US20090171383A1 - Gastric space occupier systems and methods of use - Google Patents

Gastric space occupier systems and methods of use Download PDF

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Publication number
US20090171383A1
US20090171383A1 US12/270,607 US27060708A US2009171383A1 US 20090171383 A1 US20090171383 A1 US 20090171383A1 US 27060708 A US27060708 A US 27060708A US 2009171383 A1 US2009171383 A1 US 2009171383A1
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US
United States
Prior art keywords
stomach
tubular
space
gastric
elongate member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US12/270,607
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English (en)
Inventor
David Cole
Samuel T. Crews
Bretton Swope
Andrew Smith
John Lunsford
Daniel J. Balbierz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Barosense Inc
Original Assignee
Barosense Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Barosense Inc filed Critical Barosense Inc
Priority to US12/270,607 priority Critical patent/US20090171383A1/en
Assigned to BAROSENSE, INC. reassignment BAROSENSE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LUNSFORD, JOHN, BALBIERZ, DANIEL J., COLE, DAVID, CREWS, SAMUEL T., SMITH, ANDREW, SWOPE, BRETTON
Publication of US20090171383A1 publication Critical patent/US20090171383A1/en
Priority to US13/224,233 priority patent/US8945167B2/en
Priority to US14/486,737 priority patent/US20150039011A1/en
Abandoned legal-status Critical Current

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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
    • A61F5/0036—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
    • A61F5/003—Implantable devices or invasive measures inflatable

Definitions

  • the present invention relates generally to the field of implants for inducing weight loss in patients, and specifically to devices and methods for reducing the effective volume of a patient's stomach.
  • Prior art treatments for obesity range from diet and medication to highly invasive surgical procedures. Some of the more successful surgical procedures are the vertical banded gastroplexy or the proximal gastric pouch with a Roux-en-Y anastomosis. However, known complications are present with each of these procedures. More successful and less invasive options are desired.
  • a less invasive prior art treatment for obesity includes implantation of a gastric space occupier delivered into the stomach via the esophagus.
  • the space occupier is an obstructive device—it prevents overeating by occupying volume within the stomach.
  • implantation of a space occupier is less invasive than other surgical procedures, complications do exist.
  • space occupiers are typically fluid filled balloons, rupture of balloons can and does occur.
  • a punctured balloon can migrate into the intestines, potentially causing life-threatening intestinal obstruction.
  • Some prior systems attempt to avoid the risk of migration by anchoring space occupiers within the stomach, but these systems tend to nevertheless detach from the stomach wall, resulting in migration.
  • a space occupier which does not pose the treat of obstruction is highly desirable. However, the size of space occupier necessary for weight loss makes a single unit space occupier design difficult.
  • the stomach is a dynamic organ capable of adapting to changes—including those associated with positioning of a space occupier. Given the adaptive nature of the stomach, space occupiers do not adequately provide for long term weight loss. It would be advantageous to have a system which could accommodate such adaptations, thus allowing for long term weight loss.
  • the present application describes space occupier designs that minimize risk of obstruction, as well as methods for using the designs in a manner that addresses stomach adaptations and/or changes to the amount of volume consumption needed for a given patient.
  • FIG. 1 schematically shows a cross-section view of a stomach, with a plurality of space occupiers positioned within the stomach;
  • FIG. 2 is similar to FIG. 1 , and shows one of the space occupiers deflated and passing through the intestine;
  • FIG. 3 is similar to FIG. 1 and illustrates use of a second type of space occupier
  • FIG. 4A is a side elevation view of an alternative to the space occupier of FIG. 3 ;
  • FIG. 4B is a cross-section view taken along the plane designated 4 B- 4 B in FIG. 4A ;
  • FIGS. 5 and 6 are cross-section views of the space occupier of FIG. 4A , in which FIG. 5 shows the space occupier in an insertion position and FIG. 6 shows locking of the space occupier into an expanded position;
  • FIG. 7 is a side elevation view of yet another embodiment of a space occupier
  • FIG. 8 is similar to FIG. 1 , and illustrates the ability of the space occupier of FIG. 7 to shoot upwardly when it migrates into contact with the pyloric sphincter;
  • FIGS. 9A and 9B illustrate steps in the manufacture of the space occupier of FIG. 7 .
  • the disclosed embodiments address the shortcomings of prior art space occupier technologies.
  • the disclosed systems utilize a number of space occupiers positioned in the stomach. Such an arrangement provides sufficient stomach volume consumption to induce weight loss, but enables use of space occupiers that are proportioned to minimize the threat of obstruction even if they should migrate into the intestine.
  • numerous small volume space occupiers are placed in the stomach such that the total volume equals or exceeds the single volume of known space occupiers.
  • each individual space occupier is proportioned so that it will pass without obstruction if it moves into the intestine.
  • the devices are capable of being inserted transorally, but once in the stomach the space occupiers are expanded or otherwise changed into a shape or size which prevents migration into the intestinal tract. Because they are smaller than known space occupiers, additional individual units may be introduced into the stomach to increase the rate of weight loss or to accommodate changes in the stomach size.
  • FIG. 1 shows a first embodiment of a space occupier system in which a number of fluid filled space occupiers 10 are transorally passed into the stomach.
  • the volume of each individual balloon is between 50-200 cc, but preferably between 75 and 125 cc.
  • the collective volume occupied by the collection of space occupiers can be 300 cc or more (e.g. in a range between approximately 300 cc and 700 cc).
  • Each space occupier has a deflated or compressed position allowing its insertion into the stomach via the esophagus as shown.
  • the system may be provided with instruments that facilitate implantation, such as an overtube positionable in the esophagus (through which the space occupiers are passed), and instruments for advancing the space occupiers through the overtube or directly through the esophagus.
  • instruments might include push tools that push the space occupiers through the esophagus or overtube, or graspers or alternative instruments that can be used to carry space occupiers through the esophagus or overtube.
  • fluid e.g. liquid, gas, gel
  • an inflation tube 14 is coupled to the valve prior to introduction of the space occupier into the stomach, and is subsequently detached from the space occupier following inflation.
  • Inflation tube is coupled to a fluid source 16 such as a fluid-filled syringe or canister.
  • the space occupiers are shown as spherical but may be any shape that will resist passage into the digestive tract when filled with fluid, but that will readily pass into the digestive tract, as shown in FIG. 2 , when the fluid is released such as through rupture.
  • the number of space occupier units implanted at any given time is selected to give a target stomach volume consumption selected to yield the desired weight loss results. Additional units may be added, or some units removed, during the course of weight loss treatment to increase or decrease the total volume consumption and the corresponding rate of weight loss and/or to respond to adaptive changes in the stomach's volume.
  • FIG. 3 illustrates use of an alternate form of space occupier 10 a that need not be inflatable but that is positioned in a first streamlined shape 18 a for insertion into the stomach and is then manipulated into a different, less streamlined shape 18 b that will resist passage into the digestive tract.
  • the space occupier 10 a is an elongate band 20 having a locking feature that joins the ends of the band to form a cylindrical element or oval shaped element.
  • the locking feature includes a tab 22 on one end and a receptacle 24 on the other end for receiving the tab in locking engagement.
  • FIG. 3 embodiment may be constructed to form a wide variety of alternate shapes beyond a cylindrical or oval shape.
  • FIG. 4A shows a modification to the FIG. 3 embodiment in which the ends of band 20 a are coupled together to form a space occupier 10 b having a triangular shape.
  • Band 20 a may have a circular cross-section as shown in FIG. 4B to give the space occupier a smooth exterior surface. Suitable diameters for the band range from 0.25-1 inches, or more preferably 0.5-0.75 inches.
  • the band 20 a may formed to include predetermined bend locations 26 formed using, for example, weakened or thinned regions of band material.
  • bend locations are formed by forming v-shaped hinges into the band material.
  • the band is positioned in its linear/streamlined configuration and introduced into the stomach as shown in FIG. 3 .
  • Overtubes, pushers, graspers etc may be used to facilitate instruction of the band into the stomach as indicated in connection with the FIG. 1 embodiment.
  • a tether 28 is coupled to tab 22 and threaded through the receptacle 24 and also through a pusher tube 30 .
  • tether 28 is withdrawn while pusher tube 30 is pushed against the band 20 a as shown in FIG. 6 , causing the tab 22 to pass into and become engaged in the receptacle 24 .
  • the tether 28 and pusher 30 are proportioned such that their proximal ends may be manipulated in this manner from outside the body. If the tab should become disengaged, the band will return to the streamlined shape and thus will be able to pass through the intestinal tract without harm to the patient.
  • multiple units of the space occupier 10 a, 10 b are preferably used at one time to achieve a desired collective volume consumption within the stomach, such as that described in connection with the FIG. 1 embodiment.
  • the number of units placed in the stomach may be decreased or increased as needed to achieve the target weight loss.
  • FIG. 7 illustrates yet another embodiment of a gastric space occupier 10 c having a shape that inhibits passage of the space occupier into the digestive tract.
  • Space occupier 10 c is a tubular balloon.
  • the balloon has inner and outer walls 32 a, 32 b, and a fluid between the inner and outer walls.
  • a lumen 34 extends longitudinally through the tubular balloon.
  • the construction of the space occupier 10 c is similar to that of a children's' toy known as a “water snake”.
  • the space occupier is configured such that squeezing the outer surface at one end will “squirt” the space occupier away from the point of compression by causing the layer of wall lining the lumen 34 to roll to the outside of the balloon while the layer of wall lining the outer surface of the balloon rolls into the lumen as indicated by arrows in FIG. 7 . This feature aids in preventing the device from passing into the digestive tract.
  • the device should the device begin to migrate into the digestive tract, its distal-facing end will be compressed or squeezed as it descends into the pyloric antrum and/or abuts the pyloric sphincter. In response to this compression, the device walls will propel the device away from the pyloric sphincter as shown in FIG. 8
  • FIGS. 9A and 9B illustrate steps of manufacturing the space occupier 10 c.
  • a tube 36 having lumen 34 is provided.
  • Tube 36 may have a uniform diameter, and it can be formed of a thin-walled extrusion of silicone, urethane, or other suitable material.
  • the ends 40 of the tube are everted and brought together on the exterior of the tube, thus giving the tube a double-layer wall.
  • Fluid is introduced into the space 38 between the layers 32 a, 32 b of the wall.
  • a seal 42 is applied to seal the ends 40 together and to seal the fluid within the space 38 .
  • Seal 42 may include a valve, allowing the fluid to be introduced in situ as described with respect to the FIG. 1 embodiment. Alternatively, the seal may be provided without a valve. This embodiment may be used as a single unit, or multiple units may be implanted in the stomach.
  • obesity using the space occupier 10 c may involve placing a single space occupier or multiple space occupiers within the stomach to achieve a desired collective volume consumption within the stomach, such as that described in connection with the FIG. 1 embodiment.
  • the overall and/or rate of weight loss is monitored, and the number of units may be decreased or increased as needed to achieve the target weight loss or rate of weight loss.
  • the space occupiers 10 c may be passed through an endogastric overtube or introduced into the stomach by some other means.
  • the disclosed space occupiers and associated systems may be provided with instructions for use instructing the user to utilize the space occupiers according to the various steps described herein.

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  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
US12/270,607 2007-12-31 2008-11-13 Gastric space occupier systems and methods of use Abandoned US20090171383A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US12/270,607 US20090171383A1 (en) 2007-12-31 2008-11-13 Gastric space occupier systems and methods of use
US13/224,233 US8945167B2 (en) 2007-12-31 2011-09-01 Gastric space occupier systems and methods of use
US14/486,737 US20150039011A1 (en) 2007-12-31 2014-09-15 Gastric space occupier systems and methods of use

Applications Claiming Priority (2)

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US1840507P 2007-12-31 2007-12-31
US12/270,607 US20090171383A1 (en) 2007-12-31 2008-11-13 Gastric space occupier systems and methods of use

Related Child Applications (1)

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US13/224,233 Division US8945167B2 (en) 2007-12-31 2011-09-01 Gastric space occupier systems and methods of use

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US20090171383A1 true US20090171383A1 (en) 2009-07-02

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US12/270,607 Abandoned US20090171383A1 (en) 2007-12-31 2008-11-13 Gastric space occupier systems and methods of use
US13/224,233 Expired - Fee Related US8945167B2 (en) 2007-12-31 2011-09-01 Gastric space occupier systems and methods of use
US14/486,737 Abandoned US20150039011A1 (en) 2007-12-31 2014-09-15 Gastric space occupier systems and methods of use

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US14/486,737 Abandoned US20150039011A1 (en) 2007-12-31 2014-09-15 Gastric space occupier systems and methods of use

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US (3) US20090171383A1 (ja)
EP (1) EP2227194B1 (ja)
JP (2) JP5520832B2 (ja)
AU (1) AU2008344966B2 (ja)
CA (1) CA2710978C (ja)
WO (1) WO2009086549A1 (ja)

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US9180035B2 (en) 2003-10-10 2015-11-10 Boston Scientific Scimed, Inc. Devices and methods for retaining a gastro-esophageal implant
US9314361B2 (en) 2006-09-15 2016-04-19 Boston Scientific Scimed, Inc. System and method for anchoring stomach implant
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US9526648B2 (en) 2010-06-13 2016-12-27 Synerz Medical, Inc. Intragastric device for treating obesity
US10010439B2 (en) 2010-06-13 2018-07-03 Synerz Medical, Inc. Intragastric device for treating obesity
US10137023B2 (en) 2012-09-14 2018-11-27 Medibotics Llc Colonnade (TM) expandable intragastric food flow lumen device
US10413436B2 (en) 2010-06-13 2019-09-17 W. L. Gore & Associates, Inc. Intragastric device for treating obesity
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US20090171383A1 (en) 2007-12-31 2009-07-02 David Cole Gastric space occupier systems and methods of use
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US8282598B2 (en) 2009-07-10 2012-10-09 Metamodix, Inc. External anchoring configurations for modular gastrointestinal prostheses
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US9173760B2 (en) 2009-04-03 2015-11-03 Metamodix, Inc. Delivery devices and methods for gastrointestinal implants
US9278019B2 (en) 2009-04-03 2016-03-08 Metamodix, Inc Anchors and methods for intestinal bypass sleeves
US8961539B2 (en) 2009-05-04 2015-02-24 Boston Scientific Scimed, Inc. Endoscopic implant system and method
US8979887B2 (en) * 2012-02-24 2015-03-17 Elwha Llc Devices, systems, and methods to control stomach volume
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