Medical probe device and method relationship to copending application

• US 20020183740A1
• Filed: 04/15/2002
• Published: 12/05/2002
• Est. Priority Date: 08/12/1992
• Status: Active Grant

• 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.
• Granted Patent: US 6,852,091 B2
• Time in Patent Office: Days
• 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 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 probe device comprising a catheter having a control end and a probe end, the probe end including a stylet guide housing having at least one stylet port in a side thereof and stylet guide means for directing a flexible stylet outward through at least one stylet port and through intervening tissue to a target tissue, a stylet positioned in at least one of said stylet guide means, the stylet comprising an electrical conductor enclosed within a non-conductive sleeve, the electrical conductor being a radiofrequency electrode.

2. A medical probe device of claim 1 wherein the non-conductive sleeve is mounted for longitudinal movement on the electrical conductor to expose a selected portion of the electrical conductor surface in the target tissue.

3. A medical probe of claim 1 wherein the electrode is a tube having an axial lumen extending therethrough.

4. A medical probe of claim 3 wherein a solid wire is disposed in the axial lumen for longitudinal movement therein.

5. A medical probe of claim 1 wherein the stylet guide housing includes at least two of said stylet ports.

6. A medical probe of claim 1 wherein the stylet guide housing includes two of said stylet ports positioned approximately in a plane perpendicular to the central axis of the housing.

7. A medical probe of claim 1 wherein a ultrasound reflecting means or an ultrasound transponder means is positioned in the distal end of the catheter for providing a signal indicating the position of the catheter in the body.

8. A medical probe of claim 1 including a temperature sensor means mounted on the stylet guide housing for indicating the temperature in the tissue adjacent to the guide housing.

9. A medical probe of claim 1 including an ultrasound transponder means mounted on the distal end of the non-conductive sleeve for emitting a signal indicating the position of the stylet in the body.

10. A medical probe of claim 1 including a temperature sensor means mounted on the distal end of the non-conductive sleeve for indicating the temperature of tissue at the distal end of the sleeve.

11. A medical probe of claim 1 wherein the electrical conductor is a highly flexible metal.

12. A medical probe of claim 11 wherein the highly flexible metal is nickel-titanium alloy.

13. A medical probe of claim 1 wherein the stylet guide means defines a stylet path from an axial orientation in the catheter through a curved portion to a lateral orientation at the stylet port.

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 guide and deflect the stylet during deployment to the desired angle.

15. A medical probe of claim 14 wherein the curved portion has a radius of up to 0.5 cm.

16. A medical probe of claim 15 wherein the stylet guide means defines a stylet path having a first curved portion extending in a direction away from the stylet port and a second curved portion, continuing from the first curved portion and extending to the stylet port.

17. 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 catheter through curved portions to lateral orientations at stylet ports having central axes forming an angle of up to 180°

.

18. A medical probe of claim 17 wherein the angle is less than 180°

.

19. A medical probe of claim 17 wherein the angle is less than 90°

.

20. A medical probe of claim 17 in combination at least one grounding plate, the grounding plate being adapted to draw electrical current passing from the electrodes through target tissue to be ablated.

21. A medical probe of claim 13 wherein the stylet guide means defines at least four non-intersecting stylet paths from parallel axial orientations in the catheter through curved portions to lateral orientations at stylet ports extending outward at approximately 90°

interval directions about the axis of the catheter.

22. A medical probe of claim 1 wherein the non-conductive sleeve comprises a leading tip, a rigid proximal control section, and a flexible portion extending from the leading tip to the rigid proximal control section, enabling the sleeve to be extended through a curved path from an axial orientation to an orientation extending outward through a stylet port.

23. A medical probe of claim 22 wherein the leading tip is tapered inward to converge toward its terminal end.

24. A medical probe of claim 22 wherein the flexible portion comprises a spiral coil or wire braid.

25. A medical probe of claim 24 wherein the flexible portion is made of conductive material enclosed in an outer non-conductive material.

26. A medical probe of claim 1 wherein the electrical conductor has a sharp blade tip.

27. A medical probe of claim 26 wherein the distal portion of the sharp blade tip defines a shoulder, and the distal end of the sleeve tapers inward to a tip having a diameter that does not significantly exceed the thickness of the shoulder.

28. A medical probe of claim 1 wherein the distal portion of the catheter is more flexible than the proximal portion thereof, facilitating its passage through curved ducts.

29. A medical prove of claim 28 wherein the more flexible portion of the catheter comprises a spiral coil, wire braid or slotted tube having a smooth outer layer.

30. A medical probe of claim 1 comprising a control handle attached to the control end of the catheter, and stylet movement means attached to a stylet and engaging the handle for longitudinal movement of the stylet in the stylet guide means.

31. A medical probe of claim 30 wherein the stylet movement means comprises manual engagement means for translating manual motion into longitudinal motion of the stylet in the stylet guide means.

32. A medical probe of claim 2 comprising a control handle attached to the control end of the catheter, a non-conductive sleeve movement means attached to a non-conductive sleeve and an electrical conductor movement means attached to the electrical conductor enclosed therein, the non-conductive sleeve movement means comprising means for translating manual motion into longitudinal motion of the non-conductive sleeve in the stylet guide means, the electrical conductor movement means comprising means for translating manual motion into longitudinal motion of the electrical conductor in the non-conductive sleeve, the non-conductive sleeve movement means and the electrical conductor movement means engaging the handle for movement thereon.

33. A medical probe of claim 32 wherein the non-conductive sleeve movement means and the electrical conductor movement means include separate, adjacent manual movement means mounted on the handle for both separate and coordinated movement thereon.

34. A medical probe of claim 32 wherein the control handle has at least two parallel longitudinal slots through a wall thereof, the manual movement means each including a finger engaging surface connected to a slide extending through one of the longitudinal slots to a connector in the interior of the housing, the connector being attached to a respective non-conductive sleeve or electrical conductor.

36. A medical probe of claim 35 wherein the stylet is directed outward at an angle in a plane through the central axis of the catheter housing of from about 20°

to 160°

with the central axis of the stylet guide housing.

37. A medical probe of claim 35 wherein the catheter 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.

38. A medical probe of claim 35 wherein the stylet is an electrical conductor enclosed within a non-conductive layer, the electrical conductor being a radiofrequency electrode.

39. A medical probe of claim 38 wherein the non-conductive layer is a sleeve which is longitudinally moveable on the electrical conductor to expose a selected portion of the electrical conductor surface in the target tissue.

40. A medical probe of claim 35 wherein the stylet is a microwave antenna.

41. A medical probe of claim 35 wherein the stylet is a cannula having an axial treatment fluid supply lumen extending therethrough and the catheter has a treatment fluid transport lumen communicating with the treatment fluid supply lumen.

42. A medical probe of claim 35 wherein the stylet guide housing includes an array of said stylet ports.

43. A medical probe of claim 35 wherein the catheter includes an inflation fluid delivery lumen extending therethrough, and the probe end includes at least one inflatable balloon in communication with the inflation fluid delivery lumen.

44. A medical probe of claim 43 wherein the inflatable balloon is an annular dilation stabilizer balloon means for expanding outwardly against a duct wall and is positioned adjacent a stylet port.

45. A medical probe of claim 35 wherein an ultrasound transponder is attached to a distal end of the stylet.

46. A medical probe of claim 35 wherein an ultrasound transducer is attached to a distal end of the probe.

47. A medical probe of claim 35 wherein the stylet includes a radiofrequency electrode or microwave antenna, and at least one temperature sensor is attached to at least one of the probe end, stylet guide housing and stylet.

48. A medical probe of claim 47 wherein the temperature sensor is a thermistor, thermocouple or fiber optic cable.

49. A medical probe of claim 35 wherein the stylet comprises a fiber optic cable means for laser treatment.

35. A medical probe device comprising a catheter having a control end and a probe end, the probe end including a stylet guide housing having at least one stylet port in a side wall thereof and guide means for directing a flexible stylet outward through the stylet port and through intervening tissue to a target tissue.

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

a) introducing a catheter to a zone adjacent to the target tissue to be treated;

b) moving a flexible stylet from the catheter through a catheter port in the sidewall of the catheter and through surrounding tissue into a target tissue to be treated; and

c) performing the medical treatment of the target tissue with the stylet.

51. A method of claim 50 wherein the stylet is a radiofrequency electrode at least partially enclosed within a non-conductive sleeve means for preventing significant transfer of current from the electrode to tissue surrounding the sleeve, and the medical treatment energy comprises generating heat in the target tissue by passing electric current from the electrode into the target tissue.

52. A method of claim 51 comprising moving the non-conductive sleeve means from a preselected area of the electrode in the target tissue to be treated and generating heat in the target tissue by passing electrode current from the preselected area of the electrode into the target tissue.

53. A method of claim 50 wherein the stylet is a microwave antenna.

54. A method of claim 50 wherein the electrical conductor is extended into the tissue to be treated, positioned by use of ultrasound imaging.

55. A method of claim 54 wherein the ultrasound imaging is obtained with an ultrasound transponder positioned on the stylet.

56. A method of claim 54 wherein the ultrasound imaging is obtained with an ultrasound transducer positioned at the end of the catheter.

57. A method of claim 50 wherein the temperature of the target tissue being treated is monitored during the treatment using a temperature sensor attached to the catheter or flexible stylet.

59. A method of claim 58 including the additional steps for creating a drainage canal from the treated target tissue comprising:

c) retracting the non-conductive sleeve means from a length of the conductor which corresponds to the position and length of the desired drainage canal, and

d) generating sufficient destructive heat in the tissue adjacent the exposed conductor from an electric current from the exposed conductor to form a canal.

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

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

b) moving the non-conductive sleeve means to remove it from a preselected portion of the conductor positioned in the body mass to be treated, and generating heat in the body mass from an electric current from the preselected portion of the conductor.

60. A method for treating a target tissue such as the prostate comprising:

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

b) moving two flexible stylets from the catheter through catheter ports in the sidewall of the catheter and through the urethra wall and surrounding tissue into the prostate target tissue to be treated, the catheter ports having axes forming an angle of less than 180°

; and

c) performing the medical treatment of said target tissue with the stylet.

61. A method of claim 60 wherein the angle is less than 110°

.

62. A method of claim 60 wherein the stylets are flexible electrical conductors surrounded by moveable non-conductive sleeves for preventing significant transfer of energy from the conductors to tissue surrounding the sleeves, and the non-conductive sleeves are retracted to remove them from preselected portions of the conductors positioned at the prostate to be treated, and generating heat in the prostate from electric current from the preselected portions of the conductors.

63. A method of claim 60 wherein the stylets are flexible electrical conductors surrounded by a non-conducting sleeve means for preventing significant transfer of energy from the conductor to tissue surrounding the sleeve, and grounding plates are placed on the skin in positions which draw electrical current passing from the electrodes through target tissue to be ablated, and ablating heat is generated in the target tissue from electrical current passing through the electrodes to the grounding plates.

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

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

b) placing a grounding plate on the skin to direct an electrical current passing from the electrode through the target tissue to be ablated; and

c) generating heat in the target tissue from an electrical current passing from the electrode to the grounding plate.

65. A method of claim 64 wherein the stylets are flexible electrical conductors surrounded by moveable non-conductive sleeves for preventing significant transfer of energy from the conductors to tissue surrounding the sleeves, and the non-conductive sleeves are retracted to remove them from preselected portions of the conductors positioned in the prostate, and generating heat in the prostate from electric current from the preselected portions of the conductors.