WO2009085764A1 - An intragastric device - Google Patents
An intragastric device Download PDFInfo
- Publication number
- WO2009085764A1 WO2009085764A1 PCT/US2008/087007 US2008087007W WO2009085764A1 WO 2009085764 A1 WO2009085764 A1 WO 2009085764A1 US 2008087007 W US2008087007 W US 2008087007W WO 2009085764 A1 WO2009085764 A1 WO 2009085764A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bundles
- bundle
- delivery tube
- intragastric
- distal end
- Prior art date
Links
- 230000002496 gastric effect Effects 0.000 claims abstract description 37
- 238000000034 method Methods 0.000 claims abstract description 21
- 239000000463 material Substances 0.000 claims description 12
- 208000008589 Obesity Diseases 0.000 claims description 11
- 235000020824 obesity Nutrition 0.000 claims description 10
- 238000005192 partition Methods 0.000 claims description 8
- 210000001187 pylorus Anatomy 0.000 claims description 4
- 241000124008 Mammalia Species 0.000 claims description 2
- 238000000638 solvent extraction Methods 0.000 abstract description 3
- 230000015572 biosynthetic process Effects 0.000 abstract description 2
- 206010004542 Bezoar Diseases 0.000 description 7
- 210000002784 stomach Anatomy 0.000 description 6
- 230000003247 decreasing effect Effects 0.000 description 4
- 230000004580 weight loss Effects 0.000 description 4
- 239000011324 bead Substances 0.000 description 3
- 238000010276 construction Methods 0.000 description 3
- 230000037406 food intake Effects 0.000 description 3
- -1 polyethylene Polymers 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 210000003238 esophagus Anatomy 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 239000004812 Fluorinated ethylene propylene Substances 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 206010041101 Small intestinal obstruction Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 206010000059 abdominal discomfort Diseases 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003570 air Substances 0.000 description 1
- 238000013542 behavioral therapy Methods 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 208000012696 congenital leptin deficiency Diseases 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 239000005038 ethylene vinyl acetate Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 230000009969 flowable effect Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 235000019525 fullness Nutrition 0.000 description 1
- 210000003736 gastrointestinal content Anatomy 0.000 description 1
- 235000003642 hunger Nutrition 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 229920000126 latex Polymers 0.000 description 1
- 239000004816 latex Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 235000020845 low-calorie diet Nutrition 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 208000001022 morbid obesity Diseases 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229920009441 perflouroethylene propylene Polymers 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 235000019627 satiety Nutrition 0.000 description 1
- 230000036186 satiety Effects 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 235000019615 sensations Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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
- A61F5/0089—Instruments for placement or removal
-
- 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
Definitions
- This invention relates to medical devices, and more particularly to obesity devices that can be placed in the stomach of a patient to occupy volume in the gastric lumen.
- balloons In the early 1980s, physicians began to experiment with the placement of intragastric balloons to reduce the size of the stomach reservoir, and consequently its capacity for food. Once deployed in the stomach, the balloon helps to trigger a sensation of fullness and a decreased feeling of hunger.
- These balloons are typically cylindrical or pear-shaped, generally range in size from 200- 500 ml or more, are made of an elastomer such as silicone, polyurethane, or latex, and are filled with air, water, or saline. While some studies demonstrated modest weight loss, the effects of these balloons often diminished after three or four weeks, possibly due to the gradual distension of the stomach or the fact that the body adjusted to the presence of the balloon.
- balloons include a tube exiting the nasal passage that allows the balloon to be periodically deflated and re- insufflated to better simulate normal food intake.
- the disadvantages of having an inflation tube exiting the nose are obvious.
- the experience with balloons as a method of treating obesity has provided uncertain results, and has been frequently disappointing. Some trials failed to show significant weight loss over a placebo, or were ineffective unless the balloon placement procedure was combined with a low-calorie diet. Complications have also been observed, such as gastric ulcers, especially with use of fluid- filled balloons, and small bowel obstructions caused by deflated balloons.
- bezoars are subject to weight loss, presumably due to the decrease in the size of the stomach reservoir.
- bezoars may be removed endoscopically, especially in conjunction with a device known as a bezotome or bezotriptor, they, particularly larger ones, often require surgery.
- an intragastric member comprises a tubular sheet of material that is partitioned into a first bundle and a second bundle by a first retaining member and a second retaining member.
- the second retaining member is disposed distal of the first retaining member, and the first and second bundles extend circumferentially to form a lumen.
- a first suture tie and a second suture tie are provided.
- the first suture tie comprises a first proximal end and a first distal end.
- the first proximal end is a first free end that extends within the lumen and the first distal end is affixed to the first retaining member.
- the second suture tie comprises a second proximal end and a second distal end.
- the second proximal end is a second free end that extends within the lumen and the second distal end is affixed to the second retaining member.
- the first suture tie comprises a first ratcheted element and the second suture tie comprises a second ratcheted element, the first and the second ratcheted elements adapted to maintain the first and the second bundles in a compressed configuration.
- an intragastric device for the treatment of obesity comprising a delivery tube comprising a proximal end, a distal end, and a lumen extends therebetween.
- An intragastric member is provided comprising a tubular sheet of material. The intragastric member is partitioned into a first bundle and a second bundle by a first retaining member and a second retaining member disposed distal of the first retaining member, the first and the second bundles being slidably disposed along the delivery tube and extending circumferentially about the delivery tube.
- a first suture tie and a second suture tie are provided.
- the first suture tie comprises a first proximal end and a first distal end, the first proximal end being a first free end that extends within the lumen of the delivery tube and the first distal end affixed to the first retaining member.
- the second suture tie comprises a second proximal end and a second distal end, the second proximal end being a second free end that extends within the lumen of the delivery tube and the second distal end affixed to the second retaining member.
- the retaining member extends circumferentially about the intragastric member to partition the intragastric member into a first and a second bundle, the second bundle positioned proximal of the first bundle.
- the retaining member is secured with a suture tie comprising a proximal and a distal end, the proximal end being a free end that extends within a lumen and the distal end affixed to the retaining member.
- the proximal end of the suture tie is pulled in a proximal direction through the lumen such that the first and the second bundles advance distally along the delivery tube.
- FIG. 1 is a side view of an intragastric member partitioned into bundles and disposed onto a delivery tube;
- FIG. 2 is a side view of the delivery device of Figure lin which the bundles have been advanced distally;
- FIG. 3 is a side view of the delivery device of Figure 1 in which the first bundle has been deployed into the gastric lumen;
- FIG. 4 is a side view of the delivery device of Figure 1 in which each of the three bundles have advanced distally;
- FIG. 5 is a side view of the delivery device of Figure 1 in which the second bundle has been deployed into the gastric lumen;
- FIG. 6 is a side view of the delivery device of Figure 1 in which each of the two bundles have been advanced distally;
- FIG. 7 is a side view of the delivery device of Figure 1 in which the third bundle has been deployed into the gastric lumen;
- FIG. 8 is a side view of the delivery device of Figure 1 in which the bundle has been advanced distally;
- FIG. 9 is a blown up view of Figure 1 of the intragastric member;
- FIG.10 shows each of the bundles removed from the delivery tube and cinched by ratcheting elements
- FIG. 11 shows the intragastric member fully deployed in the gastric lumen.
- the obesity treatment apparatus depicted in FIGS. 1-11 comprises an intragastric member 11.
- the intragastric member 11 is preferably a high surface area mesh material (e.g., expandable polyethylene mesh), as shown in Figures 1 and 10 that is designed to displace volume within the gastric lumen.
- the implanted intragastric member 11 occupies a sufficient volume within the gastric lumen such that it does not pass through the pylorus 1010, as shown in Figure 11.
- the exact volume required is patient specific, depending on the volume of the patient's gastric lumen.
- the apparent volume of the intragastric member 11 may range from about 500 rnL to about 1500 mL.
- the term "apparent volume" as used herein refers to the volume of the intragastric member 11 prior to deployment into the gastric lumen.
- delivery of the intragastric member 11 is enabled by partitioning the intragastric member 11 into a plurality of discrete bundles with retaining members that are circumferentially disposed along the longitudinal length of the intragastric member 11.
- formation of the intragastric member 11 into bundles facilitates controlled delivery into the gastric lumen.
- the use of pull strings or suture ties enables deployment of the intragastric member 11 into the gastric lumen.
- the distal ends of the suture ties are affixed to the bundles. Pulling on the proximal free end of each of the suture ties enables the corresponding bundles to be advanced distally along a delivery tube.
- FIG. 1 shows an exemplary intragastric member 11 that has been partitioned into a plurality of discrete bundles.
- the intragastric member 11 may comprise a relatively large number of bundles, for purposes of simplicity and clarity, only four bundles are shown.
- bundles 14, 15, 16, 17 are shown extending along the distal portion of the intragastric member 11. Compartmentalizing the intragastric member 11 into discrete bundles 14-17 facilitates its delivery and deployment into the gastric lumen.
- Retaining members 34, 35, 36, 37, 38 are circumferentially disposed at predetermined longitudinal lengths of the intragastric member 11 to form the bundles 14-17.
- each bundle 14, 15, 16, and 17 may vary and is partially dependent upon the degree of compartmentalization required. The shorter the longitudinal length of each of the bundles 14-17, the greater the ease of control may be in maneuvering the intragastric member 11 during delivery and deployment.
- Retaining member 35 partitions the distal end of the intragastric member 11 into bundle 14 and bundle 15.
- Retaining member 36 further partitions the distal end of the intragastric member 11 into bundle 16, and retaining member 37 further partitions the intragastric member 11 into bundle 17.
- Additional retaining members 34 and 38 may be provided to further constrain the intragastric member 11 into a low profile during delivery by substantially preventing the ends of bundle 14 and bundle 17 from undesirably flaring outwards and freely moving relative to delivery tube 18.
- the intragastric member 11 with retaining members 34-38 are shown mounted over a delivery tube 18.
- Figure 1 shows that the bundles 14-17 are constrained about delivery tube 18 at discrete intervals. Such constrainment of the bundles 14-17 enables a controlled delivery and deployment of the intragastric member 11 into a gastric lumen.
- the retaining members 34-38 may be elastic bands or other structures, such as elastic rings.
- the retaining members 34-38 are secured to the intragastric member 11 and are not substantially moveable relative to each other.
- the attachment of the retaining members 34-38 to the intragastric member 11 at discrete locations enables the overall member 11 to achieve a low profile capable of being delivered to the gastric lumen.
- the retaining members 34-38 extend circumferentially about the intragastric member 11 , as shown in Figure 1.
- Each of the retaining members 34-38 is attached to its respective distal end of the suture tie that it contacts.
- Figure 10 shows retaining member 38 attached by an adhesive to suture tie 64 at the distal end 85 of suture tie 64.
- the attachment of retaining member 38 to the distal end 85 of the suture tie 64 is sufficient so as to enable distal movement of both retaining member 38 and distal end 85 of suture tie 64 when the proximal end 65 of suture tie 64 is pulled.
- Other means of securing the retaining member 38 to the distal end 85 of suture tie 64 are contemplated.
- the distal end 85 of suture tie 64 may be knotted to retaining member 38.
- the suture tie 64 may be riveted or crimped to the retaining member 38.
- the suture tie 64 may also be interwoven through the interstices 920 of the mesh 910.
- the retaining members 34-38 extend circumferentially about an intragastric member 11 to secure it onto a delivery tube 18.
- the retaining members 34-38 may be spaced apart from about
- retaining members 34-38 are shown in Figure 1, more than five or less than five retaining members may be used.
- the number of retaining members to be used is partially dependent upon the degree of partitioning of the intragastric member 11 that is desired during delivery. Generally speaking, a suitable number of retaining members should be disposed at a predetermined interval such that substantial portions of the intragastric member
- Suture ties 61-64 are shown affixed to the bundles 14-17.
- the suture ties 61-64 are shown as pull strings which enable the bundles 14-17 to be advanced distally along the delivery tube 18 and ultimately to be released from the tube 18 into the gastric lumen.
- Suture tie 61 has a proximal end 66 and a distal end 82.
- the distal end of each suture tie as used herein refers to that portion of the suture tie that extends along the outer surface of the bundles 14-17.
- the proximal end of each suture tie as used herein refers to that portion of the suture tie that extends along the inner surface of the bundles 14-17 within the lumen 17 of the delivery tube 18.
- Suture tie 62 has a proximal end 67 and a distal end 83. The distal end
- proximal end 67 is a free end that extends proximally within the lumen 18. Note that the distal end 83 of the suture tie 62 also is attached to the retaining member 35.
- Suture tie 63 has a proximal end 68 and a distal end 84. The distal end
- the proximal end 68 is a free end that extends proximally within the lumen 18. Note that the distal end 84 of the suture tie 63 also is attached to retaining members 35 and 36.
- Suture tie 64 has a proximal end 65 and a distal end 85. The distal end
- the proximal end 66 is a free end that extends proximally within the lumen 18.
- the distal end 85 of the suture tie 64 extends proximally to the retaining members 35, 36, 37, and 38.
- Each of the free ends of the proximal ends 65-68 of the suture ties 61-64 extends proximally within the lumen 18 of the patient's esophagus and terminates out of the patient's mouth, thereby allowing a physician access to the suture ties 61-64 during deployment of the intragastric member 11.
- the intragastric member 11 may be formed from a variety of materials.
- the member 11 comprises a woven polymeric mesh, as shown in Figures 1-11.
- the mesh member 11 resembles a sock-like structure that is disposed about the delivery tube 18.
- the mesh sock-like structure is compliant and capable of being partitioned into bundles.
- the mesh sock-like structure is also flowable such that the individual bundles can be distally advanced along the delivery tube 18.
- the mesh 910 ( Figure 10) is formed from a low-density polyethylene having a thickness of about 40-50 microns. Details of a medical device formed from a mesh-like structure are described in U.S. Patent Application No.
- 11/743,732 which is incorporated herein by reference.
- Other types of materials are contemplated.
- many well-known plasties such as polyesters, polyurethanes, polyethylenes, polyamides, and silicone may be used.
- Mammalian hair has been found to form natural bezoars, and thus, is also a possible material.
- Fluorinated ethylene propylene, ethylene vinyl acetate copolymer, nylon, or types of polymers that are biocompatible and to which food will generally not adhere may also be utilized.
- the intragastric member 11 is loaded onto a delivery tube 18 ( Figure 1).
- the intragastric member 11 may be configured to extend circumferentially about the delivery tube 18.
- the retaining members 34-38 are likewise disposed circumferentially about the intragastric member 11 at predetermined intervals to create the partition of bundles 14-17, as described above.
- the retaining members 34-38 also help secure the intragastric member 11 onto the delivery tube 18 in a constrained, low profile configuration.
- the retaining members 34-38 may be spaced apart at about 30 cm increments along the distal end of the delivery tube 18.
- Suture ties 61-64 may be attached longitudinally to the bundles 14-17 by interweaving the ties 61-64 through the interstices 920 of the mesh 910 ( Figure 10).
- the distal ends 82-85 of respective ties 61-64 may be disposed underneath the retaining members 34-38.
- Various other mechanisms for securing the intragastric member 11 to the delivery tube 18 are contemplated.
- the sutures ties 61, 62, 63, 64 may be looped, sewn or threaded through the interstices 920 of the mesh 910 ( Figure 10).
- the proximal ends 65-68 are free ends that extend within the lumen 17 of the delivery tube 18, through the overtube 1000 ( Figure 10) and out of the patient's mouth for a physician to access during deployment of the bundles 14-17.
- the intragastric member 11 and delivery tube 18 may be navigated through an overtube 1000 ( Figure 11) that spans along the patient's esophagus and into the entrance of the gastric lumen 1020 ( Figure 11).
- the delivery tube 18 may be navigated through the overtube 1000 and into the gastric lumen 1020 with the intragastric member 11 being configured in the constrained, low profile state by virtue of the bundles 14-17 ( Figure 1).
- proximal ends 65-68 may be color coded to help the operator identify which of the suture ties 61-64 is being pulled.
- Other means for logically identifying and organizing the proximal ends 61-64 are contemplated.
- the proximal ends 61-64 may be wound so as to create a user- friendly configuration.
- Proximal end 66 of suture tie 61 is pulled (as indicated by the arrow in Figure 1) with a predetermined amount of force to cause the first bundle 14 to move toward the distal (forward) end of the delivery tube 18. Movement of the first bundle 14 towards the distal edge of the delivery tube 18 causes the first bundle 14 to become compressed, as shown in Figure 2.
- Figure 2 shows that the first bundle 14 has compressed, as indicated by the crease lines.
- the predetermined amount of force with which the proximal end 66 of suture tie 61 is pulled and the elasticity of retaining member 35 may help to maintain the first bundle 14 in a compressed configuration at the distal end of the delivery tube 18.
- the elasticity of retaining member 35 about the mesh 910 ( Figure 10) of intragastric member 11 provides sufficient frictional engagement of bundle 14 with the delivery tube 18 such that the bundle 14 does not readily slide off from the distal end of the delivery tube 18 at this juncture. Such frictional engagement may provide incremental and controlled deployment of each bundle 14-17 from the delivery tube 18. As the first bundle 14 shortens in length, the length of the distal end 82 of the suture tie 61 (i.e., the portion outside the tube 18) decreases while the length of the proximal end 66 of the suture tie 61 (i.e., the portion within the tube 18) proportionately increases.
- the predetermined amount of force with which the proximal end 67 of suture tie 62 is pulled and the elasticity of retaining member 36 may help to maintain the second bundle 15 in a compressed configuration at the distal end of the delivery tube 18.
- the elasticity of retaining member 36 about the mesh 910 ( Figure 10) of intragastric member 11 provides sufficient frictional engagement of the second bundle 15 with the delivery tube 18 such that the second bundle 15 does not readily slide off from the distal end of the delivery tube 18 at this juncture.
- the length of the distal end 83 of the suture tie 62 i.e., the portion outside the tube 18
- the length of the proximal end 67 of the suture tie 62 i.e., the portion inside the tube 18
- the predetermined amount of force with which the proximal end 68 of suture tie 63 is pulled and the elasticity of retaining member 37 may help to maintain the third bundle 16 in a compressed configuration at the distal end of the delivery tube 18.
- the elasticity of retaining member 37 about the mesh 910 ( Figure 10) of intragastric member 11 provides sufficient frictional engagement of bundle 16 with the delivery tube 18 such that the bundle 16 does not readily slide off from the distal end of the delivery tube 18 at this juncture.
- the length of the distal end 84 of the suture tie 63 i.e., the portion outside the tube 18
- the length of the proximal end 68 of the suture tie 63 i.e., the portion inside the tube 18
- the elasticity of retaining member 38 about the mesh 910 ( Figure 10) of intragastric member 11 provides sufficient frictional engagement of bundle 17 with the delivery tube 18 such that the bundle 17 does not readily slide off from the distal end of the delivery tube 18 at this juncture.
- the length of the distal end 85 of the suture tie 64 i.e., the portion outside the tube 18
- the length of the proximal end 65 of the suture tie 64 i.e., the portion inside the tube 18
- Figure 9 shows all of the bundles 14-17 deployed from the delivery tube 18.
- Beads 90-93 are shown affixed to the surface of their respective suture ties 61-64.
- the beads 90-93 serve as ratcheted structures which cinch their respective bundles 14-17 in the longitudinal direction and maintain the bundles 14-17 in a compressed and bundled configuration ( Figure 9).
- Other types of ratcheted structures to cinch the bundles 14-17 are contemplated and would be appreciated by one of ordinary skill in the art.
- proximal and distal stoppers could be used to maintain the bundles 14-17 in a compressed configuration.
- all of the bundles 14-17 may be knotted or tied together.
- the above described procedure of delivery may be repeated by loading additional intragastric members 11 over the delivery tube 18 and pushing these intragastric members 11 against the previously inserted bundles 14-17 until all of the bundles 14 have been inserted into the gastric lumen. Deployment of additional intragastric members 11 may occur if greater displacement of the gastric lumen is required.
- suture tie 64 may be pulled to cause distal movement of bundle 17.
- Distal movement of bundle 17 may push against bundles 14-16 thereby causing them to also move distally such that bundles 14-17 attain a compressed configuration at the distal end of the delivery tube 18.
- Figure 11 show the completely deployed intragastric member 11 implanted in the gastric lumen 1020.
- the deployed intragastric member 11 is shown in an unconstrained state without any stoppers to constrain the bundles 14- 17.
- the bundles 14-17 are in a compressed configuration yet occupy sufficient volume such that they do not exit through the pylorus 1010. Beads 90-93 cinch the bundles 14-17 and maintain the bundles 14-17 in a compressed configuration within the gastric lumen 1020.
- the intragastric member 11 is sufficiently large such that it occupies a volume in the gastric lumen 1020 that prevents the bundles 14-17 from passing through the pylorus 1010.
- the intragastric member 11 occupies a sufficiently large volume in the gastric lumen 1020 to cause a patient to eat less and achieve satiety.
- an intragastric bag having a starting longitudinal length of about four feet and a width of about six inches may be partitioned into four bundles, each of the four bundles having a longitudinal length of about one foot and a width of about one inch. More retaining members may be utilized to further partition the intragastric bag, thereby reducing the profile of the assembled bundles onto the delivery tube 18.
- each of the bundles may have a width of about six inches and a longitudinal length of about one-and-a-half inches.
- the width of the deployed bundles 14-17 is greater than the width of the bundles 14-17 assembled onto delivery tube 18.
- the retaining members 34-38 are typically cut so as to enable the bundles 14-17 to uncompress and be withdrawn from the lumen 1020.
- One end of the member 11 is then grasped by forceps or similar device and pulled out of the patient.
- Any other undisclosed or incidental details of the construction or composition of the various elements of the disclosed embodiment of the present invention are not believed to be critical to the achievement of the advantages of the present invention, so long as the elements possess the attributes needed for them to perform as disclosed. The selection of these and other details of construction are believed to be well within the ability of one of even rudimentary skills in this area, in view of the present disclosure.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2709949A CA2709949C (en) | 2007-12-21 | 2008-12-16 | An intragastric device |
EP08866522A EP2222256B1 (en) | 2007-12-21 | 2008-12-16 | An intragastric device |
JP2010539707A JP5469611B2 (en) | 2007-12-21 | 2008-12-16 | Gastric appliance |
AU2008343346A AU2008343346B2 (en) | 2007-12-21 | 2008-12-16 | An intragastric device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/963,577 | 2007-12-21 | ||
US11/963,577 US7883524B2 (en) | 2007-12-21 | 2007-12-21 | Method of delivering an intragastric device for treating obesity |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2009085764A1 true WO2009085764A1 (en) | 2009-07-09 |
Family
ID=40429949
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2008/087007 WO2009085764A1 (en) | 2007-12-21 | 2008-12-16 | An intragastric device |
Country Status (6)
Country | Link |
---|---|
US (1) | US7883524B2 (en) |
EP (1) | EP2222256B1 (en) |
JP (1) | JP5469611B2 (en) |
AU (1) | AU2008343346B2 (en) |
CA (1) | CA2709949C (en) |
WO (1) | WO2009085764A1 (en) |
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WO2014082044A1 (en) | 2012-11-26 | 2014-05-30 | Spatz Fgia, Inc. | System and methods for internalization of components of an adjustable intragastric balloon |
US9974680B2 (en) | 2004-12-27 | 2018-05-22 | Spatz Fgia, Inc. | System and methods for internalization of external components of adjustable intragastric balloon |
WO2007110866A2 (en) * | 2006-03-28 | 2007-10-04 | Spatz-Fgia Inc | Floating gastrointestinal anchor |
CN102387762B (en) | 2009-04-03 | 2014-08-06 | 美特默迪克斯公司 | Modular gastrointestinal prostheses |
US8702641B2 (en) | 2009-04-03 | 2014-04-22 | Metamodix, Inc. | Gastrointestinal prostheses having partial bypass configurations |
US9173760B2 (en) | 2009-04-03 | 2015-11-03 | Metamodix, Inc. | Delivery devices and methods for gastrointestinal implants |
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