WO1993025136A2

WO1993025136A2 - Method and apparatus for prostatic treatment

Info

Publication number: WO1993025136A2
Application number: PCT/US1993/005359
Authority: WO
Inventors: Albert K. Chin; R. Scott Neely; Kirsten Lee Valley; Randy Kesten; Lynette Marie Ross; Benjamin Gordon Shaw; Stephen J. Schoenberg
Original assignee: Chin Albert K; Neely R Scott; Kirsten Lee Valley; Randy Kesten; Lynette Marie Ross; Benjamin Gordon Shaw; Schoenberg Stephen J
Priority date: 1992-06-05
Filing date: 1993-06-04
Publication date: 1993-12-23
Also published as: WO1993025136A3; AU4407093A

Abstract

The invention provides a method and apparatus for treatment of the prostate. In a preferred embodiment, the apparatus includes a shaft having a first axial lumen and a sleeve disposed in the axial lumen of the shaft, the sleeve having an axial passage with an open distal end. The axial passage of the sleeve has a distal portion disposed at an angle relative to the axial direction. An optical fiber is disposed in the axial passage of the sleeve and has a connector at its proximal end for connection to a laser and a sharp distal tip for tissue penetration. The optical fiber may be advanced distally in the axial passage of the sleeve and deflected toward the prostate by the angled distal portion of the axial passage. The optical fiber thus penetrates out of the urethra and into the prostate. Laser energy may then be delivered through the optical fiber directly into the prostate for ablation of prostatic tissue. The apparatus may further include optical means in the shaft for visualizing distally of the shaft to facilitate penetration of the prostate at the desired site.

Description

METHOD AND APPARATUS FOR PROSTATIC TREATMENT

BACKGROUND OF THE INVENTION The present invention relates to methods and apparatus for treatment of hollow body organs, and more specifically for treatment of the prostate gland.

Benign prostate hyperplasia (BPH) is a widespread disease in males generally involving gradual enlargement of the prostate gland. As the prostate enlarges, it commonly leads to obstruction of the urethra in the region below the bladder. A variety of techniques have been developed for treatment of BPH. For example, balloon dilatation has been used to enlarge the urethra in the obstructed region. However, symptoms of obstructive voiding often recur within one to two years of the dilatation procedure.

Another well known procedure for BPH treatment is transurethral resection (TUR). TUR involves positioning a resectoscope through the urethra into the prostate, and using a cutting instrument, such as a heated wire, to incise obstructing portions of the prostate. Unfortunately, TUR commonly produces a number of undesirable side effects, including retrograde ejaculation, urinary retention, and impotence. Moreover, TUR procedures have a morbidity rate as high as 25%. Other techniques for treatment of BPH have involved hypothermia or hyperthermia. The use of microwave energy for hyperthermic ablation of the prostate has been used in recent years with promising results. Present methods of microwave prostatic ablation employ a microwave antenna placed in the urethra or in the rectum to delivery energy to the prostate. Such methods suffer from several disadvantages, however. First, because much of the prostate gland lies anterior to the prostatic urethra, the energy must be applied to the prostate anteriorly. This leaves the rectal wall vulnerable to heating in the posterior direction, requiring a shield or cooling mechanism for the rectum. Such shielding is imprecise and difficult to implement. Second, it is difficult to focus the microwave energy transmitted radially from the antenna to the treatment area, without heating nearby tissue as well. Heating the mucosa of the urethra during the treatment of the prostate may lead to complications such as urethral stricture, urinary retention, or retrograde ejaculation.

In order to decrease the injury to urethral mucosa during microwave ablation, it is known to infuse saline into the urethra around the microwave antenna to cool the mucosa during prostatic ablation. This, however, leads to further problems in controlling the rate and extent of ablation due to the effect of the saline on energy delivery. Moreover, if the microwave energy overheats the saline, mucosal damage may still result. Further, the complexity and traumatic impact of TUR generally require the procedure to be performed in hospital surgical facilities on an in-patient basis, with patients remaining in the hospital up to three or more days for post-operative recovery.

For these and other reasons, a method and apparatus for treating BPH and other prostatic diseases is desired which overcome the problems of known techniques. The method and apparatus should provide for debulking the prostate gland to reduce obstruction of the urethra, while reducing the incidence of undesirable side effects such as retrograde ejaculation, urinary retention, urethral stricture or impotence. Preferably, the method and apparatus should facilitate ablative heating of the prostate gland with precision and controllability, so as to prevent heating of nearby tissue, such as urethral mucosa or rectal tissue. Most desirably, the method and apparatus should permit direct treatment of specific sites in the prostate gland by direct contact therewith. In addition, the method and apparatus should be minimally invasive, and should minimize the need for anesthetics, surgical facilities and equipment, multiple personnel and complex procedures of long duration.

SUMMARY OF THE INVENTION The present invention provides a method and apparatus for treatment of the prostate which eliminate many of the disadvantages of previous techniques. The method and apparatus facilitate placement of an energy conductive fiber directly into a desired site in the prostate gland, by penetrating through the urethral wall and into the prostate using the tip of the fiber itself. Once the fiber is in place, it may be coupled to an energy source, such as a laser, microwave, ultrasound, RF power or other source, for direct application of heat to the site in the gland. Usually, two or more fibers are positioned in one or both the lateral lobes of the prostate for direct application of heat thereto. The method and apparatus may further be used to perform biopsies, cauterizing, drug delivery and a variety of other procedures, including treatment of organs other than the prostate.

In a preferred embodiment, the apparatus of the invention comprises a shaft positionable in the urethra, the shaft having a distal end, a proximal end and a first axial lumen with an opening at the distal end. A first energy conductive fiber is slidably disposed in the first lumen and has a distal end and a proximal end, the proximal end including means for connecting to an energy source and the distal end including means for penetrating prostatic tissue. Means are provided at the distal end of the shaft for deflecting the first conductive fiber in a first direction toward the prostate, wherein the first conductive fiber may be advanced distally from the shaft to penetrate prostatic tissue for direct delivery of energy thereto. Preferably, optical means are disposed in the shaft for visualization distally of the distal end of the shaft.

In a preferred embodiment, the first conductive fiber comprises an optical fiber, and it has a connector at its proximal end configured for connection to a laser. The means for penetrating preferably comprises a sharp point on the fiber for penetrating the urethral wall and the prostatic tissue.

In an exemplary embodiment, the means for deflecting comprises a distal portion of the first lumen disposed at a first angle relative to the axial direction, the first angle being selected so as to direct the first conductive fiber toward the prostate as the fiber is advanced relative to the shaft. Alternatively, a sleeve is disposed in the first lumen having a proximal end, a distal end and an axial passage therebetween. The first conductive fiber is slidably disposed in the axial passage of the sleeve, and the means for deflecting comprises a distal portion of the axial passage disposed at a first angle relative to the axial direction. The first angle is selected to direct the first conductive fiber toward the prostate as the fiber is advanced relative to the sleeve. Preferably, the sleeve will be removably disposed in the first lumen of the shaft, permitting the use of various types and numbers of conductive fibers with the shaft, as well as permitting the shaft to be withdrawn from the urethra once the fibers have been positioned in the prostate. The apparatus will preferably include two or more conductive fibers slidably disposed in axial lumens in the shaft. The shaft may include multiple axial lumens in which the conductive fibers are disposed, the lumens having a distal portion disposed at an angle relative to the axial direction selected to direct the conductive fibers toward the prostate. Alternatively, each fiber is disposed in a sleeve disposed in the first axial lumen of the shaft, each sleeve having an axial passage. The conductive fibers are slidably disposed in the axial passage of each sleeve, and the axial passages of the sleeves have a distal portion disposed at an angle relative to the axial direction to direct the conductive fibers toward the prostate. The sleeves may by configured so that the conductive fibers may penetrate a single lobe of the prostate at the same time, or so that the conductive fibers may penetrate two different lobes of the prostate at the same time. Further, the sleeves may be axially slidable or rotatable relative to the shaft such that the fibers penetrate the prostate at different axial or radial positions relative to the shaft. The shaft may be either rigid or flexible, and, in one embodiment, may comprise a cystoscope of conventional construction. The optical means will usually comprise an eyepiece at the proximal end of the shaft, a lens at the distal end of the shaft, and an optical passage therebetween. Advantageously, the first conductive fiber may include markings on a distal portion thereof for indicating the position of the distal end of the fiber. In this way, the markings may be observed through the optical means as the fiber is advanced to facilitate penetration of the prostate at the desired site.

Either the shaft or the sheaths of the apparatus may include expansion means near the distal end for engaging the walls of the urethra. The expansion means will usually comprise a balloon with an inflation lumen extending from the proximal end of the shaft to the balloon. The expansion means may be used to anchor the shaft or sheaths in place, or for dilation of the urethra during or after treatment. Such dilation may be advantageous during treatment to reduce blood flow in the treatment area, or after treatment to reduce constriction of the urethra from swelling induced by tissue ablation. In a particular embodiment, the apparatus further includes means at the distal end of the first conductive fiber for anchoring the fiber in the prostatic tissue. The anchoring means may comprise a balloon attached to the first conductive fiber and an inflation lumen extending from the proximal end of the shaft to the balloon. In this way, once the fibers have been positioned in the prostate, the anchoring means may be used to hold the fibers in place during delivery of energy to prostatic tissue, permitting removal of the shaft from the urethra if desired.

The method of the present invention includes, in a preferred embodiment, the steps of positioning an optical fiber in the urethra of a patient; deflecting a distal end of the optical fiber toward a portion of the prostate; penetrating through the urethra and into the prostate with the distal end of the optical fiber; and delivering laser energy directly to the prostate through the optical fiber to ablate a portion of prostatic tissue. Preferably, the method will further include looking distally of the shaft through a lens disposed in the shaft to assist positioning the fiber to penetrate the prostate. The method may include positioning a plurality optical fibers in the urethra, deflecting the distal ends of the optical fibers toward the prostate, penetrating out of the urethra and into the prostate with the distal end of the fibers, and delivering laser energy through the optical fibers to the prostate. Multiple optical fibers may be positioned in a single lateral lobe of the prostate at the same time, or in two different lateral lobes. The present invention provides a method and apparatus which facilitate prostatic ablation and other medical procedures with improved precision, reduced complexity, lower cost and minimal invasiveness. The method and apparatus allow treatment of BPH in a manner which eliminates many of the undesirable side effects of previous techniques, such as retrograde ejaculation, urethral stricture, urinary retention, and impotence. The method and apparatus allow direct application of heat to a specific treatment site in the prostate without risk of overheating sensitive tissue in the urethra or rectum. Moreover, the method and apparatus facilitate the use of a variety of energy sources for such heating, including lasers, microwave sources, infrared sources and others. The treatment method of the present invention may be performed in very little time and at very little cost relative to previous procedures. The procedure may be performed on an outpatient basis without the need for complex surgical facilities, numerous personnel or sophisticated equipment. Traumatic impact on the patient is further minimized.

A further understanding of the nature and advantages of the invention may be realized by reference to the remaining portions of the specification and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view of a prostatic treatment apparatus constructed in accordance with the principles of the present invention.

Fig. 2 is a perspective cutaway view of a distal end of the prostatic treatment apparatus of Fig. 1.

Fig. 3 is a top elevational view of the prostatic treatment apparatus of Fig. 1. Fig. 4 is a transverse cross-sectional view of a proximal portion of the prostatic treatment apparatus of Fig. 1.

Fig. 5 is a transverse cross-sectional view of the distal portion of the prostatic treatment apparatus of Fig. 1. Fig. 6 is a top elevational view of the stylet and sheath of the prostatic treatment apparatus of Fig. 1.

Figs. 7A-7C are side cross-sectional views illustrating the method of prostatic ablation performed in accordance with the principles of the present invention.

Fig. 8 is a perspective view a distal portion of a further embodiment of the prostatic treatment apparatus constructed in accordance with the principles of the present invention.

Fig. 8A is a transverse cross section through line A-A in Fig. 8.

Fig. 9 is a perspective view of a distal portion of an alternative embodiment of the prostatic treatment apparatus constructed in accordance with the principles of the present invention.

Fig. 10 is a perspective view of yet another embodiment of a prostatic treatment apparatus constructed in accordance with the principles of the present invention.

Fig. 10A is transverse cross-section through line A-A in Fig. 10.

Fig. 11 is a side cross-sectional view of the sleeve, fiber and actuator of the apparatus of Fig. 10 in a first embodiment.

Fig. 11A is an enlarged side cross-sectional view of distal end of the sleeve of Fig. 11.

Fig. 12 is a side cross-sectional view of the sleeve, fiber and actuator of the apparatus of Fig. 10 is a second embodiment thereof. Fig. 12A is a enlarged side cross-sectional view of the distal end of the sleeve of Fig. 12.

Fig. 13 is a side cross-sectional view of the sleeve, fiber and actuator of the apparatus of Fig. 10 in a third embodiment thereof.

Fig. 13A is a enlarged side cross-sectional view of the distal end of the sleeve of Fig. 13.

Fig. 13B is a distal end view of the sleeve of Fig. 13.

Fig. 14A-14B are side cross-sectional views of two further embodiments of the sleeve, fiber and actuator of Fig. 10. DESCRIPTION OF SPECIFIC EMBODIMENTS Referring to Fig. 1 , the apparatus of the present invention includes, in a preferred embodiment, a catheter 10 having a distal end 12 and a proximal end 14. Usually, a handle 16 is attached to the proximal end 14 of the catheter 10 to facilitate a firm, one-handed grip on the apparatus.

Catheter 10 is a rigid or semi-rigid tube constructed of biocompatible metal or plastic. Usually, the catheter 10 is rigid enough to have sufficient column strength to negotiate the urethra to the area of the prostate. The catheter will have a length in the range of 20 cm to 40 cm, and a diameter typically in the range of 20 French to 30 French. A pair of lumens 18, 20 extend from the proximal end 14 to a point near the distal end 12. A proximal portion 22, 24 of each lumen angles away from the longitudinal axis of catheter 10 with openings 26, 28 at the distal ends of lumens 18, 20 being disposed on the lateral surface of catheter 10. A pair of probes 30, 32 are disposed in lumens 18, 20, as will be described more fully below. Distal end 12 of the catheter 10 is typically rounded so that it may be inserted into the urethra easily and with minimal trauma. Distal end 12 of the catheter may also comprise a flexible nose piece extending distally from a point distal of openings 26, 28 for negotiating a curved portion of the urethra posterior to the portion adjacent the prostate. A balloon 34 is attached to a distal portion of catheter 10 on its exterior at a point proximally of openings 26, 28 of lumens 18, 20. An inflation lumen 36 connects balloon 34 to inflation port 38, which may be connected to tubing 40 from an inflation fluid source. Usually, balloon 34 is an elastic thermoplastic material of well known construction. The balloon will typically be inflatable to a diameter of 10-15 mm. Referring now to Fig. 2, a distal portion of catheter 10 is illustrated. It can be seen that probes 30, 32 may be extended distally and laterally through openings 26, 28 in lumens 18, 20. The probes include stylets 50, 52 removably disposed within sheaths 46, 48. Distal tips 42, 44 of stylets 50, 52 have sharp points for penetrating the urethra wall and the prostate. Distal ends 54, 56 of sheaths 46, 48 are tapered to facilitate entry into the prostate with minimal interference. Distal portions 22, 24 of lumens 18, 20 are configured to deflect the distal portions of probes 30, 32 at an angle which will direct the probes into lateral lobes 58, 60 of the prostate (shown in phantom). Handle 16 further provides a visual reference to indicate to the user the rotational position of the catheter and the distal openings 26, 28 therein, so as to properly position the probes adjacent the lateral lobes.

Referring now to Fig. 3, probes 30, 32 extend through lumens 18, 20 of catheter 10. When tips 42, 44 of the probes are retracted so as to be in a proximal position relative to openings 26, 28, the proximal ends 62, 64 of the probes extend proximally of the proximal end 14 of catheter 10. Thumb pads 62, 64 are disposed at the proximal end of probes 30, 32, as shown in Fig. 6, allowing the user to grip handle 16 with the fingers and position the thumb on thumb pads 62, 64. When the catheter has been positioned in the urethra, probes 30, 32 can be extended through openings 26, 28 by pushing distally on thumb pads 62, 64. The catheter may further include one or more thermocouples 71 disposed at or near distal end 12. The thermocouple leads (not shown) extend through a separate lead lumen 73 in catheter 10.

Referring to Fig. 4, a transverse cross-section of the proximal portion of catheter 10 is illustrated. The proximal portion of the catheter includes lumens 18, 20 in a lower portion thereof, and inflation lumen 36 in an upper portion. If thermocouple 71 is used, a lead lumen 73 is provided to house the thermocouple leads.

In a distal portion of the catheter, as shown in Fig. 5, lumens 18, 20 curve laterally upward and outward such that openings 26, 28 are disposed at an angle θ, which may range from approximately 50° to 150°. Usually, the angle θ is chosen such that extending probes 30, 32 will cause distal points 42, 44 to penetrate the lateral lobes of the prostate, as will be described more fully below. Lumens 18, 20 curve at a gentle radius through distal portions 22, 24 to openings 26, 28, to facilitate extension of the probes through the curve and the openings without interference or kinking.

Referring to Fig. 6, probes 30, 32 include a sheath 46, 48 and an stylet 50, 52. The sheath is typically made of a plastic material which is flexible and biocompatible. The sheath is usually heat resistant to accommodate a heating applicator, as described below. Stylet 50, 52 is removably disposed in the sheath, with distal tip 42, 44 extending from the tapered distal end 54, 56 of the sheath. Preferably, sharpened tip 42, 44 extends a short distance from distal end 54, 56 of the sheath when thumb pad 62, 64 is positioned against proximal end 66 of the sheath. Stylet 50, 52 is typically solid steel or stainless steel for rigidity and flexibility. Tip 42, 44 is sharpened to allow penetration of the prostate. In a preferred embodiment, sheath 46, 48 further includes a thermocouple 68 at its distal end and a lead 69 which may be connected to a thermocouple meter 70. Preferably, thermocouple lead 69 is disposed in a lumen 72 in the wall of sheath 46, 48. Referring to Figs. 7A-7C, the method of the present invention will now be described. In a preferred embodiment, the apparatus of the present invention is positioned with a distal portion of catheter 10 in the urethra 74 of a patient. Catheter 10 is inserted into the urethra until distal end 12 lies within the region surrounded by prostate 76. Balloon 34 is uninflated during the insertion of catheter 10, and probes 30, 32 are in a retracted position such that their distal tips do not protrude from openings 26, 28. Usually, an ultrasonic probe 78 positioned in the rectum 80 allows the position of the lateral lobes in prostate 76 to be identified. By using ultrasound probe 80 to locate the position and angular displacement between the lateral lobes, an apparatus can be selected with the proper angle between openings 26, 28 such that probes 30, 32 will be directed toward the lateral lobes. Ultrasound probe 80 positioned in the rectum further facilitates precise positioning of the catheter with openings 26, 28 aligned with the lateral lobes. Stylets 50, 52, typically being steel or stainless steel, are echogenic, so that they are readily visualized on the ultrasound monitor. This assists in the positioning of catheter 10.

When the catheter 10 has been inserted into urethra 74 to the proper location, balloon 34 is inflated through inflation port 38 using inflation fluid through tubing 40. The expansion of balloon 34 in the distal portion of catheter 10 anchors the catheter in position and prevents unintentional retraction of the catheter from urethra 74.

With the apparatus properly positioned with openings 26, 28 residing near the lateral lobes of prostate 76, thumb pads 62, 64 in probes 50, 52 are pushed distally so as to extend the distal ends of the probes 30, 32 through openings 26, 28. The probes are advanced a desired distance, and the stylets 50, 52 are then withdrawn from sheaths 46, 48, leaving the apparatus configured as shown in Figs. 7B. Distal ends 54, 56 of the sheaths extend through openings 26, 28 of catheter 10 and penetrate the lateral lobes of prostate 76. With sheaths 46, 48 positioned with their distal ends 54, 56 in the lateral lobes of prostate 76, the treatment of the prostate may begin. In a preferred embodiment, this will include inserting a heating applicator through sheaths 46, 48 with a distal portion of the heating applicators 82, 84 extending distally of the distal ends 54, 56 of the sheaths. The shafts of the heating applicators may include markers or fittings to indicate when the probes have been advanced to the proper positions within sheaths 46, 48. The heating applicators are connected to a control console 86 providing an energy source for the heating applicators. The energy source may comprise a laser, infrared, microwave, ultrasound or other such source. The nature of the heating applicators used will of course depend upon the energy source selected. Console 86 is activated to deliver energy through the heating applicators into lateral lobes 58, 60, thereby ablating prostatic tissue in the area surrounding distal tips 82, 84. Thermocouples in the distal tip 12 of catheter 10 and/or in the distal ends 54, 56 of sheaths 46, 48 allow monitoring of tissue temperature in the region of the ablation to control the heating of the tissue. In this manner, heating can be precisely focused on a desired treatment area, without adversely affecting other sensitive tissue.

In an exemplary embodiment, energy is applied to the tissue of the lateral lobes to heat the tissue to a temperature in the range of 40°C to 60°C, for a time of approximately 15 mins.to 60 mins. This results in necrosis of a portion of tissue in the interior of prostate 76, reducing the prostate in size and thereby alleviating obstruction of urethra 74. At the same time, the ability to focus heat application to the lateral lobe tissue near the distal ends of sheaths 46, 48 greatly reduces the risk of damage to mucosal tissue in urethra 74, tissue in rectum 80, or other heat-sensitive tissue. Following treatment, the heating applicators are withdrawn from sheaths 46,

48 and the sheaths are removed from catheter 10. Balloon 34 is deflated through inflation port 38, and the catheter is removed from urethra 74.

Alternate embodiments of the apparatus of the invention are depicted in Figs. 8-15. These embodiments include fibers for conducting energy into the tissue of the prostate. In these embodiments, the fibers are provided with sharpened tips at their distal ends so that the prostatic tissue may be penetrated by the fibers themselves. The fibers will be sufficiently flexible to be deflected from the urethra toward the prostate, but will have sufficient column strength to penetrate the urethral wall and prostatic tissue. In a preferred embodiment, the fibers will be optical fibers for transmission of laser light for tissue ablation. However, it will be understood that the fibers may alternatively be constructed to conduct energy in a variety of other forms, including RF power, microwave or ultrasound. Referring to Fig. 8, the apparatus is depicted including a shaft 100 and a pair of optical fibers 105. Shaft 100 may be constructed similarly to catheter 10 described above with reference to Figs. 1-7. Figure 8A is a cross-sectional view through the shaft at section lines A-A. As can be seen in Fig. 8A, shaft 100 includes at least one fiber lumen 110 in which fiber 105 is slidably disposed. The shaft may also have a visualization lumen 115 and an irrigation lumen 120. Visualization lumen 115 provides a pathway through which a fiber optic visualization device may be positioned for viewing the area in the vicinity of the distal end 125 of shaft 100. Irrigation lumen 120 provides a path for the introduction of fluid for irrigation in the vicinity of distal end 125. In some embodiments, shaft 100 will be flexible; in other embodiments the shaft may be relatively rigid. The shaft may be constructed of biocompatible metals, polymeric material, or composites of the two. In flexible embodiments, the shaft may be constructed of a polymeric extrusion, with braided metal reinforcement embedded in its walls if greater rigidity is desired.

When the apparatus is used, fibers 105 are extended through lumens 110 until they are deflected toward the prostate 130 by means near the distal end 125 of the shaft. In the embodiment depicted in Fig. 8, the deflecting means comprises openings 135 in the side of shaft 100 through which fibers 105 exit towards the prostate. Lumens 110 have a distal portion (shown in phantom) disposed at an angle relative to the axial direction for directing the distal end of each fiber toward the prostate, much like lumens 30, 32 described above in connection with Figs. 1-7. In the embodiment depicted, the openings 135 are disposed so that one fiber is directed into each of the two lobes of the prostate 130.

As the fibers are extended, sharpened tips 137 at the distal end of the fibers penetrate through the wall of the urethra and into the tissue of the prostate. With the distal ends of the fibers embedded in the prostate, energy may be conducted along the fibers directly into the prostatic tissue. Usually, a laser will be connected to the proximal end of fibers 105, and laser light will be delivered through the fibers to ablate prostatic tissue in the vicinity of tips 137.

Figure 9 depicts an embodiment in which shaft 100 is again provided with deflecting means in the form of angled distal portions (shown in phantom) leading to openings 135. In this embodiment, however, the openings are disposed so that both fibers are directed to penetrate the tissue of a single lobe of the prostate at the same time. This configuration is particularly advantageous in that it permits simultaneous application of heat at two or more different location within the same lobe, significantly increasing the volume of tissue which may be treated at a given time.

In some embodiments, the fibers may be positioned in the urethra through a shaft of a separate instrument such as a cystoscope. In the embodiment depicted in Figs. 10-lOA, fibers 105 are slidably disposed in axial passages 147 in sleeves 140 (Fig. 10A). Sleeves 140 carrying fibers 105 are carried by the hollow shaft 155 of cystoscope 160. Cystoscope 160 includes visualization means including an eyepiece 165 at the proximal end, a lens 170 near the distal end, and a tube therebetween defining a visualization lumen 175. Preferably, eyepiece 165, tube 167 and lens 170 are removable from shaft 155. The region of the urethra distally of shaft 155 may be viewed through eyepiece 165 and lens 170 to properly position cystoscope 160 in the urethra and to position fibers 105 such that they penetrate the prostate at the desired sites.

Sleeves 140 are configured to deflect fibers 105 in a direction away from the axial direction (the longitudinal axis of the shaft), as described more fully below. Each sleeve 140 also has an actuator 190 coupled to its proximal end, which is also coupled to a fiber 105. By moving the actuator 190 with respect to the sleeve, fibers 105 may be extended out of or retracted into sleeves 140. In some embodiments, fibers 105 may be provided with markings 195 to indicate the location and degree of extension of the fibers, which may be viewed through eyepiece 165 and lens 170. Fibers 105 have connections 200 at their proximal ends for connection to a source of energy for tissue ablation, which will usually be a laser.

Fiber-sleeve combinations for use with cystoscope 160 may be constructed in a variety of configurations. In the embodiment depicted in Fig. 11, sleeves 140 include deflecting means in the form of bends 150 in axial passages 147 near their distal ends, as depicted in more detail in Fig. 11 A. When the fiber is extended, it exits the sleeve at an angle away from the axial direction (the longitudinal axis of the sleeve). By moving the sleeves axially and rotating the sleeves radially relative to the shaft and then extending the fibers from the sleeves, the user of the apparatus may cause the fibers to penetrate the tissue of the prostate in a variety of desired locations. Multiple fibers may be penetrated into a single lobe simultaneously, or the fibers may be directed into different lobes, as desired by the user.

Figure 12 depicts an embodiment in which a pair of sleeves 140 run parallel to one another. In this embodiment, each fiber 105 exits its sleeve 140 at an angle, as can be more clearly seen in Fig. 12 A. Referring again to Fig. 12, one of the fibers exits its sleeve parallel to but axially separated a fixed distance from the other fiber. This sleeve- fiber combination will be useful when it is desirable to penetrate the prostate in a single lobe in a pair of separate locations. Figure 13 depicts an embodiment in which the fibers exit their respective sleeves at approximately the same axial location (as can be seen in Fig. 13A) but at differing angles (as can be seen in Fig. 13B). Fibers 105 will usually be disposed at an angle between 100" and 140^* , and preferably about 120^* relative to one another. Use of this sleeve-fiber combination will be useful for penetrating both lobes of the prostate simultaneously.

Referring now to Figs. 14A-14B, either the sleeve or the fiber may be equipped with anchoring/dilation means near their distal ends. Preferably, anchoring/dilation means 210 comprises an inflatable balloon 215 on sleeve 140. The sleeve will further include an inflation lumen running parallel to lumen 147 for delivering inflation fluid to the balloon. Anchoring means 210 will be useful for fixing the location of the sleeve with respect to the urethra. In addition, balloon 215 may be used for dilation of the urethra during or after treatment, to reduce constriction from swelling induced by ablation of prostatic tissue.

A balloon 220 disposed on fiber 105 may be provided for anchoring the fiber within the tissue of the prostate. Balloon 220 may also be used during treatment to hold prostatic tissue away from direct contact with fiber 105 to reduce charring. Balloon 220 is inflatable by delivery of fluid through an inflation lumen extending axially along fibers 105 from their proximal ends. In this way, fibers 105 may be anchored in the prostate, permitting cystoscope 160 to be removed from the urethra during treatment to ease patient discomfort.

To facilitate removal of the cystoscope from the urethra, sleeves 140 and fibers 105 may be made of sufficient length from their distal ends to actuators 190 to allow the cystoscope to slide proximally along the sleeves until shaft 155 is removed from the urethra. Alternatively, actuators 190 (and the associated housing) may be constructed to be removable from sleeves 140 and fibers 105, permitting the cystoscope to slide over the proximal ends of the sleeves and fibers. Sleeves 140 may further be constructed with a "peel-away" design, e.g., with longitudinal slits extending the length of the sleeves, to allow the sleeves themselves to be removed from fibers 105 along with actuators 190. In a further embodiment of the invention, not pictured, the fibers may be configured for antegrade placement into the prostate, whereby the distal ends of the fibers may be directed proximally to penetrate the prostate in the region adjacent the external sphincter. This is particularly important in prostatic treatment, as the external sphincter controls voiding. Various techniques may be used to achieve the antegrade orientation of the distal ends of the fibers, such as looping the fibers in the bladder distally of the shaft. Alternatively, a reflector may be positioned at the distal end of each fiber to reflect the light beam proximally into a second fiber oriented in the antegrade direction.

While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used.

Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.

Claims

1. Apparatus for prostatic treatment comprising: a shaft positionable in the urethra, the shaft having a distal end, a proximal end and a first axial lumen with an opening at the distal end; optical means in the shaft for visualization distally of the distal end of the shaft; a first energy conductive fiber slidably disposed in the first lumen having a distal end and a proximal end, the proximal end including means for connecting to an energy source and the distal end including means for penetrating prostatic tissue; and means at the distal end of the shaft for deflecting the first conductive fiber in a first direction toward the prostate, wherein the first conductive fiber may be advanced distally from the shaft to penetrate prostatic tissue for direct delivery of energy thereto.

2. The apparatus of claim 1 wherein the means for deflecting comprises a distal portion of the first lumen disposed at a first angle relative to the axial direction, the first angle being selected so as to direct the first conductive fiber toward the prostate as the fiber is advanced relative to the shaft.

3. The apparatus of claim 1 wherein the means for penetrating comprises a sharp point on the first conductive fiber.

4. The apparatus of claim 1 wherein the first conductive fiber comprises an optical fiber, the means for connecting being configured for connection to a laser.

5. The apparatus of claim 1 further comprising a sleeve disposed in the first lumen having a proximal end, a distal end and an axial passage therebetween, the first conductive fiber being slidably disposed in the axial passage, wherein the means for deflecting comprises a distal portion of the axial passage disposed at a first angle relative to the axial direction, the first angle being selected to direct the first conductive fiber toward the prostate as the fiber is advanced relative to the sleeve. 6. The apparatus of claim 1 further comprising a second conductive fiber slidably disposed in an axial lumen in the shaft, and means at the distal end of the shaft for deflecting the second conductive fiber in a second direction toward the prostate.

7. The apparatus of claim 6 wherein the shaft further includes a second axial lumen in which the second conductive fiber is disposed, the means for deflecting the second conductive fiber comprising a distal portion of the second axial lumen disposed at a second angle relative to the axial direction, the second angle being selected to direct the second conductive fiber toward the prostate.

8. The apparatus of claim 6 further comprising a second sleeve disposed in the first axial lumen and having an axial passage, the second conductive fiber being slidably disposed in the axial passage of the second sleeve, wherein the means for deflecting the second conductive fiber comprises a distal portion of the axial passage of the second sleeve disposed at a second angle relative to the axial direction, the second angle being selected to direct the second conductive fiber toward the prostate.

9. The apparatus of claim 6 wherein the first and second directions are selected so that the first and second conductive fibers may penetrate a single lobe of the prostate at the same time.

10. The apparatus of claim 6 wherein the first and second directions are selected so that the first and second conductive fibers may penetrate two different lobes of the prostate at the same time.

12. The apparatus of claim 6 wherein the first and second fibers are axially positionable relative to each other so as to penetrate the prostate at different axial positions relative to the shaft.

13. The apparatus of claim 6 wherein the first and second fibers are radially positionable relative to each other so as to penetrate the prostate at different radial positions relative to the shaft. 14. The apparatus of claim 1 wherein the shaft is flexible.

15. The apparatus of claim 1 wherein the optical means comprises an eyepiece at the proximal end of the shaft, a lens at the distal end of the shaft, and an optical passage therebetween.

16. The apparatus of claim 1 further comprising means at the distal end of the first conductive fiber for anchoring the fiber in the prostatic tissue.

17. The apparatus of claim 16 wherein the anchoring means comprises a balloon attached to the first conductive fiber and an inflation lumen extending from the proximal end of the shaft to the balloon.

18. The apparatus of claim 1 further comprising means near the distal end of the shaft for expanding in the urethra.

20. The apparatus of claim 18 wherein the expanding means comprises a balloon and an inflation lumen extending from the proximal end of the shaft to the balloon.

21. The apparatus of claim 20 wherein the first conductive fiber further includes markings on a distal portion thereof for indicating the position of the distal end of the fiber.

22. Apparatus for prostatic treatment comprising: a shaft positionable in the urethra, the shaft having a distal end, a proximal end, and a first axial lumen therebetween with an opening at the distal end; a first sleeve disposed in the first lumen having a proximal end, an open distal end and an axial passage therebetween, the axial passage having a distal portion disposed at a first angle relative to the axial direction; and a first optical fiber slidably disposed in the first sleeve, the first optical fiber having a proximal end for coupling to a laser and a distal end configured for penetrating prostatic tissue, wherein the first optical fiber may be advanced distally of the open distal end of the first sleeve at said first angle to penetrate prostatic tissue for direct delivery of laser energy thereto.

23. The apparatus of claim 22 further comprising: a second sleeve disposed in the first lumen of the shaft having a proximal end, an open distal end and an axial passage therebetween, the axial passage having a distal portion being disposed at a second angle relative to the axial direction; and a second optical fiber slidably disposed in the second sleeve, the second optical fiber having a proximal end for coupling to a laser and a distal end configured for penetrating prostatic tissue, wherein the second optical fiber may be advanced distally of the open distal end of the second sleeve at said second angle to penetrate prostatic tissue for direct delivery of energy thereto.

24. The apparatus of claim 23 wherein the first and second sleeves are positioned such that the first and second optical fibers may penetrate a single lobe of the prostate at the same time.

25. The apparatus of claim 22 wherein the first sleeve is removably disposed in the first axial lumen.

26. The apparatus of claim 25 further comprising optical means disposed in the first lumen for visualization distally of the distal end of the shaft.

27. The apparatus of claim 26 wherein the optical means comprises a tube disposed in the first axial lumen having proximal and distal ends, a lens at the distal end of the tube and an eyepiece at the proximal end of the tube.

28. A method of prostatic treatment, the method comprising the steps of: positioning an optical fiber in the urethra of a patient; deflecting a distal end of the optical fiber toward a portion of the prostate; penetrating through the urethra and into the prostate with the distal end of the optical fiber; and delivering laser energy directly to the prostate through the optical fiber to ablate a portion of prostatic tissue.

29. The method of claim 28 wherein the step of positioning comprises positioning a shaft in the urethra, the shaft having an axial lumen with a distal opening, the optical fiber being slidably disposed in the axial lumen.

30. The method of claim 29 wherein the step of deflecting comprises advancing the fiber distally through an axial passage of a sleeve disposed in the axial lumen, the axial passage having a distal portion disposed at an angle relative to the catheter to direct the distal end of the optical fiber toward the prostate.

31. The method of claim 29 further comprising looking distally of the shaft through a lens in the shaft to assist positioning the optical fiber to penetrate the prostate.

32. The method of claim 29 further comprising anchoring the optical fiber in the prostate before the step of delivering.

33. The method of claim 32 wherein the step of anchoring comprises expanding a balloon attached to the distal end of the optical fiber.

34. The method of claim 32 further comprising removing the shaft from the urethra with the optical fiber anchored in the prostate.