RESTRICTIVE AND/OR OBSTRUCTIVE IMPLANT FOR INDUCING WEIGHT LOSS
Described herein is a system for inducing weight loss in a patient, which comprises an extragastric space occupier positionable in contact with an exterior surface of a stomach wall to form an inward protrusion of wall into the stomach, and a retention device positionable in contact with the wall to retain the inward protrusion and to thereby capture the extragastric space occupier within the protrusion.
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This application is a divisional of U.S. patent application Ser. No. 12/765,177 filed Apr. 22, 2010, now allowed, which is a continuation of U.S. patent application Ser. No. 11/114,400 filed Apr. 26, 2005, now U.S. Pat. No. 7,717,843 which claims the benefit of U.S. Provisional Patent Application No. 60/565,378 filed Apr. 26, 2004, each of which are incorporated herein by reference in their entirety.
FIELD OF THE INVENTIONThe present invention relates generally to the field of implants for inducing weight loss in patients, and specifically to devices and methods for reducing the effective volume of a patient's stomach and or creating restrictions to slow passage of food into the stomach.
BACKGROUND OF THE INVENTIONAn anatomical view of a human stomach S and associated features is shown in
Stomach S includes a fundus F at its proximal end and an antrum A at its distal end. Antrum A feeds into the pylorus P which attaches to the duodenum D, the proximal region of the small intestine. Within the pylorus P is a sphincter that prevents backflow of food from the duodenum D into the stomach. The middle region of the small intestine, positioned distally of the duodenum D, is the jejunum J.
Prior art treatments for obesity range from diet and medication to highly invasive surgical procedures. Some of the more successful surgical procedures are the vertical banded gastroplexy or the proximal gastric pouch with a Roux-en-Y anastomosis. However, known complications are present with each of these procedures. More successful and less invasive options are desired.
A less invasive prior art treatment for obesity includes implantation of a gastric balloon delivered into the stomach via the esophagus. The balloon is an obstructive device—it prevents overeating by occupying volume within the stomach. Although implantation of a gastric balloon is less invasive than other surgical procedures, gastric balloons can migrate down the GI tract, causing obstruction and thus necessitating removal.
Referring to
Various positions for the implant are illustrated in the drawings. Depending on the size and positioning of the implant, it may function as an obstructive device, a restrictive device, or both. In some embodiments, the implant may have an expanded volume in the range of approximately 200-700 cc, sufficient to cause the inwardly-protruding pocket 2 to fill a portion of the stomach, thereby causing the patient to feel full and thus limiting food intake. In
The configuration illustrated in
A section of reinforcing and/or ingrowth-promoting material 15 (
If adhesion of adjacent mucosal tissue surfaces is desired, modification of the interior tissue surface may further be needed in order to optimize adhesion of opposed regions of internal stomach tissue. In particular, it is believed that better adhesion of the interior wall surfaces may be achieved when a portion of the mucosal layer of tissue lining the stomach interior is removed, such that the tissue surfaces sutured in apposition to one another are serosal, sub-mucosal or muscularis layers. It is believed that opposed layers of mucosal tissue do not adhere together as well as opposed layers of serosal, sub-mucosal, or muscularis tissue. Surface modification methods for promoting such tissue adhesion include cutting, ablating (using RF, laser, or chemical ablation) or abrading the mucosal surface within the stomach as indicated by dashed lines. This modification is ideally performed before the folds are placed in apposition. Depending on the depth to which cutting, ablation or abrasion is performed, the sub-mucosal, musclaris, or serosal layer beneath the mucosal layer is exposed. This allows the exposed regions of tissue to be placed in apposition and causes the opposed surfaces to tightly adhere over time.
Although the implants shown in
Many other shapes beyond those shown in this application may be used for the implant (such as for accommodating the shape of the anatomy, or for creating a restriction or obstruction of a particular size/shape), without departing from the scope of the present invention.
There are likewise many suitable structures and materials useful for the implant. Some structures and materials are shown and described herein, although again many others may be used without exceeding the scope of the present invention.
For example, the implant may be an elastic or inelastic balloon that is implantable in a deflated state and then inflated within the body using a gas or liquid. A balloon of this type may include a port such as port 26 shown in
Other configurations besides balloons are also suitable for the implant. The implant 10d may have fluted walls 28 as shown in
The implant need not be a hollow structure, but could instead be entirely solid.
The implant may be implanted endoscopically using tools passed into the stomach via the esophagus. According to the endoscopic approach, the implant is inserted into the stomach and then passed through an opening formed in the stomach wall. Alternatively, a laparoscopic method may be used to pass the implant into the abdominal cavity through incisions or trocar punctures in the skin. The implant may also be introduced using an open surgical approach. In both the laparoscopic and surgical procedures, the retention band 12 is preferably introduced endoscopically into the stomach.
Referring to
Next, tension is applied to the inflation tube 46 to pull the implant 10 towards the stomach so as to create the pocket 2. This step draws the implant 10 and the surrounding stomach wall through the retention band 12 as shown in
Referring to
The retention band 12 may take alternate forms or be replaced altogether using other types of structures that help to capture the implant 10 in the pocket 2 at the implant site.
The retention band itself may be inflatable. Referring to
Referring to
Referring to
Components of the type described herein may be supplied individually or as systems which may include various combinations of components such as implants (e.g. implant 10), retention devices (e.g. band 12), implantation instruments, and/or instructions for use. If included, instructions for use may include instructions instructing a user to implant the implant using methods such as any of those described above. For example, the instructions may instruct the user to create an inward protrusion in the stomach wall such as by positioning an instrument or the implant against an exterior surface of the stomach wall. The instructions may further instruct the user to position the retention device in a manner that at least partially retains the protrusion in the wall and that thus captures implant within the protrusion, externally of the stomach. In some embodiments where a retention band is provided, the instructions for use may instruct the user to encircle a portion of the protrusion in the wall with the retention band. The instructions may instruct the user as to laparoscopic, endoscopic, and/or open surgical approaches such as those described above.
Various components and methods have been described herein. These embodiments are given by way of example and are not intended to limit the scope of the present invention. It should be appreciated, moreover, that the various features of the embodiments that have been described might be combined in various ways to produce numerous additional embodiments.
Claims
1. A system for inducing weight loss in a patient, the system comprising:
- an extragastric space occupier positionable in contact with an exterior surface of a stomach wall to form an inward protrusion of wall into the stomach; and
- a retention device positionable in contact with the wall to retain the inward protrusion and to thereby capture the extragastric space occupier within the protrusion.
2. The system according to claim 1, wherein the extragastric space occupier is proportioned to cause the protrusion to fill a portion of the stomach, thereby causing the patient to feel full.
3. The system according to claim 1, wherein the extragastric space occupier has in expandable within the stomach to an expanded volume in the range of 200-800 cc.
4. The system according to claim 1, wherein the extragastric space occupier is proportioned to cause the protrusion to create a restriction in the stomach that will slow the rate at which food can descend from the esophagus into the stomach.
5. The system according to claim 1, wherein the retention device comprises at least one suture.
6. The system according to claim 1, wherein the retention device comprises at least one staple.
7. The system according to claim 1, wherein the retention device comprises at least one band positionable around the protrusion within the stomach.
8. The system according to claim 7, wherein the band is positionable encircling the protrusion.
9. The system according to claim 7, wherein the band is inflatable.
10. The system according to claim 1, wherein the extragastric space occupier is inflatable.
11. The system according to claim 1, wherein the extragastric space occupier includes an inflation port, and wherein the system includes an inflation needle extendable through the esophagus into the stomach, the inflation needle engageable with the inflation port.
12. The system according to claim 11, wherein the inflation port is extendable through an opening in the stomach wall.
13. The system according to claim 11, wherein the inflation port includes a resealable portion of the extragastric space occupier, and wherein the needle is extendable through the stomach wall into engagement with the inflation port.
14. The system according to claim 1, further including instructions setting forth a method for implanting the system, including the steps of:
- positioning the extragastric space occupier into contact with an exterior of a wall of the stomach, causing the wall to protrude inwardly into the stomach; and
- coupling a retention device to the stomach so as to retain the inward protrusion and to thereby capture the extragastric space occupier within the protrusion.
15. The system according to claim 14, wherein the instructions set forth that the positioning step includes the step of passing the extragastric space occupier through the esophagus into the stomach, and then passing the extragastric space occupier through an opening formed in the wall of the stomach and into contact with the exterior of the wall.
16. The system according to claim 14, wherein the instructions set forth that the positioning step includes the step of passing the extragastric space occupier laparoscopically into an abdominal cavity and into contact with the exterior of the wall.
17. A method of assisting weight loss in a patient, comprising the steps of:
- positioning an extragastric space occupier into contact with an exterior surface of a stomach wall to form an inward protrusion of wall into the stomach; and
- placing a retention device in contact with the wall to retain the inward protrusion and to thereby capture the extragastric space occupier within the protrusion.
18. The method of claim 17, wherein the placing step places the retention device into contact with an interior surface of the wall.
19. The method of claim 18, wherein the retention device comprises a band and wherein the placing step includes encircling the protrusion using the band.
20. The method of claim 17, wherein the placing step includes the step of drawing portions of the wall into contact with one another and attaching a retention device to the wall to retain the protrusion.
21. The method of claim 20, wherein the retention device comprises at least one suture or staple.
22. The method of claim 17, wherein the extragastric space occupier is expandable, and wherein the method includes the step of expanding the space occupier to a volume sufficient to cause the protrusion to fill a portion of the stomach, thereby causing the patient to feel full.
23. The method of claim 22, wherein the expanding step includes expanding the space occupier to a volume in the range of 200-800 cc.
24. The method of claim 17, wherein the space occupier is expandable, and wherein the method includes the step of expanding the space occupier to cause the protrusion to create a restriction in the stomach that will slow the rate at which food can descend from the esophagus into the stomach.
25. The method of claim 17, wherein the space occupier includes an inflation port, and wherein the method includes the step of passing an inflation needle extendable through the esophagus into the stomach, engaging inflation port with the inflation needle, and inflating the space occupier using the inflation needle.
26. The method of claim 25, wherein the positioning step includes positioning the inflation port to extend an opening in the stomach wall.
27. The method of claim 25, wherein the inflation port includes a resealable portion of the space occupier, and engaging step includes passing the needle through the stomach wall into engagement with the inflation port.
28. The method of claim 17, wherein the positioning step includes passing the extragastric space occupier through the esophagus into the stomach, and then passing the extragastric space occupier through an opening formed in the wall of the stomach and into contact with the exterior of the wall.
29. The method of claim 17, wherein the positioning step includes passing the extragastric space occupier laparoscopically into an abdominal cavity and into contact with the exterior of the wall.
Type: Application
Filed: Jul 17, 2012
Publication Date: Jan 24, 2013
Applicant: Barosense, Inc. (Redwood City, CA)
Inventors: Daniel J. Balbierz (Redwood City, CA), William L. Athas (Chapel Hill, NC), John Lunsford (San Carlos, CA), William S. Eubanks, JR. (Durham, NC), Kevin van Bladel (Livermore, CA)
Application Number: 13/551,504
International Classification: A61F 2/00 (20060101);