WO2011106157A1 - Devices for treating morbid obesity using hydrogel - Google Patents
Devices for treating morbid obesity using hydrogel Download PDFInfo
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- WO2011106157A1 WO2011106157A1 PCT/US2011/024213 US2011024213W WO2011106157A1 WO 2011106157 A1 WO2011106157 A1 WO 2011106157A1 US 2011024213 W US2011024213 W US 2011024213W WO 2011106157 A1 WO2011106157 A1 WO 2011106157A1
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- 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
-
- 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
- A61F5/003—Implantable devices or invasive measures inflatable
-
- 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
- A61F5/0036—Intragastrical devices
-
- 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
-
- 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
- A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
-
- 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
- A61F2013/00655—Plasters adhesive
- A61F2013/00676—Plasters adhesive hydrogel
Definitions
- Some such systems and devices include adjustable gastric band systems, which are operable to restrict the flow of food from the esophagus into the stomach.
- Some gastric bands include a fluid-filled elastomeric bladder with fixed endpoints that encircles the stomach just inferior to the gastro-esophageal junction. When fluid is added to the bladder, the band expands against the stomach, creating a food intake restriction or stoma in the stomach. To decrease this restriction, fluid is removed from the bladder. Examples of gastric bands are disclosed in U.S. Pat. No.
- Fluid may be added to the bladder by using a syringe and needle (e.g., Huber needle) to inject the fluid through an implanted injection port that is coupled with the bladder.
- a syringe and needle e.g., Huber needle
- fluid may be removed from the bladder by using a syringe and needle to withdraw the fluid through the implanted injection port.
- a gastric band system may include a pump that is used to adjust the level of fluid in the bladder of the gastric band.
- a gastric band system incorporating a pump is described in U.S. Pat. No. 7,390,294, entitled “Piezo Electrically Driven Bellows Infuser for Hydraulically Controlling an Adjustable Gastric Band,” issued June 24, 2008, the disclosure of which is incorporated by reference herein.
- Other examples of such a system are described in U.S. Pat. No. 7,351,240, entitled “Thermodynamically Driven Reversible Infuser Pump for Use as a Remotely Controlled Gastric Band,” issued April 1, 2008, the disclosure of which is incorporated by reference herein.
- Gastric sleeves may be placed within an interior portion of the stomach (or elsewhere within the gastrointestinal tract) instead of being placed about an exterior of the stomach. Some types of gastric sleeves may also be configured to restrict the absorption of nutrients within the gastrointestinal tract (e.g., within the duodenum). Examples of gastric sleeves are disclosed in U.S. Pat. No. 7,037,344, entitled “Apparatus and Methods for Treatment of Morbid Obesity,” issued May 2, 2006, the disclosure of which is incorporated by reference herein.
- Gastric valves may be placed inside or outside the stomach (e.g., at the esophagus or pylorus, etc.) and may selectively restrict the flow of food into the stomach.
- the degree of restriction provided by a gastric valve may be based at least in part on an amount of fluid in one or more inflatable portions of the gastric valve.
- Such a fluid level may be adjusted in a variety of ways. Examples of gastric valves are disclosed in U.S. Pub. No. 2006/0235448, entitled "Artificial Gastric Valve,” published October 19, 2006, the disclosure of which is incorporated by reference herein.
- Space occupying devices may include a device such as a balloon that is implanted in the stomach.
- the space occupying balloon may be substantially non-digestable, and its presence in the stomach may lead to relatively early satiety.
- the amount of space occupied by the balloon may be based at least in part on an amount of fluid in the balloon.
- Such a fluid level may be adjusted in a variety of ways.
- a space occupying device may even form a restriction within the stomach by providing a relatively narrow passageway for passage of food, with the size of the passageway being based at least in part on an amount of fluid in the space occupying device. Examples of space occupying devices are disclosed in U.S. Pub. No. 2008/0103593, entitled "Use of Biosurgical Adhesive on Inflatable Device for Gastric Restriction," published May 1, 2008, the disclosure of which is incorporated by reference herein.
- Bulking devices may include a device that is placed between layers of the stomach to reduce the internal volume or capacity of the stomach. Like a space occupying device, presence of a bulking device in the stomach may lead to relatively early satiety, and the amount of volume reduced by the presence of the bulking device may be based at least in part on an amount of fluid in the bulking device. In addition or in the alternative, a bulking device may be placed between layers of the esophagus to restrict the flow of food into the stomach. Examples of an adhesive being used as a bulking device are disclosed in U.S. Pub. No.
- the above-described devices to treat morbid obesity or other conditions may lack a fluid filled member, such that the devices may be adjusted using some method other than adjusting the amount or pressure of fluid in the device. For instance, such devices may be adjusted on a mechanical or electromechanical, non-hydraulic basis.
- Hydrogels have also been used in a variety of biomedical applications. For instance, examples of such uses are described in Peppas, Hydrogels in Medicine and Pharmacy, CRC Press, Boca Raton, FL (1986); and Hoffman, “Hydrogels for Biomedical Applications,” Adv. Drug Deliv. Revs., 54, 3-12 (2002). Hydrogels may be configured to respond to changing conditions in their environment, such as temperature, pH, electric fields, ionic strength, the presence of a liquid, chemical stimuli, etc. Examples of environmentally responsive hydrogels (and uses thereof) are described in Peppas, "Physiologically Responsive Gels," J. Bioact. Compat.
- Physiological changes of the digestive system between fasting and consumption may be described in terms of changes in gastric acidity as measured using pH (the log concentration of hydronium ion concentration, or log[H + ]).
- the pH scale spans from 1 (acidic) to 14 (basic), with 7.0 being neutral.
- the stomach pH may be relatively low (acidic).
- intragastric acidity may be buffered, with an elevation of gastric pH.
- the change in pH may occur rapidly with the initiation of consumption as food enters into the stomach. This change may also occur even in light of the secretion of gastric acids continuously during consumption.
- the buffering capacity of foods including acidic or "spicy" foods, may be sufficient to provide a significant change in gastric pH.
- Some examples described below relate to the use of a hydrogel to make adjustments in a method or device for treating morbid obesity in accordance with changes in environmental conditions within a patient. While a variety of devices and methods have been made and used to treat morbid obesity, it is believed that no one prior to the inventor(s) has made or used an invention as described herein.
- FIG. 1 depicts a perspective view of an implantable portion of an exemplary gastric band system
- FIG. 2 depicts a perspective view of the gastric band of FIG. 1, showing the band positioned around the gastro-esophageal junction of a patient;
- FIG. 3 depicts a cross-sectional view of the gastric band of FIG. 1, showing the band positioned around the gastro-esophageal junction of a patient in a deflated configuration;
- FIG. 4 depicts a cross-sectional view of the gastric band of FIG. 1, showing the band positioned around the gastro-esophageal junction of a patient in an inflated configuration to create a food intake restriction;
- FIG. 5 A depicts a schematic view of an exemplary hydrogel pump that may be used with the gastric band of FIG. 1, with the hydrogel in a collapsed state;
- FIG. 5B depicts a schematic view of the hydrogel pump of FIG. 5A, with the hydrogel in an expanded state
- FIG. 6 A depicts a schematic view of an exemplary hydrogel fluid reservoir that may be used with the gastric band of FIG. 1, with the hydrogel in an expanded state, and with a portion of the hydrogel removed to show a hollow interior;
- FIG. 6B depicts a schematic view of the hydrogel fluid reservoir of FIG. 6A, with the hydrogel in a collapsed state;
- FIG. 7 A depicts a schematic view of another exemplary hydrogel fluid reservoir that may be used with the gastric band of FIG. 1, with the hydrogel in a collapsed state, and with a portion of the reservoir removed to show a interior portions of the reservoir;
- FIG. 7B depicts a schematic view of the hydrogel fluid reservoir of FIG. 7 A, with the hydrogel in an expanded state, and with a portion of the reservoir removed to show interior portions of the reservoir;
- FIG. 8 A depicts a schematic view of an exemplary hydrogel space occupying device, with the hydrogel in a collapsed state
- FIG. 8B depicts a schematic view of the hydrogel space occupying device of FIG.
- FIG. 9 A depicts a schematic view of an exemplary hydrogel actuated gastric sleeve, with the hydrogel in a collapsed state
- FIG. 9B depicts a schematic view of the hydrogel actuated gastric sleeve of FIG.
- morbid obesity treatment method or device that is dynamically responsive to physiological parameters of a patient.
- a trigger system in which a physical and/or chemical change in a patient produces a dynamically responsive change in a morbid obesity treatment device.
- the following examples include the use of pH levels within a patient's stomach as the basis for triggering a dynamic response from a morbid obesity treatment device.
- any other types of physical and/or chemical changes in a patient may be used as a basis for triggering a dynamic response from a device.
- such changes may include gastric motility (e.g., as a physical stimulus to trigger a response) that changes and cycles with various stages of fasting and consumption; respiration (e.g., as a physical stimulus based on changes in diaphragm to trigger a response) that changes and cycles with different levels or types of activity (e.g., rest, sleep, daily routine activities, etc.); and/or electrical activity via muscle activity associated with changes in motility, etc.
- Such alternative bases may be used in addition to or in lieu of the pH level within a patient's stomach; and/or such alternative bases may be used in combination with other bases.
- Various types of physical and/or chemical changes in a patient that may be used as a basis for triggering a dynamic response from a device will be apparent to those of ordinary skill in the art in view of the teachings herein.
- examples described explicitly herein use a hydrogel material in order to trigger a dynamic response in a device.
- examples described herein use an environmentally sensitive hydrogel as a sensor and/or actuation mechanism in a device. Examples of suitable hydrogels and suitable hydrogel properties will be briefly discussed before discussion of how hydrogels may be incorporated into a dynamically responsive device system.
- the monomers used to fabricate functional polymer gel networks may exhibit a relatively large physical change in response to minute chemical or biological stimuli.
- the responsive materials may include polymers prepared from multifunctional acrylates, hydroxyethylmethacrylate (HEMA), elastomeric acrylates, and related monomers.
- Incorporation of an environmentally sensitive hydrogel into a device used as a sensor or actuation mechanism may also involve a non-responsive material.
- the non-responsive materials may be used to define the walls or boundaries of the responsive or active system and form structural components of permeable, semi-permeable, and/or impermeable flexible or rigid barriers.
- Non-responsive materials may be prepared from a wider variety of monomers and polymers.
- Environmentally sensitive hydrogels that may be used in the examples described herein may include those that demonstrate a reversible pH-dependent swelling behavior. These pH-sensitive hydrogels may be based on ionic networks.
- Anionic networks contain acidic pendant groups, such as carboxylic acid, with a characteristic pI ; while cationic networks contain basic pendant groups, such as amine groups, with a characteristic pKt,.
- anionic networks ionization of these acid groups may occur once the pH of the environment is above the acid group's characteristic pK a .
- the network With deprotonation of the acid groups, the network may have fixed charges on its chains resulting in an electrostatic repulsion between the chains and, in addition, an increased hydrophilicity of the network. Because of these alterations in the network, water may be absorbed into the polymer to a greater degree causing swelling of the polymer.
- a biological signal or parameter that triggers a response from a hydrogel may be a chemical species.
- the chemical species is the hydrogen ion
- the state of swelling of the hydrogel network may be impacted as a function of the pKa or pKb with respect to the hydrogen ion concentration or the pH of the surrounding fluid or environment of the hydrogel.
- hydrogel polymer is a cross-linked network of hydrophilic monomers taken from the group consisting of unsaturated organic acid monomers, acrylic substituted alcohols, and acrylamides.
- the monomers may be taken from the group consisting of methacrylic acids, acrylic acids, glycerolacrylate, glycerolmethacryulate, 2-hydroxyethylmethacrylate, 2-hydroxyethylacrylate, 2- (dimethylaminoethyl methacrylate, N-vinyl pyrrolidone, methacrylamide, and N, N- dimethylacrylamide poly(methacrylic acid) containing amounts of poly(ethylene glycol) n dimethacrylate, where n is the average molecular weight of the PEG chain.
- any other suitable type of hydrogel may be used.
- hydrogel polymer When a hydrogel polymer is configured to swell in response to pH levels, this volume change can be considerable.
- some hydrogel polymers may be capable of changing volume on the order of 300% to 400%, or even on the order of 600%.
- the driving force or potential to undergo the change in volume may be significant, resulting in high expansion forces if the hydrogel is constrained during the expansion phase.
- these expansion forces may be harnessed or otherwise be used to trigger a response in a morbid obesity treatment device.
- hydrogels to trigger a dynamic response in a device
- one or more electronic and/or chemical based sensors may be used to trigger a response in a device, in addition to or in lieu of using a hydrogel to trigger a response.
- one or more electrorheological fluids (sometimes referred to as ER fluids), which change their viscosity (e.g., from liquid to gel and back) in response to electrical fields or currents, may be used to trigger a dynamic response in a device.
- ER fluids may include starch solutions, though any other suitable type of ER fluid may be used.
- FIGS. 1-4 illustrate an exemplary gastric band system (10).
- gastric band system (10) comprises an injection port (12), a gastric band (20), and a catheter (18), which together form a closed fluid circuit.
- Injection port (12) of the present example comprises a housing (14) and a needle penetrable septum (16).
- Housing (14) defines a fluid reservoir (not shown), such that a needle may pierce septum (16) to reach the reservoir and add or withdraw fluid (e.g., saline, etc.) as described in greater detail below.
- Housing (14) may be formed of titanium, plastic, or any other suitable material or combination of materials.
- Septum (16) may be formed of silicone or any other suitable material or combination of materials.
- Injection port (12) may be subcutaneous ly secured over a patient's sternum, to the patient's abdominal fascia, or in any other suitable location. Injection port (12) may be secured at approximately 10 cm below the surface of the patient's skin or at any other suitable depth. In some versions, injection port (12) is configured and operable in accordance with the teachings of U.S. Pub. No. 2005/0283118, entitled “Implantable Medical Device with Simultaneous Attachment Mechanism and Method," published December 22, 2005, the disclosure of which is incorporated by reference herein. Alternatively, injection port (12) may have any other suitable configuration and/or operability.
- Gastric band (20) of the present example comprises an inflatable bladder (22) that is secured to a flexible strap (24).
- Inflatable bladder (22) may be formed of silicone or any other suitable material or combination of materials.
- Catheter (18) provides fluid communication between bladder (22) and the reservoir of injection port (12). Accordingly, a needle that is inserted through septum (16) may be used to add or withdraw fluid from inflatable bladder (22), to adjust the restriction created by gastric band (20).
- gastric band (20) is configured and operable in accordance with the teachings of U.S. Pat. No. 7,416,528, entitled "Latching Device for Gastric Band," issued August 26, 2008, the disclosure of which is incorporated by reference herein.
- gastric band (20) may have any other suitable configuration and/or operability.
- gastric band (20) is applied about the gastro-esophageal junction of a patient.
- gastric band (20) is installed such that bladder (22) is adjacent to the tissue of the gastro-esophageal junction, with strap (24) on the outside of bladder (22).
- the ends of strap (24) are secured relative to each other when gastric band (20) is sufficiently wrapped about the patient's stomach (2).
- strap (24) is flexible in this example, strap (24) substantially resists stretching along its length. Accordingly, when fluid is added to bladder (22) (e.g., using a needle inserted through septum (16) of injection port (12), etc.), bladder (22) expands and exerts inward forces on the gastro-esophageal junction of the patient.
- an installed gastric band (20) at least substantially encloses the upper portion of stomach (2) near the junction with esophagus (4) in the present example.
- FIG. 3 shows gastric band (20) in a deflated configuration, where bladder (22) contains little to no fluid, thereby maximizing the size of the stoma opening into stomach (2).
- FIG. 4 shows gastric band (20) in an inflated, fluid-filled configuration, where bladder (22) contains substantially more fluid than is shown in FIG. 3.
- bladder (22) contains substantially more fluid than is shown in FIG. 3.
- the pressure of gastric band (20) against stomach (2) is increased due to the fluid within bladder (22), thereby decreasing the stoma opening to create a food intake restriction.
- FIG. 4 also schematically illustrates the dilation of esophagus (4) above gastric band (20) to form an upper pouch (6) beneath the diaphragm muscle (8) of the patient.
- gastric band system (10) After gastric band system (10) has been implanted in the patient and an initial amount of fluid (e.g., saline, etc.) has been introduced to gastric band system (10), a physician may need to occasionally adjust the amount of fluid in gastric band system (10) by using a needle (e.g., Huber needle, etc.) that is inserted through septum (16) of injection port (12). For instance, such adjustments may be desirable to account for weight loss achieved by the patient, and may be started around one month (or any other suitable time period) after gastric band system (10) has been implanted.
- a needle e.g., Huber needle, etc.
- FIGS. 5A-5B illustrate an exemplary hydrogel pump (100) that may be incorporated into gastric band system (10).
- hydrogel pump (100) may be in fluid communication with a catheter (19) that is coupled with catheter (18) of gastric band system (10).
- catheter (19) may be joined with catheter (18) by a conventional "T” or “Y” coupling or in any other suitable fashion.
- catheter (19) may be joined directly with bladder (22) of gastric band (20), may be joined directly with injection port (12), or may be otherwise incorporated into gastric band system (10).
- hydrogel pump (100) is in fluid communication with gastric band system (10) in the present example, hydrogel pump (100) and gastric band system (10) together still form a closed fluid circuit like the gastric band system (10) shown in FIG. 1.
- hydrogel pump (100) comprises a housing (102) that is secured to the wall (3) of a patient's stomach (2).
- hydrogel pump (100) is secured within the interior of the patient's stomach (2), with catheter (19) extending exteriorly from the patient's stomach (2) to couple with gastric band system (10).
- housing (102) may be secured in the lower/distal region of the patient's stomach (2), though any other suitable location or locations may be used.
- Catheter (19) is fed through an opening formed in the wall (3) of the patient's stomach (2), and a pair of flanges (104, 106) are secured to opposite faces of the wall (3) adjacent to this opening.
- Flanges (104, 106) seal against catheter (19) and against the opposite faces of the wall (3), such that fluids may not leak through the interface between flanges (104, 106) and catheter (19), and such that fluids may not leak through the interface between flanges (104, 106) and wall (3).
- the inner lumen of catheter (19) is the only path for fluid communication through wall (3) in the present example.
- Flanges (104, 106) may be sealed to wall (3) using one or more biosurgical adhesives (e.g., cyanoacrylate, isocyanate, etc.) and/or using any other suitable devices, substances, or techniques.
- Flanges (104, 106) may also be sealed to catheter (19) in any suitable fashion.
- Flange (106) may form a lid of housing (102), such that flange (106) is also sealed to housing (102).
- Housing (102) of the present example is formed of a substantially rigid material that can substantially withstand acid and other fluids in the stomach (2), grinding and churning mechanisms of gastric motility, and enzymatic attack by digestive enzymes.
- housing (102) may be formed of a biocompatible plastic, metal, or any other suitable material or combination of materials.
- Housing (102) includes an upper section (110) and a lower section (120). While housing (102) is shown in cross-section in FIGS. 5A-5B, it should be understood that housing (102) may have any suitable shape, including but not limited to cylindraceous. Upper section (110) and lower section (120) are separated by a piston disc (130) in the present example.
- a fluid (112) such as saline is provided in upper section (110), and is in fluid communication with gastric band system (10) via catheter (19).
- upper section (110) has a fluid capacity of approximately two cc's.
- upper section (110) may have any other suitable fluid capacity.
- An environmentally sensitive hydrogel (122) is provided in lower section (120) of housing (120).
- Piston disc (130) substantially seals against the inner wall (132) of housing (102), such that piston disc (130) fluidly isolates upper section (110) from lower section (120).
- Piston disc (130) is movable along the longitudinal axis defined by housing (102), to expel fluid (112) from upper section (110) as will be described in greater detail below.
- Piston disc (130) maintains the seal between upper section (110) and lower section (120) even during and after such movement within housing (110).
- a rim (134) protrudes radially inwardly from inner wall (132) of housing, and presents an inner diameter that is less than the outer diameter of piston disc (130). Rim (134) thus restricts downward movement of piston disc (130), such that piston disc (130) may not move lower than the position shown in FIG. 5A.
- rim (134) is merely optional.
- Lower section (120) of housing (102) has a plurality of openings (124) formed therein, such that gastric fluids may enter and leave lower section (120) of housing (102) freely to allow changing physiological conditions occurring in stomach (2) (e.g., relating to consumption and fasting) to also occur inside lower section (120) of housing (102).
- hydrogel (122) is in fluid communication with the interior of stomach (2) via openings (124) in the present example.
- hydrogel (122) of the present example is formulated and configured such that it is in a collapsed state in a low pH environment (FIG. 5A); and such that it will swell and expand in response to an increased pH level (FIG. 5B).
- hydrogel (122) may be formulated and configured such that it swells to an expanded state (FIG. 5B) when it is exposed to a pH level that is at or greater than approximately 4 (or at or greater than approximately 5); and such that it will be in the collapsed state (FIG. 5A) when it is exposed to a pH level that is less than approximately 4 (or less than approximately 5).
- hydrogel (122) may be formulated and configured such that it swells or shrinks in response to any other suitable pH levels.
- hydrogel (122) When hydrogel (122) swells in the present example, it forces piston disc (130) upwardly as shown in FIG. 5B, which in turn forces fluid (112) from upper section (1 10) of housing to gastric band system (10). Openings (124) are sized and configured such that swelling hydrogel (122) will favor forcing piston disc (130) upwardly over protruding through openings (124). Hydrogel (122) thus drives piston disc (130) based on the pH level of fluid within the patient's stomach (2). A particular hydrogel formulation and configuration may be selected such that the pressure imposed by swelling hydrogel (122) on piston disc (130) (FIG. 5B) provides a desired pressure of fluid (112) for gastric band system (10).
- hydrogel (122) may be in the collapsed state shown in FIG. 5 A.
- gastric band (20) may also be in the collapsed state shown in FIG. 3.
- hydrogel (122) As the patient begins to consume food, the pH level in the patient's stomach (2) begins to rise. This increase in pH is sensed by hydrogel (122) due to fluid in stomach (2) leaking into lower section (120) via openings (124).
- hydrogel (122) swells to the expanded state shown in FIG. 5B. This swelling drives piston disc (130) to a raised position, thereby forcing fluid (112) from upper section (110) of housing to gastric band system (10).
- Gastric band (20) then reaches the expanded state shown in FIG. 4, creating a restriction at the gastro-esophageal junction of a patient.
- the patient's physiology eventually returns to the fasting stage, and the pH level in the patient's stomach decreases. This decrease in pH level causes hydrogel (122) to collapse back to the configuration shown in FIG. 5 A.
- the pressure of fluid (112) in gastric band system (10) drives piston disc (130) back down to the position shown in FIG. 5 A, such that fluid (112) is drained from gastric band system (10) into upper section (110) of housing (120), and such that gastric band (20) returns to the collapsed state shown in FIG. 3.
- hydrogel pump (100) may be modified, substituted, or supplemented in various ways; if not be omitted altogether. Numerous suitable variations of hydrogel pump (100) will be apparent to those of ordinary skill in the art in view of the teachings herein.
- hydrogel (122) is configured to expand in response to a low pH level (FIG. 5A) and collapse in response to a high pH level (FIG. 5B).
- a reversed response may be suitable in a scenario where gastric band (20) is being used to treat gastroesophageal reflux disease (GERD) or some other condition (e.g., rather than being used to treat morbid obesity).
- GERD gastroesophageal reflux disease
- pump (100) may be placed closer to the patient's esophagus (4) or in some other suitable location where it could provide a response to an occurrence of undesired acid reflux. By constricting a band (20) in response to an occurrence of undesired acid reflux, the likelihood of harm caused by such acid reflux may be reduced.
- hydrogel pump (100) may be coupled with a gastric valve to drive the valve between substantially restrictive and substantially non-restrictive configurations.
- hydrogel pump (100) may be coupled with a gastric valve as described in U.S. Pub. No. 2006/0235448, entitled "Artificial Gastric Valve,” published October 19, 2006, the disclosure of which is incorporated by reference herein.
- a gastric valve as described in U.S. Pub. No. 2006/0235448, entitled "Artificial Gastric Valve," published October 19, 2006, the disclosure of which is incorporated by reference herein.
- Various suitable ways in which hydrogel pump (100) may be coupled with such a gastric valve will be apparent to those of ordinary skill in the art in view of the teachings herein.
- Still other suitable ways in which a hydrogel pump (100) (or variations thereof) may be used will also be apparent to those of ordinary skill in the art in view of the teachings herein.
- FIGS. 6A-6B show an exemplary hydrogel fluid reservoir (200) that may be incorporated into a gastric band system (10).
- Hydrogel fluid reservoir (200) may thus be used as an alternative to hydrogel pump (100) described above.
- hydrogel fluid reservoir (200) may be in fluid communication with a catheter (19) that is coupled with catheter (18) of gastric band system (10).
- catheter (19) may be joined with catheter (18) by a conventional "T" or "Y” coupling or in any other suitable fashion.
- catheter (19) may be joined directly with bladder (22) of gastric band (20), may be joined directly with injection port (12), or may be otherwise incorporated into gastric band system (10).
- hydrogel fluid reservoir (200) is in fluid communication with gastric band system (10) in the present example, hydrogel fluid reservoir (200) and gastric band system (10) together still form a closed fluid circuit like the gastric band system (10) shown in FIG. 1.
- hydrogel fluid reservoir (200) comprises a hollow sphere formed of hydrogel (202). While hydrogel (202) is formed as a sphere in this example, it should be understood that any other suitable shape may be used. Hydrogel sphere (202) is secured to the wall (3) of a patient's stomach (2). In particular, hydrogel sphere (202) is secured within the interior of the patient's stomach (2), with catheter (19) extending exteriorly from the patient's stomach (2) to couple with gastric band system (10). By way of example only, sphere (202) may be secured in the lower/distal region of the patient's stomach (2), though any other suitable location or locations may be used.
- Catheter (19) is fed through an opening formed in the wall (3) of the patient's stomach (2), and a pair of flanges (104, 106) are secured to opposite faces of the wall (3) adjacent to this opening.
- Flanges (104, 106) may be configured the same as is described above with respect to hydrogel pump (100); or may have any other suitable configuration.
- the inner lumen of catheter (19) is the only path for fluid communication through wall (3) in the present example.
- Hydrogel sphere (202) defines a hollow interior (204) or reservoir, within which resides a fluid (212) (e.g., saline, etc.).
- Hollow interior (204) and fluid (212) are in communication with catheter (19), such that fluid (212) may be forced toward gastric band (20) via catheter (19) when hydrogel sphere (202) collapses as described in greater detail below.
- hydrogel sphere (202) is formed entirely of hydrogel.
- the hollow interior (204) is lined with silicone or some other material (not shown), such as to fluidly isolate fluid (212) from hydrogel (202).
- a jacket or case may be provided about the exterior of hydrogel sphere (202). Such a jacket or case may be porous, have openings formed in it, or otherwise permit fluids in stomach (2) to contact hydrogel (202).
- a jacket provided on the exterior of hydrogel sphere (202) is substantially resilient in addition to being porous.
- a resilient jacket may be resiliently biased to a shrunk position, similar to what is shown in FIG. 6B.
- the resilient jacket is stretched against its bias when hydrogel sphere (202) is in the expanded configuration shown in FIG. 6A; and the resilient bias of jacket assists hydrogel sphere (202) to reach the collapsed configuration shown in FIG. 6B.
- the resilient jacket may simply travel with hydrogel sphere (202) to the collapsed configuration shown in FIG. 6B, without necessarily assisting hydrogel sphere (202) in reaching the collapsed configuration.
- hydrogel sphere (202) may be configured, including but not limited to other components that may be provided on or within hydrogel sphere (202), will be apparent to those of ordinary skill in the art in view of the teachings herein.
- catheter (19) may be coupled with hydrogel sphere (202) will be apparent to those of ordinary skill in the art in view of the teachings herein.
- the hydrogel that forms hydrogel sphere (202) in the present example is environmentally sensitive, such that hydrogel sphere (202) will change between a swelled state (FIG.
- hydrogel of hydrogel sphere (202) is formulated and configured such that it is in an expanded state in a low pH environment (FIG. 6A); and such that it will collapse in response to an increased pH level (FIG. 6B).
- a low pH environment FIG. 6A
- a higher pH level FIG. 6B
- hydrogel sphere (202) may be formulated and configured such that it shrinks to a collapsed state (FIG.
- hydrogel sphere (202) when it is exposed to a pH level that is at or greater than approximately 4 (or at or greater than approximately 5); and such that it swells to an expanded state (FIG. 6A) when it is exposed to a pH level that is less than approximately 4 (or less than approximately 5).
- hydrogel sphere (202) may be formulated and configured such that it swells or shrinks in response to any other suitable pH levels.
- hydrogel sphere (202) When hydrogel sphere (202) is in the expanded state as shown in FIG. 6A, its hollow interior (204) provides a reservoir having a capacity of approximately two cc's. Alternatively, hollow interior (204) of expanded hydrogel sphere (202) may have any other suitable capacity.
- hydrogel sphere (202) shrinks to the collapsed state as shown in FIG. 6B, the capacity of the reservoir provided by hollow interior (204) is reduced, which in turn forces fluid (212) from hollow interior (204) to gastric band system (10). Hydrogel sphere (202) thus drives fluid (212) from hollow interior (204) toward gastric band system (10) based on the pH level of fluid within the patient's stomach (2).
- a particular hydrogel formulation and configuration may be selected such that the pressure imposed by shrinking hydrogel sphere (202) on fluid (212) (FIG. 6B) provides a desired pressure of fluid (212) for gastric band system (10).
- hydrogel sphere (202) may be in the expanded state shown in FIG. 6A.
- gastric band (20) may also be in the collapsed state shown in FIG. 3.
- the pH level in the patient's stomach (2) begins to rise. This increase in pH is sensed by hydrogel sphere (202) due to fluid in stomach (2) communicating with hydrogel sphere (202).
- hydrogel sphere (202) shrinks to the collapsed state shown in FIG. 6B. This shrinking reduces the capacity of hollow interior (204), thereby forcing fluid (212) from hydrogel sphere (202) to gastric band system (10).
- Gastric band (20) then reaches the expanded state shown in FIG. 4, creating a restriction at the gastro-esophageal junction of a patient.
- the patient's physiology eventually returns to the fasting stage, and the pH level in the patient's stomach decreases.
- This decrease in pH level causes hydrogel sphere (202) to swell back to the expanded configuration shown in FIG. 6A, which in turn increases the capacity of the reservoir provided by hollow interior (204).
- the pressure of fluid (212) in gastric band system (10) urges fluid (212) back into hollow interior (204), such that fluid (212) is drained from gastric band system (10) into hollow interior (204), and such that gastric band (20) returns to the collapsed state shown in FIG. 3.
- hydrogel reservoir (200) may be modified, substituted, or supplemented in various ways; if not be omitted altogether. Numerous suitable variations of hydrogel reservoir (200) will be apparent to those of ordinary skill in the art in view of the teachings herein.
- hydrogel sphere (202) is configured to collapse in response to a low pH level (FIG. 6B) and swell in response to a high pH level (FIG. 6A).
- Such a reversed response may be suitable in a scenario where gastric band (20) is being used to treat gastroesophageal reflux disease (GERD) or some other condition (e.g., rather than being used to treat morbid obesity).
- reservoir (200) may be placed closer to the patient's esophagus (4) or in some other suitable location where it could provide a response to an occurrence of undesired acid reflux.
- a band (20) in response to an occurrence of undesired acid reflux, the likelihood of harm caused by such acid reflux may be reduced.
- FIGS. 7A-7B show another exemplary hydrogel fluid reservoir (300) that may be incorporated into a gastric band system (10).
- Hydrogel fluid reservoir (300) may thus be used as an alternative to hydrogel pump (100) and hydrogel fluid reservoir (200) described above.
- hydrogel fluid reservoir (300) may be in fluid communication with a catheter (19) that is coupled with catheter (18) of gastric band system (10).
- catheter (19) may be joined with catheter (18) by a conventional "T" or "Y” coupling or in any other suitable fashion.
- catheter (19) may be joined directly with bladder (22) of gastric band (20), may be joined directly with injection port (12), or may be otherwise incorporated into gastric band system (10).
- hydrogel fluid reservoir (300) is in fluid communication with gastric band system (10) in the present example, hydrogel fluid reservoir (300) and gastric band system (10) together still form a closed fluid circuit like the gastric band system (10) shown in FIG. 1.
- hydrogel fluid reservoir (300) comprises an outer jacket (302) encasing a hollow sphere formed of hydrogel (304). While hydrogel fluid reservoir (300) is formed as a sphere in this example, it should be understood that any other suitable shape may be used. Hydrogel fluid reservoir (300) is secured to the wall (3) of a patient's stomach (2). In particular, hydrogel fluid reservoir (300) is secured within the interior of the patient's stomach (2), with catheter (19) extending exteriorly from the patient's stomach (2) to couple with gastric band system (10). By way of example only, hydrogel fluid reservoir (300) may be secured in the lower/distal region of the patient's stomach (2), though any other suitable location or locations may be used.
- Catheter (19) is fed through an opening formed in the wall (3) of the patient's stomach (2), and a pair of flanges (104, 106) are secured to opposite faces of the wall (3) adjacent to this opening.
- Flanges (104, 106) may be configured the same as is described above with respect to hydrogel pump (100); or may have any other suitable configuration.
- the inner lumen of catheter (19) is the only path for fluid communication through wall (3) in the present example.
- Hydrogel sphere (304) defines a hollow interior (306) or reservoir, within which resides a fluid (312) (e.g., saline, etc.). Hollow interior (306) and fluid (312) are in communication with catheter (19), such that fluid (312) may be forced toward gastric band (20) via catheter (19) when the hydrogel forming hydrogel sphere (302) expands as described in greater detail below.
- jacket (302) is formed of a porous, non-extensible material that can substantially withstand acid and other fluids in the stomach (2), grinding and churning mechanisms of gastric motility, and enzymatic attack by digestive enzymes.
- jacket (302) may be formed of a porous DACRON or polyester material, or any other suitable material or combination of materials, including but not limited to other materials referred to elsewhere herein.
- the porous property of jacket (302) permits fluids in stomach (2) to contact hydrogel (304), such that gastric fluids may enter and leave jacket (302) freely to allow changing physiological conditions occurring in stomach (2) (e.g., relating to consumption and fasting) to also occur inside jacket (302).
- Jacket (302) may have openings formed in it in addition to or as an alternative to being formed of a porous material.
- the non-extensible property of jacket (302) provides resistance to outward swelling of hydrogel sphere (304) as described in greater detail below.
- the hollow interior (306) of hydrogel sphere (304) is lined with silicone or some other material (not shown), such as to fluidly isolate fluid (312) from hydrogel (304).
- hydrogel fluid reservoir (300) may be configured, including but not limited to other components that may be provided on or within hydrogel sphere (304), will be apparent to those of ordinary skill in the art in view of the teachings herein.
- catheter (19) may be coupled with hydrogel fluid reservoir (300) will be apparent to those of ordinary skill in the art in view of the teachings herein.
- the hydrogel that forms hydrogel sphere (304) in the present example is environmentally sensitive, such that hydrogel sphere (304) will change between a collapsed state (FIG. 7A) and a swelled state (FIG. 7B).
- the hydrogel of hydrogel sphere (304) is formulated and configured such that it is in a collapsed state in a low pH environment (FIG. 7A); and such that it will swell in response to an increased pH level (FIG. 7B).
- hydrogel sphere (304) may be formulated and configured such that it swells to an expanded state (FIG. 7B) when it is exposed to a pH level that is at or greater than approximately 4 (or at or greater than approximately 5); and such that it shrinks to a collapsed state (FIG. 7A) when it is exposed to a pH level that is less than approximately 4 (or less than approximately 5).
- hydrogel sphere (304) may be formulated and configured such that it swells or shrinks in response to any other suitable pH levels.
- hydrogel sphere (304) When hydrogel sphere (304) is in the collapsed state as shown in FIG. 7A, its hollow interior (306) provides a reservoir having a capacity of approximately two cc's. Alternatively, hollow interior (306) of collapsed hydrogel sphere (304) may have any other suitable capacity.
- jacket (302) When hydrogel sphere (304) swells to the expanded state as shown in FIG. 7B, jacket (302) substantially prevents hydrogel sphere (304) from expanding outwardly, such that hydrogel sphere (304) expands inwardly. The capacity of the reservoir provided by hollow interior (306) is thereby reduced, which in turn forces fluid (312) from hollow interior (306) to gastric band system (10).
- Hydrogel sphere (304) thus drives fluid (312) from hollow interior (306) toward gastric band system (10) based on the pH level of fluid within the patient's stomach (2).
- a particular hydrogel formulation and configuration may be selected such that the pressure imposed by swelling hydrogel sphere (304) on fluid (312) (FIG. 7B) provides a desired pressure of fluid (312) for gastric band system (10).
- hydrogel sphere (304) may be in the collapsed state shown in FIG. 7A.
- gastric band (20) may also be in the collapsed state shown in FIG. 3.
- the pH level in the patient's stomach (2) begins to rise. This increase in pH is sensed by hydrogel sphere (304) due to fluid in stomach (2) communicating with hydrogel sphere (304) via jacket (302).
- hydrogel sphere (304) swells to the expanded state shown in FIG. 7B.
- hydrogel reservoir (300) the pressure of fluid (312) in gastric band system (10) urges fluid (312) back into hollow interior (306), such that fluid (312) is drained from gastric band system (10) into hollow interior (306), and such that gastric band (20) returns to the collapsed state shown in FIG. 3.
- hydrogel reservoir (300) a variety of features and components of hydrogel reservoir (300) may be modified, substituted, or supplemented in various ways; if not be omitted altogether. Numerous suitable variations of hydrogel reservoir (300) will be apparent to those of ordinary skill in the art in view of the teachings herein. In a merely illustrative variation of hydrogel reservoir (300), the responsiveness of hydrogel sphere (304) to pH levels is reversed.
- hydrogel sphere (304) is configured to swell in response to a low pH level (FIG. 7B) and shrink in response to a high pH level (FIG. 7A).
- a reversed response may be suitable in a scenario where gastric band (20) is being used to treat gastroesophageal reflux disease (GERD) or some other condition (e.g., rather than being used to treat morbid obesity).
- reservoir (300) may be placed closer to the patient's esophagus (4) or in some other suitable location where it could provide a response to an occurrence of undesired acid reflux. By constricting a band (20) in response to an occurrence of undesired acid reflux, the likelihood of harm caused by such acid reflux may be reduced.
- a hydrogel reservoir (300) (or variations thereof) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
- a gastric band system may include a pump that is operable to adjust the level of fluid in bladder (22) in gastric band (20).
- a pump that is operable to adjust the level of fluid in bladder (22) in gastric band (20).
- bladder (22) in gastric band (20) may be operable to adjust the level of fluid in bladder (22) in gastric band (20).
- U.S. Pat. No. 7,390,294 entitled "Piezo Electrically Driven Bellows Infuser for Hydraulically Controlling an Adjustable Gastric Band," issued June 24, 2008, the disclosure of which is incorporated by reference herein.
- Other merely illustrative examples of such pumps are described in U.S. Pat. No.
- gastric band system 10
- gastric band system 10
- such a switch mechanism may include a housing in which a hydrogel resides, with the housing being located within the stomach (2), and with the housing including pores or openings permitting fluid inside the stomach (2) to contact the hydrogel.
- the housing may also include a switch that is closed by swelled hydrogel; and that is left open when the hydrogel is collapsed.
- Such a switch may include a conventional or custom electromechanical switch that is resiliently biased to an open position.
- the hydrogel may swell in response to a relatively high pH level as described above with respect to hydrogel (122).
- the switch When the switch is closed by swelled hydrogel (e.g., when the patient begins eating), such closing of the switch may activate the pump to drive more fluid into bladder (22), to place gastric band (20) in the configuration shown in FIG. 4.
- the switch When the switch is opened by collapsed hydrogel (e.g., when the patient is fasting or otherwise not eating), such opening of the switch may activate the pump to draw fluid from bladder (22), to place gastric band (20) in the configuration shown in FIG. 3.
- the switch mechanism may be in communication with the pump via a wire fed through stomach wall (3). Alternatively, the switch mechanism may be in communication with the pump wirelessly.
- a hydrogel based switch mechanism may be coupled with a gastric valve to activate driving of the valve between substantially restrictive and substantially non-restrictive configurations.
- a hydrogel based switch mechanism may be coupled with a gastric valve as described in U.S. Pub. No. 2006/0235448, entitled "Artificial Gastric Valve,” published October 19, 2006, the disclosure of which is incorporated by reference herein.
- Various suitable ways in which a hydrogel based switch mechanism may be coupled with such a gastric valve will be apparent to those of ordinary skill in the art in view of the teachings herein.
- Various other suitable components, features, and configurations, and uses for such a hydrogel based switch mechanism will also be apparent to those of ordinary skill in the art in view of the teachings herein.
- FIGS. 8A-8B illustrate an exemplary hydrogel space occupying device (400) that may be provided within a patient's stomach (2).
- Space occupying device (400) of this example comprises a pouch or jacket (402) housing a plurality of hydrogel pellets (404). While three hydrogel pellets (404) are shown, it should be understood that any other suitable number of hydrogel pellets (404) may be used, including but not limited to just one single hydrogel pellet (404).
- Jacket (402) may be secured within a patient's stomach (2) (e.g. to the wall (3) of stomach (2)) using sutures, staples, tacks, rivets adhesives, and/or using any other suitable components, devices, or techniques, including combinations thereof.
- Jacket (402) of the present example is formed of a porous, extensible material that can substantially withstand acid and other fluids in the stomach (2), grinding and churning mechanisms of gastric motility, and enzymatic attack by digestive enzymes.
- the porous property of jacket (402) permits fluid in stomach (2) to contact hydrogel pellets (404), such that gastric fluids may enter and leave jacket (402) freely to allow changing physiological conditions occurring in stomach (2) (e.g., relating to consumption and fasting) to also occur inside jacket (402).
- Jacket (402) may have openings formed in it in addition to or as an alternative to being formed of a porous material.
- jacket (402) permits jacket (402) to expand with hydrogel pellets (404) when hydrogel pellets (404) swell as described in greater detail below.
- jacket (402) is flexible but non-extensible.
- jacket (402) may non-extensibly collapse with hydrogel pellets (404) in the configuration shown in FIG. 8 A; and may non-extensibly flex to accommodate swelled hydrogel pellets (404) in the configuration shown in FIG. 8B.
- jacket (402) may be formed of any of the following materials, including combinations thereof: metals such as NiTi; polyesters such as polyethylene terephthalate or PET; polyolefms such as polypropylene, polyethylene, and copolymers; silicone elastomers from the family of polymers based on dimethyl siloxane, including materials functionalized with phenyl or fiuro groups to include phenyl silicones and fluorosilicones; fiuoropolymers such as expanded PTFE, PTFE, copolymers or terpolymers synthesized with monomer groups containing tetrafiuoroetheylene (TFE), hexafluoropropylene (HFP), vinylidene fluoride (VDF), and others that make up the class of materials known as fiuoropolymers and fiuoroelastomers.
- metals such as NiTi
- polyesters such as polyethylene terephthalate or PET
- polyolefms such as
- hydrogel that forms hydrogel pellets (404) in the present example is environmentally sensitive, such that hydrogel pellets (404) will change between a collapsed state (FIG. 8A) and a swelled state (FIG. 8B).
- the hydrogel of hydrogel pellets (404) is formulated and configured such that it is in a collapsed state in a low pH environment (FIG.
- hydrogel pellets (404) may be formulated and configured such that they swell to an expanded state (FIG. 8B) when they are exposed to a pH level that is at or greater than approximately 4 (or at or greater than approximately 5); and such that they shrink to a collapsed state (FIG. 8A) when they are exposed to a pH level that is less than approximately 4 (or less than approximately 5).
- hydrogel pellets (404) may be formulated and configured such that they swell or shrink in response to any other suitable pH levels.
- hydrogel pellets (404) may be in the collapsed state shown in FIG. 8A.
- space occupying device (400) occupies a relatively minimal amount of volume within the patient's stomach (2), such that space occupying device (400) has a relatively negligible effect on the patient's satiety.
- the pH level in the patient's stomach (2) begins to rise. This increase in pH is sensed by hydrogel pellets (404) due to fluid in stomach (2) communicating with hydrogel pellets (404) via jacket (402).
- hydrogel pellets (404) swell to the expanded state shown in FIG. 8B.
- This swelling of hydrogel pellets (404) reduces the capacity of empty volume in the patient's stomach (2), thereby providing a relatively early sense of satiety in the patient upon or shortly after the patient begins consuming food. The patient may then cease their food intake earlier than they otherwise would in the absence of space occupying device (400). After the patient is done eating, the patient's physiology eventually returns to the fasting stage, and the pH level in the patient's stomach decreases. This decrease in pH level causes hydrogel pellets (404) to shrink back to the collapsed configuration shown in FIG. 8A.
- space occupying device (400) may be modified, substituted, or supplemented in various ways; if not be omitted altogether. Numerous suitable variations of space occupying device (400) will be apparent to those of ordinary skill in the art in view of the teachings herein. By way of example only, some versions may include two or more space occupying devices (400) being positioned at different locations within the patient's stomach (2).
- FIGS. 9A-9B illustrate an exemplary hydrogel actuated gastric sleeve (500).
- Gastric sleeve (500) is installed in the patient's duodenum (5) in the present example, though it should be understood that gastric sleeve (500) may alternatively be positioned at any other suitable location within the patient's gastrointestinal tract (e.g., within stomach (5) and/or esophagus (4), etc.).
- Gastric sleeve (500) of this example comprises a hydrogel impregnated body (502) that forms a mesh-like construction defining a plurality of openings (504).
- Hydrogel impregnated body (502) is substantially cylindraceous and elongate, such that it may be installed directly against the inner surface of the duodenum (5).
- hydrogel impregnated body (502) may be fixed in place within the duodenum (5) using sutures, staples, tacks, rivets adhesives, and/or using any other suitable components, devices, or techniques, including combinations thereof.
- hydrogel impregnated body (502) has a substantially hollow interior along its longitudinal axis, such that food and fluids may be communicated longitudinally through hydrogel impregnated body (502).
- hydrogel impregnated body (502) remains fixed within the duodenum (5), regardless of whether hydrogel impregnated body (502) is in a collapsed state (FIG. 9A) or a swelled state (FIG. 9B).
- Hydrogel impregnated body (502) is environmentally sensitive, such that the hydrogel will change between a collapsed state (FIG. 9A) and a swelled state (FIG. 9B).
- the hydrogel impregnating the body (502) is formulated and configured such that it is in a collapsed state in a low pH environment (FIG. 9A); and such that it will swell in response to an increased pH level (FIG. 9B).
- the hydrogel impregnating the body (502) may be formulated and configured such that it swells to an expanded state (FIG. 9B) when it is exposed to a pH level that is at or greater than approximately 4 (or at or greater than approximately 5); and such that it shrinks to a collapsed state (FIG. 9 A) when it is exposed to a pH level that is less than approximately 4 (or less than approximately 5).
- the hydrogel impregnating the body (502) may be formulated and configured such that it swells or shrinks in response to any other suitable pH levels.
- Hydrogel may be impregnated into body (502) using a process similar to known processes of impregnating vascular grafts with collagen; or using any other suitable process or combination of processes.
- they hydrogel polymer may essentially be formed (synthesized) in situ, directly on body (502). Such synthesis may be a liquid reaction, such that the liquid impregnates the porous body (502), forming an interpenetrating network.
- Various other suitable ways in which hydrogel may be impregnated into body (502), and/or other suitable ways in which hydrogel may otherwise be incorporated into body (502), will be apparent to those of ordinary skill in the art in view of the teachings herein.
- openings (504) permit substantially free communication of nutrients to the inner surface of the duodenum (5), where nutrients are absorbed through the inner surface.
- openings (504) shrink in size. These relatively small openings (504) substantially restrict communication of nutrients to the inner surface of the duodenum (5).
- openings (504) may be reduced in size so much that they prevent communication of nutrients to the inner surface of duodenum (5) along the full length of hydrogel impregnated body (502).
- Such restriction or prevention of communication of nutrients to the inner surface of duodenum (5) may substantially restrict or prevent the duodenum (5) from absorbing such nutrients. In some settings, such prevention of nutrient absorption may result in weight loss in the patient, as described in U.S. Pub. No. 2008/0269715, entitled “Use of an Adhesive as an Intestinal Barrier for Bariatrics,” published October 30, 2008, the disclosure of which is incorporated by reference herein.
- gastric sleeve (500) may be in the collapsed state shown in FIG. 9A.
- openings (504) are relatively large.
- the pH level in the patient's duodenum (5) begins to rise. This increase in pH is sensed by hydrogel impregnated body (502) due to fluid in duodenum (5) communicating with hydrogel impregnated body (502).
- gastric sleeve (500) swells to the expanded state shown in FIG. 9B.
- gastric sleeve (500) is installed in the patient's esophagus (4), just above the stomach (2) (e.g., just above the lower esophageal sphincter), and the responsiveness of hydrogel impregnated body (502) to pH levels is reversed.
- hydrogel impregnated body (502) is configured to swell in response to a low pH level (FIG. 9B) and collapse in response to a high pH level (FIG. 9A).
- stomach acid that is refluxed into esophagus (4) may cause hydrogel impregnated body (502) to swell, which may significantly reduce the size of openings (504), which may in turn allow gastric sleeve (500) to essentially act as a shield for tissue of the esophagus (4) against the refluxed acid.
- swelling hyrdogel impregnated body (502) in response to an occurrence of undesired acid reflux may reduce the likelihood of harm caused to esophagus (4) by such acid reflux.
- a gastric sleeve (500) (or variations thereof) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
- an environmentally sensitive hydrogel may be used formulated and configured such that it is sensitive to glucose concentrations.
- changes in glucose concentration can be used to monitor food intake, track patterns, and potentially provide a signal for a change in eating habits, band adjustment, physician visit, etc.
- nutritional intake information may be compared to physical activity via heart rate monitoring and/or other physiological parameters.
- nutritional intake information may be used to create an algorithm balancing energy in vs. energy out. Such an algorithm may be used to trigger or signal a restriction by a gastric band (20), adjustment a gastric band (20), signal information to patient or physician that behavior modification or adjustment is required, etc.
- Various other suitable ways in which nutritional intake information may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
- teachings herein may also be applied to the treatment of a variety of other conditions, including but not limited to acid reflux, incontinence (e.g., urinary incontinence, fecal incontinence), motility disorders (e.g., gastroparesis, dumping syndrome, etc), and/or other conditions, including combinations of conditions.
- incontinence e.g., urinary incontinence, fecal incontinence
- motility disorders e.g., gastroparesis, dumping syndrome, etc
- other conditions including combinations of conditions.
- bands are used for the treatment of fecal incontinence.
- One such band is described in U.S. Pat. No. 6,461,292, entitled “Anal Incontinence Treatment with Wireless Energy Supply,” issued October 8, 2002, the disclosure of which is incorporated by reference herein.
- Bands can also be used to treat urinary incontinence.
- One such band is described in U.S. Pat. No. 7,621,863, entitled “Urinary Incontinence Treatment with Wireless Energy Supply,” issued November 24, 2009, the disclosure of which is incorporated by reference herein.
- Bands can also be used to treat heartburn and/or acid reflux.
- Versions of the devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, embodiments of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, embodiments of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
- reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
- versions described herein may be sterilized before and/or after a procedure.
- the device is placed in a closed and sealed container, such as a plastic or TYVEK bag.
- the container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
- the radiation may kill bacteria on the device and in the container.
- the sterilized device may then be stored in the sterile container for later use.
- a device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
- Versions of the present invention have application in conventional endoscopic and open surgical instrumentation as well as application in robotic-assisted surgery.
Abstract
Description
Claims
Priority Applications (5)
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EP11705108.6A EP2538894B1 (en) | 2010-02-25 | 2011-02-09 | Devices for treating morbid obesity using hydrogel |
CN201180011413.4A CN102781374B (en) | 2010-02-25 | 2011-02-09 | Devices for treating morbid obesity using hydrogel |
JP2012555021A JP5697694B2 (en) | 2010-02-25 | 2011-02-09 | Device for treating morbid obesity using hydrogels |
CA2791052A CA2791052C (en) | 2010-02-25 | 2011-02-09 | Devices for treating morbid obesity using hydrogel |
AU2011218900A AU2011218900B2 (en) | 2010-02-25 | 2011-02-09 | Devices for treating morbid obesity using hydrogel |
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US12/712,466 | 2010-02-25 | ||
US12/712,466 US8608642B2 (en) | 2010-02-25 | 2010-02-25 | Methods and devices for treating morbid obesity using hydrogel |
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PCT/US2011/024213 WO2011106157A1 (en) | 2010-02-25 | 2011-02-09 | Devices for treating morbid obesity using hydrogel |
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JP (1) | JP5697694B2 (en) |
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Also Published As
Publication number | Publication date |
---|---|
JP5697694B2 (en) | 2015-04-08 |
US20110207994A1 (en) | 2011-08-25 |
EP2538894B1 (en) | 2016-04-06 |
CN102781374B (en) | 2014-08-20 |
EP2538894A1 (en) | 2013-01-02 |
US8608642B2 (en) | 2013-12-17 |
CN102781374A (en) | 2012-11-14 |
CA2791052C (en) | 2018-06-12 |
AU2011218900B2 (en) | 2014-01-23 |
JP2013520282A (en) | 2013-06-06 |
AU2011218900A1 (en) | 2012-09-06 |
CA2791052A1 (en) | 2011-09-01 |
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