Medical segmented gastric band

<u>Background of the Invention</u>

Field of the Invention:

0001The present invention generally relates to a device for the treatment of morbid obesity. More particularly, the present invention relates to an easily insertable and removable gastric banding device that encircles and compresses a portion of the stomach thereby forming a stoma opening having a reduced diameter.

0002Over the years many methods of treating morbid obesity have been undertaken. One of the more promising methods employs the placement of a circumscribing band around a portion of the stomach whereby the stomach may be compressed thereby creating a stoma opening that is smaller than the normal interior diameter of the stomach thereby restricting food intake into the lower digestive portion of the stomach.

0003Such a band has been described in <patcit id="pcit0001" dnum="US4592339A"><text>US 4,592,339</text></patcit> which teaches a stoma-adjustable gastric band that includes a balloon section that is expandable and deflatable through a remote injection site. The balloon expandable section adjusts the size of the stoma opening both intraoperatively and post-operatively. <patcit id="pcit0002" dnum="US5152770A"><text>US 5,152,770</text></patcit> and <patcit id="pcit0003" dnum="US4399809A"><text>US 4,399,809</text></patcit> both disclose implantable devices that include a flexible, elongate plate, a plurality of communicating bulbs which are arranged on one side of the plate and have a variable volume, and a connection for supplying fluid to the bulbs. <patcit id="pcit0004" dnum="US4428365A"><text>US 4,428,365</text></patcit> discloses an anti-incontinent prosthesis comprising a support member formable into at least one generally spiral turn and a plurality of inflatable chambers disposed on the turn and connected to a pump means for applying fluid pressure to the chambers.

0004During the last several years, manufacturers of prior art bands have improved the designs of the balloons of these bands. One significant area of further improvement, however, is the development of a stoma-adjustable gastric band that includes a balloon section that conforms to the patient's anatomy even better than prior art bands. Such an improvement will further assure that the balloon fills uniformly, and that no portion of the balloon wall is highly stressed.

<u>Summary of the Invention</u>

0005The present invention overcomes the above noted and other deficiencies in the prior art by providing an implantable band which is configured such that it will not fold or crease and, as a result, that will reliably and substantially fill with a filling solution.

0006In particular, the present invention provides an implantable band as recited in the claims.

0007The above summary of the present invention is not intended to describe each embodiment or every implementation of the present invention. Advantages and attainments, together with a more complete understanding of the invention, will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.

<u>Brief Description of the Drawings</u>

0008The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention. <ul id="ul0001" list-style="none"><li><figref idref="f0001">Figure 1</figref> presents a pictorial view of a prior art gastric band and associated injection port;</li><li><figref idref="f0001">Figure 2</figref> is a cross-sectional view taken along line 2-2 in <figref idref="f0001">Figure 1</figref>;</li><li><figref idref="f0002">Figure 3</figref> is an isometric view of a removable gastric band embodying the present invention;</li><li><figref idref="f0003">Figure 4</figref> is a cross-sectional view taken along line 4-4 of <figref idref="f0002">Figure 3</figref>;</li><li><figref idref="f0004">Figure 5</figref> is a cross-sectional view taken along line 6-6 of <figref idref="f0003">Figure 4</figref>;</li><li><figref idref="f0004">Figure 6</figref> is a partial cross-sectional view similar to the cross-sectional view of <figref idref="f0004">Figure 5</figref> showing an alternate location for the fluid supply tube;</li><li><figref idref="f0004">Figure 7</figref> is a cross-sectional view of an alternate embodiment of the fluid supply tube having a one-way check valve in the inlet of the fluid supply tube; and</li><li><figref idref="f0005">Figure 8</figref> is a side view of a gastric band which docs not fall within the scope of the claims, including a partial cut away of the balloon portion showing a cross-sectional view of a reinforced section thereof.</li></ul>

<u>Detailed Description of the Invention</u>

0009Referring now to the Figures wherein like numerals indicate like elements throughout, <figref idref="f0001">Figures 1 and 2</figref> depict a stomach 10 having a fluidly inflatable, circumscribing band 12 as is known in the art. A fluid supply tube 14, fluidly communicating with band 12 is in fluid communication with a remotely located fluid injection port 15. Band 12 generally comprises an outer tension carrying belt having an inflatable balloon 18 affixed to the inside thereof. Balloon 18, when inflated, restricts the volume of stomach 10. To inflate balloon 18, a filling solution is injected into injection port 15 and the filling solution is conveyed to balloon 18 by way of supply tube 14.

0010The balloon 18 of the prior art band 12 has a tendency to fold and create creases when the band 12 is placed around the stomach 10. These creases may, in some instances, restrict flow of the filling solution to all areas of the balloon 18. This will affect the geometry of the balloon 18 and may also damage the balloon 18.

0011Referring now to <figref idref="f0002 f0003 f0004">Figures 3 through 5</figref>, the segmented gastric band 20 of the present invention is shown. Similar to prior art gastric bands, the segmented gastric band 20 has a tension carrying belt 22, a fluid supply tube 24 in fluid communication with a balloon 28 and a remotely located fluid injection port (not shown). The balloon 28 is preferably of a length of about 8cm to about 15 cm and more preferably about 11 cm; however, it should be appreciated that the balloon 28 may be of any length which would provide sufficient compression of the stomach. The balloon 28 is preferably comprised of material with a thickness between about 0.3cm and 0.7mm and more preferably about 0.5mm. Obviously, the thickness of the material is dependent on the balloon material and it should be appreciated that the thickness of the balloon may vary depending on the balloon composition. The tension carrying belt 22 is preferably longer than the balloon 28 and may be of any suitable length sufficient to accommodate the type of latching mechanism 50 employed. All components of segmented gastric band 20 are preferably comprised of medical grade silicone polymer but may be comprised of any flexible biocompatible material including implantable polyurethane.

0012As best shown in <figref idref="f0003">Figure 4</figref>, the segmented gastric band 20 also has one or more partitions 30 located inside balloon 28, which separate the interior volume of balloon 28 into one or more chambers 32. The partitions may be evenly spaced within the balloon (as shown), unevenly spaced within the balloon, perpendicular to the longest edge of the tension carrying belt 22 or at an angle relative to the longest edge of the tension carrying belt 22. Also, partitions 30 may be reinforced with alternate material configurations or features such as multiple layers including one or more materials, thicker material, textured material, or a more dense material so as to help the balloon 28 bend at these locations.

0013Fluid supply tube 24 has inlets 34 each of which correspond with and distribute the filling solution to each chamber 32. Inlets 34 may be of substantially identical diameters. Alternatively, inlets 34 may be ordered along the tube 24 from smallest diameter to largest diameter from end closest to fluid injection port such that the chamber closest to injection port fills with the filling solution at substantially the same rate as chambers further from the injection port. Also, in some applications, and as shown in <figref idref="f0004">Figure 7</figref>, it may be beneficial to place a one way check valve in inlet 34 such that the filling solution is allowed to enter the chamber but is not allowed to leave chamber via inlet 34. For example, <figref idref="f0004">Figure 7</figref> shows fluid supply tube with inlet 34 including a duck bill type check valve 36 whereby the filling solution is allowed to enter chamber but is not allowed to escape via inlet 34. While a duck bill type check valve is shown in the illustrative embodiment, any type of one way check valve which would allow the filling solution to enter chamber and prevent the filling solution from escaping chamber via inlet would suffice. Alternatively, since, on occasion, the filling solution may need to be removed from the balloon, it may be advantageous to use a two-way check valve where the two-way check valve only allows the filling solution to leave the chambers when the pressure in the fluid supply tube becomes less than the pressure of the filling solution in the chambers. Preferably, this pressure differential would be created by using a syringe to withdraw fluid through the injection port.

0014The fluid supply tube 24 may be attached atop the surface of belt portion 22 inside balloon 28, or fluid supply tube 24 may be imbedded in belt portion 22 inside balloon 28, as shown in <figref idref="f0004">Figure 5</figref>. Fluid supply tube 24 may also be attached atop the surface of belt portion 22 outside of balloon 28, as shown in <figref idref="f0004">Figure 6</figref>, or fluid supply tube 24 may be imbedded in belt portion 22 outside of balloon 28.

0015Alternatively, each of the partitions may have a small opening which would allow the filling solution to flow from one chamber to the next via the opening. In this case, the fluid supply tube would only need an inlet to one chamber, preferably one of the chambers at either end of the balloon; although, multiple inlets could still be used.

0016The segmented gastric band 20 also includes a latching mechanism 50 so that the segmented gastric band may be releasably secured in an encircled position around a portion of the stomach. Latching mechanism 50 may be of any suitable configuration to hold segmented gastric band 50 in an encircled position such as, but not limited to, a guide tab and buckle configuration, a slide and channel configuration, a hook and eye configuration or, as shown in <figref idref="f0002">Figures 3</figref>, <figref idref="f0003">4</figref> and <figref idref="f0005">8</figref>, tabs which are sutured together.

0017Installation of the segmented gastric band 20 is accomplished by first inserting the band into the patient's abdomen through a trocar. Next, a tunnel is created behind the stomach near the esophagogastric junction using a blunt dissection device. The segmented gastric band 20 is then grasped by an instrument, such as a grasper or blunt dissection device, and wrapped around the patient's stomach through the created tunnel. The latching mechanism 50 is then engaged. The injection port is then attached to the gastric band and the injection port is secured subcutaneously in the abdomen or other suitable location. A suitable filling solution, such as saline, is then injected into injection port whereby the solution is conveyed to chambers 32 of balloon 28 by way of inlets 34 in fluid supply tube 24. If necessary either at the time the gastric band is installed or at some time in the future, a predetermined quantity of the filling solution may be withdrawn for the balloon 28 by inserting a syringe into the injection port and withdrawing the solution.

0018A gastric band which does not fall within the scope of the present invention is shown in <figref idref="f0005">Figure 8</figref>. In this embodiment the gastric band 100 similarly includes a tension carrying belt 105, a fluid supply tube 110 in fluid communication with a balloon 115 and a remotely located fluid injection port (not shown). In this embodiment, the balloon 115 has one or more reinforced sections 120. Preferably, the reinforced sections 120 are spaced evenly along the interior length of the balloon 115. Reinforced sections 120 may be comprised of a thicker material, textured material, a harder or softer material, or other similar configurations that would help balloon 115 bend between adjacent reinforced sections 120 when placed in an encircling position around stomach. In the preferred embodiment, shown in <figref idref="f0005">Figure 8</figref>, each end of each reinforced section 120 is substantially the same thickness as the balloon 115; however, each reinforced section is thickest,' and thicker than the balloon, at its midpoint. At the midpoint, each reinforced section 120 is preferably between about two and eight times the thickness of the balloon 115, and more preferably about four times the thickness of the balloon 115. Reinforced sections 120 may or may not be used to cause balloon 115 to segment into chambers when encircled around stomach.

0019While the present invention has been illustrated by the description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.

0020Further, it will become readily apparent to those skilled in the art that the above invention has equally applicability to other types of implantable bands. For example, bands are used for the treatment of fecal incontinence. One such band is described in <patcit id="pcit0005" dnum="US6461292B"><text>U.S. Patent 6,461,292</text></patcit>. Bands can also be used to treat urinary incontinence. One such band is described in <patcit id="pcit0006" dnum="US20030105385A" dnum-type="L"><text>U.S. Patent Application 2003/0105385</text></patcit>. Bands can also be used to treat heartburn and/or acid reflux. One such band is described in <patcit id="pcit0007" dnum="US6470892B"><text>U.S. Patent 6,470,892</text></patcit>. Bands can also be used to treat impotence. One such band is described in <patcit id="pcit0008" dnum="US20030114729A" dnum-type="L"><text>U.S. Patent Application 2003/0114729</text></patcit>.