CN213554888U - Device for treating prostate disease - Google Patents

Abstract

Disclosed is an apparatus for treating prostate disease, the apparatus comprising: a urethral catheter for insertion into a urethra; an electrode assembly slidably received within the urethral catheter, the electrode assembly including a plurality of extendably mounted electrodes to extend into the prostate adjacent the urethra, wherein the plurality of extendably mounted electrodes are for electrolytically generating at least one of a necrotic base and a necrotic acid within the prostate; an inflatable balloon adjacent the distal end of the urethral catheter for inflation within a bladder in fluid communication with the urethra.

Description

Device for treating prostate disease

The present application is a divisional application of a chinese patent application having an application number of 201821968262.7 entitled "a device for treating prostate diseases" filed on 27/11/2018.

Technical Field

The present disclosure generally relates to a device for treating prostate diseases.

Background

Fig. 1 shows a simplified view of the interpretation and position of the prostate 3, 4. The urethra 1 passes up through the urethral membrane 2 ("external sphincter"), through the prostate 3, 4 surrounding the urethra, and into the bladder 5. Prostate 3, 4 includes three lobes: two main leaves 3, 4 and a middle leaf. The central lobe is generally located behind the main lobes 3, 4.

Prostate diseases include benign prostatic hypertrophy, benign prostatic hyperplasia ("BPH"), and prostate cancer. BPH is usually caused by hypertrophy of the middle lobes of the prostate. BPH may cause the prostate 3, 4 to compress the adjacent urethra 1. Symptoms of BPH include frequent urination, decreased urine flow, lack of urinary control, painful urination, and hematuria.

These very common prostate diseases can be treated with drugs, lifestyle changes, and ablation of prostate tissue. Ablation therapy includes surgery, inducing necrosis of prostate tissue, and subsequent removal of the necrotic tissue by bodily absorption or via urethral drainage. Methods of inducing necrosis of prostate tissue include heating and/or cooling of prostate tissue, introduction of toxic chemicals, and ultrasound. Examples of such methods include laser prostatectomy, interstitial laser coagulation, photosensitive vaporization of the prostate, holmium laser ablation of the prostate, holmium laser enucleation of the prostate, microwave irradiation of the prostate, radiofrequency current heating, direct current ablation, and ultrasound therapy. Ablation and pharmacotherapy may have side effects including decreased libido, impotence, retrograde ejaculation, fatigue, dizziness, headache and decreased blood pressure.

Minimally invasive treatment of prostate disorders is desirable that provides at least one of less pain, faster recovery, lower cost, shorter treatment time, fewer side effects of treatment, and reduced use of anesthetics and sedatives. It would be desirable to economically and/or easily treat prostate disorders.

SUMMERY OF THE UTILITY MODEL

An apparatus for treating prostate disease is disclosed herein. The device includes a urethral catheter for insertion into the urethra. The device includes an electrode assembly slidably received within the urethral catheter. The electrode assembly includes a plurality of extendably mounted electrodes for extension into the prostate adjacent the urethra. A plurality of extendably mounted electrodes are used to electrolytically generate at least one of a necrotic base and a necrotic acid within the prostate.

One embodiment includes an inflatable balloon adjacent the distal end of the urethral catheter for inflation within the bladder in fluid communication with the urethra, and another inflatable balloon disposed proximal of and in fluid communication with the bladder.

In one embodiment, each of the plurality of extendably mounted electrodes is slidably mounted and attached at a proximal end thereof to a user-actuatable electrode pusher. The electrode pusher may be linearly actuated by a user.

One embodiment includes a sleeve attached to the proximal end of the electrode assembly and rotationally fixed to the electrode pusher. The cannula and the electrode pusher may be joined at a sliding key connection. The distal end of the urethral catheter may include a plurality of electrode pathways connecting the interior and exterior thereof, and the urethral catheter and the electrode assembly are configured to engage one another in a predetermined rotational orientation such that the plurality of extendably mounted electrodes are aligned with the plurality of electrode pathways. The urethral catheter and the electrode assembly can be joined to form a sliding bond. The flange may be attached to the cannula, wherein the flange and the electrode pusher are cooperatively arranged such that the flange is received by a finger of a hand, and when the flange is so received, the electrode pusher is actuated by a thumb of the hand.

One embodiment comprises a disengageable stop arranged to prevent actuation of the electrode pusher prior to disengagement.

In one embodiment, at least one of the electrode assembly and the urethral catheter includes a fastener configured to secure the electrode assembly to the urethral catheter when the electrode assembly is slidingly received within the urethral catheter.

One embodiment includes a power supply and a controller for the power supply.

One embodiment includes a monitor configured to generate electrical parameter information indicative of an electrical parameter associated with power supplied to a plurality of extendable mounted electrodes, wherein the controller is configured to control the power supplied to the plurality of extendable mounted electrodes in accordance with the electrical parameter information. The controller is configured to vary power during electrolytic generation of at least one of the necrotic base and the necrotic acid within the prostate. The controller may have multiple electrical modes for multiple prostate mass types.

In one embodiment, the power is direct current.

In one embodiment, the plurality of extendably mounted electrodes includes electrodes within an insulating sheath defining at least two uninsulated distal end portions of the electrodes.

In one embodiment, each of the plurality of extendably mounted electrodes includes a rounded tip.

In one embodiment, each of the plurality of extendably mounted electrodes has a cross-shaped cross-section.

One embodiment includes a chemical that can be introduced into the prostate by at least one of the plurality of electrodes.

One embodiment defines a plurality of channels for each electrode to selectively position each electrode within the prostate.

In one embodiment, at least one of the plurality of extendable mounted electrodes is more extendable than at least another of the plurality of extendable lengths.

In one embodiment, the urethral catheter is more flexible than the electrode assembly.

In one embodiment, the urethral catheter includes a fixation element.

In one embodiment, the urethral catheter comprises a Foley catheter.

A method for treating prostate disease is disclosed herein. The method includes inserting a urethral catheter into the urethra. The method includes inserting an electrode assembly into the urethra. The electrode assembly includes a plurality of extendably mounted electrodes. The method includes extending a plurality of extendably mounted electrodes into the prostate adjacent the urethra. The method includes supplying electrical power to a plurality of extendably mounted electrodes, wherein at least one of a necrotic base and a necrotic acid are generated within the prostate.

In one embodiment, the electrode assembly is disposed within the urethral catheter during insertion of the urethral catheter into the urethra. Alternatively, the electrode assembly may be inserted into a urethral catheter, and thus into the urethra.

In one embodiment, the urethral catheter is more flexible than the electrode assembly.

One embodiment includes extending a plurality of electrodes into the prostate adjacent the urethra including a user actuating an electrode pusher attached to the plurality of electrodes to extend a plurality of tips of the plurality of electrodes out of the electrode assembly and into the prostate.

One embodiment includes the step of rotationally securing a sleeve attached to the proximal end of the electrode assembly to the electrode pusher.

One embodiment includes the step of engaging the electrode pusher and the sleeve to form a sliding key connection.

One embodiment comprises disengaging a stop arranged to prevent actuation of the electrode pusher to enable actuation of the electrode pusher.

One embodiment includes the step of generating electrical parameter information indicative of the power supplied to the plurality of extendable mounted electrodes, wherein the controller is configured to control the power supplied to the plurality of extendable mounted electrodes in accordance with the electrical parameter information.

One embodiment includes the step of varying the power supplied to the plurality of extendably mounted electrodes during the electrolytic generation of at least one of a necrotic base and a necrotic acid.

One embodiment includes the step of selecting one of a plurality of supply power modes for treating a plurality of prostate mass types.

One embodiment includes the steps of changing a setting of at least one of a plurality of extendably mounted electrodes within a prostate and supplying power to at least one of the plurality of extendably mounted electrodes.

One embodiment includes the step of introducing a chemical into the prostate volume, wherein the chemical belongs to the group of chemicals comprising a chemical resistant to at least one of a necrotic acid and a necrotic base, and a necrotic chemical that decreases or increases the pH within the prostate.

One embodiment includes the step of introducing a chemical into the prostate via a lumen in at least one of the plurality of electrodes.

One embodiment includes using electromyography to detect a sphincteric urethral membrane adjacent to a urethra, and positioning a plurality of electrodes relative to the sphincteric urethral membrane.

One embodiment includes a first balloon attached to a distal end of a urethral catheter within a bladder in fluid communication with a urethra, and a second balloon disposed adjacent a proximal end of the urethral catheter and in fluid communication with the first balloon.

One embodiment includes introducing a fluid into a balloon attached to a distal end of a urethral catheter and disposed within a bladder in fluid communication with the urethra, and monitoring a pressure of the fluid introduced into the balloon.

One embodiment includes the step of reading an additional identification tag.

In one embodiment, the step of supplying power to the plurality of extendably mounted electrodes comprises supplying power to the plurality of electrodes asynchronously.

One embodiment includes the steps of retracting a plurality of extendable electrodes from the prostate and extending another plurality of extendable, mounted electrodes of another electrode assembly into the prostate at a different prostate location.

One embodiment includes the step of activating a fixation element of the urethral catheter.

In one embodiment, the urethral catheter comprises a foley catheter.

An apparatus for treating prostate disease is disclosed herein. The device includes an electrode assembly slidably received within the urethral catheter, the electrode assembly including a plurality of extendably mounted electrodes for extending through urethral tissue and into the prostate, wherein the plurality of extendably mounted electrodes are for electrolytically generating at least one of a necrotic base and a necrotic acid within the prostate.

In the embodiments of the apparatus or method disclosed above, the plurality of extendably mounted electrodes includes at least one electrolytically corrodible electrode.

A urethral catheter comprising an inflatable balloon attached to a distal end for inflation in a body and an inflatable balloon attached to a proximal end in fluid communication with the inflatable balloon attached to the distal end for disposition outside the body when the inflatable balloon attached to the distal end is so inflated in the body.

An apparatus for treating prostate disease is disclosed herein. The device includes an electrode assembly slidably received within the urethral catheter. The electrode assembly includes a plurality of extendably mounted electrodes for extending through urethral tissue and into the prostate. A plurality of extendably mounted electrodes are used for electrolytic generation of at least one of a necrotic base and a necrotic acid within the prostate.

Any of the various features of each of the above-described disclosures, as well as the various features of the embodiments described below, may be combined as appropriate and desired.

Drawings

Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

figure 1 shows a simplified view of the anatomy and location of the prostate.

Figures 2 and 3 show a perspective view and an exploded view, respectively, of an embodiment of an apparatus for treating prostate disorders.

Fig. 4 shows a detail of the distal end of the electrode assembly of the device of fig. 2.

Figure 5 shows a detail of the proximal end of the urethral catheter of the device of figure 2.

Fig. 6 shows a detail of the proximal end of the electrode assembly of fig. 4 with a detachable stopper, and fig. 7 shows a detail of the proximal end of the electrode assembly of fig. 4 without a detachable stopper.

Figure 8 shows a detail of the flange shown in figures 6 and 7.

Figure 9 shows a detail of the distal end of the urethral catheter of the device of figure 2.

Fig. 10 shows a flow diagram of an embodiment of a method for treating prostate disease, which can be implemented using the apparatus of fig. 2.

Detailed Description

Figures 2 and 3 show a perspective view and an exploded view, respectively, of an embodiment of a device for treating prostate disorders, the device being generally designated by reference numeral 10. The device 10 may be non-implantable. The device 10 comprises a urethral catheter 12 in the form of a foley catheter for insertion into the urethra 1. The device 10 includes an electrode assembly 14 slidably received within the urethral catheter 12. Figure 2 shows the electrode assembly 14 received within the urethral catheter 12. Fig. 4 shows details of the distal tip 18 of the electrode assembly 14 inserted into the proximal opening 24 of the lumen 31 of the urethral catheter 12. The proximal opening is best seen in fig. 5. The electrode assembly 14 includes a plurality of extendably mounted electrodes 20, 22 in the form of shape memory alloy wires to extend into the prostate 3, 4 adjacent the urethra 1. A plurality of extendably mounted electrodes 20, 22 are used to electrolytically generate at least one of a necrotic base and a necrotic acid within prostate 3, 4.

The plurality of electrodes may include, for example, a pair of electrodes 20, an electrode 22, or multiple pairs of electrodes. One electrolytic reaction that may occur in the prostate is electrolysis of water, whereby a necrotic base (OH-) may be generated at an electrode as a cathode, and a necrotic acid (H +) may be generated at an electrode as an anode. The necrotic base and the necrotic acid may each cause necrosis of the prostate tissue to form a necrotic volume of the prostate tissue, which in some embodiments is predetermined prior to treatment. The necrotic prostate tissue is absorbed by the body or expelled through the urethra, leaving a void, thus reducing the prostate volume, which can reduce the symptoms of BPH or the size of the tumor.

In use, a portion of the catheter including port 24 and port 25 remains outside the body. The urethral catheter includes a fixation element in the form of an inflatable balloon adjacent its distal end to secure the catheter at the treatment site. The inflatable balloon is adapted to be inflated within the bladder in fluid communication with the urethra, which helps maintain the urethral catheter within the urethra. The balloon may be inflated with saline, air, or generally any suitable form of fluid. Saline or air may be introduced through the urethral catheter inflation port 25, the urethral catheter inflation port 25 being in fluid communication with the balloon via a fluid conduit in the form of another lumen of the urethral catheter 12. The urethral catheter 12 includes another inflatable balloon disposed adjacent to and in fluid communication with the proximal end of the urethral catheter 12. The other balloon is positioned such that it is outside the urethra when the balloon is inflated within the bladder. The other balloon is a visual indicator of the inflation status of the balloon in the bladder, and the deflation of the other balloon indicates a potentially dangerous state in which the urethral catheter may slip and thus cause the stretched electrode count to examine the urothelium. Alternatively, embodiments may include a pressure gauge in fluid communication with the balloon to monitor the pressure of the fluid within the balloon. For example, when the fluid pressure signal indicates balloon deflation, the pressure gauge may generate a fluid pressure signal that may trigger an alarm, or stop the supply of electrical power.

Each of the plurality of extendably mounted electrodes 20, 22 is slidably mounted in a channel 29 of the electrode assembly 14, the channel 29 being turned outwardly at its distal end. A plurality of extendably mounted electrodes 20, 22 are attached at their proximal ends to an electrode pusher 26, which electrode pusher 26 may be in the form of a handle or generally any user-engageable form (including but not limited to a user-actuatable knob or piston). The electrode pusher 26 may be linearly actuated by a user, thereby reducing separation of the electrode pusher 26 and the distal end of the electrode assembly 14. The sleeve 28 is attached to the proximal end 30 of the electrode assembly 14. The sleeves may be integral or distinct. A flange 32 is disposed distally and attached to the sleeve 28. The flange 32 and the electrode pusher 26 are cooperatively arranged such that the flange 32 is received by the fingers of the hand and when the flange 28 is so received, the electrode pusher 26 is actuated by the thumb of the hand. The thumb may be inserted into the ring 34 of the electrode pusher 26. As shown in fig. 6 and 7, the disengageable stop 36 is arranged to prevent actuation of the electrode pusher 26 prior to disengagement.

As best understood with reference to fig. 7 and 8, the sleeve 28 is rotatably secured to the electrode pusher 26. The cannula 28 and the distal end 30 of the electrode assembly, which in this embodiment is the electrode pusher 28, are joined by a sliding key connection 38. One of the distal end 30 of the electrode assembly and the sleeve 28 includes a key 40 in the form of a longitudinal rib and the other of the distal end 30 of the electrode assembly and the sleeve 28 includes a keyway 42 in the form of a longitudinal groove. The key 40 is received within the keyway 42 to slide longitudinally between the sleeve 28 and the electrode pusher 26 while fixing the relative rotational orientation of the sleeve 28 and the electrode pusher 26 about the common axis.

As best shown in fig. 9, the distal end 44 of the urethral catheter 12 includes a plurality of electrode pathways 46 connecting the lumen to the exterior. The present embodiment has two electrode paths facing each other for passage of the electrodes 20, 22. The urethral catheter 12 and the electrode assembly 14 are configured to engage one another in a predetermined rotational orientation to align the plurality of extendably mounted electrodes 20, 22 with the plurality of electrode pathways. As shown in fig. 4, electrode assembly 18 has a "D" shaped transverse cross-section that is received by an internal cavity 31 having a complementary "D" shape (as shown in fig. 8). In general, the electrode assembly and the lumen 31 may generally have any suitable interlocking cross-sectional shape, such as hexagonal, decagonal, or any irregular shape. The urethral catheter 12 and the electrode assembly 14 can be joined to form a sliding key connection, as shown in figure 2.

Also shown in fig. 4 is the attached electrode assembly tip 23. Attachment may be by ultrasonic, RF welding, or using an adhesive. The assembly tip 23 has a spade to aid insertion. The tip may be replaced with another tip having a different electrode port 33, 35 location.

As in the present embodiment, at least one of the electrode assembly 14 and the urethral catheter 12 can include a fastener 48 in the form of a clamp configured to secure the electrode assembly 14 to the urethral catheter 12 when the electrode assembly is slidingly received within the urethral catheter. This may prevent accidental retraction of the electrode during surgery, for example.

Embodiments may include a power supply 27, typically, but not necessarily, in the form of direct current, and a controller for the power supply 27. The power supplied to the electrodes is lower than in prior methods for treating BPH. The power supplied may be in the order of milliwatts, for example, in the range of 20 to 3200 milliwatts per electrode pair. Typically the power for each electrode pair is between approximately 190 milliwatts (25 milliamps per 300 ohm tissue impedance) and 1600 milliwatts (40 milliamps per 1000 ohm tissue impedance). A common impedance level seen in tissue is 400 ohms and treatment with 50 milliamps is equivalent to the 1000 milliwatts of power output required. This relatively low power results in negligible heat transfer between the device 10 and the body tissue. This reduces or eliminates the heating-induced pain and discomfort of the surrounding tissue experienced during treatment with significantly higher power thermal techniques. It also reduces or eliminates scarring and longer healing times associated with thermal wounds. Radiofrequency and microwave techniques that use thermal energy to create necrosis in soft tissue typically have power ranges between 15 watts and 75 watts. The amount of power delivered by the thermal ablation system is not based directly on a measurement of the power delivered, but rather is based on a measurement of the temperature generated by the power delivered. In contrast, the amount of charge delivered by the present embodiment is directly based on a measurement of the delivered charge, allowing for more precise control of the size of the necrotic area.

The device 10 may have an electrical connector 29 in electrical communication with the plurality of extendably mounted electrodes for making electrical connection with the power source 27. Ablation of prostate tissue is non-thermal and is a form of direct current ablation. Some embodiments may include a monitor configured to generate electrical parameter information indicative of an electrical parameter associated with the power supplied to the plurality of extendable mounted electrodes. The controller is configured to control the power supplied to the plurality of extendably mounted electrodes based on the electrical parameter information. For example, the monitor may measure the impedance experienced by a current (in the form of a DC current supplied to the electrodes) flowing from one of the plurality of electrodes 20, 22 to the other of the plurality of electrodes 20, 22. For example, during electrolytic generation of at least one of a necrotic base and a necrotic acid within the prostate 3, 4, bubbles in the form of hydrogen and oxygen gas may be generated in the prostate tissue adjacent to the plurality of extendably mounted electrodes, which generally increases the impedance of the flowable current and decreases the rate at which the necrotic acid and/or base is generated. Chlorine gas may saturate the cathode surface. The tissue may be dehydrated at the anode. To counteract the increase in impedance, the controller is in this embodiment, but not necessarily in all embodiments, configured to vary the power during electrolytic generation of at least one of a necrotic base and a necrotic acid within the prostate. For example, the current and/or voltage may be decreased or increased such that the gas generation rate is approximately equal to the gas absorption rate of the prostate, which exhibits stable impedance. Alternatively, the controller may turn off the current to allow the gas to be absorbed and turn on the current after the gas is absorbed. In this embodiment, the controller reduces and/or turns off the supplied current when the impedance satisfies the first impedance condition, for example, when the impedance is equal to or greater than the first impedance condition. As the gas is absorbed, the impedance may drop. When the measured impedance satisfies a second impedance condition, e.g., the impedance is equal to or less than a second threshold impedance, the controller increases and/or turns on the supplied current. In another embodiment, the controller may dither the supplied current in response to the determined impedance, for example, oscillating or fluctuating the current.

The power supplied to the electrodes can be adjusted to prevent the accumulation of bubbles.

The power may be supplied to the plurality of electrodes asynchronously, e.g., first to one pair of electrodes and then to the other pair of electrodes. Switching the power supply to another pair of electrodes may result in a decrease in impedance because there is no bubble there. The controller has multiple electrical modes for multiple prostate mass types. For example, the prostate may have different impedances depending on its age or ability to absorb the generated gases. MRI or ultrasound imaging may be used to determine the type of prostate mass. Different modes may have different time power profiles.

In some embodiments, the plurality of extendably mounted electrodes 20, 22 may include electrodes within an insulating sheath defining at least two uninsulated distal end portions of the electrodes. The uninsulated distal portions each serve as a site for electrolysis and may help reduce gas accumulation or other sources of impedance. The sheath may take the form of a film, membrane, tube or generally any suitable form. This may allow for omission of electrolysis between uninsulated distal end portions in response to a change in impedance between the uninsulated distal end portions.

Each of the plurality of extendably mounted electrodes includes a rounded or ground tip coated with platinum. This may reduce the incidence of urothelium count examination as the electrodes are withdrawn. The electrodes are insulated with a polyimide film or any suitable form generally intermediate the distal and proximal ends.

In an alternative embodiment, each of the plurality of extendably mounted electrodes has a cruciform cross-section. This may maximize the surface area of the extendably mounted electrode and enable greater current delivery for a given voltage, which may help to minimize gas generation in the tissue.

Embodiments may include a chemical that may be introduced into the prostate through at least one of the plurality of electrodes. At least one electrode may include a lumen connected to the exterior for delivering a chemical into the prostate. Alternatively, the chemical substance may be attached to a surface of the at least one electrode and may be a chemical coating on the at least one electrode. The chemical substance generally belongs to a group of chemical substances comprising a chemical substance resistant to at least one of a necrotic acid and a necrotic base, and a necrotic chemical substance that decreases or increases the pH within the prostate. Alternatively or additionally, the chemical may be resistant to the prostate native pH buffer. The chemical may act before sufficient necrotic base or acid is generated by electrolysis. For example, the chemical may include an acid salt coating or a base salt coating that may cause necrosis before sufficient necrotic acid and/or necrotic base are electrolytically generated. For example, when power is supplied to at least one of the electrodes, chemical substances may be shed. The chemical substance may be deposited for treating the first volume and then the electrode is placed elsewhere to treat the second volume by generating a necrotic acid or base by electrolysis. The shape of the treated volume may be affected by the introduction of the chemical.

A saline solution or saline gel may be introduced into the volume of tissue that is not desired to be ablated. In some embodiments, a saline solution having a pH of 7 may be supplied adjacent to the treatment volume. This substantially prevents the necrotic acids and bases from entering the volume of tissue that is not desired to be ablated. Saline at neutral pH dilutes the advancing acidic and basic gradients to prevent necrosis of the flush volume. The saline solution may be delivered by any suitable method. For example, saline may be introduced into a body lumen, such as the urethra, where preservation is desired, through a therapeutic delivery catheter or through a separate dedicated irrigation catheter.

In some embodiments, at least one of the plurality of extendable mounted electrodes is more extendable than at least another of the plurality of extendable lengths. When the impedance exceeds a threshold value, the more stretchable electrode may be moved during treatment.

The plurality of extendably mounted electrodes comprise a titanium-nickel alloy (nitinol) and may be coated with a corrosion resistant coating, for example in the form of platinum. The electrodes may be configured to be atraumatic. When extended, the tip of the extendably mounted electrode pierces the urethral wall and then the prostate. The electrode tip may be sharp enough to pierce the urethral wall.

In one embodiment, at least one of the plurality of extendably mounted electrodes is electrolytically corrodible. The electrolytically erodable electrode is eroded by an electrolytic process resulting in the deposition of favorable or at least neutral ions in the ablated prostate area. The beneficial ions may include silver, magnesium or iron ions that are resistant to infection. An electrode material that is less expensive than platinum may be used.

Fig. 10 shows a flow chart 50 of steps of an embodiment of a method for treating prostate disease that may be performed using the apparatus 10. The method includes the step 52 of inserting the urethral catheter 12 into the urethra 1. The method includes the step 54 of inserting the electrode assembly 14 into the urethra. The method includes the step 56 of extending the plurality of extendably mounted electrodes 20, 22 into the prostate adjacent the urethra 1. The method includes the step 58 of supplying electrical power to the plurality of extendably mounted electrodes 20, 22. When an electric current flows from one electrode to the other electrode via the prostate, one of a necrotic base and a necrotic acid is electrolytically generated within the prostate.

In this embodiment, the electrode assembly 14 is disposed within the urethral catheter 12 during insertion of the urethral catheter 12 into the urethra 1. However, in another embodiment, the electrode assembly 14 is inserted into the urethral catheter 12 after the urethral catheter 12 is inserted into the urethra 1. The urethral catheter 12 is more flexible than the electrode assembly 14. The urethral catheter 12 can comprise, for example, silicone. It may be easier to insert the urethral catheter first. Once inserted, the urethral catheter 12 serves as a guide for the electrode assembly 12 as it is inserted, and protects the urethra 1 from accidental puncture, for example by a relatively less flexible electrode assembly.

In some embodiments for treating BPH, the cathode may be placed near the bladder neck or the bottom of the prostate. The cathode thus placed produces necrosis over a large area with small relative variations. The area of the prostate closest to the bladder neck contributes most to lower urinary tract symptoms due to BPH. The anode can be placed closer to the verumontanum. Another embodiment includes placing the cathode in a lateral posterior quadrant of the tissue relative to the urethra, and placing the anode in a lateral or lateral anterior quadrant of the tissue relative to the urethra. The treatment zone is formed around each electrode and typically passively diffuses out. Thus, the electrodes may be placed in the tissue relative to each other such that the treatment regions overlap and coalesce.

After treatment, the electrode assembly 14 can be removed and the urethral catheter retained to assist in removing urine from the bladder 5 until at least one of urethral healing, reduced inflammation, and reduced swelling, for example, occurs.

One embodiment includes the step of changing a setting of at least one of a plurality of extendably mounted electrodes within the prostate. After changing its setting, power is supplied to at least one of the plurality of extendably mounted electrodes. For example, the plurality of electrodes may be partially retracted or further extended. The electrodes may be fully retracted, the urethral catheter partially retracted or inserted deeper, and the extended electrodes extended to a new site within the prostate. Different sites may be treated or new sites may be found with little or no gas generation.

Electromyography can be used to detect the sphincter urethral membrane 2 ("external sphincter") adjacent the urethra 1 and the prostate, and to position a plurality of electrodes relative to the external urethral sphincter. This may result in a better positioning of the electrodes.

A plurality of extendably mounted electrodes may be retracted from the prostate and another plurality of extendably mounted electrodes of another electrode assembly may be extended into the prostate at a different prostate location. The volume of treatment can be increased, or a new volume with less impedance or no bubbles can be increased, which can reduce the treatment time.

Additional identification tags may be read. In this but not all embodiments the identification tag may be in the form of a radio frequency identification tag, but other types of identification tags may be used. The identity information read from the identification tag may be associated with, for example, process parameter information for a recall, business monitoring information, adverse event information. The association may be within a computer data store, for example, that information to associate via a computer network has been received.

In one embodiment, the electrical assembly includes a sensing electrode. The sensing electrode is used to confirm that the electrode is fully retracted in the device 10. An impedance between each of the extendable mounted electrodes and the sensor electrode is determined and a signal indicative of an extension state of at least one of the plurality of extendable mounted electrodes is generated. The impedance between each telescopically mounted electrode and the sensor electrode is typically low when the telescopically mounted electrodes are retracted. The monitor may generate a signal indicating that at least one of the extendable mounted electrodes is extended and removal of the electrode is unsafe when the impedance between each telescopically mounted electrode and the sensor electrode is less than a threshold value-indicating that the electrode is retracted and removal of the device from the urethra-or greater than a threshold value.

Now that embodiments have been described, it should be appreciated that some embodiments may have some of the following advantages:

treatment of prostate disease may be minimally invasive.

The treatment time may be less than prior art treatment times, such as no more than 10 minutes, such as no more than 8 minutes or no more than 5 minutes.

The device may be inserted by a person less skilled than the urologist (e.g., a nurse or technician) and may be inserted without the use of rectal ultrasound guidance.

The prostate tissue temperature may not increase significantly, e.g., by no more than 10 degrees celsius.

Various embodiments and methods of using those embodiments are described in the following paragraphs.

An apparatus for treating prostate disease, the apparatus comprising:

a urethral catheter for insertion into a urethra; and

an electrode assembly slidably received within the urethral catheter, the electrode assembly including a plurality of extendably mounted electrodes for extending into a prostate adjacent the urethra, wherein the plurality of extendably mounted electrodes are for electrolytically generating at least one of a necrotic base and a necrotic acid within the prostate.

The apparatus defined in the preceding paragraph, comprising: an inflatable balloon adjacent the distal end of the urethral catheter for inflation within a bladder in fluid communication with the urethra; and another inflatable balloon disposed proximal to and in fluid communication with the bladder.

The apparatus defined in any of the preceding paragraphs, wherein each of the plurality of extendably mounted electrodes is slidably mounted and attached at a proximal end thereof to a user-actuatable electrode pusher.

The apparatus defined in the preceding paragraph, wherein the electrode pusher is linearly actuatable by a user.

The device defined in any of the preceding paragraphs, comprising a sleeve attached to a proximal end of the electrode assembly and rotationally fixed to the electrode.

The apparatus defined in the preceding paragraph, wherein the cannula and the electrode pusher are joined at a sliding key connection.

The device defined in any of the preceding paragraphs, wherein the distal end of the urethral catheter comprises a plurality of electrode pathways connecting an interior and an exterior thereof, and the urethral catheter and the electrode assembly are configured to engage with one another in a predetermined rotational orientation to align the plurality of extendably mounted electrodes with the plurality of electrode pathways.

The device defined in the preceding paragraph, wherein the urethral catheter and the electrode assembly can be joined to form a sliding bond.

The apparatus defined in any one of the preceding paragraphs, comprising a flange attached to the cannula, wherein the flange and the electrode pusher are cooperatively arranged such that the flange is received by a finger of a hand, and when the flange is so received, the electrode pusher is actuated by a thumb of the hand.

The apparatus defined by any of the preceding paragraphs includes a disengageable stop arranged to prevent actuation of the electrode pusher prior to disengagement.

The device defined by any of the preceding paragraphs, wherein at least one of the electrode assembly and the urethral catheter comprises a fastener configured to fasten the electrode assembly to the urethral catheter when the electrode assembly is slidingly received within the urethral catheter.

The apparatus defined by any one of the preceding paragraphs, comprising a power source and a controller for the power source.

The apparatus defined in the preceding paragraph, comprising a monitor, the electrical parameter information being indicative of an electrical parameter associated with the power supplied to the plurality of extendable mounted electrodes, wherein the controller is configured to control the power supplied to the plurality of extendable mounted electrodes in dependence on the electrical parameter information.

The apparatus defined in any of the preceding paragraphs, wherein the controller is configured to vary the electrical power during the electrolytic generation of at least one of the necrotic base and the necrotic acid within the prostate.

The apparatus defined in any of the preceding paragraphs, wherein the controller has a plurality of electrical modes for a plurality of prostate mass types.

The apparatus defined in any one of the preceding paragraphs, wherein the electrical power is direct current.

The apparatus defined in any of the preceding paragraphs, wherein the plurality of extendably mounted electrodes comprises electrodes within an insulating sheath defining at least two uninsulated distal end portions of the electrodes.

The apparatus of any of the preceding paragraphs, wherein each of the plurality of extendably mounted electrodes comprises a rounded tip.

The apparatus defined in any one of the preceding paragraphs, wherein each of the plurality of extendably mounted electrodes has a cross-shaped cross-section.

The apparatus defined in any of the preceding paragraphs, wherein the prostate chemical is introduced by at least one of the plurality of electrodes.

The apparatus defined in any one of the preceding paragraphs, a plurality of channels being defined for each electrode to selectively position each electrode within the prostate.

The apparatus defined in any of the preceding paragraphs, wherein at least one of the plurality of extendably mounted electrodes is more extendable than at least another of the plurality of extendable lengths.

The device defined by any of the preceding paragraphs, wherein the urethral catheter is more flexible than the electrode assembly.

The device defined in any of the preceding paragraphs, wherein the urethral catheter comprises a fixation element.

The device defined in any of the preceding paragraphs, wherein the urethral catheter comprises a Foley catheter.

A method of treating prostate disease using a device as defined in any of the preceding paragraphs, the method comprising:

inserting a urethral catheter into the urethra;

inserting an electrode assembly into the urethra, the electrode assembly comprising a plurality of extendably mounted electrodes;

extending a plurality of extendably mounted electrodes into the prostate adjacent the urethra;

supplying power to a plurality of extendably mounted electrodes, wherein at least one of a necrotic base and a necrotic acid is generated within the prostate.

The method defined by the preceding paragraph, wherein the electrode assembly is disposed within the urethral catheter during insertion of the urethral catheter into the urethra.

The method defined by the preceding paragraph, wherein the electrode assembly is inserted into the urethral catheter, thereby inserting the urethra.

The method defined in any of the preceding paragraphs, wherein the urethral catheter is more flexible than the electrode assembly.

The method defined by any of the preceding paragraphs, wherein stretching the plurality of electrodes into the prostate adjacent the urethra comprises a user actuating an electrode pusher attached to the plurality of electrodes to stretch a plurality of tips of the plurality of electrodes out of the electrode assembly and into the prostate.

The method defined in the preceding paragraph, including the step of rotationally securing a sleeve attached to a proximal end of the electrode assembly to the electrode pusher.

The method defined in the preceding paragraph, including the step of engaging the electrode pusher and the cannula to form a sliding key connection.

The method defined in any of the preceding paragraphs, comprising disengaging a stop arranged to prevent actuation of the electrode pusher to enable actuation of the electrode pusher.

The method defined in any one of the preceding paragraphs, comprising the step of generating electrical parameter information indicative of the power supplied to the plurality of extendable mounted electrodes, wherein the controller is configured to control the power supplied to the plurality of extendable mounted electrodes in dependence on the electrical parameter information.

A method as defined in the preceding paragraph, including the step of varying the power supplied to the plurality of extendable mounted electrodes during electrolytic generation of at least one of a necrotic base and a necrotic acid.

The method defined in any of the preceding paragraphs, the step of selecting one of a plurality of supply power modes for treating a plurality of prostate quality types.

The method defined in any of the preceding paragraphs, comprising the step of varying a setting of at least one of the plurality of extendably mounted electrodes within the prostate and supplying power to the at least one of the plurality of extendably mounted electrodes.

The method defined in any of the preceding paragraphs, comprising the step of introducing a chemical into the prostate volume, wherein the chemical belongs to a group of chemicals that comprises a chemical that is resistant to at least one of a necrotic acid and a necrotic base, and a necrotic chemical that decreases or increases the pH within the prostate.

The method defined in the preceding paragraph, including the step of introducing the chemical into the prostate via a lumen in at least one of the plurality of electrodes.

The method defined in any of the preceding paragraphs, comprising detecting a sphincter-urethral membrane adjacent the urethra using electromyography, and positioning the plurality of electrodes relative to the sphincter-urethral membrane.

The method defined in any of the preceding paragraphs, comprising attaching a first balloon to a distal end of a urethral catheter within a bladder in fluid communication with the urethra, and a second balloon disposed adjacent a proximal end of the urethral catheter and in fluid communication with the first balloon.

The method defined in any of the preceding paragraphs, comprising introducing fluid into a balloon attached to a distal end of the urethral catheter and disposed within a bladder in fluid communication with the urethra, and monitoring pressure of the fluid introduced into the balloon.

The method defined in any one of the preceding paragraphs, comprising the step of reading the additional identification tag.

The method defined in any one of the preceding paragraphs, wherein the step of supplying power to the plurality of extendably mounted electrodes comprises supplying power to the plurality of electrodes asynchronously.

The method defined in any of the preceding paragraphs, comprising the step of retracting a plurality of extendable electrodes from the prostate and extending another plurality of extendable mounting electrodes of another electrode assembly into the prostate at a different prostate location.

The method defined in any of the preceding paragraphs, comprising the step of activating the fixation element of the urethral catheter.

The method defined in any of the preceding paragraphs, wherein the urethral catheter comprises a Foley catheter.

An apparatus for treating prostate disease, the apparatus comprising an electrode assembly slidably received within a urethral catheter, the electrode assembly comprising a plurality of extendably mounted electrodes for extending through urethral tissue and into a prostate, wherein the plurality of extendably mounted electrodes are for electrolytically generating at least one of a necrotic base and a necrotic acid within the prostate.

The apparatus or method defined in the preceding paragraph, wherein the plurality of extendably mounted electrodes includes at least one electrolytically corrodible electrode.

A urethral catheter comprising an inflatable balloon attached to a distal end for inflation in a body and an inflatable balloon attached to a proximal end in fluid communication with the inflatable balloon attached to the distal end for disposition outside the body when the inflatable balloon attached to the distal end is so inflated in the body.

Variations and/or modifications may be made to the described embodiments without departing from the spirit or scope of the invention. While the illustrated embodiment includes a urethral catheter, alternative embodiments may not include a urethral catheter, for example, which may be provided separately for use in surgery. While the urethral catheter in this embodiment is a foley catheter or a variation thereof, any suitable urethral catheter may generally be used, examples of which include, but are not limited to, intermittent catheters and elbow catheters. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. Reference to a feature disclosed herein does not imply that all embodiments necessarily include the feature.

The prior art described herein, if any, should not be taken as an admission that the prior art forms part of the common general knowledge in any jurisdiction.

In the claims which follow and in the preceding description of the invention, unless the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims (15)

1. An apparatus for treating prostate disease, the apparatus comprising:

a urethral catheter for insertion into a urethra;

an electrode assembly slidably received within the urethral catheter, the electrode assembly including a plurality of extendably mounted electrodes to extend into the prostate adjacent the urethra, wherein the plurality of extendably mounted electrodes are for electrolytically generating at least one of a necrotic base and a necrotic acid within the prostate;

an inflatable balloon adjacent the distal end of the urethral catheter for inflation within a bladder in fluid communication with the urethra.

2. The apparatus of claim 1, wherein each of the plurality of extendably mounted electrodes is slidably mounted and attached at a proximal end thereof to a user-actuatable electrode pusher, and wherein the electrode pusher is linearly actuatable by a user.

3. The device of claim 2, comprising a sleeve attached to a proximal end of the electrode assembly and rotationally fixed to the electrode, wherein the sleeve and the electrode pusher are joined at a sliding key connection.

4. The device of claim 3, wherein the distal end of the urethral catheter includes a plurality of electrode pathways connecting the interior and exterior thereof, and the urethral catheter and the electrode assembly are configured to engage each other in a predetermined rotational orientation to align the plurality of extendably mounted electrodes with the plurality of electrode pathways.

5. The apparatus of claim 4, comprising a flange attached to the cannula, wherein the flange and the electrode pusher are cooperatively arranged such that the flange is received by a finger of a hand and the electrode pusher is actuated by a thumb of the hand when the flange is received.

6. The apparatus of claim 2, comprising a disengageable stop arranged to prevent actuation of the electrode pusher prior to disengagement.

7. The device of claim 1, wherein at least one of the electrode assembly and the urethral catheter includes a fastener configured to secure the electrode assembly to the urethral catheter when the electrode assembly is slidingly received within the urethral catheter.

8. The apparatus of claim 1, comprising a power source, a controller for the power source, and a monitor configured to generate electrical parameter information indicative of an electrical parameter associated with the power supplied to the plurality of extendable mounted electrodes, wherein the controller is configured to control the power supplied to the plurality of extendable mounted electrodes based on the electrical parameter information.

9. The apparatus of claim 8, wherein the controller is configured to vary the power during the electrolytic generation of the at least one of the necrotic base and the necrotic acid within the prostate, and wherein the power is direct current.

10. The apparatus of claim 1, wherein the plurality of extendably mounted electrodes comprises electrodes within an insulating sheath defining at least two uninsulated distal end portions of the electrodes.

11. The apparatus of claim 1, comprising a chemical that can be introduced into the prostate by at least one of the plurality of electrodes.

12. The device of claim 11, wherein a plurality of channels are defined for each electrode to selectively position each electrode within the prostate.

13. The apparatus of claim 1, wherein at least one of the plurality of extendable mounted electrodes is more extendable than at least another one of the plurality of extendable lengths.

14. The device of claim 1, wherein the urethral catheter is more flexible than the electrode assembly.

15. The device of claim 1, wherein the urethral catheter includes a fixation element of another inflatable balloon disposed at a proximal end of the urethral catheter for inflation within the bladder and in fluid communication with the bladder.

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