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WO2011005898A2 - Appareil de traitement d'etats pathologiques de structures anatomiques creuses - Google Patents

Appareil de traitement d'etats pathologiques de structures anatomiques creuses Download PDF

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Publication number
WO2011005898A2
WO2011005898A2 PCT/US2010/041262 US2010041262W WO2011005898A2 WO 2011005898 A2 WO2011005898 A2 WO 2011005898A2 US 2010041262 W US2010041262 W US 2010041262W WO 2011005898 A2 WO2011005898 A2 WO 2011005898A2
Authority
WO
WIPO (PCT)
Prior art keywords
energy
stomach
expandable member
hollow anatomical
anatomical structure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/041262
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English (en)
Other versions
WO2011005898A3 (fr
Inventor
Thomas C. Wehman
Peter H. Muller
Stuart D. Edwards
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SILHOUETTE MEDICAL Inc
Original Assignee
SILHOUETTE MEDICAL Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SILHOUETTE MEDICAL Inc filed Critical SILHOUETTE MEDICAL Inc
Priority to PCT/US2010/041262 priority Critical patent/WO2011005898A2/fr
Publication of WO2011005898A2 publication Critical patent/WO2011005898A2/fr
Publication of WO2011005898A3 publication Critical patent/WO2011005898A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A61B2018/046—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid in liquid form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1053—Stomach
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Definitions

  • the present invention is generally related to devices and methods for treating medical conditions of hollow anatomical structures, and more particularly, and by way of example, to devices and methods for treating the hollow anatomical structures of the digestive system to treat body -weight related conditions.
  • the human body has several anatomical structures that are considered hollow, such as but not limited to: hollow anatomical structures of the GI tract (e.g., esophagus, stomach, small and large intestines), bladder, ear canal, nasal sinuses, female reproductive system (e.g., vagina, vaginal canal, uterus, fallopian tubes), and the lungs; as well as various veins and arteries.
  • hollow anatomical structures of the GI tract e.g., esophagus, stomach, small and large intestines
  • bladder ear canal
  • nasal sinuses e.g., vagina, vaginal canal, uterus, fallopian tubes
  • the lungs e.g., as well as various veins and arteries.
  • Each of these and other hollow anatomical structures can be subject to medical conditions such as cancer or conditions resulting from loosening of the muscles underlying the HAS, tissue proliferation, and the like. Treatment for these medical conditions range from pharmaceutical therapies to highly invasive surgeries.
  • obesity is one major medical condition that affects several hollow structures of the GI tract.
  • Obesity is directly associated with other medical disorders, such as: osteoarthritis (especially in the hips), sciatica, varicose veins, thromboembolism, ventral and hiatal hernias, hypertension, insulin resistance, and hyperinsulinemia; premature death; type 2 diabetes, heart disease, stroke, hypertension, gall bladder disease, GI tract cancers, incontinence, psychological disorders, sleep apnea, gastro esophageal reflux disease (GERD), and liver disease. Reducing obesity reduces the effects of these conditions provided the weight loss is significant and enduring. This, of course, is the challenge to the patient and practitioner.
  • Amphetamine analog treatments involve habitual use of addictive drugs to produce and maintain significant weight loss.
  • Dexfenfluramine and fenfluramine treatments often result in primary pulmonary hypertension and cardiac valve abnormalities.
  • Drugs such as sibutramine substantially increase blood pressure in many patients.
  • Surgical obesity treatments include invasive surgical procedures such as: gastric banding, bariatric surgery, and liposuction. While current surgical procedures can be effective, the overall rates of surgical mortality and associated hepatic dysfunction are so high that surgical treatments are only indicated for younger patients who are morbidly obese.
  • USP 7,326,207 proposes treating obesity by mapping (for example, using a visualization apparatus, such as but not limited to endoscopes or fluoroscopes) and ablating nerves in targeted stomach areas by creating patterns of thermal lesions.
  • the nerves are ablated using electrodes that penetrate the nerves during energy application. Mapping is required to properly position the electrodes where they can penetrate the nerves.
  • Physiological changes caused by tissue ablation create a sense of satiety in the patient by directly modulating nerves responsible for hunger sensation or by modulating the nerves inhibiting the let-down reflex of the stomach muscles that are digestion precursors.
  • the present invention relates to devices and methods for treatment of hollow anatomical structures ("HAS").
  • HAS hollow anatomical structures
  • the present invention relates to devices and methods for treatment of the digestive system, such as the stomach, for weight-related conditions.
  • the apparatus and methods of the present invention are described in the context of treating the stomach, it should be appreciated that the present devices and methods are applicable and useful in treatment of other hollow anatomical structures and may be adapted to suit the particular hollow anatomical structure under treatment.
  • Exemplary hollow anatomical structures include, but are not limited to, the lungs, urinary tract, nasal passages, the reproductive tract, as well as body lumens and blood vessels such as, but not limited to, the perforator veins which connect the superficial veins to the deep veins in the leg, truncal superficial veins of the leg (e.g., great saphenous vein, short saphenous vein, and the like), superficial tributary veins of the leg, internal spermatic veins (varicoceles), ovarian veins, gonadal veins, hemorrhoidal vessels, fallopian tubes, a-v malformations, a-v fistula side branches, esophageal varices, and the like.
  • the perforator veins which connect the superficial veins to the deep veins in the leg
  • truncal superficial veins of the leg e.g., great saphenous vein, short saphenous vein, and the like
  • superficial tributary veins of the leg e.g.,
  • Methods of treatment embodying features of the present invention include applying energy to, among other things, any one or more of muscles, nerves, mucosa (or tissue), or glands associated with and/or underlying the hollow anatomical structure (including vessels) to alter any one or more of the muscular profile of the structure, its biomechanical operation, or physiological properties (e.g., shrinkage, coagulation, ablation, constriction).
  • the treatments embodying features of the present invention enable the modification of any one or more of the nerve signal transmission, muscle profile, or the gland's enzyme release.
  • the term "ablative energy” denotes energy to bring about any of such physiological or other changes mentioned above.
  • the point of entry for the introduction of the present devices to access the structures may differ to suit the particular application.
  • the present apparatus and methods may be adapted for use in various endoluminal, percutaneous, surgical, or laparoscopic procedures.
  • the desired treatment sites of the hollow anatomical structure are those of the stomach's and include any one or more areas corresponding to or in the vicinities of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach, as well as the small intestine.
  • the nerves, muscles, and/or glands are exposed to a source of ablative energy by expanding the structure beyond its normal volume until the structures mucosa (or tissue) is separated and the underlying nerves, muscles, and/or glands are exposable to the energy.
  • the nerves, muscles, mucosa, and/or glands are exposed by way of expanding an expandable member (“expander member”) sized and configured to expand within the structure, and conforming the structure's inner volume to that of the expanded member.
  • the expandable expander member is formed from non-compliant or semi-compliant material such that it cannot at least substantially expand beyond a pre-defined size.
  • the expandable member upon expansion, expands the structure to a size greater than its normal (e.g., as it is at least prior to the treatment) size, thus conforming the hollow structure's volume to that of the expandable member in the expanded configuration.
  • the methods of treatment provide for guided delivery of energy to the desired treatment areas of the hollow anatomical structure.
  • An apparatus for treating medical conditions of hollow anatomical structures embodying features of the present invention may include a treating assembly having an expander assembly including an expandable member configured for expansion in the structure to expose at least a portion of either or both the hollow structure's underlying nerves or muscle.
  • the expandable member such as an expandable balloon, is disposed at a distal end of an elongate body such as a catheter.
  • the expandable Balloon includes treatment areas corresponding to any one or more of desired treatment sites of the HAS.
  • the desired treatment sites are those of the stomach's and include any one or more areas corresponding to or in the vicinities of any one or more of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach, or the small intestine.
  • the balloon treatment areas include conductive regions adapted to deliver ablative energy to the surface of the hollow anatomical structure.
  • the regions comprise a surface such as a film lining the inside and/or the outside of the expandable member at its treatment areas.
  • the conductive regions may form a continuous band or multiple bands with interruptions.
  • the shape of the regions may be uniform throughout or different regions may have different shapes.
  • the conductive regions form conductive surfaces (e.g., electrodes) for direct surface (e.g., physically non-penetrating) contact with and transferring energy to the inner surface of the hollow anatomical structure.
  • Inflation of the expandable balloon expands the stomach to stretch the pleated mucosa of the stomach and expose underlying nerves and stomach muscle and brings the conductive regions into surface (e.g., substantially non- penetrating) contact with the treatment site.
  • Leads connect the different conductive regions to an energy source connectable to an energy generator by way of a conduit.
  • the source of energy may be energy in the form of electromagnetic energy (e.g., RF, microwave) and ultrasonic energy, infrared energy, visible laser energy, heat energy, or the like.
  • the conductive regions may be formed of any suitable material such as conductive film forming metals and/or polymers.
  • the conductive regions additionally, may comprise multiple layers including one or more additional conductive layers disposed on or below the film forming layer.
  • the various layers may comprise one or more of the same or different material.
  • the additional layers may comprise individual electrodes, sheets of metal, or other conductive material.
  • the additional conductive material may be secured, painted, sprayed, sputtered, or deposited on or beneath the surface of the conductive film forming material.
  • the additional conductive material may be formed of gold, copper, stainless steel, silver, or other suitable conductive material.
  • the film forming conductive material may comprise polymeric material with adhesive material or may be positioned on the surface of the expandable member (inner or outer surface) or the additional conductive material by other securing means such as separate adhesive material.
  • the film forming conductive material comprises isotropic conductive adhesives (ICAs), anisotropy systems (or Z-axis adhesives), either film or paste (ACA(F)).
  • ICAs isotropic conductive adhesives
  • anisotropy systems or Z-axis adhesives
  • ACA(F) film or paste
  • the preferred systems are the silver epoxy adhesives. Typical curing times are on the order of 3-10 minutes at 120-150 0 C.
  • Acrylic and polyamide type adhesives and silicones are also useful but have either lower electrical performance or more difficult processing (polyamide).
  • Another form may be that of nanoparticles instead of silver flakes in the micrometer range.
  • Anisotropy (or Z-axis) adhesives offer several attractive advantages, e.g. very high resolution potential (pitch down to 50 1 Am due to the possibility of non-specific application), and fast curing.
  • very high resolution potential pitch down to 50 1 Am due to the possibility of non-specific application
  • anisotropy adhesives preferably, pressure contact during curing is used due to their restricted current density.
  • anisotropy adhesives range from Au coated plastic spheres, to Ni particles with oxide breaking power, solder (SnBi) filles systems.
  • thermo-hardening resins as well as thermo-hardening resins may be utilized.
  • Other anisotropy materials include Ag-filled UV-acrylate and UV-initiated epoxy systems for very fast curing at relatively low temperatures.
  • Other suitable film forming conductive adhesives include carbon based (e.g., graphite) adhesives.
  • carbon based (e.g., graphite) adhesives include carbon based (e.g., graphite) adhesives.
  • suitable silver and graphite based conductive adhesives include those available from Electron Microscopy Sciences of Hatfield, Pennsylvania.
  • the energy source is provided by an energy generator controllable by a control assembly.
  • the amount and level of energy at its source is set to provide a sufficient level of energy at the point of treatment.
  • the desired energy levels differ for different hollow anatomical structures.
  • the temperature at the point of treatment is sufficiently high to effectuate the desired treatment.
  • the temperature at the point of treatment, for the stomach may range from about 50 to about lOO C, from about 60 ° to about 95 ° C, from about 60 ° to about 80 ° C.
  • the apparatus can also include one or more sensors.
  • the one or more sensors may be located within or about the expandable member, at or near the conductive regions. These sensors can be used to detect a variety of operating parameters including the amount of energy delivered, and the temperature of a region adjacent the apparatus. These sensors can also be used to provide feedback for controlling the operation of an energy source which delivers energy to the energy transmitting regions.
  • chemical or biochemical sensors can be used to detect ablation.
  • the at least one temperature sensor is a thermocouple or thermistor.
  • the temperature sensor is coupled to a communication link (such as a conductor), which is coupled to a processor.
  • the communication link may comprise a D/ A converter coupled to a register disposed for reading by the processor.
  • the processor reads a sensor value from the sensor and, responsive thereto, controls the signal generator so as to achieve delivery of an effective amount of energy to a desired section of tissue to be ablated.
  • the processor uses the information from the signal generator, the energy transmitting regions, and temperature sensor, as a feedback loop for controlled delivery of energy to a section of a stomach (or other treatment areas of a hollow anatomical structure).
  • the processor may control the level of energy to achieve a selected temperature, or to achieve a selected amount of ablation of a section of a stomach.
  • the sensor is coupled to the expandable member.
  • the temperature or some other property of the tissue being ablated, or of the energy delivery device can be monitored using a variety of sensors.
  • open and a closed loop feedback systems may be utilized for coupling a sensor used in the apparatus to an energy source so that the output energy of the energy source is adjusted in relation to the property sensed by the sensor.
  • One or more sensors may be located within or about the expandable member, or at or about the conductive regions. It should be appreciated that the sensor may take any appropriate form, as for example formed of wireless construction, and may further be configured to sense and convey the necessary information in any number of ways and formats and is not limited to direct thermal sensors.
  • the temperature may be sensed by optical means which can assess a change in the color of at least a portion of expandable member (e.g., conductive regions).
  • colorants may be present in the material forming the expandable member/regions or be painted or deposited on its material (on the inner or outer surface). Once the colored area is exposed to the elevated temperature, the colorant may change its characteristics.
  • Information as to the temperature may then be conveyed to the practitioner. The information may be conveyed automatically by instrumentation or by direct visualization through the endoscopic device. As stated, such sensors may also be present on or in the expandable member.
  • the treatment assembly may further include a visualization device, such as an endoscope (or bronchoscope in the case of the hollow structure being the lung), disposable within the elongate body (e.g., catheter), or deliverable though any other suitable means.
  • a visualization device such as an endoscope (or bronchoscope in the case of the hollow structure being the lung), disposable within the elongate body (e.g., catheter), or deliverable though any other suitable means.
  • the endoscope may include an illumination source such as lights for visualization of the structure.
  • the endoscope is disposed within the expander assembly prior to advancement into the structure.
  • the expander assembly and the endoscope are accessible through a hand-piece disposed at the proximal end of the treatment assembly.
  • the expandable expander member may be formed from any suitable material such as, but not limited to, expandable, noncompliant (or semi-compliant) material including Mylar, Nylon, PET, PeBax, IEBA.
  • the material for balloons is formed from non-compliant material.
  • Mylar while expandable, is noncompliant and restricts expansion of the expandable balloon within the stomach. Therefore, an expandable balloon formed from Mylar cannot infinitely expand and patient injury resulting from unintended over-inflation of an expandable balloon can be reduced.
  • expandable balloon when used for obesity treatment, expandable balloon is constructed such that when inflated within the stomach, the stomach expands from its empty volume (about 1 liter) to at least about twice the stomach's empty volume (e.g. 2 liters).
  • the expandable member may have different profiles or volumes.
  • the expandable member is pre-shaped such that as the expandable member is expanded within the hollow anatomical structure, the interior of the hollow anatomical structure conforms to the profile of the expandable member.
  • Optional visual markings corresponding to desired target sites of the HAS, may be located on the expandable member.
  • the visual markings are used to aid in locating the desired treatment target sites.
  • Such visual markings may be incorporated into or deposited on or within the material forming the expandable expander member.
  • the visual markings may take the form of colorant, metallic or polymeric material.
  • the practitioner may identify the necessary areas for transfer of energy using practitioner's experience.
  • the visual markings may be positioned to correspond to any one or more areas corresponding to or in the vicinities of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone,
  • gastric/fundic zone gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach, or the small intestine.
  • a treatment assembly may include a reference point positioner disposed at a distal end of the expander assembly.
  • reference point positioner comprises a positioning balloon adapted for inflation in the patient's body using means such as a conventional air or liquid tube that may also acts as a catheter guide.
  • positioning balloon is inflated after passing through the pyloric sphincter and seats against the distal side of the pyloric sphincter. Once seated, inflated positioning balloon sets a reference point for tube and allows proper positioning of the balloon assembly without necessarily using a visualization apparatus.
  • the expanding balloon and its treatment sites may extend into the small intestine to provide treatment to at least a portion of the small intestine.
  • the treatment assembly further includes an external treatment controller (portions of which were described above) for controlling various parameters useful in the treatment procedure.
  • the external treatment controller includes any one or more of the following subassemblies: treatment energy source for providing and controlling energy source, input/output (I/O) device, inflation fluid delivery unit for inflating/deflating the expandable member, and/or a positioning balloon when present.
  • an exemplary method for treating the hollow anatomical structures embodying features of the present invention includes using a source of energy to apply energy to at least one surface of the HAS to affect its operation.
  • energy is thermal energy provided from a source of energy in the form of electromagnetic energy (e.g., RF, microwave), ultrasonic energy, infrared, visible laser energy, heat energy, or the like.
  • the hollow anatomical structure is the stomach and the at least one surface of the HAS to which energy is applied is either or both stomach's muscle surface or the surface in the vicinity of at least a portion of a nerve communicating with the stomach and brain.
  • the treatment includes applying energy to at least one surface of the stomach's underlying glands to affect glandular emissions, such as ghrelin, pepsin, rennin, and/or HCl.
  • the treatment includes transferring energy from the energy transmitting conductive regions on, in, or about the expandable member to the hollow anatomical structure's surface (or underlying muscles, nerves, glands, etc), by way of direct or indirect surface contact.
  • a method for treating the hollow anatomical structure includes introducing an expandable member into the hollow anatomical structure; expanding the hollow anatomical structure with the expandable member to bring into surface contact at least a portion of a surface of the expandable member (e.g., conductive regions) with at least a portion of a surface of the hollow anatomical structure to expose any one or more of the underlying nerves, muscles, or glands of the HAS.
  • a source of energy such as RF energy, is controllably provided, through the leads, to the conductive regions extending along at least a portion of the expandable balloon. As energy is provided to the conductive regions, energy is emitted (e.g.,
  • the expanded expandable member comes into direct surface contact with the desired target areas of the hollow anatomical structure.
  • At least one or more of underlying nerve, muscle, or gland of the stomach are treated (e.g., ablated).
  • the at least one or more of underlying muscle is at least in one of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach.
  • a gastric introducer is positioned in the patient's throat and protects the esophageal walls during the procedure.
  • the expander assembly preloaded with the endoscope (when present) is inserted into patient's body through the introducer.
  • the expandable balloon is advanced distally positioning the shaped distal portion against the distal side of the pyloric sphincter.
  • the expandable member is inflated until the stomach's volume reaches the desired volume, such as at least about twice its empty volume (e.g. to about 2 liters).
  • the pre- shaped distal portion, at the expanded configuration seats against the distal side of the pyloric sphincter, providing an anchor and aiding in position and placement of the expander assembly within stomach.
  • the optional endoscope may be pulled back completely or partially into the introducer.
  • the practitioner using a control unit and foot pedal, introduces energy from an energy source, such as an RF generator, by way of leads to the conductive region/s.
  • energy such as thermal energy
  • the conductive regions As energy is transmitted to the conductive regions, energy, such as thermal energy, is emitted from the conductive regions and the expandable member to the desired treatment area/s of the target hollow anatomical structure.
  • at least a portion of the expanded expandable member, including the conductive regions comes into direct surface contact with the desired target areas of the hollow anatomical structure.
  • the desired treatment area/s include any one or more areas corresponding to or in the vicinities of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach.
  • the emitted energy is sufficiently high to cause a change (e.g., physical, biochemical, physiological change) in the treatment target areas as described earlier.
  • a change e.g., physical, biochemical, physiological change
  • the endoscope after patient sedation, the endoscope introduces the reference point positioner (e.g., reference point balloon), into the patient's alimentary canal.
  • the endoscope forwards positioning balloon through the stomach and onto the distal side of the pyloric sphincter.
  • the endoscope is retracted and positioning balloon inflated to seal against the distal side of the pyloric sphincter. This sets a fixed reference point for the tube.
  • a gastric introducer positioned in the patient's throat, protects the esophageal walls during the next steps in the process.
  • the expander assembly is now introduced into the patient's digestive system through the gastric introducer and by the catheter riding over tube.
  • distal tip of the catheter contacts the positioning balloon and the closed pyloric sphincter, the practitioner stops inserting the stomach expander into the patient.
  • Balloon member is then inflated until the stomach's volume becomes about twice its empty volume.
  • the desired target areas are treated as described above.
  • FIGs. IA and IB are simplified illustrations of a mammalian digestive system.
  • FIG. 2 A illustrates an exemplary assembly embodying features of the present invention for treating hollow anatomical structures.
  • FIGs. 3 A and 3B are schematic representations of different expandable members embodying features of the present invention.
  • FIGs. 3AA-3AA are schematic cross sectional views of the exemplary expandable member of FIG. 3 A embodying features of the present invention.
  • FIG. 4A is a schematic representation of a treatment assembly embodying features of the present invention and for treating hollow anatomical structure.
  • FIGs. 4 AA- AC are cross sectional views of portions of the HAS expander assembly, endoscope, and the introducer of FIG. 4 A.
  • FIG. 4B is a schematic representation of another treatment assembly embodying features of the present invention and for treating hollow anatomical structure.
  • FIG. 5 illustrates a schematic of an exemplary external control unit embodying features of the present invention for use with the stomach treatment assembly of FIGS. 4 A and 4B.
  • FIGs. 6 A and 6B are schematic representations of neural communication between the stomach and the brain.
  • FIG. 7 illustrates a schematic profile of a treated stomach about 8-12 weeks, post-op.
  • the hollow organ of the digestive system such as the stomach
  • the use of this exemplary organ is not intended to limit the scope of the present invention.
  • FIGs. IA and IB are simplified depictions of a mammalian digestive system.
  • FIGs. are not intended to be strictly accurate in an anatomic sense or imply that the teachings of this patent application are limited strictly to treating the digestive system.
  • the drawings show the digestive system in somewhat diagrammatic form for purposes of discussion.
  • FIG. IA illustrates esophagus 10, a muscular tube, for carrying food from the mouth to the stomach 12, by way of wavelike contractions of the muscles in the walls of the esophagus 10.
  • the interior esophagus walls include glands that secrete mucus, which further aid the movement of food by acting as lubricants.
  • Stomach 12 located in the upper left hand side of the abdomen, lies between the esophagus 10 and the small intestine 14. In humans and most other animals, stomach 12 is a simple baglike organ.
  • FIG. IB depicts branches 15 of the vagal nerve that connect stomach 12 with the hindbrain H which is believed to be the neurological source for the hunger sensation.
  • the upper end of stomach 12 connects with the esophagus 10 at cardiac notch 16 (FIG. IA).
  • the muscular ring called the lower esophageal sphincter 18 surrounds the opening between the esophagus 10 and the stomach 12.
  • the funnel-shaped region of the stomach 12 immediately next to sphincter 18 is the cardia.
  • the cardia also known as Z-line or esophagogastric junction or gastroesophageal junction
  • the cardia is the anatomical term for the junction orifice of the stomach and the esophagus.
  • the mucosa of the esophagus transitions into gastric mucosa.
  • the cardia is also the site of the lower esophageal sphincter 18 (LES which is also termed cardiac sphincter).
  • LES lower esophageal sphincter 18
  • the greater curvature of the stomach, 26, starts from the cardiac orifice at the cardiac notch, and forms an arch backward, upward, and to the left; the highest point of the convexity is on a level with the sixth left costal cartilage.
  • the lesser curvature 27 of the stomach is opposite the greater curvature and extends between the cardiac and pyloric orifices, forming the right or posterior border of the stomach.
  • the volume of an average adult stomach, an organ for storing and digesting food, is a little over one quart (-0.95 liter).
  • Pyloric sphincter 22 keeps non-liquid food in stomach 12 until the food is processed into a more flowable liquid form, thereafter allowing for the flow of the liquefied food from stomach 12 into the intestine 14.
  • the time food spends in stomach 12 varies and usually ranges from about three to about five hours.
  • a treatment according to the body -weight related conditions is achieved by applying energy to or in the vicinities of any one or more of:
  • stomach tissue to ablate tissue in one or more areas where food is either processed and/or absorbed by the body for example, the cardiac, gastric/fundic, and pyloric zones.
  • treatment may be expanded to other areas, such as the small intestine (and associated nerves), where about 95% of all food absorption occurs.
  • Ablation, or causing cell death produces lesions which when large enough, evoke tissue-healing and intervention of fibroblasts, myofibroblasts, macrophages, and other cells.
  • healing results in tissue contraction (shrinkage), decreased volume, and/or altered biomechanical properties.
  • the current devices and methods embodying features of the present invention further provide for directly affecting the digestive process and may reduce food absorption.
  • ablation of cells in the cardiac, gastric/fundic, and/or pyloric zones enables treatment of weight-related conditions and reduces a patient's body weight, among other things, for the following reasons:
  • CARDIAC AND FUNDIC-GASTRIC ZONES The cardia and fundic-gastric zone contain, respectively, the cardiac glands (not shown) and the fundic glands (not shown).
  • the cardiac and fundic glands release digestive enzymes (e.g., ghrelin, pepsin and rennin) and hydrochloric acid (HCl) which are used during digestion to break down food.
  • digestive enzymes e.g., ghrelin, pepsin and rennin
  • HCl hydrochloric acid
  • PYLORIC ZONE The pyloric sphincter controls the size of food particles and their flow from the stomach (emptying cycle). The wider the opening of the sphincter, the larger the size of the food particles that may flow out of the stomach. Without limiting the scope of the present invention, it is believed that ablating the pyloric muscle tissue decreases the size of the pyloric opening and the size of food particles that may flow out, thereby lengthening the emptying cycle (longer sensation of satiety).
  • the gastric zone also includes the lesser curvature of the stomach which contains nerves that control peristalsis of the stomach walls. Peristalsis contributes to digestion by physically reducing the size of food particles in the stomach. It is also believed, without limiting the scope of the present invention, that ablating portions of the muscles of the lesser curvature reduces peristalsis and increases food particle size. These larger food particles, when passed through the pyloric sphincter, cannot be digested through the small intestine and therefore would pass through the patient's body undigested. Finally, ablating gastric zone tissue may also affect the gastric glands and reduce HCl production in the stomach (see above).
  • FIGs. 2A through 5 show features of an exemplary embodiment of apparatus 80 for treating hollow anatomical structures ("HAS"). ").
  • HAS hollow anatomical structures
  • the digestive tract e.g., stomach 12
  • FIGs. IA and IB the apparatus and methods of the present invention are described in the context of treating the digestive tract (e.g., stomach), it should be appreciated that the present devices and methods are applicable and useful in treatment of other hollow anatomical structures.
  • the shape, size, and specific configuration of the various components may be modified and adapted for use in the particular application and the anatomical structure (e.g., respiratory tract, lung, reproductive tract and/or organ, urinary tract and organs, nasal passage, sinus, veins, artery, tunsile, tympanic membrane, or joints).
  • anatomical structure e.g., respiratory tract, lung, reproductive tract and/or organ, urinary tract and organs, nasal passage, sinus, veins, artery, tunsile, tympanic membrane, or joints.
  • Assembly 80 (FIG. 2) includes a hollow anatomical structure treating assembly 100 (FIGs. 4A and 4B) and an external control assembly 500 (FIG. 5). At least a portion of the HAS treating assembly 100 works inside the patient's body for treatment of the hollow anatomical structures such as hollow organs and blood vessels.
  • External control assembly 500 (FIG. 5) includes components for, among other things, controlling, monitoring, and viewing, at least parts of the HAS treating assembly 100.
  • FIG. 3 A a portion of a HAS treating assembly 100, such as treatment assembly 100, is shown including an expander assembly 300 such as balloon assembly 310 embodying features of the present invention.
  • the balloon assembly 310 including an expandable member such as expandable balloon 320 is disposed, in an expanded configuration, in the stomach 12.
  • the expandable balloon is adapted for expansion within the interior of the HAS conforming an inner wall 123 of the HAS 120 to the shape and volume of the expanded expandable member such that at least portions of the outer surface 325 of the balloon 320 are in surface contact with the inner wall 123 of the HAS.
  • An interior 330 of balloon 320 is in fluid communication with an inflation/deflation source (FIG. 4B) through a conduit, such as lumen of an elongate body, such as catheter 400 (by way of example and not limitation, inflation deflation may be achieved through the same or different lumens).
  • Balloon 320 as shown, is disposed at a distal end 403 of the catheter 400.
  • a distal portion 335 of the balloon 320 is shaped to conform, upon expansion, to a portion of the HAS, preferably, distal to the desired treatment site; such as the pyloric sphincter 22.
  • the shaped distal portion 335 is inflated and seats against the distal end of the pyloric sphincter.
  • Balloon 320 includes treatment areas 340 (shown as dashed pattern) corresponding to any one or more of desired treatment sites of the HAS.
  • the desired treatment sites are those of the stomach's and include any one or more areas corresponding to or in the vicinities of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach.
  • the balloon treatment areas 340 include conductive regions 345, comprising conductive material 346, adapted to deliver ablative energy to the surface of the hollow anatomical structure.
  • the regions 345 comprise a surface such as a film lining the inside and/or the outside of the expandable member at its treatment areas 340.
  • the conductive regions may form a continuous band or multiple interrupted bands.
  • the shape of the region may be uniform throughout or different regions may have different shapes.
  • Inflation of expandable balloon 320 expands the stomach to stretch the pleated mucosa of the stomach and expose underlying nerves and stomach muscle and brings into surface contact (e.g., substantially non-penetrating) the treatment site with the conductive regions.
  • the conductive regions may be formed from any one or more suitable materials such as conductive film forming metals and/or polymers. As shown in FIGs. 3 AA-3 AA", the conductive film forming layer may be disposed on an inside of the balloon, on the outside surface of the balloon, or in between two layers 325' and 325" of balloon material as for example when the balloon is formed of multiple layers. Additionally, the conductive region may comprise additional layers of conductive material. The additional layers may comprise one or more of the same or different material such as individual electrodes, sheets of metal, or other conductive material.
  • the additional conductive material may be secured, painted, sprayed, sputtered, or deposited on or beneath the surface of the conductive film forming material.
  • the additional conductive material may be formed of gold, copper, stainless steel, silver, or other suitable conductive material.
  • the film forming conductive material may comprise polymeric material with adhesive material or may be positioned on the surface of the expandable member (inner or outer surface) or the additional conductive material by other securing means such as separate adhesive material.
  • the film forming conductive material comprises isotropic conductive adhesives (ICAs), anisotropy systems (or Z-axis adhesives), either film or paste (ACA(F)).
  • ICAs isotropic conductive adhesives
  • anisotropy systems or Z-axis adhesives
  • ACA(F) film or paste
  • the preferred systems are the silver epoxy adhesives. Typical curing times are on the order of 3-10 minutes at 120-150 0 C.
  • Acrylic and polyamide type adhesives and silicones are also useful but have either lower electrical performance or more difficult processing (polyamide).
  • Another form may be that of nanoparticles instead of silver flakes in the micrometer range.
  • Anisotropy (or Z-axis) adhesives offer several attractive advantages, e.g. very high resolution potential (pitch down to 50 1 Am due to the possibility of non-specific application), and fast curing.
  • very high resolution potential pitch down to 50 1 Am due to the possibility of non-specific application
  • anisotropy adhesives preferably, pressure contact during curing is used due to their restricted current density.
  • anisotropy adhesives range from Au coated plastic spheres, to Ni particles with oxide breaking power, solder (SnBi) filles systems.
  • thermo-hardening resins as well as thermo-hardening resins may be utilized.
  • anisotropy material include Ag-filled UV-acrylate and UV-initiated epoxy systems for very fast curing at relatively low temperatures.
  • suitable film forming conductive adhesives include carbon based (e.g., graphite) adhesives.
  • carbon based (e.g., graphite) adhesives One such example of suitable silver and graphite based conductive adhesives includes those available from Electron Microscopy Sciences of
  • the expanded balloon 320 extends from a distal end 606 of an introducer 600, such as gastric introducer 603.
  • the expanding balloon and its treatment areas may extend into the small intestine to provide treatment to at least a portion of the small intestine.
  • a HAS treatment assembly 100 may include a reference point positioner 700 disposed at a distal end 103 of the expander assembly 300".
  • reference point positioner 700 comprises a positioning balloon 703 adapted for inflation in the patient's body using means such as a conventional air or liquid tube 710 that may also acts as a catheter guide.
  • positioning balloon 703 is inflated after passing through the pyloric sphincter 22 and seats against the distal side of the pyloric sphincter 22. Once seated, inflated positioning balloon 703 sets a reference point for tube 710 and allows proper positioning of the balloon assembly 310 without necessarily using a visualization apparatus.
  • the expanding balloon and its treatment sites may extend into the small intestine to provide treatment to at least a portion of the small intestine.
  • the expander assembly 300' of FIG. 3A is shown as part of a HAS treating assembly 100'.
  • the expander assembly 300' includes an elongate body such as catheter 400with proximal and distal ends, 406 and 403, respectively; and at least one lumen, such as lumen 410 extending along at least a distal portion thereof. (FIG. 4A).
  • the balloon member 320 is disposed at the distal end of the HAS catheter 400 (not shown) and extends from a distal end 606 of the introducer 600.
  • an endoscope 800 may optionally be disposed within the catheter 400.
  • Endoscope 800 during a procedure, may be extended into the interior 330 of the expandable balloon 320 for better visualization of the treatment site.
  • Endoscope 800 may include an illumination source such as lights (not shown) for visualization of the HAS when it is disposed within the HAS interior 130.
  • the expander assembly and endoscope are accessible through hand-piece 750 disposed at the proximal end 110 of the treatment assembly 100.
  • FIGs. 4AA-4AC only the overall structure of the introducer, catheter, and/or endoscope are shown (the conductive regions are not shown).
  • expander assembly of FIG. 3B is shown as part of a HAS treating assembly 100.
  • a distal end 103 of HAS treating assembly 100 includes the reference point positioner 700 with the positioning balloon 703 adapted for inflation in the patient's body using the conventional air or liquid tube 710 that also acts as a catheter guide.
  • the expander assembly 30 comprises, for example, the balloon assembly 310 integrated with the catheter 400 having a distal tip 420.
  • balloon assembly 310 is collapsed.
  • Catheter 400 allows balloon assembly 310 to be inserted into the patient's body over tube 710. Then, using an air line in handpiece 750 disposed at the proximal end 110 of the treating assembly 100", balloon member 320 is inflated to expand the stomach's volume.
  • the HAS expander assembly, the reference point positioner, and tube 710 (and the endoscope when present) are accessible through hand-piece 750 disposed at the proximal end of the HAS treatment assembly.
  • the conductive regions are configured for communication with the energy source 900 which is connectable to energy generator 520 by way of conduit 512 controllable by the control assembly 500.
  • the amount and level of energy at its source is set to provide a sufficient level of energy at the point of treatment.
  • the desired energy level differs for different hollow anatomical structures.
  • the temperature at the point of treatment is sufficiently high to effectuate the desired treatment.
  • the temperature at the point of treatment, for the stomach, may range from about 50 to about lOO C, from about 60 ° to about 95 ° C, from about 60 ° to about 80 ° C.
  • One or more sensors may be located within or about the expandable member, at or near the conductive regions.
  • the sensor is a thermocouple or thermistor.
  • the temperature sensor is coupled to a communication link (such as a conductor), which is coupled to a processor.
  • the communication link may comprise a D/A converter coupled to a register disposed for reading by the processor.
  • the processor reads a sensor value from the sensor and, responsive thereto, controls the signal generator so as to achieve delivery of an effective amount of energy to a desired section of tissue to be ablated.
  • the processor uses the information from the signal generator, the information from the conductive regions, and temperature sensor, as a feedback loop for controlled delivery of energy to a section of the stomach (or other treatment areas of a hollow anatomical structure).
  • the processor may control the delivery of energy to achieve delivery of a selected amount of energy, to achieve a selected temperature, or to achieve a selected amount of ablation of a section of a stomach.
  • a variety of positionings for the sensors are possible. In one
  • the senor is coupled to the expandable member.
  • the temperature or some other property of the tissue being ablated, or of the energy can be monitored using a variety of sensors.
  • open and a closed loop feedback systems may be utilized for coupling a sensor used in the apparatus to an energy source so that the output energy of the energy source is adjusted in relation to the property sensed by the sensor.
  • One or more sensors may be located within or about the expandable member, or at or about the conductive regions. It should be appreciated that the sensor may take any appropriate form, as for example formed of wireless
  • the temperature may be sensed by optical means which can assess a change in the color of at least a portion of expandable member (e.g., conductive regions).
  • colorants may be present in the material forming the expandable member/regions or be painted or deposited on its material (on the inner or outer surface). Once the colored area is exposed to the elevated temperature, the colorant may change its characteristics.
  • Information as to the temperature may then be conveyed to the practitioner. The information may be conveyed automatically by instrumentation or by direct visualization through the endoscopic device. As stated, such sensors may also be present on or in the expandable member.
  • HAS expandable member 320 may be formed from any suitable material such as, but not limited to expandable, noncompliant (or semi- compliant) material including Mylar, Nylon, PET, PeBax, IEBA.
  • the material for balloons 320 is formed from non-compliant material.
  • Mylar while expandable, is noncompliant and restricts expansion of the expandable balloon within the stomach. Therefore, an expandable balloon formed from Mylar cannot infinitely expand and patient injury resulting from unintended over-inflation of expandable balloon can be reduced.
  • expandable balloon when used for obesity treatment, expandable balloon is constructed such that when inflated within the stomach, the stomach expands from its empty volume (about 1 liter) to at least about twice the stomach's empty volume (e.g. 2 liters).
  • the expandable member may have different profiles or volumes.
  • the expandable member is pre- shaped such that as the expandable member is expanded within the hollow anatomical structure, the interior of the hollow anatomical structure conforms to the profile of the expandable member.
  • Optional visual markings corresponding to desired target areas of the HAS, may be located on the expandable member.
  • the visual markings are used to aid in locating the desired treatment target areas.
  • Such visual markings may be incorporated into or deposited on or within the material forming the member.
  • the visual markings may take the form of colorant, metallic or polymeric material.
  • the practitioner may identify the necessary areas for transfer of energy using practitioner's experience.
  • the visual markings may be positioned to correspond to any one or more areas corresponding to or in the vicinities of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach.
  • Control unit 510 may include any one or more of the following subassemblies: treatment energy source 520 for providing and controlling energy source 900, controller 530, I/O device 540, inflation fluid delivery unit 250, and GUI 560.
  • control unit 510 governs the power levels, cycles, and duration of energy transmitted through line 512 to the energy source and the conductive regions to achieve and maintain temperature levels that achieve treatment objectives. Foot switch 511 allows hands- free control of energy delivery. In tandem, control unit 510 controls delivery of processing (inflation) fluid and, if needed, the removal of aspirated material through fluid lines 555.
  • Controller 510 includes an Input/Output (I/O) device 540.
  • the I/O device 540 allows practitioners to enter control and processing factors enabling control unit 510 to generate correct command signals.
  • the I/O device 540 also receives real time processing feedback information from the one or more sensors associated with the expandable member or the conductive regions, as well as the endoscope (e.g., visualization data) when present.
  • the feedback information is processed by the controller 530, to govern energy application and processing inflation fluid as well as energy delivery.
  • the I/O device 540 also includes a graphical user interface (GUI) 560 that graphically presents processing information to the practitioner for viewing and/or analysis.
  • the energy may be in the form of electromagnetic energy (e.g., RF, microwave) and ultrasonic energy, infrared, visible laser energy, heat energy, or the like.
  • exemplary therapeutic methods embodying features of the present invention will be described in the context of the treatment of the stomach.
  • the methods of the present invention are equally applicable in the treatment of other hollow anatomical structures and variations as to the steps, complementary components, visualization tools, introducers, and points of access to the anatomical structure may be modified as necessary.
  • the treatment according to the present invention is minimally invasive.
  • the procedure takes about one hour, including preparation and minimal recovery times.
  • patients can be treated on an out-patient basis using conscious sedation and since the risk of serious problems during the treatment is low it does not necessarily require the complete back-up of a hospital for emergencies.
  • a gastric introducer is positioned in the patient's throat and protects the esophageal walls during the procedure.
  • the expander assembly preloaded with the endoscope (when present) is inserted into patient's body through the introducer.
  • the expandable balloon is advanced distally positioning the shaped distal portion against the distal side of the pyloric sphincter.
  • an inflation fluid line such as an air line (e.g., extending along an inner lumen of catheter 400)
  • expandable member is inflated until the stomach's volume reaches the desired volume, such as at least about twice its empty volume (e.g. to about 2 liters).
  • the pre-shaped distal portion, at the expanded configuration seats against the distal side of the pyloric sphincter, providing an anchor and aiding in position and placement of the expander assembly within stomach.
  • the optional endoscope may be pulled back completely or partially into the introducer.
  • the practitioner using control unit and foot pedal delivers energy from an energy source through leads, to the conductive regions extending along at least portions of expandable balloon.
  • energy is emitted (e.g., transmitted) from the conductive regions and the expandable member to the desired treatment area/s of the target hollow anatomical structure.
  • the expanded expandable member comes into direct surface contact, preferably at least substantially non-penetrating physical contact, with the desired target areas of the hollow anatomical structure.
  • the desired treatment area/s include any one or more areas corresponding to or in the vicinities of the greater curvature of the stomach, smaller curvature of the stomach, cardiac zone, gastric/fundic zone, pyloric zone, or the vagal nerve within the stomach.
  • the transferred energy is sufficiently high to cause a change (e.g., physical, biochemical, physiological change) in the treatment target areas as described earlier.
  • a change e.g., physical, biochemical, physiological change
  • the energy may be in the form of electromagnetic energy (e.g., RF, microwave) and ultrasonic energy, infrared, visible laser energy, heat energy, or the like.
  • electromagnetic energy e.g., RF, microwave
  • ultrasonic energy infrared, visible laser energy, heat energy, or the like.
  • the practitioner can monitor the temperature at the site.
  • the duration of time and frequency of applied energy are, of course, responsive to judgments of medical personnel.
  • the endoscope after patient sedation, the endoscope introduces the reference point positioner (e.g., reference point balloon), into the patient's alimentary canal.
  • the endoscope forwards positioning balloon through the stomach and onto the distal side of the pyloric sphincter.
  • the endoscope is retracted and positioning balloon inflated to seal against the distal side of the pyloric sphincter. This sets a fixed reference point for the tube.
  • a gastric introducer positioned in the patient's throat, protects the esophageal walls during the next steps in the process.
  • the expander assembly is now introduced into the patient's digestive system through the gastric introducer and by the catheter riding over tube.
  • distal tip of the catheter contacts the positioning balloon and the closed pyloric sphincter, the practitioner stops inserting the stomach expander into the patient.
  • Balloon member is then inflated until the stomach's volume becomes about twice its empty volume.
  • the reference positioner and the expandable member are deflated and withdrawn from the patient, as is the gastro introducer.
  • FIGs. 6A and 6B very schematically show the disruption and slowing of the travel of nerve pulses S, S' between the stomach 12, the small intestine 14, and the brain.
  • smaller ablated portions Q of exemplary nerve 15 disrupt the straight flow of nerve signal impulses S between the stomach, small intestine, and brain.
  • larger ablated portions Q' of exemplary nerve 15 more greatly disrupt the straight flow of nerve signal impulses S' between the stomach, small intestine, and brain.
  • the size of ablated portions Q, Q' and the desired degree of associated signal disruption are left to the sound judgment of the practitioner after considering, for example, the degree of patient's obesity, strength of patient's hunger sensations, and variation in nerve size from patient to patient.
  • FIG. 7 is an exemplary depiction of the appearance of the muscle profile of a treated stomach about 3 months post-op.
  • These muscular constrictions and associated lesions should cause patient weight loss for the reasons discussed above. Because the procedure does not cause complete cell death in the treated areas, over long periods of time continued healing may cause the stomach's muscle profile to return to normal. Accordingly, follow-up treatments may be required. However, due to the process' simplicity, this should not pose any undue risk or inconvenience to the patient.

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Abstract

Appareil mini-invasif et méthode de traitement d'états pathologiques de structures anatomiques creuses. L'appareil de traitement et la méthode de l'invention permettent d'envoyer de l'énergie d'un élément expanseur possédant des régions conductrices, dans la surface intérieure de la structure anatomique creuse en contact avec les glandes, nerfs et parois musculaires sous-jacents de la structure.
PCT/US2010/041262 2009-07-09 2010-07-07 Appareil de traitement d'etats pathologiques de structures anatomiques creuses Ceased WO2011005898A2 (fr)

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JP2014176653A (ja) * 2013-03-13 2014-09-25 Biosense Webster (Israel) Ltd 分割リング電極とリードワイヤとの間に低オーム圧力接触の電気的接続を作製するための方法

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SE9400821D0 (sv) * 1994-03-10 1994-03-10 Siemens Elema Ab Implanterbart infusionssystem med tryckneutral läkemedelsbehållare
US6126647A (en) * 1999-05-17 2000-10-03 Hermetic Switch, Inc. Magnetically guided catheter with sensor
US6432136B1 (en) * 2000-04-25 2002-08-13 The Penn State Research Foundation Apparatus and method for removing a pocket of air from a blood pump
JP2010537744A (ja) * 2007-08-30 2010-12-09 シンクロ メディカル イノベーションズ， インコーポレイテッド 取外し可能な磁気ガイドを有するガイド付きカテーテル

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JP2014176653A (ja) * 2013-03-13 2014-09-25 Biosense Webster (Israel) Ltd 分割リング電極とリードワイヤとの間に低オーム圧力接触の電気的接続を作製するための方法
US10004417B2 (en) 2013-03-13 2018-06-26 Biosense Webster (Israel) Ltd. Method for making a low ohmic pressure-contact electrical connection between split ring electrode and lead wire
EP2783652B1 (fr) * 2013-03-13 2018-07-11 Biosense Webster (Israel) Ltd. Procédé de fabrication d'une connexion électrique par contact ohmique faible entre anneau fendu électrode et fil conducteur

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