Gastric space filler device, delivery system, and related methods

Information

  • Patent Grant
  • 9283102
  • Patent Number
    9,283,102
  • Date Filed
    Tuesday, March 29, 2011
    13 years ago
  • Date Issued
    Tuesday, March 15, 2016
    8 years ago
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
BACKGROUND

1. Field


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.


2. General Background


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 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 compartment 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

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.


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.


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.


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.


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 the space filler with a fluid, and a sleeve disposed between the opening and an outer periphery of the space filler; allowing the fluid to enter the space filler through the opening; and preventing the fluid from exiting the space filler through the opening.


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

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:



FIG. 1 shows an embodiment of a gastric space filler device and delivery system;



FIG. 2A shows an embodiment of an infusing member without proximal sleeve or distal sleeve;



FIG. 2B shows an embodiment of an infusing member with a proximal sleeve and a distal sleeve;



FIG. 3 shows a cross-sectional view of an embodiment of an infusing member, a proximal sleeve, and a proximal opening;



FIG. 4 shows a cross-sectional view of an embodiment of an infusing member, a distal sleeve, and a distal opening;



FIG. 5 shows a rear view of an embodiment of a gastric space filler device containing a distal space filler;



FIG. 6 shows a front view of an embodiment of a gastric space filler device containing a proximal space filler;



FIG. 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;



FIG. 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;



FIG. 9 shows an embodiment of a gastric space filler device and a delivery system containing a sheath, a stitch, and a sheath release clip;



FIG. 10A shows an embodiment of a delivery system containing a handle;



FIG. 10B shows a cross-sectional view of an embodiment of a delivery system containing a handle;



FIG. 10C shows an embodiment of a delivery system and a handle detached from delivery system;



FIG. 11A shows an embodiment of a gastric space filler device and sheaths wherein a proximal space filler and a distal space filler are deflated;



FIG. 11B shows an embodiment of a gastric space filler device, wherein a distal space filler is inflated;



FIG. 11C shows an embodiment of a gastric space filler device, wherein a proximal space filler is inflated.





DETAILED DESCRIPTION

According to an embodiment as schematically depicted in FIG. 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 19.


According to an illustrative embodiment, proximal space filler 91A 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 10 to approximately 40 mm. The overall axial length of gastric space filler device 19 is between about 100 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.


According to an illustrative embodiment, the longitudinal length of proximal space filler 91A is between about 70 and about 80 mm, preferably about 75 mm. Proximal space filler 91A may be expanded to a space volume of between about 100 and about 600 cc. In an embodiment, the longitudinal length of distal space filler 91B is between about 60 and about 70 mm, preferably about 65 mm.


Distal space filler 91B may be expanded to a space volume of between about 100 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 40 and about 60 mm, and a radial diameter of distal space filler 91B may be expanded to a diameter between about 20 and about 40 mm. According to an illustrative embodiment, proximal space filler 91A 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 91A and distal space filler 91B is between about 0.2 and about 1.0 mm, effectively between about 0.3 to about 0.5 mm.


According to an embodiment as depicted in FIG. 2B, infusing member 93 contains proximal sleeve 110A that wraps around infusing member 93 and covers proximal opening 96A, which connects proximal space filler 91A to proximal infusing lumen 94A. Infusing member 93 also contains distal sleeve 110B that wraps around infusing member 93 and covers distal opening 96B, which connects distal space filler 91B to distal infusing lumen 94B.


According to an embodiment as depicted in FIG. 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 FIG. 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 91A 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 illustrative embodiment, proximal infusing lumen 94A is substantially larger than distal infusing lumen 94B.


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 110A wraps around infusing member 93 and covers proximal opening 96A. Proximal sleeve 110A may be disposed between proximal opening 96A and outer periphery of proximal space filler 91A.


As proximal space filler 91A is being inflated, proximal sleeve 110A 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 110A allows an insufflation fluid to enter proximal space filler 91A by moving at least part of proximal sleeve 110A away from proximal opening 96A. According to an illustrative embodiment, at least part of proximal sleeve 110A is moved away from proximal opening 96A as a result of higher pressure outside proximal space filler 91A in relation to pressure inside proximal space filler 91A.


According to an illustrative embodiment, after proximal space filler 91A is inflated, proximal sleeve 110A is pressed against proximal opening 96A; thus proximal sleeve 110A 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 91A, relative to pressure outside proximal space filler 91A, presses proximal sleeve 110A against proximal opening 96A.


According to another embodiment, proximal sleeve 110A 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 91A is being inflated and is also configured to block proximal opening 96A after proximal space filler 91A has been inflated.


According to an embodiment as depicted in FIG. 4, distal sleeve 110B covers distal opening 96B. Distal sleeve 110B allows inflation of distal space filler 91B through distal opening 96B and prevents deflation of distal space filler 91B through distal opening 96B while distal space filler 91B is inflated. Appropriate materials for proximal sleeve 110A or distal sleeve 110B include any elastomeric material, such as silicone.


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 91B 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 91A is inflated to this point, mineral oil is infused through proximal opening 96A and received between proximal sleeve 110A and proximal opening 96A. The mineral oil displaces the insufflation fluid in the area between proximal sleeve 110A and proximal opening 96A. Mineral oil between proximal sleeve 110A and proximal opening 96A has the effect of decreasing leakage of the insufflation fluid out of proximal space filler 91A 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 110B and distal opening 96B. Unexpectedly, this teaching substantially improves leakage and has yet to have been disclosed.


According to an embodiment as depicted in FIG. 6, proximal infusing lumen 94A contains proximal gate 112A, 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 206A 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 206B 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 206A or distal barb 206B.


According to an embodiment as depicted in FIG. 7, after gastric space filler device 19 is delivered to the stomach of a patient, delivery system 200 is inserted 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 200 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 208 of gastric space filler device 19.


According to an illustrative embodiment, delivery system 200 contains proximal barb 206A and distal barb 206B. Proximal barb 206A is in fluid communication with proximal delivery lumen 210A, and distal barb 206B is in fluid communication with distal delivery lumen 210B. When delivery system 200 is securely coupled with proximal end of gastric space filler device 19, proximal barb 206A and distal barb 206B are at least partially inserted into proximal infusing lumen 94A and distal infusing lumen 94B, respectively.


Proximal space filler 91A may be inflated by delivering an insufflation fluid into proximal delivery lumen 210A, thereby delivering insufflation fluid through proximal barb 206A and into proximal infusing lumen 94A. Similarly, distal space filler 91B may be inflated by delivering an insufflation fluid into distal delivery lumen 210B, thereby delivering insufflation fluid through distal barb 206B and into the distal infusing lumen 94B.


According to an embodiment as depicted in FIG. 8, gastric space filler device 19 contains filler guide wire channel 108, 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 108 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.


According to an embodiment as depicted in FIG. 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 91A or distal space filler 91B is ready to inflate, stitch 204 is removed.


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.


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.


According to an embodiment as depicted in FIG. 10A, delivery system 200 may contain handle 216, which may be removably attached to delivery system 200. According to an embodiment as depicted in FIG. 10B, handle 216 contains inner compartment 226. Proximal luer 220A and distal luer 220B 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 220A and distal luer 220B may not be accessed to infuse fluid into proximal space filler 91A or distal space filler 91B.


According to an embodiment as depicted in FIG. 10C, 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 91A or distal space filler 91B. Likewise, removal of handle 216 exposes proximal luer 220A and distal luer 220B, 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.


According to an embodiment as depicted in FIG. 11A, FIG. 11B, and FIG. 11C, gastric space filler device 19 is at least partially covered by three sheaths: proximal sheath 202A, central sheath 202C, and distal sheath 202B. Distal sheath 202B at least partially covers distal portion of distal space filler 91B, central sheath 202C at least partially covers proximal portion of distal space filler 91B and distal portion of proximal space filler 91A, and proximal sheath 202A at least partially covers proximal portion of proximal space filler 91A.


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 200 attached to proximal end of gastric space filler device 19, such that when proximal space filler 91A is inflated, proximal sheath 202A is rolled onto delivery system 200 and when delivery system 200 is detached and removed, proximal sheath 202A is removed with delivery system 200.


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 202B 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.


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 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 proximal space filler 91A. Alternatively, as proximal space filler 91A is inflated, central sheath 202C may be rolled from center of gastric space filler device 19 toward proximal end of gastric space filler device 19.


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
  • 1. A method of delivering a gastric space filler device, the method comprising: attaching a delivery system to a gastric space filler device by releasably coupling a docking clip of the delivery system to a docking notch at a proximal end of an infusing member of the gastric space filler device;delivering a guidewire through an esophagus to a stomach;after the delivery system is attached to the gastric space filler, guiding the gastric space filler device and the delivery system together over the guidewire to the stomach;inflating a space filler of the gastric space filler device with a fluid provided from the delivery system through an infusing lumen in the infusing member of the gastric space filler device;detaching the delivery system from the gastric space filler device by removing the docking clip from the docking notch; andremoving the delivery system from the stomach without removing the gastric space filler device from the stomach.
  • 2. The method of claim 1 wherein the delivery system is attached to the gastric space filler device before the gastric space filler device and the delivery system are guided along the path defined by the guidewire.
  • 3. The method of claim 1 wherein attaching the delivery system to the gastric space filler device further comprises inserting a barb of the delivery system into a gate at the proximal end of the infusing member of the gastric space filler device.
  • 4. The method of claim 3 wherein attaching the delivery system to the gastric space filler device comprises attaching the delivery system such that the barb provides fluid communication between a delivery lumen of the delivery system and the infusing lumen of the gastric space filler device when the barb is inserted into the gate.
  • 5. The method of claim 3 wherein detaching the delivery system from the gastric space filler device further comprises removing the barb from the proximal end of the infusing member after at least partially inflating the space filler.
  • 6. The method of claim 5 wherein removing the barb from the proximal end of the infusing member causes the gate to close.
  • 7. The method of claim 1 wherein the infusing member of the gastric space filler device comprises a filler guide wire channel and the delivery system comprises a delivery guide wire channel, and wherein the method further comprises threading the guidewire through at least one of the filler guide wire channel and the delivery guide wire channel before guiding the gastric space filler device and the delivery system along the path defined by the guidewire.
  • 8. The method of claim 7 wherein the filler guide wire channel extends from a proximal end of the infusing member to a distal end of the infusing member.
  • 9. The method of claim 1, further comprising at least partially covering the gastric space filler device with a sheath before guiding the gastric space filler device along the guidewire.
  • 10. The method of claim 1 wherein the infusing member extends completely through the space filler and includes a guidewire channel separate from the infusing lumen, and wherein the guidewire channel extends completely through the infusing member and is configured to receive the guidewire.
  • 11. A gastric space filler system, comprising: a gastric space filler device comprising a flexible, elongate infusing member having a proximal end, a distal end, a filler guide wire channel extending completely through the infusing member from the proximal end to the distal end, and an infusing lumen separate from the filler guide wire channel;a plurality of inflatable gastric space fillers secured to the infusing member, wherein the infusing member extends completely through the gastric space fillers; anda docking notch at the proximal end of the infusing member; anda delivery system having a docking clip configured to be attached over the docking notch to releasably attach the delivery system to the gastric space filler device, wherein the delivery system includes a delivery guide wire channel in communication with the filler guide wire channel and a fluid delivery lumen in communication with the infusing lumen when the delivery system is attached to the gastric space filler device.
  • 12. The gastric space filler system of claim 11 wherein: the plurality of inflatable gastric space fillers comprise a proximal inflatable space filler and a distal inflatable space filler;the infusing lumen of the gastric space filler device comprises a proximal lumen in fluid communication with the proximal inflatable gastric space filler and a distal lumen in fluid communication with the distal inflatable gastric space filler; andthe delivery system further comprises a proximal barb configured to be inserted into the proximal lumen of the infusing member and provide fluid communication between the delivery system and the proximal inflatable space filler; anda distal barb configured to be inserted into the distal lumen of the infusing member and provide fluid communication between the delivery system and the distal inflatable space filler.
  • 13. The gastric space filler system of claim 12 wherein the proximal inflatable space filler and the proximal infusing lumen are not in fluid communication with the distal inflatable space filler and the distal infusing lumen.
  • 14. The gastric space filler system of claim 11, further comprising a guidewire threaded through the filler guide wire channel and the delivery guide wire channel.
  • 15. The gastric space filler system of claim 11 wherein at least one of the gastric space fillers has an outer diameter of at least about 40 mm when inflated with a fluid.
  • 16. The gastric space filler system of claim 11 wherein the gastric space fillers are configured to at least partially fill a portion of a stomach of a human patient to create a feeling of satiety.
CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application is a continuation of U.S. patent application Ser. No. 11/768,152, filed Jun. 25, 2007, the disclosure of which is incorporated herein by reference in its entirety. This application incorporates by reference in their entirety each of the following applications: (a) U.S. patent application Ser. No. 11/694,536, filed Mar. 30, 2007; (b) PCT/US06/42336, filed Oct. 31, 2006; (c) PCT/US06/42711, filed Oct. 31, 2006; (d) PCT/US06/42710, filed Oct. 31, 2006; and (e) PCT/US06/48647, filed Dec. 20, 2006.

US Referenced Citations (191)
Number Name Date Kind
2493326 Trinder Jan 1950 A
4133315 Berman et al. Jan 1979 A
4198983 Becker et al. Apr 1980 A
4246893 Berson Jan 1981 A
4356824 Vazquez Nov 1982 A
4368739 Nelson, Jr. Jan 1983 A
4416267 Garren et al. Nov 1983 A
4465072 Taheri Aug 1984 A
4465818 Shirahata et al. Aug 1984 A
4485805 Foster, Jr. Dec 1984 A
4543089 Moss Sep 1985 A
4598699 Garren et al. Jul 1986 A
4694827 Weiner et al. Sep 1987 A
4723547 Kullas et al. Feb 1988 A
4899747 Garren et al. Feb 1990 A
4940458 Cohn Jul 1990 A
5073347 Garren et al. Dec 1991 A
5084061 Gau et al. Jan 1992 A
5123840 Nates Jun 1992 A
5234454 Bangs Aug 1993 A
5259399 Brown Nov 1993 A
5263934 Haak Nov 1993 A
5273536 Savas Dec 1993 A
5318530 Nelson, Jr. Jun 1994 A
5334187 Fischell et al. Aug 1994 A
5431173 Chin et al. Jul 1995 A
5496271 Burton et al. Mar 1996 A
5516812 Chu et al. May 1996 A
5575772 Lennox Nov 1996 A
5639810 Smith, III et al. Jun 1997 A
5643209 Fugoso et al. Jul 1997 A
5730722 Wilk Mar 1998 A
5779728 Lunsford et al. Jul 1998 A
5857991 Grothoff et al. Jan 1999 A
5876376 Schwab et al. Mar 1999 A
5904701 Daneshvar May 1999 A
5938669 Klaiber et al. Aug 1999 A
5976073 Ouchi Nov 1999 A
5993473 Chan et al. Nov 1999 A
5997503 Willis et al. Dec 1999 A
6050274 Gelardi et al. Apr 2000 A
6149621 Makihara Nov 2000 A
6179878 Duerig et al. Jan 2001 B1
6254355 Gharib Jul 2001 B1
6276567 Diaz et al. Aug 2001 B1
6280411 Lennox Aug 2001 B1
6423058 Edwards et al. Jul 2002 B1
6427089 Knowlton Jul 2002 B1
6454785 De Hoyos Garza Sep 2002 B2
6524234 Ouchi Feb 2003 B2
6535764 Imran et al. Mar 2003 B2
6540789 Stein et al. Apr 2003 B1
6547788 Maguire et al. Apr 2003 B1
6579301 Bales et al. Jun 2003 B1
6592552 Schmidt Jul 2003 B1
6613018 Bagga et al. Sep 2003 B2
6613037 Khosravi et al. Sep 2003 B2
6689051 Nakada Feb 2004 B2
6706010 Miki et al. Mar 2004 B1
6746460 Gannoe et al. Jun 2004 B2
6826428 Chen et al. Nov 2004 B1
6850128 Park Feb 2005 B2
6866657 Shchervinsky Mar 2005 B2
6869431 Maguire et al. Mar 2005 B2
6890300 Lloyd et al. May 2005 B2
6890346 Ganz et al. May 2005 B2
6902535 Eberhart et al. Jun 2005 B2
6923754 Lubock Aug 2005 B2
6931286 Sigg et al. Aug 2005 B2
6939299 Petersen et al. Sep 2005 B1
6942680 Grayzel et al. Sep 2005 B2
6958052 Charlton Oct 2005 B1
7001419 DiCaprio et al. Feb 2006 B2
7016735 Imran et al. Mar 2006 B2
7020531 Colliou et al. Mar 2006 B1
7033373 de la Torre et al. Apr 2006 B2
7056305 Garza Alvarez Jun 2006 B2
7076305 Imran et al. Jul 2006 B2
7081125 Edwards et al. Jul 2006 B2
7131945 Fink et al. Nov 2006 B2
7483746 Lee et al. Jan 2009 B2
7625355 Yu Dec 2009 B2
7749254 Sobelman et al. Jul 2010 B2
7828749 Douglas et al. Nov 2010 B2
7931693 Binmoeller et al. Apr 2011 B2
8083757 Gannoe et al. Dec 2011 B2
8556925 Makower et al. Oct 2013 B2
8840952 Ashby et al. Sep 2014 B2
8894568 Pecor et al. Nov 2014 B2
9050174 Pecor et al. Jun 2015 B2
9149611 Bouasaysy et al. Oct 2015 B2
20010022988 Schwarz et al. Sep 2001 A1
20010037127 De Hoyos Garza Nov 2001 A1
20020055757 Torre et al. May 2002 A1
20020107515 Edwards et al. Aug 2002 A1
20020161388 Samuels et al. Oct 2002 A1
20020173804 Rousseau Nov 2002 A1
20030105800 Cullen Jun 2003 A1
20030114878 Diederich et al. Jun 2003 A1
20030171768 McGhan Sep 2003 A1
20030187390 Bates et al. Oct 2003 A1
20040044354 Gannoe et al. Mar 2004 A1
20040059289 Garza Alvarez Mar 2004 A1
20040059290 Palasis Mar 2004 A1
20040073162 Bleam et al. Apr 2004 A1
20040087902 Richter May 2004 A1
20040093058 Cottone et al. May 2004 A1
20040106899 McMichael et al. Jun 2004 A1
20040116897 Aboul-Hosn Jun 2004 A1
20040127915 Fleenor et al. Jul 2004 A1
20040186502 Sampson et al. Sep 2004 A1
20040220665 Hossainy et al. Nov 2004 A1
20040236280 Rice et al. Nov 2004 A1
20040236361 Sakurai Nov 2004 A1
20040254600 Zarbatany et al. Dec 2004 A1
20050027283 Richard et al. Feb 2005 A1
20050027313 Shaker Feb 2005 A1
20050038415 Rohr et al. Feb 2005 A1
20050055039 Burnett et al. Mar 2005 A1
20050059990 Ayala et al. Mar 2005 A1
20050075624 Miesel Apr 2005 A1
20050085792 Gershowitz Apr 2005 A1
20050119674 Gingras Jun 2005 A1
20050131442 Yachia et al. Jun 2005 A1
20050143784 Imran Jun 2005 A1
20050159769 Alverdy Jul 2005 A1
20050177103 Hunter et al. Aug 2005 A1
20050192615 Torre et al. Sep 2005 A1
20050267595 Chen et al. Dec 2005 A1
20050267596 Chen et al. Dec 2005 A1
20050273060 Levy et al. Dec 2005 A1
20060058829 Sampson et al. Mar 2006 A1
20060178691 Binmoeller Aug 2006 A1
20060184112 Horn et al. Aug 2006 A1
20060259020 Sharratt Nov 2006 A1
20070016262 Gross et al. Jan 2007 A1
20070078476 Hull et al. Apr 2007 A1
20070083224 Hively Apr 2007 A1
20070093728 Douglas et al. Apr 2007 A1
20070100367 Quijano et al. May 2007 A1
20070100368 Quijano et al. May 2007 A1
20070100369 Cragg et al. May 2007 A1
20070135829 Paganon et al. Jun 2007 A1
20070142770 Rioux et al. Jun 2007 A1
20070149994 Sosnowski et al. Jun 2007 A1
20070173881 Birk et al. Jul 2007 A1
20070233161 Weller et al. Oct 2007 A1
20070250020 Kim et al. Oct 2007 A1
20070265369 Muratoglu et al. Nov 2007 A1
20070265598 Karasik Nov 2007 A1
20070288033 Murature et al. Dec 2007 A1
20080058887 Griffin et al. Mar 2008 A1
20080082056 Mauch et al. Apr 2008 A1
20080085887 Didiuk et al. Apr 2008 A1
20080097513 Kaji et al. Apr 2008 A1
20080119729 Copa et al. May 2008 A1
20080172079 Birk Jul 2008 A1
20080190363 Chen et al. Aug 2008 A1
20080208135 Annunziata et al. Aug 2008 A1
20080208241 Weiner et al. Aug 2008 A1
20080233167 Li et al. Sep 2008 A1
20080243071 Quijano et al. Oct 2008 A1
20080243166 Paganon et al. Oct 2008 A1
20080255601 Birk Oct 2008 A1
20080312679 Hardert et al. Dec 2008 A1
20080319471 Sosnowski et al. Dec 2008 A1
20090048624 Alverdy Feb 2009 A1
20090259236 Burnett et al. Oct 2009 A2
20090275973 Chen et al. Nov 2009 A1
20090287231 Brooks et al. Nov 2009 A1
20100023047 Simpson Jan 2010 A1
20100130998 Alverdy May 2010 A1
20100234853 Pecor et al. Sep 2010 A1
20100243135 Pepper et al. Sep 2010 A1
20100251837 Bouasaysy et al. Oct 2010 A1
20110172767 Rathi et al. Jul 2011 A1
20120191126 Pecor et al. Jul 2012 A1
20120271336 Hamman et al. Oct 2012 A1
20120271338 Bouasaysy et al. Oct 2012 A1
20120289992 Quijano et al. Nov 2012 A1
20130035710 Bouasaysy et al. Feb 2013 A1
20130053880 Bouasaysy et al. Feb 2013 A1
20130102876 Limon et al. Apr 2013 A1
20130261654 Bouasaysy et al. Oct 2013 A1
20130296914 Quijano et al. Nov 2013 A1
20140031850 Bouasaysy et al. Jan 2014 A1
20140257358 Alverdy et al. Sep 2014 A1
20140371775 Ashby et al. Dec 2014 A1
20150216529 Kwok et al. Aug 2015 A1
20150238342 Sosnowski et al. Aug 2015 A1
20150265811 Pecor Sep 2015 A1
Foreign Referenced Citations (41)
Number Date Country
8708978 Nov 1987 DE
0103481 Mar 1984 EP
0457456 Nov 1991 EP
0485903 May 1992 EP
1781183 May 2007 EP
2862525 May 2005 FR
2892297 Apr 2007 FR
2090747 Jul 1982 GB
2139902 Nov 1984 GB
S57168674 Oct 1982 JP
S6415063 Jan 1989 JP
H091872 Apr 1989 JP
H08322943 Dec 1996 JP
2001128985 May 2001 JP
2006333888 Dec 2006 JP
9000369 Jan 1990 WO
9925418 May 1999 WO
WO-0141700 Jun 2001 WO
WO-0166166 Sep 2001 WO
WO0240081 May 2002 WO
WO-2006035446 Apr 2006 WO
WO-2006056944 Jun 2006 WO
WO-2006128978 Dec 2006 WO
WO-2007027812 Mar 2007 WO
WO-2007053556 May 2007 WO
WO-2007053706 May 2007 WO
WO-2007053707 May 2007 WO
WO-2007075810 Jul 2007 WO
WO-2008042819 Apr 2008 WO
WO-2008121831 Oct 2008 WO
WO-2009112786 Sep 2009 WO
WO-2010048021 Apr 2010 WO
WO-2010115161 Oct 2010 WO
WO-2011011629 Jan 2011 WO
WO-2011011741 Jan 2011 WO
WO-2011011743 Jan 2011 WO
WO-2011024077 Mar 2011 WO
WO-2011038270 Mar 2011 WO
WO-2011097637 Aug 2011 WO
WO-2011127205 Oct 2011 WO
WO-2012048226 Apr 2012 WO
Non-Patent Literature Citations (80)
Entry
International Search Report; International Application No. PCT/US2011/024082, Applicant: ReShape Medical, Inc., Mailing Date Apr. 6, 2011, 10 pages.
International Search Report; International Application No. PCT/US2011/024077; Applicant: ReShape Medical, Inc., Mailing Date Apr. 6, 2011, 12 pages.
International Search Report; International Application No. PCT/US2010/042948; Applicant: ReShape Medical, Inc., Mailing Date Apr. 1, 2011, 11 pages.
International Search Report; International Application No. PCT/US2010/043136; Applicant: ReShape Medical, Inc., Mailing Date Apr. 12, 2011, 9 pages.
International Search Report; International Application No. PCT/US2010/043134; Applicant: ReShape Medical, Inc., Mailing Date Apr. 27, 2011, 12 pages.
International Search Report; International Application No. PCT/US2011/0426233; Applicant: ReShape Medical, Inc., Mailing Date Apr. 26, 2011, 9 pages.
“ReShape Inflatable Gastric Ballon Going on Trial as Weight Loss Option,” MedGadget: Internet Journal of Emerging Medical Technologies. Feb. 4, 2010. (5 pages).
Wahlen Ch et al. “The BioEnterics Intragastric Balloon: How to use it” Obesity Surgery 2001; 11:524-527.
Patient Information “Living with the BIB” by INAMED Health (2004).
International Search Report; International Application No. PCT/US2008/058677, Applicant: ReShape Medical et al., Mailing Date Aug. 21, 2008, 12 pages.
International Search Report; International Application No. PCT/US2006/042710, Applicant: Abdominus, Inc. et al., Mailing Date Mar. 15, 2007, 9 pages.
International Search Report; International Application No. PCT/US2006/048647, Applicant: Abdominus, Inc. et al., Mailing Date May 22, 2007, 12 pages.
International Search Report; International Application No. PCT/US2008/068058, Applicant: ReShape Medical, Inc. et al, Mailing Date Nov. 19, 2008, 11 pages.
International Search Report; International Application No. PCT/US2006/042711, Applicant: Abdominus, Inc. et al, Mailing Date Mar. 16, 2007, 9 pages.
Supplementary European Search Report for EP 03726447.0, mailed Mar. 1, 2006.
International Search Report; International Application No. PCT/US2003/012782, Applicant: Applied Medical Resources Corporation, Mailing Date Oct. 28, 2003, 7 pages.
International Search Report; International Application No. PCT/US2006/042336, Applicant: Abdominus, Inc., Mailing Date Mar. 14, 2007, 9 pages.
International Search Report; International Application No. PCT/US2010/029865, Applicant: ReShape Medical, Inc., Mailing Date Jan. 5, 2011, 9 pages.
Final Office Action; U.S. Appl. No. 11/694,536, Mailing Date Mar. 11, 2011, 13 pages.
Final Office Action; U.S. Appl. No. 11/768,152, Mailing Date Jan. 19, 2011, 13 pages.
Extended European Search Report; Application No. EP6827098.3, Applicant: Reshape Medical Corporation, mailed on Aug. 25, 2014, 3 pages.
Extended European Search Report; Application No. EP6827314.3, Applicant: ReShape Medical Corporation, mailed Aug. 1, 2014, 3 pages.
Extended European Search Report; Application No. EP6827313.5, Applicant: ReShape Medical Corporation, mailed Jul. 30, 2014, 5 pages.
Extended European Search Report; Application No. EP6847847.8, Applicant: ReShape Medical Corporation, mailed Aug. 14, 2014, 5 pages.
Final Office Action: U.S. Appl. No. 13/858,767, mailed on May 30, 2014, 12 pages.
Non-Final Office Action; U.S. Appl. No. 13/386,638, mailed on Jun. 27, 2014, 12 pages.
International Search Report; International Application No. PCT/US1155373, Applicant: Reshape Medical, Inc., dated: Jan. 20, 2012, 7 pages.
International Search Report; International Application No. PCT/US2010/050260; Applicant: ReShape Medical, Inc., Mailing Date: Jun. 17, 2011, 9 pages.
International Search Report; International Application No. PCT/US2011/031463; Applicant: ReShape Medical, Inc., Mailing Date: Jun. 27, 2011, 10 pages.
Non-Final Office Action; U.S. Appl. No. 11/263,302; dated: Oct. 9, 2012, 6 pages.
Non-Final Office Action; U.S. Appl. No. 11/694,536; dated: Oct. 26, 2011, 13 pages.
Non-Final Office Action; U.S. Appl. No. 12/625,473; dated Jul. 12, 2012; 10 pages.
Non-Final Office Action; U.S. Appl. No. 12/625,473; dated Oct. 24, 2011, 18 pages.
Non-Final Office Action; U.S. Appl. No. 12/723,545; dated Feb. 29, 2012, 10 pages.
Non-Final Office Action; U.S Appl. No. 12/753,751; dated Oct. 5, 2012, 8 pages.
European Supplementary Search Report; EP Application No. 10802994.3, Applicant: ReShape Medical, Inc., mailed Jun. 28, 2013, 8 pgs.
European Supplementary Search Report; EP Application No. 10802918.2, Applicant: ReShape Medical, Inc., mailed Jun. 5, 2013, 6 pgs.
Extended European Search Report; Application No. EP11748141.6, Applicant: Reshape Medical, Inc., mailed Feb. 25, 2014, 6 pages.
Extended European Search Report; Application EP11740536.5, Applicant: ReShape Medical, Inc., mailed Jul. 3, 2014, 8 pages.
Extended European Search Report; Application EP11831683.5, Applicant: Reshape Medical, Inc., mailed Jul. 3, 2014, 8 pages.
Final Office Action: U.S. Appl. No. 13/556,0-32, mailed on Jan. 28, 2014, 8 pages.
Non-Final Office Action: U.S. Appl. No. 13/386,650, mailed on Jun. 3, 2014, 15 pages.
Notice of Allowance; U.S. Appl. No. 12/753,803, dated May 13, 2014, 18 pages.
Ostrovsky, ReShape Inflatable Gastric Balloon going on Trial as Weight Loss Option: http://www.medgadget.com/2010/reshape—inflatable—gastric—balloon—system—going—on—trial—as—wieight—loss—option.html Feb. 4, 2010, retrieved on Feb. 10, 2013.
Final Office Action; U.S. Appl. No. 13/858,767, Mailing Date May 22, 2013, 12 pages.
Extended European Search Report; Application No. EP11766679.2; Applicant: Reshape Medical, Inc., mailed Dec. 12, 2013, 6 pages.
Cronin et al., “Normal small bowel wall characteristics on MR enterography,” European Journal of Radiology 74(2)207-211, Aug. 2010.
Canadian 2nd Office Action Application No. 2680124, Applicant: ReShape Medical, Inc., mailed Jul. 9, 2015, 3 pages.
European Examination Report; Application No. 06827313.5, Applicant: ReShape Medical Inc., mailed Jul. 13, 2015, 5 pages.
European Examination Report; Application No. 06847847.8, Applicant: ReShape Medical Inc., mailed Jul. 13, 2015, 4 pages.
Japanese Office Action; Application No. 2013-532976; Applicant: ReShape Medical, Inc., mailed Jun. 26, 2015, 10 pages.
Canadian Office Action: Application No. CA 2680124, Applicant: Reshape Medical Corporation, mailed Nov. 4, 2014, 3 pages.
Canadian Office Action; Application No. 2,691,530, mailed Dec. 18, 2014, 4 pages.
Canadian Office Action; Application No. CA 2638163, Applicant: Reshape Medical Corporation, mailed Mar. 10, 2015, 4 pages.
Canadian Office Action; Application No. CA 2638988, Applicant Reshape Medical Corporation, mailed Dec. 22, 2014 3 pages.
Canadian Office Action; Application No. CA 2638988, Applicant Reshape Medical Corporation, mailed Mar. 6, 2014, 4 pages.
Canadian Office Action; Application No. CA 2638989, Applicant: Reshape Medical Corporation, mailed May 22, 2013 3 pages.
Canadian Office Action; Application No. CA 2640554, Applicant: Reshape Medical Corporation, mailed May 27, 2013, 2 pages.
Canadian Office Action; Application No. CA2484838, Applicant: Reshape Medical, Inc., mailed Nov. 13, 2009, 3 pages.
Canadian Office Action; Application No. CA2484838, Applicant: Reshape Medical, Inc., mailed Sep. 24, 2010, 3 pages.
Canadian Office Action; Application No. CA2638163, Applicant: Reshape Medical Corporation, mailed Jul. 17, 2013, 2 pages.
Canadian Office Action; Application No. CA2638988, Applicant: Reshape Medical Corporation, mailed May 28, 2013, 3 pages.
Canadian Office Action; Application No. CA2780085, Applicant: Reshape Medical, Inc., mailed Jul. 23, 2012, 2 pages.
European Examination Report; Application No. 03726447.0, Applicant: Applied Medical Resources Corporation: Oct. 26, 2007, 4 pages.
European Examination Report; Application No. EP108002918.2, Applicant: Reshape Medical Inc., mailed Dec. 17, 2014, 5 pages.
European Examination Report; Application No. EP108029943, Applicant: Reshape Medical Inc., mailed Dec. 18, 2014, 4 pages.
European Examination Reported; Application No. 08771842.5, May 7, 2015, 5 pages.
European Supplementary Search Report; Application No. 08771842.5, Apr. 24, 2015, 3 pages.
Extended European Search Report; Application No. 08732989.2, Applicant: Reshape Medical, Inc., mailed Oct. 16, 2014, 7 pages.
Japanese Final Office Action; Application No. JP2013-043712, mailed Nov. 15, 2013, 5 pages.
Japanese Office Action; Application No. 2013-142327, mailed May 29, 2014, 4 pages.
Japanese Office Action; Application No. 2014-52972; mailed Feb. 25, 2015, 7 pages.
Japanese Office Action; Application No. JP2010-501261, mailed Sep. 7, 2012, 10 pages.
Japanese Office Action; Application No. JP2010-515040, mailed Jan. 7, 2013, 18 pages.
Japanese Office Action; Application No. JP2012-503759, mailed Mar. 24, 2014, 5 pages.
Japanese Office Action; Application No. JP2013-43712, mailed Jan. 8, 2015, 8 pages.
Japanese Office Action; Application. No. JP2013-043712, mailed Apr. 22, 2013, 5 pages.
Gray, Henry. Anatomy of the Human Body. Philadelphia: Lea & Febiger, 1918. Section XI Splanchnology, 2g. The Small Intestine. Bartleby.com, 2000. Web. URL: www.bartleby.com/107/248.html. Accessed: Oct. 26, 2015. 12 pages.
Partial Supplementary European Search Report for European Application No. 11740535.7, Applicant: ReShape Medical, Inc., mailed Oct. 20, 2015, 7 pages.
Final Office Action for Japanese Application No. 2014-52972, Applicant: ReShape Medical, Inc., mailed on Oct. 9, 2015, 8 pages.
Related Publications (1)
Number Date Country
20110178544 A1 Jul 2011 US
Continuations (1)
Number Date Country
Parent 11768152 Jun 2007 US
Child 13074956 US