US20080132809A1 - Methods of delivering energy to body portions to produce a therapeutic response - Google Patents
Methods of delivering energy to body portions to produce a therapeutic response Download PDFInfo
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- US20080132809A1 US20080132809A1 US11/984,059 US98405907A US2008132809A1 US 20080132809 A1 US20080132809 A1 US 20080132809A1 US 98405907 A US98405907 A US 98405907A US 2008132809 A1 US2008132809 A1 US 2008132809A1
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- gall bladder
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N7/02—Localised ultrasound hyperthermia
Abstract
The invention relates to methods of applying energy to various body portions to produce a therapeutic response. According to embodiments, the applied energy is ultrasound and may be delivered by an ultrasound focusing device deployed in the body, for example, by using an endoscope. The energy may be used to effect a variety of therapeutic responses, including ablating lesions in the gall bladder, treating gastrointestinal reflux disease, or treating fecal incontinence.
Description
- This patent application claims the benefits of priority under 35 U.S.C. §§119, 120 to U.S. Provisional Patent Application No. 60/496,926, entitled METHODS OF DELIVERING ENERGY TO BODY PORTIONS TO PRODUCE A THERAPEUTIC RESPONSE, filed on Aug. 22, 2003, the entirety of which is incorporated herein by reference.
- 1. Field of the Invention
- The invention relates to methods of applying energy to various body portions to produce a therapeutic response. According to embodiments, the applied energy is ultrasound and may be delivered by an ultrasound focusing device deployed in the body, for example, by using an endoscope. The energy may be used to effect a variety of therapeutic responses, including ablating lesions in the gall bladder or other organs, treating gastrointestinal reflux disease, or treating fecal incontinence.
- 2. Background of the Invention
- Minimizing the invasiveness of medical procedures is desirable. Generally, more invasive procedures are more expensive and result in more complications and more discomfort to the patient. For example, open surgery is an invasive medical procedure with significant attendant risks. Due to relatively large incisions necessary in the performance of open surgery, relatively large amounts of blood may be lost, the risk of infection increases, and the potential for post-operative hernias is high. Further, the relatively large incisions necessary in the performance of open surgery require extended recovery times for the incisions to heal.
- Laparoscopic procedures are less invasive than open surgery. Laparoscopic procedures often involve performing laparotomies for trocar ports (penetrations of the abdominal walls), percutaneous endoscopic gastronomies (incisions through the skin into the various bodily organs), and the installation of ports through which medical devices are inserted. This procedure also requires incisions through, for example, the abdominal walls, risking infection. The location of the incision in the bodily wall also presents a risk of other negative effects, such as sepsis, which can be caused by leakage of septic fluid contained in the stomach.
- Medical treatments that would benefit from less invasive procedures include, for example, vascular sealing, ablating lesions in the gall bladder or other body organs, treatment of gastrointestinal reflux disease, or treatment of fecal incontinence, among others.
- Vascular sealing is often necessary in medical procedures that access the vascular system of the patient. Although various means may be used to obtain access into a vein or artery, typically access is obtained by inserting a cannula or introducer sheath through the skin and into the selected blood vessel. A medical device or diagnostic instrument, such as a guide wire, guiding catheter, balloon angioplasty device, atherectomy device, or the like, then is inserted into the vascular system through the cannula or introducer sheath.
- To permit the insertion of a medical device or instrument therethrough, the introducer sheath must be of a relatively large diameter. Introducer sheaths typically have a diameter in the range between one millimeter and six millimeters, thus creating a significant puncture in the blood vessel, such as a
puncture 17 into avessel 10 as shown inFIGS. 1A and 1B . After the intravascular medical procedure is completed,puncture 17 must be closed and bleeding from theblood vessel 10 stopped. In the examples shown inFIGS. 1A and 1B , thepuncture 17 goes through thesubcutaneous tissue 13, thevascular sheath 12, and thevessel wall 11. The vessel wall includes theadventitia 16,media layer 15, andintima layer 14, as shown inFIGS. 1C and 1D . - At present, bleeding may be stopped by the application of direct digital pressure over the puncture by a trained physician or other suitably trained medical personnel. Such direct pressure must be applied for a sufficiently long time for hemostasis to occur so that the puncture is effectively closed and further bleeding is prevented. In the case of punctures into the femoral artery, the pressure is generally applied for twenty to thirty minutes, but it may be necessary to apply pressure for longer and/or through other devices that apply pressure.
- Stopping bleeding using digital pressure is not an efficient use of medical professional services. The procedure also results in a substantial reduction, if not virtual arrest, of blood flow through the vessel. Since thrombosis is one of the major problems that can occur in the immediate post-operative period, reduction in blood flow caused by the application of digital pressure is undesirable. Furthermore, when digital pressure is applied, an undesirable bruise or hematoma can form at the entry site, since internal bleeding of the punctured artery continues until clotting blocks the puncture. There is also a risk that upon movement by the patient, the puncture will reopen and begin bleeding again, resulting in a hematoma or other complications. In addition, when anticoagulants used in the medical procedure are left active in the body, the introducer sheath is generally left inside the patient for a relatively long period of time in order for the anticoagulants to clear from the blood. Because the patient may be required to remain immobile and because of the risk of complications, patients are usually required to remain overnight in the hospital for observation, increasing the cost of the overall procedure.
- Devices exist to effect vascular sealing. Once such device is an expandable plug pushed through the puncture into the blood vessel and into the blood stream. Once exposed to blood, the plug expands. The expanded plug is then pulled back against the puncture where, because of its expanded size, it plugs the opening. A similar device is an expandable closure. Such devices may work satisfactorily, but require inserting and leaving a foreign object in the vessel for a period of time. It is usually medically preferable to avoid leaving objects in a vessel, even if they eventually biodegrade.
- Ablating portions of a gall bladder, or other bodily organs, is sometimes necessary to treat and/or destroy cancerous or noncancerous lesions that may exist on the surface or in the interior of the gall bladder, such as a
lesion 51 ingall bladder 50 shown inFIG. 2 . Removal of these lesions is desirable to prevent them from spreading and/or infecting additional portions of the gall bladder, as even lesions in a noncancerous form may interfere with the proper functioning of the gall bladder. - Current methods of removing such lesions include open surgery where the lesion is either cut away from the surface of the gall bladder, or if the lesion is on the interior of the gall bladder, the gall bladder is cut open to gain access to the interior of the gall bladder, at which point the lesion is removed. Laparoscopic methods of removing a lesion also exist where a removal device is inserted through the abdominal wall and into the gall bladder to remove the lesion. However, the attendant complications that accompany open surgery and laparoscopic procedures are present in these cases, and are particularly relevant where the lesions are on the interior portion of the gall bladder. Accordingly, a less invasive method of removing such lesions is desired.
- Gastroesophageal reflux occurs when stomach acid enters the esophagus from the stomach. (See a portion of the gastrointestinal tract, as shown in
FIGS. 3A and 3B , that depictsesophagus 33 and stomach 30). This reflux of acid into the esophagus occurs naturally in healthy individuals, but also may become a pathological condition in others. Effects from gastroesophageal reflux range from mild to severe. Mild effects include heartburn, a burning sensation experienced behind the breastbone. More severe effects include a variety of complications, such as esophageal erosion, esophageal ulcers, esophageal stricture, abnormal epithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration. These various clinical conditions and changes in tissue structure that result from reflux of stomach acid from the stomach into the esophagus are referred to generally as Gastroesophageal Reflux Disease (GERD). - Many mechanisms contribute to prevent gastroesophageal reflux in healthy individuals. One such mechanism is the functioning of the lower esophageal sphincter (LES), shown as
element 34 inFIGS. 3A and 3B . The LES is a ring of smooth muscle and increased annular thickness existing in approximately the last four centimeters of the esophagus. In its resting state, the LES creates a region of high pressure (approximately 15-30 mm Hg above intragastric pressure) at the opening of the esophagus into the stomach. This pressure essentially closes the esophagus so that contents of the stomach cannot pass back into the esophagus. The LES opens in response to swallowing and peristaltic motion in the esophagus, allowing food to pass into the stomach. After opening, however, a properly functioning LES should return to the resting, or closed state. Transient relaxations of the LES do occur in healthy individuals, typically resulting in occasional bouts of heartburn. - The physical interaction occurring between the gastric fundus and the esophagus also prevents gastroesophageal reflux. The gastric fundus, shown as
element 35 inFIGS. 3A and 3B , is a lobe of the stomach situated at the top of the stomach distal to the esophagus. In asymptomatic individuals, the fundus presses against the opening of the esophagus when the stomach is full of food and/or gas. This effectively closes off the esophageal opening to the stomach and helps to prevent acid reflux back into the esophagus. More specifically, as the food bolus is immersed in gastric acid, it releases gas which causes the fundus of the stomach to expand and thereby exert pressure on the distal esophagus causing it to collapse. The collapse of the esophagus lumen reduces the space for the stomach acid to splash past the closed esophagus lumen and thereby protect the proximal esophagus from its destructive contact. - In individuals with GERD, the LES functions abnormally, either due to an increase in transient LES relaxations, decreased muscle tone of the LES during resting, or an inability of the esophageal tissue to resist injury or repair itself after injury. These conditions often are exacerbated by overeating, intake of caffeine, chocolate or fatty foods, smoking, and/or hiatal hernia. Avoiding these exacerbating mechanisms helps curb the negative side effects associated with GERD, but does not change the underlying disease mechanism. Accordingly, some type of medical treatment is often necessary to correct, or at least improve, this condition.
- A surgical procedure, known generally as fundoplication, has been developed to prevent acid reflux in patients whose normal LES functioning has been impaired, either as a result of GERD or other adverse effects. This procedure involves bringing the fundus wall into closer proximity of the esophageal wall to help closed off the esophageal opening into the stomach. Traditionally, this procedure has been performed as an open surgery, but also has been performed laparoscopically. As with any surgery or laparoscopic procedure, however, fundoplication involves certain attendant risks. Thus, an alternative, minimally invasive technique is preferable.
- Fecal incontinence, which is most common in the elderly, is the loss of voluntary control to retain stool in the rectum, shown as
element 40 inFIGS. 4A and 4B . In most cases, fecal incontinence is the result of an impaired involuntary internalanal sphincter 41. The internal sphincter may be incompetent due to laxity or discontinuity. Discontinuity, or disruption of the internal anal sphincter, can be caused by a number of different muscle injuries. - In most patients, fecal incontinence is initially treated with conservative measures, such as biofeedback training or alteration of the stool consistency. Biofeedback is successful in approximately two-thirds of patients who retain some degree of rectal sensation and functioning of the external
anal sphincter 42. However, multiple sessions are often necessary, and patients need to be highly motivated. Electronic home biofeedback systems are available and may be helpful as adjunctive therapy. - Several surgical approaches to fecal incontinence have been tried, with varying success, when conservative management has failed. These treatments include sphincter repair, gracilis or gluteus muscle transposition to reconstruct an artificial sphincter, and colostomy. The approach that is used depends on the cause of the incontinence and the expertise of the surgeon. However, the attendant risks associated with there surgical approaches are still present. Accordingly, a less invasive medical procedure for treating fecal incontinence is desired.
- Patients may have mechanical devices implanted in their body, for example, to treat cancer, or mechanical devices placed in the body to perform a treatment. Examples of mechanical devices that may be implanted in the body or placed in the body to perform a treatment include stents, grafts, needles, and knives. Some of these mechanical devices may, once implanted or placed in the body, require activation. One method of activating these mechanical devices is to run a wire from the mechanical device to the exterior of the patient's body, and then apply energy to the mechanical device through the wire. However, running wires through the body for prolonged periods of time are especially undesirable as it may lead to medical complications such as internal hemorrhaging. Accordingly, a less invasive way of activating the mechanical devices is desired.
- In accordance with the invention, an embodiment of the invention includes a method of treating a patient with gastrointestinal reflux disease by applying energy to an esophageal sphincter to produce a therapeutic response.
- According to another aspect of the invention, an embodiment of the invention includes a method of treating a patient with fecal incontinence by applying energy to an anal sphincter to produce a therapeutic response.
- According to yet another aspect of the invention, an embodiment of the invention includes a method of ablating tissue in a gall bladder by applying energy to the gall bladder to produce a therapeutic response.
- In embodiments, the applied energy is ultrasound, and the amount of applied energy may be adjusted as desired. In other embodiments, an endoscope with a working channel is inserted into the body, and an ultrasound device is advanced through the working channel to the desired body portion. In yet other embodiments, the energy is applied via an ultrasound device. In still other embodiments, the energy is applied below the surface of the desired body portion. In another embodiment, the energy from the ultrasound device is focusing on the desired body portion. In yet, another embodiment, the ultrasound device is positioned outside of the patient.
- Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
- It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
- The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.
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FIG. 1A is a schematic view of an exemplary method of sealing vascular punctures. -
FIG. 1B is a schematic view of another exemplary method of sealing vascular punctures. -
FIG. 1C is a schematic view of a sealed vascular puncture resulting from the method shown inFIG. 1A . -
FIG. 1D is a schematic view of a sealed vascular puncture resulting from the method shown inFIG. 1B . -
FIG. 2A is a schematic view of an exemplary method of ablating a gall bladder. -
FIG. 2B is a schematic view of another exemplary method of ablating a gall bladder. -
FIG. 3A is a schematic view of an exemplary method of treating GERD. -
FIG. 3B is a schematic view of another exemplary method of treating GERD. -
FIG. 4A is a schematic view of an exemplary method of treating fecal incontinence. -
FIG. 4B is a schematic view of another exemplary method of treating fecal incontinence. -
FIG. 5A is a schematic view of a method of activating a mechanical implant. -
FIG. 5B is a schematic view of another method of activating a mechanical implant. - Reference will now be made in detail to the present exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
- Energy such as ultrasound may be used to minimize the invasiveness of medical procedures to treat the body. Ultrasound can provide therapeutic responses to internal and external body portions without the need for cuts or incisions, and can act on tissue below the surface of the tissue or organ.
- An ultrasound device that may be used in medical procedures is an ultrasound transducer or ultrasound focusing device disclosed in United States Patent Application Publication No. 2001/0031922 A1 to Weng et al. (“Weng”), the complete disclosure of which is incorporated herein by reference. Weng discloses using the ultrasound transducer for imaging and therapeutic purposes. For imaging purposes (for example, imaging internal human organs for diagnostic purposes) ultrasound in the frequency range of 2-20 MHz and/or an intensity of less that 0.1 watts per square centimeter is used. For therapeutic purposes, a much more high intensity ultrasound above 200 watts per square centimeter is used. Such high intensity ultrasound can raise the temperature of a desired tissue region to above 60 degrees Celsius in a few seconds.
- One application for ultrasound is vascular sealing. Accordingly, a method of effecting vascular sealing without the insertion of foreign objects into the blood vessel puncture includes the use of ultrasound.
FIGS. 1A-1D show the sealing of blood vessel punctures through the use ofultrasound 22, for example, by using theultrasound focusing device 20 disclosed in Weng. To seal ablood vessel puncture 17 usingultrasound 22,ultrasound focusing device 20 is positioned proximate theblood vessel puncture 17. If theblood vessel puncture 17 is close enough to the surface of the skin, theultrasound focusing device 20 may be placed outside of the body, as shown inFIG. 1A . If, however, theblood vessel puncture 17 is further in the body, for example close to an internal organ, acatheter 24 with alumen 25 may be advanced through the cardiovascular system until it is proximate theblood vessel puncture 17, and then theultrasound focusing device 20 is advanced through thelumen 25 ofcatheter 24 until it also is proximate theblood vessel puncture 17, as shown inFIG. 1B . At this point, theultrasound focusing device 20 is preferably past the distal end ofcatheter 24.Ultrasound focusing device 20 then is positioned, configured, and calibrated such that thefocal point 23 of theultrasound 22 will be centered on the portion of thepuncture 17 to be sealed. Methods of positioning, configuring, and calibrating theultrasound focusing device 20, for example by adjusting anultrasound array 21, are disclosed in Weng, the disclosure of which is incorporated by reference herein. The geometry and/or positioning of theultrasound focusing device 20 can be adjusted so that thefocal point 23 will be at a proper distance from theultrasound focusing device 20, particularly if the desiredfocal point 23 is below the surface of the subcutaneous tissue 18 and/orblood vessel wall 11, as shown inFIGS. 1B and 1D . However, the desired focal point may also be on a surface of thetissue 13 orblood vessel wall 11, as shown inFIGS. 1A and 1C . The geometry and positioning of theultrasound focusing device 20 can also be adjusted such that it will only act on a specified volume of tissue at and/or surrounding thefocal point 23. Both thefocal point 23 and the volume of tissue to be energized can be adjusted at any time during the procedure, for example, prior to, during, and/or subsequent to the application of energy to various tissue portions (i.e. any or all of thesubcutaneous tissue 13,vascular sheath 12,adventitia 16,media layer 15, or intima layer 14) via theultrasound focusing device 20. - Once properly positioned, the
ultrasound focusing device 20 is activated such that energy is applied viaultrasound 22 to the tissue at the desiredfocal point 23. In this case, because the object of the procedure is to the seal theblood vessel puncture 17, the amount of energy supplied by theultrasound focusing device 20 to the desiredfocal point 23 is rapidly and significantly increased such that the temperature of the tissue at thefocal point 23 rises very rapidly. For example, energy in the frequency range of 10 kHz to 300 GHz may be applied to the tissue for between 1 and 10 seconds such that the temperature of the tissue at thefocal point 23 rises to over 60 degrees Celsius. For medical reasons, the frequency may be above 25 kHz. The rapid rise in temperature causes the tissue at thefocal point 23, for example theadventitia 16 and thevascular sheath 12, to denature so that thepuncture 17 is closed, and then fuse so that thepuncture 17 is sealed. In effect, the tissue is cauterized so as to effect sealing, as shown inFIGS. 1C and 1D . In addition, the heat generated at thefocal point 23 may cause thrombosis and/or coagulate the blood around thefocal point 23 and/or in thevascular puncture 17, which may further facilitating the vascular sealing. However, such thrombosis and/or coagulation is not necessary, and sometimes even undesired as it may lead to additional complications, especially if such thrombosis and coagulation spreads to outside of thevascular puncture 17 and into theblood vessel 10. When thepuncture 17 has been sufficiently closed and sealed, the application of energy to the tissue at thefocal point 23 is terminated and theultrasound focusing device 20 is either moved to another body portion, or removed from the body completely. -
FIGS. 2A and 2B disclose exemplary methods of ablating a portion of thegall bladder 50 during inside-out surgery through the use ofultrasound 22, for example, by using theultrasound focusing device 20 disclosed in Weng. Inside-out surgery is the performance of surgery from the inside of the body portion (e.g. without making any cuts or incisions in that body portion). To ablate a portion of thegall bladder 50, for example alesion 51 in thegall bladder 50, anultrasound focusing device 20 is positioned proximate thegall bladder 50. For example, anendoscope 26 with a workingchannel 27 is advanced through the gastrointestinal system until it is proximate thegall bladder 50. Theendoscope 26 is advanced through the gastrointestinal tract due to the tract's close proximity to thegall bladder 50, however, advancing an endoscope or other access device through any body lumen that provides access to thegall bladder 50 is also contemplated. Then, theultrasound focusing device 20 is advanced through the workingchannel 27 of theendoscope 26 until it is distal the end ofendoscope 26 and proximate thegall bladder 50, as shown inFIG. 2A . In another example, however, theultrasound focusing device 20 may be positioned external to the body such that it is proximate thegall bladder 50, as shown inFIG. 2B . Theultrasound focusing device 20 is then positioned, configured, and calibrated such that thefocal point 23 of theultrasound 22 will be centered on the portion of thegall bladder 50 with thelesion 51, for example, using methods disclosed in Weng for theultrasound array 21. The geometry and or positioning of theultrasound focusing device 20 can be adjusted so that thefocal point 23 will be at a proper distance from theultrasound focusing device 20, as in this case thelesion 51 is either inside thegall bladder 50 or on the gall bladder's surface. The geometry and positioning of theultrasound focusing device 20 can also be adjusted such that it will only act on a specified volume of tissue at and/or surrounding the focal point 23 (i.e. it will only act on thelesion 51 or other undesirable portion of thegall bladder 50, or a portion of the undesirable tissue orlesion 51, and not significantly affect other healthy tissue portions). Both thefocal point 23 and the volume of tissue can be adjusted at any time during the procedure, for example, prior to, during, and/or subsequent to the application of energy. - Once properly positioned, the
ultrasound focusing device 20 is activated such that energy is applied viaultrasound 22 to thelesion 51 or at least a portion of thelesion 51. In this case, because the object of the procedure is to ablate thelesion 51, the amount of energy supplied by theultrasound focusing device 20 to thelesion 51 at the desiredfocal point 23 is rapidly and significantly increased such that the temperature of thelesion tissue 51 rises very rapidly. For example, energy in the frequency range of 10 kHz to 300 GHz may be applied to the tissue for between 1 and 10 seconds such that the temperature of the tissue at thefocal point 23 rise to over 60 degrees Celsius. For medical reasons, the frequency may be above 25 kHz. The rapid rise in temperature causes almost immediate tissue ablation and/or tissue necrosis of at least a portion of thelesion 51, and effectively destroys the tissue. If theentire lesion 51 has not been destroyed at this point, the position and/or volume of thefocal point 23 of theultrasound focusing device 20 can be shifted around, for example by adjusting theultrasound array 21, so as to destroy other portions of the lesion for which destruction is desired. Such shifting of the position and/or volume of thefocal point 23 may occur while the energy is still being applied, or during periods where energy is not applied. In some cases, however, destruction of theentire lesion 51 may not be desired, as destroying all of thelesion 51 may also cause the destruction of healthy tissue. During this procedure, the surrounding healthy tissue should be relatively unaffected as only the energy from theultrasound 22 converging at thefocal point 23 should have enough magnitude to affect the tissue in any significant way. After the desired tissue has been destroyed, theultrasound focusing device 20 andendoscope 26 can be removed. During the healing process, the healthygall bladder tissue 50 should absorb the destroyed tissue and/or remnants of thelesion 51. -
FIGS. 3A and 3B depict exemplary methods of treating gastrointestinal reflux disease (GERD) through the use ofultrasound 22, for example, by using theultrasound focusing device 20 disclosed in Weng. For example, anendoscope 26 may be advanced through theesophagus 33 until its distal end is proximate theLES 34. Theultrasound focusing device 20 is then advanced through the workingchannel 27 of theendoscope 26 until it also is proximate theLES 34, as shown inFIG. 3A . In another example, however, theultrasound focusing device 20 may be positioned external to the body such that it is proximate theLES 34, as shown inFIG. 3B . Theultrasound focusing device 20 is then adjusted, for example as described above in other ultrasound applications, such that thefocal point 23 of thedevice 20 is targeted at the desired tissue portion, for example by adjusting theultrasound array 21 using methods disclosed above. In this case,ultrasound focusing device 20 can be used to induce hyperplasia in theesophageal wall 36, and particularly to theLES 34, to help close off the esophageal opening into the stomach and/or to accommodate the proper placement of thediaphragm 31 relative to theLES 34. Furthermore, the ultrasound focusing device can also be used to heat the collagen in theesophagus 33, specifically theesophageal wall 36, which will cause the lumen of theesophagus 33 to shrink. This will also help close off the esophageal opening into the stomach and/or accommodate the proper placement of thediaphragm 31 relative to theLES 34. - For hyperplasia, once the
ultrasound focusing device 20, for example theultrasound array 21, has been positioned and/or adjusted, ultrasound energy is applied to the tissue portion in sufficient amounts to cause injury to the desired tissue portion. The surrounding tissue should be relatively unaffected as only the energy from theultrasound 22 converging at thefocal point 23 should have enough magnitude to affect the desired tissue in any significant way. After sufficiently injuring desired tissue portions such that a healing response will result in hyperplasia or other tissue growth, theultrasound focusing device 20 is either moved to another body portion, or completely removed from the body. The injured tissue and the surrounding tissue ofesophageal wall 36 andLES 34 then invokes its natural healing response and repairs the damaged tissue. In injuring the tissue, hyperplasia often results where new tissue is formed in and/or around the injured tissue, thus adding bulk and mass to the tissue portion. In addition, by controlling the amount ofultrasound 22 applied to the targeted tissue area, the amount of tissue injury, and hence the amount of tissue that will be added by the hyperplasia process, can be controlled. The amount and/or duration of energy applied may also take into account other factors, such as the characteristics of the tissue being affected, distance of the desiredfocal point 23 from theultrasound focusing device 20, distance of the desiredfocal point 23 from the surface of the tissue, and/or acceptable risk that overexposing the tissue will not result in the amount of hyperplasia desired. - For heating the collagen in the
esophageal wall 36, once theultrasound focusing device 20, for example theultrasound array 21, has been positioned and/or adjusted, ultrasound energy is applied to the desired collagen portions in sufficient amounts to heat the collagen to the temperature at which it breaks down and/or denatures. This denaturing and/or breaking down will cause the collagen to shrink, and hence cause the lumen of theesophagus 33 to shrink as well. The surrounding tissue should be relatively unaffected as only the energy from theultrasound 22 converging at thefocal point 23 should have enough magnitude to affect the desired tissue in any significant way. After sufficiently heating the collagen portions such that they denature and/or break down, theultrasound focusing device 20 is either moved to another body portion, or completely removed from the body. The heated collagen portions shrink, also causing shrinkage to the lumen of theesophagus 33. In addition, by controlling the amount ofultrasound 22 applied to the targeted collagen portions, the amount of heat applied to the collagen, and hence the amount of shrinkage that the lumen of theesophagus 33 will undergo, can be controlled. The amount and/or duration of energy applied may also take into account other factors, such as the characteristics of the collagen being affected, distance of the desiredfocal point 23 from theultrasound focusing device 20, distance of the desiredfocal point 23 from the surface of the collagen, and/or acceptable risk that overexposing the collagen will destroy it. -
FIGS. 4A-4B disclose exemplary methods of treating fecal incontinence through the use ofultrasound 22, for example, by using theultrasound focusing device 20 disclosed in Weng. For example, an ultrasound focusing device can be used to rebuild the anal sphincter, specifically by inducing hyperplasia. To do this, theultrasound focusing device 20 is positioned such that its distal end is proximate either the internalanal sphincter 41, as shown inFIG. 4A , or externalanal sphincter 42 as shown inFIG. 4B . As the externalanal sphincter 42 is close to the surface of the skin, and the internalanal sphincter 41 is also relatively close to the surface of the skin, the ultrasound focusing device can be positioned outside the body, as shown inFIG. 4B . However, theultrasound focusing device 20 may also be positioned just inside the body in thelower colon 40 for treating either the internalanal sphincter 41 or externalanal sphincter 42, as shown inFIG. 4A . In the latter case, anendoscope 26 first may be positioned with itsdistal end 40 proximate thesphincter channel 27 of theendoscope 26 until it is proximate theanal sphincter ultrasound focusing device 20 is then adjusted, for example as in the procedures disclosed in this application for adjusting theultrasound array 21, such that thefocal point 23 of thedevice 20 is targeted at the desired tissue portion. In this case, the desired tissue portion is a part of theanal sphincter anal sphincter focal area 23 of theultrasound focusing device 20 will also be adjusted so that theultrasound 22 will be directed to the proper volume of tissue at and/or surrounding thefocal point 23. - Once the
ultrasound focusing device 20 has been adjusted, energy is applied viaultrasound 22 to the tissue portion in sufficient amounts to only cause injury to the desired tissue portion, for example using one of the methods disclosed above. The surrounding tissue should be relatively unaffected as only the energy from theultrasound 22 converging at thefocal point 23 should have enough magnitude to affect the desired tissue in any significant way. After sufficiently injuring desired tissue portions such that a healing response will result in hyperplasia or other tissue growth, the ultrasound focusing device is moved. The injured tissue and the surrounding tissue, here the internalanal sphincter 41 or externalanal sphincter 42, then invokes its natural healing response and repairs the damaged tissue. In doing so, hyperplasia often results where new tissue is formed in and/or around the injured tissue, thus adding bulk and mass to the tissue portion. In addition, by controlling the amount ofultrasound 22 applied to the targeted tissue area, the amount of tissue injury, and hence the amount of bulk and mass that will be added to the tissue by the hyperplasia process, can be controlled. The amount and/or duration of energy applied may also take into account other factors, such as the characteristics of the tissue being affected, distance of the desiredfocal point 23 from theultrasound focusing device 20, distance of the desiredfocal point 23 from the surface of the tissue, and/or acceptable risk that overexposing the tissue will not result in the amount of hyperplasia desired. -
FIGS. 5A and 5B depict exemplary methods of activating amechanical implant 60. Once amechanical device 60 has been implanted in the body, it may require activation. Accordingly, anultrasound focusing device 20 may be positioned proximate themechanical implant 60 using any of the methods disclosed above. For example, theultrasound focusing device 20 may be advanced through the workingchannel 27 of anendoscope 26 disposed in the gastrointestinal tract, as shown inFIG. 5A , or it may be positioned external to the body proximate themechanical implant 60, as shown inFIG. 5B . Once properly positioned, theultrasound focusing device 20 is then adjusted, for example as in the procedures disclosed in this application for adjusting theultrasound array 21, such that thefocal point 23 of thedevice 20 is targeted at themechanical implant 60 or the desired portion of themechanical implant 60. In this case, the desired implant portion is a part of theimplant 60 which requires activation. Thefocal area 23 of theultrasound focusing device 20 will also be adjusted so that theultrasound 22 will be directed to the proper volume of theimplant 60 and/or tissue at and/or surrounding thefocal point 23. - Once the
ultrasound focusing device 20 has been adjusted, energy is applied viaultrasound 22 to theimplant 60 in sufficient amounts to activate theimplant 60, for example using one of the methods disclosed above. The surrounding tissue should be relatively unaffected as only the energy from theultrasound 22 converging at thefocal point 23 should have enough magnitude to affect theimplant 60 and/or the tissue in any significant way. After sufficiently activating theimplant 60, the ultrasound focusing device is moved. Theimplant 60 then performs its allotted function. In addition, by controlling the amount ofultrasound 22 applied to theimplant 60, the amount of activation, and hence the amount of treatment by the implant, can be controlled. The amount and/or duration of energy applied may also take into account other factors, such as the characteristics of theimplant 60 and/or tissue being affected, distance of the desiredfocal point 23 from theultrasound focusing device 20, distance of the desiredfocal point 23 from the surface of the tissue, and/or acceptable risk that overexposing theimplant 60 will not result in the desired activation and/or treatment. The activation may only occur while energy is being applied to implant 60 via ultrasound, or may continue even after application of energy has stopped. In other embodiments, a mechanical device such as a surgical instrument placed in the body to perform a treatment, as opposed to an implant in the body, may be activated through ultrasound. - In various embodiments, the delivery of ultrasonic energy to treat various internal organs or tissue is exemplary. Other types of energy and/or energy delivery devices may be used, including radio frequency, microwaves, lasers, electromagnetics, cryogenic fluids, heat, mechanical devices, or other energy delivery systems known in the art.
- In various embodiments, the application of energy, for example via
ultrasound 22, can be to either the surface or internal portions of any vessel, organ, and/or other body portion. Using any of the methods disclosed above, the application of energy viaultrasound 22 may be used to treat tumors, lesions, cancerous tissue, non-cancerous tissue, benign tissue growths, and other desirable or undesirable tissue. - In various embodiments, steps in above described methods can be interchanged and substituted into any of the other above described methods. For example, in treating GERD, it may be desirable to cause tissue necrosis in a portion of the
esophagus 33,LES 34,fundus wall 35, oresophageal wall 36. Accordingly, some of the steps in the method of ablating tissue in the gall bladder may be used to cause tissue necrosis in any of the aforementioned portions. In another example, in treating fecal incontinence, it may be desirable to cause tissue necrosis in a portion of theanal sphincter gall bladder 50 may be used to cause tissue necrosis in a portion of theanal sphincter gall bladder 50. Accordingly, some of the steps in the method of increasing tissue mass in either theLES 34 oranal sphincter gall bladder 50. In addition, any of the steps in any of the above-described methods may be repeated as necessary, for example, to treat multiple sections of theesophagus 33, ablatemultiple lesions 51, or closemultiple punctures 17. Also, certain steps in any of the above-described methods may be deleted as desired or necessary. For example, devices other than an endoscope may be used to deliver theultrasound focusing device 20. - In various embodiments, the use and/or treatment of specific organs and/or body parts in describing each of the above methods is exemplary. Other organs and/or body parts may be treated or used for access to treated tissue or organs, as desired. For example, the method for ablating tissue is not be limited to the
gall bladder 50, as other internal organs (e.g., the liver, lung, kidney, pancreas, prostate, bladder, uterus, or brain) from which tissue removal is required may also have tissue removed by ablation substantially as described above. In another example, the method for bulking up tissue is not be limited to portions of the gastrointestinal tract, as other organs, vessels, or tissue in the body that requires an increase in bulk or mass may also be treated using the methods described above. In yet another example, the method for sealing is not limited toblood vessels 10, as other tissue, organs, or walls which has apuncture 17, whether artificial or natural, that requires sealing may be sealed using the method as described above. - In various embodiments, the use of ultrasound to produce a therapeutic response in the body and the use of ultrasound for imaging purposes may be combined. For example, an ultrasound device may be used to both view the desired body portion and also to direct the ultrasound focusing device in the desired body portion. Any other method of viewing the desired body portion and/or directing the ultrasound focusing device is also contemplated.
- Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
Claims (22)
1-27. (canceled)
28. A method of ablating tissue in a gall bladder comprising:
applying energy to the gall bladder to produce a therapeutic response.
29. The method of claim 28 , wherein the applied energy is ultrasound.
30. The method of claim 28 , further comprising adjusting the amount of energy applied to the gall bladder.
31. The method of claim 28 , further comprising:
inserting an endoscope with a working channel into the body; and
advancing an ultrasound device through the working channel proximate the gall bladder, the ultrasound device for applying the energy.
32. The method of claim 28 , wherein the therapeutic response is ablating tissue in the gall bladder.
33. The method of claim 28 , wherein the therapeutic response is causing tissue necrosis in the gall bladder.
34. The method of claim 28 , wherein the energy is applied to a portion of the gall bladder below a surface of the gall bladder.
35. The method of claim 28 , wherein the energy is applied to the gall bladder via an ultrasound device, and further comprising focusing the energy from the ultrasound device on a portion of the gall bladder.
36. The method of claim 35 , wherein the energy is focused below a surface of the gall bladder.
37. The method of claim 35 , wherein the ultrasound device is positioned outside of a body.
38. A method of activating a device, the method comprising:
applying ultrasound energy to the device to activate the device.
39. The method of claim 38 , wherein the device is an implant.
40. The method of claim 39 , further comprising:
adjusting the amount of energy applied to the implant.
41. The method of claim 39 , wherein the implant is implanted within a patient.
42. The method of claim 41 , further comprising:
inserting an endoscope with a working channel into the patient; and
advancing an ultrasound device through the working channel to a location proximate the implant, the ultrasound device for applying the energy.
43. The method of claim 41 , wherein the energy is applied to the implant via an ultrasound device, and further comprising focusing the energy from the ultrasound device on a portion of the implant.
44. The method of claim 43 , wherein the ultrasound device is positioned outside of the patient.
45. The method of claim 38 , wherein the device is a tool inserted into a patient for performing a treatment.
46. A method of providing a treatment to a patient, the method comprising:
providing an ultrasound actuable implant;
implanting the implant within the patient;
providing an ultrasound device;
positioning the ultrasound device at a location proximate the implant; and
applying ultrasound energy from the ultrasound device to the implant to activate the implant for providing the treatment.
47. The method of claim 46 , further comprising:
focusing the energy from the ultrasound device on a portion of the implant; and
adjusting the amount of energy applied to the implant.
48. The method of claim 47 , wherein the entire ultrasound device is positioned outside of the patient.
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Also Published As
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US20140323925A1 (en) | 2014-10-30 |
US7294125B2 (en) | 2007-11-13 |
US20050055053A1 (en) | 2005-03-10 |
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