This invention relates to medical devices, and more particularly to obesity treatment devices that can be placed in the stomach of a patient to occupy volume in the gastric lumen.
It is well known that obesity is a very difficult condition to treat. Methods of treatment are varied, and include drugs, behavior therapy, and physical exercise, or often a combinational approach involving two or more of these methods. Unfortunately, results are seldom long term, with many patients eventually returning to their original weight over time. For that reason, obesity, particularly morbid obesity, is often considered an incurable condition. More invasive approaches have been available which have yielded good results in many patients. These include surgical options such as bypass operations or gastroplasty. However, these procedures carry high risks, and are therefore not appropriate for most patients.
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. Other 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. However, 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. In addition, there have been documented instances of the balloon blocking off or lodging in the opening to the duodenum, wherein the balloon may act like a ball valve to prevent the stomach contents from emptying into the intestines.
Unrelated to the above-discussed methods for treating obesity, it has been observed that the ingestion of certain indigestible matter, such as fibers, hair, fuzzy materials, etc., can collect in the stomach over time, and eventually form a mass called a bezoar. In some patients, particularly children and the mentally handicapped, bezoars often result from the ingestion of plastic or synthetic materials. In many cases, bezoars can cause indigestion, stomach upset, or vomiting, especially if allowed to grow sufficiently large. It has also been documented that certain individuals having bezoars are subject to weight loss, presumably due to the decrease in the size of the stomach reservoir. Although bezoars may be removed endoscopically, especially in conjunction with a device known as a bezotome or bezotriptor, they, particularly larger ones, often require surgery.
What is needed is method of delivering an intragastric device that provides the potential weight loss benefits of a bezoar or intragastric balloon without the associated complications. Ideally, such a-method should be well-tolerated by the patient, effective over a long period of time, and easy to place and retrieve.
These and other advantages, as well as the invention itself, will become apparent in the details of construction and operation as more fully described below. Moreover, it should be appreciated that several aspects of the invention can be used with other types of intragastric devices or procedures used for the treatment of obesity.
In a first aspect, an intragastric member is provided. The 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.
In a second aspect, an intragastric device for the treatment of obesity is provided. 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.
In a third aspect, a method of treatment of obesity in mammals is provided. An intragastric member is provided comprising a tubular sheet of material. The intragastric member is secured onto a delivery tube with a 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.
Several embodiments of the present invention will now be described by way of example with reference to the accompanying drawings, in which:
The obesity treatment apparatus depicted in
As will be discussed with reference to
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, as shown in
The intragastric member 11 with retaining members 34-38 are shown mounted over a delivery tube 18.
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
In the illustrative embodiments, the retaining members 34-38 (see
Although five retaining members 34-38 are shown in
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. The distal end 82 is affixed to the retaining member 35, and the proximal end 66 is a free end that extends proximally within the lumen 18.
Suture tie 62 has a proximal end 67 and a distal end 83. The distal end 83 is attached to retaining member 36, and the 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 84 is affixed to the retaining member 37, and 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 85 is attached to the retaining member 38, and the proximal end 66 is a free end that extends proximally within the lumen 18. Note that 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. Preferably, the member 11 comprises a woven polymeric mesh, as shown in
Having described the structure of the intragastric member 11, a method of delivery and deployment of the intragastric member 11 will now be described. The intragastric member 11 is loaded onto a 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 (
Having loaded the intragastric member 11 onto the delivery tube 11 with retaining members 34-38 and suture ties 61-64, delivery of the intragastric member 11 may begin. The intragastric member 11 and delivery tube 18 may be navigated through an overtube 1000 (
After the delivery tube 18 has been introduced into the gastric lumen 1020, deployment of the bundles 14-17 of the intragastric member 11 may begin by pulling on each of the proximal ends 65-68 of the suture ties 61-64 as will now be described. The 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. For example, 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
Further pulling of the suture tie 61 at its proximal end 66 (
Further pulling of the suture tie 62 at its proximal end 67 with a predetermined amount of force causes the bundle 15 to slide off from the distal end of the delivery tube 18 (
Further pulling of the suture tie 63 at its proximal end 68 (
Further pulling of the suture tie 64 at its proximal end 65 (
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.
As an alternative to the above-described procedure, 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.
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.
The above-described embodiments discuss a method for delivering a large volume of material into a gastric lumen in a controlled and incremental manner. Various sized intragastric bags may be delivered using the above embodiments. In one example, 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. After deployment into the gastric lumen, each of the bundles may have a width of about six inches and a longitudinal length of about one-and-a-half inches. Generally speaking, the width of the deployed bundles 14-17 is greater than the width of the bundles 14-17 assembled onto delivery tube 18.
To remove the intragastric member 11 from the gastric lumen 1020, 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. Illustrative embodiments of the present invention have been described in considerable detail for the purpose of disclosing a practical, operative structure whereby the invention may be practiced advantageously. The designs described herein are intended to be exemplary only. The novel characteristics of the invention may be incorporated in other structural forms without departing from the spirit and scope of the invention.
Number | Name | Date | Kind |
---|---|---|---|
2508690 | Schmerl | May 1950 | A |
4133315 | Berman et al. | Jan 1979 | A |
4134405 | Smit | Jan 1979 | A |
4246893 | Berson | Jan 1981 | A |
4315509 | Smit | Feb 1982 | A |
4403604 | Wilkinson et al. | Sep 1983 | A |
4416267 | Garren et al. | Nov 1983 | A |
4485805 | Foster, Jr. | Dec 1984 | A |
4558699 | Bashour | Dec 1985 | A |
4607618 | Angelchik | Aug 1986 | A |
4694827 | Weiner et al. | Sep 1987 | A |
4696288 | Kuzmak et al. | Sep 1987 | A |
4723547 | Kullas et al. | Feb 1988 | A |
4803985 | Hill | Feb 1989 | A |
4878905 | Blass | Nov 1989 | A |
4899747 | Garren et al. | Feb 1990 | A |
4925446 | Garay et al. | May 1990 | A |
4952339 | Temus et al. | Aug 1990 | A |
5129915 | Cantenys | Jul 1992 | A |
5234454 | Bangs | Aug 1993 | A |
5246456 | Wilkinson | Sep 1993 | A |
5306300 | Berry | Apr 1994 | A |
5327914 | Shlain | Jul 1994 | A |
5345949 | Shlain | Sep 1994 | A |
5868141 | Ellias | Feb 1999 | A |
5938669 | Klaiber et al. | Aug 1999 | A |
5993473 | Chan et al. | Nov 1999 | A |
6067991 | Forsell | May 2000 | A |
6210347 | Forsell | Apr 2001 | B1 |
6348056 | Bates et al. | Feb 2002 | B1 |
6427089 | Knowlton | Jul 2002 | B1 |
6450946 | Forsell | Sep 2002 | B1 |
6454699 | Forsell | Sep 2002 | B1 |
6460543 | Forsell | Oct 2002 | B1 |
6511490 | Robert | Jan 2003 | B2 |
6540789 | Silverman et al. | Apr 2003 | B1 |
6558400 | Deem et al. | May 2003 | B2 |
6605111 | Bose et al. | Aug 2003 | B2 |
6627206 | Lloyd | Sep 2003 | B2 |
6656194 | Gannoe et al. | Dec 2003 | B1 |
6669721 | Bose et al. | Dec 2003 | B1 |
6675809 | Stack et al. | Jan 2004 | B2 |
6676674 | Dudai | Jan 2004 | B1 |
6733512 | McGhan | May 2004 | B2 |
6740121 | Geitz | May 2004 | B2 |
6746460 | Gannoe et al. | Jun 2004 | B2 |
6755869 | Geitz | Jun 2004 | B2 |
6802868 | Silverman et al. | Oct 2004 | B2 |
6845776 | Stack et al. | Jan 2005 | B2 |
6879859 | Boveja | Apr 2005 | B1 |
6916326 | Benchetrit | Jul 2005 | B2 |
6946002 | Geitz | Sep 2005 | B2 |
6981980 | Sampson et al. | Jan 2006 | B2 |
6994715 | Gannoe et al. | Feb 2006 | B2 |
7033373 | de la Torre et al. | Apr 2006 | B2 |
7033384 | Gannoe et al. | Apr 2006 | B2 |
7037344 | Kagan et al. | May 2006 | B2 |
7054690 | Imran | May 2006 | B2 |
7056305 | Garza Alvarez | Jun 2006 | B2 |
7066945 | Hashiba et al. | Jun 2006 | B2 |
7090699 | Geitz | Aug 2006 | B2 |
7097665 | Stack et al. | Aug 2006 | B2 |
7112186 | Shah | Sep 2006 | B2 |
7121283 | Stack et al. | Oct 2006 | B2 |
7152607 | Stack et al. | Dec 2006 | B2 |
7172613 | Wazne | Feb 2007 | B2 |
7175638 | Gannoe et al. | Feb 2007 | B2 |
7177693 | Starkebaum | Feb 2007 | B2 |
20010011543 | Forsell | Aug 2001 | A1 |
20020188354 | Peghini | Dec 2002 | A1 |
20030049325 | Suwelack et al. | Mar 2003 | A1 |
20030109892 | Deem et al. | Jun 2003 | A1 |
20030120265 | Deem et al. | Jun 2003 | A1 |
20030158564 | Benchetrit | Aug 2003 | A1 |
20030199989 | Stack et al. | Oct 2003 | A1 |
20030199990 | Stack et al. | Oct 2003 | A1 |
20030199991 | Stack et al. | Oct 2003 | A1 |
20040019388 | Starkebaum | Jan 2004 | A1 |
20040024386 | Deem et al. | Feb 2004 | A1 |
20040039452 | Bessler | Feb 2004 | A1 |
20040044353 | Gannoe | Mar 2004 | A1 |
20040044354 | Gannoe et al. | Mar 2004 | A1 |
20040049209 | Benchetrit | Mar 2004 | A1 |
20040082963 | Gannoe et al. | Apr 2004 | A1 |
20040092892 | Kagan et al. | May 2004 | A1 |
20040092974 | Gannoe et al. | May 2004 | A1 |
20040117031 | Stack et al. | Jun 2004 | A1 |
20040122452 | Deem et al. | Jun 2004 | A1 |
20040122453 | Deem et al. | Jun 2004 | A1 |
20040122526 | Imran | Jun 2004 | A1 |
20040138760 | Schurr | Jul 2004 | A1 |
20040138761 | Stack et al. | Jul 2004 | A1 |
20040143342 | Stack et al. | Jul 2004 | A1 |
20040153106 | Dudai | Aug 2004 | A1 |
20040158331 | Stack et al. | Aug 2004 | A1 |
20040186503 | DeLegge | Sep 2004 | A1 |
20040220682 | Levine et al. | Nov 2004 | A1 |
20040243152 | Taylor et al. | Dec 2004 | A1 |
20050049718 | Dann et al. | Mar 2005 | A1 |
20050070921 | Ortiz et al. | Mar 2005 | A1 |
20050096750 | Kagan et al. | May 2005 | A1 |
20050149141 | Starkebaum | Jul 2005 | A1 |
20050149142 | Starkebaum | Jul 2005 | A1 |
20050177181 | Kagan et al. | Aug 2005 | A1 |
20050192531 | Birk | Sep 2005 | A1 |
20050192614 | Binmoeller | Sep 2005 | A1 |
20050209653 | Herbert et al. | Sep 2005 | A1 |
20050222637 | Chen | Oct 2005 | A1 |
20050222638 | Foley et al. | Oct 2005 | A1 |
20050240239 | Boveja et al. | Oct 2005 | A1 |
20050240279 | Kagan et al. | Oct 2005 | A1 |
20050245957 | Starkebaum et al. | Nov 2005 | A1 |
20050246037 | Starkebaum | Nov 2005 | A1 |
20050250979 | Coe | Nov 2005 | A1 |
20050256587 | Egan | Nov 2005 | A1 |
20050267405 | Shah | Dec 2005 | A1 |
20060015151 | Aldrich | Jan 2006 | A1 |
20060020247 | Kagan et al. | Jan 2006 | A1 |
20060030949 | Geitz | Feb 2006 | A1 |
20060074450 | Boveja et al. | Apr 2006 | A1 |
20060079944 | Imran | Apr 2006 | A1 |
20060089571 | Gertner | Apr 2006 | A1 |
20060129027 | Catona | Jun 2006 | A1 |
20060129094 | Shah | Jun 2006 | A1 |
20060161172 | Levine et al. | Jul 2006 | A1 |
20060206063 | Kagan et al. | Sep 2006 | A1 |
20060206064 | Kagan et al. | Sep 2006 | A1 |
20060206160 | Cigaina et al. | Sep 2006 | A1 |
20060249165 | Silverman et al. | Nov 2006 | A1 |
20060253142 | Bjerken | Nov 2006 | A1 |
20060257444 | Tropsha et al. | Nov 2006 | A1 |
20060257445 | Tropsha et al. | Nov 2006 | A1 |
20060257446 | Tropsha et al. | Nov 2006 | A1 |
20060282107 | Hashiba et al. | Dec 2006 | A1 |
20060293742 | Dann et al. | Dec 2006 | A1 |
20070004963 | Benchetrit | Jan 2007 | A1 |
20070010794 | Dann et al. | Jan 2007 | A1 |
20070010864 | Dann et al. | Jan 2007 | A1 |
20070010865 | Dann et al. | Jan 2007 | A1 |
20070010866 | Dann et al. | Jan 2007 | A1 |
20070021761 | Phillips | Jan 2007 | A1 |
20070038308 | Geitz | Feb 2007 | A1 |
20070239284 | Skerven et al. | Oct 2007 | A1 |
Number | Date | Country |
---|---|---|
0137 878 | Nov 1983 | EP |
1520531 | Apr 2005 | EP |
WO 0110290 | Feb 2001 | WO |
WO 2007136468 | Nov 2007 | WO |
Number | Date | Country | |
---|---|---|---|
20090164028 A1 | Jun 2009 | US |