CA2691530A1 - Gastric space filler device, delivery system, and related methods - Google Patents

Gastric space filler device, delivery system, and related methods Download PDF

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Publication number
CA2691530A1
CA2691530A1 CA002691530A CA2691530A CA2691530A1 CA 2691530 A1 CA2691530 A1 CA 2691530A1 CA 002691530 A CA002691530 A CA 002691530A CA 2691530 A CA2691530 A CA 2691530A CA 2691530 A1 CA2691530 A1 CA 2691530A1
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CA
Canada
Prior art keywords
space filler
gastric
filler device
proximal
gastric space
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
CA002691530A
Other languages
French (fr)
Inventor
Stephen A. Sosnowski
Tyler J. Holschlag
Daniel E. Kincade
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.)
Reshape Medical Inc
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to CA2892287A priority Critical patent/CA2892287C/en
Publication of CA2691530A1 publication Critical patent/CA2691530A1/en
Abandoned legal-status Critical Current

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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
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A61F5/0033—Implantable devices or invasive measures inflatable with more than one chamber
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0177—Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes

Abstract

According to features of the present disclosure, a gastric space filler device and methods effective for reducing stomach volume are disclosed. A gastric space filler comprising at least one inflatable space filler and a sleeve to prevent leakage out of the gastric space filler device is disclosed. The gastric space filler device may be inflated with an insufflation fluid and with mineral oil, which further has the effect of reducing leakage. Delivery systems and methods for inserting a gastric space filler device into a patient are also disclosed. Sheaths and methods for covering a gastric space filler device during delivery into a patient are also disclosed.

Description

GASTRIC SPACE FILLER DEVICE, DELIVERY SYSTEM, AND
RELATED METHODS

BY
STEPHEN A. SOSNOWSKI, VISTA, CA.
TYLER J. HOLSCHLAG, CARISBAD, CA.
AND

DANIEL E. KINCADE, CHULA VISTA, CA.
RELATED APPLICATION

[oool] This application claims full Paris Convention benefit of and priority to U.S.
patent application (a) Serial No. 11/694,536, filed March 30, 2007 and PCT
applications (b) Serial No. PCT/USo6/42336, filed October 31, 2oo6, (c) Serial No.
PCT/USo6/42711, filed October 31, 20o6, and (d) Serial No. PCT/USo6/42710, filed October 31, 2oo6, and (e) Serial No. PCT/USo6/48647, filed December 20, 2oo6, the contents of which are hereby incorporated by reference in their entirety, as if fully set forth herein.

BACKGROUND
[0002] 1. Field
[0003] This disclosure relates to implantable weight control devices. More particularly, this disclosure relates to a gastric space filler device which is retrievably implantable in a patient, an improved device and method for delivery of a gastric space filler device, and a method and device for retaining fluid in a gastric space filler device, among other things.
[0004] 2. General Background
[0005] Gastric space fillers used for achieving loss of weight in extremely obese persons have been known in the art. Some gastric space fillers utilized for this purpose i function on the principle that an empty bag or space filler is placed into the stomach through the esophagus. Thereafter, the bag or space filler is fully or partially filled with a suitable insufflation fluid, such as saline solution, through a filler tube or catheter which is inserted into the stomach through the mouth or the nose. The space filler occupies space in the stomach thereby leaving less room available for food and creating a feeling of satiety for the obese person. Clinical experience has shown that, for many obese patients, reducing the size of the gastric compartment with gastric space fillers significantly helps to control appetite and accomplish weight loss. The present disclosure is directed to a device which non-operatively reduces the size of the gastric coinpartment and which is easily removed. Artisans shall readily appreciate that emergency operative morbidity rates and co-morbidity statistics relating to such devices which have migrated beyond the stomach underscore the need for an effective medical device that can be removed.

SUMMARY
[ooo6] According to features of the present disclosure, a gastric space filler device and methods effective for reducing stomach volume are disclosed. A gastric space filler comprising at least one inflatable space filler and a sleeve to prevent leakage out of the gastric space filler device is disclosed. The gastric space filler device may be inflated with an insufflation fluid and with mineral oil, which further has the effect of reducing leakage. Delivery systems and methods for inserting a gastric space filler device into a patient are also disclosed. Sheaths and methods for covering a gastric space filler device during delivery into a patient are also disclosed.

[0007] According to embodiments of the instant teachings, there is disclosed a gastric space filler device comprising a space filler, an opening to inflate the space filler, and a sleeve that is configured to receive mineral oil between the sleeve and the opening.
According to at least one embodiment, the sleeve is disposed between the opening and the outer periphery of the space filler. According to at least one embodiment, the sleeve allows fluid to enter the space filler during inflation, but does not allow fluid to exit the space filler when mineral oil is received between the sleeve and the opening.

[ooo8] According to embodiments of the instant teachings, there is disclosed a gastric space filler device comprising a space filler and a sheath, wherein the sheath at least partially covers the space filler. According to at least one embodiment, the sheath is secured around the space filler with a stitch that can be released by pulling on the stitch:
According to at least one embodiment, the sheath automatically uncovers the space filler as the space filler is inflated.

[ooo9] According to embodiments of the instant teachings, there is disclosed a delivery system comprising a delivery lumen, a barb configured for coupling with an infusing lumen of a gastric space filler device, and a docking clip configured for securely attaching the delivery system to the gastric space filler device. According to at least one embodiment, the delivery system contains a handle that, when removed from the infusing lumen, pulls a stitch to release a space filler and simultaneously uncovers a luer for infusing a fluid into the gastric space filler device.

[ooio] According to embodiments of the instant teachings, there is disclosed a method for treating obesity challenged patients comprising providing a gastric space filler device comprising a space filler, an opening to inflate said space filler, and a sleeve, wherein said sleeve is configured to receive mineral oil between said sleeve and said opening.
According to at least one embodiment, the sleeve allows an insufflation fluid to enter the space filler during inflation, but the sleeve does not allow the insufflation fluid to exit the space filler after the mineral oil is received between the sleeve and the opening.

[ooii] According to embodiments of the instant teachings, there is disclosed a method for emplacing a gastric space filler device in a patient comprising providing a delivery system attached to a gastric space filler device comprising a space filler;
covering at least part of the space filler with a sheath; and delivering the delivery system and the gastric space filler device through an esophagus into a stomach of a patient.

DRAWINGS
[0012] The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which:

[0013] Figure 1 shows an embodiment of a gastric space filler device and delivery system;

[00141 Figure 2A shows an embodiment of an infusing member without proximal sleeve or distal sleeve;

[0015] Figure 2B shows an embodiment of an infusing member with a proximal sleeve and a distal sleeve;

[0016] Figure 3 shows a cross-sectional view of an embodiment of an infusing member, a proximal sleeve, and a proximal opening;

[0017] Figure 4 shows a cross-sectional view of an embodiment of an infusing member, a distal sleeve, and a distal opening;

[oo18] Figure 5 shows a rear view of an embodiment of a gastric space filler device containing a distal space filler;

[ooi9] Figure 6 shows a front view of an embodiment of a gastric space filler device containing a proximal space filler;

[002o] Figure 7 shows a cross-sectional view of an embodiment of a gastric space filler device and a delivery system containing a proximal delivery lumen and a distal delivery lumen;

[oo2i] Figure 8 shows a cross-sectional view of an embodiment of a gastric space filler device and a delivery system containing a stitch channel and a delivery guide wire channel;

[0022] Figure 9 shows an embodiment of a gastric space filler device and a delivery system containing a sheath, a stitch, and a sheath release clip;

[0023] Figure ioA shows an embodiment of a delivery system containing a handle;
[0024] Figure ioB shows a cross-sectional view of an embodiment of a delivery system containing a handle;

[0025] Figure loC shows an embodiment of a delivery system and a handle detached from delivery system;

[0026] Figure 11A shows an embodiment of a gastric space filler device and sheaths wherein a proximal space filler and a distal space filler are deflated;

[0027] Figure i1B shows an embodiment of a gastric space filler device, wherein a distal space filler is inflated;

[0028] Figure 11C shows an embodiment of a gastric space filler device, wherein a proximal space filler is inflated.

DETAILED DESCRIPTION

[0029] According to an embodiment as schematically depicted in Figure 1, gastric space filler device 19 comprises proximal space filler 91A, distal space filler 91B, and infusing member 93. Proximal space filler 91A is filled with an insufflation fluid through proximal opening 96A of infusing member 93, and distal space filler 91B is filled with fluid from distal opening 96B of infusing member 93. Delivery system 200 infuses and expands gastric space filler device i9.

[003o] According to an illustrative embodiment, proximal space filler 9iA and distal space filler 91B are spaced apart and secured to each other by infusing member 93.
According to an illustrative embodiment, the distance between the two space fillers is between at least about io to approximately 40 mm. The overall axial length of gastric space filler device 19 is between about ioo and about 300 mm. According to an illustrative embodiment, infusing member 93 may be made of semi-flexible or flexible material. The semi-flexible material may be selected from space filler-compatible polymer, such as, polyethylene, polystyrene, polyurethane, silicone, fluoro-polymer, and co-polymers thereof.

[0031] According to an illustrative embodiment, the longitudinal length of proximal space filler 91A is between about 7o and about 8o mm, preferably about 75 mm.
Proximal space filler 91A may be expanded to a space volume of between about ioo and --------------- -about 6oo cc. In an embodiment, the longitudinal length of distal space filler 91B is between about 6o and about 70 mm, preferably about 65 mm.

[0032] Distal space filler 91B may be expanded to a space volume of between about ioo and about 400 cc. According to a further embodiment, a radial diameter of proximal space filler 91A may be expanded to a diameter between about 4o and about 6o mm, and a radial diameter of distal space filler 91B may be expanded to a diameter between about 2o and about 40 mm. According to an illustrative embodiment, proximal space filler 91-A is substantially larger than distal space filler 91B in gastric space filler device 19 to take the advantage of the restricted space at the entrance region of the stomach and to create a better feeling of satiety for the patient.
According to an illustrative embodiment, the thickness of proximal space filler 9iA and distal space filler 91B is between about 0.2 and about i.o mm, effectively between about 0.3 to about 0.5 mm.

[0033] According to an embodiment as depicted in Figure 2B, infusing member 93 contains proximal sleeve 11oA that wraps around infusing member 93 and covers proximal opening 96A, which connects proximal space filler 91-A to proximal infusing lumen 94A. Infusing member 93 also contains distal sleeve iioB that wraps around infusing member 93 and covers distal opening 96B, which connects distal space filler 91B to distal infusing lumen 94B.

[0034] According to an embodiment as depicted in Figure 3, proximal infusing lumen 94A of infusing member 93 has proximal opening 96A that provides fluid communication between infusing lumen 94A and proximal space filler 91A.
According to an embodiment as depicted in Figure 4, distal infusing lumen 94B of infusing member 93 has distal opening 96B that provides fluid communication between distal infusing lumen 94B and distal space filler 91B. Proximal space filler 91-A and proximal infusing lumen 94A are not in fluid communication with either distal space filler 91B or distal infusing lumen 94B. According to an illustrative embodiment, infusing member 93 has an inner diameter of between about 1 and about 6 mm. According to an
6 illustrative embodiment, proximal infusing lumen 94A is substantially larger than distal infusing lumen 94B.

[0035] According to an illustrative embodiment, proximal opening 96A connects proximal space filler 91A to proximal infusing lumen 94A. According to an illustrative embodiment, proximal sleeve iioA wraps around infusing member 93 and covers proximal opening 96A. Proximal sleeve iloA may be disposed between proximal opening 96A and outer periphery of proximal space filler 91-A.

[0036] As proximal space filler 91A is being inflated, proximal sleeve iloA
allows an insufflation fluid to enter proximal space filler 91A from proximal infusing lumen 94A
through proximal opening 96A. According to an illustrative embodiment, proximal sleeve iioA allows an insufflation fluid to enter proximal space filler 91A by moving at least part of proximal sleeve iloA away from proximal opening 96A. According to an illustrative embodiment, at least part of proximal sleeve iloA is moved away from proximal opening 96A as a result of higher pressure outside proximal space filler 9iA in relation to pressure inside proximal space filler 91A.

[0037] According to an illustrative embodiment, after proximal space filler 91A is inflated, proximal sleeve iloA is pressed against proximal opening 96A; thus proximal sleeve iloA does not allow fluid to exit proximal space filler 91A through proximal opening 96A. According to an illustrative embodiment, higher pressure inside proximal space filler 9iA, relative to pressure outside proximal space filler 91A, presses proximal sleeve iloA against proximal opening 96A.

[0038] According to another embodiment, proximal sleeve iloA is not wrapped around infusing member 93, but is attached to infusing member 93 and is configured to move at least partially away from proximal opening 96A while proximal space filler 9iA
is being inflated and is also configured to block proximal opening 96A after proximal space filler 9iA has been inflated.

[0039] According to an embodiment as depicted in Figure 4, distal sleeve lioB
covers distal opening 96B. Distal sleeve iioB allows inflation of distal space filler 91B through distal opening 96B and prevents deflation of distal space filler 91B through distal
7 opening 96B while distal space filler 91B is inflated. Appropriate materials for proximal sleeve iloA or distal sleeve 11oB include any elastomeric material, such as silicone.
[0040] According to an illustrative embodiment, an insufflation fluid, such as a saline solution, is used to inflate proximal space filler 91A or distal space filler g1B to a desired volume effective to fill the desired portion of a stomach of a patient and create the desired feeling of satiety. When proximal space filler giA is inflated to this point, mineral oil is infused through proximal opening 96A and received between proximal sleeve iioA and proximal opening 96A. The mineral oil displaces the insufflation fluid in the area between proximal sleeve 1ioA and proximal opening 96A. Mineral oil between proximal sleeve iloA and proximal opening 96A has the effect of decreasing leakage of the insufflation fluid out of proximal space filler 91-A through proximal opening 96A. According to an illustrative embodiment, an effective amount of mineral oil is the amount of mineral oil with volume equal to the volume of the insufflation fluid to be displaced by the mineral oil. According to an illustrative embodiment, mineral oil is received between distal sleeve 1loB and distal opening 96B. Unexpectedly, this teaching substantially improves leakage and has yet to have been disclosed.

[0041] According to an embodiment as depicted in Figure 6, proximal infusing lumen 94A contains proximal gate ii2A, and distal infusing lumen 94B contains distal gate 112B, disposed at proximal end of infusing member 93. Proximal gate 112A
prevents at least some of any fluid from traveling into or out of proximal infusing lumen 94A until proximal barb 2o6A is inserted through proximal gate 112A and into proximal infusing lumen 94A. Similarly, distal gate 112B prevents at least some of any fluid from traveling into or out of distal infusing lumen 94B until distal barb 2o6B is inserted through distal gate 112B and into distal infusing lumen 94B. Proximal gate 112A or distal gate 112B
may be made of a flexible material that substantially covers proximal infusing lumen 94A or distal infusing lumen 94B and can be manipulated to allow insertion of proximal barb 2o6A or distal barb 2o6B.

[0042] According to an embodiment as depicted in Figure 7, after gastric space filler device 19 is delivered to the stomach of a patient, delivery system 200 is inserted
8
9 PCT/US2008/068058 through the mouth to securely couple with proximal end of gastric space filler device 19.
According to another embodiment, delivery system 200 is securely coupled to gastric space filler device 19 before gastric space filler device 19 and delivery system 20o are delivered to the stomach of a patient. According to an illustrative embodiment, delivery system 200 may be coupled to gastric space filler device 19 by docking clip 222 of delivery system 200, which is configured to securely attach to docking notch 2o8 of gastric space filler device 19.

[0043] According to an illustrative embodiment, delivery system 200 contains proximal barb 2o6A and distal barb 2o6B. Proximal barb 2o6A is in fluid communication with proximal delivery lumen 21oA, and distal barb 2o6B is in fluid communication with distal delivery lumen 21oB. When delivery system 200 is securely coupled with proximal end of gastric space filler device 19, proximal barb 2o6A and distal barb 2o6B are at least partially inserted into proximal infusing lumen 94A and distal infusing lumen 94B, respectively.

[00441 Proximal space filler 91A may be inflated by delivering an insufflation fluid into proximal delivery lumen 21oA, thereby delivering insufflation fluid through proximal barb 2o6A and into proximal infusing lumen 94A. Similarly, distal space filler 91B may be inflated by delivering an insufflation fluid into distal delivery lumen 21oB, thereby delivering insufflation fluid through distal barb 2o6B and into the distal infusing lumen 94B.

[0045] According to an embodiment as depicted in Figure 8, gastric space filler device 19 contains filler guide wire channel io8, and delivery system 200 contains delivery guide wire channel 224. According to an illustrative embodiment, guide wire 218 is laid along a path to be traveled by gastric space filler device 19 or delivery system 200.
Guide wire 218 is then threaded through at least one of guide wire channel io8 of gastric space filler device 19 and delivery guide wire channel 224 of delivery system 200. Once threaded, gastric space filler device 19 or delivery system 200 may travel along guide wire 218.

[0046] According to an embodiment as depicted in Figure 9, sheath 202 at least partially covers proximal space filler 91A and distal space filler 91B before or during insertion through an esophagus of a patient. Sheath 202 may be made from flexible or semi-flexible materials, including mesh fabric and silicone. According to an illustrative embodiment, sheath 202 is secured to gastric space filler device 19 by stitch 204.
Various stitching patterns are known in the art. Stitch 204 may comprise an easily releasable stitching pattern, such as one that may be released by pulling on one end of stitch 204. When proximal space filler 9iA or distal space filler 91B is ready to inflate, stitch 204 is removed.

[00471 According to an illustrative embodiment, at least part of stitch 204 is secured by sheath release clip 212 until gastric space filler device 19 is ready to be inserted into patient. Sheath release clip 212, while engaged, secures at least part of stitch 204, such that stitch 204 may not be released. When sheath release clip 212 is removed, stitch 204 is capable of being released.

[0048] According to an illustrative embodiment, at least part of stitch 204 is located inside stitch channel 214 of delivery system 200. This allows stitch 204 to be pulled away from gastric space filler device 19 without additional instruments. Where stitch 204 is released from sheath 202 by pulling on an end of stitch 204, stitch 204 may be released by pulling stitch 204 through stitch channel 214.

[00491 According to an embodiment as depicted in Figure loA, delivery system may contain handle 216, which may be removably attached to delivery system 200.
According to an embodiment as depicted in Figure ioB, handle 216 contains inner compartment 226. Proximal luer 220A and distal luer 22oB may be contained within inner compartment 226 while handle is attached to delivery system 200. While handle 216 is attached to delivery system 200, proximal luer 22oA and distal luer 22oB may not be accessed to infuse fluid into proximal space filler 91A or distal space filler 91B.

[005o] According to an embodiment as depicted in Figure ioC, stitch 204 may be attached to handle 216, such that when handle 216 is removed from delivery system 200, stitch 204 is pulled away from sheath 202, thereby releasing sheath 202 from -covering proximal space filler 9iA or distal space filler 91B. Likewise, removal of handle 216 exposes proximal luer 22oA and distal luer 22oB, such that proximal space filler 91A and distal space filler 91B can be infused only when handle 216 is removed. In this embodiment, proximal space filler 91A and distal space filler 91B cannot be inflated until sheath 202 is released.

[0051] According to an embodiment as depicted in Figure 11A, Figure iiB, and Figure 11C, gastric space filler device 19 is at least partially covered by three sheaths: proximal sheath 2o2A, central sheath 2o2C, and distal sheath 202B. Distal sheath 2o2B
at least partially covers distal portion of distal space filler 91B, central sheath 202C at least partially covers proximal portion of distal space filler 9iB and distal portion of proximal space filler 91A, and proximal sheath 202A at least partially covers proximal portion of proximal space filler 9 iA.

[0052] As distal space filler 91B is inflated, distal sheath 202B is rolled onto itself toward distal end of gastric space filler device 19 and distal portion of central sheath 202C is rolled onto itself toward center of gastric space filler device 19. As proximal space filler 91A is inflated, proximal sheath 202A is rolled onto itself toward proximal end of gastric space filler device 19, and proximal portion of central sheath 202C is rolled onto itself toward center of gastric space filler device 19. In an illustrative embodiment, as proximal space filler 91A is inflated, proximal sheath 202A is rolled onto itself toward delivery system 2oo attached to proximal end of gastric space filler device 19, such that when proximal space filler 9iA is inflated, proximal sheath 202A is rolled onto delivery system 2oo and when delivery system 200 is detached and removed, proximal sheath 202A is removed with delivery system 200.

[0053] In an illustrative embodiment, gastric spacer filler device 19 is at least partially covered by two sheaths: proximal sheath 202A and distal sheath 202B. Distal sheath 2o2B at least partially covers distal space filler 91B until distal space filler 91B is inflated, which causes distal sheath 202B to be rolled onto itself, either toward distal end of gastric space filler device 19 or toward center of gastric space filler device 19.
Similarly, proximal sheath 202A at least partially covers proximal space filler 91A until proximal space filler 91A is inflated, which causes proximal sheath 202A to be rolled onto itself, either toward proximal end of gastric space filler device 19 or toward the center of gastric space filler device 19.

[00541 In an illustrative embodiment, gastric space filler device 19 is at least partially covered by a single sheath: central sheath 202C. Central sheath 202C at least partially covers each of proximal space filler 91A and distal space filler 91B. As distal space filler 91B is inflated, central sheath 202C is rolled onto itself from proximal end of gastric space filler device 19 toward center of gastric space filler device 19 until central sheath 202C no longer covers distal space filler 91B. As proximal space filler 91A is inflated, central sheath 2o2C is rolled onto itself from proximal end of gastric space filler device 19 toward center 'of gastric space filler device 19 until central sheath 202C
no longer covers proximal space filler 91A. Alternatively, as proximal space filler 91A
is inflated, central sheath 2o2C may be rolled from center of gastric space filler device 19 toward proximal end of gastric space filler device 19.

[0055] While the apparatus and method have been described in terms of what are presently considered to be the most practical embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.

Claims (19)

1. A gastric space filler device comprising, in combination: a space filler, an opening to inflate said space filler, and a sleeve, wherein said sleeve is configured to receive mineral oil between said sleeve and said opening.
2. The gastric space filler device of Claim 1, wherein said sleeve is disposed between said opening and an outer periphery of said space filler.
3. The gastric space filler device of Claim 1, wherein said sleeve allows an insufflation fluid to enter said space filler during inflation of said space filler.
4. The gastric space filler device of Claim 3, wherein said sleeve does not allow said insufflation fluid to exit said space filler after said mineral oil is received between said sleeve and said opening.
5. The gastric space filler device of Claim 1, further comprising an infusing member coupled with said space filler.
6. The gastric space filler device of Claim 5, wherein said infusing member comprises an infusing lumen in fluid communication with said opening.
7. The gastric space filler device of Claim 6, wherein said infusing lumen comprises a gate to reduce passage of a fluid until a barb is inserted into said infusing lumen.
8. The gastric space filler device of Claim 1, further comprising a sheath, wherein said sheath at least partially covers said space filler.
9. The gastric space filler device of Claim 8, wherein said sheath is secured around said space filler with a stitch.
10. The gastric space filler device of Claim 9, wherein said stitch is released by pulling said stitch.
11. The gastric space filler device of Claim 10, further comprising a sheath release clip, wherein said sheath release clip prevents said stitch from being released while said sheath release clip is engaged on said gastric space filler device and said sheath release clip allows said stitch to be released when said sheath release clip is removed from said gastric space filler device.
12. The gastric space filler device of Claim 10, further comprising a delivery system comprising a delivery lumen configured to deliver an insufflation fluid to said space filler, a luer connected to said delivery lumen, and a handle removably attached to said delivery lumen, wherein said handle contains an inner compartment and said luer is disposed inside said inner compartment of said handle while handle is attached, said luer is exposed when said handle is removed, and said stitch is attached to said handle such that said stitch is pulled when said handle is removed.
13. The gastric space filler device of Claim 8, wherein said sheath automatically uncovers said space filler as said space filler is inflated.
14. A method for emplacing a gastric space filler device in a patient comprising, in combination: providing a delivery system attached to a gastric space filler device comprising a space filler; covering at least part of said space filler with a sheath;
and delivering said delivery system and said gastric space filler device through an esophagus into a stomach of a patient.
15. The method of Claim 14, further comprising the steps of uncovering said space filler and inflating said space filler.
16. The method of Claim 14, further comprising the step of inflating said space filler, wherein said sheath automatically uncovers said space filler as said space filler is inflated.
17. A gastric space filler device, the improvement comprising:
a plurality of independently filled chambers;

wherein upon the unexpected deflation of one chamber, at least one other chamber remains inflated to prevent passage of the gastric space filler device through the pylorus.
18. The gastric space filler device of claim 17, wherein the gastric space filler device comprises two independent chambers.
19. The gastric space filler device of claim 17, wherein the chambers are disposed whereby they conform to about the shape of the stomach.
CA002691530A 2007-06-25 2008-06-24 Gastric space filler device, delivery system, and related methods Abandoned CA2691530A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2892287A CA2892287C (en) 2007-06-25 2008-06-24 Gastric space filler device, delivery system, and related methods

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/768,152 2007-06-25
US11/768,152 US8142469B2 (en) 2007-06-25 2007-06-25 Gastric space filler device, delivery system, and related methods
PCT/US2008/068058 WO2009002989A1 (en) 2007-06-25 2008-06-24 Gastric space device, delivery system, and related methods

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2892287A Division CA2892287C (en) 2007-06-25 2008-06-24 Gastric space filler device, delivery system, and related methods

Publications (1)

Publication Number Publication Date
CA2691530A1 true CA2691530A1 (en) 2008-12-31

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