VERTICALLY ORIENTED BAND FOR STOMACH

Abstract

An adjustable band or clamp or non-adjustable clamp is placed about the greater curvature of the stomach in a vertical orientation. The band or clamp completely compartmentalizes the stomach between a small vertical pouch and the fundus and body of the stomach. The fundus and body of the stomach are excluded from nutrients and are separated from a long narrow channel where the food travels. A small passage at the level of the antrum allows gastric juices to empty from the fundus and body of the stomach. The clamp may be applied during open surgery in laproscopic surgery or using a single port technique, or through any natural orifice in NOTES (Natural Orifice Transluminal Endoscopic surgery) or using a hybrid surgical technique.

Description

BACKGROUND

For patients whose obesity presents an immediate serious health risk, surgical procedures are available to promote weight loss. Two of the most common surgical procedures are gastric bypass and gastric band. During gastric bypass, the stomach is made smaller and food bypasses part of the small intestine. The smaller size stomach causes the patient to eat less and the bypass of the small intestines leads to less calories being absorbed by the body.

In the most common type of gastric bypass surgery, roux-en-y, a small pouch is formed at the top of the stomach using staples. The smaller stomach is connected to the middle portion of the small intestines bypassing the upper portion of the small intestines.

Devices have been developed to form the smaller stomach from the patient's original stomach. One such device is disclosed in U.S. Patent Publication No. 2002/0022851 to Kalloo et al. (Kalloo). Kalloo discloses a loop 80 reducing the volume of the gastric cavity. A feeder line is pulled to reduce the diameter of the loop and collapse the walls of the stomach to define a smaller pouch.

U.S. Patent Publication No. 2006/0157067 to Saadat et al. (Saadat) discloses the use of tissue anchors to form a gastric pouch acting as a restriction to the passage of fluids and food. U.S. Pat. No. 5,345,949 to Shlain (Shlain) discloses a clip placed across the fundus of the stomach to restrict the inlet chamber or proximal pouch. Likewise, U.S. Pat. No. 6,869,438 to Chao (Chao) discloses a gastric partitioning clip creating a stomach pouch from the stomach to restrict the amount of food intake.

It is an object of the invention to provide a device for separating the stomach into two compartments but allowing communication between the compartments.

It is another object of the invention to provide a device for forming a smaller stomach pouch, the size of the pouch being tailored to the patient's individual circumstances.

It is another object of the invention to provide a procedure creating a small stomach pouch to limit intake of food separate from the stomach but allowing gastric juices from the excluded stomach to flow into the pouch.

It is still another object of the invention to provide a system for creating a small pouch from the main stomach that is reversible.

It is still another object of the invention to alter the production of hormones, enzymes and chemicals that affect metabolism, energy levels, hunger, digestion, absorption of nutrients, weight loss, maintenance or gain that may be affected by exclusion of the gastric fundus and body of the stomach.

These and other objects of the invention will become apparent after reading the disclosure of the invention.

SUMMARY

An adjustable band or clamp or non-adjustable clamp is placed about the greater curvature of the stomach in a vertical orientation. The band or clamp completely compartmentalizes the stomach between a small vertical pouch and the fundus and body of the stomach. The fundus and body of the stomach are excluded from nutrients and are separated from a long narrow channel where the food travels. A small passage at the level of the antrum allows gastric juices to empty from the fundus and body of the stomach. The clamp may be applied during open surgery in laproscopic surgery or using a single port technique, or through any natural orifice in NOTES (Natural Orifice Transluminal Endoscopic surgery) or using a hybrid surgical technique.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a view of the band applied to a stomach;

FIG. 2 is a cross-sectional view of an inflatable clamp useable with the invention;

FIG. 3 is a view of a non-adjustable clamp used with the invention;

FIG. 4 is a detailed view of the strap attachment to the band;

FIG. 5 is a perspective view of a second embodiment of the band; and

FIG. 6 is a view of the band in FIG. 5 applied to a stomach.

DETAILED DESCRIPTION OF THE DRAWINGS

In FIG. 1, a stomach having the band 10 applied can be seen dividing the stomach into the pouch 12 and fundic and body area 14. Food traveling down the esophagus enters the pouch 12 and exits into the antrum. The band 10 applies pressure against the sides of the stomach to separate the stomach into the two compartments, but does not apply pressure to the stomach walls at the bottom part of the stomach. This creates a passage 16 allowing flow of gastric juices from the fundic and body area 14 into the antrum. Food will not enter the fundic and body of the stomach through this passage, however. At least one horizontal strap 18 may be used to secure the band in place. The straps may be adjustable and may apply pressure sufficient to impact the size and function of the pouch 12.

FIG. 2 shows an embodiment of the clamp having an inflatable chamber 20 and a connecting section 22. The clamp is placed about the stomach in a vertical orientation to separate the stomach into the two compartments and inflated. The clamp may have an asymmetrically placed chamber 20, that when inflated applies pressure on the stomach to seal the two compartments from one another except for the passage 16. The connecting section 22, being not inflated, does not apply pressure to the bottom portion of the stomach, allowing for the formation of the passage 16. In addition, the clamp may have an asymmetrically placed inflatable chamber that faces the lesser curvature side of the stomach, that when inflated or deflated only alters the lumen of the vertical compartment through which the nutrients pass and does not play a role in the creation of the two compartments.

FIG. 3 shows the rigid clamp embodiment having a U portion formed by two legs 32, 34 connected by a bight portion 36. When the clamp is placed on the stomach, the bight portion 36 fits over the top of the stomach with the legs 32, 34 applying enough pressure to collapse the walls of the stomach against one another to create the two compartments. The legs 32, 34 may or may not extend the full vertical extent of the stomach to allow for the creation of the passage 16. The legs are attached by a connector 38. When applied to the stomach, the legs serve to push the sides of the stomach together to form a complete seal but the connector allows for the formation of a passage between the two compartments. The clamp may be adjustable. The legs of the clamp may be made or adjusted to any length depending on the size of the stomach the legs can be made shorter or longer. The two legs may be connected by a magnetic coupler rather than a solid bight portion but may not be connected at all at the proximal end of the stomach. The apposition of the clamp legs about the stomach must be accomplished without sufficient force to cause ischemia of the gastric walls when the legs are closed.

Besides a clip, the vertical band may be formed as or with an inflatable balloon, as discussed with reference to FIG. 2. The orientation of the balloon is such that, upon inflation, the balloon bulges to the left to decrease the size of the compartment 12. The bottom portion may or may not be inflatable. The balloon may be attached to a tube exiting the body so that the balloon may be adjusted without the need for invasive surgery.

Straps 18 can be secured to the band in any number of conventional ways. One possible way in which to secure the straps to the band is depicted in FIG. 4. The band engages and is secured by clips 19 which extend outwardly from the band. This arrangement allows the straps to be tightened by being pulled through the clip and, if desired, the straps can be released for the removal of the band. These straps may also have an inflatable chamber and may be adjustable so as to also increase or decrease the lumen of the vertical compartment through which the nutrients pass.

An alternative construction of the band is seen in FIG. 5. In this embodiment, the band has a first section 42 having two parallel arms and a second section with two space members so that, when applied to a stomach, the passageway 16 is formed. The clamp itself may be curved to allow for better accommodation about the lesser curvature. The arms may be straight, curved or undulating. The surface may be smooth or serrated. The arms of the first section 42 are resiliently biased against one another and are spaced from one another in order that, when applied, the first section maintains the walls of the stomach together to separate the stomach into the first and second compartments. The pressure applied must be enough that the two compartments are formed but not so much that the walls of the stomach are damaged or compromise the blood supply. The section 44 is connected together by a section 46 acting as a hinge. This allows the arms of the first section 42 to be separated from one another in order that the band may be applied. Conversely, it is possible to have the two arms of the first section 42 hinged to one another and the two arcuate portions forming the second section 44 not connected to one another.

The band of FIG. 5 applied to stomach is seen in FIG. 6. Seen here as the first section 42 extending along the stomach to separate the stomach into two compartments, including pouch 12 and fundic and body area 14, whereas the second section has arcuate arms forming a passage 16. At least one of the arms of the first section is provided with apertures 48. The apertures, which may be large or small, allow part of the stomach wall to enter the aperture to help prevent movement of the band once it has been applied.

There are many ways in which the clamp can be applied including Natural orifice transluminal endoscopic surgery (NOTES) and the combination of NOTES and an assistant trochar placed in to the abdominal cavity. Combinations include any combination of the conventional, laproscopic, NOTES and one port techniques. The NOTES technique includes transgastric, transvaginal, transrectal, transcolonic and combinations of these. Another possibility is the one port technique wherein one port is used for the introduction of several instruments. The one port technique encompasses a one port abdominal (including umbilical), perineal, retroperitoneal approaches and combinations of these.

To facilitate application of the band, a bougie may be utilized in any suitable manner, such as placed transorally, transgastrically or transintestinally. The bougie, having a vacuum suction apparatus, collapses the stomach wall to align and help the placement the clamp. To help with alignment and placement of the clamp, the bougie may have magnets to mate with the magnets or metallic areas when the clamp is provided with such. Also, the band may be made of bioabsorbable material to negate the need to remove it.

While the invention has been described with reference to preferred embodiments, various modifications would be apparent to one of ordinary skill in the art. The invention encompasses such variations and modifications.

Claims

1. A gastric band configured to be positioned on a stomach to partition the stomach into a first portion and a second portion, and to provide a passage between the first and second portions of the stomach, the gastric band comprising: a partitioning section comprising a first end of the gastric band having a first arm with a bent end and a first elongate member extending a majority of a length of the gastric band and a second arm with a bent end and a second elongate member extending a majority of the length of the gastric band and at least a portion of the second elongate member spaced apart a first distance from at least a portion of the first elongate member;

2. The gastric band of claim 1, further comprising an inflatable portion comprising at least a portion of at least one of the partitioning section and the passage-forming section.

3. The gastric band of claim 2, wherein the inflatable portion comprises at least a portion of the partitioning section.

4. The gastric band of claim 1, wherein the curved member is one-piece from the joining of the bent end of the first arm to the joining of the bent end of the second arm.

5. The gastric band of claim 1, wherein the first and second arms of the partitioning section are in a parallel relation to one another.

6. The gastric band of claim 1, further comprising one or more opening in at least one of the first or second arms of the partitioning section.

7. The gastric band of claim 1, wherein the first elongate member and the second elongate member are a same length.

8. The gastric band of claim 1, wherein the gastric band further comprises at least one strap coupled to the first and second arms of the partitioning section.

9. The gastric band of claim 1, further comprising a biasing section configured to bias at least the first and second arms of the partitioning section to form the first and second portions of the stomach.

10. The gastric band of claim 9, wherein the biasing section is further configured to bias the first and second passage-forming portions to form the passage between the first and second portions of the stomach.

11. The gastric band of claim 9, wherein the biasing section is disposed towards the distal end of the gastric band.

12. The gastric band of claim 9, wherein the biasing section is disposed towards the proximal end of the gastric band.

13. The gastric band of claim 9, wherein the biasing section comprises at least one of a hinge, bight portion, and magnetic coupler.

14. A gastric band, comprising: a first section having first and second arms spaced from one another a first distance when positioned on a stomach and configured to close walls of the stomach together to form a first compartment of the stomach and a second compartment of the stomach, said first section extending a majority of a length of said gastric band;a second section disposed at an end of the gastric band opposite the first section, the second section having first and second portions, the first portion coupled with the first arm of the first section at a bent end of the first arm and the second portion coupled with the second arm of the first section at a bent end of the second arm, and the first and second portions at least partially spaced from one another a second distance at the bent ends greater than the first distance, the second section configured to form a passage between the first compartment of the stomach and the second compartment of the stomach, wherein the second section is curved along its entire length, positioning the first and second arms opposite the second section and cantilevering from the second section.

15. The gastric band of claim 14, wherein the passage formed by the second section provides a passage from the second compartment into an antrum of the stomach.

16. The gastric band of claim 14, further comprising a biasing section configured to bias at least the first and second arms of the first section to form the first and second compartments of the stomach.

17. The gastric band of claim 14, wherein the second section serves as a biasing section configured to bias at least the first and second arms of the first section.

18. The gastric band of claim 14, wherein the first and second arms are a same length.

19. A gastric band to partition a stomach into a first portion and a second portion, and to provide a passage between the first and second portions of the stomach, the gastric band comprising: a partitioning section comprising a distal end of the gastric band;a passage-forming section comprising a curved proximal end of the gastric band;wherein the partitioning section comprises: a first arm extending a portion of a length of the gastric band; anda second arm extending a portion of the length of the gastric band,wherein at least a portion of the second arm is spaced apart from at least a portion of the first arm by a first distance to partition the stomach into the first and second portions;wherein the passage-forming section comprises: a caudal-most curved portion extending toward the first arm and the second arm of the partitioning section,a first passage-forming portion, wherein the first passage-forming portion is at least partially curved,wherein the first passage-forming portion is adjacent to the first arm of the partitioning section, andwherein the first passage-forming portion extends substantially in a cranial direction towards the partitioning section;a second passage-forming portion, wherein the second passage-forming portion is at least partially curved,wherein the second passage-forming portion is adjacent to the second arm of the partitioning section,wherein the second passage-forming portion is adjacent to the first passage-forming portion, andwherein the second passage-forming portion extends substantially in the cranial direction towards the partitioning section;wherein the first passage-forming portion and the second passage forming portion are both united to the caudal-most curved portion;wherein the first passage-forming portion and the second passage-forming portion are at least partially spaced apart at a location by a second distance, andwherein no portion of the gastric band crosses a tangent line that is tangent to the caudal-most point on the caudal-most curved portion.

20. A gastric band configured to be positioned on a stomach to partition the stomach into a first portion and a second portion, and to provide a passage between the first and second portions of the stomach, the gastric band comprising: a partitioning section, the partitioning section, comprising a first end of the gastric band having a first arm with a bent end and a first elongate member extending a majority of a length of the gastric band and a second arm with a bent end and a second elongate member extending a majority of the length of the gastric band and spaced apart a first distance from the first elongate member; anda passage-forming section comprising a second end of the gastric band, and having a curved member joining together the bent ends of the first and second arm of the partitioning section and spacing the bent ends apart by a second distance greater than the first distance.