US20020183735A1 - Ablation of rectal and other internal body structures - Google Patents

Abstract

The invention provides an apparatus and system for ablation of body structures or tissue in the region of the rectum. A catheter is inserted into the rectum, and an electrode is disposed thereon for emitting energy. The environment for an ablation region is isolated or otherwise controlled by blocking gas or fluid using a pair of inflatable balloons at upstream and downstream locations. Inflatable balloons also serve to anchor the catheter in place. A plurality of electrodes are disposed on the catheter and at least one such electrode is selected and advanced out of the catheter to penetrate and ablate selected tissue inside the body in the region of the rectum. The electrodes are coupled to sensors to determine control parameters of the body structure or tissue, and which are used by feedback technique to control delivery of energy for ablation or fluids for cooling or hydration. The catheter includes an optical path disposed for coupling to an external view piece, so as to allow medical personnel to view or control positioning of the catheter and operation of the electrodes. The catheter is disposed to deliver flowable substances for aiding in ablation, or for aiding in repair of tissue, such as collagen or another substance for covering lesions or for filling fissures. The flowable substances are delivered using at least one lumen in the catheter, either from at least one hole in the catheter, from an area of the catheter covered by a microporous membrane, or from microporous balloons.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 09/557,993, filed Apr. 25, 2000 (Attorney Docket No. STUA0012C).[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• This invention relates to ablation of rectal and other internal body structures.[0003]
• 2. Description of Related Art[0004]
• Human beings are subject to a number of disorders in the area of the rectum and colon, including hemorrhoids (external and internal), prolapse of the rectal muscles, rectal muscle spasms, anal fissures, polyps, diverticulosus and diverticulitus, and pilonital cysts. Other internal disorders in nearby regions of the body include (in men) prostate cancer, (in women) incontinence, vaginal bleeding, vaginal cysts, vaginal fibroids, prolapse of the uterus, and related tumors or cancerous tissue.[0005]
• Although there are treatments available for these disorders, such as surgery, systemic or topical medication, these treatments suffer from various drawbacks, including (for surgery) their relative invasiveness and expense, and (for medicinal approaches) their relative ineffectiveness and the causation of serious side-effects. Accordingly, it would be advantageous to provide methods and apparatus for treatment which are not subject to the drawbacks of surgery and medicinal approaches.[0006]
• Although it is known to use RF energy to ablate tissue in the body (such as heart muscle tissue) to treat disorders, one problem which has arisen in the art is accounting for the flow of bodily fluids and gases while ablating tissue. Bodily fluids can dissipate, and can detrimentally absorb, energy to be applied to tissue.[0007]
• Accordingly, it would be advantageous to provide improved techniques for treatment of disorders in the area of the rectum and colon. This advantage is achieved by a method and system according to the present invention in which a catheter is inserted into the rectum, and at least one electrode is disposed thereon for emitting energy to ablate body structures or other tissue in an ablation region in or near the rectum, such as the sphincter, rectum, colon, or prostate.[0008]
SUMMARY OF THE INVENTION
• The invention provides a method and system for ablation of body structures or tissue in an ablation region in or near the rectum (such as the sphincter, rectum, colon, or prostate). A catheter is inserted into the rectum, and at least one electrode is disposed thereon for emitting energy to ablate body structures or other tissue, such as by cell death, dehydration, or denaturation. The environment for the ablation region is isolated or otherwise controlled, such as by blocking gas or fluid using a pair of inflatable balloons at upstream and downstream locations from the ablation region. In a preferred embodiment, inflatable balloons also serve to anchor the catheter in place and prevent the catheter from being expelled from the body.[0009]
• In preferred embodiments, the catheter is flexible for reaching a selected internal organ or region, a plurality of electrodes are disposed on the catheter and at least one such electrode is selected and advanced out of the catheter to penetrate and ablate selected tissue inside the body in ablation region in or near the rectum, such as an individual cyst, hemorrhoid, polyp, tumor, or other selected lesion or tissue. The electrodes are coupled to sensors to determine control parameters of the body structure or tissue, such as impedance or temperature, and which are used by feedback technique to control delivery of energy for ablation or fluids for cooling or hydration. In a preferred embodiment, the catheter includes an optical path disposed for coupling to an external view piece, so as to allow medical personnel to view or control positioning of the catheter and operation of the electrodes.[0010]
• In further preferred embodiments, the catheter is disposed to deliver flowable substances for aiding in ablation, such as saline or antibiotics, or for aiding in repair of tissue (either before or after ablation), such as collagen or another substance for covering lesions or for filling fissures in or near the ablation region, or for other medicinal effects, such as anesthetic, anti-inflammatory, or antispasmodic substances. The flowable substances are delivered using at least one lumen in the catheter, either from at least one hole in the catheter, from an area of the catheter covered by a microporous membrane, or from microporous balloons (either the same as or in addition to balloons used to anchor the catheter in place or to block gas or fluid).[0011]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1 and 1[0012]ashow a side view of a catheter and electrode assembly.
• FIGS. 2 and 2[0013]ashow a cut-away view of a catheter and electrode, taken along aline2--2 in FIG. 1.
• FIG. 3 shows a method of treatment of a hemorrhoid.[0014]
• FIG. 4 shows a method of treatment of a prolapsed or spasmodic muscle.[0015]
• FIG. 5 shows a method of treatment of an anal fissure.[0016]
• FIG. 6 shows a method of treatment of a tumor in the prostate.[0017]
DESCRIPTION OF THE PREFERRED EMBODIMENT
• Catheter and Electrode Assembly[0018]
• FIG. 1 shows a side view of a catheter and electrode assembly.[0019]
• An assembly[0020]100 for ablating rectal and other internal body structures includes acatheter110, a control anddelivery linkage120, and acontrol element130.
• The[0021]catheter110 is coupled to the control anddelivery linkage120 using agearing element121, which allows thecatheter110 to be rotated with respect to the control anddelivery linkage120 by an operator using thecontrol element130.
• The[0022]catheter110 includes abase111, having a substantially cylindrical shape, coupled at a proximal end to thegearing element121, and having a distal end. Thecatheter110 is preferably disposed for insertion into the rectum at an angle to the control anddelivery linkage120, preferably an angle between about 30° and about 45° less than a right angle. Thecatheter110 is between about 1 inch (2.54 cm) and about 2 inches (5.08 cm) in diameter, and between about 6 inches (15.24 cm) and about 8 inches (20.32 cm) in length.
• The[0023]catheter110 includes a plurality ofholes112, and a plurality ofelectrodes113 which may be extended from at least some of theholes112. Theholes112 are spaced regularly around the circumference and along the length of thecatheter110, having a spacing of about 0.25 inches (0.64 cm) betweenadjacent holes112. Theelectrodes113 are spaced regularly to occupy about one-half of theholes112, and are between about 0.5 cm and about 1.0 cm in length.
• The[0024]electrodes113 each include ametallic tube114 defining ahollow lumen115, shaped similarly to an injection needle, so as to be disposed to deliver at least one flowable substance to aregion140 near thecatheter110. In a preferred embodiment, the deliverable flowable substance includes saline with a concentration of less than about 10% NaCl, which aids in both hydration of body structures and other tissue, and in delivery of RF energy to theregion140. However, in alternative embodiments, the deliverable flowable substance includes other substances, including saline with other concentrations, systemic or topical antibiotics, collagen or another hardenable substance, or other bioactive, chemoactive, or radioactive substances (including anesthetic, anti-inflammatory, or antispasmodic substances, or tracer materials).
• The[0025]catheter110 includes at least oneballoon116, disposed for inflation so as to block gas or fluid from the body from entering theregion140. In a preferred embodiment, there is adistal balloon116 disposed at the distal end of thecatheter110 and there is aproximal balloon116 disposed at the proximal end of thecatheter110. Thedistal balloon116 and theproximal balloon116 preferably each comprise ring-shaped balloons, disposed so that when inflated each surrounds thecatheter110 and makes a gas-tight or fluid-tight seal, both with thecatheter110 and with awall141 of the rectum or other body structure into which thecatheter110 is inserted. However, in alternative embodiments, thedistal balloon116 may comprise a spherical or ellipsoidal balloon disposed at the distal end of thecatheter110 in such manner that when inflated it surrounds thecatheter110 and makes a gas-tight or fluid-tight seal with thewall141.
• The[0026]catheter110 also includes at least oneballoon116 disposed to anchor thecatheter110 at a selected location within the rectum or other body structure into which thecatheter110 is inserted. In a preferred embodiment, theballoon116 used to anchor thecatheter110 is theproximal balloon116, which when inflated prevents thecatheter110 from being expelled from the body in like manner as the operation of a Foley catheter. However, in alternative embodiments, theballoon116 used to anchor thecatheter110 may comprise an additional or alternative balloon which is disposed solely or primarily for the purpose of anchoring thecatheter110 into its selected place, again in like manner as the operation of a Foley catheter.
• The[0027]catheter110 includes afluid circulation system117, including at least one fluid outlet port and at least one fluid inlet port. Thefluid circulation system117 is disposed for providing fluid in the region near thecatheter110, such as for delivering fluid for cooling theregion140 and for removing other fluid for aspirating theregion140.
• The[0028]catheter110 includes anoptical view port118, possibly including a lens or other transparent or translucent covering, disposed to allow inflow of light (visible or infrared) for transmission to an operator for viewing and control of the operation of thecatheter110.
• The[0029]catheter110 includes at least onesensor119, such as asensor119 for impedance or temperature. In a preferred embodiment, thetemperature sensor119 includes a thermocouple, but in alternative embodiments, thetemperature sensor119 may include a thermistor or other device for sensing temperature and providing signals responsive to temperature near thecatheter110.
• The control and[0030]delivery linkage120 includes ametallic tube223 defining ahollow lumen224, and is further described with reference to FIG. 2.
• In a preferred embodiment, the control and[0031]delivery linkage120 is between about ½ inch (1.27 cm) and about ⅝ inches (1.59 cm) in diameter, and between about 6 inches (15.24 cm) and about 8 inches (20.32 cm) in length.
• The[0032]control element130 includes anelectrode actuation element131 for advancing theelectrodes113 out from thecatheter110, a electrode retraction element132 for retracting theelectrodes113 into from thecatheter110, and anoperation element133 for controlling operation of thecatheter110, including delivery of flowable substances using theholes112 and delivery of energy using theelectrodes113.
• Advancing and Retracting Electrodes[0033]
• FIG. 2 shows a cut-away view of a catheter, taken along a[0034]line2--2 in FIG. 1.
• The[0035]catheter110 comprises a rotatable element210 which is disposed for rotation in afirst direction211 to advance theelectrodes113 out of thecatheter110 and in asecond direction212 opposite thefirst direction211 to retract theelectrodes113 back into thecatheter110.
• In a preferred embodiment, the rotatable element[0036]210 is coupled to a spring (not shown) or other device which holds the rotatable element210 in a steady state with theelectrodes113 retracted into thecatheter110.
• The rotatable element[0037]210 is coupled to theelectrode actuation element131, which forces the rotatable element210 to rotate in thefirst direction211 so as to advance theelectrodes113 out of thecatheter110. When the actuator element is not actuated, the spring causes the rotatable element210 to rotate in thesecond direction212 so as to retract theelectrodes113 back into thecatheter110.
• Each[0038]electrode113 is coupled to anelectrode carrier220. In a preferred embodiment, eachelectrode carrier220 is substantially bar-shaped (but is shown end-on in the figure) and is coupled to a plurality ofelectrodes113, such as about between about three and about sixelectrodes113, so as to substantially simultaneously advance that plurality ofelectrodes113 out of thecatheter110 and retract that plurality ofelectrodes113 back into the catheter. A plurality ofelectrode carriers220 are each disposed in a set of lines corresponding to lines ofelectrodes113 disposed for advancement out of thecatheter110 and retraction back into thecatheter110.
• In a preferred embodiment, the[0039]electrodes113 may be disposed so that when advanced, theelectrodes113 extend to selected depths within the body structure to be ablated. These selected depths may be the same depth for allelectrodes113 which are advanced, or may include a first depth for a first set ofelectrodes113 and a second depth for a second set ofelectrodes113.
• In a preferred embodiment, the[0040]electrode carriers220 are coupled to a set of controls (not shown) in thecontrol element130 for selecting one ormore electrode carriers220 independently using one ormore actuation levers221, so as to be able to independently advance one or more sets ofelectrodes113 coupled thereto out of thecatheter110 and to independently retract one or more sets ofelectrodes113 back into thecatheter110.
• Each[0041]electrode carrier220 is coupled to the rotatable element210 using abearing222, in such manner so as to translate rotation of the rotatable element210 into linear radial movement of theelectrodes113. When the rotatable element210 is rotated in thefirst direction211, the electrodes are advanced in a firstlinear movement223, while when the rotatable element210 is rotated in thesecond direction212, the electrodes are retracted in a secondlinear movement224.
• An interior[0042]230 of the rotatable element210 includes alumen225 through which fluids and other flowable substances are provided, and in which conductors providing control signals and sensor signals are disposed.
• Operation of the Catheter and Electrode Assembly[0043]
• Operation of the catheter and electrode assembly[0044]100 includes at least the following steps:
• The[0045]catheter110 is inserted into the body at an opening, such as the rectum.
• In a preferred embodiment, the opening is the rectum. A region of the rectum is first infused with a lubricant, such as K-Y jelly, and with an anesthetic, such as lidocaine. An anti-inflammatory, antispasmodic, or other condign medication would also be applied as appropriate. Thereafter, the[0046]catheter110 is inserted into the lubricated region of the rectum. Due to the potential pain induced by the presence of thecatheter110 orelectrodes113, during operation thecatheter110 infuses a mixture of saline and lidocaine into theregion140 to be ablated.
• In alternative embodiments, the opening may be another opening into the body, such as a natural orifice such as the vagina or the urethra, or an opening which has been made surgically, such as an incision which allows the[0047]catheter110 to be inserted into a blood vessel.
• The preferred size of the[0048]catheter110 will of course be responsive to the size of the opening if other than the rectum. The choice of medicinal elements to be infused prior to or coeval with thecatheter110 will of course be responsive to judgments by medical personnel, and may include lubricants, anesthetics, antispasmodics, antiinflammatories, antibiotics, or other materials with bioactive, chemoactive, or radio-active effect.
• The[0049]catheter110 is positioned within the body at a selected orientation and location, such as a position near a hemorrhoid.
• In one preferred embodiment, the[0050]catheter110 is positioned in the rectum near an eternal or internal hemorrhoid, in a manner as shown in FIG. 3. In this preferred embodiment, theelectrodes113 are ultimately advanced into the hemorrhoid to ablate the hemorrhoid.
• In another preferred embodiment, the[0051]catheter110 is positioned in the rectum near a prolapsed or spasmodic muscle, in a manner as shown in FIG. 4. In this preferred embodiment, theelectrodes113 are ultimately advanced into the prolapsed or spasmodic muscle to ablate selected portions of the prolapsed or spasmodic muscle.
• In another preferred embodiment, the[0052]catheter110 is positioned in the rectum near an anal fissure, in a manner as shown in FIG. 5. In this preferred embodiment, collagen is deposited into the fissure and theelectrodes113 are ultimately advanced into a region near the collagen to harden the collagen for filling the fissure.
• In another preferred embodiment, the[0053]catheter110 is positioned in the colon near a polyp, in a manner similar to that shown in FIG. 3. In this preferred embodiment, theelectrodes113 are ultimately advanced into the polyp to ablate the polyp.
• In another preferred embodiment, the[0054]catheter110 is positioned in the rectum near a pilonital cyst, in a manner similar to that shown in FIG. 3. In this preferred embodiment, theelectrodes113 are ultimately advanced into the cyst to ablate the cyst.
• In another preferred embodiment, the[0055]catheter110 is positioned in the rectum, colon, large intestine, or small intestine, near a cyst or tumor, in a manner similar to that shown in FIG. 3. In this preferred embodiment, theelectrodes113 are ultimately advanced into the cyst or tumor to ablate the cyst or tumor.
• In another preferred embodiment, the[0056]catheter110 is positioned in a male patient, in the rectum near the prostate, in a manner as shown in FIG. 6. In this preferred embodiment, theelectrodes113 are ultimately advanced into a tumor in the prostate to ablate the tumor.
• In another preferred embodiment, the[0057]catheter110 is positioned in a female patient, in the vagina, near a cyst or fibroid, in a manner similar to that shown in FIG. 3. In this preferred embodiment, theelectrodes113 are ultimately advanced into the cyst or fibroid to ablate the cyst or fibroid.
• In another preferred embodiment, the[0058]catheter110 is positioned in a female patient, in the vagina, near a prolapsed uterus, in a manner similar to that shown in FIG. 4.
• In this preferred embodiment, the[0059]electrodes113 are ultimately advanced into the prolapsed uterus selected portions of the prolapsed uterus.
• The[0060]catheter110 is anchored into place at the selected orientation and location by inflating aballoon116, such as thedistal balloon116 and theproximal balloon116.
• In embodiments where the[0061]catheter110 is positioned in the rectum, thecatheter110 is anchored into place using theproximal balloon116 and theproximal balloon116 operates in similar manner as a Foley catheter.
• In alternative embodiments, the[0062]catheter110 includes astop balloon116, such as a ring balloon (as shown in FIG. 3), disposed outside the body so as to prevent thecatheter110 from being inserted “too far”, i.e., beyond its selected location.
• The[0063]region140 near thecatheter110 is isolated from the rest of the body by inflating thedistal balloon116 and theproximal balloon116. In a preferred embodiment, this step uses the samedistal balloon116 and theproximal balloon116 as the step of anchoring thecatheter110 into place.
• Isolation of the[0064]region140 near thecatheter110 from the rest of the body need not be absolute. In a preferred embodiment, thedistal balloon116 and theproximal balloon116 are microporous, are inflated using saline or water, and thus are disposed to provide saline or water into theregion140 near thecatheter110. However, in such an embodiment, gas and fluids from the rest of the body are allowed to leak into one or more of theballoons116 and from there are allowed to leak into theregion140 near thecatheter110.
• Moreover, while in a preferred embodiment the seal made with the[0065]wall141 of theregion140 by theballoon116 is gas-tight, in alternative embodiments, that seal is allowed to be simply fluid-tight, and might allow gas to leak from the rest of the body into theregion140 near thecatheter110.
• One or more sets of[0066]electrodes113 are selected for advancement into a selected mass of tissue in theregion140. The rotatable element210 is rotated in thefirst direction211, causing the selected sets ofelectrodes113 to advance out of thecatheter110 and into the selected mass of tissue.
• The selected set of[0067]electrodes113 are just thoseelectrodes113 which are needed to penetrate the selected mass of tissue for ablation.
• In a preferred embodiment where the selected mass of tissue for ablation is a hemorrhoid, the selected set of[0068]electrodes113 are just thoseelectrodes113 which are needed to penetrate the hemorrhoid. If a plurality of hemorrhoids are selected for ablation, either (1)electrodes113 needed to penetrate the plurality of hemorrhoids are selected, or (2)electrodes113 needed to penetrate one of the hemorrhoids are selected, and the operation is repeated for each individual one of the hemorrhoids.
• Similarly, in preferred embodiments where the selected body structure for ablation is an individual cyst, fibroid, polyp, or tumor, the selected set of[0069]electrodes113 are just thoseelectrodes113 which are needed to penetrate the selected body structure. If there is more than one such selected body structure, either (1) more than one set ofelectrodes113 may be selected, or (2) just one set ofelectrodes113 may be selected and the operation is repeated for each individual such body structure.
• Similarly, in preferred embodiments where the selected body structure for ablation is muscle tissue or other tissue which is part of a larger body structure, such as a prolapsed or spasmodic muscle, the selected set of[0070]electrodes113 are just those one or more sets ofelectrodes113 which are needed to penetrate the portion of the body structure which has been selected for ablation.
• Flowable substances are provided using the[0071]holes112, and energy is provided to theelectrodes113, so as to ablate the mass of tissue in theregion140.
• In a preferred embodiment, the flowable substances are provided using the[0072]holes112 to theregion140 near thecatheter110.
• In alternative embodiments, the flowable substances may be provided, in addition or instead, (1) from an area of the catheter covered by a microporous membrane, or (2) from one or more microporous balloons. The microporous balloons may either be the same as or in addition to the[0073]balloons116 used to anchor the catheter in place or to block gas or fluid.
• In preferred embodiments, the flowable substances have one of the following functions: (1) to aid in ablation, such as by transmitting RF energy from the[0074]electrodes113 to the body structure to be ablated, as is done by saline or other electrolytic solutions, (2) to rehydrate tissue, as in done by saline or water, or (3) to repair tissue, such as by flowing into cysts or fissures or voids, or by covering lesions, as is done by collagen in a soft form which can be hardened by RF energy.
• In a preferred embodiment, the[0075]electrodes113 deliver RF energy having a frequency between about 435 megahertz and about 485 megahertz, for a period between about 5 minutes and about 10 minutes. The RF energy is received by and heats tissue and other body structures near theelectrodes113, causing ablation by means of cell death, dehydration, or denaturation.
• In alternative embodiments, the[0076]electrodes113 may deliver other forms of energy, such as heat, microwaves, or infrared or visible laser energy.
• The[0077]electrodes113 are controlled by a feedback technique, using the at least onesensor119. In embodiments where there is more than onesensor119, the feedback technique may be responsive to eachsensor119.
• In one preferred embodiment, the at least one[0078]sensor119 includes atemperature sensor119 and the feedback technique includes a microprocessor (not shown) disposed in or coupled to thecontrol element130 and operating under control of application software for maintaining the temperature of the body structure to be ablated at a selected temperature, such as a temperature exceeding between about 90° Celsius and about 120° Celsius. In this preferred embodiment, the microprocessor also controls delivery of fluids for cooling or hydration, so as to maintain the temperature of surrounding tissue (i.e., other than the tissue selected for ablation) at temperatures less than between about 90° Celsius and about 120° Celsius.
• In another preferred embodiment, the at least one[0079]sensor119 also includes animpedance sensor119 and the feedback technique includes a microprocessor operating to terminate delivery of RF energy when a measured impedance of the body structure to be ablated undergoes a substantial change indicative of dehydration or denaturation.
• One or more sets of[0080]electrodes113 are selected for retraction back from the selected mass of tissue in theregion140. The rotatable element210 is rotated in thesecond direction211, causing the selected sets ofelectrodes113 to retract out of the selected mass of tissue and back into thecatheter110.
• The[0081]same electrodes113 which were advanced out of thecatheter110 are retracted back into thecatheter110.
• The[0082]catheter110 is withdrawn from the body at the opening through which it was inserted.
• Before removal, the[0083]balloons116 are deflated so thecatheter110 is no longer anchored in place, allelectrodes113 are retracted back into thecatheter110, and thecatheter113 is configured to no longer provide flowable substances or energy for ablation.
• Particular Methods and Apparatus for Treatments[0084]
• In preferred embodiments, the catheter and electrode assembly[0085]100 may also be used for treatments in addition to, or instead of, ablation of body structures or tissue.
• In one preferred embodiment, operation of the catheter and electrode assembly[0086]100 includes at least the following steps:
• The[0087]catheter110 is inserted into a natural body lumen, such as the urethra.
• In a preferred embodiment, the natural body lumen comprises a normally tubular body structure which has prolapsed, is spasmodic, or is otherwise subject to blockage (partial or complete) or damage (such as to a wall of the natural body lumen).[0088]
• The[0089]catheter110 infuses a hardenable substance into the natural body lumen, so as to coat at least one selected section of the wall of the natural body lumen.
• In a preferred embodiment, the hardenable substance includes a collagen which is capable of being flowed onto the wall of the natural body lumen and which is capable of being hardened by application of RF energy, heat, or another agent to be provided by the catheter and electrode assembly[0090]100.
• The[0091]electrodes113 are advanced and deliver energy to the hardenable substance to harden it.
• In a preferred embodiment, the[0092]holes112 provide saline and theelectrodes113 deliver RF energy to the collagen to harden it, so as to form a hard covering to the wall of the natural body lumen. If appropriate, more than one layer of collagen is applied, so as to provide a hard covering having a thickness exceeding a selected threshold, such as 0.1 inch (0.25 cm). The particular selected threshold will of course depend on the preferred diameter of the natural body lumen.
• In a preferred embodiment for treatment of a prolapsed or spasmodic muscle, (1) the[0093]catheter110 is inserted and pushed through a region where the muscle has prolapsed or blocked the rectum, colon, large intestine, or small intestine, (2) the prolapsed or spasmodic muscle is partially ablated, and (3) collagen is infused and hardened to strengthen the muscle wall. In alternative embodiments, the collagen may be infused before ablation in one or more boluses deposited within the muscle (or on the muscle or near the muscle), so that the steps of muscle ablation and collagen hardening will occur substantially simultaneously.
• In a preferred embodiment for treatment of an anal fissure, (1) the[0094]catheter110 is inserted into a region where the fissure has occurred, (2) a suspension of collagen and saline is infused and fills the fissure, and (3) the collagen is hardened while the saline is removed from the suspension. In this preferred embodiment, the isolated region between thedistal balloon116 and theproximal balloon116 is maintained at a positive differential pressure with respect to the rest of the rectum, so that the collagen infuses into the fissure; this procedure or a similar procedure is also followed for treatment of diverticulosus and diverticulitus.
• In a preferred embodiment for treatment, in a female patient, of a prolapsed uterus, (1) the[0095]catheter110 is inserted into a region where the uterus has prolapsed, (2) the prolapsed uterus is partially ablated, and (3) collagen is infused and hardened to strengthen, the muscle wall. Similarly to treatment of a prolapsed muscle, in alternative embodiments, the collagen may be infused before ablation, so that the steps of muscle ablation and collagen hardening will occur substantially simultaneously.
• Although preferred embodiments are disclosed herein, many variations are possible which remain within the concept, scope, and spirit of the invention, and these variations would become clear to those skilled in the art after perusal of this application.[0096]

Claims (39)

We claim:

1. A method for ablating a structure within a body, said method including the steps of:

inserting a catheter into a region of said body;

isolating said region from gas or fluid from outside said region;

emitting, from an electrode coupled to said catheter into said region, an effective amount of energy to ablate said structure.

2. A method as inclaim 1, wherein said region is in or near the sphincter, rectum, colon, or prostate.

3. A method as inclaim 1, wherein said structure includes a cyst, hemorrhoid, polyp, tumor, or lesion.

4. A method as inclaim 1, wherein said energy includes RF energy having a frequency between about 435 megahertz and about 485 megahertz.

5. A method as inclaim 1, wherein said step of emitting is conducted for less than about 10 minutes.

6. A method as inclaim 1, including the step of advancing said electrode from within said catheter to a point inside a selected mass of tissue within said region.

7. A method as inclaim 1, wherein said step of isolating includes the step of blocking gas or fluid from entering said region using at least one balloon.

8. A method as inclaim 7, wherein said at least one balloon includes a balloon disposed at an upstream location or disposed at a downstream locations from said region.

9. A method as inclaim 7, wherein said step of isolating includes the step of inflating said at least one balloon.

10. A method as inclaim 7, including the step of anchoring said catheter in a selected location using said at least one balloon.

11. A method as inclaim 1, including the step of anchoring said catheter in a selected location.

12. A method as inclaim 11, wherein said step of anchoring includes the step of disposing at least one balloon against a wall of said region.

13. A method as inclaim 1, including the steps of:

sensing at least one control parameter of said region; and

controlling said step of emitting using a feedback technique including said control parameter.

14. A method as inclaim 1, including the step of delivering a flowable substance to said region.

15. A method as inclaim 14, including the steps of:

sensing at least one control parameter of said region; and

controlling said step of delivering using a feedback technique including said control parameter.

16. A method as inclaim 14, wherein said flowable substance includes an effective amount of fluid to cool said region to a selected temperature.

17. A method as inclaim 14, wherein said flowable substance includes an effective amount of fluid to rehydrate a selected mass of tissue in said region.

18. A method as inclaim 14, wherein said flowable substance includes saline.

19. A method as inclaim 14, wherein said flowable substance includes an antibiotic.

20. A method as inclaim 14, wherein said flowable substance includes collagen.

21. A method as inclaim 14, wherein said flowable substance includes a substance for covering or filling a selected structure within said region.

22. A method as inclaim 14, wherein said step of delivering includes exuding said flowable substance from at least one hole in said catheter.

23. A method as inclaim 14, wherein said step of delivering includes exuding said flowable substance from a microporous membrane.

24. A method as inclaim 14, wherein said step of delivering includes exuding said flowable substance from a balloon having a microporous membrane.

25. A method as inclaim 1, including the step of coupling light from said region to a point outside the body, whereby an operator is able to view said region.

26. A method as inclaim 1, including the steps of:

receiving light from said region representative of a view of said region; and

controlling an orientation or position of said catheter responsive to said view.

27. A method for treatment of a sphincter in a body, comprising the following steps:

providing RF energy from a source coupled to a catheter;

disposing said catheter in a region of said body near said sphincter;

delivering said RF energy from said catheter to a tissue of said sphincter in an amount effective for treatment of said tissue.

28. A method as inclaim 27, wherein said sphincter is a lower esophogeal sphincter, a GI sphincter, a rectum, a colon, a blood vessel, an organ, a urethra, a vagina, a prostate.

29. A method as inclaim 27, wherein at least a portion of said region is a cavity in said body.

30. A method as inclaim 29, wherein said cavity is an element of a gastrointestinal tract, a vascular system, a circulatory tract, a uro-genital tract, a pulmonary system, a lymphatic tract, or an organ.

31. A method as inclaim 27, wherein at least a portion of said tissue is an esophogeal varice, a hemorrhoid, a cyst, a polyp, a tumor, or a lesion.

32. A method as inclaim 27, wherein said effective amount of RF is effective to heat at least a portion of said tissue, to ablate at least a portion of said tissue, to destroy at least a portion of said tissue, or to contract at least a portion of said tissue.

33. A method as inclaim 27, including:

providing a substance effective to treat said tissue;

providing said substance from a source coupled to said catheter; and

delivering said substance from said catheter to said tissue in an amount effective to treat said tissue.

34. A method as inclaim 33, wherein said substance comprises a flowable substance, a medicament, a saline solution, an astringent, a collagenous fluid or other bulking agent, a bio-active substance, a chemo-active substance, a radioactive substance, or a sclerosing agent.

35. A method as inclaim 1, wherein said region is in or near a ligament, bone or cartilage.

36. A method as inclaim 1, wherein said energy includes microwave, infrared, ultraviolet, visible and invisible laser, visible and invisible light.

37. A method as inclaim 27, wherein said sphincter is in or near ligament, bone or cartilage.

38. A method as inclaim 27, wherein at least a portion of said tissue is a ligament, bone or cartilage.

39. A method as inclaim 29, wherein said cavity is an element of a ligament, bone or cartilage.

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