Abstract:
A method for the treatment of Barrett&#39;s Esophagus of a patient having endothelial esophageal complications. The treatment comprises connecting a wavelength specific light source to an elongated light guide having a distal end, the light guide arranged within a lumen of a steerable endoscope, guiding the endoscope into the esophagus of the patient, energyzing the light source, and manipulating the distal end of the light source onto a target on the endothelial complications inside of the patient&#39;s esophagus for the selective thermolysis of the target in the esophagus, thereby reverting the red secretory esophageal lining to a normal lining.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates to the apparatus and the method of using that apparatus for the treatment of Barrett&#39;s Esophagus, and more particularly the utilization of a light apparatus to accomplish that treatment. 
   2. Prior Art 
   A condition known as Barrett&#39;s Esophagus, develops in some people who have chronic gastroesophageal reflux disease (GERD) or otherwise known as inflammation of the esophagus (esophagitis). 
   The esophagus is a muscular, membranous tube, about 25 cm long, through which food passes from the pharynx at the rear of the mouth, into the stomach. 
   The inner mucosa of the esophagus is lined with nonkeratinized stratified squamous epithelium arranged in longitudinal folds. A number of mucous glands in the mucosa and submucosa provide a film of lubricating mucus to ease the passage of food to the stomach. The submucosa also contains blood vessels. The middle muscular&#39;s externa consists wholly of striated voluntary muscle in the upper third of the esophagus, a combination of smooth and striated muscle in the middle third, and wholly smooth muscle in the lower third. The slow contractions of the smooth muscle in this area allow food to pass into the stomach without the force generated by the skeletal muscle. The outer fibrous layer is called the adventitia, because it lacks an epithelial layer. 
   The esophagus is located just in front of the vertebral column and behind the trachea. It passes through the lower neck and thorax before penetrating the diaphragm and joining the stomach. 
   Each end of the esophagus is closed by a sphincter muscle when the tube is at rest and collapsed. The upper sphincter is the superior esophageal sphincter. Closing of this sphincter is caused not by active muscular contraction but rather by the passive elastic tension in the wall of the esophagus when the esophageal muscles are relaxed. The lower esophageal sphincter is a band of smooth muscle that includes the last 4 cm of the esophagus just before it connects to the stomach. The lower sphincter relaxes only long enough to allow food and liquids to pass into the stomach. The rest of the time, it is in a contracted configuration to prevent food and hydrochloric acid from being forced back into the esophagus when pressure increases in the abdomen. Such pressure usually increases when the abdominal muscles contract during the breathing cycle, during the late stages of pregnancy, and during the normal stomach contractions during digestion. If the lower esophageal sphincter does not close, the hydrochloric acid in the stomach may be forced up into the lower esophagus. The resultant irritation of the lining of the esophagus is known as heartburn, called this because it is a painful sensation and appears to be located near the heart. Damage to the lining of the esophagus caused by that hydrochloric acid known as acid reflux, and abbreviated “GERD”, that causes the normal cells that line the esophagus, those cells being called the squamous cells, to turn into a type of cell not usually found in humans, called specialized columnar cells. That conversion of cells in the esophagus by the acid reflux, is known as Barrett&#39;s Esophagus. Symptoms of such a condition may include waking during the night because of a heartburn pain, vomiting, blood in the vomit or stool, and in difficulty with swallowing. 
   The diagnosis of such a condition involves the use of an endoscope inserted down the esophagus to as to evaluate the lining thereof, and to permit a biopsy to be taken of the tissue therein. This treatment is called an endoscopy, wherein the doctor thus guides the thin endoscopic tube through the mouth and into the esophagus. The scope may contain instruments that permit the doctor to see the lining of the esophagus and to remove a small sample of tissue from the esophagus lining. That tissue sample, called a biopsy, would be examined to see whether the normal squamous cells have been replaced with the columnar cells. 
   Cells in the lining of the esophagus, after having turned into columnar cells, will not revert back to normal squamous cells. There is, unfortunately, no cure presently for Barrett&#39;s Esophagus. Present treatment of this disease is effected to attempt to prevent further damage by stopping any additional acid reflux from the stomach. Some types of medications may be helpful, such as H2 receptor antagonists and proton pump inhibitors, which reduce the amount of acid produced by the stomach. There is a risk of developing cancer by about 5 to 10 percent of the people who have Barrett&#39;s Esophagus. 
   It is an object of the present invention to provide a treatment for patients who have Barrett&#39;s Esophagus disease. 
   It is a further object of the present invention to provide an arrangement to reverse abnormal columnar epithelial cells and secretory lining in the esophagus, to become the normal “whitish” squamous type of cell through precise modification of the lesion&#39;s vasculature. 
   It is yet a further object of the present invention to provide an optical radiation source which takes advantage of the optical differentiation of abnormal and normal tissue lining the esophagus to provide a treatment for that abnormal cellular condition. 
   BRIEF SUMMARY OF THE INVENTION 
   The present invention relates to several preferred embodiments for the treatment of Barrett&#39;s Esophagus, a first preferred embodiment including a light transmissiant apparatus which is arranged to extend through the patient&#39;s esophagus and direct selected pulses of optical radiation (i.e. light) through a wave guide and out a directable optical tip to be aimed onto selected portions of the patient&#39;s esophageal wall which wall portions include both particular cellular targets such as lesions and normal cells in the wall at the lower end of that esophagus. 
   Another preferred embodiment of that optical radiation delivery apparatus includes a wave guide arranged through an endoscope. The endoscope is guided down into the patient&#39;s esophagus. The wave guide has a laser source arranged at its proximalmost end, comprising a flashlamp housed adjacent a reflector. An optical filter and condensor lens directs the optical radiation through the wave guide arranged within the endoscope and then to the distal end of that wave guide which extends distally from the endoscope. The endoscope has viewing capabilities at its proximal end with an illuminator and an optical viewing lumen as well, to permit the attending physician to manipulate and directionally guide the distal end of the light guide optics. The distal end of the wave guide comprises the discharge means for the optical radiation passed therethrough. The distal end of the wave guide may be adapted to engage in direct physical contact with the spot or tissue to be treated, or may be held a spaced distance thereapart for directed treatment of light thereon. 
   The wave guide itself may be comprised of a liquid-containing lumen, which directs the optical radiation such as light, from its proximalmost end at the laser source to the distribution end at its distalmost portion. 
   Light-emitting diodes (LEDs) for light treatment of the patient comprises yet a further light-treatment embodiment of the optical radiation source of the present invention. In that embodiment, the light-emitting diodes would have power cables to a power source at the proximal end of the endoscope. Such a light apparatus included within that endoscope, which endoscope includes a visual optic guide, and an illumination lumen, provides light for the guiding physician to utilize the LEDs as light treatment apparatus. 
   An optical coupler may be arranged on the distal end of the endoscope as another embodiment. The optical coupler may have a prism thereon which includes a collimating optic on its side face. The prism and collimating optic are in communication with the optical fiber running down the endoscope. The optical coupler may have a key extending proximally therefrom, which key mates with a keyway arranged on the distal end of the endoscope. Rotation of the endoscope would thus affect rotation of the optical coupler for improved sensing and treatment of the epithelial cells on the lowermost portion of the esophagus. 
   The distal tip of the endoscope may in a further light-treatment embodiment include a LED light projection source arranged therewithin for distributing light through a grid and lens arrangement onto the treatment site. 
   If a laser is to be utilized within the present treatment arrangement, the wave or light guide is preferably made of a glass or a quartz core. Flexibility of the light guide is important. Such a light guide may have between 100 to 1,000 microns in diameter to permit such flexibility. A laser source should be specifically designed to treat vessels and be selectively absorbed by blood inside those vessels. Such a laser source may have wavelengths in the range of between 530 to 600 nm. Preferably a pulsed dye laser having a wavelength of 580 to 600 nm with a pulse duration of 0.35 to 100 ms. A further light source may be considered such as a filtered arc lamp or laser diodes or light emitting diodes. Dye lasers with a wavelength of 585 nm and a 0.5 ms pulse duration and a fluence range of 4 to 1000 J/cm 2  is preferred. Dosimetry is important in the treatment of cellular structure within the esophagus. Divergence of the delivered laser beam is minimized for an accurate fluence on the tissue being treated. To provide an accurate fluence delivery to the tissue being treated, a depth of field projection may be displayed onto the target site. The treatment fiber would extend out the distal tip of the endoscope and indicate an image size on the tissue site, indicating the appropriate distance from the treatment fiber to the target. This will ensure consistent spot size for optimizing the treatment of that target tissue. 
   A further preferred embodiment comprises the use of a contact tip on the distalmost end of the light guide, which tip may be longitudinally displacable. Precise dosimetry is thus guaranteed when the contact tip is in touching contact with the lesion on the esophagus wall. 
   Thus, what has been shown is an arrangement for the treatment of Barrett&#39;s Esophagus by vascular laser light absorption for selective photothermolysis, in which a light pulse is tailored to heat certain blood-containing targets which will have absorbed the energy and coagulated the target vessels killing the abnormal columnar epithelial cells lining the esophagus, a condition present in Barrett&#39;s Esophagus. Thus the adjacent normal tissue in the esophagus that contains no chromophores absorb the treatment optical radiation, is unharmed by that optical radiation therapy. 
   The invention thus comprises a method for the treatment of Barrett&#39;s Esophagus to reverse abnormal columnar epithelial cells and secretory lining in the esophagus of a patient having as a target, red secretory esophageal lining complications The steps include: connecting a wavelength specific optical radiation energy source to an elongated wave guide having a distal end, the wave guide arranged within a lumen of a steerable endoscope; guiding the endoscope into the esophagus of the patient; energyzing the optical energy source; manipulating the distal end of the light source onto a target on the endothelial complications inside of the esophagus for the selective thermolysis of the target in the esophagus; causing the red secretory esophogeal lining to revert to normal tissue, wherein the optical radiation has a fluence range of 4-1000 J/cm 2 . The optical radiation energy source may comprise a pulse dye laser. The pulsed dye laser may have a wavelength range of about 580-600 nm. The optical radiation energy source may comprise light emitting diodes or a diode laser. The distal end of the optical radiation energy source may have an optical coupler thereon. The optical coupler may include a prism in light communication with the wave or light guide to direct a treatment light to the target site. The method may include: moving the distal end of the optical radiation energy source towards and/or away from the red secretory target lining of the esophagus to focus the light thereon, touching the red secretory lining of the esophagus by the light source to insure proper light contact dosimetry thereof. The light treatment energy may have an energy density of about 4-1000 J/cm 2 . 
   The invention may also include a method for the treatment of Barrett&#39;s Esophagus to reverse abnormal columnar epithelial cells and secretory lining in the esophagus of a patient having a target of those abnormal cells comprising a red secretory esophageal lining complications. The method may comprise: connecting a wavelength specific optical radiation energy source to an elongated wave guide having a distal end, the wave guide arranged within a lumen of a steerable endoscope; guiding the endoscope into the esophagus of the patient; energyzing the optical energy source to generate a beam of light energy; manipulating the distal end of the light source onto the red secretory lining target comprising the endothelial complications inside of the esophagus for the selective thermolysis of the red secretory lining in the esophagus; causing the red secretory esophogeal to revert to a normal non-secretory “whitish” tissue by maintenance of the energyzing of the optical energy source, wherein the optical radiation has a fluence range of 4-1000 J/cm 2  and is inversely proportional to its spot size. The spot size of said beam of light energy has a range of between 0.4 mm. to 10 mm. in diameter. 
   The optical radiation energy source may comprise a pulse dye laser. The pulse dye laser may have a wavelength of about 580-600 nm. The optical radiation energy source may comprise light emitting diodes or a diode laser. The distal end of the optical radiation energy source may have an optical coupler thereon. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The objects and advantages of the present invention will become more apparent when viewed in conjunction with the following drawings in which: 
       FIG. 1  is a diagrammatical representation of the light treatment by the present invention applied to both a lesion and unaffected tissue; 
       FIG. 2  is a schematic representation of a flashlamp for treatment with a light source utilized with a light guide and endoscope threaded through an esophagus for treatment thereof; 
       FIG. 3  is a perspective representation of the distal tip of the endoscope carrying an array of LEDs for the light treatment; 
       FIG. 4  is a representation of an endoscope and an energy dispensing manipulable tip therewith; 
       FIG. 5  is an exploded perspective representation of an energy directing tip that is adaptable to the distal end of a fiber extending from an endoscope; 
       FIG. 6  is a plan view of the distal tip of a scope and image plane representation therewith as a spot size control arrangement; 
       FIG. 7  is a side view of an endoscope with a contact tip for contactable treatment of a lesion within an esophagus; and 
       FIG. 8  is a chart showing the relationship between maximum treatment fluence and spot size. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   Referring now to the drawings in detail, and particularly to  FIG. 1 , there is shown a generic preferred embodiment the present invention which comprises an optical radiation (i.e. light) delivery apparatus  10  for the treatment of Barrett&#39;s Esophagus, wherein a light transmissiant apparatus  100  which is arranged to extend through the patient&#39;s esophagus  12  and direct selected pulses of optical radiation  106  (i.e. light) through a wave guide  102  and out a directable optical tip  104  to be aimed onto selected portions of the patient&#39;s esophageal wall “W” which wall portions include both particular (treatable) cellular targets “L” such as lesions as well as normal cells “O” (oblivious to the treatment optical radiation  104 ) in the wall “W” at the lower end of that esophagus  12 . Since the unaffected (disease free, normal) tissue also receives treatment light  106 , it is of minor consequence because that tissue “O” contains an insignificant quantity of chromophores, and is thus unaffected by such treatment light  106 . 
   A more specific preferred embodiment of that optical radiation delivery apparatus  10  includes a wave or light guide  18  arranged through an endoscope  20 . The endoscope  20  is guided down into the patient&#39;s esophagus  12 , as is represented in FIG.  2 . The light guide  18  has an optical radiation source  22  arranged at its proximalmost end, in this embodiment, comprising a flashlamp  24  housed adjacent a reflector  26 . An optical filter  28  and condenser lens  30  directs the optical radiation through the wave guide  18  arranged within the endoscope  20  and then to the distal end of that wave guide  18  which extends distally from the endoscope  20 , as depicted in  FIGS. 2 ,  4  and  5 . The endoscope  20  has a viewing port  21  and a steering mechanism  23  at its proximal end with a target site illuminator  32  and an optical viewing lumen  34  as well, to permit the attending physician to manipulate and directionally guide the distal end of the light guide optics  33 , as represented in FIG.  4 . The distal end of the light guide  18  comprises the discharge means for the light passed therethrough. The distalmost end  90  of the wave guide  18  may be adapted to engage in direct physical contact with the spot or tissue to be treated, as represented in  FIG. 7 , or may be held a spaced distance thereapart for directed treatment of light thereon, as represented in  FIG. 6  to permit the optical radiation treatment beam  75  to be adjustably “sized” to a proper diameter corresponding to the focused grid or image  77  from a light projection source  70 . 
   In one embodiment of the wave guide  18 , it may be comprised of a liquid-containing lumen, which lumen utilizes a liquid therein to direct the light from its proximalmost end at the laser source to the light treatment distribution end at its distalmost portion. 
   A further preferred embodiment is shown in  FIG. 3 , wherein an array of light-emitting diodes (LEDs)  40  comprise the treatment optical radiation source of the present invention. In that embodiment, the light-emitting diodes  40  would have power cables  42  to a power source at the proximal end of the endoscope  20 . Such an LED optical radiation generation apparatus included within that endoscope  20  would also include a visual optic guide  44 , and an illumination lumen  46  to provide light for the guiding physician to utilize and thereby guide the LEDs as a light treatment apparatus. 
   Shown in  FIG. 5  is a removably adjustable optical coupler  50  that is arranged on the distal end of the endoscope  20 . The optical coupler  50  may have a directional prism  52  thereon which includes a collimating optic  54  on its side face  56 . The prism  52  and collimating optic  54  are in optical communication with the wave guide  18  and the optical fiber  58  running down the inside of the endoscope  20 . The optical coupler  50  may have a key  60  extending proximally therefrom, which key  60  mates with a keyway  62  arranged on the distal end of the endoscope  20 . Rotation of the endoscope  20  would thus effect rotation of the optical coupler  50  for improved sensing and treatment of the epithelial cells  66  on the lowermost portion of the esophagus  12 , above the sphincter  67 , as depicted in FIG.  1 . 
   In  FIG. 6 , the distal tip of the endoscope  20  is shown including a LED light source  70  arranged therewithin, distributing light  72  through a grid  74  and a lens  76  arrangement as a grid pattern onto the treatment site lesion “T”, for adjustable “sizing” comparison with a size and intensity adjustable treatment beam  75 , as viewed and controlled by the attending physician through adjacent viewing optics, not shown for simplicity of the figure. The focused image  77  thus indicates the correct focal plane  79  in which the optical radiation (laser) may be fired with precise dosimetry. 
   If a laser is to be utilized within the present treatment arrangement, the light guide is preferably a glass or a quartz core. Flexibility of the light guide is important. Such a light guide may have between 100 to 1,000 microns in diameter to permit such flexibility. A laser source should be specifically designed to treat vessels and be selectively absorbed by blood inside those vessels. Such a laser source may have wavelengths in the range of between 530 to 600 nm. Preferably a pulsed dye laser having a wavelength of 580 to 600 nm with a pulse duration of 0.35 to 100 ms. A further light source may be considered such as a filtered arc lamp or laser diodes or light emitting diodes. Dye lasers with a wavelength of 585 nm and a 0.5 ms pulse duration and an fluence of 4 to 1000 J/cm 2  is preferred. Dosimetry is important in the treatment of cellular structure within the esophagus. Divergence of the delivered laser beam  75  is minimized for an accurate fluence on the target tissue. To provide an accurate fluence delivery to the tissue being treated, a grid or depth of field projection  79  may be displayed onto the target site “T” by a treatment fiber  82 , as shown in FIG.  6 . The treatment fiber  82  would extend out the distal tip of the endoscope  20  and indicate an image size on the tissue site, indicating the appropriate distance from the light source to the target “T” as aforementioned. This will ensure consistent spot size for optimizing the treatment of that target tissue. Such treatment is possible because there is a distinct optical differentiation of abnormal and normal tissue. The redness of the target lesion defines the use of a light source which targets red-hemoglobin. 
     FIG. 7  shows a further embodiment using a longitudinally displaceable contact tip  90  on the distalmost end of the light or wave guide  18 . Precise dosimetry is guaranteed when the contact tip  90  is in touching contact with the lesion “T” on the wall of the esophagus  12 . 
   A graph showing the relationship of maximum treatment fluence to spot size of the treatment radiation is shown in FIG.  8 . The fluence may be as high as 1000 J/cm 2 , depending on the size in mm. of the optical radiation. Because of the wavelength and pulse duration and the target chromophores, the relatively high fluences are tolerated by adjacent, struck, non-target tissues. 
   Thus, what has been shown is an arrangement for the treatment of Barrett&#39;s Esophagus by vascular laser light absorption for selective photo thermolysis. A pulse of optical radiation (i.e. light) is thus tailored to heat certain blood-containing targets which will have absorbed the light energy and coagulate the target&#39;s blood vessels. The killing of the abnormal columnar epithelial cells lining the esophagus is thus accomplished by the treatment for Barrett&#39;s Esophagus as proposed by the present invention, without harming adjacent non-diseased tissue.