Abstract:
Systems and methods treat hemorrhoids by introducing a treatment device into the anal canal to extend above a hemorrhoidal plexus and adjacent a tissue region containing blood vessels that feed the hemorrhoidal plexus. The systems and methods operate the treatment device to affect tissue morphology in the tissue region to occlude or otherwise reduce blood flow through the vessels.

Description:
RELATED APPLICATIONS  
       [0001]     This application is a divisional of co-pending U.S. patent application Ser. No. 10/653,448, filed Sep. 2, 2003, which claims the benefit of U.S. patent application Ser. No. 09/556,169, filed Apr. 21, 2000, (now U.S. Pat. No. 6,645,201) entitled “Systems and Methods for Treating Dysfunctions in the Intestines and Rectum,” which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention relates generally to systems and methods for treating interior tissue regions of the body. In particular, this invention relates to the treatment of hemorrhoids.  
       BACKGROUND OF THE INVENTION  
       [0003]     Hemorrhoids are cushions of tissue and varicose veins located in and around the rectal area. Hemorrhoids are very common, especially during pregnancy and after childbirth. It has been estimated that about half the population has hemorrhoids by age 50. They are caused by increased pressure in the veins of the anus. The most common cause is straining during bowel movements. Constipation, prolonged sitting during bowel movements, and anal infection may also contribute to the development of hemorrhoids. In some cases, hemorrhoids may be a manifestation of other diseases, such as liver cirrhosis.  
         [0004]     Symptoms of hemorrhoids include rectal bleeding, particularly after bowel movements, pain during bowel movements, anal itching, mucus discharge, epithelial cell changes, thrombosis, incarcerations, skin tags, and disordered defecation. Symptoms may range from mild to severe.  
         [0005]     In many cases, hemorrhoids are diagnosed by rectal examination. However, stool guaiac testing for the presence of occult blood, as well as sigmoidoscopy, anoscopy, and proctoscopy procedures may also be useful in establishing a diagnosis.  
         [0006]     Treatment is generally based on the severity of symptoms. Mild cases may be controlled by conservative, non-invasive techniques such as drinking fluids, adhering to a high-fiber diet, use of stool softeners, and/or use of stool-bulking agents such as fiber supplements. In addition, treatments for symptomatic relief may include corticosteroid cream and/or warm baths to reduce pain and swelling.  
         [0007]     For more severe cases involving severe pain and itching in patients who have not responded to conservative therapy, surgical intervention may be required to prevent more serious complications. For example, frequent or prolonged bleeding may result in iron deficiency anemia.  
         [0008]     Conventional surgical techniques may be generally classified in three categories as being directed to either the anal sphincter, the hemorrhoidal tissue, or to the hemorrhoid feeding vessels. Surgical procedures directed to stretching or cutting of the internal anal sphincter include Lord&#39;s procedure, incisional sphincterotomy, and closed lateral anal sphincterotomy. However, these procedures may result in incontinence and thus are rarely indicated.  
         [0009]     Surgical procedures directed to hemorrhoidal tissue include excisional hemorrhoidectomy and laser-assisted hemorrhoidectomy. Such procedures are relatively invasive and thus have a longer recovery period.  
         [0010]     Surgical procedures directed to the feeder vessels include elastic or rubber band ligation, sclerosis, and photocoagulation. These procedures are associated with a variety of complications, including infection, hemorrhage, ulceration, oleogranuloma, allergic reaction, and prostate infection.  
         [0011]     The need remains for minimally-invasive systems and methods for treating hemorrhoids.  
       SUMMARY OF THE INVENTION  
       [0012]     The invention provides systems and methods that treat hemorrhoids. The systems and methods introduce a treatment device into the anal canal to extend above a hemorrhoidal plexus and adjacent a tissue region containing blood vessels that feed the hemorrhoidal plexus. The systems and methods operate the treatment device to affect tissue morphology in the tissue region to occlude or otherwise reduce blood flow through the vessels. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  is an anatomical view of the rectum and anal canal.  
         [0014]      FIG. 2  is a section view taken along line  2 - 2  in  FIG. 1 .  
         [0015]      FIG. 3  is an anatomical view of an external hemorrhoid.  
         [0016]      FIG. 4  is an anatomical view of an internal hemorrhoid.  
         [0017]      FIG. 5  is an anatomical view of a mixed internal and external hemorrhoid.  
         [0018]      FIG. 6  is a schematic view of a system for treating hemorrhoids that includes a treatment device with a tissue-piercing member.  
         [0019]      FIG. 7  illustrates a treatment device deployed in the anal canal with the tissue-piercing member in a retracted position.  
         [0020]      FIG. 8  is a view similar to  FIG. 7  and illustrating the tissue-piercing member piercing tissue containing blood vessels that feed the internal and external hemorrhoidal plexes.  
         [0021]      FIG. 9  illustrates a treatment device with multiple tissue-piercing members deployed in the anal canal and having multiple tissue-piercing members in a retracted position.  
         [0022]      FIG. 10  is a view similar to  FIG. 9  and illustrating the tissue-piercing members piercing tissue containing blood vessels that feed the internal and external hemorrhoidal plexes.  
         [0023]      FIG. 11  illustrates the shrinkage of tissue in a feeder vessel region that occludes or otherwise reduces flow through the feeder vessels. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0024]     Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structure. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.  
         [0000]     I. Anatomy of the Rectum and Anal Canal  
         [0025]     As  FIG. 1  shows, the rectum  10  is the terminal part of the large intestine  12 . The rectum  10  extends from the sigmoid flexure  14  (which is the narrowest part of the colon) to the anal orifice  16 . The rectum  10  is about 15 to 17 cm in overall length.  
         [0026]     The lower or inferior portion of the rectum  10  is called the anal canal  18 . It typically extends about 4 to 5 cm above the anal orifice  16 . A visible line of demarcation between tissue, called the pectinate (dentate) line  20 , exists about 2.5 to 3 cm above the anal orifice  16 .  
         [0027]     As best seen in  FIG. 2 , feeder vessels  22  descend to the anal canal  18  in three locations, the right posterior (RP), right anterior (RA), and left posterior (LP). Each of the three locations (RP, RA, and LP) then splits to form an internal hemorrhoidal plexus (or cushion)  24  (see  FIG. 3 ) located above the dentate line  20  and an external hemorrhoidal plexus (or cushion)  26  located below the dentate line  20 . That is, there are three internal hemorrhoidal plexes  24  (RP, RA, and LP) located above the dentate line  20  and three external hemorrhoidal plexes  26  (RP, RA, and LP) located below the dentate line  20 .  
         [0028]     Increased pressure in the veins of the anus causes the enlargement and swelling of one or more hemorrhoidal plexes  24  or  26 . This inflamed state is commonly referred to as a hemorrhoid (or pile). When the inflammation occurs in a hemorrhoidal plexus  26  below the dentate line  20  at the anal opening  16 , it is referred to as an external hemorrhoid, shown in  FIG. 3 . When the inflammation occurs in a hemorrhoidal plexus  24  above the dentate line  20  near the beginning of the anal canal  18 , it is referred to as an internal hemorrhoid, shown in  FIG. 4 . In some cases, a mix of internal and external hemorrhoids may be present, as illustrated in  FIG. 5 . A hemorrhoid may even protrude outside the anus.  
         [0029]     It should be noted that the views of the rectum  10  and anal canal  18  shown in  FIG. 1 , and elsewhere in the drawings, are not intended to be strictly accurate in an anatomic sense. The drawings show the rectum  10  and anal canal  18  in somewhat diagrammatic form to demonstrate the features of the invention.  
         [0000]     II. System Overview  
         [0030]     A tissue treatment system  28  that embodies features of the invention is shown in  FIG. 6 . The tissue treatment system  28  includes a tissue treatment device  30 . The treatment device  30  is sized and configured to affect tissue morphology above the dentate line  20 , to occlude or otherwise reduce blood flow through one or more feeder vessels for one or both hemorrhoidal plexus  24  or  26 .  
         [0031]     The treatment device  30  can affect tissue morphology by different physiologic mechanisms. For example, the treatment device  30  can serve to inject an agent used to seal vascular access sites, e.g., collagen or PEG hydrogel material—or to place a material that cause blood to clot, e.g., platinum coils deployed at the site of an aneurysm. In the illustrated embodiment, heat is applied to shrink tissue. In this arrangement, the treatment device  30  is coupled to a source of energy  32  by cable  33 . If desired, the system  28  can also include certain auxiliary processing equipment. In the illustrated embodiment, the auxiliary processing equipment comprises an external fluid delivery or irrigation source  34  coupled to the treatment device  30  by tubing  35 .  
         [0032]     A. The Tissue Treatment Device  
         [0033]     The tissue treatment device  30  serves to deliver energy to tissue regions at or near feeder vessels  22  above the internal or external hemorrhoidal plexes  24  and  26  to occlude or otherwise reduce the blood supply to the hemorrhoidal plexes  24  and  26 . In the illustrated embodiment, the energy source  32  supplies radiofrequency energy. It is contemplated that other forms of energy can be applied, e.g., coherent or incoherent light, heated or cooled fluid, resistive heating, microwave, ultrasound, a tissue ablation fluid, or a cryogenic fluid. Energy is delivered submucosally to heat targeted feeder vessel regions to create scar tissue and shrink tissue, thereby occluding or otherwise reducing blood flow through a vessel or vessels  22 . By occluding or otherwise reducing blood supply from above the hemorrhoidal plexes  24  or  26 , blood is essentially prevented from pooling in the vessels  22  and the hemorrhoidal plexes  24  or  26 . Since blood is prevented from pooling, hemorrhoids are shrunk or prevented.  
         [0034]     As  FIG. 6  shows, the tissue treatment device  30  includes a handle or hand grip  36  that carries an operative element  38 . In the illustrated embodiment, the operative element  38  takes the form of a hollow tubular barrel  40 , although it should be appreciated that a semi-circular device, e.g., shaped like curved tongue depressor, could be used as well. In the illustrated embodiment, the barrel  40  may be made from a transparent, molded plastic material or other suitable material to enable visualization through the barrel  40 . The barrel  40  terminates with a blunt, rounded distal working end  42  to aid passage of the barrel  40  through the anal canal  18  without need for a separate introducer. The hand grip  36  desirably includes a viewing port  44  for looking into the transparent, hollow interior of the barrel  40  to visualize surrounding tissue.  
         [0035]     The hand grip  36  and operative element  38  can form an integrated construction intended for single use and subsequent disposal as a unit. Alternatively, the hand grip  36  can comprise a nondisposable component intended for multiple uses. In this arrangement, the operative element  38  comprises a disposable assembly, which the physician releasably connects to the hand grip  36  at the time of use and disconnects and discards after use. The proximal end of the barrel  40  can, for example, include a male plug connector that couples to a female plug receptacle on the hand grip  36 .  
         [0036]     With reference to  FIGS. 7 and 8 , a tissue-piercing member  46  is movably contained within the barrel  40 . In the illustrated embodiment, the tissue-piercing member  46  takes the form of a needle electrode. The electrode  46  is selectively movable between a retracted position ( FIG. 7 ) and an extended position ( FIG. 8 ). Means are provided for moving the electrode  46  between the retracted and extended positions. For example, the needle electrode  46  can be mechanically linked to a finger-operated pull lever  48  on the hand grip  36 . By operation of the pull lever  48 , the distal ends of the needle electrodes  46  are moved between the retracted position and the extended position. An electrical insulating material  50  is desirably coated about the needle electrodes  46 , except for a prescribed region of the distal ends, where radio frequency energy is applied to tissue.  
         [0037]     In an alternate embodiment, the operative element  38  carries an array of needle electrodes  46 . The array of electrodes  46  is configured to deliver energy in a prescribed pattern to a targeted treatment site. It is contemplated that the number and placement of electrodes  46  can vary as needed for the desired procedure and to accommodate individual anatomy.  FIGS. 9 and 10  illustrate an embodiment in which a pair of needle electrodes  46  is movably contained in a side-by-side relationship on the barrel  40 .  
         [0038]     The barrel  40  also preferably carries temperature sensor  52 , one of which is associated with each needle electrode  46 . The sensors  52  sense tissue temperature conditions in the region adjacent to each needle electrode  46 . Preferably, the distal end of each needle electrode  46  also carries a temperature sensor  54 .  
         [0039]     In an optional embodiment, the treatment agent delivery apparatus  30  may convey processing fluid from a fluid source  34  for discharge at or near the treatment site. The processing fluid can comprise, e.g., saline or sterile water, to cool surface tissue while energy is being applied by the electrode  46  to thereby protect the surface tissue from thermal injury. For example, as seen in  FIG. 6 , barrel  40  may be coupled via tubing  35  to the fluid source  34  to convey fluid, e.g., through holes (not shown) in the barrel  40 , to contact tissue at a localized position surrounding the electrodes  46 . Alternatively, one or more electrodes  46  deployed by the operative element  38  can also be used to inject the fluid into the treatment site. In this arrangement, the electrode  46  includes an interior lumen (not shown) and the fluid source  34  is coupled to the lumen.  
         [0000]     III. System Use  
         [0040]     In use, the physician grasps the hand grip  36  and guides the barrel  40  into the anal canal  18  (see  FIGS. 7 and 9 ). The pull lever  48  is in the neutral position and not depressed, so the needle electrodes  46  occupy their normal retracted position. Looking through the viewing port  44 , the physician visualizes the pectinate (dentate) line  20  through the barrel  40 . Looking through the barrel  40 , the physician positions the distal ends of the needle electrodes  46  at a desired location above the pectinate (dentate) line  20 , e.g., 2-4 cm above the dentate line  20 . A fiberoptic can also be inserted into the barrel  40  to provide local illumination, or the physician can wear a headlamp for this purpose. In an embodiment where the barrel is not completely circumferential, but more U-shaped (thereby not occupying the entire anal canal  18 ), an endoscope or mirrors may be used to acquire visualization of the dentate line  20 .  
         [0041]     It may be desirable to bias the end of the treatment device  30  with a bend, to thereby facilitate contact with tissue in this region of the anal canal, as tissue in this region tends to be loose or flaccid. An expandable member may be desired to dilate tissue in this region in concert with use of the treatment device  30 .  
         [0042]     Once the distal end of the barrel  40  is located at the targeted site, the physician depresses the pull lever  48 . The needle electrodes  46  advance to their extended positions (see  FIGS. 8 and 10 ). The distal ends of the electrodes  46  pierce and pass through the mucosal tissue adjacent the targeted feeder vessel region without penetration of a hemorrhoidal plexus  24  or  26 . The physician applies radio frequency energy through the needle electrodes  46 . The energy can be applied simultaneously by all electrodes  46 , or in any desired sequence, to apply energy in a selective fashion to a targeted feeder vessel region below mucusal tissue. The applied energy creates one or more lesions, or a prescribed pattern of lesions, below the mucosal surface. The electrodes  46  are then retracted, and the device  30  withdrawn.  
         [0043]     If desired, the process may be repeated to form a desired lesion pattern at a single location or at multiple locations. With the electrodes  46  in the retracted position, the operative element  38  may be rotated and/or axially advanced or retracted. The electrodes  46  are then advanced to their extended position and energy is again applied to form a lesion or series of lesions. The lesion pattern may be along a particular feeder vessel region for treatment of a single hemorrhoidal plexus  24  or  26 . Alternatively, the lesions may be created in multiple feeder vessel regions for treatment of multiple hemorrhoidal plexes  24  or  26 . For example,  FIG. 11  illustrates the formation of a pair of lesions  58 A in a first internal hemorrhoidal plexus  24 A, and a second pair of lesions  58 B in a second internal hemorrhoidal plexus  24 B. As  FIG. 11  also illustrates, the lesions  58 A and  58 B occlude or otherwise reduce, at least in part, blood flow through the feeder vessels  22  and thereby occlude or otherwise reduce the blood supply from above the hemorrhoidal plexes  24 A and  24 B. As a result, blood is essentially prevented from pooling in the vessels  22  and the hemorrhoidal plexes  24 A and  24 B. Since blood is prevented from pooling, hemorrhoids are shrunk or prevented. By targeting selected feeder vessel regions, the procedure can be adapted for the treatment of a single or multiple internal hemorrhoids, a single or multiple external hemorrhoids, or a combination of internal and external hemorrhoids.  
         [0044]     The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.