EP2685945A2 - Anneau gastrique à auto-ajustement - Google Patents

Anneau gastrique à auto-ajustement

Info

Publication number
EP2685945A2
EP2685945A2 EP12713446.8A EP12713446A EP2685945A2 EP 2685945 A2 EP2685945 A2 EP 2685945A2 EP 12713446 A EP12713446 A EP 12713446A EP 2685945 A2 EP2685945 A2 EP 2685945A2
Authority
EP
European Patent Office
Prior art keywords
self
reservoir
gastric band
inflatable portion
compliant
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.)
Withdrawn
Application number
EP12713446.8A
Other languages
German (de)
English (en)
Inventor
Sean Snow
Mitchell H. Babkes
Marcos Borrell
Christopher R. Deuel
Zachary P. Dominguez
Ethan Franklin
Babak Honaryar
Erik Torjesen
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.)
Apollo Endosurgery Inc
Original Assignee
Allergan 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
Priority claimed from US13/049,453 external-priority patent/US20110270024A1/en
Priority claimed from PCT/US2011/032404 external-priority patent/WO2011139505A1/fr
Priority claimed from US13/149,585 external-priority patent/US20120095288A1/en
Priority claimed from US13/216,132 external-priority patent/US9044298B2/en
Application filed by Allergan Inc filed Critical Allergan Inc
Publication of EP2685945A2 publication Critical patent/EP2685945A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A61F5/0056—Gastric bands remotely adjustable using injection ports

Definitions

  • the present invention generally relates to medical systems, devices and uses thereof for treating obesity and/or obesity-related diseases. More specifically, the present invention relates to gastric banding systems that may self- adjust to changes in a patient.
  • Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures.
  • sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, CA) gastric band or the LAP-BAND AP® (Allergan, Inc., Irvine, CA) gastric band.
  • gastric bands are placed about the cardia, or upper portion, of a patient's stomach forming a stoma that restricts food's passage into a lower portion of the stomach.
  • gastric band apparatus When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating.
  • gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract.
  • An example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference. [0003]
  • a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive.
  • prior art gastric band systems provide a subcutaneous fluid access port connected to an expandable or inflatable portion of the gastric band.
  • a hypodermic needle inserted into the access port By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction.
  • the level of tightness of the gastric band may effect the patient's sensations and satisfaction level.
  • the patient may experience hunger; but if the gastric band is overfilled (and thus "too tight") , the patient may experience tightness in the chest region, suffer from a food bolus blockage, and the like.
  • adjustment of a gastric band may be desirable in between adjustments made by a physician.
  • the band applies pressure to the outer surface of the upper stomach.
  • it may be difficult to achieve the most effective level of tightness, and further, physicians may tend to err on the side of underfilling the gastric band (thereby decreasing efficacy of the gastric band system) as they consider the risk of overfilling the gastric band.
  • 2010/0191271 discloses an elastic bladder that is in constant fluid communication with the expandable balloon portion of a gastric band in order to continuously adjust the gastric band.
  • Lau, et al . , U.S. Patent Pub. No. 2010/0191265 discloses an alternative elastic bladder having four wings .
  • FIG. 2A Coe, et al . , U.S. Patent Pub. No. 2009/0216255 discloses a flow control device A that moves fluid between a hydraulic restriction system and a fluid source B. The additional flow control device A controls a rate of fluid flow between the restriction device and the fluid source B.
  • Coe, et al . , European Patent Application No. 2 074 970 Al discloses a separate restriction device and pressure adjustment device C. The pressure
  • adjustment device C regulates a constant force applied by the restriction device using, for example, a bellows and a spring.
  • U.S. Patent Pub. No. 2009/0054914 discloses a controllable stomach band that has a chamber for controlling restriction of the stomach band.
  • the chamber is coupled to a separate pressure chamber D that
  • the pressure chamber D is separated from the esophageal-gastric junction of the patient's stomach.
  • Steffen, U.S. Patent Pub. No. 2009/0062826 discloses an adjustable gastric band with a "conveyance device" that is powered by a “power storage device.”
  • the power storage device operates the conveyance device to move fluid between expandable chambers to adjust the gastric band.
  • a self-adjusting gastric band that will provide the needed pressure to the stomach to create the stoma and facilitate weight control, but that will also adapt and open up to allow a large bolus to pass through. It is further desirable to create an automatically self-adjusting gastric band that does not require an electrical power source and/or external adjustments, to allow a large bolus to pass through.
  • the gastric banding systems described herein may also help prevent pouch dilatation and/or erosion.
  • the apparatus and systems described herein may aid in facilitating obesity control and/or treating obesity-related diseases while generally being non-invasive once implanted.
  • the automatic adjustments may also be made in response to other changes in the patient's esophageal-gastric junction, for example, in response to size, shape, and or location changes.
  • a self-adjusting gastric banding system for the treatment of obesity that adjusts to allow a bolus to pass through a constriction in a patient's stomach formed by the self-adjusting gastric banding system is
  • the self-adjusting gastric banding system comprises a gastric band having an inflatable portion disposed about the stomach of the patient, the inflatable portion capable of constricting the stomach, an access port fluidly coupled to the inflatable portion, the access port capable of receiving a fluid to inflate, or removing a fluid to deflate, the inflatable portion of the gastric band, a tubing coupled to the gastric band and the access port, the tubing carrying fluid between the inflatable portion of the gastric band and the access port, and a compliant reservoir attached to at least a portion of the tubing and configured to receive fluid from the inflatable portion of the gastric band for automatically relaxing the constriction formed by the inflatable portion of the gastric band sufficiently to allow the bolus to pass through the
  • the gastric band comprises a first compliant portion coupled to a part of the system.
  • the first compliant portion may be coupled to the inflatable portion, the access port, and/or the tubing.
  • the first compliant portion automatically relaxes the constriction formed by the self- adjusting gastric band and allows the large bolus to pass through the constriction. After the bolus passes through the constriction, the gastric band automatically returns to its previous state.
  • the first compliant portion facilitates automatically relaxing the first compliant portion
  • the self-adjusting gastric band may comprise a ring coupled to the inflatable portion of the gastric band.
  • the ring provides structure and support to the inflatable portion, and the ring facilitates disposing the inflatable portion about the esophageal-gastric junction.
  • the ring may be a flexible ring with a diameter that expands when a predetermined pressure is generated in the inflatable portion.
  • the predetermined pressure may be generated in response to the large bolus passing through the esophageal-gastric junction.
  • the flexible ring expands to automatically relax the constriction formed by the self- adjusting gastric band.
  • the ring has a durometer in the range of approximately 20 to approximately 70.
  • the first compliant portion receives a first amount of fluid from the inflatable portion when the large bolus causes a pressure in the first compliant portion to exceed an expansion pressure. Receiving the first amount of fluid from the inflatable portion
  • the first compliant portion is fluidly coupled to the inflatable portion.
  • the first compliant portion facilitates removing the first amount of fluid from the
  • the self-adjusting gastric band further comprises a second compliant portion fluidly coupled to the access port.
  • the second compliant portion automatically removes a second amount of fluid from the inflatable portion via the access port to facilitate relaxing the constriction formed by the inflatable portion.
  • the tubing of the gastric banding system may be any suitable material
  • compliant tubing that expands in response to a pressure in the tubing exceeding a tubing expansion pressure when the large bolus passes through the constriction formed by the self- adjusting gastric band.
  • a third amount of fluid is removed from the inflatable portion when the compliant tubing expands.
  • the tubing may be perforated to facilitate receiving the fluid from the inflatable portion via the tubing.
  • another embodiment of the self-adjusting gastric band comprises a third compliant portion fluidly coupled to the tubing for automatically receiving a third amount of fluid from the inflatable portion via the tubing when the large bolus enters the esophageal-gastric junction. Receiving the third amount of fluid from the inflatable portion facilitates relaxing the constriction formed by the gastric band and
  • the compliant components may comprise a leak-resisting feature.
  • These components may be an elastic polymer, a balloon, a rubber container, a silicone container, a collapsible container, a bellows, and combinations thereof.
  • a vacuum device may be used in an embodiment.
  • a gastric banding system may include a tube with a gap or cut located within a balloon or reservoir.
  • the gap or cut may allow for fluid transfer between fluidly- coupled components to the balloon or reservoir. In this manner, fluid may flow to the reservoir from an inflatable portion of the gastric banding system to relieve the pressure induced by the large bolus.
  • a gastric banding system may include a tube with slits or holes located within a balloon or reservoir.
  • the slits or holes may allow for fluid transfer between fluidly- coupled components to the balloon or reservoir. In this manner, fluid may flow to the reservoir from an inflatable portion of the gastric banding system to relieve the pressure induced by the large bolus.
  • a gastric banding system may include a tube-like reservoir configured to inflate and deflate based on a volume level within the reservoir.
  • the tube-like reservoir may be compliant and may have a star-shaped outer circumference in a first state and a circular, uniform outer circumference in a second state.
  • portions of the tube-like reservoir may expand in diameter as more fluid is added.
  • a gastric banding system may include a flattened reservoir having a uniform configuration, an indented configuration or a u-shaped configuration for inflating and deflating based on a volume level within the reservoir.
  • improved performance may be achieved through reduction of the effects of the external forces on fluid within an adjacent, non-compliant component.
  • a gastric banding system may include a tube-on-tube reservoir having an outer non-compliant tube intended to prevent kinking, bending, or any other fluid
  • the inner compliant tube may be separated from the outer non-compliant tube by a gap which allows the inner compliant tube to expand (to fill the gap) .
  • a gastric banding system may include a reservoir with a winged portion, a coiled portion or an enlarged portion configured to inflate and deflate based on a volume level within the reservoir. These reservoirs may be attached or coupled to an access port of a gastric banding system.
  • a gastric banding system may include a reservoir with internal structures such as a spring, a cage or a ring.
  • the internal structures may act to prevent kinking, bending of the compliant portion, or otherwise prevent fluid flow interruptions within the reservoir.
  • a gastric banding system may include a reservoir with external structures such as a skeleton or a protective layer.
  • the external structures may act to prevent kinking, bending of the compliant portion, or otherwise prevent fluid flow interruptions within the reservoir.
  • a gastric banding system may include a reservoir having depressions, pleatings or longitudinal
  • the depressions, pleatings or longitudinal structures may allow for easier and more predictable deflation of the reservoir, e.g., during implantation or removal procedures.
  • a gastric banding system may have one or more reservoirs oriented radially from the gastric band.
  • a gastric banding system may include non-saline fill substances such as a gel, a pseudoplastic material, or a Bingham plastic.
  • the non-saline fill substances may have different properties that allow for different pressure behaviors when an external pressure is applied to the gastric banding system (e.g., when a large or small bolus is swallowed by the patient) .
  • a gastric banding system may be self- contained and may be filled with one or more of a various number of different fill substances.
  • the self-contained gastric banding system may include a ring, one or more cushions, and one or more hinges that flex when a pressure is exerted on the cushions (e.g., when a patient swallows a large or small bolus of food) .
  • a gastric banding system may include a hybrid gas-saline component.
  • the gas component may be a balloon or other gas filled member coated with a gas-impermeable coating and may be designed to flow between other components of the gastric banding system based on the pressure exerted, e.g., by a large bolus passing through a constriction formed by the gastric band .
  • a gastric banding system may include an access port having a movable surface, which may move in response to a pressure change within the gastric banding system.
  • the movable surface may be a complaint portion that moves to increase the volume of the fluid portion (and therefore increases compliance) when the pressure increases within the gastric banding system (e.g., in response to a large bolus moving through a constriction of the gastric band) .
  • the movable surface may return to its original position, thereby decreasing the volume of the fluid portion of the access port.
  • the access port may further include a septum, a fluid-permeable membrane, o-rings and a gas spring portion filled with a gas.
  • the gas spring portion may be replaced with a wave spring, a cantilever spring, a constant force spring, a coil spring, a leaf spring, a
  • Belleville spring a hybrid polymer coil-air spring and the like .
  • a gastric banding system may include a flow-rate control device.
  • the flow rate control device may improve comfort of a patient when a large bolus is passing through the constriction by increasing the rate that fluid flows out of the gastric band and into the reservoir. In this manner, the pressure increase may be significantly reduced. Once the bolus passes, the reservoir-side pressure may gradually decrease as the gastric band begins to inflate again with fluid, and the gastric banding system may approach the equilibrium pressure.
  • a gastric banding system may include a gastric band without a locking portion, and with a more
  • inflexible ring portion inflexible ring portion. More particularly, instead of having a flexibly-stiff ring locked in place at an open end (as
  • the gastric banding system does not include a locking portion and replaces the flexibly-stiff ring with a more inflexible ring such as a snap ring, a split ring, retaining ring and the like.
  • a gastric banding system may include a ring and corresponding inflatable portions having a wider portion.
  • the wider portion may operate to stimulate and
  • the wider portion may channel the medium bolus through the standard portions. And when the patient swallows large boluses, the wider portion may function to relieve the stress on the patient's tissue and assist to prevent formations of pouch dilatations.
  • a gastric banding system may include a gastric band without a ring portion.
  • the gastric band without a ring portion may be more flexible (e.g., by having decreased ring stiffness) than a standard gastric band, thereby resulting in a gastric banding system having muted pressure or force spikes on the tissues (e.g., in the esophageal-gastric junction) in a patient when the patient consumes a large bolus of food.
  • a gastric banding system may include a gastric band with a modified ring portion.
  • the modified ring portion may be more flexible (e.g., by having decreased ring stiffness) than a standard gastric band, thereby resulting in gastric banding systems having muted pressure or force spikes on the tissues (e.g., in the esophageal-gastric junction) in a patient when the patient consumes a large bolus of food.
  • FIG. 1A illustrates a prior art system that includes a elastic bladder.
  • FIG. IB illustrates a prior art system that includes an elastic bladder having a fold.
  • FIG. 1C illustrates a prior art system that includes an elastic bladder having four wings.
  • FIG. 2A illustrates a prior art system that includes a flow rate limiting device.
  • FIG. 2B illustrates a prior art system that includes a fluid control mechanism.
  • FIG. 2C illustrates a prior art system that includes a valve and a chamber separated from the esophageal-gastric junction .
  • FIG. 3 illustrates a prior art system that includes a gastric band with a “conveyance device” that is powered by a “power storage device.”
  • FIG. 4 illustrates an exploded, perspective view of a self-adjusting gastric banding system according to an embodiment of the present invention.
  • FIG. 5 illustrates an exploded, perspective view of a self-adjusting gastric banding system having various compliant components according to an embodiment of the present invention.
  • FIG. 6 illustrates an exploded, perspective view of another self-adjusting gastric banding system having various compliant components according to an embodiment of the present invention .
  • FIG. 7A illustrates a chart showing pressure-volume curves for a standard gastric band and a self-adjusting gastric band according to an embodiment of the present invention.
  • FIG. 7B illustrates a chart showing pressure-time curves for a standard gastric band and a self-adjusting gastric band subject to a period of obstruction according to an embodiment of the present invention.
  • FIG. 8A illustrates a vacuum device configured to provide suction on a patient's skin proximal to the compliant reservoir according to an embodiment of the present invention.
  • FIG. 8B illustrates the vacuum device of FIG. 8A in an operational state according to an embodiment of the present invention .
  • FIG. 9 illustrates a cross-sectional view of a compliant tubing-reservoir system according to an embodiment of the present invention.
  • FIG. 10 illustrates a cross-sectional view of a
  • compliant tubing-reservoir system having a gap or cut sealed within a reservoir according to an embodiment of the present invention .
  • FIG. 11 illustrates a cross-sectional view of a
  • compliant tubing-reservoir system having slits or holes sealed within a reservoir according to an embodiment of the present invention .
  • FIG. 12 illustrates an exploded, perspective view of a compliant tubing-reservoir system according to an embodiment of the present invention.
  • FIG. 13A illustrates an exploded, perspective view of a compliant tubing-reservoir system having a tube-shaped reservoir according to an embodiment of the present invention.
  • FIG. 13B illustrates a cross-sectional view of a non- extruded area of the tube-shaped reservoir of FIG. 13A according to an embodiment of the present invention.
  • FIG. 13C illustrates a cross-sectional view of an as- extruded area of the tube-shaped reservoir of FIG. 13A according to an embodiment of the present invention.
  • FIG. 14A illustrates a perspective view of a tube-shaped reservoir in a non-expanded state according to an embodiment of the present invention.
  • FIG. 14B illustrates a perspective view of the tube- shaped reservoir of FIG. 14A in an as-expanded state according to an embodiment of the present invention.
  • FIG. 15 illustrates an exploded, perspective view of a compliant tubing-reservoir system having a tube-shaped reservoir according to an embodiment of the present invention.
  • FIG. 15A illustrates a cross-sectional view of the tube- shaped reservoir of FIG. 15 according to an embodiment of the present invention.
  • FIG. 16 illustrates a cross-sectional view of another tube-shaped reservoir according to an embodiment of the present invention .
  • FIG. 17A illustrates a cross-sectional view of a tube- shaped reservoir in a first state according to an embodiment of the present invention.
  • FIG. 17B illustrates a cross-sectional view of the tube- shaped reservoir of FIG. 17A in a second state according to an embodiment of the present invention.
  • FIG. 17C illustrates a cross-sectional view of the tube- shaped reservoir of FIG. 17A in a third state according to an embodiment of the present invention.
  • FIG. 18A illustrates a close-up view of a compliant tube-on-tube reservoir system according to an embodiment of the present invention.
  • FIG. 18B illustrates a cross-sectional view of the compliant tube-on-tube reservoir system of FIG. 18A according to an embodiment of the present invention.
  • FIG. 18C illustrates a partial, exploded view of the compliant tube-on-tube reservoir system of FIG. 18A according to an embodiment of the present invention.
  • FIG. 18D illustrates a partial, exploded view of the compliant tube-on-tube reservoir system of FIG. 18A according to an embodiment of the present invention.
  • FIG. 18E illustrates a cross-sectional view of the compliant tube-on-tube reservoir system of FIG. 18D according to an embodiment of the present invention.
  • FIG. 18F illustrates a perspective view of a portion of the compliant tube-on-tube reservoir system of FIG. 18A
  • FIG. 18G illustrates a partial, exploded view of the compliant tube-on-tube reservoir system of FIG. 18A according to an embodiment of the present invention.
  • FIG. 19A illustrates a perspective view of a coiled reservoir in a first state according to an embodiment of the present invention.
  • FIG. 19B illustrates a perspective view of the coiled reservoir of FIG. 19A in a second state according to an
  • FIG. 20A illustrates a perspective view of a reservoir having winged portions in a first state according to an
  • FIG. 20B illustrates a perspective view of the reservoir having winged portions of FIG. 20A in a second state according to an embodiment of the present invention.
  • FIG. 21A illustrates a perspective view of a tube-shaped reservoir having a closed end in a first state according to an embodiment of the present invention.
  • FIG. 21B illustrates a perspective view of the tube- shaped reservoir having a closed end of FIG. 21A in a second state according to an embodiment of the present invention.
  • FIG. 21C illustrates a perspective view of a tube-shaped reservoir having a closed end of FIG. 21A in a third state according to an embodiment of the present invention.
  • FIG. 22 illustrates a perspective view of a reservoir having an internal spring according to an embodiment of the present invention.
  • FIG. 23 illustrates a perspective view of a reservoir having an internal cage according to an embodiment of the present invention.
  • FIG. 24 illustrates a perspective view of a reservoir having internal rings according to an embodiment of the present invention .
  • FIG. 25 illustrates a perspective view of a reservoir having an external shell according to an embodiment of the present invention.
  • FIG. 25A illustrates a cross-sectional view of the reservoir having the external shell of FIG. 25 according to an embodiment of the present invention.
  • FIG. 26 illustrates a cross-sectional view of another reservoir having an external shell according to an embodiment of the present invention.
  • FIG. 27 illustrates a perspective, cross-sectional view of a reservoir having depressions according to an embodiment of the present invention.
  • FIG. 28 illustrates a cross-sectional view of a
  • FIG. 29 illustrates a cross-sectional view of a reservoir having depressions according to an embodiment of the present invention.
  • FIG. 30A illustrates a top view of a gastric banding system having a compliant reservoir about the circumference of the gastric band according to an embodiment of the present invention .
  • FIG. 30B illustrates a side view of the gastric banding system of FIG. 30A according to an embodiment of the present invention .
  • FIG. 31 illustrates a side view of a gastric banding system of having a compliant reservoir about the circumference of the gastric band according to an embodiment of the present invention .
  • FIG. 32 illustrates an orientation of a gastric banding system having a plurality of reservoirs extending radially from the gastric band according to an embodiment of the present invention .
  • FIG. 33A illustrates a large bolus/small bolus pressure- time graph for two distinct gastric banding systems.
  • FIG. 33B illustrates a large bolus/small bolus pressure- time graph for two distinct gastric banding systems.
  • FIG. 34A illustrates a perspective view of a self- contained gastric banding system according to an embodiment of the present invention.
  • FIG. 34B illustrates a top view of the self-contained gastric banding system of FIG. 34A according to an embodiment of the present invention.
  • FIG. 35 illustrates a top perspective view of another self-contained gastric banding system according to an embodiment of the present invention.
  • FIG. 36 illustrates an exploded, perspective view of a gastric banding system having gas-impermeable components
  • FIG. 37A illustrates an exploded, perspective view of a hybrid gas-fluid gastric banding system having gas-impermeable components according to an embodiment of the present invention.
  • FIG. 37B illustrates an exploded, perspective view of a hybrid foam-fluid gastric banding system having gas-impermeable components according to an embodiment of the present invention.
  • FIG. 38A illustrates an exploded, perspective view of a hybrid gas-fluid gastric banding system having a gas-spring according to an embodiment of the present invention.
  • FIG. 38B illustrates a close-up view of the gas-spring within a reservoir of FIG. 38A according to an embodiment of the present invention.
  • FIG. 38C illustrates a close-up view of the gas-spring of FIG. 38A according to an embodiment of the present invention.
  • FIG. 38D illustrates a cross-sectional view of the gas- spring of FIG. 38A according to an embodiment of the present invention .
  • FIG. 39 illustrates a close up view of an access port for a gastric banding system according to an embodiment of the present invention.
  • FIG. 40 illustrates a close up view of another access port for a gastric banding system according to an embodiment of the present invention.
  • FIG. 41 illustrates a close up view of another access port for a gastric banding system according to an embodiment of the present invention.
  • FIG. 42 illustrates a perspective view of a gastric banding system having a flow rate restrictor according to an embodiment of the present invention.
  • FIG. 43 illustrates a time-pressure curve for a gastric banding system without a flow rate restrictor and a time- pressure curve for a gastric banding system with a flow rate restrictor .
  • FIG. 44A illustrates an always-open gastric banding system according to an embodiment of the present invention.
  • FIG. 44B illustrates an always-open gastric banding system having an elastic member according to an embodiment of the present invention.
  • FIG. 45 illustrates a cross-sectional view of a gastric band located about an esophageal-gastric junction of a patient.
  • FIG. 46 illustrates a cross-sectional view of a gastric band having a funnel shape according to an embodiment of the present invention.
  • FIG. 47A illustrates an exploded, perspective view of a gastric banding system including a gastric band without a ring according an embodiment of the present invention.
  • FIG. 47B illustrates a perspective view of the gastric band of FIG. 47A according to an embodiment of the present invention .
  • FIG. 48A illustrates an exploded, perspective view of a gastric banding system including a gastric band having a ring with holes according an embodiment of the present invention.
  • FIG. 48B illustrates a perspective view of the gastric band of FIG. 48A according to an embodiment of the present invention .
  • FIG. 49A illustrates an exploded, perspective view of a gastric banding system including a gastric band having a ring with cut-out portions according an embodiment of the present invention .
  • FIG. 49B illustrates a perspective view of the gastric band of FIG. 49A according to an embodiment of the present invention .
  • the present invention generally provides self-adjusting gastric banding systems, for example, for treatment of obesity and obesity related conditions, as well as systems for allowing automatic self-adj ustment of gastric bands when a patient swallows a large bolus.
  • Self-adjusting gastric bands are effective in helping a patient lose weight when the band is properly tightened around the patient's esophageal-gastric junction.
  • the band applies pressure to the outer surface of the upper stomach.
  • the patient may swallow a bolus which is too large to pass through the constriction produced by the band — for example, when the patient swallows a large piece of steak.
  • the result can be a painful experience which, if it persists, may require medical intervention to release the blockage.
  • the self-adjusting gastric band provides the needed pressure to the stomach to encourage weight loss.
  • the self-adjusting gastric band temporarily and automatically opens up to allow the bolus through. After the bolus passes through, the mechanisms within the band return the band to its original size and shape.
  • electrical power and/or power external to the patient is not utilized to perform these adjustments.
  • complicated fluid control mechanisms, flow rate limiting devices, and/or valves are not utilized to
  • a self-adjusting gastric banding system 400 includes a gastric band 405 coupled to a subcutaneous injection port 435 via tubing 403.
  • the gastric band 405 is coupled to a subcutaneous injection port 435 via tubing 403.
  • the inflatable portion 410 separates the patient's stomach from the ring 407 when the gastric band 405 is implanted around the esophageal-gastric junction of the patient's stomach.
  • the ring 407 provides structure and support to the inflatable portion 410, and
  • the access port 435 may be sutured onto the rectus muscle sheath or any other conveniently accessible muscle.
  • the rectus muscle sheath provides a secure surface on which to attach the access port 435 under a layer of fat that separates the patient's skin from the muscle.
  • the inflatable portion 410 may be filled and drained with a fluid via the tubing 403.
  • the tubing 403 may be connected to the subcutaneous access port 435 for filling and draining the inflatable portion 410 via subcutaneous
  • the inflatable portion 410 may also be coupled to a reservoir to facilitate automatic adjustment of the inflatable portion 410, and the constriction it causes, when a large bolus attempts to pass through the constriction.
  • the constriction around the stomach generally becomes tighter.
  • the constriction loosens and/or opens up.
  • the fluids used within the gastric band 405 may include any fluid that is biocompatible and incompressible.
  • the fluid has no adverse effect on the patient in the unlikely event that a leak emanates from the system.
  • the fluid can simply be water or any biocompatible polymer oil such as caster oil.
  • the fluid is saline, a drug, and/or
  • the ring 407 is designed to be a compliant portion of the gastric band 405.
  • the ring 407 may flex and/or expand in response to a bolus of food moving through the constriction caused by the gastric band 405.
  • the ring 407 may have flexible components and rigid components, such that the flexible components expand when a certain elevated and/or maximum pressure is reached in the inflatable portion 410. This elevated pressure may exist due to the presence of an obstruction such as a bolus near the gastric band 405. As the ring 407 expands, the diameters of the ring 407 and the
  • inflatable portion 410 increase, and the constriction on the stomach due to the gastric band 405 is reduced to allow the bolus to pass through.
  • the elevated pressure no longer exists, and the gastric band 405 returns to the pre-obstruction state.
  • the entire ring 407 may be flexible and/or expandable such that a diameter of the ring 407 increases in response to the elevated pressure in the inflatable portion 410.
  • the ring 407 may be constructed of silicone that has a durometer in the range of approximately 20 to approximately 70.
  • adjusting the constriction of the gastric band 405 are only example embodiments. Any mechanism for automatically adjusting the constriction of the gastric band 405 that does not include electrical power, power external to the patient, complicated fluid control mechanisms, flow rate limiting devices, and/or valves is contemplated within the scope of the present
  • the term “automatically” refers to situations when the compliant member expands, moves, contracts or is altered without the use of an electronic device causing the change .
  • various compliant components may be utilized to automatically adjust the constriction of the gastric band 505 about the esophageal-gastric junction of the patient's stomach. Although three compliant components are illustrated in FIG. 5, as noted above, one or more of the components may be present in various embodiments of the present invention .
  • the component 512 is fluidly coupled to the inflatable portion 510 of the gastric band 505.
  • the compliant component 512 is located on the outside of the ring 507, opposite the inflatable portion 510, and may be coupled to the ring 507 and the inflatable portion 510. Further, in an embodiment, one or more fluid ports may extend from the inflatable portion 510 to the compliant component 512 to fluidly couple the inflatable portion 510 to the compliant component 512.
  • a tube compliant component 514, 614 may be fluidly coupled to the tubing 503, 603. As illustrated in FIG. 6, the compliant component 614 may run along substantially the entire length of the tubing 603. In another embodiment, as illustrated in FIG. 5, the compliant component 514 may be limited to a smaller section of the entire length of the tubing 503. The compliant component 514, 614 may be fluidly coupled to the tubing 503 at one or more locations. For example, with reference to FIG. 6, the compliant component 614 and the tubing 603 may be perforated to allow for efficient transfer of the fluid between the tubing 603 and the compliant component 614.
  • tubing 603 itself may be compliant, and the durometer, thickness, and/or diameter of the tubing 603 may be altered to achieve a desired degree of
  • Other components of the gastric band 605 may similarly have altered properties in order to achieve a desired degree of compliance.
  • the compliant component 514, 614 may have features
  • the compliant component 514, 614 may include rigid portions (e.g., similar to a skeleton) and flexible portions.
  • the rigid components may give structure to the compliant component 514, 614 and/or the tubing 503, 603 to prevent kinking and/or leakage due to external forces on the compliant component 514, 614 and/or the tubing 503, 603.
  • the flexible components may automatically expand in response to an increased pressure in the inflatable portion 510, 610 of the gastric band 505, 605.
  • the access port 535, 635 may be fluidly coupled to a port compliant component 516, 616.
  • the compliant component 516 may be a balloon, reservoir, or other expandable device that is adjacent to the port 535.
  • the compliant component 616 may substantially surround the access port 635.
  • the compliant component 616 may be fluidly coupled to the access port 635 at a single location near a coupling between the tubing 603 and the access port 635. In another embodiment, the compliant component 616 may be fluidly coupled to the access port 635 at multiple locations.
  • the compliant components 407, 512, 514, 516, 614, 616 in any particular configuration or combination, expand to receive an amount of the fluid from the inflatable portion 510, 610 via the inflatable portion 510, 610, the tubing 503, 603, and/or the access port 535, 635, and/or to reduce the constriction formed by the gastric band 405, 505, 605.
  • the predetermined pressure may be predetermined based on a pressure that would indicate an obstruction is attempting to pass through the constriction caused by the gastric band 405, 505, 605.
  • the compliant components 407, 512, 514, 516, 614, 616 described herein, in accordance with various embodiments, may be designed with an expansion pressure at which pressure the components 407, 512, 514, 516, 614, 616 begin to expand, to receive fluid from the inflatable portion 510, 610 of the gastric band 505, 605, and/or to reduce the constriction formed by the gastric band 405, 505, 605.
  • the expansion pressure may be configured to correspond to a predetermined pressure in the inflatable portion 410, 510, 610 that may indicate an
  • the obstruction may result in a large spike in intra-esophageal pressure that exceeds the expansion pressure and causes the compliant components to expand and receive fluid from the inflatable portion 510, 610.
  • the reduction in fluid in the inflatable portion 510, 610 causes the constriction around the patient's stomach to loosen, in order to relieve the spike in pressure and allow the obstruction to pass through the esophageal-gastric junction.
  • the obstruction passes, the increased pressure in the inflatable portion 510, 610 is reduced, and the fluid flows back into the inflatable portion 510, 610 due to the elasticity of the compliant components 512, 514, 516, 614, 616, to restore the original amount of
  • constriction of the gastric band 505, 605 This change in constriction of the gastric band 505, 605 results or is achieved without the use of flow rate limiting devices or valves.
  • the various compliant components disclosed herein may have any shape or configuration that facilitates removing an amount of fluid from the inflatable portion of the gastric band in response to an increased pressure in the inflatable portion.
  • the compliant components may be selected from a group consisting of a compressible reservoir, an elastic polymer, a balloon, a rubber container, a silicone container, a collapsible container, a bellows, and combinations thereof that are configured to contain the fluid.
  • the graph in FIG. 7A illustrates, according to various embodiments, the effect the compliant components described herein have on the pressure in the gastric banding system.
  • a standard gastric banding system without compliant components has a certain pressure-volume relationship.
  • the pressure-volume relationship generally takes the form illustrated by the
  • the self-adjusting gastric banding system may include a greater volume of saline than a standard gastric banding system for a given level of pressure .
  • the graph in FIG. 7B illustrates, according to various embodiments, pressure characteristics of a "Standard" gastric banding system and a "Self-Adj usting" gastric banding system during use of the systems in a patient.
  • the two systems are set to the same operating pressure, for example, for a desired level of constriction of the patient's stomach.
  • the pressure in each system increases.
  • the standard system has a larger pressure increase during the period of obstruction than the self-adjusting gastric banding system experiences.
  • This smaller increase in pressure is due to the addition of the reservoir space in the compliant component (s) .
  • pressure in the gastric banding system increases, fluid is transferred into the reservoir space. Once the obstruction passes, the fluid is automatically returned from the reservoir space back into the gastric band.
  • FIG. 8A illustrates an embodiment of a vacuum device 800 which may be used to assist the patient in transferring fluid into a reservoir 805 from a gastric band (not shown) to allow a large bolus to pass through the constriction of the gastric band.
  • the vacuum device 800 may include a tip 810, which in one embodiment, may have a diameter substantially equal to the diameter of the reservoir 805.
  • the vacuum device 800 when the vacuum device 800 is activated and brought close to a patient's skin 815, the vacuum device 800, by using suction, may form a seal on a contacted area of the patient's skin 815 and slightly pull or tug on the patient's skin 815 and a subcutaneous fat layer 820 located below the skin 815.
  • the vacuum device 800 may be configured to provide suction strength of differing magnitudes, but without harming the patient. Since there is no pathway for air or bodily fluids to collect between the subcutaneous fat layer 820 of the patient and the top surface of the reservoir 805, the top surface of the reservoir 805 may be pulled towards the vacuum device 800 along with the subcutaneous fat layer 820.
  • fluid may flow out of the gastric band (not shown) and into the reservoir 805 thereby relaxing a constriction caused by the gastric band and allowing a bolus of food to pass through the constriction.
  • the compliant tubing-reservoir system 900 may include a tubing 905 which terminates at or inside a balloon or a reservoir 910.
  • the tubing (not shown in FIG. 5) may connect an injection port (e.g., injection port 535 of FIG. 5) and a reservoir (e.g., port compliant portion 516 of FIG. 5) thereby allowing a fluid path to travel through the tubing 905 to the reservoir 910.
  • the tubing 905 may, in one embodiment, continue and pass through.
  • the tubing-reservoir system 900 may relieve increases in pressure, for example, generated by the passing of a large bolus swallowed by the patient.
  • the relief may result from the transfer of fluid or other substances from an inflatable portion (not shown) through the tubing 905 and into the elastically deformable balloon or reservoir 910.
  • FIG. 10 illustrates one embodiment of a fluid path connecting component for a pass-through tubing-reservoir system 1000 where a tubing 1005 passes through both a first opening
  • the tubing 1005 may include a gap or cut 1015 inside the reservoir 1010 (which creates a fluid path between the tubing 1005 and the reservoir 1010) .
  • the gap 1015 is sealed within the reservoir 1010 such that the addition of fluid may enlarge the reservoir 1010 while the reduction of fluid may shrink or decrease the size of the reservoir 1010.
  • the tubing-reservoir system 1000 may relieve increases in pressure, for example, generated by the passing of a large bolus swallowed by the patient. The relief may result from the transfer of fluid or other substances from an inflatable portion (not shown) through the tubing 1005 and into the elastically deformable reservoir 1010.
  • FIG. 11 illustrates an embodiment of a pass-through tubing-reservoir system 1100 where a tubing 1105 passes through both a first opening 1120 and a second opening 1125 of a balloon or reservoir 1110.
  • the tubing 1105 is shown with a series of holes or slits 1115 located at a position inside the reservoir 1110 which allows fluid and/or other substances to exit the tubing 1105 and into the reservoir 1110.
  • the same holes or slits 1115 further allow fluid and/or other substances to enter the tubing 1105 from the reservoir 1110, thereby creating the fluid path between the tubing 1105 and the reservoir 1110.
  • the tubing-reservoir system 1100 may relieve
  • FIG. 12 illustrates an embodiment of a compliant pass- through tubing-reservoir system 1200 where a tubing 1203 passes through both a first opening 1255 and a second opening 1260 of a balloon or reservoir 1250.
  • the system 1200 may also include a first collar 1265 and a second collar 1270 for facilitating the connection of the reservoir 1250 to the tubing 1203.
  • the tubing 1203 may be fixed to the reservoir 1250 by the customizably- fitted first collar 1265 and the customizably-fitted second collar 1270.
  • the tubing 1203 and/or the reservoir 1250 may be compliant components creating a fluid path between a gastric band 1205 and a port 1235.
  • the gastric band 1205 and the port 1235 may be the gastric band 405 and the port 435 of FIG. 4, respectively.
  • the gastric band 1205 may include a circular ring 1207 and an inflatable portion 1210. Similarly, the circular ring 1207 and the inflatable portion
  • the tubing-reservoir system 1200 may relieve increases in pressure, for example, generated by the passing of a large bolus swallowed by the patient.
  • the relief may result from the transfer of fluid or other substances from the inflatable portion 1210 through the tubing 1203 and into the elastically deformable reservoir 1250.
  • the balloons/reservoirs 910, 1010, 1110 and 1250 may be a spherical balloon constructed of
  • balloon/reservoirs 910, 1010, 1110 and 1250 may be any other shape (e.g., a cylindrical balloon, etc.).
  • each of the tubing-reservoir systems 900, 1000, 1100 and 1200 may be considered a compliant system having one or more compliant components.
  • the systems 900, 1000, 1100 and 1200 may be arranged with other components of a gastric banding system (e.g., gastric banding system 500 or 600) in series or in parallel with each other to optimize the overall compliance, and to add redundancy to the gastric banding system (e.g., gastric banding system 500 or 600), if desired.
  • a gastric banding system e.g., gastric banding system 500 or 600
  • FIGS. 13A-C illustrate one embodiment of a compliant gastric banding system 1300 having a compliant reservoir 1303.
  • the compliant gastric banding system 1300 may further include a gastric band 1305 having a ring 1307 and an inflatable portion 1310 fluidly coupled to an access port 1335 via the reservoir 1303.
  • the reservoir 1303 may have a tube-like
  • balloon-type reservoir e.g., reservoir/balloon 910, 1010, 1110, 1250
  • FIG. 13A generally illustrates the reservoir 1303 in an as-extruded view.
  • the reservoir 1303, as further shown by FIGS. 13B and 13C, may include a star-shaped structure defining an outer circumference 1350 and may be sized to expand when holding fluid that is displaced from an adjacent non-compliant fluid-carrying device (e.g., the inflatable portion 1310) .
  • the reservoir 1303 may include star-shaped folds when in a natural, deflated state as shown in FIG. 13B.
  • the star-shaped folds may deform and expand, thereby changing the appearance of the outer circumference 1350 as shown in FIG. 13C.
  • the outer circumference 1350 may appear more similar to a normal, cylindrical tube.
  • the star-shaped folds may begin to re ⁇ appear and the outer circumference 1350 may revert back to its star-shaped form as shown in FIG. 13B.
  • the reservoir 1303 may be constructed from a polymer such as silicone, in various durometers so as to expand at a controlled rate.
  • FIGS. 14A and 14B illustrate one embodiment of a compliant tube-like reservoir 1403 in an as-molded state (e.g., when not overly filled with a fluid) and an expanded state (e.g., when filled with a fluid above a threshold volume), respectively.
  • the reservoir 1403 may replace a balloon-type reservoir (e.g., reservoir/balloon 910, 1010, 1110, 1250) or another tube-like reservoir (e.g., reservoir 1303) as a
  • the reservoir 1403 may appear very similar to a non- compliant, stiff tube when in a natural, as-molded state as shown in FIG. 14A. However, as fluid and/or other substances begin to move into the reservoir 1403 and exert pressure on the inner walls, the elastic wall of the reservoir 1403 may begin to deform and expand, thereby appearing more similar to the
  • the reservoir 1403 may be constructed from a polymer such as silicone, in various durometers so as to expand at a controlled rate.
  • the reservoir 1403 may have a uniform diameter of between about 1 and 100 millimeters in a natural, as-molded state and may inflate to a diameter of about 10 to 1000 millimeters in an expanded state (as measured at the location of the greatest diameter) .
  • FIG. 15 illustrates one embodiment of a compliant gastric banding system 1500 having a compliant reservoir 1503.
  • the compliant gastric banding system 1500 may further include a gastric band 1505 having a ring 1507 and an inflatable portion 1510 fluidly coupled to an access port 1535 via the reservoir 1503.
  • the reservoir 1503 may have a flattened tube ⁇ like appearance and may replace a balloon-type reservoir (e.g., reservoir/balloon 910, 1010, 1110, 1250) as a compliant
  • the reservoir 1503 may appear to have a flattened, tubular structure and may be sized to expand and hold fluid displaced from an adjacent non- compliant reservoir (e.g., inflatable portion 1510).
  • the reservoir 1503 may be a fluid conduit for fluid transfer between the gastric band 1505 and the access port 1535.
  • the reservoir 1503 may be designed to be the
  • compliant component may function to allow for expansion so that unwanted fluid may move from a coupled stiffer tube (e.g., tube 1512 or 1513) , thus reducing the amount of fluid in the stiffer tube (e.g., the tube 1512 or 1513), for a short period of time, when pressure is applied to the fluid within the stiffer tube (e.g., the tube 1512 or 1513).
  • a coupled stiffer tube e.g., tube 1512 or 1513
  • the stiffer tube e.g., the tube 1512 or 1513
  • FIG. 15A is a cross-sectional view of the reservoir 1503 of FIG. 15 and illustrates that a cross-sectional area 1515 within the reservoir 1503 where the fluid flows is continuous and smaller than a cross-sectional area 1517 of the reservoir 1503 itself.
  • improved performance may be achieved through reduction of the effects of the external forces on fluid within an adjacent, non-compliant component.
  • the reservoir 1503 of FIG. 15 may be replaced by a reservoir 1603 of FIG. 16.
  • a cross-section of the tube 1603 is illustrated in FIG. 16.
  • a cross- sectional area 1615 within the reservoir 1603 where the fluid flows is continuous and smaller than a cross-sectional area 1617 of the tube reservoir itself.
  • improved performance may be achieved through reduction of the effects of the external forces on fluid within an adjacent, non- compliant component.
  • the tube 1603 may, in one embodiment, have a smaller cross- sectional area 1617 where fluid may flow such that, an increase in fluid may cause indented portions 1619 and 1621 to expand.
  • the reservoir 1503 of FIG. 15 may be replaced with a reservoir 1703 of FIG. 17A.
  • a cross-section of the reservoir 1703 is illustrated in FIG. 17A.
  • a cross-sectional area 1715 within the reservoir 1703 where the fluid flows is continuous and smaller than a cross-sectional area 1717 of the reservoir 1703 itself.
  • the reservoir 1703 may, in one embodiment, include a U-shaped tubular structure sized to expand such that a top portion 1719 may be configured to expand from a U-shaped curve to a flatter curve (as shown in FIG. 17B) when more fluid is added to the reservoir 1703.
  • the flatter curve may protrude outward (as shown in FIG. 17C) .
  • the bottom portion 1721 may expand
  • FIGS. 17B and 17C longitudinally (e.g., straighten out) as shown in FIGS. 17B and 17C.
  • the reservoirs 1503, 1603 and 1703 may each be
  • durometers By controlling the durometer of the constructed material, the expansion rates as fluid is added to the
  • reservoirs 1503, 1603 and 1703 may be controlled.
  • FIG. 18A illustrates an embodiment of a compliant tube- on-tube reservoir system 1800.
  • the reservoir system 1800 may replace a balloon-type reservoir (e.g., reservoir/balloon 910, 1010, 1110, 1250) or another tube-like reservoir (e.g.,
  • the compliant tube-on-tube reservoir system 1800 may include a tube 1803 having an outer tube 1810 and joining portions (first joining portion 1807 shown here) configured to couple the tube 1803 (including an inner compliant tube 1805, shown in FIG. 18B) with non-compliant tube portions 1811 and 1813.
  • FIG. 18B illustrates a cross sectional view of the system 1800, including the internal structure not shown in FIG. 18A.
  • the inner compliant tube 1805 may enlarge when fluid is introduced into the cavity of the inner compliant tube 1805.
  • the inner compliant tube 1805 may include a diameter
  • the inner compliant tube 1805 may be coupled to the non-compliant tube portions 1811 and 1813 by the first joining portion 1807 and a second joining portion
  • the joining portions 1807 and 1809 may be configured to have an inner circumference sized to fit both the inner compliant tube 1805 and the non-compliant tube portions 1811 and 1813.
  • the joining portions 1807 and 1809 do not contact one another, but instead form a gap 1806 between them.
  • the gap 1806 may further be defined by the outer surface of the inner compliant tube 1805 and the inner surface of the outer tube 1810.
  • the gap 1806 may serve as a sealed space for expansion of the inner compliant tube 1805 and to provide a buffer when the outer tube 1810 is compressed.
  • the outer tube 1810 may, in one embodiment, be rigid, and may be further sized to fit the joining portions 1807 and 1809 within its internal cavity. Generally, as a patient's body presses on the non-compliant tube portions 1811 and 1813, and/or on the outer tube 1810, kinks, bending, or compression which disrupts fluid flow may be prevented.
  • FIGS. 18C - 18G illustrate a method of constructing the system 1800 of FIGS. 18A and 18B.
  • the inner compliant tube 1805 may be inserted into the first joining portion 1807 and the second joining portion 1809.
  • an adhesive may be used to attach the surfaces.
  • FIG. 18D illustrates the outer tube 1810
  • FIG. 18F illustrates the compliant tube 1803 as fully constructed.
  • FIG. 18G illustrates the insertion of the two non-compliant tube portions 1811 and 1813 into the compliant tube 1803 to complete the tube-on-tube reservoir system 1800.
  • port compliant components 516 and 616 may be used in accordance with various embodiments, such that when the pressure in the
  • FIGS. 19A-19B, 20A-20B and 21A-21C illustrate additional compliant reservoir systems 1900, 2000 and 2100, respectively, that may be implemented as port compliant components 516 and 616.
  • the compliant reservoir systems 1900, 2000 and 2100 may be constructed such that a portion of their compliance comes from a conformational change or a shape-change in the systems 1900, 2000 and 2100. For example, as the pressure inside the reservoir systems 1900, 2000 and 2100 increases, one or more portions may move to a different location or change to a different state. More particularly, the systems 1900, 2000 and 2100 take on a different shape in a pressurized state.
  • the compliant reservoir system 1900 may be "coiled" in a precurved shape as shown in an
  • a proximal end 1905 of the coiled, precurved shape may begin to "uncoil” and straighten out as the system
  • the 1900 expands from a flat tube to a more rounded tube, as shown in FIG. 19B. As the pressure is removed, the system 1900 may reform and revert into the coil-like shape due to stresses in the material.
  • FIG. 20A illustrates a compliant reservoir system 2000 having a distal end 2010 and "coiled wings" 2005.
  • system 2000 may have four “coiled wings” but any number of “coiled wings” may be implemented.
  • the “coiled wings” in FIG. 20A are shown in an unpressurized state.
  • FIG. 20B illustrates the system 2000 in a pressurized state.
  • the "coiled wings” are straightened out and no longer in the coiled position.
  • the system 2000 may reform and revert into the coil-like shape due to stresses in the material.
  • FIG. 21A illustrates a compliant reservoir system 2100 having a distal opening 2110, a body portion 2115 and a bulged proximal end 2105.
  • the bulged proximal end 2105 may enlarge.
  • FIG. 21B illustrates the system 2100 in a pressurized state with an enlarged bulged proximal end 2105 storing the fluid.
  • the bulged proximal end 2105 may further increase in size.
  • the body portion 2115 may remain substantially the same size or increase slightly in response to the introduction of fluid.
  • FIG. 21C illustrates the system 2100 when a large amount of fluid is introduced into the system 2100, thereby causing the preferential inflation of the bulged proximal end 2105.
  • other portions of the system 2100 may also incrementally increase in size such as the body portion 2115. As pressure is removed, the system 2100 may revert to the shape of FIG. 21A due to stresses in the material.
  • compliant reservoirs may include internal structures such as springs, cages and/or rings .
  • FIG. 22 illustrates an embodiment of a compliant
  • the compliant reservoir 2200 which may be integrated into the tubing (e.g., tubing 403 or 503) , added as an additional compliant component and/or attached to the access port (e.g., compliant component 516) .
  • the compliant reservoir 2200 may include a spring 2205 which provides a skeletal structure. As the patient's body presses on the compliant reservoir 2200, the spring 2205 prevents the compliant reservoir 2200 from being kinked, bent or compressed in a way that disrupts flow of fluid or causes unwanted fluid to move into the inflatable portions
  • the spring 2205 may provide the compliant reservoir 2200 properties including high radial stiffness and low axial stiffness. The radial stiffness allows the compliant reservoir 2200 to support weight applied externally while the low axial stiffness provides for volumetric expansion of the compliant reservoir 2200
  • the spring 2205 may provide internal support to resist loading from body tissues without an increase in pressure inside the compliant reservoir 2200.
  • FIG. 23 illustrates one embodiment of a compliant reservoir 2300 having an internal structure in the form of a cage 2305.
  • the compliant reservoir 2300 may be integrated into a tubing (e.g., tubing 403 or 503), added as an additional compliant component and/or attached to the access port (e.g., compliant component 516).
  • the compliant reservoir 2300 may include the internal cage 2305, which
  • the cage 2305 may provide the compliant reservoir with a skeletal structure. As the patient's body presses on the compliant reservoir 2300, the rings and bars of the cage 2305 may prevent the compliant reservoir 2300 from being kinked, bent or compressed in a way that disrupts the flow of fluid or causes unwanted fluid to move into the inflatable portions (e.g., inflatable portions 510 and 610) . In one embodiment, the cage 2305 may provide the
  • compliant reservoir 2300 high radial stiffness and low axial stiffness.
  • the radial stiffness may allow the compliant
  • the cage 2305 may provide internal support to resist loading from body tissues without an increase in pressure inside the compliant reservoir 2300.
  • the cage 2305 and the compliant reservoir 2300 may be configured to increase pressure relative to the volume displaced.
  • FIG. 24 illustrates one embodiment of a compliant reservoir 2400 having an internal structure in the form of parallel rings 2405.
  • the compliant reservoir 2400 may be integrated into a tubing (e.g., tubing 403 or 503), added as an additional compliant component and/or attached to the access port (e.g., compliant component 516).
  • the compliant reservoir 2400 may include the parallel rings 2405, which provides the compliant reservoir 2400 with a skeletal structure.
  • the parallel rings 2405 may be joined together.
  • the rings 2405 may prevent the compliant reservoir 2400 from being kinked, bent or compressed in a way that disrupts flow of fluid or causes unwanted fluid to move into the inflatable portions (e.g., inflatable portions 510 and 610) .
  • the rings 2405 may provide the compliant reservoir 2400 high radial stiffness and low axial stiffness. The radial stiffness may allow the compliant reservoir 2400 to support weight applied externally while the low axial stiffness provides for volumetric expansion of the compliant reservoir 2400 internally.
  • the rings 2405 may provide internal support to resist loading from body tissues without an increase in pressure inside the compliant reservoir 2400.
  • the rings 2405 and the compliant reservoir 2400 may be configured to increase pressure relative to the volume displaced.
  • the spring 2205, the cage 2305 and the parallel rings 2405 may be made of metals or polymers such as stainless steel, titanium, nitinol, PEEK, ultem, delrin, polycarbonate, polysulfone, among other materials. Materials used may further be combined to provide the desired properties. With respect to construction, the spring 2205, the cage 2305 and the parallel rings 2405 may be over-molded and/or contiguous with the compliant reservoir (e.g., compliant reservoirs 2200, 2300 and 2400).
  • the compliant reservoir e.g., compliant reservoirs 2200, 2300 and 2400.
  • Fig. 25 illustrates a reservoir 2500 with an outer protective layer 2505.
  • the outer protective layer 2505 may be an exoskeleton configured to wrap axially about the reservoir 2500.
  • the outer protective layer 2505 may protect the reservoir 2500 from external forces.
  • the outer protective layer 2505 may include a hinge cut 2510 causing a gap within the outer protective layer 2505.
  • the hinge cut 2510 may allow the outer protective layer 2505 to be deformable, thereby allowing the reservoir 2500 to be compliant even after the fluid-volume level of the reservoir 2500 causes the outer diameter of the reservoir 2500 to exceed the inner diameter of the outer protective layer 2505.
  • the hinge cut 2510 allows the outer protective layer 2505 to expand (increasing the width of the gap) , which in turn allows the reservoir 2500 to continue to expand as it receives additional fluid.
  • FIG. 25A is a cross- sectional view of the reservoir 2500 having the separate, overlaying outer protective layer 2505.
  • the reservoir 2500 may be attached or integrated with the outer protective layer 2505 (e.g., by using an adhesive).
  • the outer protective layer 2505 may further be used with reservoirs of different shapes.
  • FIG. 26 illustrates a cross sectional view of an outer protective layer 2605 surrounding a u-shaped reservoir 2600.
  • the outer protective layer 2605 may include an optional hinge cut 2610.
  • the reservoirs e.g., reservoirs
  • FIG. 27 illustrates a reservoir 2700 having four patterned depressions 2705 which may buckle (inward) in a reproducible manner when suction is applied to the reservoir 2700 by a surgical trocar (not shown) .
  • FIG. 28 illustrates a cross section of a reservoir 2800 having eleven patterned depressions 2805.
  • FIG. 29 illustrates a cross section of a reservoir 2900 having three patterned
  • FIGS. 27-29 illustrate reservoirs 2700, 2800 and 2900 having equally spaced depressions of different depths, non-uniformly spaced depressions are also possible for the purpose of guiding deflation.
  • FIG. 30A illustrates one embodiment of a compliant reservoir system 3000 which may include a gastric band 3005 having an inflatable portion 3010, a ring 3007 and a compliant portion
  • the gastric band 3005 may be fluidly coupled to a tubing 3003 and an access port 3035.
  • the compliant reservoir 3012 may be oriented circumferentially about the ring 3007.
  • the compliant reservoir 3012 may be in fluid communication (not shown) with the inflatable portion 3010 through a hole or other path (e.g., extending across the ring 3007). Accordingly, when a large bolus is swallowed by the patient, the fluid within the inflatable portion 3010 may be dispersed and may flow into the compliant reservoir 3012, thereby allowing the large bolus to pass through. Similar to the reservoirs 910, 1010, 1110 and
  • the compliant reservoir 3012 may be any compliant reservoir 3012.
  • FIG. 30B is a side view of the compliant reservoir system 3000 of FIG. 30A.
  • a compliant reservoir system 3100 may include a gastric band 3105 having an inflatable portion 3110, a ring 3107 and a compliant portion 3112.
  • the gastric band 3105 may be fluidly coupled to a tubing 3103 and an access port 3135.
  • the compliant reservoir system 3100 may further include vertical molding portions 3114.
  • the vertical molding portions 3114 may be equally spaced apart about the outer circumference of compliant reservoir 3112 and may, in one embodiment, be attached to the ring 3107, functioning to provide the compliant reservoir 3112 with structural support. In this manner, the compliant reservoir 3112 may be integrated with the ring 3107.
  • FIG. 32 illustrates a compliant reservoir system 3200 having a gastric band 3205 with an inflatable portion 3210 and a ring 3207.
  • the gastric band 3205 may in fluid communication with an access port 3235 and a plurality of compliant reservoirs 3212.
  • seven reservoirs 3212 may be oriented radially around the gastric band 3205 and may be coupled to the gastric band 3205 via corresponding tubing 3203. While each reservoir 3212 is shown to be substantially equidistant from the gastric band 3205, alternative geometries are possible (e.g., one or more of the reservoirs 3212 may be closer to the gastric band 3205 via shorting tubing) .
  • reservoirs 3212 may vary (e.g., any number of reservoirs 3212 between one and twenty inclusive, may be included) . These reservoirs 3212 may function similarly as the reservoirs 3012 and 3112 of FIGS. 30A and 31, respectively. For example, when a large bolus is swallowed by the patient, the fluid within the inflatable portion 3210 may be dispersed and may flow into any or all of the compliant reservoirs 3212, thereby allowing the large bolus to pass through.
  • the reservoir 3212 may be constructed out of any one or a combination of
  • the fill substances discussed herein may be applicable to any gastric banding system, including any of the compliant reservoir systems discussed above (e.g., systems 900, 1000, 1100, and 1200).
  • FIG. 33A illustrates a pressure-time graph 3300
  • a compliant reservoir system utilizing saline or another fluid with a non-compliant gastric banding system comparing a compliant reservoir system utilizing saline or another fluid with a non-compliant gastric banding system.
  • a large spike in pressure 3305 is exerted whereas the same large bolus passing through the constriction of a compliant reservoir system utilizing saline may result in a lower pressure spike 3310.
  • a higher pressure spike 3315 may occur when a small bolus passes through the constriction of the non-compliant gastric banding system
  • a lower pressure spike 3320 may occur when the same small bolus passes through the constriction of the compliant reservoir system utilizing saline.
  • FIG. 33A illustrates the benefits of a compliant reservoir system utilizing saline for situations where a large bolus is present over a non-compliant gastric banding system, further improvement may be possible with respect to small bolus reactions .
  • FIG. 33B illustrates a pressure-time graph 3350.
  • the pressure-time spikes 3305 and 3315 correspond to a large bolus and a small bolus, respectively, passing through a constriction formed by a non-compliant gastric banding system.
  • the pressure spikes 3355 and 3365 correspond to a large bolus and a small bolus, respectively, passing through a constriction formed by a compliant reservoir system utilizing non-saline substances. More particularly, when a large bolus is introduced, the compliant reservoir system utilizing non-saline substances may perform substantially similar to a compliant reservoir system utilizing saline substances (e.g., comparing pressure spike 3310 of FIG. 33A and pressure spike 3355 of FIG. 33B) . However, when a small bolus is introduced, the compliant reservoir system utilizing non-saline substances may perform substantially similar to a non-compliant reservoir system (e.g., comparing pressure spike 3315 of FIG. 33A and pressure spike
  • These non-saline substances which provide for the preferred pressure spikes 3315 and 3365 of FIG. 33B may include a pseudoplastic fluid, a Bingham plastic, and the like.
  • a pseudoplastic fluid may be utilized to fill a gastric banding system (e.g., gastric banding system 500, 600) .
  • a pseudoplastic fluid may exhibit a decrease in viscosity under increases in the shear rate. Accordingly, only a slight increase in pressure would lead to relatively low shear rates (and relatively high viscosity) while a more substantial increase in pressure would lead to relatively high shear rates
  • gastric banding system 500, 600 small to medium increases in pressure within the gastric banding system (e.g., gastric banding system 500, 600) will yield results similar to existing non-compliant gastric banding systems, while under higher pressure spikes, the pseudoplastic fluid (due to its lower viscosity at higher pressures) would flow out of the inflatable portions and into a reservoir, curbing the intensity of the pressure spike.
  • large pressure spike may occur, for example, when a large bolus is attempting to pass through a constriction of the non-compliant gastric banding system. Once the pressure minimizes and the baseline pressure in the gastric banding system is re-established, the pseudoplastic fluid may gradually return to the inflatable portions.
  • a Bingham plastic may be utilized as the fluid within the gastric banding system (e.g., gastric banding systems 500, 600) .
  • the Bingham plastic may be a
  • the Bingham plastic acts as a solid.
  • the Bingham plastic acts a fluid and may flow from the inflatable portions (e.g., the inflatable portion 510, 610) to a fluidly-coupled reservoirs (e.g., the reservoir 514, 614).
  • the inflatable portions e.g., the inflatable portion 510, 610
  • a fluidly-coupled reservoirs e.g., the reservoir 514, 614.
  • Bingham plastic may flow again and may return to the inflatable portions (e.g., inflatable portions 510, 610).
  • FIG. 34A illustrates a perspective view of one
  • gastric band system 3400 having a different fill material than saline.
  • the gastric band system 3400 may form a circumference about an upper stomach region of a patient and may provide pressure on the patient's stomach to induce satiety.
  • the gastric band system 3400 may include a gastric band 3405 having an outer ring 3407, cushions 3409 and one or more hinges 3411.
  • the cushions 3409 may be filled with a gel and/or other substances.
  • the cushions 3409 may be low durometer foam pads (e.g., less than 40
  • the gastric band 3405 may be self-contained and might not involve fluid systems having components such as tubing and access ports. As shown, the gastric band 3405 may include four cushions 3409 separated by four hinges 3411. However, additional cushions 3409 and/or hinges 3411 may be added, or one or more cushions 3409 and/or hinges 3411 may be removed.
  • the hinges 3411 and the outer ring 3407 may be constructed out of a plastic or other polymer having dimensional stability, low creep and relatively high modulus of elasticity such that it may operate to function as a torsion spring. For example, a PEEK or polysufone material may be utilized, among other materials. Alternatively, the hinges 3411 may be constructed out of metal (e.g., stainless steel, titanium, etc.). In one or more
  • a silicone rubber may encapsulate the hinge 3411.
  • each may function as a torsion spring generating a substantially constant force on the patient's stomach even when the inside diameter of the gastric band 3405 increases due to the passage of a large bolus of food.
  • an increase in the lever arm of the hinges 3411 partially opposes (and thus cancels out) the effect of the increasing deflection, thereby resulting in a constant force.
  • FIG. 34B illustrates a top view of the gastric banding system 3400 of FIG. 34A.
  • the hinges 3411 may be integrated with the outer ring 3407 and the cushions 3409 may have a length substantially spanning a non- hinge portion of the outer ring 3407.
  • the gastric banding system 3400 of FIGS. 34A and 34B may include a tunable hoop spring rate and may be customized to have an initial diameter for a given patient.
  • FIG. 35 illustrates a gas-filled gastric banding system 3500. While similar in appearance to the gastric banding system 3400 of FIGS. 34A and 34B, and including features like one or more hinges 3511 and one or more ring portions 3507, one
  • the cushions 3509 may be constructed out of different materials and may be filled with one or more gases including carbon dioxide, nitrogen, among others.
  • the gas-filled cushions 3509 By utilizing the gas-filled cushions 3509, lower radial stiffness may be achieved, thereby reducing discomfort for the patient when a large bolus attempts to pass through the
  • a suitable gas-impermeable membrane may be used in constructing the cushions 3509 to prevent the gas from leaking out.
  • a silicone rubber may be used.
  • coatings to further prevent gas leakage such as a diamond-like carbon, titanium nitrite, parylene, aclar, among other gas impermeable substances, and combinations thereof may be applied to the silicone rubber.
  • the gastric banding system 3500 might not require a traditional access port for occasional adjustment. Instead, an adjustment just prior to implantation may provide a constant pressure configured to serve the constriction and/or the neural
  • a gastric banding system 3600 may include a gastric band 3605 having a ring 3607 and an inflatable portion 3610 connected to a tube 3609 and an access port 3635.
  • the inflatable portion 3610, the tube 3609 and the access port 3635 may all be constructed out of gas impermeable substances such as silicone rubber and/or coated with gas impermeable substances including, but not limited to, a diamond-like carbon, titanium nitrite, parylene, aclar, among other gas impermeable substances and combinations of substances.
  • a hybrid gas-saline gastric banding system 3700 is illustrated in FIG. 37A.
  • the hybrid gas-saline gastric banding system 3700 may include a gastric band 3705 having a ring 3707 and an inflatable portion 3710.
  • the gastric band 3705 may be in fluid communication with a reservoir 3712 and an access port 3735 via tubing 3703.
  • the gastric banding system 3700 may be filled with a standard saline solution.
  • a further encapsulated member 3713 may also be present within the hybrid gas-saline gastric banding system 3700.
  • the encapsulated member 3713 may be a balloon filled with a gas such as carbon dioxide, nitrogen, and the like.
  • the encapsulated member 3713 may function to further provide
  • the encapsulated member 3713 is within the fluid path and may travel to any component of the gastric banding system 3700 in response to fluid movement through, e.g., the tubing 3703.
  • the tubing 3703 may travel to any component of the gastric banding system 3700 in response to fluid movement through, e.g., the tubing 3703.
  • encapsulated member 3713 may be configured to be located within or traverse back into the inflatable portion 3710 when a large bolus is not attempting to pass through (e.g., when the hybrid gas-saline gastric banding system 3700 is in an equilibrium state) .
  • the encapsulated member 3713 may be constructed out of silicone rubber and may be coated with one or more materials to enhance the ability of the silicone rubber to be gas impermeable thereby preventing the encapsulated member
  • the encapsulated member 3713 might not be designed to not fit through the tubing 3703 and traverse between the different components of the hybrid gas-saline gastric banding system 3700.
  • the encapsulated member 3713 may permanently reside in any one of the components, e.g., the reservoir 3712.
  • FIG. 37B illustrates the hybrid gas-saline gastric banding system 3700 utilizing a different encapsulated member
  • the encapsulated member 3714 in place of the encapsulated member 3713 of FIG. 37A.
  • the encapsulated member 3714 may have the functionality similar to the encapsulated member 3713 of FIG. 37A, but may be constructed out of a closed cell foam instead of gas.
  • Modifications may be further made to the hybrid gas- saline gastric banding system 3700. For example, other
  • the hybrid gas-saline gastric banding system 3700 as discussed above with respect to FIGS. 37A and 37B may be further modified to eliminate the access port
  • Eliminating the access port 3735 renders the hybrid gas-saline gastric banding system 3700 self-adjusting and may provide constant pressure on the stoma of the patient.
  • FIG. 38A illustrates another embodiment of a hybrid gas- saline gastric banding system 3800.
  • the hybrid gas- saline gastric banding system 3800 may include a gastric band 3805 having a ring 3807 and an inflatable portion 3810.
  • the gastric band 3805 may be in fluid communication with a reservoir 3812 and an access port 3835 via tubing 3803.
  • the gastric banding system 3800 may be filled with a standard saline
  • the reservoir 3812 may be cylindrical in shape and may be constructed out of a silicon rubber or another durable, gas impermeable material.
  • the tubing 3803 may be held in place within the reservoir 3812 by an adhesive layer or patch.
  • the reservoir 3812 may house a gas spring 3813.
  • the gas spring 3813 may be retained in the reservoir 3813 by radial interference (e.g., the gas spring 3813 may be designed to fit tightly within the reservoir 3812 to avoid slippage or other un-intended movement) .
  • radial interference e.g., the gas spring 3813 may be designed to fit tightly within the reservoir 3812 to avoid slippage or other un-intended movement
  • the gas spring 3813 while being movably fixed within the reservoir 3812, may still allow for fluid to pass through by having uneven surfaces (e.g., non-circular geometry which creates gaps and/or openings for fluid to pass through between an outside surface of the gas spring 3813 and an inner diameter of the reservoir 3812) .
  • the gas spring 3813 may operate to provide volume flexibility and/or low radial stiffness in the gastric banding system 3800. For example, when a large bolus of food passes through a constriction of the gastric band 3805, pressure caused by the bolus on the
  • inflatable portion 3810 may cause a transfer of fluid from the inflatable portion 3810 to the reservoir 3812.
  • One function of the gas spring 3813 is to alleviate the pressure spike caused by the food bolus by moving a piston within the gas spring 3813 and winding the gas spring 3813. Once the pressure is removed
  • the gas spring 3813 may unwind and revert back to a non- compressed orientation.
  • FIG. 38B illustrates the reservoir 3812 and the gas spring 3813 apart from the other portions of the hybrid gas- saline gastric banding system 3800.
  • FIG. 38C illustrates a further deconstructed view of the gas spring 3813 apart from the reservoir 3812.
  • a pin 3814 may be fixed in place to the inner diameter of the gas spring housing 3815 thereby limiting the movement of the piston 3816.
  • Arrow 3817 illustrates a direction of fluid pressure (e.g., caused by a large bolus passing through the constriction of the gastric band 3805) which may move the piston 3816 and compress the gas within the gas spring housing 3815.
  • the gas within the gas spring housing 3815 may be sealed between the piston 3816 and
  • the piston 3816 and the inner surface of the gas spring housing 3815 may be formed out of materials with very low coefficient of friction such that the overall friction force does not overly prevent the piston 3816 from moving when a fluid pressure is introduced.
  • the outside surface of the gas spring housing 3815 may include contact segments 3821 and fluid passageway segments 3820 configured in an alternating manner. An outer diameter of any given fluid passageway segment 3820 may be smaller than an outer diameter of any given contact segment 3821.
  • the contact segments 3821 may further include curved portions 3818 for contacting an inner diameter of the reservoir 3812 of FIG. 38B, thereby holding or fixing the gas spring 3813 in place.
  • the contact segments 3821 may further include flat portions 3819 which might not contact the inner diameter of the reservoir 3812, thereby allowing fluid flowing through the fluid passageway segment portions 3818 to also flow through the contact segments 3821. In this manner, fluid within the gastric banding system 3800 may flow from, for example, the gastric band 3805 to the access port 3835, and vice versa.
  • the flat portions 3819 and the curved portions 3813 of each contact segment 3821 may alternate in configuration around the circumference of the gas spring housing 3815.
  • FIG. 38D is a cross-sectional view of the reservoir 3812 and the gas spring 3813 apart from the other portions of the hybrid gas-saline gastric banding system 3800 to better
  • gas spring 3813 e.g., gas spring housing 3815, piston 3816, etc.
  • gas spring housing 3815, piston 3816, etc. may include gas-impermeable and/or saline-impermeable substances such as plastics like PTFE.
  • gastric banding system other components of the gastric banding system may be the gas-saline component.
  • an access port of any gastric banding system may be the gas-saline component.
  • FIGS. 39-41 illustrate various embodiments of access ports 3935, 4035, 4135. While the rest of the gastric banding system is not shown in these figures, the access ports 3935, 4035, 4135 may be in fluid communication with other components of the gastric banding system (e.g., a gastric band and/or a reservoir) via tubes 3903, 4003, 4103, respectively. For example, access ports 3935, 4003, 4103 may each be the access port 435 or 535.
  • the access ports 3935, 4003, 4103 may each be the access port 435 or 535.
  • the access port 3935 may include a movable surface 3936 which may move in response to a pressure change within the gastric banding system.
  • the movable surface 3936 may be a complaint portion that moves to increase the volume of the fluid portion 3941 (and therefore increases compliance) when the pressure increases within the gastric banding system (e.g., in response to a large bolus moving through a constriction of the gastric band) .
  • the movable surface 3936 may return to its original position, thereby decreasing the volume of the fluid portion 3941 of the access port 3935.
  • the access port 3935 may further include a septum 3938, a fluid-permeable membrane 3937, o-rings 3939 and a gas spring portion 3940 filled with a gas
  • the gas spring portion 3940 may be replaced with a wave spring, a cantilever spring, a constant force spring, a coil spring, a leaf spring, a Belleville spring, a hybrid polymer coil-air spring and the like.
  • a vacuum (not shown) may be incorporated in order to achieve the desired pressure response.
  • FIG. 40 illustrates an example of an access port 4035 having a wave spring 4040.
  • the access port 4035 may be in fluid communication with other components of the gastric banding system (e.g., a gastric band and/or a reservoir) via tube 4003.
  • the access port 4035 may include a movable surface 4036 which may move in response to a pressure change.
  • the movable surface 4036 may be a complaint portion that moves to increase the volume of the fluid portion 4041 (and therefore increases compliance) in response to a large bolus moving through a constriction of the gastric band (not shown) .
  • the movable surface 4036 may return to its original position thereby decreasing the volume of the fluid portion 4041 of the access port 4035.
  • the access port 4035 may be in fluid communication with other components of the gastric banding system (e.g., a gastric band and/or a reservoir) via tube 4003.
  • the access port 4035 may include a movable surface 4036 which may move in response to
  • 4035 may further include a septum 4038, a fluid-permeable membrane 4037, o-rings 4039 and a wave spring 4040.
  • the spring e.g., gas spring 3940 of FIG. 39 or wave spring 4040 of FIG. 40
  • the moving surface 4136 may comprise a flexible membrane that deforms when subjected to pressures above a certain threshold (which in one example, may be set to
  • the moving surface 4136 may return to its
  • the moving surface 4136 may be
  • the moving surface 4136 may be attached to the inner wall of the access port 4135 or may be integrated with a septum 4138 of the access port 4135.
  • Each of the access ports 3935, 4035 and 4135 may include a corresponding septum 3938, 4038 and 4138.
  • the septum 3938, 4038 and 4138 may function to allow a penetrating needle to add or remove fluid thereby adjusting the total fluid volume within the corresponding gastric banding system.
  • the access ports 3935, 4035 and 4135 may include a corresponding fluid-permeable membrane 3937, 4037 and 4137 having a plurality of small openings (not shown) which may be large enough to allow fluid to pass through, but are small enough to prevent the passage of the needle.
  • the fluid-permeable membranes 3937, 4037 and 4137 may be constructed out of a metal, ceramic, carbon, polymer or any combination thereof. Other materials may also be used so long as the material prevents the passage of the needle.
  • the fluid-permeable membranes 3937, 4037 and 4137 may be
  • the access ports 3935 and/or 4035 may include a corresponding sealing ring 3939 and 4039 to prevent fluid from entering the spring portions 3940 and 4040.
  • the sealing rings 3939 and 4039 may be a polymer o-ring, a metal seal ring, a ceramic seal ring, a polymer seal ring and the like .
  • restriction devices may also be utilized.
  • a one-way valve, a pressure relief valve, orifices, turbulence controllers, sponges, environment-adapting devices, among other restriction devices may control a rate at which a component (e.g., a compliant reservoir) may receive fluid from another component (e.g., a gastric band) .
  • FIG. 42 illustrates an embodiment of a gastric banding system 4200 having a gastric band 4205, an inflatable portion 4210, and a ring 4207 in fluid communication with a reservoir 4212 through a restriction device 4220. Also shown is an access port 4235 in fluid communication with the above-mentioned components of the gastric banding system 4200.
  • the restriction device 4220 may be electronically controlled, modulated with an external adjustment system or may be a passive restriction device configured to be independent from being controlled by an external tool or device.
  • restriction devices may be used within the fluid path of the gastric banding system 4200 or any other gastric banding system. Further, additional restriction devices may be added to achieve the desired flow rates.
  • FIG. 43 illustrates a graph 4300 depicting how the time-pressure curve may change when such a restriction device 4220 is used (e.g., an orifice having an inner diameter which limits the flow rate of the fluid in both directions) in one embodiment.
  • line 4305 is a time-pressure curve corresponding to a standard non-compliant band.
  • the pressure may sharply rise when a large bolus encounters the constriction formed by the standard non-compliant band may become obstructed.
  • the pressure may remain high for the duration of the obstruction caused by the bolus, and the patient may experience discomfort for a long period of time.
  • Line 4315 is a time- pressure curve corresponding to a compliant band without a restriction device. As shown, the large bolus of food may cause only a modest increase in pressure (and hence, lesser patient discomfort) as the bolus passes through a constriction formed by the compliant band without the restriction device. This
  • Line 4310 is a time-pressure curve corresponding to a compliant band with a restriction device (e.g., as shown in FIG. 42) .
  • the pressure may rise quickly causing the patient to feel pressure for a short period of time as the fluid drains slowly from the band (e.g., the gastric band 4205) and into the reservoir (e.g., the reservoir 4212).
  • the band drains enough fluid into the reservoir to allow the bolus to pass through, thereby returning the pressure near equilibrium.
  • FIG. 44A illustrates an embodiment of an always-open gastric banding system 4400 including a gastric band 4405 having a ring 4407 and an inflatable portion 4410. Instead of having a flexibly-stiff ring locked in place at an open end (as
  • the gastric band 4405 does not include a locking portion and replaces the flexibly-stiff ring with a more inflexible ring (e.g., ring
  • the gastric band 4405 may flex open when a large bolus moves through the constriction of the gastric band 4405 on the stomach region. Once the large bolus passes the constriction of the gastric band 4405, the gastric band 4405 may return to its original
  • the gastric banding system 4400 may include a variable width gap 4440 between the opposite ends of the gastric band 4405.
  • the gap 4440 may serve to provide a more effective response to a patient's anatomy and physiological conditions (e.g., swallowing a large bolus).
  • FIG. 44B illustrates another embodiment of the gastric banding system 4400 of FIG. 44A.
  • the gastric banding system 4400 further includes elastic members 4450, which may be tethered to "close" the variable width gap 4440.
  • the elastic members 4450 may be constructed out of a flexible polymer and may function to enhance the ability of the gastric banding system 4400 to remain in place.
  • a gastric band may also be used in addition to and/or as an alternative to gastric banding systems having an "open" configuration (e.g., the gastric banding system 4400)
  • a gastric band may also be
  • FIG. 45 is configured to have portions of various sizes.
  • the standard gastric band 4505 having a ring 4507 providing structural support to an inflatable portion 4510. As shown, the standard gastric band 4505 is placed or fixed about the esophageal-gastric junction between a patient's esophagus 4570 and stomach 4580.
  • FIG. 46 illustrates an embodiment with a wider section. As shown in the cross-sectional view of FIG. 46, the improved gastric band 4605 may still include a ring 4607 and an
  • the design of the ring 4607 may include a standard portion 4617 and a wider portion 4627, and the inflatable portion 4610 may include a corresponding standard portion 4611 and a corresponding wider portion 4612.
  • the wider portions 4612 and 4627 may be placed orad (closer or toward the mouth of the patient) as compared to the standard portions 4611 and 4617.
  • the wider portions 4612 and 4627 may operate to stimulate and restrict the patient's esophageal- gastric junction when the patient is not eating or swallowing small boluses.
  • the wider portions 4612 and 4627 may channel the medium bolus through the standard portions 4611 and 4617.
  • the wider portions 4612 and 4627 may function to relieve the stress on the patient's tissue and assist to prevent formations of pouch dilatations.
  • the wider portions 4612 and 4627 may increase in diameter in the orad direction.
  • Optional suture tabs may also be added to the gastric band 4605, for example, when the additional width of the wider portions 4612 and 4627 render it preferable that a standard gastro-gastric suturing process is not used.
  • the wider portions 4612 and 4627 may be adjustable.
  • the wider portions 4612 and 4627 may have the same properties as the standard portions 4611 and 4617 (e.g., same materials, durometer, balloon-to-ring width ratio). Additionally, and/or as an alternative, the height of the ring 4607 and/or the height of the inflatable portion 4610 may be adjustable and might not span the entire height of the gastric band 4600 (not shown) .
  • FIG. 47A illustrates a gastric banding system 4700 having a gastric band 4705, a tube 4703 and an access port 4735.
  • the gastric band 4705 may include inflatable portion 4710 without the presence of a ring.
  • the gastric banding system 4700 may be more compliant.
  • the gastric banding system 4700 may rely on the inflatable portion 4710 alone for ring structure.
  • FIG. 47B illustrates a
  • FIG. 48A illustrates another embodiment of a gastric banding system 4800 having a gastric band 4805, a tube 4803 and an access port 4835.
  • the gastric band 4805 may include inflatable portion 4810 and modified ring 4807 having holed portions 4808.
  • the addition of the holed portions 4808 may increase the compliance of the gastric banding system 4800.
  • FIG. 48B illustrates a perspective view of the gastric band 4805 with holed portions 4808.
  • the inflatable portion 4810 and the other structures of the gastric banding system 4800 have been omitted for clarity.
  • FIG. 49A illustrates another embodiment of a gastric banding system 4900 having a gastric band 4905, a tube 4903 and an access port 4935.
  • the gastric band 4905 may include an inflatable portion 4910 and modified ring 4907 having cut-out or tapered portions 4908.
  • the cut-out or tapered portions 4908 may increase the compliance of the gastric banding system 4900.
  • FIG. 49B illustrates a perspective view of the gastric band 4905 with the cut-out or tapered portions 4908.
  • the inflatable portion 4910 and the other structures of the gastric banding system 4800 have been omitted for clarity.
  • the gastric bands 4705, 4805 and 4905 may be more flexible (e.g., by having decreased ring stiffness) than a standard gastric band, thereby resulting in gastric banding systems 4700, 4800 and 4900, respectively, having muted pressure or force spikes on the tissues (e.g., in the esophageal-gastric junction) in a patient when the patient consumes a large bolus of food.
  • each of the gastric bands 4705, 4805 and 4905 may have different, configurable torsional and ring
  • an embodiment may include one compliant component
  • any combination of the ring, the tubing, and the access port may be compliant.
  • an embodiment may include a compliant ring and a compliant port, an embodiment may include compliant tubing and a compliant port, or an embodiment may include a compliant ring and compliant tubing. Any combination of compliant components is within the scope of the present invention.
  • each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
  • each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims .

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Abstract

L'invention concerne, de manière générale, des systèmes d'anneaux gastriques à auto-ajustement automatique et des améliorations apportées à ceux-ci, lesdits systèmes étant aptes à se relâcher et de se contracter automatiquement en réponse à un grand bolus passant à travers la zone d'estomac restreinte par un anneau gastrique d'un patient. En variante et/ou en outre dans un ou plusieurs modes de réalisation, les systèmes d'anneaux gastriques selon l'invention peuvent également empêcher une dilatation et/ou une érosion de poche. L'appareil et les systèmes selon l'invention aident à faciliter le contrôle de l'obésité et/ou à traiter des maladies liées à l'obésité tout en étant généralement non invasifs une fois implantés. De plus, certains modes de réalisation des systèmes d'anneaux gastriques à auto-ajustement selon l'invention sont automatiquement ajustables sans mécanismes compliqués de commande de fluide, dispositifs de limitation de débit et/ou soupapes. Les ajustements automatiques peuvent également être faits en réponse à d'autres changements dans la jonction œsophago-gastrique du patient, par exemple en réponse à des changements de dimension, de forme et/ou d'emplacement.
EP12713446.8A 2011-03-16 2012-03-14 Anneau gastrique à auto-ajustement Withdrawn EP2685945A2 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US13/049,453 US20110270024A1 (en) 2010-04-29 2011-03-16 Self-adjusting gastric band having various compliant components
PCT/US2011/032404 WO2011139505A1 (fr) 2010-04-29 2011-04-14 Bande gastrique à ajustement automatique ayant différents composants élastiques
US13/149,585 US20120095288A1 (en) 2010-04-29 2011-05-31 Self-adjusting gastric band
US13/216,132 US9044298B2 (en) 2010-04-29 2011-08-23 Self-adjusting gastric band
PCT/US2012/029041 WO2012125700A2 (fr) 2011-03-16 2012-03-14 Anneau gastrique à auto-ajustement

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EP2685943A2 (fr) 2014-01-22
WO2012125694A3 (fr) 2012-11-22
WO2012125700A3 (fr) 2012-12-13
WO2012125694A2 (fr) 2012-09-20
EP2685943B1 (fr) 2016-03-09
WO2012125700A2 (fr) 2012-09-20
WO2012125698A1 (fr) 2012-09-20
EP2685944A1 (fr) 2014-01-22

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