GASTRIC SPACE OCCUPIER SYSTEMS AND METHODS OF USE
Systems for controlling obesity utilize a number of space occupiers positioned in the stomach to reduce the effective volume of the stomach. Such arrangements provides sufficient stomach volume consumption to induce weight loss, but enable use of space occupiers that are proportioned to minimize the threat of obstruction even if they should migrate into the intestine. In general, numerous small volume space occupiers are placed in the stomach such that the total volume equals or exceeds the single volume of prior art single unit space occupiers. However, each individual space occupier is proportioned so that it will pass without obstruction if it moves into the intestine.
This application is a divisional of U.S. patent application Ser. No. 12/270,607, filed Nov. 13, 2008, which claims the benefit of U.S. Provisional Application No. 61/018,405, filed Dec. 31, 2007, both of which are incorporated herein by reference.
TECHNICAL 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.
BACKGROUNDPrior 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 space occupier delivered into the stomach via the esophagus. The space occupier is an obstructive device—it prevents overeating by occupying volume within the stomach. Although implantation of a space occupier is less invasive than other surgical procedures, complications do exist. In particular, because space occupiers are typically fluid filled balloons, rupture of balloons can and does occur. A punctured balloon can migrate into the intestines, potentially causing life-threatening intestinal obstruction. Some prior systems attempt to avoid the risk of migration by anchoring space occupiers within the stomach, but these systems tend to nevertheless detach from the stomach wall, resulting in migration. A space occupier which does not pose the threat of obstruction is highly desirable. However, the size of space occupier necessary for weight loss makes a single unit space occupier design difficult.
Additionally, the stomach is a dynamic organ capable of adapting to changes including those associated with positioning of a space occupier. Given the adaptive nature of the stomach, space occupiers do not adequately provide for long term weight loss. It would be advantageous to have a system which could accommodate such adaptations, thus allowing for long term weight loss.
The present application describes space occupier designs that minimize risk of obstruction, as well as methods for using the designs in a manner that addresses stomach adaptations and/or changes to the amount of volume consumption needed for a given patient.
The disclosed embodiments address the shortcomings of prior art space occupier technologies. In preferred modes of use, the disclosed systems utilize a number of space occupiers positioned in the stomach. Such an arrangement provides sufficient stomach volume consumption to induce weight loss, but enables use of space occupiers that are proportioned to minimize the threat of obstruction even if they should migrate into the intestine. In general, numerous small volume space occupiers are placed in the stomach such that the total volume equals or exceeds the single volume of known space occupiers. However, each individual space occupier is proportioned so that it will pass without obstruction if it moves into the intestine. The devices are capable of being inserted trans orally, but once in the stomach the space occupiers are expanded or otherwise changed into a shape or size which prevents migration into the intestinal tract. Because they are smaller than known space occupiers, additional individual units may be introduced into the stomach to increase the rate of weight loss or to accommodate changes in the stomach size.
The disclosed embodiments are preferably formed using materials such as silicone that are capable of withstanding the acidic environment of the stomach, and they are sufficiently soft and appropriately shaped to be atraumatic to the tissue of the stomach. Numerous embodiments are conceivable, a few of which are shown herein.
Each space occupier has a deflated or compressed position allowing its insertion into the stomach via the esophagus as shown. The system may be provided with instruments that facilitate implantation, such as an overtube positionable in the esophagus (through which the space occupiers are passed), and instruments for advancing the space occupiers through the overtube or directly through the esophagus. Such instruments might include push tools that push the space occupiers through the esophagus or overtube, or graspers or alternative instruments that can be used to carry space occupiers through the esophagus or overtube.
Once a space occupier is positioned in the stomach, fluid (e.g. liquid, gas, gel) is introduced into the space occupier through a valve 12. In one example, an inflation tube 14 is coupled to the valve prior to introduction of the space occupier into the stomach, and is subsequently detached from the space occupier following inflation. Inflation tube is coupled to a fluid source 16 such as a fluid-filled syringe or canister. The space occupiers are shown as spherical but may be any shape that will resist passage into the digestive tract when filled with fluid, but that will readily pass into the digestive tract, as shown in
The number of space occupier units implanted at any given time is selected to give a target stomach volume consumption selected to yield the desired weight loss results. Additional units may be added, or some units removed, during the course of weight loss treatment to increase or decrease the total volume consumption and the corresponding rate of weight loss and/or to respond to adaptive changes in the stomach's volume.
The
As shown in
For implantation, the band is positioned in its linear/streamlined configuration and introduced into the stomach as shown in
Once the band has been passed into the stomach, the ends of the band are brought together to form the band into a shape that will be unable to pass into the intestinal tract (such a shape may be referred to herein as a “non-passable shape”). Various tools or actuators may be used for this purpose. In one example shown in
As with the
The construction of the space occupier 10c is similar to that of a children's' toy known as a “water snake”. In particular, the space occupier is configured such that squeezing the outer surface at one end will “squirt” the space occupier away from the point of compression by causing the layer of wall lining the lumen 34 to roll to the outside of the 25 balloon while the layer of wall lining the outer surface of the balloon rolls into the lumen as indicated by arrows in
As with previously described embodiments, obesity using the space occupier 10c may involve placing a single space occupier or multiple space occupiers within the stomach to achieve a desired collective volume consumption within the stomach, such as that described in connection with the
The disclosed space occupiers and associated systems may be provided with instructions for use instructing the user to utilize the space occupiers according to the various steps described herein.
It should be recognized that a number of variations of the above-identified embodiments will be obvious to one of ordinary skill in the art in view of the foregoing description. Moreover, various features of the disclosed embodiments may be combined in a variety of ways. Accordingly, the invention is not to be limited by those specific embodiments and methods of the present invention shown and described herein. Rather, the scope of the invention is to be defined by the following claims and their equivalents.
Any and all prior patents and applications referred to herein, including for purposes of priority, are fully incorporated by reference.
Claims
1-20. (canceled)
21. A method of treating a patient including a stomach, comprising:
- placing a plurality of space occupiers intraorally into the stomach in a first configuration; and
- transforming each of multiple space occupiers of the plurality of space occupiers into a second configuration in the stomach, wherein a size of each space occupier in the second configuration is larger than a size of the space occupier in the first configuration.
22. The method of claim 21, wherein each space occupier of the plurality of space occupiers is a balloon, and the step of transforming each of multiple space occupiers includes inflating multiple balloons with a fluid.
23. The method of claim 22, wherein each of the multiple space occupiers in the second configuration has a volume between 50-200 cc.
24. The method of claim 22, wherein placing a plurality of space occupiers includes attaching an inflation tube to at least one space occupier of the plurality of space occupiers.
25. The method of claim 21, wherein each space occupier of the plurality of space occupiers in the first configuration has an elongated shape that extends from a first end to a second end, and the step of transforming each of multiple space occupiers includes bending each space occupier of the multiple space occupiers to couple the first end to the second end.
26. The method of claim 25, wherein the first end of each space occupier includes a tab and the second end includes a recess, and the step of transforming each of multiple space occupiers includes bending each space occupier of the multiple space occupiers to attach the tab to the recess.
27. The method of claim 25, wherein each space occupier in the second configuration has one of a ring shape or an oval shape.
28. The method of claim 25, wherein each space occupier in the second configuration has a triangular shape.
29. A method of treating a patient including a stomach, comprising:
- placing a space occupier in the stomach, the space occupier including an elongate member extending from a first end to a second end; and
- bending the space occupier in the stomach to couple the first end to the second end.
30. The method of claim 29, further comprising locking the first end to the second end.
31. The method of claim 30, wherein the first end includes a tab and the second end includes a recess, and the step of locking the first end to the second end includes engaging the tab with the recess.
32. The method of claim 30, wherein locking the first end to the second end transforms the elongate member of the space occupier to one of a ring shape or an oval shape.
33. The method of claim 30, wherein locking the first end to the second end transforms the elongate member of the space occupier to a triangular shape.
34. The method of claim 29, wherein the elongate member of the space occupier includes one or more hinge members located between the first end and the second end, and the step of bending the space occupier includes bending the elongate member at the one or more hinge members.
35. A space occupier configured to be placed in a subject's stomach, comprising:
- an elongate member extending between a first end and a second end;
- a recess at the first end; and
- a tab at the second end, wherein the tab is configured to fit into the recess to couple the first end of the elongate member to the second end.
36. The space occupier of claim 35, wherein the elongate member is configured to have a ring shape when the tab is fit into the recess.
37. The space occupier of claim 35, wherein the elongate member is configured to have an oval shape when the tab is fit into the recess.
38. The space occupier of claim 35, wherein the elongate member is configured to have a triangular shape when the tab is fit into the recess.
39. The space occupier of claim 35, wherein the elongate member further including one or more hinges located between the first end and the second end.
40. The space occupier of claim 35, wherein a cross-sectional shape of the elongate member is circular.
Type: Application
Filed: Sep 15, 2014
Publication Date: Feb 5, 2015
Inventors: David COLE (San Mateo, CA), Samuel T. CREWS (Woodside, CA), Bretton SWOPE (Gaithersburg, MD), Andrew SMITH (San Francisco, CA), John LUNSFORD (San Carlos, CA), Daniel J. BALBIERZ (Redwood City, CA)
Application Number: 14/486,737
International Classification: A61F 5/00 (20060101);