Patent Description:
Hemorrhoids are swollen blood vessels in the rectum. There are two basic types of hemorrhoids: internal and external.

Internal hemorrhoids are swollen and inflamed veins far up in the rectum. Internal hemorrhoids cannot be seen or felt and usually are not painful due to the paucity in nerve endings in the upper portion of the rectum. While internal hemorrhoids are most commonly manifested by anal bleeding, they may prolapse or protrude outside the anal sphincter. Usually, prolapsed internal hemorrhoids may be gently pushed back into place in the rectum.

External hemorrhoids are swollen blood vessels in the anus and are usually manifested by pain as well as bleeding. When external hemorrhoids prolapse or protrude from the anal sphincter, blood clots sometimes form, causing an extremely painful condition known as thrombosis. While they usually disappear by themselves within about a week, thrombosed hemorrhoids may be removed by a physician or may be treated with a pain- reducing medication to reduce the pain.

It is believed that hemorrhoids are caused by the exertion of abdominal pressure on rectal veins, causing the veins to swell and become irritated. The abdominal pressure may be caused by a variety of factors and conditions, including obesity, pregnancy, prolonged standing or sitting, liver disease, straining during bowel movements, coughing, sneezing, vomiting, or holding the breath during physical activity. Hemorrhoids are largely preventable by the adoption of a high-fiber diet. On the other hand, person whose diet consists largely of low-fiber and processed foods tend to run the highest risk of developing hemorrhoids. Furthermore, inadequate fluid intake can contribute to the development of hemorrhoids by causing the development of hard stools, which irritate and inflame the rectal veins.

About half of population living in the United States will be afflicted with hemorrhoids at some point during their lives. Hemorrhoids most often strike people between the ages of <NUM> and <NUM>. Some evidence indicates that "weak" veins, which are most susceptible to developing hemorrhoids, are inherited.

The present invention relates to applying heat energy by forms of conductive, resistive heating, and Radiofrequency heating. More particularly, the present invention relates to utilizing an innovative anoscope to position, monitor, and treat hemorrhoids. Lastly, the present invention utilized various probes to apply heat energy.

<CIT> discloses an anoscope for inspection and/or surgery. The anoscope includes a tubular body having a distal end, a proximal end, and a longitudinal axis defined there between, where the tubular body includes at least one elongated slot. The anoscope also includes an insert removably attached to the at least one elongated slot in the tubular body. The insert includes an elongated slot with a width that is smaller than that of the at least one elongated slot in the tubular body.

According to the present invention a system for treating hemorrhoids includes an anoscope assembly and a treatment probe. The anoscope assembly includes an elongated anoscope body and a sliding element. The elongated anoscope body has a distal end and a proximal end. The anoscope body is configured to be insertable into the rectum of a patient. The elongated anoscope body includes a main portion and a proximal portion. The main portion has a longitudinal slot configured to function as a window opening to trap hemorrhoids. The proximal portion depends proximally from the main portion. The proximal portion has handles thereon configured to be manipulated by a user so as to adjust the cross-sectional area of the proximal portion. The sliding element is configured to slide through the proximal portion and through the longitudinal slot when the cross-sectional area of the proximal portion is sufficiently increased by a user by manipulation of the handles. This provides access and secure placement of the sliding element within the longitudinal slot. The treatment probe operably connected to the anoscope assembly is configured to provide energy to a hemorrhoid during treatment. Said proximal portion defining a broken away ring type structure, said broken away ring type structure separates from the main portion by a cutaway radial slot and remains integrally connected to the main portion by an integrally connecting portion.

In an aspect of the present disclosure, not falling within the scope of the claims, there is a method for treating hemorrhoids that includes providing an anoscope assembly, providing a treatment probe, inserting the anoscope assembly into the rectum, inserting the treatment probe into the rectum, performing a treatment by utilizing the treatment probe, and removing the anoscope assembly. The anoscope assembly includes an elongated anoscope body and a sliding element. The elongated anoscope body has a distal end and a proximal end. The anoscope body is configured to be insertable into the rectum of a patient. The elongated anoscope body includes a main portion and a proximal portion. The main portion has a longitudinal slot configured to function as a window opening to trap hemorrhoids. The proximal portion depends proximally from the main portion. The proximal portion has handles thereon configured to be manipulated by a user so as adjust the cross-sectional area of the proximal portion. The sliding element is configured to slide through the proximal portion and through the longitudinal slot when the cross-sectional area of the proximal portion is sufficiently increased by a user by manipulation of the handles. This provides access and secure placement of the sliding element within the longitudinal slot. The treatment probe operably connected to the anoscope assembly is configured to provide energy to a hemorrhoid during treatment.

In one aspect, the ablating apparatus for use in treating a hemorrhoid of the present invention includes a combination of an anoscope, ablation catheter/paddle probe, dilator, and ground pad. The anoscope incorporates an adjustable window on the side of the scope body, which is positionable within an orifice. The window is closed during the insertion of the scope but is opened to receive the hemorrhoid tissue and applies clamping pressure onto the tissue. The adjustable window could further incorporate a return path for the RF signal and/or a temperature measuring element to monitor the tissue temperature. The ablation catheter includes an ablating element for treating the tissue and a temperature measuring element for monitoring the ablating element during treatment. The dilator includes a hollow lancing shaft within which an ablation catheter is situated. The dilator sheath (a hollow lancing shaft) has a central passage for the drainage of fluids. The ablation catheter, the dilator, and the anoscope is controlled or monitored by a control unit that displays the temperatures from the temperature measuring elements of the ablating apparatus and supplies energy to the ablating element of the catheter.

The ablating element may use any number of modalities that are suitable for ablating a hemorrhoidal tissue. The ablating element may be a contact catheter that can be used without the dilator. The ablating element may be a heating element that does not require electricity to flow from the ablation element to the body. Examples of ablation elements include but are not limited to a resistive heater, a radiofrequency electrode, a laser heating fiber, and a microwave antenna probe. If it is a resistive heater, it may be, for example, a resistive wire heater, semi-conductor material heater, or resistive sheath heater. The energy source may be, for example, direct current, alternating current, or radiofrequency current. The ablating element may be a cooling element, such as a cryosurgical device.

The ablating apparatus can be used with a multi-functional control system for controlling the overall ablative process, including, for example, monitoring the temperature of the ablating device and surrounding tissue, timing the ablation, controlling the energy level to the ablating device, and controlling the energy path from the ablation catheter to anoscope and/or to ground pad.

Other objects, advantages, and novel features will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings.

Referring to <FIG>, dilator assembly <NUM> includes a dilator connector <NUM> connected to a dilator needle <NUM>.

The length and diameter of the dilator needle <NUM> are configured with dilator sheath <NUM> such that the needle <NUM> has to fit inside of the sheath <NUM> and the needle <NUM> has to extend beyond the end of the sheath <NUM> by the length of the ablation zone formed by ablation catheter <NUM>. The dilator may be formed of rigid materials, for example, but not limited to stainless steel and titanium. The tip of the dilator needle <NUM> has a smaller diameter than the diameter of the proximal end of the catheter for penetration into tissues. Examples of the tips are, for example, but not limited to, trocar and needlepoint tips.

Dilator connector <NUM> is designed to mate with sheath connector <NUM>. Dilator connector <NUM> is attached to dilator <NUM>. The dilator connector <NUM> may be formed with a dielectric material, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

Referring now to <FIG>, dilator sheath assembly <NUM> includes dilator sheath connector <NUM> and dilator sheath <NUM>. There is a channel formed in the middle of the dilator connector <NUM>, which extends along the length of the dilator sheath <NUM>, allows dilator <NUM> to be positioned inside of the sheath assembly <NUM>. The dilator connector <NUM> mates with dilator sheath connector <NUM>. The dilator connector <NUM> is designed to mate with the connector of syringe <NUM>. The dilator sheath <NUM> may be formed with high dielectric and rigid material, for example, but not limited to mylar and PTFE. The dilator sheath connector <NUM> may be formed with a dielectric material, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

Referring to <FIG>, ablation catheter assembly <NUM> includes and ablation catheter element <NUM>. Ablation catheter element <NUM> includes ablation catheter temperature sensor <NUM>, ablation catheter sheath <NUM>, ablation catheter temperature sensing cable <NUM>, and ablation catheter connector <NUM>. the ablation catheter assembly <NUM> also includes ablation catheter connectors including ablation catheter power cable <NUM>, an ablation catheter power connector <NUM>, and an ablation catheter temperature sensing connector <NUM>, cable <NUM>, cable <NUM>, connector <NUM>, and connector <NUM>, collectively define a connector system designated generally as <NUM>.

The ablation catheter temperature sensor <NUM> is preferably attached near the tip <NUM> of the inside of the ablation catheter sheath <NUM>. The temperature sensor <NUM> is used to monitor the maximum temperature reached at the ablation zone of the ablation catheter <NUM>. For the safety of the ablation, it is ideal, not only to measure the temperature at the extent of the targeted hemorhoid <NUM>, but also to measure the temperature at the energy source to prevent the over treatment of the tissues adjacent to the catheter tip <NUM> while the other tissues of hemorrhoid away from the tip <NUM> has not reached the temperature. The temperature sensor <NUM> can be utilized using different temperature measuring modalities, for example, but not limited to thermocouples, thermistors, and RTDs (Resistance Thermometer Detectors).

The ablation catheter sheath <NUM> is attached to the ablation catheter connector <NUM> and extends therefrom. The ablation catheter sheath <NUM> fits inside of the dilator sheath element <NUM> and extends beyond the end of the dilator sheath element <NUM>. The outside surface of the ablation catheter sheath <NUM> touches hemorrhoid <NUM> (see, for example, <FIG>). For one of the embodiments that utilizes RF power flow from the ablation catheter to the hemorrhoid tissue to deliver heat, the ablation catheter sheath is formed from electrically conductive and biocompatible materials, for example, but not limited to stainless steel and titanium. Preferably, the tip of the ablation catheter sheath has a smaller diameter than the diameter of the proximal end of the catheter. Examples of the tips are, for example, but not limited to, trocar and needlepoint tips. If the user utilizes a dilator to penetrate the hemorrhoid before inserting the ablation catheter element <NUM> into hemorrhoid, the tip <NUM> of the ablation catheter sheath <NUM> can be blunt.

One end of the ablation catheter temperature sensing cable <NUM> is attached to the temperature sensor <NUM>. The other end of the temperature sensing cable is attached to the temperature sensor connector <NUM>. The temperature sensing cable <NUM> is positioned inside of the catheter probe sheath <NUM> for the portion that extends along the ablation probe sheath. If a thermocouple is used for temperature sensor <NUM>, temperature sensing cable <NUM> and temperature sensor <NUM> is the same assembly of a thermocouple junction wire. If the temperature sensor <NUM> is a thermistor or RTD, etc., the temperature sensing cable comprises a pair of electrical wires insulated from each other.

The ablation catheter connector <NUM> is connected to the ablation catheter sheath <NUM> and configured to mate with the dilator sheath assembly <NUM>. The ablation catheter connector <NUM> can be formed with dielectric materials, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

One end of the ablation catheter power cable <NUM> is connected to the ablation catheter power connector <NUM>. For the embodiment of utilizing RF energy, the other end of the catheter power connector <NUM> is connected to the ablation catheter sheath <NUM>. The ablation catheter power cable <NUM> is positioned inside of the catheter probe sheath <NUM> for the portion that extends along the ablation probe sheath. The ablation catheter power cable is a single or multiple conduction cables.

In an embodiment utilizing thermocouple wires as the ablation catheter temperature sensor <NUM>, temperature sensing connector <NUM> is a thermocouple connector that matches the compound of the thermocouple wire used. In an embodiment using a thermistor or RTD as temperature sensor <NUM>, temperature sensing connector <NUM> is an electrical connector. One end of the temperature connector is attached to the thermocouple cable <NUM>, and the other end plugs into the system <NUM>.

One end of the ablation catheter power connector <NUM> is connected to the ablation catheter power cable <NUM>, and the other end of the power connector plugs into the system <NUM>(see <FIG>). The ablation catheter power connector <NUM> has a portion that is electrically conductive that mates to electrically conductive material located inside of the system <NUM>. The conductive material in the power connector <NUM> is preferably not exposed to the user. Outside housing of the power connector <NUM> can be formed with dielectric materials, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

Referring to <FIG>, a paddle ablation probe assembly <NUM> includes a paddle ablation probe element <NUM>. Paddle ablation probe element <NUM> includes paddle ablation disk <NUM>, paddle ablation probe sheath <NUM>, paddle ablation probe temperature sensor <NUM>, paddle ablation probe sensor cable <NUM>, paddle ablation probe insulation sheath <NUM>, paddle ablation probe handle <NUM>. The paddle ablation probe assembly <NUM> also includes a paddle ablation power cable <NUM>, paddle ablation probe power connector <NUM>, and paddle ablation probe temperature connector <NUM>. In another embodiment (see <FIG>) the paddle ablation probe <NUM> includes resistive material <NUM> to apply heat energy to hemorrhoid.

The paddle ablation disk <NUM> is attached to the paddle ablation probe sheath <NUM>. The paddle ablation disk <NUM> is designed to fit inside of the anoscope body <NUM> and apply operable contact and pressure to hemorrhoid <NUM>. One surface of the paddle ablation disk is designed to touch hemorrhoid <NUM> during treatment. The other side could also be designed to be used during treatment but it's not necessary. It is preferable to have the side designed to treat the hemorrhoid be flat, but it could also be arched or be different shapes to increase the contact area between the paddle ablation probe surface to the hemorrhoid. If the other side is not utilized for treatment, it could be designed to have a different shape and surface than the treatment side, for example, but limited to dome shape, triangular shape, etc. For one of the embodiments that utilizes RF power flow from the paddle ablation probe <NUM> to the hemorrhoid tissue to deliver heat, the surface that delivers energy is formed with electrically conductive and biocompatible materials, for example, but not limited to stainless steel and titanium. The rest of the body, including the side that is not designed to deliver energy, can be formed using biocompatible and non-conductive materials, for example, but not limited to various plastics such as polycarbonate, ABS, and nylons. For the other embodiment that utilizes resistive material to apply heat, the surface that delivers energy can be formed with biocompatible, thermally conductive, and electrically non-conductive materials.

The paddle ablation probe sheath <NUM> is attached to paddle ablation probe disk <NUM> and paddle ablation probe housing (handle)<NUM>. The diameter is narrower than the height of the paddle ablation probe disk <NUM>. It is preferable to have the diameter as small as possible for better viewing of the treatment area during treatment, but the paddle ablation sheath <NUM> has to be sufficiently rigid for the user to apply operable contact pressure to the hemorrhoid during treatment. The outside surface of the paddle ablation probe sheath <NUM> is not necessarily touching hemorrhoids during treatment, but it is preferable to make the sheath bio-biocompatible.

The paddle ablation probe temperature sensor <NUM> is located inside of the paddle ablation probe disk <NUM>. The temperature sensor <NUM> is used to monitor the maximum temperature reached at the ablation zone of the paddle ablation probe <NUM>. For the safety of the ablation, it is ideal, not only to measure the temperature at the extent of the targeted hemorrhoid <NUM>, but to also measure the energy source to control the heating of the tissue adjacent to the ablation zone. The temperature sensor <NUM> can be utilized using different temperature measuring modalities, for example, but not limited to thermocouples, thermistors, and RTDs.

One end of the paddle ablation probe temperature sensing cable <NUM> is attached tothe paddle ablation probe temperature sensing sensor <NUM>. The other end of the temperature sensing cable is attached to the paddle ablation probe temperature sensor connector <NUM>. The paddle ablation probe temperature sensing cable is positioned inside of the paddle ablation probe sheath <NUM> for the portion that extends along the paddle ablation probe sheath. If a thermocouple is used for temperature sensor <NUM>, temperature sensing cable <NUM> and temperature sensor <NUM> is the same assembly of a thermocouple junction wire. If the temperature sensor is a thermistor or RTD, etc., the temperature sensing cable is a pair of electrical conductors insulated from each other.

One end of the paddle probe handle <NUM> is attached to the paddle probe sheath <NUM> and paddle probe insulator sheath <NUM>. The other end of the paddle probe handle <NUM> is attached to the paddle probe temperature cable <NUM> and power cable <NUM>. For the embodiment that utilizes RF energy for treatment, attachment of the paddle probe sheath <NUM> and paddle probe power cable <NUM> can be done inside of the paddle probe handle <NUM>. The housing of the probe handle <NUM> can be formed with dielectric materials, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

One end of the paddle ablation probe power cable <NUM> is connected to the paddle ablation probe power connector <NUM>. The paddle ablation probe power cable <NUM> is located inside of the paddle ablation probe sheath <NUM> for the portion that extends along the paddle ablation probe sheath. For the embodiment of utilizing RF energy, the other end of the paddle ablation probe power connector <NUM> is connected to the paddle ablation probe sheath <NUM>. The paddle ablation probe power cable <NUM> may be a single cable or use multiple conduction cables. In another embodiment utilizing resistive material <NUM> to deliver heat energy, one end of the paddle ablation probe power cable <NUM> is attached to the resistive material <NUM>. The other end is attached to the paddle ablation probe power connector <NUM>.

For another embodiment using conductive heat to deliver heat energy to hemorrhoid <NUM>, resistive material <NUM> is utilized. The resistive material <NUM> is located at the inside wall of the paddle ablation probe disk <NUM>. Several different materials can be used for resistive material <NUM>, for example, but not limited to resistive wire, thermocouple wire, and semi-conductor materials. In an embodiment using thermocouple wire as resistive material, temperature sensor <NUM>, resistive material <NUM>, paddle ablation probe power cable <NUM>, and paddle ablation probe temperature sensor cable <NUM> can be a single assembly of one thermocouple wire.

For an embodiment using RF energy to deliver heat energy and using paddle ablation probe sheath <NUM> to conduct electricity to the paddle ablation probe disk <NUM>, paddle ablation probe insulation sheath <NUM> is utilized to prevent electrical conduction from the probe sheath <NUM> to surrounding tissues and/or to the user. The paddle ablation probe insulation sheath <NUM> is positioned outside of the paddle ablation probe sheath <NUM> along the length of the sheath. The paddle ablation probe insulation sheath can be formed using electrically insulating materials such as, but not limited to, mylar, PTFE, Nylon, and PVC, etc..

In an embodiment utilizing thermocouple wires as the paddle probe temperature sensor <NUM>, temperature sensing connector <NUM> is a thermocouple connector that matches the compound of the thermocouple wire used. In an embodiment using a thermistor or RTD as temperature sensor <NUM>, temperature sensing connector <NUM> is an electrical connector. One end of the thermocouple connector is attached to the temperature cable <NUM>, and the other end plugs into the system <NUM>.

One end of the ablation catheter power connector <NUM> is connected to the paddle power cable <NUM>, and the other end of the power connector plugs into the system <NUM>. The paddle power connector <NUM> has a portion that is electrically conductive that mates to electrically conductive material located inside of the system <NUM>. The conductive material in the power connector <NUM> is preferably not exposed to the user. Outside housing of the power connector, <NUM> can be formed with dielectric materials, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

Referring to <FIG>, <FIG>, an anoscope assembly <NUM> includes an elongated anoscope body <NUM> having a distal end <NUM> and a proximal end <NUM>. The anoscope body includes a main portion <NUM> having a longitudinal slot <NUM> configured to function as a window opening to trap hemorrhoids. The proximal portion <NUM> depends proximally from the main portion <NUM>. The proximal portion <NUM> has handles <NUM> thereon configured to be manipulated by a user so as to adjust the cross sectional area of the proximal portion <NUM>. The anoscope assembly <NUM> includes an anoscope sliding element (window) <NUM>, anoscope return path plate <NUM>, anoscope temperature sensor <NUM>, anoscope return path cable <NUM>, anoscope temperature sensor cable <NUM>, anoscope return path connector <NUM>, and anoscope temperature sensor connector <NUM>.

The sliding element <NUM> is configured to slide through the proximal portion <NUM> and through the longitudinal slot <NUM> when the cross sectional area of the proximal portion <NUM> is sufficiently increased by a user by manipulation of the handles, thus providing access and secure placement of the sliding element <NUM> within the longitudinal slot.

The proximal portion <NUM> defines a broken away ring type structure separated from the main portion by a cutaway radial slot <NUM>. It remains integrally connected to the main portion <NUM> by integrally connecting portion <NUM>.

The anoscope body <NUM> is configured to be insertable into the human rectum. Thus, as described above, there is an opening on one side designed to trap hemorrhoids. The opening <NUM> is designed to fit and slide anoscope sliding element (window) <NUM>. The anoscope body teeth <NUM> are configured to engage the anoscope sliding element teeth <NUM>. The engagement of both teeth prevents the anoscope sliding window from backing out once it has pushed out distally. The anoscope body gap <NUM> is designed to make the area of the anoscope body where the anoscope body teeth is attached moveable outward when the anoscope sliding window is removed from the anoscope body. Anoscope handles <NUM> can be used to move the body where the anoscope body tooth is attached outward. In the preferred embodiments shown in <FIG> (and in <FIG>) the sliding element teeth <NUM> are angled and thus configured to be complementary operable with the proximal portion teeth <NUM> to provide insertion without manipulation of the handles. Manipulation of the handles is required to slide the sliding element in the reverse direction out from the proximal portion. The anoscope body is preferably but not necessarily made with transparent materials, for example, but not limited to polycarbonate, and acrylic, etc., for better viewing of the rectal wall for observation.

The length and diameter of the anoscope sliding window <NUM> are designed to fit the window opening of the anoscope <NUM>. The anoscope sliding window is preferably but not necessarily made with transparent materials, for example, but not limited to polycarbonate, and acrylic, etc., for better viewing of the rectal wall for observation. Anoscope sliding window has an anoscope return path plate <NUM> attached to the distal end. Anoscope temperature sensor <NUM> is attached on or near the return path plate <NUM>, where the temperature can be read tissue temperature at or adjacent to the return path plate <NUM>. During ablation of hemorrhoid, the temperature read from the anoscope temperature sensor <NUM> may be the determining factor when to stop the procedure after completing it and/or interrupting it for safety. The temperature sensor <NUM> can be utilized using different temperature measuring modalities, for example, but not limited to thermocouples, thermistors, and RTDs. The anoscope temperature sensor cable <NUM> is attached to the anoscope temperature sensor <NUM>. For the portion of the anoscope temperature sensor cable <NUM> that extends along the length of the anoscope sliding window <NUM>, it is preferable but not limited to position the cable through the channel created inside of the sliding window. The other end of the anoscope temperature sensor cable <NUM> is attached to the anoscope temperature connector <NUM>. In an embodiment that utilize thermocouples as the anoscope temperature sensor <NUM>, the anoscope temperature cable <NUM> and anoscope temperature sensor <NUM> can be one assembly of thermocouple junction wire. The anoscope return path cable <NUM> is attached to the anoscope return path plate <NUM>. For the portion of the anoscope return path cable <NUM> that extends along the length of the anoscope sliding window <NUM>, it is preferable but not limited to position the cable through the channel created inside of the sliding window. The other end of the anoscope return path cable <NUM> is attached to the anoscope return path connector <NUM>.

One end of the anoscope return path connector <NUM> is connected to the anoscope return path power cable <NUM>, and the other end of the anoscope return path connector plugs into the system <NUM>. The return path connector <NUM> has a portion that is electrically conductive that mates to electrically conductive material located inside of the system <NUM>. The conductive material in the return path connector <NUM> is preferably not exposed to the user. Outside housing of the return path connector, <NUM> can be formed with dielectric materials, for example, but not limited to polycarbonate, ABS, and Nylon, etc..

In an embodiment of utilizing thermocouple wires as the return path temperature sensor <NUM>, temperature sensing connector <NUM> is a thermocouple connector that matches the compound of the thermocouple wire used. In an embodiment of using a thermistor or RTD as temperature sensor <NUM>, temperature sensing connector <NUM> is an electrical connector. One end of the temperature connector is attached to the temperature cable <NUM>, and the other end plugs into the system <NUM>.

For another embodiment of using resistive material <NUM> to deliver heat energy to hemorrhoid, the anoscope return path plate <NUM>, the anoscope return path cable <NUM>, and the anoscope return path connector <NUM> may not be necessary.

Referring to <FIG>, <FIG>, procedure steps using the ablation catheter <NUM> are illustrated. The steps include:.

For another method of not using the dilator and removing trapped blood from hemorrhoid, after mating the ablation catheter <NUM> and dilator sheath <NUM>, mated assembly of the ablation catheter and the dilator sheath can be penetrated inside of the hemorrhoid. Steps from C) through G) can be taken to proceed with the rest of the treatment.

Referring to <FIG>, <FIG>, procedure steps using the paddle ablation probe assembly <NUM> are illustrated. The steps include:.

Referring to <FIG>, a system block diagram is illustrated of a preferred embodiment of the overall system for treating hemorrhoids, designated generally as <NUM>. The system <NUM> uses an ablation control system assembly having microcontroller-based electronics capable of measuring different types of sensors as well as providing electric power to the ablation catheter and/or paddle probe. The power maybe, for example, RF power, DC power, or microwave power. System <NUM> includes ports to attach power output to the ablation catheter <NUM> or ablation paddle probe <NUM>. The connection is made by attaching power connectors <NUM> or <NUM> to the system. System <NUM> also has a temperature sensing connection for the alation catheter temperature sensor <NUM> or paddle probe temperature sensor <NUM>. The connection is made by attaching ablation catheter temperature connector <NUM> or the paddle probe temperature connector <NUM>. It is preferable but not necessary to combine the power and temperature connectors into a one connector assembly both on the control system <NUM>, and the catheter <NUM> / paddle probe <NUM> for ease of operation. System <NUM> also has a return path connection for the anoscope <NUM>. The connection is made by attaching return path power connector <NUM> into the system. The system also has a connection to the return path temperature sensor by attaching a temperature sensor connector <NUM> into the system. The system also has a connector to attach ground pad <NUM>. It is preferable but not necessary to combine the power and temperature connectors into one connector assembly both on the system <NUM>, and the anoscope <NUM> for ease of operation.

When ground pad <NUM> is attached, the system will sense the connection and it can automatically operate the system as a monopolar system described in <FIG>. In this mode, the system will ignore the power connection between system <NUM> and the anoscope power connector <NUM> regardless of whether the connection is made or not.

When ground pad <NUM> is not attached, the system will sense the presence of the anoscope power connection <NUM> into the system. If the anoscope power connection is present, the system will operate the system as a bipolar system between the ablation catheter <NUM> or the paddle probe <NUM> and the anoscope return path pad. If the anoscope power connection is not present or the impedance between two poles described above is large at the time of the treatment, the system will operate the system as a resistive heating method and ignore the connection to the return path.

Ground pad <NUM> may or may not be needed based on the operating methods described in the following sections.

The user interface module assembly <NUM> is preferably a touch screen display used to communicate with the user in two ways. The screen displays the current status of the treatment as well as gives users valuable information during treatment, such as timer, temperature, power, voltage, current, or impedance information. It also provides user commands to the system by providing user clickable options. The system can also incorporate a treatment switch as a foot petal (not shown) and/or a button switch on the ablation catheter (or paddle probe) (not shown) to make it easier for the user to start and stop the procedure.

Referring to <FIG>, the diagram and current flow for several ablation methods are illustrated. The bar on the lefthand side represents ablation catheter <NUM> (or paddle probe <NUM>). The circle in the middle represents a hemorrhoid <NUM>. The bar on the right side represents the anoscope return path plate <NUM>. The square represents ground pad <NUM>. The arrows represent the current flow.

Referring to <FIG>, the non-electrically conductive ablation method (i.e. resistive heating mode) is illustrated. The ablation catheter <NUM> (or paddle probe <NUM>) are activated using resistive material <NUM>. Therefore, there is no current flow from the catheter and probe <NUM>/<NUM> to hemorrhoid or the adjacent tissue. Conductive heat transfer is used to deliver heat to hemorrhoids. The return path plate <NUM> is not needed for the current path. Temperature measurement is the only function required from the return path. It is ideal to limit how high the catheter <NUM> and/or probe <NUM> can reach in terms of temperature in order to prevent over treatment of the tissue adjacent to the catheter and probe. In order to do that, ablation catheter temperature sensor <NUM> or paddle probe temperature sensor <NUM> is monitored to control the current going into the resistive material from the system <NUM>. An ideal safeguard is to limit the maximum time that the current can flow to the resistive material by means of a maximum duty cycle and/or total treatment time limitation. The anoscope temperature sensor <NUM> located at or near the return path plate <NUM> is used to determine whether ablation is completed throughout the hemorrhoid. When the targeted temperature is reached, system <NUM> will shut off the treatment.

Referring to <FIG>, a bipolar or return path plate mode is illustrated. The ablation catheter <NUM> (or paddle probe <NUM>) are activated using RF or other methods that flow current from the source to the body. The current will flow from the ablation catheter <NUM> or paddle probe <NUM> to hemorrhoid <NUM>, then to the return path plate <NUM>. By minimizing the current flow distance from the catheter/probe to the return path plate, the energy requirement for treatment is relatively smaller compared to the method of using ground pad. In order to safeguard, it is ideal to limit the maximum time that the current can flow to hemorrhoids by means of maximum duty cycle and/or total treatment time limitation. It is also ideal to limit the maximum current that can flow into hemorrhoids. It can be achieved by impedance measurement of hemorrhoids and use a predetermined maximum current allowed to flow. The anoscope temperature sensor <NUM> located at or near the return path plate <NUM> is used to determine whether ablation is completed throughout hemorrhoid. When the targeted temperature is reached, system <NUM> will shut off the treatment.

Referring to <FIG>, a monopolar mode is illustrated. The ablation catheter <NUM> (or paddle probe <NUM>) are activated using RF or other methods that flow current from the source to the body. The current will flow from the ablation catheter <NUM> (or paddle probe <NUM>) to hemorrhoid <NUM>, then to the ground pad attached further away from the return path pad. One of the possible issues with the method illustrated in <FIG> is that when the ablation and return path area are similar in size, usually the hottest area in terms of temperature is next to two poles. Since the temperature sensors are located near the two poles, it is possible that the two temperature sensors would present a temperature higher than the actual temperature of the hemorrhoid tissue; therefore, under treatment can occur. The method illustrated in <FIG> eliminates this issue by placing the ground pad away from the anoscope temperature sensor which is relatively distanced from the targeted area. Temperature sensor <NUM> or <NUM> is activated to control the power output. As a safeguard, it is ideal to limit the maximum time that the current can flow to hemorrhoids by means of a maximum duty cycle and/or total treatment time limitation. It is also ideal to limit the maximum current that can flow into hemorrhoids. Although power control based on impedance measurement is feasible with monopolar systems, real-time impedance measurement and power control is less precise with monopolar systems due to higher impedance measurements due to the distance between the source and return path of the energy. Temperature sensor <NUM> is used as a safety feature not to increase the temperature at the anoscope temperature sensor <NUM> above a certain temperature. In this method, since the anoscope temperature sensor <NUM> is in the current path rather than at the end, the temperature measured would be highly reflective of the temperature of hemorrhoid.

Referring now to <FIG>, a first preferred embodiment of a treatment probe is illustrated, designated generally as <NUM>, which includes a domed top ablation tip <NUM> on one end and a handle <NUM> on the other end. An ablation surface <NUM> opposes the dome shaped top surface <NUM>.

<FIG> illustrates a thin paddle probe, designated generally as <NUM>. It includes an ablation surface <NUM> that can be a resistive or conductive surface. It can be active on both sides.

Referring now to <FIG> a preferred second embodiment of an anoscope assembly is illustrated, designated generally as <NUM>. This embodiment includes the same salient features as the.

<FIG> embodiment. It includes a main portion <NUM>, proximal portion <NUM>, and sliding element <NUM>. The tip <NUM> is also shown in this illustration. The proximal portion <NUM> preferably has a relatively thin section <NUM> and a relatively thick section <NUM> to enhance flexibility. The ears <NUM> descend tangentially from the surface of the proximal portion <NUM> to provide ease in use.

The different methods to treat after trapping the hemorrhoid can be described as follows;.

It is to be understood that although the invention has been described above in terms of particular embodiments, the foregoing embodiments are provided as illustrative only, and do not limit or define the scope of the invention. Various other embodiments, including but not limited to the following, are also within the scope of the claims. For example, elements and components described herein may be further divided into additional components or joined together to form fewer components for performing the same functions.

Any of the functions disclosed herein may be implemented using means for performing those functions. Such means include, but are not limited to, any of the components disclosed herein, such as the computer-related components described below.

The techniques described above may be implemented, for example, in hardware, one or more computer programs tangibly stored on one or more computer-readable media, firmware, or any combination thereof. The techniques described above may be implemented in one or more computer programs executing on (or executable by) a programmable computer including any combination of any number of the following: a processor, a storage medium readable and/or writable by the processor (including, for example, volatile and non- volatile memory and/or storage elements), an input device, and an output device. Program code may be applied to input entered using the input device to perform the functions described and to generate output using the output device.

Embodiments of the present invention include features which are only possible and/or feasible to implement with the use of one or more computers, computer processors, and/or other elements of a computer system. Such features are either impossible or impractical to implement mentally and/or manually. For example, embodiments of the present invention may read and write data to electronic memory devices (such as RFID tags) and/or to distributed ledgers (such as a blockchain), which are functions that cannot be performed mentally or manually.

Any claims herein which affirmatively require a computer, a processor, a memory, or similar computer-related elements, are intended to require such elements, and should not be interpreted as if such elements are not present in or required by such claims. Such claims are not intended, and should not be interpreted, to cover methods and/or systems which lack the recited computer-related elements. For example, any method claim herein which recites that the claimed method is performed by a computer, a processor, a memory, and/or similar computer-related element, is intended to, and should only be interpreted to, encompass methods which are performed by the recited computer-related element(s). Such a method claim should not be interpreted, for example, to encompass a method that is performed mentally or by hand (e.g., using pencil and paper). Similarly, any product claim herein which recites that the claimed product includes a computer, a processor, a memory, and/or similar computer-related element, is intended to, and should only be interpreted to, encompass products which include the recited computer-related element(s). Such a product claim should not be interpreted, for example, to encompass a product that does not include the recited computer-related element(s).

Each computer program within the scope of the claims below may be implemented in any programming language, such as assembly language, machine language, a high-level procedural programming language, or an object-oriented programming language. The programming language may, for example, be a compiled or interpreted programming language.

Each such computer program may be implemented in a computer program product tangibly embodied in a machine-readable storage device for execution by a computer processor. Method steps of the invention may be performed by one or more computer processors executing a program tangibly embodied on a computer-readable medium to perform functions of the invention by operating on input and generating output. Suitable processors include, by way of example, both general and special purpose microprocessors. Generally, the processor receives (reads) instructions and data from a memory (such as a read-only memory and/or a random access memory) and writes (stores) instructions and data to the memory. Storage devices suitable for tangibly embodying computer program instructions and data include, for example, all forms of non-volatile memory, such as semiconductor memory devices, including EPROM, EEPROM, and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto- optical disks; and CD-ROMs. Any of the foregoing may be supplemented by, or incorporated in, specially-designed ASICs (application-specific integrated circuits) or FPGAs (Field- Programmable Gate Arrays). A computer can generally also receive (read) programs and data from, and write (store) programs and data to, a non-transitory computer-readable storage medium such as an internal disk (not shown) or a removable disk. These elements will also be found in a conventional desktop or workstation computer as well as other computers suitable for executing computer programs implementing the methods described herein, which may be used in conjunction with any digital print engine or marking engine, display monitor, or other raster output device capable of producing color or gray scale pixels on paper, film, display screen, or other output medium.

Claim 1:
A system (<NUM>) for treating hemorrhoids, wherein the system comprises:
a) an anoscope assembly (<NUM>), comprising:
i) an elongated anoscope body (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>), said anoscope body (<NUM>) being configured to be insertable into the rectum of a patient, said elongated anoscope body (<NUM>), comprising:
<NUM>. a main portion (<NUM>) having a longitudinal slot (<NUM>) configured to function as a window opening to trap hemorrhoids;
<NUM>. a proximal portion (<NUM>) extending proximally from said main portion (<NUM>), said proximal portion (<NUM>) having handles (<NUM>) thereon configured to be manipulated by a user so as to adjust the cross-sectional area of the proximal portion (<NUM>);
ii) a sliding element (<NUM>) configured to slide through the proximal portion (<NUM>) and through said longitudinal slot (<NUM>) when the cross-sectional area of the proximal portion (<NUM>) is sufficiently increased by a user by manipulation of said handles (<NUM>), thus providing access and secure placement of the sliding element (<NUM>) within the longitudinal slot (<NUM>); and,
b) a treatment probe operably connected to said anoscope assembly (<NUM>), configured to provide energy to a hemorrhoid during treatment;
characterized in that
said proximal portion (<NUM>) defines a broken away ring type structure, said broken away ring type structure separates from the main portion (<NUM>) by a cutaway radial slot (<NUM>), and remains integrally connected to the main portion (<NUM>) by an integrally connecting portion (<NUM>).