of claim 1 wherein the layer of insulating material is an insulating sleeve coaxially mounted on the conductive radio frequency electrode.

23. A medical probe device of claim 22 wherein the insulating sleeve is mounted for longitudinal movement on the conductive radio frequency electrode.

24. A medical probe of claim 22 wherein the means for causing advancement of the stylet through the passageway includes means connected to the conductive radio frequency electrode and the insulating sleeve for causing relative movement between the insulating sleeve and the conductive radio frequency electrode so that a preselected length of the conductive radio frequency electrode can be exposed.

25. A medical probe of claim 24 wherein the means for causing relative movement between the insulating sleeve and the conductive radio frequency electrode include separate, adjacent manual movement means mounted on the handle for both separate and coordinated movement thereon.

26. A medical probe of claim 25 together with means for relating movement of the insulating sleeve to inflation of the balloon means which includes gauge means for measuring the inflation of the balloon means and graduations on the handle for accurate manual adjustment of the insulating sleeve in relation to the inflation of the balloon means.

27. A medical probe of claim 24 together with means for relating movement of the insulating sleeve to inflation of the balloon means.

28. A medical probe of claim 27 wherein the means for relating movement of the insulating sleeve to inflation of the balloon means includes automatic linkage means for automatically advancing the sleeve in relation to the expansion of the balloon means, the linkage means having gauge means for measuring the inflation of the balloon means.

29. A medical probe of claim 28 wherein the linkage means includes a pneumatic or hydraulic cylinder assembly linking the sleeve to the gauge means.

30. A medical probe of claim 28 wherein the linkage means includes a linear electric motor linking the sleeve to the gauge means.

31. A medical probe of claim 28 wherein the linkage means includes a servo motor linking the sleeve to the gauge means and electronic control means for controlling the servo motor.

32. A method for medical treatment of a tissue mass comprising:

(a) introducing a catheter along a body duct to a zone adjacent to the target tissue to be treated;

(b) moving a flexible stylet comprising a radiofrequency electrode partially surrounded by a non-conductive sleeve from the catheter through a catheter port and surrounding tissue into a target tissue to be treated;

(c) exerting an outward force on the wall of the body duct by means of a force exerting means attached to the catheter; and

(d) generating heat in the target tissue by passing electrical energy from an exposed area of the electrode into the target tissue.

33. A method of claim 32 comprising moving the non-conductive sleeve relative to the electrode to expose a preselected area of the electrode in the target tissue to be treated.

34. A method of claim 33 wherein the position of the non-conductive sleeve is adjusted in relation to the position of the wall of the body duct.

35. A method of claim 34 wherein the sleeve position is automatically adjusted by means of a control means obtaining information from the force exerting means.

36. A method of claim 32 wherein the force exerting means includes at least one inflatable balloon and wherein exerting a force on the wall of the body duct includes inflating the balloon.

37. A method of claim 32 wherein the catheter is positioned adjacent to the target tissue by use of ultrasound imaging.

38. A method of claim 32 wherein the catheter is positioned using a scope connected to the catheter.

39. A method of claim 32 wherein the stylet comprises a hollow tube and wherein the temperature of the target tissue being treated is monitored during the treatment using a temperature sensor disposed in the tube.

40. A method for treatment of target tissue without exposing tissue surrounding the target tissue to destructive temperatures comprising:

(a) advancing a flexible stylet through surrounding tissue into the target tissue to be ablated, the stylet being a radiofrequency electrode surrounded by a moveable non-conductive sleeve means for preventing significant transfer of energy from the electrode to tissue surrounding the sleeve;

(b) moving the non-conductive sleeve means to expose a preselected portion of the electrode positioned in the target tissue and generating heat in the target tissue by causing electrical energy to flow between the preselected portion of the electrode and a second electrode; and

(c) exerting a compressive force on the target tissue.

41. A method of claims 40 further comprising adjusting the position of the sleeve means as the position of the tissue surrounding the target tissue changes due to the compressive force.

42. A method for treating a target tissue such as the prostate of a patient comprising:

(a) introducing a catheter into the urethra to a zone adjacent to the prostate target tissue to be treated;

(b) moving two flexible stylets, each comprising a radiofrequency electrode partially surrounded by a non-conductive sleeve which is axially moveable relative to the electrode, from the catheter through catheter ports and through the urethra wall and surrounding tissue into the prostate target tissue to be treated, the catheter ports having respective axes disposed relative to each other at an angle of less than 90°

;

(c) exerting an outwardly directed force on the urethra wall by means of at least one inflatable balloon attached to the catheter; and

(d) generating heat in the target tissue by passing electrical energy from the exposed areas of the electrodes into the target tissue.

43. A method of claim 42 further comprising adjusting the position of the sleeve in relation to changes in position of the urethra wall due to the force exerted on the wall by the inflatable balloon.

44. A method of claim 42 wherein the axes are disposed relative to each other at an angle of 60°

.

45. A method of claim 42 wherein the method includes retracting the sleeves relative to the electrodes to expose preselected portions of the electrodes positioned in the prostate target tissue.

46. A method of claim 42 wherein grounding plates are placed against the body of the patient to draw electrical energy passing from the electrodes through the target tissue to be ablated.

47. A medical probe device for medical treatment of tissue of a prostate through a urethra defined by a urethral wall comprising a guide housing having proximal and distal extremities and having a passageway extending from the proximal extremity to the distal extremity, a stylet slidably mounted in the passageway of the guide housing, guide means carried by the distal extremity of the guide housing and in communication with the passageway for directing the stylet sidewise of the guide housing, the stylet including a flexible radio frequency electrode with a sharpened tip and an insulating sleeve slidably disposed on the radio frequency electrode, handle means mounted on the proximal extremity of the guide housing for introducing the distal extremity of the guide housing into the urethra to the vicinity of the prostate, the handle means including means secured to the stylet for advancing the stylet from the passageway of the guide housing to cause the sharpened tip of the radio frequency electrode and the insulating sleeve to penetrate the urethral wall and to extend into the tissue of the prostate with the insulating sleeve extending through the urethral wall, the handle means also including means for causing relative movement between the insulating sleeve and the radio frequency electrode to expose a predetermined length of the radio frequency electrode in the tissue of the prostate with the insulating sleeve extending through the urethral wall, means for supplying radio frequency energy to the radio frequency electrode to cause the temperature of the tissue of the prostate adjacent the predetermined length of the radio frequency electrode to be raised to cause destruction of cells in the tissue of the prostate, the guide housing having a fluid delivery lumen extending from the proximal extremity to the distal extremity of the guide housing and inflatable balloon means mounted on the distal extremity of the guide housing in communication with the fluid delivery lumen.

48. A medical probe as in claim 47 wherein the balloon means extends around only a portion of the distal extremity of the guide housing.

49. A medical probe as in claim 48 wherein the balloon means is expandable from said portion of the distal extremity of the guide housing and the stylet extends sidewise of the guide housing from another portion of the distal extremity of the guide housing which is generally opposite to said first-named portion.

50. A medical probe as in claim 47 wherein the stylet passes through the balloon means as it extends sidewise of the guide housing.

51. A medical probe as in claim 47 together with an additional stylet slidably mounted in the passageway of the guide housing which is of the same type as said first-named stylet.

52. A medical probe as in claim 47 wherein the balloon means includes an annular balloon.

53. A method for the treatment of benign prostatic hypertrophy in the prostate of the 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 prostate having tissue surrounding the urethra near the base of the bladder, comprising dilating the urethra in the vicinity of the prostate with an expandable balloon disposed in the urethra, selecting a target volume of the tissue of the prostate beyond the urethral wall, introducing radio frequency energy through the urethral wall into the target volume of the tissue of the prostate to cause ablation of tissue in the target volume of the tissue in the prostate and protecting the urethral wall from ablation by the radio frequency energy supplied to the target volume of tissue in the prostate.

54. A method as in claim 53 together with a radio frequency electrode formed of an electrically conductive material and a layer of insulating material surrounding at least a portion of the radio frequency electrode, further comprising the step of introducing the radio frequency electrode into the target volume of the tissue of the prostate with the layer of insulating material extending through the urethral wall, the radio frequency energy being supplied to the radio frequency electrode.

55. A method as in claim 54 wherein the layer of insulating material is an insulating sleeve slidably mounted on the radio frequency electrode, further comprising the step of causing relative sliding movement between the radio frequency electrode and the insulating sleeve to expose a preselected length of the radio frequency electrode corresponding to the size of the target volume while retaining the insulating sleeve in a position so that it continues to extend through the wall.

56. A method for medical treatment of a prostate through a urethra formed by a urethral wall by the use of a catheter having a distal extremity carrying expandable balloon means and having a flexible radio frequency electrode with a sharpened tip and an insulating sleeve mounted on and surrounding the flexible radio frequency electrode to expose a predetermined length of the radio frequency electrode, the radio frequency electrode and the insulating sleeve being slidably mounted in the catheter and being movable through the distal extremity of the catheter, comprising introducing the catheter through the urethra to a region adjacent the prostate, expanding the balloon means in the urethra, advancing the flexible radio frequency electrode and the insulating sleeve using the sharpened tip to penetrate the urethral wall and pass through the urethral wall into the prostate, passing sufficient radio frequency energy through the radio frequency electrode to raise the temperature of the prostate adjacent the predetermined length of the radio frequency electrode to a temperature causing destruction of cells by ablation in the prostate while protecting the urethral wall by the insulating sleeve from the radio frequency energy.

57. A method as in claim 56 wherein the radio frequency electrode and the insulating sleeve are movable relative to each other, further comprising the step of establishing a relationship between the radio frequency electrode and the insulating sleeve so that a predetermined portion of the radio frequency electrode extends out of the insulating sleeve and is exposed in the prostate.

58. A method as in claim 56 further comprising the step of expanding the balloon means along one side of the distal extremity of the catheter so as to urge the catheter against the urethral wall.

59. A method as in claim 56 wherein the advancing step includes advancing the radio frequency electrode and the insulating sleeve through the balloon means.