WO1996022739A1

WO1996022739A1 - Medical probe device with scope and proximal aspiraton openings and method for treatment of the prostate with same

Info

Publication number: WO1996022739A1
Application number: PCT/US1996/000498
Authority: WO
Inventors: James Allen Baker, Jr.; Phillip R. Sommer
Original assignee: Vidamed, Inc.
Priority date: 1995-01-24
Filing date: 1996-01-11
Publication date: 1996-08-01
Also published as: AU4756396A

Abstract

A medical probe device (21) comprising an elongate member (22) having proximal and distal extremities (22a, 22b) and first and second lumens (148, 28) extending from the proximal extremity (22a) to the distal extremity (22b). An opening (153) is provided in the distal extremity (22b) of the elongate member (22) in communication with the first lumen (148). A handle (29) is mounted on the proximal extremity (22a) of the elongate member (22a) for introducing the distal extremity (22b) of the elongate member (22) through the natural body opening into the canal. A scope (86) is positioned in the elongate member (22) and has a field of view which extends forwardly of the elongate member (22). A fitting (166) is coupled to the elongate member (22) for permitting a liquid to be suplied to the first lumen (148) and out the opening (153) to provide a clear field of view for the scope (86). The elongate member (22) is provided with at least one additional opening (182) proximal of the first named opening (153) in the elongate member (22) and in communication with the second lumen (28) for permitting aspiration of the liquid while liquid is being introduced through the first named opening (153) in the elongate member (22).

Description

- 1 -

MEDICAL PROBE DEVICE WITH SCOPE

AND PROXIMAL ASPIRATION OPENINGS

AND METHOD FOR TREATMENT OF THE PROSTATE WITH SAME

This invention pertains generally to medical probe devices having scopes such as endoscopes and, more particularly, to transurethral medical probe devices with scopes and fluid flushing for permitting a clear field of view. Medical probe devices such as transurethral needle ablation devices have heretofore been provided for treating the tissue of the prostate of human males. These devices often utilize scopes such as endoscopes to facilitate positioning of the device within the urethra and penetrating the urethral wall to perform needle ablations within the prostate. It has been found that visibility within the urethra is improved when a liquid such as a saline solution is supplied through a device into the field of view within the urethra. Unfortunately, this flushing can require interruption of the procedure to void the bladder. In addition, most current probe devices do not accommodate both a rod lens and a fiber optic scope. There is therefore a need for a device and method which overcomes these disadvantages.

In general, it is an object of the present invention to provide a medical probe device with scope and method which can be utilized for a transurethral needle ablation procedure in the prostate of a human male.

_Another object of the invention is to provide a medical probe _device with scope and method of the above character which permits the transurethral needle ablation procedure to be performed with a single device and with a single introduction of the device into the urethra. Another object of the invention is to provide a medical probe device with scope and method of the above character which introduces a saline or other flushing fluid for providing a clear field of view for the scope. Another object of the invention is to provide a medical probe device with scope and method of the above character which aspirates the saline or other flushing fluid to inhibit filling of the bladder during the needle ablation procedure. Another object of the invention is to provide a medical probe device with scope and method of the above character which aspirates the flushing fluid from at least one opening located proximal of the outlet opening through which the flushing fluid is introduced into the urethra. Another object of the invention is to provide a medical probe device with scope and method of the above character which aspirates the flushing fluid from a plurality of openings located on an outer cylindrical wall of the device.

Another object of the invention is to provide a medical probe device with scope and method of the above character which introduces the flushing fluid through a reusable scope so as to reduce the cost of the disposable portion of the device.

Another object of the invention is to provide a medical probe device with scope and method of the above character which permits viewing of the interior of the urethra as the distal extremity of the device is advanced therein.

Another object of the invention is to provide a medical probe device with scope and method of the above character which permits viewing of the needle ablation stylets as they are advanced into the prostate. Another object of the invention is to provide a medical probe device of the above character which can alternatively accommodate a rod lens scope or a fiber optic scope.

Additional objects and features of the invention will appear from the following description from which the preferred embodiments are set forth in detail in conjunction with the accompanying drawings. FIG. 1 is a perspective view of an embodiment of the medical probe device of the present invention.

FIG.2 is an enlarged side-elevational view of the medical probe device of FIG. 1 taken along the line 2-2 of FIG. 1. FIG. 3 is a cross-sectional view of the medical probe device of FIG. 1 taken along the line 3-3 of FIG. 2.

FIG. 4 is a cross-sectional view of the medical probe device of FIG. 1 taken along the line 4-4 of FIG. 2.

FIG. 5 is a fragmentary cross-sectional view of the medical probe device of FIG. 1 taken along the line 5-5 of FIG. 1.

FIG. 6 is a cross-section view of the medical probe device of FIG. 1 taken along the line 6-6 of FIG. 5.

FIG. 7 is a cross-sectional view, partially cut away, of the medical probe device of FIG. 1 taken along the line 7-7 of FIG. 1.

FIG. 8 a fragmentary view, somewhat schematic, of a portion of the medical probe device of FIG. 1 with the distal extremity of the device rotated 90°.

FIG. 9 is a cross-section view of the medical probe device of FIG. 1 taken along the line 9-9 of FIG. 1.

FIG. 10 is a perspective view of another embodiment of the medical probe device of the present invention.

FIG. 11 is a perspective view of a rod lens optical device for use with the medical probe device of FIG. 10. FIG. 12 is a perspective view of a fixed focus fiber optic lens optical device for use with the medical probe device of FIG. 10.

FIG. 13 is a cross-section view of the fiber optic lens optical device of FIG. 12 taken along the line 13-13 of FIG. 12. The medical probe device of the present invention can be in the form of the transurethral needle ablation device 21 illustrated in FIGS. 1-9 and including an elongate tubular member or torque tube 22 having proximal and distal extremities 22a and 22b. Rigid sheath or tube 22 can be of any suitable type and size, as for example a 22 French catheter-like guide housing having a length of approximately 25 centimeters and can be formed of a suitable material such as stainless steel. Torque tube 22 extends along a longitudinal central axis 23 and has an outer cylindrical sidewall 26 which extends arcuately about longitudinal axis 23 and includes means in the form of inner surface 27 for forming an internal passageway or lumen 28 extending from proximal extremity 22a to distal extremity 22b. Tube 22 can have an outer diameter of approximately 0.272 inch and an inner diameter of approximately 0.250 inch.

Handle means in the form of handle 29 is mounted on proximal extremity 22a of elongate member 22. Handle 29 is formed from a two piece housing 31 made from any suitable material such as plastic and shaped so as to be easily grasped by a human hand. Housing 31 includes a first or top portion 31a and a second or bottom portion 31b. Torque tube 22 is secured to handle 29 so as to be at least partially rotatable or twistable about longitudinal axis 23. In this regard, a twist control knob 32 made from any suitable material such as plastic is rigidly secured to proximal extremity 22a of the torque tube adjacent handle 29.

At least one flexible radio frequency electrode is carried within torque tube 22 and, as shown in FIGS. 1-3, two flexible radio frequency needle ablation electrodes 33 are carried within the torque tube. Each elongate electrode 33 has a proximal extremity 33a and a distal extremity 33b and is formed of a suitable material such as a nickel titanium alloy having superelastic properties so that the needle electrode will return to its original configuration after being bent as hereinafter described. Needle electrodes 33 each have a sharpened tip 34 which is adapted to readily penetrate tissue and are made from a tubular member so as to have an internal bore or lumen 36 extending longitudinally therethrough. As so formed, electrodes 33 have an outer or external diameter of approximately 0.018 inch and an inner or internal diameter of approximately 0.010 inch. It should be appreciated, however, that solid needle electrodes 33 can be provided without internal lumens and be within the scope of the present invention. Proximal extremities 33a of the needle electrodes 33 are connected by first and second leads 37 distally carried by a wire 38 to a connector 39 formed at the proximal end of handle 29. A flexible tube member or sleeve 41 is coaxially carried about each of needle electrodes 33. Insulating sleeves 41 each have proximal and distal extremities 41a and 41b and are made from any suitable nonconductive material such as nylon. The insulating sleeves 41 are each formed with first and second passageways or lumens 42 and 43 which extend longitudinally the length thereof and the respective needle electrodes 33 are slidably disposed in the first lumens 42 of the insulating sleeves (see FIGS. 3-4) . First and second elongate tubular member or tension tubes 44 serve to couple insulating sleeves and internally carried needle electrodes 33 to handle 29 of device 21. In this regard, the distal ends of tension tubes 44 extend into first lumens 42. Insulating sleeves 41 are stretched and annealed so as to shrink proximal extremities 41b thereof about said distal ends of tension tubes 44 and thus secure the insulating sleeves to the tension tubes (see FIG. 3) . The elongated insulating sleeves, as illustrated in cross section in FIG. 4, are oval shaped in cross section and have outer transverse dimensions of approximately 0.041 x 0.034 inch. First lumens 42 each have inner diameter of approximately 0.021 inch, which is slightly larger than the external diameter of needle electrodes 33, and second lumens 43 are each generally oval shaped in cross section with inner transverse dimensions of approximately 0.014 x 0.009 inch. Each needle electrode 33 and its related insulating sleeve 41 form a stylet 46 which, together with the related tension tube 44 secured to the proximal extremity 41b of the insulating sleeve 41, is carried within an elongate tubular member or stylet tube 47 extending longitudinally within passageway 28 of torque tube 22. In this manner, each of the two stylet tubes 47 serves as means carried by torque tube 22 for forming a passageway or first lumen 48 extending from proximal extremity 22a to distal extremity 22b of the torque tube in a direction parallel to longitudinal axis 23. Operative means 56 is mounted on proximal extremity 22a of torque tube 22 and connected to handle 29 and to proximal extremities 33a of needle electrodes 33 and proximal extremities ₄₁a of insulating sleeves 41 for causing advancement of the needle electrodes and coaxially mounted insulating sleeves through respective first or stylet lumens 48. As more fully explained in copending U.S. patent application Serial No. 08/313,715 filed September 27, 1994 and copending U.S. patent application Serial No. 08/191,258 filed February 2, 1994, operative means 56 includes first and second electrode tabs or slides 57 slidably mounted to top portion 31a of handle housing 31 and respectively coupled and connected to first and second needle electrodes 33 and first and second sleeve tabs or slides 58 slidably mounted along opposite sides of handle top portion

31a in juxtaposition with respective electrode slides 57 and respectively coupled and connected via tension tubes 44 to first and second insulating sleeves 41.

Distal extremity 22b of torque tube 22 is in communication with each of stylet lumens 48 so as to permit distal extremities 33b of needle electrodes 33 to be advanced out of the stylet lumens sideways at an angle with respect to longitudinal axis 23. More specifically, guide means which includes a guide housing or stylet guide 61 made from any suitable material such as plastic is mounted by an adhesive (not shown) or any other suitable means to distal extremity 22b of torque tube 22. Stylet guide 61 has a rounded tip 62 at its distal extremity and includes a separate curved or arcuately extending guide passageway 63 in communication with each of stylet lumens 48 for causing the respective stylets 46 to extend sideways at said angle as they are advanced distally from the stylet lumens 48 by electrode and sleeve slides 57 and 58 (see FIGS. 1-2) . A transversely extending recess 64 is formed in stylet guide 61 proximal of rounded tip 62 and approximately midway between the proximal and distal ends of the stylet guide as more particularly described in U.S. copending application Serial No. 08/062,364 filed May 13, 1993 so as to provide the stylet guide with a shape resembling a boxing glove. Guide passages 63 extend internally of the stylet guide 61 beyond recess 64 so that stylets 46 therein each exit the stylet guide through openings disposed between rounded tip 62 and recess 64. A first temperature sensor means in the form of first thermocouple 67 is carried by distal extremity 41b of each of insulating sleeves 41 (see FIG. 2) . Thermocouples 67 are disposed within second lumens 43 of the insulating sleeves 41 a distance of approximately one millimeter from the distal end of the insulating sleeves. First and second leads 68 are carried within each of second lumens 43 of the insulating sleeves and extend from the thermocouples 67 to proximal extremities 41a where the leads then continue down the interior of torque tube 22 and extend through wire 38 to connector 39 carried by handle housing 31.

Means is coupled to proximal extremity 33a of each needle electrode 33 and in communicationwith electrode lumen 36 therein for permitting a liquid to be supplied to the electrode lumens as illustrated in FIG. 7. A Y-like tubular fitting 76 made from nylon or any other suitable material has first and second portions coupled to the proximal extremities of the needle electrodes and a stem portion coupled to a flexible tube 77 made from nylon or any other suitable material. Tube 77 extends through housing 31 of handle 29 and has a Luer fitting 78 mounted on the free end thereof.

Temperature sensor means in the form of second thermocouple 81 is carried by stylet guide 61 for measuring the temperature in the urethra adjacent the stylet guide (see FIG. 2) . First and second leads 82 and 83 are connected at one end to thermocouple 81 and extend through a tubular member or tube 84 made from plastic or any other suitable material and carried within torque tube 22 along the length thereof (see FIG. 3) . Leads 82 and 83 extend through wire 38 to connector 39. Device 21 is adapted to accommodate any suitable optical viewing device or scope as shown in FIG. 1 where an endoscope 86 with a distal viewing extremity having an approximately 70° field of view is mounted to handle 29. Endoscope 86, more particularly illustrated in FIG. 8, includes a central member in the form of a coupler or tricoupler 87 made from plastic or any other suitable material and formed with a hub 88 extending distally along the central longitudinal axis of tricoupler 87 and provided with a central bore 91. The endoscope includes a tubular member in the form of bayonet shaft 92 having a proximal extremity 92a received within central or hub bore 91 and a distal extremity 92b. Bayonet shaft 92 is secured within hub bore 91 by a dowel 93 pressed into a groove 96 provided in proximal extremity 92a. The bayonet shaft is further provided with an annular groove 97 for receiving an O-ring 98 so as to provide a fluid-tight seal between the bayonet shaft and tricoupler 87. A central passageway 102 extends through proximal and distal extremities 92a and 92b of bayonet shaft 92 and is sized so as to have an internal diameter of approximately 0.104 inch.

An elongate optical element 103 having proximal and distal extremities 103a and 103b is carried by tricoupler 87. Optical element 103 is circular in cross section with an external diameter of approximately 0.050 inch and, as illustrated in FIG. 3, is formed with a centrally disposed bundle of optical fibers shown collectively as fiber optic lens 106. A plurality or bundle of densely packed light fiber elements collectively identified in FIG. 3 as lighting fibers 107 concentrically surround fiber optic lens 106 and the lighting fibers are encased by a rigid sheath 108 formed from any suitable material such as stainless steel.

Proximal extremity 103a of optical element 103 extends through central passageway 102 of bayonet shaft 92 into a cylindrical central chamber 112 provided in tricoupler 87. Optical element 103 is centrally positioned within tricoupler 87 by a flange 113 which extends inwardly into central chamber 112 so as to grip the outside of the optical element. Proximal extremity 103a extends beyond flange 113 through a centrally aligned recess

116 into rear chamber 117 extending proxi ally or rearwardly from the tricoupler through an axially extending fitting 121 protruding rearwardly opposite hub 88. An additional O-ring 122 is disposed about optical element 103 in recess 116 and an annular plug 123 is press fit or otherwise secured within the recess 116 so as to assist in securing the optical element to tricoupler 87 and permit O-ring 122 to form a fluid-tight seal between the central chamber 112 and recess 116 of the tricoupler. A focusing assembly (not shown) is disposed within rear chamber

117 and retained therein by lens housing 129 secured by any suitable means about fitting 121. Lens housing 129 has an eye piece 131.

Tricoupler 87 of endoscope 86 includes means for permitting a light source to be coupled to lighting fibers 107 of optical element 103 and is formed with a first side boss 132 extending rearwardly or proximally at an acute angle relative to longitudinal axis 23. First boss 132 has a bore 133 extending therethrough into rear chamber 117 of the tricoupler and a tubular adapter 134 having an axially-extending central passageway or bore 135 is pressed into bore 133 of the first boss. Adapter 134 is made from any suitable material such as stainless steel and is secured in bore 133 by a dowel 136 extending into a recess 137 formed on the side of the adapter. Adapter 134 is further provided with an annular groove 138 for receiving an O-ring 139 so as to provide a fluid-tight seal between the adapter and first boss 132. Although not shown in the drawings, lighting fibers 107 of optical element 103 extend into bore 133 of first boss 132 so as to be exposed to a light source (not shown) coupled to light source adapter 134. Cooperative mating means 141 is carried by handle 29 and tricoupler 87 of endoscope 86 for mounting distal extremity 103b of optical element 103 within distal extremity 22b of torque tube 22. Housing top portion 31a is formed with an optical door 142 which houses therein a tubular fitting member in the form of receiver 143 aligned parallel with central longitudinal axis 23 of device 21. Receiver 143 is provided with a longitudinally extending proximal bore 144 which is sized and shaped to slidably receive distal extremity 92b of bayonet shaft 92 included within cooperative mating means 141. An O-ring 146 is embedded within the portion of receiver 143 surrounding proximal bore 144 for providing a fluid-tight seal between receiver 143 and bayonet shaft 92. A pair of diametrically opposed L-shaped slots 147 are also provided in the portion of receiver 143 forming proximal bore 144 for reasons hereinafter described. Means is carried by torque tube 22 for forming a passageway or lumen for receiving optical element 103 of endoscope 86 and includes an elongate tubular member or optical tube 148 having proximal and distal extremities 148a and 148b and made from any suitable material such as nylon tubing. Proximal extremity 148a of the optical tube is secured to receiver 143 and, in this regard, the receiver is provided with an axially extending distal bore 151 in communication with proximal bore 144. Proximal extremity 148a of the optical tube is press fit or otherwise suitably secured within distal bore 151. Stylet guide 61 is provided with a longitudinally extending bore or passageway 152 having proximal and distal portions 152a and 152b bifurcated by transverse recess 64. Proximal portion 152a of bore 152 extends into the transverse recess at opening 153 and distal portion 152b of bore 152 extends from rounded tip 62 at opening 154. Distal extremity 148b of optical tube 148 is press fit or otherwise suitably secured within the proximal portion 152a of stylet guide bore 152. Optical tube 148 is provided with an axially extending lumen or passageway 156 in communication with bores 144 and 157 of receiver 143 and having a diameter of approximately 0.15 inch before necking down at its distal extremity to a diameter of approximately 0.11 inch. When bayonet shaft 92 of endoscope 86 is slidably received by cooperative mating means 141, optical element 103 of the endoscope extends through passageway 156 along the length thereof.

Fluid supply means is coupled to torque tube 22 and more specifically carried by tricoupler 87 for permitting a flushing fluid or liquid such as a saline solution to be supplied to optical tube 148 for providing a clear field of view for endoscope 86. Tricoupler 87 is formed with a second boss 162 formed on the opposite side of the tricoupler from first boss 132 and extending rearwardly or proximally at an acute angle relative to longitudinal axis 23. Second boss 162 has a bore 163 extending therethrough so as to be in communication with central chamber 112 of the tricoupler and thus central passageway 102 of bayonet shaft 92, passageway 156 of optical tube 148 and bore 152 of stylet guide 61. A Luer or other suitable fitting 166 having a central passageway or bore 167 extending along the length thereof is pressed into bore 163 of the second boss and is secured to the second boss by a dowel 171 extending through a recess 172 provided along one side of Luer fitting 166. An O-ring 172 is seated within an annular recess 173 formed on Luer fitting 166 so as to provide a fluid-tight seal between the Luer fitting 166 and second boss 162. An elongate tubular member or element in the form of sheath or tube 176 made from stainless steel or any other suitable material and having proximal and distal extremities 176a and 176b is concentrically carried about optical element 103 by tricoupler 87. Tube 176 has an internal passageway or lumen 177 extending along the length thereof and has respective inner and outer diameters of approximately 0.14 inch and 0.13 inch. Tube proximal extremity 176a is secured within central passageway 102 of bayonet shaft 92 by any suitable means such as an adhesive 178. Distal extremity 176b of the tube 176 extends to a distance of approximately 0.13 inch from the end of optical element distal extremity 103b. A pressurized flushing liquid source (not shown) can be connected to Luer fitting 166 so as to supply the flushing liquid to endoscope 86 and device 21. Central chamber 112 of tricoupler 87, central passageway 102 of bayonet shaft 92 and lumen 177 of tube 176 have a radial dimension or diameter greater than the outer diameter of optical element 103 so as to provide an annular space about optical element 103 and thus an annular supply lumen for the liquid supplied through Lure fitting 166 and bore 163 of second boss 162 and optical tube 148.

Torque tube 22 carries means for providing at least one additional opening which is disposed proximal of outlet opening 153 and is in communication with return lumen 28. More specifically, sidewall 26 of the torque tube is provided with a plurality of radially-extending additional openings 182 which are included in said at least one opening. Openings 182 are grouped in a plurality of longitudinally extending columns and transversely extending rows. The distal most row of openings 182 is spaced from the distal end of torque tube 22 a distance of approximately 0.375 inch and each row of openings 182 is longitudinally spaced apart a distance of approximately 0.1 inch. The openings 182 in each row are spaced apart around outer cylindrical sidewall 26 of the torque tube. As illustrated in FIG. 3, it can be seen that each row of openings 182 consists of two sets of openings 182 which are diametrically opposed and each comprised of three openings 182 radially spaced apart by an angle of approximately 30°. In this manner, opening 182 extends circumferentially about longitudinal axis 23 in a plane disposed generally at a right angle to longitudinal axis 23. As shown in FIG. 1, each of the parallel longitudinally extending columns of openings 182 consists of twelve openings, although columns of sixteen openings 182 have also been found to be desirable. Although the array of openings 182 formed in torque tube 22 has been described with some particularity, it should be appreciated that openings disposed in other patterns or arrays located proximal of fluid supply opening 153 can be provided and be within the scope of the present invention. For simplicity, inlet openings 182 are not shown in FIG. 8.

Internal passageway or lumen 28 of torque tube 22 is fluid-tight so as to permit return liquid entering openings 182 to be carried by the torque tube to handle 29. In this regard, stylet guide 61 serves as a seal for distal extremity 22b of the torque tube and the distal extremities of first and second stylet tubes 47, thermocouple tube 84 and optical tube 148 carried within the torque tube. Seal means is carried by handle 29 for forming a fluid-tight seal for proximal extremity 22a of torque tube 22 and the proximal extremities of first and second stylet tubes 47, thermocouple tube 77 and optical tube 148. As more specifically shown in FIG. 5, proximal extremity 22a of the torque tube extends through a twist block 186 and an annular seal 187 disposed within handle housing 31 before terminating in a support block 188 also disposed within the handle housing. Twist block 186 and support block 188 are each made from any suitable material such as polycarbonate, while seal 187 is made from silicone rubber or any other suitable flexible material. The twist block and support block are secured to housing 31 by any suitable means such as pins (not shown) cooperatively received within sockets (not shown) provided in the housing.

Support block 188 is provided with a central chamber 191 cooperatively sized and shaped to snugly receive proximal extremity 22a of torque tube 22. Seal 187, partially seated between the torque tube and the support block in an annular recess 192 formed in the support block, serves as a fluid-tight seal between the torque tube and the support block. Support block 188 is provided with an enlarged opening 193 which extends through the proximal side thereof and opens into central chamber 191 of the support block. First and second stylet tubes 47, thermocouple tube 84 and optical tube 148 extend through central chamber 191 and enlarged opening 193 into the central portion of handle housing 31 as discussed above and illustrated in the drawings. Second seal means is provided for forming a fluid- tight seal between first and second stylet tubes 47, thermocouple tube 84 and optical tube 148 and includes a disk-like planar seal 196 which is made from silicone or any other suitable material and is suitably sized so as to extend transversely across the enlarged opening 193. Seal 196 is provided with respective openings therethrough for permitting the fluid-tight passage of stylet tubes 47, thermocouple tube 84 and optical tube 148 and is secured to support block 188 by a retainer 197 made frompolycarbonate or any other suitablematerial. Retainer 197 has a generally rectangular cross-sectional profile and is cooperatively received within enlarged opening 193 in juxtaposition with seal 196. The retainer 197 is pressed snug against a shoulder 201 formed within enlarged opening 193 and is likewise formed with respective openings for stylet tubes 47, thermocouple tube 84 and optical tube 148. The cooperative nonrotatable seating of retainer 197 within support block 188 also serves to generally retain stylet tubes 47, thermocouple tube 84 and optical tube 148 in the spacial arrangement shown in FIG. 3 when torque tube 22 is twisted by knob 32 in opposite first and second angular directions about longitudinal axis 23. An opening 202 extends through the bottom center of support block 188 for permitting access to central chamber 191 therein. Means is carried by a proximal extremity 22a of torque tube 22 for permitting aspiration of the liquid being introduced by device 21 through outlet opening 153 in stylet guide 61. This means, which is in communication with inlet openings 182 formed in distal extremity 22b of the torque tube, includes an elbow tubular fitting 206 which is made from silicone or any other suitable material and is press fit into opening 202 of support block 188 and secured therein by any suitable means such as an adhesive (not shown). As illustrated in FIG. 6, an elongate flexible tubular member or tube 207 made from nylon or any other suitable material is secured to the free end of elbow 206. Aspiration tube 207 extends from elbow fitting 206 to a proxi ally extending Luer fitting 208 formed in bottom portion 31b of handle housing 31.

Cooperative mating means 141 includes means for moving distal extremity 176b of tube 176 and distal extremity 103b of optical element 103 relative to distal extremity 22b of torque tube 22 from a first or distal position in which distal extremities 176b and 103b extend through transverse recess 64 of stylet guide 61 into distal portion 152b of bore 152, shown in phantom lines in FIG. 2, and a second or proximal position in which distal extremities 176b and 103b are retracted from bore distal portion 152b and transverse recess 64 so that the field of view of optical element 103 commences at outlet opening 153 in stylet guide 61, shown in solid lines in FIG. 2. In this regard and as illustrated in FIGS. 1 and 9, housing top portion 31a is provided with an upstanding member or registration pin 211 extending upwardly at a right angle to longitudinal axis 23 for cooperatively interacting with latch means in the form of a latch member 212 carried by bayonet shaft 92 of endoscope 86.

Latch 212 is made from any suitable material such as plastic and is formed with a proximal or hood portion 212a which is generally semicircular in cross section and extends over the top of a portion of bayonet shaft distal portion 92b. Hood portion 212a is secured to bayonet shaft 92 by a pair of diametrically opposed pins 213 provided on the bayonet shaft distal extremity 92b. Pins 213 extend along a transverse pivot axis extending generally at a right angle to longitudinal axis 23. A longitudinally extending distal or bill portion 212b protrudes forwardly from hood portion 212a and is provided with a longitudinally extending slot 216 which is transversely sized to slidably receive pin 211. Hood portion 212 is formed with a bore 217 extending at a right angle to longitudinal axis 23 and the transverse pivot axis of pins 213 for receiving a spring 2₁8 within latch 212. As viewed in FIG. 9, spring 218 urges latch 21₂ to pivot in a clockwise direction about transverse pivot pins 213. Endoscope moves longitudinally approximately 0.5 inch between its first and second positions.

Torque tube 22 of transurethral needle ablation device 21 is provided with a plurality of markings 219 extending arcuately around sidewall 26 in respective planes which are each aligned generally at right angles to longitudinal axis 23. Markings 219 are spaced apart longitudinally along the length of torque tube 22 at approximately equal intervals of one centimeter and each have a width of approximately two millimeters. Operation and use of the transurethral needle ablation device 21 in conjunction with performing a procedure on a human male patient is described in detail in copending U.S. patent application Serial No. 08/191,258 filed February 2, 1994. The procedure can briefly be described as follows. The anatomy of interest in the male patient to undergo the procedure consists of a bladder which is provided with a base or bladder neck which empties into a urethra extending along a longitudinal axis. The urethra can be characterized as being comprised of two portions: a prostatic portion and a penal portion. The prostatic portion is surrounded by a prostate or prostate gland which is a glandular and fibromuscular organ lying immediately below the bladder. The penal portion of the urethra extends through the length of a penis. The urethra is provided with a urethral wall which extends through the length of the penis and through the prostate into the bladder. The prostate can be characterized as being comprised of five lobes: interior, posterior, medium, right lateral and left lateral. The prostate is also provided with a verumontanum.

Once the patient has been prepared, a conventional indifferent or grounding electrode (not shown) is placed on the patient's back side so that it is adherent thereto and makes good electrical contact with the skin of the patient. The electrode is connected by an electrical cable (not shown) into a control console and radio frequency generator (not shown) . A conventional foot operated switch (not shown) can be connected by a cable into the control console for controlling the application of radio frequency power. Handle 29 of device 21 is connected by cables (not shown) into the control console. Endoscope 86, which is of a reusable type, is secured to handle 29 of device 21 by inserting tube 176, optical element 103 and distal extremity 92b of bayonet shaft 92 into receiver 143 of the handle. Once bayonet shaft 92 has been disposed within proximal bore 144 of the receiver to a point where latch bill portion 212b engages pin 211, the operating physician presses his or her thumb down on hood portion 212a of the latch to pivot the hood portion about transverse pivot pins 213 against the force of spring 218 and thus cause bill portion 212b of the latch to raise up over pin 211 so as to allow bayonet shaft 92 to be further inserted into proximal bore 144. Once pin 211 has been aligned with slot 216 and bill portion 212, the operating physician releases hood portion 212a so that spring 218 causes slot 216 and bill portion 212b to receive registration pin 211. Endoscope 86 is then pushed forwardly so that registration pin 211 is moved to its rearwardly or proximal most position within slot 216 and distal extremity 176b of tube 176 and distal extremity 103b of optical element 103 are in their first or distal most position relative to torque tube 22 and stylet guide 61.

A suitable light force (not shown) is connected to adapter 134 of tricoupler 87 so as to facilitate viewing with endoscope 86 during the procedure. The outlet tube from a suitable pressurized saline solution or other flushing fluid supply source is connected to Luer fitting 116 so as to provide a flow of the flushing fluid through device 21 during the procedure. The inlet tube to an aspirator or other suitable fluid suction device is connected to Luer fitting 208 for withdrawing the flushing fluid from the urethra through inlet openings 182 provided in torque tube 22 during the procedure. If a medicament or other liquid is to be supplied or introduced into the tissue of the prostate being treated during the procedure, the outlet tube from a syringe or other suitable supply source for such medicament is connected to Luer fitting 78 on nylon tube 77 carried by handle 29. Once electrode and sleeve slides 57 and 58 have been moved rearwardly on handle 29 to their proximal most positions so that stylets 46 are retracted fully within stylet guide 61, transurethral needle ablation device 21 is ready for use. Distal extremity 22b of the torque tube 22 of the transurethral needle ablation device is introduced into the urethra so that the distal extremity 22b is in the vicinity of the prostate. This advancement of torque tube 22 is facilitated by the blunt rounded tip of stylet guide 61 and by the field of view of endoscope 86. When optical element 103 of endoscope 86 is in its distal position relative to torque tube 22 and stylet guide 61, the optical element has a field of view which extends forwardly of the torque tube. During such advancement, a steady flow of flushing fluid is introduced through endoscope 86 and out opening 154 into the urethra to provide a clear field of view for the endoscope. Tube 176 permits the flushing fluid to traverse transverse recess 64 of stylet guide 61. The operating physician utilizes endoscope 86 to view the interior of the urethra while device 21 is being advanced to ascertain an appropriate position in the urethra so that distal extremity 22b is in registration with the prostate. External markings 219 provided on torque tube 22 serve as registration means with the penis of the patient to further assist in the internal placement of torque tube distal extremity 22b.

The plurality of openings 182 provided in torque tube distal extremity 22b permit aspiration of the flushing fluid to inhibit filling of the bladder during the procedure by the flushing liquid or otherwise. The disposition of openings 182 proximal of the distal end of torque tube 22 is advantageous in that it permits a significant plurality of openings for fluid aspiration. As can be appreciated by those skilled in the art, the urethra wall is not perfectly circular in cross section. As a result, the inwardly extending portions or folds of the urethra wall can serve to obstruct openings or ports both at the tip and along the sides of a probe device. The significant number of openings 182 in device 21 and the spaced apart disposition of these openings both longitudinally and radially about torque tube 22 increases the likelihood that a sufficient number of these openings will be unobstructed so as to permit aspiration of the flushing fluid. A flow of return fluid during aspiration can also serve to cool the urethra wall during the procedure. The portion of the wall in the vicinity of unobstructed openings 182 is cooled by the return fluid passing there across or flowing into these unobstructed openings. The balance of the urethral wall, both those portions covering other openings 182 and other portions in contact with distal extremity 22b, are cooled by the flow of return fluid through torque tube 22. Once distal extremity 22b has been positioned in the urethra in the vicinity of the tissue of the prostate disposed adjacent the urethra wall, registration pin 211 and latch 212 permit endoscope 86 to be moved to its second or proximal most position so that the distal end of optical element 103 is adjacent opening 153 of stylet guide proximal bore portion 152a and distal extremity 176b of tube 176 is slightly proximal opening 153. Pin 211 is in the distal end of slot 216 as shown in FIG. 9 when endoscope 86 is in its second position.

Device 21 can now be utilized to perform a needle ablation procedure of the prostate in the manner set forth in more detail in U.S. patent application Serial No. 08/191,258 filed February 2, 1994. Briefly, electrode slides 57 and sleeve slides 58 of operative means 56 can be used to cause sharpened tips 34 on distal extremities 33b of needle electrodes 33 to penetrate the urethral wall so that the distal extremities 33b and distal extremities 41b of insulating sleeves 41 extend through the urethral wall and into the target tissue of the prostate to be treated. More specifically, movement of a related pair of electrode and sleeve slides 57 and 58 longitudinally relative to handle 29 in a distal or proximal direction cause the related stylet 46 to move distally or proximally within the related stylet lumen 48. The electrode and sleeve slides are cooperatively coupled within housing 31 so that distal movement of the sleeve slide causes the related electrode slide to be carried distally therewith. Similarly, proximal movement of the electrode slide causes the sleeve slide to likewise move proximally relative to handle 29. Operative means 56 permits relative longitudinal movement between the needle electrode 33 and the insulating sleeve 41 of each stylet 52 and, in this regard, electrode slide 57 can advance independent of the related sleeve slide 58 to cause the needle electrode to advance relative to the insulating sleeve. Similarly, the sleeve slide 58 can be retracted or moved proximally on handle 29 independent of electrode slide 57 to cause the insulating sleeve 41 to retract relative to the needle electrode 33. In this manner, the electrode and sleeve slides permit relative longitudinal movement between needle electrodes 33 and insulating sleeves 41 for controlling the location and amount of tissue to be ablated. Transverse recess 64 permits the operating physician to utilize the repositioned endoscope 86 for viewing stylets 46 being advanced distally of the transverse recess sideways at an angle with respect to longitudinal axis 23 of device 21 so as to confirm proper deployment of the stylets. The flushing fluid being introduced through endoscope 86 flows through opening 153 in transverse recess 64 to provide a clear field of view for the proximally positioned endoscope.

With stylets 46 properly placed within the tissue of the prostate and insulating sleeves 41 retracted relative to needle electrodes 33 so as to expose the desired length of the needle electrodes to the tissue of the prostate, radio frequency energy is supplied to needle electrodes 41 for a predetermined period of time to create lesions in the prostatic tissue in the vicinity of the exposed portions of the needle electrodes. These lesions serve to shrink the size of the prostate.

During the needle ablation procedure, first thermocouples 67 carried by first and second insulating sleeves 41 permit measuring of the temperature of the tissue being ablated. Second thermocouple 81 provided in stylet guide 61 allows monitoring of the temperature within the urethra during the procedure to, among other things, ensure that the urethral wall is not damaged by the procedure. The urethral wall can be viewed via endoscope 86 both during and after the procedure when the endoscope is in its second or distal position. Upon cessation of tissue ablation, a medicament such as an anesthetic can be introduced through Luer fitting 78 and electrode lumen 36 into the treatment area if deemed necessary. Once the needle ablation has been completed, electrode and sleeves slides 57 and 58 are moved rearwardly on handle 29 so that stylets 46 retract from the prostate and back into stylet guide 61. Device 21 is then withdrawn from the urethra. Endoscope 86 can be removed from handle 29 and reused in a subsequent ablation procedure as it is expected that the endoscope will have a recommended usage life which permits its utilization in more than one procedure. Although the handle 29 and torque tube 22 portion of transurethral needle ablation device 21 may have a recommended useful life which permits their use in more than one procedure, the current expectation is that the handle and torque tube will be disposed after a single use and, hence, have a recommended usage life less than the recommended usage life of endoscope 86. The introduction of the flushing fluid through endoscope 86 and the resulting inclusion in the endoscope of fluid supply means 161 reduces the relative complexity and hence relative cost of the portion of device 21 having the lesser recommended usage life, that is, handle 29 and torque tube 22. In an alternate embodiment of device 21 not shown in the drawings, an endoscope can be provided without fluid tube 86 and be within the scope of the present invention. In the operation of such a device, the flushing fluid travels down torque tube 22 in the annular space of passageway 156 defined by optical tube 148 and optical element 103 to exit outlet opening 153 into transverse recess 87. When the endoscope is in its distal position, the flushing fluid travels around and beyond rounded tip 62 of the stylet guide 61 to provide a clear field of view for optical element 103 viewing distally of tip 62. When the endoscope is in its proximal position, the flushing fluid also exits opening 153 adjacent the distal end of optical element 103 to provide a clear field of view therefor.

Although the operation and use of device 21 of the present invention has been described in connection with a transurethral needle ablation procedure, it should be appreciated that device 21 can be used for performing procedures or otherwise in other canals within the human body defined by canal walls. In this regard, distal extremity 22b of device 21 would be introduced through a natural body opening into such canal and advanced therein for diagnostic, treatment or other purposes.

The medical probe device of the present invention can have other embodiments. For example, a transurethral needle ablation device 226 is illustrated in FIGS. 10-13 which is substantially similar to device 21, like parts being identified by like reference numbers. Handle 29 and torque tube 22 of device 226 can be used with a variety of endoscopes such as endoscope 231 shown mounted to handle 29 in FIG. 10 and separately in FIG. 11. Endoscope 231 is substantially similar to endoscope 86 and has parts similar to those in endoscope 86 identified by corresponding reference numbers and includes an optical element 232 mounted to tricoupler 87 and having proximal and distal extremities 232a and 232b. The endoscope 231 does not include a tube 176. As shown in FIG. 12, optical element 232 is similar to optical element 103, but instead of a fiber optic lens element is provided with an axially extending central rod lens 233 connected to bayonet shaft 92 and concentrically surrounded by a plurality or bundle of light fibers similar to lighting fibers 107 and shown collectively as lighting fibers 234. Lens 233 and fibers 234 are enclosed by a protective rigid sheath 236 substantially similar to sheath 108 of optical element 103. Optical element 232 extends distally of tricoupler 87 a distance of approximately seventeen inches and distal extremity 232b has an end portion 237 of reduced diameter with a length of approximately two inches. For example, the outer diameter of proximal extremity 232a is approximately 0.110 inch, while the outer diameter of reduced portion 237 is approximately 0.094 inch. The reduced diameter portion 237 of optical element 232 provides a greater annular space within passageway 156 of optical tube 148 for the passage of flushing fluid and is permitted by a reduction in diameter of the portion of fiber optic lens 106 within reduced diameter portion 237.

Device 226 has cooperative mating means 238 which includes bayonet shaft 92 of endoscope 231 and receiver 143 of handle 29 for allowing mounting of the endoscope 231 to the handle 29 of device 226. Cooperative mating means 238 is provided which does not include means for adjusting the relative longitudinal positions of endoscope 231 and handle 29 as endoscope 231 is mountable to handle 29 in a single fixed position. Device 226 includes a stylet guide 241 which is mounted to distal extremity 22b of torque tube 22 and is similar to stylet guide 61 of device 21. Stylet guide 241 has a bullet configuration, however, as it does not include a transverse recess similar to transverse recess 64 of stylet guide 61. The stylet guide 241 is provided with internal guide passageways 63 (not shown) for directing the advancement of stylets 46 in a direction sideways of longitudinal axis 23 of device 226.

Coupling means 242 carried by handle 29 is included within cooperative mating means 238 of device 226 and includes O-ring 146 mounted within proximal bore 144 of receiver 143 for mounting a first scope such as endoscope 231 provided with a rod lens optical element 232 to torque tube 22. An exteriorly mounted O-ring 243 is provided on bayonet shaft 92 of endoscope 231 for cooperatively mating with by snapping past internal O-ring 146. Coupling means 242 alternatively permits mounting a second scope such as endoscope 246 shown in FIG. 13 to torque tube 22. Endoscope 246 is a fixed focus fiber optical scope which has a distally viewing field of view of approximately 70° and components substantially similar to those of endoscope 86 and thus identified by like reference numbers. Optical element 247 of endoscope 246 is carried by tricoupler 87 and has proximal and distal extremities 247a and 247b. Like endoscope 231, endoscope 246 is not provided with a fluid carrying tube such as tube 176. Bayonet shaft 92 of endoscope 246 is provided with a pair of conventional diametrically opposite first and second locking pins 256 and has a knob 257 made from plastic or any other suitable material secured thereabout adjacent tricoupler 87 thereof for twisting the bayonet shaft 92 relative to the tricoupler. Conventional slots 147 within receiver 143 cooperatively receive respective pins 256. Bayonet shaft 92 is secured to receiver 93 when knob 257 is twisted relative to tricoupler 87 to lock pins 256 within slots 147.

The operation and use of device 226 is substantially identical to that of device 21. The ability of device 226 to accommodate a variety of scopes, both of the rod lens and fiber optic type, permits usage of a rod lens endoscope 231 when practical. As can be appreciated by those skilled in the art, a rod lens scope provides greater clarity than a fiber optic scope, but can be significantly more costly than a fiber optic scope. On the other hand, many physicians prefer fiber optic scopes such as endoscope 246 because of their reduced cost and because the clarity of a rod lens scope is not needed or required in the procedure. Device 226 permits usage of both types of scopes and is advantageous in this regard. Bullet shaped stylet guide 241 does not permit viewing of stylets 46 being advanced therefrom as it does not include a transverse recess such as recess 64. As such, endoscopes 231 and 246 do not require tube 176 which, as discussed above, facilitates travel of the flushing fluid beyond such a recess in a stylet guide of the type of guide 61.

In view of the foregoing, it can be seen that a medical probe device with scope and method have been provided which can be utilized for a transurethral needle ablation procedure in the prostate of a human male. The device and method permit the transurethral needle ablation procedure to be performed with a single device and with a single introduction of the device into the urethra. A saline or other flushing fluid is introduced for providing a clear field of view for the scope and the saline or other flushing fluid is aspirated to inhibit filling of the bladder during the needle ablation procedure. The flushing fluid is aspirated from at least one opening located proximal of the outlet opening through which the flushing fluid is introduced into the urethra. The at least one opening can consist of a plurality of openings located on the outer cylindrical surface of the device. The flushing fluid is introduced through a reusable scope so as to reduce the cost of the disposable portion of the device. The device and method permit the viewing of the interior of the urethra as the distal extremity of the device is advanced therein and permit viewing of the needle ablation stylets as they are advanced into the prostate. The device can alternatively accommodate a rod lens scope or a fiber optic scope.

Claims

What is claimed is:

1. A medical probe device for introduction through a natural body opening into a canal defined by a wall comprising an elongate member having proximal and distal extremities and first and second lumens extending from the proximal extremity to the distal extremity, an opening provided in the distal extremity of the elongate member in communication with the first lumen, handle means mounted on the proximal extremity of the elongate member for introducing the distal extremity of the elongate member through the natural body opening into the canal, a scope positioned in the elongate member having a field of view which extends forwardly of the elongate member, means coupled to the elongate member for permitting a liquid to be supplied to the first lumen and out the opening to provide a clear field of view for the scope, means carried by the elongate member for providing at least one additional opening proximal of the first named opening in the elongate member and in communication with the second lumen for permitting aspiration of the liquid while liquid is being introduced through the first named opening in the elongate member.

2. A device as in Claim 1 wherein the elongate member has an outer cylindrical sidewall in which the at least one additional opening is provided.

3. A device as in Claim 2 wherein the elongate member extends along a longitudinal axis and the outer cylindrical sidewall extends accurately about the longitudinal axis.

4. A device as in Claim 3 wherein the at least one additional opening includes a plurality of openings spaced apart around the outer cylindrical surface.

5. A device as in Claim 3 wherein the at least one opening includes a plurality of openings in the outer cylindrical surface spaced apart circumferentially about the longitudinal axis.

6. A medical probe device for medical treatment of tissue of a prostate through a urethra defined by a urethral wall comprising an elongate member having proximal and distal extremities, a flexible radio frequency electrode carriedwithin the elongate member and having a sharpened tip, an insulating sleeve coaxially mounted on the radio frequency electrode, handle means mounted on the proximal extremity of the elongate member for introducing the distal extremity of the elongate member into the urethra so that the distal extremity of the elongate member is in the vicinity of the prostate, means mounted on the proximal extremity of the elongate member for advancing the sharpened tip of the radio frequency electrode to cause the sharpened tip of the radio frequency electrode to penetrate the urethral wall and extend into the tissue of the prostate, a scope having an optical element with a field of view, means carried by the elongate member for mounting the scope to the proximal extremity of the elongate member so that the optical element is positioned in the elongate member and the field of view extends forwardly of the elongate member, means carried by the elongate member for providing first and second lumens extending from the proximal extremity to the distal extremity, an opening provided in the distal extremity of the elongate member in communication with the first lumen, means coupled to the elongate member for permitting a liquid to be supplied to the first lumen and out the opening to provide a clear field of view for the optical element and means carried by the elongate member for providing at least one additional opening proximal of the first named opening and in communicationwith the second lumen for permitting aspiration of the liquidwhile liquid is being introduced through the first named opening.

7. A device as in Claim 6 wherein the elongate member extends along a longitudinal axis and has an outer cylindrical surface extending accurately about the longitudinal axis and wherein the at least one additional opening includes a plurality of openings spaced apart around the outer cylindrical surface.

8. A device as in Claim 7 wherein the radio frequency electrode is provided with a lumen extending longitudinally therethrough, means coupled to the proximal extremity of the elongate member and in communication with the lumen in the radio frequency electrode for permitting a liquid to be supplied to the lumen in the radio frequency electrode and introduced into the tissue of the prostate.

9. A device as in Claim 6 wherein the means for mounting the scope to the proximal extremity of the elongate member includes a coupling for mounting a first scope having a rod lens optical element to the elongate member and for alternatively mounting a second scope having a fiber optic element to the elongate member.

10. A medical probe device for introduction through a natural body opening into a canal defined by a wall comprising an elongate member having proximal and distal extremities and a lumen extending from the proximal extremity to the distal extremity, an opening provided in the distal extremity of the elongate member in communication with the lumen, handle means mounted on the proximal extremity of the elongate member for introducing the distal extremity of the elongate member through the natural body opening into the canal, a scope having a coupler and having an optical element carried by the coupler with a field of view, cooperative mating means carried by the coupler and the handle means for mounting the optical element in the elongate member and fluid supply means carried by the coupler and in communication with the lumen for permitting a liquid to be introduced through the lumen and the opening to provide a clear field of view for the optical element whereby the handle means has a recommended usage life and the scope has a recommended usage life greater than the recommended usage life of the handle means and whereby the inclusion of the fluid supply means on the scope reduces the relative cost of the handle means having the lesser recommended usage life.

11. A device as in Claim 10 wherein the fluid supply means includes a luer fitting having a passageway in communication with the lumen.

12. A device as in Claim 10 wherein the optical element extends longitudinally through the lumen.

13. A device as in Claim 10 together with means carried by the elongate member for providing an additional lumen extending from the proximal extremity to the distal extremity of the elongate member, at least one additional opening provided in the elongate member proximal of the first named opening in the elongate member and in communication with the additional lumen and means carried by the proximal extremity of the elongate member and in communication with the additional opening for permitting aspiration of the liquid through the additional opening while liquid is being introduced through the first named opening in the elongate member.

14. A medical probe device for use in a human body comprising an elongate member having proximal and distal extremities and having a passageway therein extending from the proximal extremity to the distal extremity along a longitudinal axis, an elongate needle mounted in the passageway and having proximal and distal extremities, handle means mounted on the proximal extremity of the elongate member, means mounted on the proximal extremity of the elongate member and connected to the handle means and to the elongate needle for causing advancement of the elongate needle through the passageway, the distal extremity of the elongate member being in communication with the passageway and permitting the distal extremity of the elongate needle to be advanced out of the passageway sideways at an angle with respect to the longitudinal axis, a scope having a distal extremity with a field of view and cooperative mating means carried by the handle means and the scope for mounting the distal extremity of the scope within the distal extremity of the elongate member, the cooperative mating means including means for moving the distal extremity of the scope relative to the distal extremity of the elongate member from a first position in which the field of view permits viewing forward of the elongate member for guiding the distal extremity of the elongate member within the body and a second position in which the field of view permits viewing the distal extremity of the elongate needle as it is advanced from the passageway sideways of the longitudinal axis.

15. A device as in Claim 14 wherein the elongate member is provided with a rounded tip at its distal extremity and a transversely extending recess proximal of the rounded tip and wherein the elongate member causes the distal extremity of the elongate needle to extend beyond the recess so as to extend sideways at an angle with respect to the longitudinal axis distally of the recess.

16. A device as in Claim 14 wherein the elongate needle is a needle electrode, an insulating sleeve coaxially mounted on the needle electrode.

17. A device as in Claim 16 together with means mounted on the proximal extremity of the elongate member and connected to the handle means and to the insulating sleeve for causing the insulating sleeve to move relative to the needle electrode.

18. A device as in Claim 14 wherein the elongate member is providedwith a first lumen extending from the proximal extremity to the distal extremity, means coupled to the elongate member for permitting a liquid to be supplied to the first lumen to provide a clear field of view for the scope.

19. A device as in Claim 18 wherein the elongate member is provided with a second lumen extending from the proximal extremity to the distal extremity and an opening proximal of the recess for permitting aspiration of the liquid being introduced through the first lumen.

20. Amethod for the treatment of benign prostatic hyperplasia of the prostate of a human male having a bladder with a base, a prostate and a penis with a urethra therein formed by a urethral wall and extending from the base of the bladder through the prostate and the penis along a longitudinal axis with the prostate having tissue disposed adjacent the urethral wall by the use of a transurethral needle ablation device with endoscope having a distal viewing extremity comprising advancing the device into the urethra, supplying a saline solution to the urethra to provide a clear field of view for the endoscope, viewing the interior of the urethra while the device is being advanced to ascertain an appropriate position in the urethra so that the distal extremity of the device is in registration with the prostate, aspirating saline solution from the urethra during the time that the saline solution is being introduced into the urethra to inhibit filling of the bladder, utilizing the device to perform a needle ablation of the prostate and viewing the urethra after the needle ablation has been performed, all of such steps being performed with the same device and with a single introduction of the device into the urethra.

21. The method of Claim 20 wherein the supplying step includes supplying the saline solution to the urethra via the endoscope.

22. The method of Claim 20 further comprising moving the endoscope relative to the device between a first longitudinal position to permit viewing of the interior of the urethra while the device is being advanced therein and a second longitudinal position to permit viewing of the commencement of the needle ablation of the prostate.