Transurethral needle ablation device and method.

Removal device for needle through urethra

This application is a partial continuation of the Serial No. 08/109,190 filed on August 19, 1993, and this is the application filed on May 13, 1993 for 08/061, 647 and 08/062. Part of the continuation of 364, which is the continuation of the application Serial No. 08/012, 370 filed on February 2, 1993, and this is the continuation of the application Serial No. 08/012, 370 filed on August 12, 1992. Part of No.07/929, 638 continues.

The present invention relates to a resection device of a needle through the urethra with a cystoscope and a method for treating male prostate conditions.

Benign prostatic hypertrophy or proliferation (BPH) is a common medical problem in older men. The surgical procedures used in the past to correct this problem have been expensive, time-consuming and painful. In addition, such surgical procedures may have many unwanted side effects. Therefore, there is a need for devices and methods that can overcome these disadvantages.

In general, the purpose of the present invention is to provide a transurethral needle resection device with a cystoscope and a method that can be used to treat male prostate conditions, especially BPH.

Another object of the present invention is to provide a device and method with the above-mentioned characteristics that use radio frequency energy.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein the urethral wall is protected from radio frequency energy during the resection.

Another object of the present invention is to provide a device and method with the above characteristics, wherein the needle electrode does not penetrate the insulating sleeve.

Another object of the present invention is to provide a device and method having the above-mentioned features, wherein the control is arranged to prevent undesired tissue destruction.

Another object of the present invention is to provide a device and method with the above-mentioned features, in which many safety features are provided.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein the insulating sleeve can be retracted without moving the position of the needle electrode.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein tenting of the urethral wall is minimized.

Another object of the present invention is to provide a device and method with the above features, wherein the length of the needle electrode exposed in the prostate and the positioning of the insulating sleeve relative to the needle electrode can be preset before the device is introduced into the patient.

Another object of the present invention is to provide a device and method having the above-mentioned features, wherein the brake mechanism is configured to keep the needle electrode in place when the insulating sleeve is retracted.

Another object of the present invention is to provide a device and method with the above-mentioned features, which can be easily used by doctors who perform procedures.

Another object of the present invention is to provide a device and method with the above-mentioned features, which can allow the use of traditional cystoscopes.

Another object of the present invention is to provide a device and method with the above-mentioned features, in which an integral cystoscope is configured.

Another object of the present invention is to provide a device and method with the above characteristics, which is minimally invasive, effective and low-cost.

Another object of the present invention is to provide a device and method with the above characteristics, which can be used to selectively remove prostate tissue.

Another object of the present invention is to provide a device and method with the above characteristics, which can deliver low-intensity radio frequency energy directly to a very local area of the prostate.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein the device can be positioned by the use of transrect-al ultrasound or direct observation.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein safety is ensured by monitoring the temperature of the urethra.

Another object of the present invention is to provide an apparatus and method with the above-mentioned characteristics, in which extensive solidification and large-scale damage can be achieved.

Another object of the present invention is to provide a device and method with the above-mentioned characteristics, wherein the treatment of the patient does not require the use of anesthesia other than the possible local anesthesia.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein the needle electrode can be introduced at substantially right angles to the longitudinal axis of the catheter and penetrate the wall of the urethra to directly extend into the prostate tissue.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein at least two lesions can be formed in the prostate tissue approximately simultaneously.

Another object of the present invention is to provide a device and method with the above-mentioned features, wherein the needle electrode can be easily redistributed to cause additional damage to the same prostate.

Another object of the present invention is to provide a device and method with the above-mentioned characteristics, in which cutting to form damage can be performed very accurately.

Other objects and features of the present invention will be apparent from the following description, in which preferred embodiments are described together with the same drawings.

Figure 1 is a side view of a bridge with a connected sheath fitted with a conventional cystoscope.

Figure 2 is a side view of the handle and catheter assembly used with the bridge shown in Figure 1 and the sheath with a traditional cystoscope to provide a transurethral resection device incorporating the present invention.

Fig. 3 is a top view taken along line 3-3 of Fig. 2;

Fig. 4 is an enlarged partial cross-sectional view of the distal end of the catheter assembly shown in Fig. 2 and encircled by arrows 4-4.

Fig. 5 is an enlarged detailed view of a partial cross-section of the distal end of the catheter assembly along the line 5-5 of Fig. 6;

Fig. 6 is a cross-sectional view taken along line 6-6 of Fig. 5;

Fig. 7 is a cross-sectional view taken along the line 7-7 of Figs. 5 and 8;

Figure 8 is a partial cross-sectional view of the distal tip of another embodiment of the catheter assembly incorporating the present invention.

Fig. 9 is a cross-sectional view taken along line 9-9 of Fig. 1;

Fig. 10 is a view taken along line 10-10 of Fig. 1;

Fig. 11 is a cross-sectional view taken along line 11-11 of Fig. 10;

Fig. 12 is a view taken along line 12-12 of Fig. 3;

Fig. 13 is a view taken along line 13-13 of Fig. 2;

Fig. 14 is an enlarged view similar to Fig. 13 and along the line 14-14 of Fig. 15 with some parts broken off.

Fig. 15 is a cross-sectional view taken along line 15-15 of Fig. 14;

Fig. 16 is a cross-sectional view taken along line 16-16 of Fig. 15;

Fig. 17 is a cross-sectional view taken along line 17-17 of Fig. 16;

Fig. 18 is a cross-sectional view taken along line 18-18 of Fig. 17;

Fig. 19 is a cross-sectional view of the handle assembly taken along the line 19-19 of Fig. 13 and showing the safety mechanism in the operating position.

Figure 20 is a cross-sectional view similar to Figure 19 but showing the safety mechanism in a separated position.

Fig. 21 is a cross-sectional view taken along line 21-21 of Fig. 19;

Fig. 22 is a cross-sectional view taken along line 22-22 of Fig. 19;

Fig. 23 is a view taken along the line 23-23 of Fig. 19;

Figure 24 is an exploded isometric view of the mechanism shown in Figure 23.

Figure 25 is a cross-sectional view taken along line 25-25 of Figure 24.

Fig. 26 is a partial cross-sectional view taken along line 26-26 of Fig. 15;

Figure 27 is a cross-sectional view taken along line 27-27 of Figure 26.

Figure 28 is a cross-sectional view taken along line 28-28 of Figure 26.

Fig. 29 is a schematic explanatory view showing a manner in which a removal device for a needle through the urethra is used to implement a detachment procedure.

Fig. 30 is an enlarged cross-sectional view of the distal end of the transurethral needle resection device showing the deployment of the needle electrode during the detachment procedure.

Fig. 31 is a view seen along the line 31-31 of Fig. 30.

Figure 32 is an enlarged cross-sectional view showing that one of the needle electrodes penetrates the urethral wall and produces a tenting effect.

Fig. 33 is a cross-sectional view similar to Fig. 32 but showing that the insulating sheath is retracted relative to the needle electrode and the tenting in the urethral wall is removed.

Fig. 34 is a temperature gradient diagram showing the temperature generated in the tissue of the prostate during the detachment sequence.

Figure 35 is a cross-sectional view of another embodiment of the resection device for a needle through the urethra incorporating the present invention.

Fig. 36 is a cross-sectional view taken along line 36-36 of Fig. 35;

Fig. 37 is a cross-sectional view taken along line 37-37 of Fig. 35;

Fig. 38 is a cross-sectional view taken along line 38-38 of Fig. 37;

Generally speaking, a needle resection device through the urethra is used to treat the prostate of a man with radiofrequency energy derived from radiofrequency power energy. The male has a bladder with a base, a prostate, and a penis with a urethra. The urethra is formed along the longitudinal axis. The urethral wall of the prostate and penis extends from the base of the bladder to form and the prostate has prostate tissue surrounding the urethral wall. The device includes a sheath having a proximal end and a distal end and having a lumen extending from the proximal end to the distal end. The catheter assembly is slidably installed in the lumen in the sheath and has a proximal end, a distal end and a longitudinal axis. The needle electrode is slidably installed in the lumen in the catheter assembly and has a proximal end and a distal end. The insulating sleeve is configured to surround the needle electrode in the lumen of the catheter assembly and has a proximal end and a distal end, and the position of the distal end of the insulating sleeve allows the distal end of the needle electrode to be exposed. The handle device is configured to form a handle so as to be suitable for being gripped by a human hand. The device forming the bridge is fixed to the handle device and the proximal end of the sheath for connecting the handle device to the proximal end of the sheath. The device carried by the handle device and the bridge device and connected to the catheter assembly is used to move the distal end of the catheter assembly from a retracted position within the distal end of the sheath to an extended position farther than the distal end of the sheath. The device carried by the handle device and connected to the catheter assembly is used to cause the distal end of the catheter assembly to be bent to form an angle with respect to its longitudinal axis, so that the lumen in the catheter assembly can be guided to face the urethral wall. The device carried by the handle device and connected to the needle electrode and the insulating sleeve is used to advance and retract the needle electrode relative to the catheter assembly and the device that connects the needle electrode to the radiofrequency power source, so when the sheath is placed in the urethra, it is far away When the tip is located near the prostate, the needle electrode can be advanced through the urethral wall and into the tissue of the prostate to allow the application of the radiofrequency energy from the radiofrequency power energy to the needle electrode to cause damage to the tissue formed in the prostate.

In the method of the present invention for treating benign prostatic hyperplasia of the prostate in men, the man has a bladder with a base, a prostate, and a penis with a urethra. The urethra extends from the base of the bladder along the longitudinal axis through the urethral wall of the prostate and the penis. The formed prostate has the prostate tissue surrounding the urethral wall. The method of using the needle electrode includes the steps of introducing the needle electrode into the urethra and advancing the needle electrode in the longitudinal direction of the urethra along the longitudinal axis until the needle electrode is located at the appendage of the prostate. The needle electrode is then advanced in a direction at a substantial angle to the longitudinal axis of the urethra to penetrate the wall of the urethra and protrude into the tissue of the prostate. The radio frequency energy is applied to the needle electrode with sufficient power and applied for a sufficient time to raise the temperature of the tissue in the prostate near the needle electrode to cause damage to the formation in the prostate tissue.

More specifically, as shown in Figures 1-31, the resection device 31 that can be used to identify needles passing through the urethra with TUNAIII includes a rigid sheath 32 that can be of a suitable type and size, for example, in the form of a 22 French catheter with a length of 25 cm. Delivery device (22French catheter-like delivery device). The sheath 32 may be made of a suitable material, such as stainless steel, and is configured with a proximal end 33 and a distal end 34 and has a lumen 36 extending from the proximal end to the distal end (see FIG. 9). As particularly shown in FIG. 1, the distal tip 34 has a curved surface 38 extending forward and upward, and an inclined opening 39 extends through the curved surface (see FIG. 30). The distal tip 34 is also provided with a portion 34a of increased thickness to form a blunt tip end for the sheath 32 suitable for entering the prostate in the urethra during the resection procedure described below.

The sheath 32 is configured with a bush 41 mounted on the proximal end 33 thereof. The bush 41 is configured with twist plugs 42 on opposite sides of the bush. The locking ring 43 is rotatably mounted to the bush 41 and is configured with a handle 44, which is adapted to be used to mount the proximal end 33 of the sheath 32, as described below.

The first and second catheter assemblies 51 and 52 are slidably installed in the lumen 36 of the sheath 32. The catheter assemblies 51 and 52 are substantially the same as each other and are installed side by side in the lumen 36 as shown in the figure and fastened together with suitable devices such as soft solder 53.

FIG. 6 shows a cross-sectional view of the catheter assembly 51. As shown in the figure, the conduit assembly 51 and similar conduit assemblies 52 include an outer conduit 56 which is made of a suitable material such as stainless steel and has a wall thickness of 15 gauge, with an outer diameter of 0.072" and The inner diameter is 0.060 ". The outer catheter 56 is configured with a proximal end 57 and a distal end 58. The proximal end 57 is configured with a flange 59. A set of several L-shaped grooves 61 extending circumferentially separated by a longitudinal interval are provided at the farthest end of the distal end 58 of the outer catheter 56, for example, the last 1.5 cm. The chord-to-arc of the groove 61 is less than 360 and has an appropriate width, such as 0.012", and is separated from each other by an appropriate distance, such as 0.033". The groove 61 is L-shaped and is configured with a front toe or short branch portion 61a with a length of 0.010". The groove 61 is not offset in the radial direction and is therefore formed in the longitudinally extending spine or rib 62 of the outer duct 56 The outer tube 56 has an appropriate length, such as 14", and the groove 61 is formed in the portion 58a with a length of 0.5" at the farthest end. The inner tube 66 is disposed in the distal end 58 of the outer tube 56 and has an appropriate length , Such as 0.7". This internal pipe is also made of stainless steel of appropriate specifications, for example, 17 gauge with an inner diameter of 0.059" and an inner diameter of 0.041". A set of several L-shaped grooves 67 extending circumferentially separated by longitudinal intervals are provided in the inner duct 66 and have the same size as the grooves 61 of the outer duct 56. The groove 67 is aligned with the groove 61 in the longitudinal direction. The groove 67 is also axially aligned so that the spine 68 is aligned with the spine 62 (see FIG. 6). The inner duct 66 is provided on its outer surface with a platform 71 extending over its length. When the inner duct 66 is arranged in the outer duct 56, a gap 72 in the form of a cross-section is formed between the inner surface of the outer duct 56 and the platform 71 (see FIG. 6) to form a gap for the brace 76, the brace 76 There is a distal end 76a overlapping the cross member 77, and the cross member 77 is fixed in the distal end 58 of the outer catheter 56 (see FIG. 5). The brace 76 extends inside the outer duct 56 to the proximal end 57 of the duct assembly 51. The use of the catheter assemblies 51 and 52 as described above is disclosed in the joint application Serial No. 08/174,791 filed on December 29, 1993.

The insulating tube assemblies 81 and 82 are slidably installed in the duct assemblies 51 and 52. The two assemblies 81 and 82 are roughly the same. The insulating tube assembly 81 includes an insulating tube 83 formed of a suitable material, such as a 19 gauge thin-walled stainless steel tube commonly referred to as a hypotube, which has an outer diameter of 0.043" and an inner diameter of 0.033". The pipe 83 is provided with a large bore 84 (see Figs. 5 and 6). A sleeve or sheath 86 made of a suitable insulating material, such as NYLON11, is connected to the distal end of the stainless steel tube 83 but is configured with a large lumen 87 and a small lumen 88. These two lumens open into the large lumen of the tube 83 Within 84. The sleeve or sheath 86 is fixed to the tube 83 in a suitable manner, such as with an adhesive (not shown) and a shrink tube 89, which extends to cover the proximal end of the sleeve or sheath 86 and almost the entire length of the tube 83 to Near the proximal end, that is, within 0.25" of the radially extending flange 90 from the tube 83. The insulating tip 91 formed of, for example, NYLON 11 is formed by applying heat to the distal end of the sheath 86. The tip is provided with The bore 92 is in registration with the bore 87. The tip 91 is provided with a tapered inclined surface 93 that extends inwardly and forwardly toward the distal end so that the inclined surface 93 extends forward about less than the total length of the tip 91 Half of the circle occupies the 240 range of the circle. A gentler slope 94 that is 15 with the horizontal is set in the remaining 120 range of the circle and extends over the length of the tip 91 as shown in FIG. 5.

The thermocouple 96 is embedded in the tip 91 and is connected to an insulated wire 97 that extends through the bore 88 in the sheath 86 and the bore 84 of the tube 83.

In order to prevent peristalsis during the bending of the distal end of the insulating tube assembly 81, the inner side of the shrink tube 89 is glued to the stainless steel secondary tube 83 and also glued to the outer side of the insulating sleeve or sheath 86.

Another embodiment of the insulating sleeve assembly that can replace the assemblies 81 and 82 is shown in FIGS. 7 and 8. The insulating tube assembly 101 shown therein includes a secondary tube 102 similar to the secondary tube 83 described above, and is provided with a lumen 103 extending through the secondary tube 102. The insulating tube 112 is fitted to cover the distal end of the secondary tube 102 and has a lumen 113 therein. The lumen 113 is suitable for accommodating the distal end of the secondary tube 102. The distal end of the insulating tube 112 is provided with an additional lumen 114, and a mandrel (not shown) large enough to accommodate the two wires 97 of the thermocouple 96 is provided in the lumen. Similarly, another mandrel is set at the distal end of the lumen 113 of the secondary tube 102 to provide a hole of appropriate size, such as 0.018". While the inner mandrel and the proximal end are clamped to the distal end of the secondary tube 102, The insulating tube 112 is stretched to approximately 150% of its original length under low heat. The mandrel is then removed. The thermocouple 96 can be installed in the lumen 114 and its end is sealed in a suitable manner, such as heat sealing. The wire 97 extends in the bore 114 at the proximal end and passes through the hole 115 provided in the insulating tube 112 (see FIG. 8), so that the thermocouple wire 97 can enter the bore 103 of the secondary tube 102. This is the case of the insulating tube 112. Stretching was found to be worthwhile, because stretching will orient the plastic resin used in the insulating tube. Therefore, the insulating tube has a higher bending coefficient and a higher tensile yield strength. This kind of stretching also increases the tube 112 The heat resistance is about 30°C. In addition, stretching reduces the cross-section of the insulating tube so that the insulating tube fits and covers the end of the stainless steel secondary tube 102. By using this structure, the shrink tube in the previous embodiment can be eliminated The use of 89.

The needle electrode 116 is slidably installed in the lumen 84 of the insulating tube 83 and extends through the bore 92 of the tip 91. The needle electrode 116 is made of a suitable material having superelastic properties, such as Nitinol, so that the needle electrode can return to its original shape after being bent as described below. The needle electrode is configured with a sharpened tip 117 adapted to easily penetrate tissue. The appropriate diameter of the insulating sleeve 116 pin is, for example, slightly smaller than the diameter of the bore 87 and the bore 92, such as 0.017".

The resection device 31 of the needle through the urethra (see FIG. 1) also includes a handle device in the form of a handle 121. The size of the handle 121 is designed so that the handle fits in the hand of an adult. The handle 121 is configured with a proximal end and a distal end or a front end 122 and a rear end 123. The device connecting the proximal ends of the duct assemblies 51 and 52 and the insulating tube assemblies 81 and 82 and the handle 121 is arranged to form a handle and duct assembly 124 as shown in FIG. 2 which will be described below. The bottom portion 126b of the casing 126 is provided with horizontally extending and longitudinally spaced serrations 127 to facilitate the grip of the casing 126 by hands.

The handle 121 includes a casing 126 formed on an upper portion 126a and a lower portion 126b (see FIG. 15). The casing 126 is made of a suitable plastic such as polycarbonate. The four sliding control members 131, 132, 133 and 134 from left to right are slidably installed on the top surface 135 of the casing 126 (see Figures 13 and 15) and are spaced apart in the transverse direction of the surface 135 and are suitable for In the longitudinal movement of the surface 135. In order to distinguish the sliding control members from each other, the sliding control members can be color-coded and can have different shapes for tactile feeling. Therefore, the sliding control member can be configured with upright protruding parts, wherein the outer sliding control members 131 and 134 are configured with upright truncated triangular parts 131a and 134a, respectively. Similarly, the sliding control members 132 and 133 have triangular upright portions 132a and 133a. For color coding, for example, the two outer sliding control members 131 and 134 may be blue and the inner control members 132 and 133 may be gray.

The two outer sliding control members 131 and 134 can be used to control the movement of the insulating tube assemblies 81 and 82, and similarly, the sliding control members 132 and 133 can be used to control the movement of the needle electrode 116. The sliding control members 131-134 are configured with inwardly extending protrusions 131b, 132b, 133b, and 134b (see FIG. 14), and these protrusions extend through parallel grooves 136 extending longitudinally and spaced apart (see FIG. 14). Parallel grooves are formed in the upper part or cover 126a. The groove 136 is opened into four longitudinally extending, spaced apart and parallel recesses 137 (see FIG. 14) formed between the downwardly and longitudinally extending ribs 138 integrally formed with the upper portion or the cover 126a. The sliding member 141, the sliding member assemblies 142 and 143, and the sliding member 144 are slidably installed in the recess 137 (see FIG. 14) for longitudinal movement of the recess. The sliding members 141 and 144 are shaped so that they are mirror images of each other. Similarly, the sliding member assemblies 142 and 143 are shaped so that they are mirror images of each other. The sliding members and assemblies 141, 142, 143, and 144 are configured with extended recesses 146 (see FIG. 14). The protruding parts 131b, 132b, 133b, and 134b are engaged in the recesses 146 and are in contact with the recesses 146. Form a friction fit.

The sliding members 141 and 144 are configured with an adjusting piece portion 151 under the intermediate rib 138 and extending across the rear end or proximal end of the sliding member assembly 142 or 143 (see FIG. 16). The adjustment piece is partially configured with a cushion bottom part 152 and a suspension part 153 that are cushioned under the sliding member assembly 142 or 143. The sliding member assembly 142 or 143 includes a sliding member 156. The sliding member 156 is provided with a bottom part 157 at one end, and the bottom part 157 is cushioned under the sliding member 141 or 144. The adjacent extended recesses 158 and 159 are formed in the sliding member 156 and the recess 158 is deeper than the recess 159. Another arcuate recess 161 is formed in the sliding member 156 at the bottom of the extended recesses 158 and 159, and at opposite ends of the arcuate recess 161 are provided with brake members 162 and 163. The brake members 162 and 163 are made of suitable materials such as poly It is made of carbonate and has a coil spring 166 arranged therebetween. The protective cover 166 (see Figure 14) is arranged in the extended recesses 158 and 159 and is slidably movable in the recesses 158 and 159 for longitudinal movement of the recesses 158 and 159. The movement is achieved by The device of two pins 167 on the opposite side of the protective cover 166 in the sliding member 156 is fixedly installed, and the device of the two pins 167 is slidably installed in the protective cover 166. The cover 166 is configured with an overhanging portion 166a (see FIG. 17). The overhanging portion 166a is slidably located in the recess 159 and allows the cover 166 to move back and forth to a limited extent. For example, 0.004" is used to move the brake mechanism from The brake position moves to a position where it is not braked. Therefore, the brake members 162 and 163 can be moved between the brake engagement position and the brake disengagement position by the movement of the cover 166 as described below.

The other end of the sliding member 156 is provided with a downwardly extending protruding portion 168 and a laterally extending insulating stop release arm 169, which arm is used and will be described below.

The U-shaped clamp member 171, which is also formed of a suitable polycarbonate material, is fixed to the upper part or is fixed to the pillar 172 formed integrally with the upper part 126a of the casing by means of heat piles, and this U-shaped clamp The jaws are located under the sliding member 141 and 144 sliding member assemblies 142 and 143. The U-shaped frame member 171 is provided with an upwardly extending protrusion 173 adapted to engage with the ramp surface 174 during the action of the sliding control members 131-134 as described below (see FIG. 17).

A device is provided for fixing the insulating sleeve assemblies 81 and 82 to the sliding members 141 and 144, and this device includes a metal adjusting piece 181 soldered to the stainless steel tube 83 just near the end of the insulating shrink tube 89. The adjusting piece 181 is fixed to the underlay portion 152 of the sliding members 141 and 144 by screws 182.

A device is provided for fixing the needle electrode 116 to the sliding member assemblies 142 and 143, and this device includes a metal adjustment piece 186 soldered to the electrode 116 just near the end of the insulating tube 118. The adjusting piece 186 is fixed to the bottom part 157 of the sliding member 156. The insulated electrical wire 191 is fastened to the screw 187 so that the wire is in electrical contact with the tab 186 and the needle electrode 116. The wire 191 extends through the guard ring 192 provided with the handle 121 and extends through the cable 193 connected to the handle 121. Similarly, the two sets of wires 97 of the thermocouple extend through the cable 193 and the guard ring 192 and into the spiral seam protection sleeve 194 and then into the sleeve 196. In the cable 193, the thermocouple wire 97 branches out of another cable 197 (see FIG. 29).

The casing 126 supports a two-part casing extension 198 formed of polycarbonate, which is used for the purpose which will be described below. The extension part is clamped to the casing 126 by having flange parts 126c and 126d in the recess 199 extending around the extension part 198 of the casing (see Figs. 20-21). The casing extension 198 is configured with a cylindrical extension 201 formed of a suitable material such as polycarbonate. The cylindrical extension 201 of the casing 126 is adapted to cooperate with the bridge 206 described below, which is mounted on the sheath 32 as described above. The cylindrical extension 201 is provided with a bore 211 (see Figures 11 and 23). The proximal end 57 of the catheter assembly 51 and 52 can enter this bore and funnel outward as shown (see Figure 3).

The device configured and connected to the proximal ends of the catheter assemblies 51 and 52 is used to cause the actuation of the brace 76 carried by the assembly, and becomes a device carried by the handle device and connected to the catheter assembly for use This results in an angled bending of the distal ends of the catheter assemblies 51 and 52 relative to the longitudinal axis. This device includes first and second lever assemblies 216 and 217 arranged on opposite sides of the casing 126. Because the two assemblies are identical, only one of them will be described. The lever assembly 216 includes a cylindrical knob 218 rotatably mounted to one end of the arm 220 by a screw 219. The arm 220 is integrally formed with the rotatable member 221, and the rotatable member 221 has a square hole 222 in it (see FIG. 19). The positioning and pin disc 223 is rotatably mounted in a cylindrical recess 224 provided in the extension 198 of the casing (see FIG. 24). The disc 223 is provided with a set of several stop claws 228 spaced apart on the circumference. The stop claws can be engaged by a plunger 229, which can be driven by a spring (not shown) loaded in the cylindrical threaded member 231 ) And pushed out yieldingly, the cylindrical threaded member is screwed into the threaded bore 232 provided in the extension 198 of the casing. The disc 226 is configured with a square protrusion 234 that extends through the wall of the casing extension 198 and fits into the square hole 222 of the cylindrical member 221, so that the pin disc 226 can be moved by the lever arm The movement of 220 is rotated between the two extreme clockwise and counterclockwise positions. The disc 226 is also equipped with an upright pin 236, which is set in a transversely extending groove 237 formed in the rectangular slider 238, which is slidably mounted on the cylindrical recess 227. The extended recess 241 is moved with a pasting. The sliding block 238 is configured with a groove 242 extending in the longitudinal direction of the sliding block. The groove is aligned with the arcuate groove 243 provided in the casing 126 and guided into the bore 202 of the cylindrical extension 201.

The proximal flange 59 at the proximal end of the outer tube 56 is located in the groove 240 of the extension 198 of the housing. The actuator or brace 766 extending at the proximal end of the flange 59 extends into the hole 244 provided in the adjustment block 246, and the adjustment block 246 has a leg 247 that can move longitudinally in the groove 242. A device is provided for fixing the actuation bar 76 in the hole 244 and this device includes a tubular member 249 made of a suitable material such as stainless steel (see FIG. 25), which can be press-fitted It is placed in the hole 244 to fix the proximal end of the brace 76 in the hole.

A device is provided for providing adjustment of the brace with respect to the slider 238, and this device includes a cap screw 251 that can be screwed into a threaded hole 252 provided in the slider 238. The adjusting block 246 is provided with a groove 254 aligned with the threaded hole 252 and has a transversely extending groove 256 located between the two ends of the groove 254, and the transversely extending groove 256 is used to accommodate the screw head of the head screw 251 . In this way, the longitudinal position of the adjustment block 246 relative to the slider 238 can be adjusted by using a conventional screwdriver and by adjusting the cap screw 251, thereby adjusting the length of the actuating bar 76 and adjusting by the lever arm assembly 216 or The bending caused by the movement of the lever arm 220 of 217.

During operation, the loosening of the screw caused by the counterclockwise rotation of the cap screw 251 may cause the adjustment block 246 to be retracted or push the adjustment block away from the slider 238 and thus stretch the brace 76. The rotation of the cap screw in the opposite direction causes the opposite situation to occur. After proper adjustment is completed, the rotation of the lever arm 220 will cause the pin 236 to slide in the groove 237 to adjust the slider 238, so that the slider 238 translates longitudinally of the extension recess 241 to cause the displacement of the brace, resulting in the following The bending of the distal end of the related catheter assembly is described. The spring-actuated plunger 229 engaged with the stop pawl 228 partially restricts the rotation of the disc 226 and can give the doctor an actual indication of the amount of rotation generated when the arm 220 is rotated, for example, from 0-30 , from 60-90 and so on.

The bridge 206 includes a bridge housing 261 formed of a suitable material such as polycarbonate (see Figures 1, 10 and 11). A sleeve 263 made of a suitable material, such as stainless steel, is installed in the casing. The distal end of the sleeve is configured with an external thread extension 264 (see FIG. 1), and the external thread extension can engage with a locking ring 43 provided on the proximal end 33 of the sheath 32. The cannula 263 is configured with a cylindrical bore (not shown) extending through the cannula, and this bore is suitable for accommodating a conventional cystoscope 271. The cystoscope 271 is typically a reusable direct vision device and is equipped with a cylindrical stainless steel light pipe 272, which can be slidably fitted into the sleeve 263 of the bridge 206. Such a light pipe 272 is well known to those skilled in the art and includes a set of several rod-shaped optical elements (not shown) to provide excellent viewing capabilities at the far end 273 of the light pipe 272. The size of the light pipe 272 is designed so that the light pipe is easy to fit into the lumen 36 of the sheath 32 and the distal end 273 is disposed adjacently behind the curved surface 38 at the distal end of the sheath 32 (see FIG. 30). The tube connector 274 is disposed at the proximal end of the light pipe 272 and carries an outlet 277 that can be connected to the light pipe 278, and the light pipe 278 is connected to a conventional light source 279 (see FIG. 29). The tube joint 274 carries the eyepiece 281.

The bridge 206 is also provided with a bifurcated part 286 which is divided into two parts 286a and 286b which hang downward. The bifurcated portion 286 is configured with a channel 287 for receiving the catheter assemblies 51 and 52. It can be seen from FIG. 1 that the channel 287 is formed in a gradually curved form and the outlet end of the channel 287 is aligned with the lower end of the lumen 36 provided in the sheath 32, so that the catheter assemblies 51 and 52 can easily enter the lumen 36 and It is advanced to the distal end 34 of the sheath 32 as shown in FIG. 30.

The bridge member 206 and the handle 121 carry a cooperative joint device to prevent the needle electrode 116 and the insulating sleeve assembly 81 and 82 from dispersing before the handle 121 and the bridge member 206 are joined. The device includes a downwardly extending rail 296 which extends longitudinally of the cylindrical extension 201. The rail 296 has a rectangular cross-section and has mutually parallel side surfaces 297 and 298 spaced apart. The rail is also provided with an inclined surface 301 that extends laterally in the proximal direction to a side surface 297 extending from the front surface 302. The first and second spaced apart parallel grooves 303 and 304 are arranged in the rail 296 and extend upward through the side surfaces 297 and 298.

The button assembly 306 has a cylindrical plunger body 307 formed of a suitable material, such as plastic. The button assembly is slidably installed in two aligned holes 308 spaced apart, and the two holes 308 are opened to form a well 309. The plunger body 307 is configured with spaced apart flanges 311 located in the well 309. The spring 312 is located on the plunger body 307 and has one end engaged with the flange 311 and the other end engaged with the wall forming the well 309. Therefore, the spring 312 can yield to fix the plunger body 307 at the center position of the well 309. The cross section of the central part 307 a of the plunger body 307 is generally rectangular and its width is slightly smaller than the width of the grooves 303 and 304. The central portion 307a is provided with recesses 316 and 317 with a rectangular cross-section and has a height in the axial direction, which is slightly larger than the thickness of the rail 296 and has a depth larger than that of the rail 296. The plunger body 307 is also equipped with cylindrical button portions 307b and 307c that extend beyond the side of the bridge 206, so that the doctor's hand can approach the button portion.

Therefore, when the catheter assemblies 51 and 52 are introduced through the borehole 288 into the channel 287 and then advanced into the lumen 36 of the sheath 32, the cylindrical extension 201 can be advanced into the borehole 288 so as to be inclined The plunger body 307 of the part 301 oblique wedge button is laterally one side, so that the notch 317 is pushed in and positioned so that the rail 296 resists the force of the spring 312. When the front of the cylindrical extension 201 continues to penetrate, the central part 307a will be positioned in the first groove 303 and the central part 307a will laterally return to engage with the groove 303 under the force of the spring 312 to prevent the cylindrical extension The extension 201 moves inward again in the bore 288. The further inward movement of the cylindrical extension 201 in the borehole can only occur when the button plunger body 307 is pushed laterally to resist the depressible force of the spring 312 so that the notch 317 or 316 is aligned with the rail again. After 296, after that, the cylindrical extension 201 can continue to move inward until the body portion 307 is moved into the groove 304 again under the force of the spring 312.

The latch device is provided to prevent the operation of the sliding control members 131, 132, 133, and 134 before the handle 121 and the bridge 206 are engaged as described above. The device includes a cam release shaft 321 (see FIG. 19) with a rectangular cross-section, and the cam release shaft can move in a channel 322 provided in the handle 121. The distal end of the cam release shaft 321 is provided with a small plunger 326, and the small plunger 326 is slidably installed in a well 327 provided in the casing 126.

The first cam member 331 carries a pin 332 that is pivotally mounted in the mechanism 126 (see FIG. 122). The cam member 331 is provided with a cutout 333 adapted to be moved to engage and disengage from the sliding rod 246. When the sliding bar 246 is engaged with the cutout 333, the sliding bar 246 cannot move. The cam release shaft 321 is equipped with a pin 336, and the position of the pin 336 allows the pin to move in the groove 337 provided in the cam member 331 to actuate the cam member 331. Therefore, the cam member 331 is characterized by being a front or distal cam member and the other cam member 341, which is also related to the cam release shaft 321, is characterized by being a rear or proximal cam releasing member. The cam release member 341 carries a pin 342 (see FIG. 21) that is mounted in the housing 126 in a rotary shaft type. The cam release member 341 is connected to the cam release shaft 321 via the pin 343, and the pin 343 extends through the cam release shaft 321 and moves within the groove 344 in the cam member 341 to drive the cam member 341 to engage with the U-shaped friction rail 171 And detach to fix the friction rail 171 at a position so that the protruding portion 173 carried by the friction rail cannot clear the front surface of the inclined slope 174 provided on the sliding member 142 or 143 (see FIG. 19). The cam member 341 is configured with two spaced apart protrusions 341a and 341b (see FIG. 21), and the two protrusions are suitable for engaging the two pillars of the U-shaped friction rail 171. The proximal end of the cam release shaft 321 is provided with a shoulder 346 which engages with one end of a compression spring 347 located in the well 348 of the mobile phone case 126.

Therefore, when the pin 326 is pressed into the well 327 by the cylindrical extension 201 in the bore 288 and the bridge 206 that is engaged with the pin 326 against the depressible force of the spring 347, the front or first cam member 331 is moved so that The cutout 334 no longer engages with the adjustment block 246 (see FIG. 20) to allow the adjustment block 246 to move. At the same time, the second and rear cam release members 341 are moved to the position shown in FIG. 20 to release the friction rail 171, so that the protruding portion 173 carried by the friction rail can move over the slope 174, thereby allowing the movement of the actuating bar 76 to The bending and sliding control members 131-134 of the distal ends of the catheter assemblies 51 and 52 as described below are allowed to move. Although the front and rear cam members 331 and 341 are a single structure, it is valuable that they both have a length extending across the width of the casing 126, so that the right and left sides of the handle 121 can be engaged with the handle 121. The operation of the corresponding parts of the cams 331 and 341 on both sides are controlled (see FIGS. 21 and 22), thereby controlling the duct assemblies 51 and 52.

It is equipped with a device for presetting the extension of the needle electrode 116 to implement the resection procedure as described below and also for pre-adjusting the retractable insulating sleeve assemblies 81 and 82 before the start of the application of radio frequency energy in the resection procedure distance. This preset device includes a front adjustable button 351 that becomes an insulated stopper that can achieve the functions described below, and a rear adjustable button 352 that becomes a needle electrode stopper that can achieve the functions described below. These buttons are installed On both sides of the casing 126 (see Figures 2 and 13). The buttons 351 and 352 have handles 353 and 354 with rectangular cross-sections, and the handles extend through rectangular slits 356 and 357 provided on the side wall of the casing 126. The handles 353 and 354 are integrally formed with the buttons 351 and 352 and carry rectangular members 366 and 367. The members 366 and 367 are integrally formed with the handle and are provided with teeth 368 and 369, respectively. The teeth 368 and 369 are adapted to be formed in The teeth 371 and 372 on the inner wall of the casing 126 mesh. The teeth 371 and 372 form fixed racks spaced apart and can be meshed by the teeth 368 and 369. A suitable device is configured to yieldably push the members 366 and 367 in the direction toward the outer wall of the casing 126 so that the teeth 368 and 369 carried by the members 366 and 367 are pushed to engage the teeth 371 and 372. This device includes and The casing 126 is integrally formed and the walls 376 and 377 are made of a suitable material such as plastic. When it is necessary to disengage the teeth 368 and 369 carried by the members 366 and 367 from the teeth 371 and 372 carried by the casing 126, the yielding force can be overcome by pressing the knobs or buttons 351 and 352 inward.

The member 366 carries the latch arm 381 and the latch arm is integrally formed with the member 366 and is also made of a suitable material such as plastic. Similarly, the latch arm 382 is mounted on the member 367. The latch wall 381 is provided with a triangular protrusion 386 extending inward, and the protrusion is provided with two adjacent inclined surfaces 388 and 389 inclined in opposite directions. The latch arm 381 is also provided with an inwardly extending protrusion 391 on its distal end. The protrusion 391 provides a shoulder 392 facing the surface 389 of the protrusion 386 and an inclined surface 393 facing away from the shoulder 382 , And the inclined face faces the direction that is angled relative to the shoulder.

The latch arm 382 is provided with an inwardly extending protrusion 396 which provides a shoulder 397. The members 366 and 367 engaged with the walls 376 and 377 in this area are provided with semicircular cutouts 378 and 379 so that the members 366 and 367 are in the rectangular seams during the positioning of the insulating stop button 351 and the needle electrode stop button 352 When 356 and 357 slide inside, the frictional contact between the members 366 and 367 and the walls 376 and 377 is reduced. The scales 398 and 399 used in conjunction with the buttons 351 and 352 may be provided on appropriate surfaces on the casing 126, for example, along the side walls as shown in FIG. 13.

The procedure for the treatment of male patients with benign prostatic hyperplasia (BPH) and the operation and use of the resection device 31 of the needle through the urethra can now be briefly described as follows. The part of the male patient 401 to undergo this procedure is shown in Figure 29, where the anatomy of the relevant part is revealed and includes a bladder 402 with a base or bladder neck 403, which is connected to the urethra 404, The urethra 404 is characterized by including a prostate part 404a and a penis part 404b. The prostate portion 404a is surrounded by the prostate or prostate 406. The prostate is a glandular organ and a fibrous and muscular organ directly below the bladder. The penile portion 404a of the urethra extends through the length of the penis 407. The urethra 404 is formed with a urethral wall 408 that extends the length of the penis and enters the bladder 402 through the prostate 406. The prostate 406 is characterized by including five lobes: anterior lobe, posterior lobe, median lobe, right lobe, and left lobe. The prostate 406 also has a fine carbur, which is a characteristic of the prostate and is used to position the device 31 of the present invention in the following procedure.

Assume that when preparing to undergo this procedure, the prostate of the male 401 has been preliminarily analyzed by using digital rectal examination and ultrasound through the rectum to identify the size of the prostate. In this inspection procedure, the typical average and peak urine flow, output, residual volume and the source of prostate specific antibodies are measured. Typically, this procedure is most suitable for prostates whose lateral diameter is between 31mm and 64mm.

Assuming that the pre-treatment identification of the patient determines that the transurethral needle resection (TUNA) procedure described below can be used, the patient 401 can be taken to an outpatient clinic or an operating room of a hospital. The patient 401 is removed from clothing and takes a horizontal position on the procedure or operating table, and the patient's leg is placed in a proper stirrup shape so that the doctor can easily access the patient's pubic area. The traditional neutral or ground electrode 411 (see Figure 29) is placed on the patient's back so that the electrode is attached there and has good electrical contact with the patient's skin. The electrode is connected to the control instrument station and the radio frequency generator 413 via a wire 412. The control instrument stand 413 is equipped with an inclined front panel 414, and a suitable digital readout indicator 415 is provided on the front panel 414. The traditional foot switch 416 is connected to the control instrument station 413 by a cable 417 to control the application of radio frequency energy as described below. The handle 121 of the device 31 is connected to the control instrument table 413 by cables 193 and 197.

Typically, the sheath 32 and the bridge 206 and the cystoscope 271 forming part of the device 31 are of reusable type and are available in the outpatient clinic or hospital where the patient will be treated. Only the handle and pipe assembly 124 can be considered as a disposable type after use and a disposable type after one use. Therefore, at the beginning of the procedure, the handle and catheter assembly 124 is taken out of the bacteria-free packaging supplied by the manufacturer. A doctor who knows the size of the prostate 406 to be treated will set the adjustable stop buttons 351 and 352 on the opposite sides of the mobile phone case 126 to the appropriate scale. In this way, according to the TUNA treatment table pre-produced by the manufacturer, the rear adjustable button 352 can be set together with the scale 399 provided on the front surface of the handle to set the needle electrode length in the range of 6-20mm to have 0.017" The needle electrode 116 with the outer diameter of the needle electrode 116 is used for the prostate with a horizontal measurement value in the range of 31-64mm. The front adjustable insulating stop button 351 can be set together with the scale 398 to determine the insulating sleeve or the shield 81 Withdrawal amount, this insulating sleeve can extend beyond the urethral wall by 4-8mm when used for the same size prostate.

When the buttons 351 and 352 are operated, the buttons are pushed inward against the depressible force of the walls 376 and 377. Once the button 351 or 352 is pushed far enough, for example, when the button 351 is pushed inward so that the tooth 368 of the button carried by the member 366 is moved out of the meshing state with the tooth 371 carried by the casing 126, the insulation stops The movable button 351 can be moved in the longitudinal direction of the casing to enter a desired position relative to the scale to cause the latch arm 381 to move. Once the button 351 is pushed to the desired position according to the scale 398, the button 351 can be released so that the tooth 368 carried by the member 366 is again engaged with the tooth 371 carried by the arm of the casing 126 again.

The needle stop button 352 can be adjusted in a similar way, by pushing the button 352 inwardly to cause the teeth 369 carried by the mechanism 367 to move out of engagement with the teeth 372 on the wall of the casing 126 to resist the wall 377. Can yield force. Once this condition is achieved, the button 352 can be pushed to the desired position relative to the scale 399 along with the latch arm 382.

After the appropriate stop setting is generated by the operation of the buttons 351 and 352, the handle and catheter assembly 124 can be introduced through the bridge 206 and through the lumen 36 of the sheath 32 by introducing the distal ends of the catheter assemblies 51 and 52 It is joined with the bridge 206. The continuous advancement of the duct assemblies 51 and 52 causes the rail 296 with the inclined wedge surface 301 of the cylindrical extension 201 to engage with the portion 307a of the plunger body 307 to move the lateral side of the plunger body 307 against the force of the spring 312 Therefore, the notch 317 is brought to the positioning of the rail 296 to allow the rail 296 to be pushed in the bridge 206 until it hits the groove 303, and the spring 312 pushes the body 307 to move the part 307a into the groove 303 This prevents the cylindrical extension 201 from moving further inward into the bore 288 until the sheath 32 is inserted into the urethra 404 as described below. Assuming that the cystoscope 271 has also been introduced through the bridge 206 and into the sheath 32 so that the distal end of the cystoscope is also located at the distal end of the sheath 32, the resection device 31 of the needle via the urethra can be used immediately.

Then, the doctor uses a syringe (not shown) to introduce a lubricating glue with a local anesthetic such as Lidocaine into the urethra 404 of the penis 407 so that the urethra can accommodate the 22 French size of the sheath 32. In the case of a patient with a small urethra, it may be appropriate to use a series of dilators (not shown), starting with the smallest dilator until a dilator of approximately 22 French size has been introduced into the urethra. After this is completed, the doctor holds the penis 407 with one hand and the handle 121 of the device 31 with the other hand to introduce the distal end of the sheath 32 into the urethra of the penis, and observe the progress through the eyepiece 281 of the cystoscope 271 At the same time, the sheath 32 is gradually advanced. During this introduction procedure, the distal ends or tips of the catheter assemblies 51 and 52 are in close proximity to the curved surface 38 of the sheath 32, so that the urethral wall is protected from the distal ends of the catheter assemblies 51 and 52, which carry There is a needle electrode 116 that extends a short distance, for example, 1-2 mm from the distal end of the insulating tube 86. In other words, the tips of the distal ends of the catheter assemblies 51 and 52 are hidden under the distal ends of the sheath 32. Another advantage is that the distal ends of the catheter assemblies 51 and 52 will not interfere with the doctor's line of sight through the cystoscope 271, so that the doctor can identify the physiological tissues in the urethra when the sheath 32 is advanced, such as the seminal carpus in the prostate and those in front of the bladder. Sphincter. Using these parts of the male anatomy, the doctor can correctly identify the location in the prostate where he wants to perform the resection procedure, and rotate the handle 121 so that the needle electrode 116 to be deployed enters the appropriate lobe of the prostate.

Once the sheath 32 is in the correct position within the prostate 406, such as the position shown in Figure 29, the doctor operates the button plunger 307 by pressing the left button portion 307b or the right button portion 307a inward to push the plunger body 307 resists the force of the spring 312 in the required direction, thus moving one of the notches 316 or 317 to the position of the rail 296 to allow the cylindrical extension 201 to penetrate deeper into the bore 288, so that the bridge 206 engages the pin 326 moves the cam release shaft 321 downward and backward against the force of the spring 347 to operate the cam members 331 and 341. The distal ends of the catheter assemblies 51 and 52 will be deployed or positioned at the distal ends of the distal ends of the sheath 31 to prepare to be bent.

It can be seen that the two steps required to fully engage the cylindrical extension 201 in the bore 288 of the bridge 206 through the use of the two grooves 303 and 304 provide safety features because of this feature It can prevent the premature deployment and bending of the catheter assembly 51 and 52 and the needle electrode 116, and the premature deployment and bending will damage the urethral wall 408 during the insertion of the sheath 32.

Once the distal ends of the catheter assemblies 51 and 52 extend beyond the distal ends of the sheath 32, the distal ends of the catheter assemblies 51 and 52 can be bent so that they are preferably 90 degrees relative to the longitudinal axis of the catheter assemblies 51 and 52 The angle is extended, as shown in FIG. 30, and the needle electrode 116 is thus extended in a direction substantially perpendicular to the urethral wall 408 of the prostate. This is achieved by pressing the knob 218 to move the lever assemblies 216 and 217 forward. While the doctor presses the knob 218, the doctor can visually observe the positioning of the distal ends of the catheter assemblies 51 and 52 through the cystoscope 271. Because the distal ends of the catheter assemblies 51 and 52 have a grooved structure as described above, the catheter assemblies 51 and 52 suitable for gripping can be bent to the required 90 degrees with a small diameter, such as 5- 10mm or less and still easily pass the distal end of the sheath 32 unimpeded. Typically, the curved distal ends of the catheter assemblies 51 and 52 are arranged in substantially the same plane at an angle to each other, such as an angle in the range of 30-75 degrees, and preferably an angle of about 60 degrees.

The sliding control members 131-134 can be propelled into two different groups, one of which is the control members 131 and 132 and the other is the control members 133 and 134. As previously explained, the sliding control members 132 and 133 control the deployment of the needle electrode 116. The movement of the sliding control members 132 and 133 in the forward direction also causes the sliding control members 131 and 134 that control the deployment of the insulating tube 86 to move at the same time, so that the deployment of the needle electrode 116 causes the insulating tube 86 to be pushed forward at the same time. The relative positioning between the needle electrode 116 and the insulating tube 86 surrounding the needle electrode is such that the needle electrode only protrudes a very small distance, for example, only protrudes 1-2 mm beyond the distal end of the insulating tube 86. This simultaneous movement occurs because the sliding control member 131 causes the sliding member 141 to move. The sliding member 141 carries the adjusting piece portion 151, and the adjusting piece portion 151 extends across the rear of the sliding member 142. Therefore, during the advancement of the sliding control members 131 and 132, the needle electrode 116 will penetrate the urethral wall 408 (see FIG. 32), followed by the insulating tube 86. Penetration of the urethral wall 408 in this way causes a tent phenomenon in the urethral wall as shown in FIG. The advancement will continue until the sliding control member 132 and the sliding control member 133 reach the appropriate stop provided by the front adjustable button 352. This determines the maximum penetration amount of the needle electrode 116 into the prostate, which is determined according to the setting of the button 352 as described above. The stop of the needle electrode is provided by the structure shown in FIG. 26, in which the shoulder 397 disposed on the protruding part 396 of the latch arm 382 is covered by a surface of the part 157 of the needle electrode sliding member 156 Meshing. When the insulating sliding members 141 and 144 are advanced, the sliding member can be easily pushed past the end of the latch arm 381 by engaging the part 153 of the wedge surface 393, and the latch arm 381 is moved to the side and the part is allowed. 153 is located in the space formed between the shoulder 392 and the inclined surface 389 provided on the protruding portion 386.

Once the sliding control members 131-134 have been advanced to their foremost positions determined by the button 351, the sliding control members 131 and 134 are retracted to cause the recovery of the insulating tube 86. This retreat of the sliding control members 131 and 134 will continue until they reach their last end determined by the front button 351. The backward movement of the insulating sliding members 141 and 144 is stopped by the engagement of the portions 153 of the insulating sliding members 141 and 144 with the shoulder 392 carried by the latch arm 381. When the insulating tube 86 is recycled, the tent phenomenon that previously occurred in the urethral wall 408 is eliminated by the pulling back of the insulating tube 86 and the needle electrodes 116 are maintained in their required extended positions. However, as explained below, the insulating sheath or tube 86 is only sufficiently retracted to still leave the insulating tube 86 extending through the urethral wall 408 to protect the urethral wall 408 as described above. During this retreat of the insulating tube 86, the sliding control members 132 and 133 tend to move together due to the frictional contact with the adjacent sliding members 131 and 134. However, the movement of the sliding member assemblies 142 and 143 in the rearward direction from the foremost position determined by the aforementioned previously adjustable button 351 will not occur because the groove moving member 156 engages the connecting ribs in a deviating and frictional manner. The braking provided by the braking members 162 and 163 of 138 are frictionally fixed.

After these procedures have been completed, the patient 401 is ready to receive the radiofrequency energy supplied to the needle electrode 116 at the desired appropriate location in the tissue of the appropriate lobe of the prostate 406. The radio frequency energy is supplied from the control instrument station and the radio frequency generator 413 (see FIG. 29) through the operation of the foot switch 416 by the doctor. This causes radio frequency energy with the required frequency and power level (pre-set by the doctor) to be supplied to the insulating sleeve 116 placed in the prostate tissue 406.

It has been found that in order to optimize the performance of the needle electrode 116, it is appropriate to supply radio frequency energy to the two needle electrodes 116 at two different frequency radio frequencies that are not mutually harmonic. Typically, the radio frequency can range from 300kHz to 1mHz, although frequencies from 250kHz to 20mHz can be used if required. For example, by supplying radio frequency energy of 460.8 kHz to one electrode and supplying radio frequency energy of 482.4 kHz to the other electrode, different required performances can be achieved.

Radio frequency energy is delivered to a surface area ranging from 0-30 square millimeters (mm) at a power level from 2-9 watts²) Of the needle electrode. Thus, for example, a needle electrode with a diameter of 0.017" and an exposed length of 6-22mm can have a diameter of 3-26mm²The surface area. The application time of radio frequency energy can be 2-15 minutes, but a time of 4-5 minutes has typically been found to be appropriate. For example, the initial power can be delivered at 4 watts for 1 minute, and then adjusted to 5 watts for the second minute, and then adjusted to 6 watts for the third, fourth, and fifth RF energy application. minute.

The temperature of the shield rising slowly and steadily is observed during the treatment, and is typically 5-8°C. If the temperature rise is less than 5°C per minute, the RF power is increased by approximately 1 watt. Conversely, if the temperature rise is greater than 8°C per minute, or if a sudden increase in impedance occurs, the applied RF energy is reduced by approximately 1 watt.

The retractable shield 86 disposed on the needle electrode 116 can protect the urethral wall 408 from radio frequency energy. Thermocouples arranged at the ends of the insulating sleeve assemblies 81 and 82 monitor the temperature of the prostatic urethral wall 408. In addition, the same thermocouple monitors the temperature of the prostate adjacent to the damage produced by the needle electrode. These damages are produced by conducting radio frequency energy from the outer surface area of the needle electrode 116 in the tissue exposed to the prostate and allowing the energy to pass through the tissue and enter the patient's body to the neutral electrode 411, and then return to the RF power supply 413 to complete the circuit for radio frequency energy. A damage 429 is formed around each electrode 116, and the urethral wall 408 is protected by an insulating tube 86 from the heat generated.

The damage surrounding the needle electrode 116 caused by the radio frequency energy supplied by the needle electrode can be explained by the fact that the bodys tissues are mainly electrolytes, fats and calcium and interact differently with electromagnetic radiation at different wavelengths. . Because the tissue is penetrated fairly evenly by the liquid with a fixed concentration of electrolyte, the tissue will behave as a poor conductor. If the wavelength of the electric field applied to the body tissues is long relative to the size of the human body (the wavelength is 600 meters at 500kHz), most of the interaction is lost by moving ions and water molecules at the frequency of electric heating. The higher the current, the more active the movement of molecules and the higher the temperature rise in a given time. If an electric field is applied between two electrodes of the same size, the current density defined by the amount of current per unit area of the electrodes will be similar to the two electrodes. If an electrode is much smaller, the current density is much higher because the total current still has to flow, and correspondingly, the small electrode has a higher temperature, such as the needle electrode. If the tissue is heated to a dry level, there is no longer conduction, the tissue becomes a medium and the current and heating cease. This shows a significant increase in tissue resistance. A representative result of the application of radio frequency energy using a device such as the device 31 of the present invention resulted in the generation of local damage with an average of 12×7 mm, and larger damage was formed when needed, showing an average of 30×15 mm A lot of coagulation and necrosis. A power of 4 to 15 watts is applied for approximately 3 minutes.

A representative thermal gradient map is shown in FIG. 34, where the isotherm 431 represents the different temperatures that are believed to be encountered in the prostate tissue 406 during the damage caused by the device 31. It can be seen from FIG. 34 that the isotherm forms a roughly ovoid-shaped envelope extending around the needle electrode 116 and in front of the needle electrode 116, and its direction is toward the neutral needle electrode 411, which starts at the needle electrode 116 at a temperature of 100°C. The neighborhood. The isotherm 431 shows that the temperature in the prostate tissue gradually decreases through the isotherm gradients of 90° C., 80° C., and 60° C. These isotherms roughly represent the total volume of damage and necrosis in the prostate tissue. Typically, the average gradient from the surface of the needle electrode 116 to the periphery of the damage produced is about 50°C per millimeter and the average maximum temperature is about 100°C. As is well known to those skilled in the art, there is no harmful degeneration of prostate tissue at temperatures below about 55°C.

By observing the isothermal gradient line 431 in FIG. 34, it can be seen that by carefully monitoring the temperature reached in the prostate tissue, the size of the damage produced can be controlled quite accurately. In this application, this purpose is achieved by the thermocouple 96 provided at the distal ends of the insulating sleeve assemblies 81 and 82. It should be more valuable if appropriate additional thermal measurements can be implemented, such as by the use of rectal probes placed adjacent to the prostate to ensure that inappropriate heating does not occur. The radio frequency generator 413 is valuablely provided with a control element that can automatically shut off the application of RF power when the thermocouple senses an excessively high temperature.

It has been found that there is a direct relationship between the amount of exposed surface area on the needle electrode and the amount and time of energy application. In this way, for example, the application of a power of about 2-3 watts can produce a small damage of 2-4 mm and is roughly independent of the number of millimeters exposed by the needle electrode. However, as the applied power increases, for example, 3-8 watts for 1 minute, the exposure of a needle electrode of 5-10 mm can obtain an intermediate size of damage with a width of 4-7 mm. With the application of 3-12 watts of radio frequency power for 2-4 minutes, when the needle electrode of 10mm and larger is exposed, a larger but still intermediate size of 4-8mm wide damage can be obtained. A large damage with a width of 8-10mm can be obtained by applying about 5-15 watts of radio frequency energy power for 3-5 minutes, and the exposure of the needle electrode is 15mm and more. Very large damage, such as damage with a width greater than 10mm, can be achieved by applying a power of 5-15 watts for more than 4 minutes and the exposure of the needle electrode is greater than 15mm.

In this way, using the procedure described above, for a more specific result, two needle electrodes 116 set to an acute angle of 60 are introduced into one of the lateral lobes of the prostate. After applying 4-15 watts of radio frequency energy for 3 minutes, the temperature at the end of the damage is about 40-50°C and the temperature at the center of the damage is about 80-100°C. The temperature of the urethral wall 408 is 37-42°C on average, which is much lower than the temperature of 55°C at which the urethral wall 408 will be thermally damaged. By the controlled application of radio frequency energy for a predetermined period of time. With this procedure, the urethral wall can be protected and the sac surrounding the prostate can be kept intact. In other words, the damage is caused in the lateral lobe and away from the urethral wall and prostate sac.

After one of the lateral lobes of the prostate 406 is treated by forming two lesions with two needle electrodes 116, the doctor pulls back the sliding control members 132 and 133 that control the deployment of the needle electrodes 116 while using the cystoscope 271 . The back pulling of the sliding control members 132 and 133 moves the sliding member assemblies 142 and 143 backward to overcome the braking action of the brake members 162 and 163, so that the sliding member assemblies 142 and 143 engage with the adjusting plate portion 151 to cause sliding at the same time Control the withdrawal of members 131 and 134. The backward movement of the sliding member assemblies 142 and 143 carrying the needle electrode 116 and the insulating sliding member carried together is possible by making the needle electrode and sliding member assemblies 142 and 143 carried by the insulating stop release arm 169 and the latch The wedge surface 388 provided by the protruding portion 386 of the lock arm 381 engages with the wedge latch arm 381 outward toward the side wall of the casing 126, thereby releasing the portion 153 carried by the insulating sliding members 141 and 144 to insulate The sliding members 141 and 144 are not restricted by the latch arm 381 (see FIG. 26), and thereafter, the sliding member assemblies 142 and 143 and the sliding members 141 and 144 carried together are allowed to continue to move backwards until they reach the rearmost position. . The pipe assemblies 51 and 52 can then be straightened by connecting them backwards on the lever assemblies 216 and 217.

Assuming that the needle electrode 116 is introduced into one of the lateral lobes of the prostate 406 in a plane, such as a plane just below the bladder neck, the sheath 32 can be retracted together with the needle electrode 116 and the insulating tube 86 so that they are recovered in Behind the urethral wall 408. The sheath 32 can then be rotated, for example 120. The distal end of the needle electrode 116 is maintained in the same plane but opposite to the other lateral lobe of the prostate. Once this repositioning is completed, the lever assemblies 216 and 217 can be operated again to bend the distal ends of the catheter assemblies 51 and 52 in the aforementioned manner. The sliding control members 131-134 can then be actuated in the aforementioned manner to cause the needle electrode 116 and the insulating sheath 86 to penetrate the urethral wall 408 and advance into the prostate tissue in the other lateral lobe. Assuming that the same setting used for the other lobe is used, the needle electrode 116 is extended into the desired position in the tissue of the other lobe and the proper length of the needle electrode is exposed by recovering the insulating tube 86 to expose the insulating tube The needle electrode 116 is still placed at a distance beyond the urethral wall 408 so that the urethral wall 480 is protected during the procedure. Then, the radio frequency energy is applied at the appropriate power level and time to cause two damages to the other side leaf. After this is completed, the needle electrode 116 and the insulating tube 86 can be retrieved as described above so that they are retracted behind the urethral wall 408. Then, if additional damage needs to be produced in different planes in the prostate 406, the doctor can hold the handle 121 to the next plane so that the distal end of the sheath 32 is repeatedly used for the same two lateral lobes. The program is repositioned on the next plane.

It has been found that the number of treatment planes or planes in which damage is to be produced depends on the size of the prostate being treated. In this way, in the case that the distance from the fine carp to the bladder neck is less than 3 cm, generally only a single treatment plane is required and this treatment plane is located at the midpoint between the fine carp and the bladder neck. If the distance from Jingfu to the bladder neck exceeds 3 cm to 4 cm, two treatment planes are generally used, and the end plane is about 2 cm away from Jingfu and the other treatment plane is about 1 cm away from Jingfu. When the distance from Jingfu to the bladder neck is greater than 4 cm, typically three cross-sectional treatment planes are formed at 1, 2 and 3 cm before Jingfu.

After the required number of lesions has been formed in the prostate tissue 406, the sliding control members 131-134 can be brought back, and then the knobs 218 of the control lever assemblies 216 and 217 can be pulled back to remove the catheter assembly 51 And the 90 bend at the far end of 52. The distal ends of the catheter assemblies 51 and 52 are retracted into the distal end of the sheath 32 by pressing the button 307b or 307c to align one of the notches 316 or 317 with the rail 296 to allow the handle and catheter assembly 124 Partial retraction allows the distal ends of catheter assemblies 51 and 52 to be retracted into the sheath. Once this is completed, the entire urethral needle resection device 31 can be removed from the urethra 404 of the penis 407 to complete the TUNA procedure.

At this time, the doctor may choose to introduce antibiotics into the urethra 404 to help prevent the occurrence of infection. After the procedure is completed, the patient can typically rest for a short period of time and then stay in the operating room and go home.

In the TUNA procedure, the position of the distal end of the needle electrode is always at least 6mm away from the capsule of the prostate to ensure that the integrity of the capsule will not be damaged by the TUNA procedure. Similarly, the insulating tube 86 is deployed beyond the urethral wall by a distance of 4-6 mm to protect the integrity of the urethral wall from being damaged by the TUNA procedure. The small hole that penetrates the urethral wall is easy to heal after the TUNA procedure.

Typically, patients who have undergone the TUNA procedure and have had difficulty urinating before this procedure will experience some kind of relaxation of smooth muscle tissue, which leads to reduced urethral constriction. Thus, in a very short period from n hours to 24-48 hours, the patient experiences a certain degree of improvement in urine flow. Over a long period of time, it has been found that no catheterization is required and the patient experiences improved urine flow in a relatively short period of 1-4 days. The longer-term results of patients who have undergone the TUNA procedure have confirmed that the patients urine flow is greatly improved after 6-12 weeks, and even after 6-9 months after the TUNA procedure, the patients urine flow is equivalent to Urine flow in young men.

In connection with this TUNA procedure, it has been found that when irreversible tissue damage is produced in the prostate tissue to provide a rising and lasting medical benefit, if a temperature above 45°C is applied for a significant period of time, it will cause cell necrosis. However, in order to achieve the thermal release related to this TUNA procedure, it is appropriate to provide a temperature of 60°C and above in order to shorten the application time of radio frequency energy to a reasonable time. In this way, even when most damages are produced in the prostate tissue, the entire process can typically be completed within 15-25 minutes using the TUNA device 31. The high temperature of 80-100°C, which partially surrounds the needle electrode 116, substantially exceeding 60°C is easily reached and must only be applied for 3-5 minutes. Thus, although the measured temperature at the tip of the insulating tube 86 can be as high as 75°C, the temperature at the tip of the needle electrode is typically higher by 30-45°C. As explained earlier, about 30 days after the TUNA procedure, the main necrotic Damage can be obtained, and the damage exhibits extensive coagulation necrosis, measuring 15×8 mm by the naked eye and 30×15 mm by the microscope.

The penetration of electromagnetic waves into the prostate tissue depends on the frequency of the electromagnetic waves. The lower the frequency, the higher the penetration. The radio frequency used for the radio frequency energy used in connection with the TUNA device 31 is about 490 kHz, which provides a deeper penetration and a more uniform temperature distribution than microwaves of 300-3000 mHz. TUNA devices can use very low power levels such as 5-10 watts to produce damage with clearly defined edges. This is due to the very steep temperature gradient from the needle electrode to the damaged periphery. This can be compared with microwave therapy through the urethra, which generates a temperature gradient of several millimeters of 5-15°C in the damaged area adjacent to the urethra and a temperature gradient of 1-2°C per millimeter near the capsule. On the other hand, the TUNA device uses radio frequency energy near 490kHz to provide a much steeper gradient, which is 58°C per millimeter near the proximal end of the needle electrode 116 (the area near the urethral wall) and near the tip of the needle electrode ( The area 1 close to the prostate capsule is 30°C per millimeter.

It can be seen from the above that the TUNA program using the TUNA device of the present invention can provide a very selective controlled partial detachment area in the prostate. The integrity of the prostate sac and urethral wall is maintained. Small perforations in the urethral wall during the procedure can heal quickly. Bleeding is minimized and the possibility of infection is greatly reduced. Although as many as 8 to 12 lesions may need to be produced in any one prostate, the procedure can still be completed in a time frame of 20-40 minutes. This procedure can be done relatively inexpensively in an outpatient setting and only requires local anesthesia. In this way, it can be seen that the TUNA procedure provides a feasible and inexpensive alternative method to replace the traditional procedure for the treatment of benign prostatic hyperplasia.

Another embodiment of the TUNA device, which may be referred to as TUNA IV, is shown in FIGS. 35-38 and is referred to as device 451 in the figures. The handle and duct assembly 452 included in this device 451 is very similar to the TUNA III is related to the handle and catheter assembly 124 described in the front. The handle and conduit assembly 452 is adapted to be engaged with the bridge 456, and the form of the bridge 456 is also the same as the previous description for TUNAIII. The sheath 461 is connected to the bridge 456 in the same manner as the sheath 32. However, the size of the sheath 461 is smaller, such as 16 French instead of the 22 French used for the sheath 32, so that the sheath 461 can enter the urethra of the penis without the additional expansion required to use the sheath 32. The urethral wall 461 has a lumen 462. In the lumen 462, a fiber optic tube 466 having a diameter smaller than that of the tube 272 is configured together with the catheter assemblies 51 and 52 to form a substantially triangular shape, as shown in FIG. 37. The fiber optic tube 466 has an outer stainless steel tube 468 with an outer diameter of 0.05". The polyurethane inner sheath 469 is arranged in the tube 468 and encloses the hollow cylindrical optical fiber bundle 471. The fiber bundle 471 surrounds the observation fiber bundle 472. The lens assembly 476, which includes a cylindrical lens unit 477 with internal steps, carries a plano-convex lens 478 at each end. One end of the lens unit 477 abuts the distal end of the observation fiber bundle 472 to a butt joint formed by an adhesive cured by ultraviolet rays The head 481. The lens unit 477 is supported in the distal end of the optical fiber bundle 471. The optical fiber bundle 471 is supported by the inner and outer polyurethane sheaths 483 and 484, and the sheaths 483 and 484 are fixed by the adhesive in the connector 486 In the tube 468 and the polyurethane sheath 469. The lens unit 477 with its plano-convex lens 478 provides a wider visual range.

The sheath 461 can be formed of stainless steel or plastic, but typically a thin-walled stainless steel tube is more suitable for obtaining appropriate rigidity to facilitate the introduction of the TUNA IV device into the urethra, and can support and support the sheath when the sheath is introduced into the prostate. Straighten the urethra.

The fiber optic tube 466 forms a part of the cystoscope 491 equipped with the eyepiece 492. The cystoscope 491 extends through a three-way coupler 496 mounted on the proximal end of the bridge 456. The three-way coupling 496 is equipped with first and second ports 497 and 498, wherein the port 497 can be used to introduce light and the other port 498 can be used to introduce fluid.

The adjustment mechanism 501 is provided on the cystoscope 491 to allow the longitudinal adjustment of the cystoscope to the bridge 456 so that the plano-convex lens 478 can be appropriately positioned relative to the distal end of the sheath 461. The adjusting device includes a threaded cap 501 which is screwed on the extension 503 of the three-way connector body 504. The optical coupling 506 is slidably installed in a well 507 formed in the body and has a radially extending flange 508 under the cap 502. The optical connector 506 extends through the hole 509 in the cap 502 and has a threaded portion 506a. A nut 511 is screwed on this portion 506a to fix the connector 506 on the cap 502. The fiber optic tube 466 is connected to the coupler 506 and moves together with the coupler 506. The coupling 506 carries the observation fiber 472 and the light transmission fiber 471. When the cap 502 is adjusted in the longitudinal direction of the body 504, the cap will carry the fiber optic tube 466 so that the distal end of the plano-convex lens 478 can be accurately adjusted relative to the distal end of the sheath 461 to optimize the observation ability of the device 451 change.

The TUNA IV device 451 can be used to implement the aforementioned TUNA program in the same manner as the TUNA III device 31. The main advantage of the TUNA IV device is that it can be used in men with a smaller urethra or in men whose urethral wall does not require a large amount of swelling. This device is also equipped with adjustment devices to optimize optical observation.