Abstract:
A method and apparatus for treatment for body structures, especially internal body structures involving disorders involving unwanted features or other disorders, that does not require relatively invasive surgery, and is not subject to other drawbacks noted with regard to the known art. A relatively minimally invasive catheter is inserted into the body, treatment of the body structures is applied using the catheter, and the unwanted features or disorders are relatively cured using the applied treatments. The applied treatments can include application of energy or substances, including application of energy (such as of radio frequency energy, microwave energy, or laser or other electromagnetic energy) or substances (such as collagen or other bulking, plumping, or shaping agents; saline or other energy-receiving electrolytes; astringents or other debulking, reducing, or shaping agents; antibiotics or other bioactive, chemoactive, or radioactive compounds). More than one applied treatment can be performed, either in conjunction, in parallel, or seriatim, so as to achieve a combined effect more substantial than any one individual such applied treatment.

Description:
RELATED APPLICATIONS 
     Inventions described herein can be used in combination or conjunction with inventions described in the following patent application(s): 
     application Ser. No. 08/731,372, filed Oct. 11, 1996, now U.S. Pat. No. 5,964,775, claiming priority dates at least as early as Jun. 24, 1994, in the name of Stuart D. Edwards, and all pending cases claiming priority thereof; 
     application Ser. No. 09/026,316, filed Feb. 19, 1998, now U.S. Pat. No. 6,056,744, in the name of Stuart D. Edwards, and all pending cases claiming priority thereof; 
     application Ser. No. 08/677,811, filed Jul. 10, 1996, now U.S. Pat. No. 5,921,954, in the name of Lawrence J. Mohr, Jr., and Stuart D. Edwards, titled “Treating Aneurisms by Applying Hardening/Softening Agents to Hardenable/Softenable Substances,” and all pending cases claiming priority thereof; 
     application Ser. No. 08/717,612, filed Sep. 20, 1996, now U.S. Pat. No. 6,077,257, in the name of Stuart D. Edwards and Steven Marcus, titled “Ablation of Rectal and Other Internal Body Structures,” assigned to the same assignee, and all pending cases claiming priority thereof; and 
     application Ser. No. 08/795,656, filed Feb. 6, 1997, in the name of Stuart D. Edwards and Muta M. Issa, titled “Treating Urinary and Other Body Structures,” assigned to the same assignee, and all pending cases claiming priority thereof. 
     These applications are each hereby incorporated by reference as if fully set forth herein. These applications are collectively referred to herein as “Incorporated Disclosures.” 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to treating body tissue, particularly to treating body tissue by altering the shape or volume of that body tissue using energy or substances deployed from an interstitial location in the body. 
     2. Related Art 
     Human beings are subject to a number of medical disorders, including those in which a body structure is subject to unwanted features or is otherwise dysfunctional. The body structure can for example include muscular tissue, mucosal tissue, gastro-intestinal tissue, lumen walls, stenotic locations in lumens or interstitial locations, or tumors or other cancerous or precancerous conditions. The unwanted features can for example include being distended or engorged, being unduly large or small, being misshapen, having cysts or tumors, or having undesirable growths. Other dysfunctions can include aneurysms, diverticuli, fissures, hemorrhoids, tumors, or simply an inability for the body structure to perform its proper function. 
     Medical disorders of these kinds can be particularly acute or discomfiting when they involve important areas of the body, including the cardiovascular system, the gastro-intestinal tract, the genito-urinary system, the pulmonary system, the vascular system, or other body systems. For a first example, disorders involving body structures in the gastro-intestinal tract can lead (at a first end thereof) to inadequate operation of the esophageal sphincter, to gastro-intestinal reflux, or to Barrett&#39;s condition. For a second example, disorders involving body structures in the gastro-intestinal tract can lead (at a second end thereof) to fecal or urinary incontinence. 
     One problem in the known art is that treatment of such disorders can involve relatively invasive and labor-intensive surgery. This has the drawbacks of incurring relatively high expense, of incurring relatively high risk (in some cases) of damage to important nerves, and of producing iatrogenic effects that are relatively hazardous to the patient. 
     Accordingly, it would be advantageous to provide a method and apparatus for treatment for body structures, especially internal body structures involving unwanted features or other disorders, that does not require relatively invasive surgery, and is not subject to other drawbacks noted with regard to the known art. This advantage is achieved in an embodiment of the invention in which a relatively minimally invasive catheter is inserted into the body, treatment of the body structures is applied using the catheter, and the unwanted features or disorders are relatively cured using the applied treatments. The applied treatments can include application of energy or substances, including application of energy (such as of radio frequency energy, microwave energy, or laser or other electromagnetic energy) or substances (such as collagen or other bulking, plumping, or shaping agents; saline or other energy-receiving electrolytes; astringents or other debulking, reducing, or shaping agents; antibiotics or other bioactive, chemoactive, or radioactive compounds). More than one applied treatment can be performed, either in conjunction, in parallel, or seriatim, so as to achieve a combined effect more substantial than any one individual such applied treatment. 
     SUMMARY OF THE INVENTION 
     The invention provides a method and system for treatment for body structures, especially internal body structures involving unwanted features or other disorders, that does not require relatively invasive surgery, and is not subject to other drawbacks noted with regard to the known art. A relatively minimally invasive catheter is inserted into the body, treatment of the body structures is applied using the catheter, and the unwanted features or disorders are relatively cured using the applied treatments. 
     In a preferred embodiment, the applied treatments can include application of energy or substances, including application of energy (such as of radio frequency energy, microwave energy, or laser or other electromagnetic energy) or substances (such as collagen or other bulking, plumping, or shaping agents; saline or other energy-receiving electrolytes; astringents or other debulking, reducing, or shaping agents; antibiotics or other bioactive, chemoactive, or radioactive compounds). 
     In a preferred embodiment, more than one applied treatment can be performed, either in conjunction, in parallel, or seriatim, so as to achieve a combined effect more substantial than any one individual such applied treatment. 
     In preferred embodiments, the unwanted features or other disorders include one or more of the following: 
     Barrett&#39;s disease, other growths on the esophageal lining or near the esophageal sphincter, or otherwise at an ingestive end of the gastro-intestinal system; 
     fecal incontinence or other failures of the musculature or sphincters at an excretory end of the gastro-intestinal system; or 
     urinary incontinence or other failures of the musculature or sphincters at an excretory end of the gastro-intestinal system. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 shows a drawing of a first device for treatment of a body structure, for possible application to body structures at an ingestive end of the gastro-intestinal system. 
     FIG. 2 shows a drawing of the first device for treatment of a body structure, as possibly positioned at or near an esophageal sphincter. 
     FIG. 3 shows a drawing of a second device for treatment of a body structure, for possible application to body structures at an excretory end of the gastro-intestinal system. 
     FIG. 4 shows a drawing of the second device for treatment of a body structure, as possibly positioned at or near a rectal sphincter. 
     FIG. 5 shows a drawing of the second device for treatment of a body structure, as possibly positioned at or near a urinary sphincter. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     In the following description, a preferred embodiment of the invention is described with regard to preferred process steps and data structures. Those skilled in the art would recognize after perusal of this application that embodiments of the invention can be implemented using processors or circuits adapted to particular process steps and data structures described herein, and that implementation of the process steps and data structures described herein would not require undue experimentation or further invention. 
     First Treatment Device 
     FIG. 1 shows a drawing of a first device for treatment of a body structure, for possible application to body structures at an ingestive end of the gastro-intestinal system. 
     A device  100  includes a catheter  110 , the catheter  110  having a distal end  111 , a proximal end  112 , a distal balloon  113 , a proximal balloon  114 , a treatment structure  115 , and a set of aspiration or delivery elements  116 . 
     The distal end  111  is disposed for insertion into a cavity of the body. In a preferred embodiment, the cavity can include a section of the gastro-intestinal tract of the body. In alternative embodiments, the cavity may include one or more of, or some combination of, the following. 
     Any portion of the bronchial system, the cardiovascular system, the genito-urinary tract, the lymphatic system, the pulmonary system, the vascular system, or other systems in the body; 
     Any biologic conduit or tube, such as a biologic lumen that is patent or one that is subject to a stricture; 
     Any biologic cavity or space, such as a cyst, a gland, a layered structure or striation, or a medical device implanted or inserted in the body; 
     Any biologic operational structure, such as a gland, or a muscular or other organ (such as the colon, the diaphragm, the heart, a kidney, a lung, the rectum, an involuntary or voluntary sphincter); 
     Any other biologic structure, such as a herniated body structure, a set of diseased cells, a set of displaisic cells, a surface of a body structure (such as the sclera), a tumor, or a layer of cells (such as fat, muscle, or skin). 
     The proximal end  112  is disposed for coupling to a medical device  120 . In a preferred embodiment, the medical device  120  can include a device for insertion and probing into the body, such as a colonoscope, an endoscope, or another type of catheter. The medical device  120  is preferably controlled from a location outside the body, such as an instrument in an operating room or an external device for manipulating the inserted catheter  110 . 
     For example, in a preferred embodiment in which the medical device  120  includes an endoscope, the device  110  can be coupled to one of a plurality of lumens  121  in the medical device  120  for sensing, for delivery or aspiration of substances, or for delivery of energy. For example, one or more of the lumens  121  can include an optical wave-guide, a delivery path for antibiotics or saline, an aspiration path for liquids or killed cells, or a delivery path for electromagnetic energy. 
     In alternative embodiments, the medical device  120  may include a device that is implanted into the body, or is inserted into the body and manipulated from inside or outside the body during a medical procedure. For example, the medical device  120  can include a programmed AICD (artificial implanted cardiac defibrillator), a programmed glandular substitute (such as an artificial pancreas), or a medical device  120  for use during surgery or in conjunction with other medical procedures. 
     In a preferred embodiment, the medical device  120  is coupled to a control element  130 , by which medical or other personnel can control operation of the medical device  120 , and of the catheter  110 . Such control can include aspiration or delivery of substances, or delivery or sensing of energy. 
     The distal balloon  113  is disposed for inflation, preferably after the catheter  110  has been inserted into the body. The distal balloon  113  can be disposed with regard to the catheter  110  in conjunction with marlings  121  on or near the proximal end  112 , so that medical or other personnel can determine a distance the distal end  111  has penetrated within the body. For example, in a preferred embodiment in which the in which the catheter  110  is inserted into the rectum for treatment of incontinence, the markings  121  can be used to determine that distance. 
     The inflated distal balloon  113  can perform one or more of, or some combination of, the following functions: 
     The distal balloon  113  can position the catheter  110  in a relatively fixed position within the body. For example, in a preferred embodiment in which the catheter  110  is inserted into the urethra, the inflated distal balloon  113  can prevent the catheter  110  from being pulled back out of the urethral canal. 
     The distal balloon  113  can isolate the catheter  110  (and its treatment structure  115 ) from the rest of the body. For example, in a preferred embodiment in which the catheter  110  is inserted into the rectum, the inflated distal balloon  113  can prevent treatment substances and any substances that result from treatment (such as killed cells) from passing into other regions of the body. 
     The distal balloon  113  can serve as a sensor. For example, the distal balloon  113  can include an x-ray opaque element or an x-ray reflector, so as to enable medical or other personnel to determine a position of the catheter  110  using a fluoroscope or an x-ray device. 
     The distal balloon  113  can serve as a delivery element for electromagnetic energy. For example, the distal balloon  113  can include a set of metallic (or metallic coated) elements, or can be coupled to a basket having a set of electrodes, for delivery of RF or other electromagnetic energy. 
     In a preferred embodiment in which the distal balloon  113  is used as a delivery element for electromagnetic energy, the distal balloon  113  is spherical (or ellipsoidal) and conceptually divided into a set of eight octants (each preferably a semidemihemisphere). Each octant can be separately activated to deliver electromagnetic energy to selected body structures near the distal balloon  113 . 
     In a preferred embodiment in which the distal balloon  113  is used as a delivery element for electromagnetic energy, the distal balloon  113  includes a microporous or otherwise partially porous membrane, so that saline or another substance can be exuded from the distal balloon  113 . The saline or other substance are preferably used to pre-condition tissue for reception of the electromagnetic energy, or to receive that electromagnetic energy itself. For example, in a preferred embodiment, the distal balloon  113  exudes about 10% saline and delivers about 460 kilohertz RF energy using the saline as a receiving antenna. 
     Delivery of RF or other electromagnetic energy is described in further detail herein below. 
     Similarly, the proximal balloon  114  is also disposed for inflation. The proximal balloon  114  can also be disposed with regard to the catheter  110  in conjunction with markings  121  on or near the proximal end  112 , so that medical or other personnel can determine a distance the distal end  111  has penetrated within the body. 
     Similarly, the inflated proximal balloon  114  can perform one or more of, or some combination of, the following functions: 
     The proximal balloon  114  can position the catheter  110  in a relatively fixed position within the body. For example, in a preferred embodiment in which the catheter  110  is inserted into the urethra, the inflated proximal balloon  114  can prevent the catheter  110  from being inserted further into the urethral canal. 
     The proximal balloon  114  can isolate the catheter  110  (and its treatment structure  115 ) from the rest of the body. For example, in a preferred embodiment in which the catheter  110  is inserted into the esophagus, the inflated proximal balloon  114  can prevent treatment substances and any substances that result from treatment (such as killed cells) from passing into other regions of the body. 
     The proximal balloon  114  can serve as a sensor. For example, the proximal balloon  114  can include an x-ray opaque element or an x-ray reflector, so as to enable medical or other personnel to determine a position of the catheter  110  using a fluoroscope or an x-ray device. 
     The proximal balloon  114  can serve as a delivery element for electromagnetic energy. For example, the proximal balloon  114  can include a set of metallic (or metallic coated) elements, or can be coupled to a basket having a set of electrodes, for delivery of RF or other electromagnetic energy. 
     The treatment structure  115  includes a shaped balloon, having a cylindrical shape with an indentation, and having a treatment element disposed in the indentation. The treatment structure  115  is further described with regard to FIG.  2 . 
     The aspiration or delivery elements  116  include a set of holes or other passages, through which substances can be exuded or flowed. For aspiration, the aspiration or delivery elements  116  can be coupled to a pump or other suction element, so as to generate suction to drain flowable material from the body. For delivery, the aspiration or delivery elements  116  can be coupled to a pump or other pressure element, and to a source of flowable substances, so as to generate pressure to source flowable material into the body. 
     Treatment Device Used for Esophagus 
     FIG. 2 shows a drawing of the first device for treatment of a body structure, as possibly positioned at or near an esophageal sphincter. 
     The catheter  110  is inserted into the body and disposed so that the treatment structure  115  is located at or near a region between the esophagus  201  and an esophageal sphincter  202  (between the esophagus  201  to the stomach  203 ). 
     The treatment structure  115  includes a shaped balloon  211 , having a cylindrical shape with an indentation  212 , and having a treatment element  213  disposed in the indentation  212 . 
     Disposed in the body, the shaped balloon  211  substantially fills the region of the esophagus  201  near the esophageal sphincter  202 . The shaped balloon  211  thus isolates a mucosal surface of the esophagus  201  from treatment, except for a region defined by the indentation  212 . 
     The region defined by the indentation  212  includes a portion of the mucosal surface area of the esophagus  201 , which portion is selected for treatment. In an embodiment used to treat Barrett&#39;s, a portion is selected for treatment that has cells foreign to a normal esophagus  201  (such as cells like those of the stomach lining, displaisic cells, or pre-cancerous cells). In a preferred embodiment, the portion selected for treatment includes no more than a 90-degree arc of a cross-section of the esophagus  201 , and preferably no more than a 45-degree arc. The indentation  212  is no more than 90 degrees of arc, and preferably no more than 45 degrees of arc. 
     The treatment element  213  includes a set of treatment points  214 , each coupled using a separate controller  215  to the medical device  120  or to the control element  130 . In a preferred embodiment, each treatment point  214  can be separately controlled using the control element  130  so as to select a variable length portion of the esophagus  201  for treatment. 
     The indentation  212  and the treatment element  213  can be rotated with the device  100  so as to select a second portion of the mucosal surface area of the esophagus  201  for treatment. In a preferred embodiment, the second portion of the mucosal surface area of the esophagus  201  is selected only after a first portion of the mucosal surface area of the esophagus  201  has been treated and given time to heal. 
     The treatment points  214  each include unipolar RF (radio frequency) electrodes, each of which can operate to treat tissue by ablation, cell death, desiccation, or other aspects of delivery of RF energy to tissue. In a preferred embodiment, the shaped balloon  211  can be expanded and filled using relatively cold saline, so that the surface of the esophagus  201  isolated by the shaped balloon  211  can be kept at a relatively lower temperature during treatment. 
     In alternative embodiments, the treatment points  214  can be disposed to treat tissue using other techniques, such as by emission of other forms of energy or by emission of substances. These can include one or more of, or some combination of, any of the following: 
     bipolar RF electrodes; 
     chemical treatment, such as acid, antibiotics, enzymes, or other bioactive, chemoactive, or radioactive substances; 
     heat, such as using heated saline or other heated substances; 
     infrared energy, such as from an infrared laser or a diode laser; 
     microwave energy, such as electromagnetic energy in the about 915 megahertz to about 2.45 gigahertz range; 
     optical energy, such as from a laser; 
     other electromagnetic energy, including direct current or ELF (extremely low frequency); 
     physical treatment, such as crushing using an expandible balloon, scraping using an attachment to an expandible balloon, or another physical treatment technique; or 
     sonic energy, including ultrasound. 
     In a preferred embodiment, the treatment points  214  can also be disposed to pre-condition or pre-treat tissue so as to be conditioned, sensitized, or otherwise prepared for treatment. In a preferred embodiment, the pre-treatment includes exuding saline for absorption into the treated tissue. The absorbed saline acts to enhance reception of electromagnetic (particularly RF) energy by the tissue. 
     In alternative embodiments, the treatment points  214  can be disposed to pre-condition or pre-treat tissue using other techniques, such as by emission of other forms of energy or by emission of other substances. These can include any of the forms of energy or substances used for treatment, and can also include one or more of, or some combination of, any of the following: 
     a bulking, plumping, or supportive agent, such as a collagen, a gel, or a stent; 
     a debulking, deplumping, or astringent or restrictive agent, such as an acid, an enzyme, or a physical constraint such as an elastic or wire; or 
     a shaping or reshaping agent, such as a cutting element or a stent. 
     In a preferred embodiment, the treatment points  214  can also be disposed to post-condition or post-treat tissue so as to be healed or otherwise repaired after treatment. In a preferred embodiment, the post-treatment includes exuding analgesic, antibiotic, or anti-inflammatory agents, for absorption into the treated tissue, and tissue nearby. The post-treatment acts to enhance the ability of the treated tissue, and tissue nearby, to recover from treatment. 
     In alternative embodiments, the treatment points  214  can be disposed to post-condition or post-treat tissue using other techniques, such as by emission of other forms of energy or by emission of other substances. 
     Second Treatment Device 
     FIG. 3 shows a drawing of a second device for treatment of a body structure, for possible application to body structures at an excretory end of the gastro-intestinal system. 
     A device  300  includes a catheter  310  and a control element  320 . 
     The catheter  310  includes a distal end  311 , a proximal end  312 , and a treatment structure  313 . 
     The distal end  311  and the proximal end  312  of the catheter are similar to the distal end  111  and proximal end  112  described with regard to FIG.  1 . 
     The treatment structure  313  includes an inflatable/deflatable structure  314 , a set of treatment elements  315 , and a set of treatment element extrusion ports  316 . 
     The inflatable/deflatable structure  314  includes a balloon disposed within a flexible basket, so that when the balloon is inflated or deflated, the flexible basket is expanded or contracted. In a preferred embodiment, the balloon is at least partially microporous or porous, so that flowable substances used to expand or fill the balloon can be exuded from the balloon into surrounding tissue. 
     The treatment elements  315  include electrodes, physically coupled to the control element  320 , and disposed for extrusion using the treatment element extrusion ports  316 . 
     The treatment element extrusion ports  316  include holes or other passageways in the flexible basket, so the electrodes can be extruded therethrough. 
     The electrodes are substantially curved, so that in a non-extruded state the electrodes are disposed within the flexible basket, and that in an extruded state the electrodes are disposed outside the flexible basket at a substantial angle to the direction at which the electrodes are extruded. The electrodes preferably have sufficient length and curve so that the substantial angle exceeds about 60 degrees of arc, and can exceed 180 degrees of arc from the direction at which the electrodes are extruded. 
     The control element  320  includes a handle  321 , an inflation/deflation port  322 , an electrode extrusion control  323 , a set of substance aspiration or deployment ports  324 , and an electrical energy port  325 . 
     The handle  321  is disposed for manipulation by medical or other personnel, and can be shaped for being held in the hand. 
     The inflation/deflation port  322  includes a receptor for coupling to a source of air, liquid, or other flowable substance. The flowable substance inflates the treatment structure  313  when input to the inflation/deflation port  322 , and deflates the treatment structure  313  when output from the inflation/deflation port  322 . 
     The electrode extrusion control  323  includes a control element for controlling the amount of extrusion of electrodes from the treatment structure  313 . 
     The substance aspiration or deployment ports  324  include receptors for aspirating flowable substances from or from near the treatment structure  313 , and for deploying flowable substances into or near to the treatment structure  313 . 
     The electrical energy port  325  includes a conductive element that can be coupled to a source of electrical energy, such as a battery, a generator, or a wall socket. 
     Treatment Device Used for Fecal Incontinence 
     FIG. 4 shows a drawing of the second device for treatment of a body structure, as possibly positioned at or near a rectal sphincter. 
     The device  300  is positioned at or near the rectum, preferably in a region of relatively insensate tissue  410  between the involuntary sphincter  420  and the voluntary sphincter  430 . 
     In operation, the treatment elements  315  are extruded into the relatively insensate tissue  410 . The treatment elements  315  apply pre-conditioning, treatment, and post-treatment to the relatively insensate tissue  410  and to internal tissue  411  located beneath the relatively insensate tissue  410 . 
     The treatment elements  315  operate to perform ablation or debulking, to perform bulking or plumping, or otherwise to perform shaping or reshaping, of the relatively insensate tissue  410  and the internal tissue  411 . After operation, the rectum (either the involuntary sphincter  420  or the voluntary sphincter  430  or both) are capable of a more tightly sealed closure, so as to militate against fecal incontinence. 
     Treatment Device Used for Urinary Incontinence 
     FIG. 5 shows a drawing of the second device for treatment of a body structure, as possibly positioned at or near a urinary sphincter. 
     The device  300  is positioned at or near a urinary sphincter  510 . In operation, a distal balloon (like that of the first device  100 ) is positioned at an exit point of the bladder  520 . Inflated, the distal balloon prevents the device  300  from being mistakenly drawn out of the urethra  530 . 
     In operation, the inflatable/deflatable structure  314  has a substantially greater length-to-width ratio, so as to fit into the urethra  530 . 
     In operation, the treatment elements  315  are extruded into the surface of the urethra  530 , and possibly into tissue there-behind. The treatment elements  315  apply pre-conditioning, treatment, and post-treatment to those tissues. 
     The treatment elements  315  operate to perform ablation or debulking, to perform bulking or plumping, or otherwise to perform shaping or reshaping, of those tissues. After operation, the urinary sphincter  510  and the urethra  530  are capable of a more tightly sealed closure, so as to militate against urinary incontinence. 
     Generality of the Invention 
     The invention has substantial generality of application to various fields for biopsy or treatment of medical conditions. These various fields include, one or more of, or a combination of, any of the following (or any related fields): 
     As noted above, the invention can be used in any area of the body, including the biologic systems and locations noted herein. The invention can be used for the general purpose of reducing, plumping, or reshaping body structures, tissues, or regions of the body otherwise empty (or filled with biologic substances. 
     For examples, the invention can be used in one or more of, or some combination of, the following: 
     In the head and neck, such as the cheeks, eyes, throat, larynx, or other structures; 
     For the purpose of reforming damaged body parts, for the purpose of reshaping misshapen body parts, or for cosmetic effects; or 
     For the purpose of replacing the volume filled by body parts that are missing, whether due to congenital defect, infection, or surgery. 
     Alternative Embodiments 
     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.