US20130310642A1 - Device and Method for Treatment of Gastroesophageal Reflux Disease - Google Patents

Abstract

A lower esophageal sphincter tightening device for treating gastro esophageal reflux disease which includes an insertion device, an energy source, and an energy transmitting device. The insertion device, by insertion through a body opening, positions the energy transmitting device in the proximity of the lower esophageal sphincter. The energy generates and transmits energy via the insertion device to the energy transmitting device which directs the transmitted energy onto the lower esophageal sphincter which is comprised largely of collagen. The energy source transmits energy at a level sufficient to cause heating of the sphincter's collagen resulting in a shrinkage of the collagen and a tightening of the sphincter.

Description

BACKGROUND OF THE INVENTION
• The invention pertains to the treatment of gastroesophageal reflux disease (GERD).
• GERD is a major health problem in the United States and Worldwide. It affects tens of millions of people and costs billions of dollars to treat. GERD is the reflux of gastric contents from a stomach into a lower area of an esophagus. The gastric contents include acid secreted by the stomach which causes discomfort and eventual damage to an inner lining of the esophagus if left untreated.
• The gastric contents are normally prevented from entering the esophagus by a lower esophageal sphincter (LES) mechanism. The LES is a physiologic, non-anatomic area involving the lower 3 centimeters of the esophagus and like other smooth muscle sphincters in the body, anal or urinary, it is tonically contracted to prevent reflux. A healthy LES opens for a brief period of several seconds in response to swallowing to allow the passage of food. It then quickly regains its tone when the food has passed.
• GERD occurs when the sphincter mechanism of the LES fails to work properly. Generally, GERD takes one of three forms: (i) complete weakness of the sphincter musculature in response to a hiatal hernia or an intrinsic weakness that occurs commonly resulting in free reflux, which is poorly understood; (ii) partial weakness of the sphincter that allows reflux when stressed such as a Valsalva maneuver; or (iii) transient or sudden inappropriate relaxation of an otherwise normally toned sphincter.
• Treatment of a weakened or inappropriately relaxing sphincter can be either medical or surgical. Known medical treatments include measures or medications that attempt to decrease acid secretion, increase gastric emptying or strengthen the LES. However, the medications are expensive and the measures typically have to be continued on a life long basis.
• A more permanent treatment method for GERD can be performed surgically. Surgical methods attempt to strengthen the LES by incising the stomach and wrapping a portion of the stomach around the lower section of the esophagus. This technique is known as a fundoplication. However, surgical treatment requires longer post treatment care, increased pain and recovery time, as well as the associated risks with any surgical procedure.
• The latest developments for treating GERD have attempted to provide a minimally invasive procedure to strengthen the lower esophageal area. One such treatment is disclosed by C. P. Swain et al.,Knot Tying At Flexible Endoscopy, Gastrointestinal Endoscopy, 1994; 40;722-29, that calls for endoscopic sewing in the lower esophageal area. However the sewn portion of the esophagus in the Swain technique may relax again requiring further or alternate forms of treatment. Another technique disclosed by Donahue injects noxious, scarring substances into the lower esophageal area to create a fibrous reaction. P. E. Donahue; et. al.,Endoscopic Ultrasonography Verifies Effect On Endoscopic Treatment Of Reflux In Dogs And Man, Surgical Endoscopy, 1993;7:524-28. However, the Donahue technique may require numerous and repeated injections.
• The esophagus and LES are composed of three tissue layers; a mucosa or inner layer, a submucosa or middle layer, and a muscle or an outer layer. The submucosa layer is largely composed of collagen. It is well-known that heating of collagen tissue within an appropriate temperature range results in a tightening or shrinkage of the collagen tissue. However, there exists no known device or technique for strengthening the LES by shrinkage of collagen tissue as a means to treat GERD.
SUMMARY OF THE INVENTION
• The invention discloses a device and method to prevent gastroesophageal reflux or GERD. The device comprises an insertion device, an energy source, and an energy transmitting device. The insertion device has a proximal end connected to the energy source and a distal end connected to the energy transmitting device. The energy source generates and transmits energy to the energy transmitting device through the insertion device. The energy transmitting device then radiates and directs the transmitted energy onto a target area. The insertion device positions the energy transmitting device in the proximity of a lower esophageal sphincter, such that the sphincter tissue becomes the target area of the energy transmitting device.
• The energy source then generates and transmits energy to the energy transmitting device which radiates the energy onto the sphincter tissue. The sphincter tissue absorbs the radiated energy which generates heat within the sphincter tissue. The sphincter tissue is largely comprised of collagen which exhibits shrinkage when heated.
• The energy source generates and transmits energy at a level sufficient to cause heating of the sphincter tissue to a temperature of between 50° C. and 70° C. (preferably between 63° C. and 65° C.) within a time Period of between about 1 microsecond and 1 minute. Heating the sphincter tissue within the appropriate range achieves sufficient collagen shrinkage to tighten the lower esophageal sphincter and prevent reflux.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a lower esophageal sphincter tightening device of the present invention.
• FIG. 2 is a cutaway diagram of an esophagus.
• FIG. 3 is a perspective view of a second embodiment of the lower esophageal sphincter tightening device of the present invention.
• FIG. 4 is a perspective view of a third embodiment of the lower esophageal sphincter tightening device of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• InFIG. 1, a preferred embodiment of a lower esophageal sphincter (LES) tightening device10 is shown in use. The LES tightening device10 comprises aninsertion device12, anenergy source14 and anenergy transmitting device16. As shown inFIG. 1, the LES tightening device10 could also include an inflation device18 and aballoon20.
• In a preferred embodiment, theinsertion device12 is an endoscope as shown inFIGS. 1,3 and4. However, workers skilled in the art will recognize that a catheter or other similar device could also be used. As shown inFIG. 1, theinsertion device12 has aproximal end22 and adistal end24. Additionally, theinsertion device12 could include aneye piece26, alight source28 and a control means30. A series ofports32 provide access from theproximal end22 to thedistal end24 through lumens located within the interior of theinsertion device12 along its longitudinal access.
• Theenergy source14 is located at theproximal end22 of theinsertion device12. Theenergy source14 generates and transmits energy to the energy transmittingdevice16 located at thedistal end24 of theinsertion device12. Theenergy source14 is connected to the energy transmittingdevice16 by a transmission line34 which passes through amanifold36. Within themanifold36, the transmission line34 becomes part of acatheter38 that is fed through one of theports32 at theproximal end22. Thecatheter38 then passes down one of the interior lumens of theinsertion device12 and is connected to the energy transmittingdevice16 at thedistal end24.
• If a preferred embodiment, theinsertion device12 enters a body opening40 and passes down anesophagus42 until thedistal end24 is in the proximity of a loweresophageal sphincter44. The control means30 aid in positioning thedistal end24 of theinsertion device12. Observation througheye piece26 insures proper placement of thedistal end24. Observation is enabled by thelight source28 which illuminates the area surrounding thedistal end24 by light transmitted through an optical cable45 which passes through one of theports32 and down another interior lumen. The optical cable45 is preferably a fiber optic bundle.
• Theenergy transmitting device16 radiates and directs energy received through thecatheter38 from theenergy source14 onto a target area. Thedistal end24 of theinsertion device12 is therefore located such that the target area of theenergy transmitting device16 is directed at tissue comprising. the loweresophageal sphincter44. Once theenergy transmitting device16 is properly positioned, theenergy source14 can transmit energy it has generated to theenergy transmitting device16 through thecatheter38.
• The transmitted energy is then radiated and directed by theenergy transmitting device16 onto the loweresophageal sphincter44 tissue. The loweresophageal sphincter44 tissue absorbs the energy resulting in the generation of heat within the tissue due to thermal conduction. The loweresophageal sphincter44 tissue is comprised largely of collagen which will exhibit shrinkage characteristics over an appropriate time temperature relationship prior to being damaged or destroyed.
• The appropriate time period to satisfy the time temperature relationship is dependent upon the temperature of the treated tissue, which in turn is dependent upon the level of energy generated in theenergy source14 and radiated by theenergy transmitting device16. The desired tissue temperature in the target area is between 50° C. and 70° C. with a preferred level between 63° C. and 65° C. This temperature increase can be achieved within a period of time between one microsecond and one minute dependent upon the amount and type of energy generated within theenergy source14. In a preferred embodiment, theenergy source14 generates radiant energy (e.g. RF or microwave electromagnetic energy) which is transmitted by a transmission line34 (such as a coaxial cable) that is then contained within thecatheter38 and connects to theenergy transmitting device16. Theenergy transmitting device16 is preferably an antenna or a directional antenna.
• The LES tightening device10 can additionally include the inflation device18 and theballoon20. Once theenergy transmitting device16 is properly positioned, theballoon20 is located at thedistal end24 of theinsertion device12 and encapsulates theenergy transmitting device16 as shown inFIG. 1. The inflation device18, located at theproximal end22, inflates or deflates theballoon20 via aconduit48. Theconduit48 connects the inflation device18 to theballoon20 by passing through the manifold36, wherein theconduit48 becomes part of thecatheter38. Air, fluid or gel could be used by the inflation device18 to inflate theballoon20. The size of theballoon20 can be adjusted to maintain proper placement of theenergy transmitting device16 in relation to the loweresophageal sphincter44 tissue and/or control the amount of collagen shrinkage and therefore control the amount of sphincter tightening.
• In a preferred embodiment, theballoon20 can be either a noncompliant balloon or a compliant balloon. The size of a compliant balloon can be controlled by observation through theeye piece26, injection of a radiopaque fluid such as fluorochrome into theballoon20 and viewing on a fluoroscope, or monitoring the pressure of theballoon20.
• FIG. 2 is a cutaway schematic view (not to scale) of the tissue comprising the loweresophageal sphincter44. The tissue is comprised of three layers; amucosa48 inner layer, asubmucosa50 middle layer and amuscle52 outer layer. In a preferred embodiment, collagen tissue in thesubmucosa50 is targeted for shrinkage. In addition, a cooling means to prevent damage to themucosa48 may be incorporated into the LES tightening device10. This can be accomplished by cooling or cycling through cooled air, liquid, or gel to inflate theballoon20. The cooled material dissipates the heat generated by absorption of the radiated energy from theenergy transmitting device16. This maintains a safe temperature level in the mucosa46 (which is less than about 50° C. or preferably less than 45° C.) The type and amount of cooled material used to inflate theballoon20 is dependent on the amount and type of energy generated within theenergy source14.
• FIG. 3 shows a second embodiment of the LES tightening device10. Reference numerals identical to those employed in connection withFIG. 1 indicate identical elements, and reference numerals followed by a suffix indicate modified but similar elements. In this preferred embodiment, theenergy transmitting device16A is attached to the outer surface of theballoon20A to direct energy at the loweresophageal sphincter44 tissue. As previously described, once thedistal end24 of theinsertion device12 properly positions theenergy transmitting device16A over the loweresophageal sphincter44 tissue, theballoon20A can be inflated and theenergy source14 can transmit energy to theenergy transmitting device16A for radiation onto the loweresophageal sphincter44 tissue. Again, a coolant can be used to inflate theballoon20A to prevent damage to themucosa48 while achieving collagen shrinkage in thesubmucosa50 resulting in the tightening of the loweresophageal sphincter44.
• A third alternative embodiment to the present invention is depicted inFIG. 4. Again, reference numerals identical to those employed in connection withFIG. 1 indicate identical elements, and reference numerals followed by a suffix indicate modified but similar elements. In this embodiment, the balloon20B is enlarged to protrude into astomach46 and anchor or retain the energy transmitting device16B in proper position with respect to the loweresophageal sphincter44 tissue. In this embodiment, theinsertion device12 positions the energy transmitting device16B such that the target area comprises the loweresophageal sphincter44 tissue. Once in place, the balloon20B is enlarged by injection of a suitable material which retains the position of the energy transmitting device16B relative to the loweresophageal sphincter44. This assures the energy radiated by the energy transmitting device16B is absorbed by the loweresophageal sphincter44. Again, the material injected into the balloon20B for inflation can be cooled to a sufficient level to offset and dissipate any heat build-up in themucosa48 and thereby enable the generation of heat and consequent shrinkage of collagen in thesubmucosa50.
• Although the present invention has been described with reference to treatment of GERD by toning the muscular LES sphincter, workers skilled in the art will recognize that this device and method could be used to shrink or tone other sphincters located in the body to overcome other medical ailments caused by the loss of sphincter muscle tone. For example, the device and method can be used on the urinary or anal sphincter to overcome incontinence.
• Furthermore, workers skilled in the art will also recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. For example, the energy source can generate energy of various wavelengths within the electromagnetic spectrum including but not limited to laser, RF, or microwave energy. Alternatively, the energy source can generate ultrasonic energy to generate heat in the targeted tissue. area. The insertion device can be an endoscope, catheter or similar type of device. Depending on the form and wavelength of the energy being used, the energy transmitting device may be an antenna, an ultrasonic transducer, a fiber optic bundle, or an electrical resistance heater. Furthermore, a directional antenna can be used to limit and control the amount of energy directed at specific locations within the targeted tissue.
• With the present invention, tissue within the lower esophageal sphincter can be toned or tightened to treat gastroesophageal reflux disease on an outpatient basis with a safe, simple procedure with decreased aftercare, treatment and pain.

Claims (19)

1.-74. (canceled)

75. A medical treatment device, comprising:

a catheter sized and shaped to be inserted into an opening of a body;

an inflatable member extending along and about a distal portion of the catheter, the inflatable member movable between an insertion configuration and an inflated configuration in which the inflatable member is radially expanded;

an energy transmitting device attached to an outer surface of the inflatable member such that energy is transmitted to a target tissue via contact between the energy transmitting device and the target tissue; and

an energy source coupled to a proximal end of the catheter, the energy source transmitting energy through the catheter to the energy transmitting device via a transmission line extending through the catheter.

76. The device ofclaim 75, further comprising an inflation device at a proximal end of the catheter for moving the inflatable member between the insertion configuration and the inflated configuration.

77. The device ofclaim 76, wherein the inflation device provides one of air, fluid and a gel to inflate the inflatable member.

78. The device ofclaim 77, wherein one of the air, fluid and gel is cooled.

79. The device ofclaim 75, wherein the energy transmitting device extends along a portion of a length of the inflatable member.

80. The device ofclaim 75, wherein the energy source generates energy including one of laser, RF, microwave and ultrasonic energy.

81. The device ofclaim 75, wherein the energy transmitting device includes a plurality of longitudinal strips of energy transmitting material distributed about the outer surface of the inflatable member.

82. A medical treatment system, comprising:

a catheter sized and shaped to be inserted into an opening of a body;

an inflatable member extending along and about a distal portion of the catheter, the inflatable member movable between an insertion configuration and an inflated configuration in which the inflatable member is radially expanded;

an energy transmitting device attached to an outer surface of the inflatable member such that energy is transmitted to a target tissue via contact between the energy transmitting device and the target tissue;

an energy source coupled to a proximal end of the catheter, the energy source transmitting energy through the catheter to the energy transmitting device via a transmission line extending through the catheter; and

a vision system permitting a user to view a positioning of the energy transmitting device in the body.

83. The system ofclaim 82, wherein the vision system includes an elongate member extending from a proximal end to a distal end and sized and shaped for insertion into the opening of the body, the elongate member including an eye piece at the proximal end thereof and a light source extending therethrough to permit visualization at the distal end thereof.

84. The system ofclaim 82, wherein the vision system is an endoscope.

85. The system ofclaim 82, further comprising an inflation device at a proximal end of the catheter for moving the inflatable member between the insertion configuration and the inflated configuration.

86. The system ofclaim 85, wherein the inflation device provides one of air, fluid and a gel to inflate the inflatable member.

87. The system ofclaim 86, wherein the one of air, fluid and gel is cooled.

88. The system ofclaim 82, wherein the energy transmitting device extends along a portion of a length of the inflatable member.

89. The system ofclaim 82, wherein the energy source generates energy including one of laser, RF, microwave and ultrasonic energy.

90. The system ofclaim 82, wherein the energy transmitting device includes a plurality of longitudinal strips of energy transmitting material distributed about the outer surface of the inflatable member.

91. A method for treating body tissue, comprising:

inserting a catheter through an opening of a body until an inflatable member extending along and about a distal portion of the catheter is at a desired position within the body;

expanding the inflatable member from an insertion to an inflated configuration in which the inflatable member is expanded radially outward such that an energy transmitting device attached to an outer surface of the inflatable member is in contact with a target tissue; and

transmitting energy from an energy source coupled to a proximal end of the catheter to the energy transmitting device via a transmission line extending through the catheter

92. The method ofclaim 91, further comprising inserting a vision system into the opening of the body to view a position of the energy transmitting device.

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