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 and apparatus and uses thereof for treating obesity and/or obesity-related diseases, and more specifically, relates to gastric banding systems that self-adjust to changes in a patient and/or provides a satiety booster.
• 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.
• 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. But in some
• the patient may swallow a bolus that is too large to pass through the constriction produced by the band.
• the result can be a painful experience which, if it persists, may require medical intervention to release the blockage.
• 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
• 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 receives fluid leaving the chamber in the stomach band.
• the pressure chamber D is separated from the esophageal-gastric junction of the patient's stomach.
• the power storage device operates the conveyance device to move fluid between expandable chambers to adjust the gastric band.
• a gastric band having a bladder that a patient may press to obtain a satiety boost.
• certain embodiments of the self-adjusting gastric banding systems disclosed herein may be automatically adjustable without complicated fluid control mechanisms, flow rate limiting
• 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 band In one embodiment, a self-adjusting gastric band
• the gastric band comprises an inflatable portion that is disposable about an esophageal-gastric junction of the patient.
• the gastric band also comprises an access port fluidly coupled to the inflatable portion via tubing to fill and drain the inflatable portion.
• 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 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.
• satiety boosting bladders which may transfer fluid from the bladder to inflatable portions of a gastric band, thereby tightening the gastric band and providing the patient a "satiety boost". After a period of time, the fluid may return from the gastric band back to the satiety boosting bladder.
• the satiety boosting bladder may be designed to allow for the free flow of fluids in and out of the gastric banding system without requiring valves and without the need to interface with an injection needle.
• the satiety boosting bladder may allow for intentional fluid transfer when the patient consciously presses on the bladder (by pressing on the skin area near the bladder) .
• a gastric band system may include a satiety boosting bladder located in fluid connection between the gastric band and an access port.
• the satiety boosting bladder may be physically located beneath the skin of a patient but above the rectus muscle fascia such that the patient may induce pressure on the bladder and disperse fluid to the gastric band by pressing on the skin area closest to the location of the bladder .
• the satiety boosting bladder may be fluidly coupled to one end of an access port, wherein the access port may be located between the satiety boosting bladder and a tube coupling the access port to a gastric band.
• the satiety boosting bladder may be spherically shaped, rectangularly shaped, or circularly shaped. Additionally, and/or alternatively, the satiety boosting bladder may have non-uniform, tapered walls.
• the satiety boosting bladder may be a series of cylindrical components or a coiled component.
• the satiety boosting bladder may include flow restriction or flow controlling components such as a flow restrictor and/or a valve.
• FIG. 1A illustrates a prior art system that includes a flow rate limiting device.
• FIG. IB illustrates a prior art system that includes a fluid control mechanism.
• FIG. 1C illustrates a prior art system that includes a valve and a chamber separated from the esophageal-gastric junction .
• FIG. 2 illustrates a prior art system with a pressable injection port.
• FIG. 3 illustrates a prior art system with a gastric banding system that is immune to deliberate influence by a patient .
• 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. 7 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. 8 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. 9 illustrates a gastric banding system with a satiety boosting bladder according to an embodiment of the present invention.
• FIG. 10 illustrates an exploded, perspective view of a gastric banding system having a satiety boosting bladder
• FIG. 11 illustrates an exploded, perspective view of another gastric banding system having a satiety boosting bladder according to an embodiment of the present invention.
• FIG. 12 illustrates an exploded, perspective view of a gastric banding system having a "T-connected" satiety boosting bladder according to an embodiment of the present invention.
• FIG. 13 illustrates a circular satiety boosting bladder according to an embodiment of the present invention.
• FIG. 14 illustrates a rectangular satiety boosting bladder according to an embodiment of the present invention.
• FIG. 15 illustrates a series of cylindrical bladders according to an embodiment of the present invention.
• FIG. 16 illustrates a series of differently sized cylindrical bladders according to an embodiment of the present invention .
• FIG. 17 illustrates a coiled bladder according to an embodiment of the present invention.
• FIG. 18 illustrates a cross-sectional view of a satiety boosting bladder according to an embodiment of the present invention .
• FIG. 19 illustrates a bladder having a flow control mechanism according to an embodiment of the present invention.
• FIG. 19A illustrates a close up view of the flow control mechanism of FIG. 19 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 gastric 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 gastric 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 gastric band return the gastric band to its original size and shape.
• electrical power and/or power external to the patient is not utilized to perform these
• a self-adjusting gastric banding system 400 comprises a gastric band 405 coupled to a
• the gastric band 405 comprises a circular ring 407 and an inflatable portion 410 disposed on the inside of the ring 407.
• 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 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
• 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 injections.
• 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
• 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
• 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
• an embodiment may include one compliant component — only the ring, the tubing, or the access port may be compliant.
• 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 contemplated within the scope of the present invention.
• 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 .
• a band compliant 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, and may be coupled to the ring 507 and the inflatable portion.
• 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.
• the 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 compliance.
• 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.
• the compliant component 616 may be fluidly coupled to the access port 635 at multiple locations.
• any combination of the inflatable portion 510, 610, the compliant component 512, the compliant ring 407, the tube compliant component 514, 614, and/or the port compliant component 516, 616 may be used in accordance with various embodiments.
• 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 increased pressure in the inflatable portion 510, 610 is
• 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 graph in FIG. 7 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. After the gastric banding system is flushed with saline to remove any air trapped within the system (e.g., in the gastric band, the tubing, and the port) , the pressure-volume
• 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. 8 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.
• 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 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.
• implanted bladder which provides a satiety boost by transfer fluid within the implanted bladder to an inflatable portion of the gastric band, thereby tightening the gastric band and causing the patient to feel full.
• FIG. 9 illustrates a gastric band system 900 which may include a gastric band 905 in fluid
• the gastric band system 900 may be implanted between the skin 955 of the patient and the rectus muscle fascia 965.
• the patient may press on the patient's skin near the location of the bladder 917 as designated by arrow 980.
• pressure may be exerted on the bladder 917, causing fluid from the bladder 917 to be transferred to the gastric band 905, thereby tightening the gastric band 905.
• the gastric band 905 and the port 935 may be implanted as usual with the bladder 917.
• an additional step may be added to the implantation procedure so that a surgeon may tunnel an extra pouch between the skin 955 and the rectus muscle fascia 965.
• the extra pouch may be positioned under the subcutaneous fat or on top of the
• subcutaneous fat and the bladder 917 may be positioned within the tunneled pouch.
• the gastric band 905 may be adjusted as usual by inserting a needle into the access port 935 and adding fluid as necessary. Once the proper adjustment has been made, the patient may feel or experience significantly increased satiety. If the patient feels hungry during a period which their physician has deemed inappropriate (e.g., between normal size meals) , the patient may want to temporarily suppress their appetite by pressing on the skin near the arrow 980, as discussed above.
• FIG. 10 illustrates one embodiment of a gastric band system 1000.
• the gastric band system 1000 may include a gastric band 1005 comprising an inflatable portion 1010 in a compliant ring 1007.
• the gastric band 1005 may be in fluid communication with the bladder 1017 which in turn may be in fluid communication with an access port 1035.
• the bladder 1017 may be of an ellipsoidal shape and may be located between the gastric band 1005 and the access port 1035.
• FIG. 11 illustrates an example of one embodiment where a bladder 1117 is attached on the other side of the access port 1135.
• the gastric band system 1100 may include a gastric band 1105 with an inflatable portion 1110 and a ring
• the gastric band 1105 may be connected to a tubing 1103 which may be connected to the access port 1135. As shown, when the patient presses on his or her skin at a location near the bladder 1117, fluid within the bladder 1117 may travel through the access port 1135 and the tubing 1103 and into the inflatable portion 1110 of the gastric band 1105, thereby increasing the amount of fluid within the gastric band 1105 and causing the patient to feel satiety.
• the bladder 1217 may be connected to the gastric banding system 1200 through a "T" connector 1219 such that the bladder 1217 is not in-line with the port 1235 nor the gastric band 1205.
• the "T" connector 1219 may be a part of the tubing 1203 and may allow the bladder 1217 to be in fluid communication with other portions of the gastric banding system 1200 such as a tube component 1214 and an end compliant portion 1216, among other components .
• a bladder e.g., bladder 1217
• a gastric band e.g., a gastric band 1205
• a "Y" connector (not shown) or any other type of connector may be used.
• bladders 1017, 1117, and 1217 in FIGS. 10, 11 and 12 respectively have been shown to be ellipsoidal, other shapes may be possible.
• FIG. 13 illustrates a flat, circular bladder 1317 while FIG. 14 illustrates a
• the bladders 1317 and 1417 may be implemented anywhere, for example, as bladder 1017 between the gastric band 1005 and the port 1035, or as bladder 1117 coupled to the port 1135.
• other shapes may be possible such as a spherical bladder, a prolate spheroid, an oblate spheroid or other suitable shapes (not shown) .
• bladders 1017, 1117, 1317 and 1417 may be useful within a limited range of pressures. However, as the pressure within the fluid increases, these bladders 1017, 1117, 1317 and 1417 may bulge and take on a more spherical shape. The bulging characteristics may be reduced or limited by choosing particular combinations of materials and shapes.
• FIGS. 15, 16 and 17 Examples of non-bulging bladder shapes are illustrated in FIGS. 15, 16 and 17.
• bladder 1517 may include a series of connected cylinders having similar shapes and similar sizes.
• the series of connected cylinders of the bladder 1517 may be in fluid communication with each other
• a gap may exist proximal to the point of attachment thereby allowing fluid to be freely transferred between the different cylinders of the bladder 1517).
• a flexible non-stretching material such as
• PTFE polytetrafluoroethylene
• FIG. 16 illustrates a bladder 1617 comprising a series of cylinders of various sizes. Again, while shown here to be five cylinders, any number of cylinders in the series may be
• the diameter of the middle cylinder of the bladder 1617 may be larger, while the diameter of the outer cylinders may be smaller. Similar to the bladder 1517 of FIG. 15, when a flexible non-stretching material such as PTFE is formed into a series of connected cylinders, the bladder 1617 may be inflated to its maximum volume and shape. As more fluid is injected into the bladder 1617, the pressure in the system dramatically increases but the shape of the bladder 1617 does not stretch and expand.
• a flexible non-stretching material such as PTFE
• FIG. 17 illustrates a coil-like bladder 1717.
• the bladder 1717 may include internal structures that allow the bladder 1717 to inflate (i.e., allowing the diameter of the coils of the bladder 1717 to increase) but without substantially altering the shape of the bladder 1717 (i.e., preventing the bladder 1717 from "uncoiling") . As such, the patient may press on any portion of the bladder 1717 to obtain a boost in satiety.
• bladder devices are not designed to encourage needle insertion.
• bladders 1017, 1117, 1317, 1417, 1517, 1617, and 1717 may be constructed out of puncture-resistant fabrics or hard shells to protect the bladders 1017, 1117, 1317, 1417, 1517, 1617, and 1717 from needle punctures.
• the bladders 1017, 1117, 1317, 1417, 1517, 1617, and 1717 may be made resistant to needle punctures by being positioned away from an injection port (e.g., injections ports 1035, 1135).
• 1517, 1617, and 1717 may be constructed out of flexible
• PE polyethylene
• PET terephthalate
• PC polycarbonate
• PP polypropylene
• PA polyamides
• PTFE polyvinyl chloride
• PSU polysolfone
• PPSU polyphenylsulfone
• PEEK polyetheretherketone
• the walls within each of the bladders may also vary.
• the bladder 1817 may include a tapered wall 1821 shown as the top wall and a uniform wall 1823 shown as a bottom wall.
• the bladder 1817 of FIG. 18 may be constructed with a tapered wall thinnest at the center of the bladder 1817 where most of the fluid is stored. When the center of the bladder 1817 is pressed, the fluid may be released in an efficient manner instead of being dispersed to the edges of the bladder 1817.
• bladders with uniform wall thicknesses throughout may also be possible.
• the bladders 1017, 1117, 1317, 1417, 1517, 1617, 1717, and 1817 described herein may be used in conjunction with each other and with other bladders of varying compliance.
• the bladder 1217 may be a non-compliant component and may be used to achieve fluid flow when the patient presses on the bladder 1217.
• the bladder 1216 may be a compliant component and may be used as an intentional fluid flow creator and as a pressure moderating device. These two bladders 1217 and 1216, among other bladders, may also be used simultaneously such that one non-compliant bladder 1217 may allow for fluid transfer while the other compliant bladder 1216 may act as a pressure monitoring device.
• bladders 1017, 1117, 1317, 1417, 1517, 1617, 1717, and 1817 may allow for fluid transfer via one or more mechanisms. Fluid transfer may be intentionally induced when the patient consciously presses on the bladder
• Fluid transfer may also be unintentionally induced when the patient undergoes daily movement (e.g.,
• bladders e.g., the bladders 1017, 1117, 1317, 1417, 1517, 1617, 1717, and 1817.
• the gastric banding system 1200 may be configured to permit the fluid to flow back to the bladder 1217 at a substantially unimpeded rate.
• a flow rate restriction device may be implemented into the bladder 1217 to restrict or control the fluid flow between the bladder 1217 and the gastric band 1205.
• FIG. 19 illustrates one embodiment of a flow rate
• FIG. 19A is a diagrammatic representation of restriction device 1947 within a bladder 1917.
• the flow rate restriction device 1947 may include a flow restrictor 1927 and a duckbill valve 1937 located proximately at an area where a tubing is joined to the bladder 1917.
• fluid may flow out of the duckbill valve 1937 at one rate and when fluid flows from the gastric band (not shown) back into the bladder 1917, the flow restrictor 1927 may control the flow of the fluid at a second rate .
• the rate that fluid leaves the bladder 1917 through the duckbill valve 1937 may be higher than the rate that fluid flows through the flow restrictor 1927 back into the bladder 1917. Conversely, the flow rate of fluid entering the bladder 1917 through the duckbill valve 1937 may be higher than the flow rate of fluid leaving the bladder 1917. Alternatively, the flow rates may be equal.

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