MX2007008755A - Method of implating a medical device using a suture tab extender. - Google Patents

Abstract

A method of implanting a surgically implantable band, the method comprising the steps of providing a band with an elongated body member having a first end with a first latching member positioned thereon, and a second end with a second latching member positioned thereon. The first latching member has a suture tab extender extending therefrom. The suture tab extender has a suture attached thereto. The second end has a gripping section positioned thereon shaped and dimensioned to facilitate gripping as the gastric band extender is passed through the second latching member. The method further includes the step of positioning the band around an anatomical structure and latching the band around the structure by placing the suture tab extender through the second latching member and thereafter coupling the first and second latching members. The method further involves the step of removing the suture tab extender from the band.

Description

A METHOD FOR IMPLANTING A MEDICAL DEVICE USING A SUTURE OUTGOING EXTENSION CROSS REFERENCE WITH RELATED REQUESTS This application is a continuation in part of the U.S. Patent Application. Serial No. 1 1 / 182,072, entitled "LATCHING DEVICE FOR GASTRIC BAND", filed July 15, 2005, which is currently pending, and claims the benefit of the US Provisional Application, Serial No. 60 / 699,369 , titled "GASTRIC BAND", filed July 15, 2005. This application is a continuation in part of the US Patent Application. Serial No. 1 1 / 364,362 entitled "GASTRIC BAND" filed March 1, 2006, which is a continuation in part of Patent Application Serial No. 1 / 364,361 entitled "GASTRIC BAND SUTURE TAB EXTENDER", filed on March 1, 2006 which is a continuation in part of the US Patent Application Serial No. 1 1 / 364,363 entitled "Precurved Gastric Band", presented on March 1, 2006 FIELD OF THE INVENTION The present invention relates to a gastric band and related accessories.

BACKGROUND OF THE INVENTION Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly ubiquitous in the United States, as well as in other countries, and the trend seems to be heading in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, infarction, congestive heart failure, multiple orthopedic problems, and pulmonary insufficiency with a markedly decreased life expectancy. With this in mind, and as those skilled in the art will surely appreciate, the economic and physical costs associated with morbid obesity are substantial. In fact, it is estimated that the cost in relation to obesity exceeds one hundred billion dollars, only in the United States. A variety of surgical procedures have been developed for the treatment of obesity. The most commonly performed procedure is gastric bypass surgery of gastric bypass surgery (RYGB). This procedure is highly complex and is commonly used to treat people who exhibit morbid obesity. Other forms of bariatric surgery include Fobi bag, bilio-pancreatic diversion and gastroplasty or "stomach stapling". Additionally, devices that can be implanted are known to limit the passage of food through the stomach and affect satiety.

In view of the highly invasive nature of many of these procedures, efforts have been made to develop less traumatic and less invasive procedures. Gastric bands are one of these methods. The use of gastric banding is a type of gastric reduction surgery that aims to limit the intake of food by reducing the size of the stomach. In contrast to RYGB and other stomach reduction procedures, the use of gastric banding does not require altering the anatomy of the digestive tract in the duodenum or jejunum. Since the early 1980s, gastric banding had provided an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for morbid obesity. Various alternative procedures have been performed under the heading of use of gastric bands. Some band-use techniques employ a gastric ring, others use a band, some use stomach staples and still other procedures use a combination of rings, bands and staples. Among the most frequently performed procedures are gastroplasty with vertical bands (VBG), silastic ring gastroplasty (SRG) and the use of adjustable silastic gastric bands (AGB). In general, the gastric band is wrapped around an upper portion of the patient's stomach, forming a stoma that is smaller than the normal interior diameter of the stomach. This restricts the passage of food from a higher portion to a lower digestive portion of the stomach. When the stoma is of an adequate size, the food maintained in the upper portion of the stomach provide a feeling of fullness that discourages the urge to be eating. More particularly, and in practice, the gastric band is inserted behind the stomach and the ends of the gastric band are coupled to securely close the device around the stomach. However, it is often difficult to maneuver the ends of the gastric band for proper secure closure. Therefore, mechanisms are needed to improve the application of gastric bands around the stomach. The present invention provides such a mechanism in the form of an extension device for use in conjunction with currently available gastric bands, which can be removed after the gastric band is installed in the proper manner. The present invention also provides an improved gastric band construction that facilitates application around a stomach and improved functionality once it is applied.

BRIEF DESCRIPTION OF THE INVENTION In accordance with the present invention, there is provided a method for implanting a surgically implantable web, the method comprising the steps of providing a web with an elongate body element having a first end with a secure first closure element positioned thereon, and a second end with a second element of Secure closure placed in it. The first secure closure element has an extension of suture projection extending therefrom. The extension of suture projection has a fixed suture thereto. The second end has a fastening section placed therein formed and sized to facilitate fastening as the extension of suture projection is passed through the second secure closure element. The method further includes the step of placing the band around an anatomical structure and securely closing the band around the structure by placing the extension suture projection through the second secure closure element and thereafter taping the first and second secure closure elements. The method further involves the step of removing the extension of suture from the band.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of a suture projection extension secured to a gastric band. Figure 2 is a perspective view of the extension of suture projection that can be removed. Figure 3 is a perspective view of the gastric band secured around the stomach. Figures 4, 5 and 5a are various perspective views of a gastric band according to the present invention.

Figures 6, 7 and 8 show the various steps in the junction of the gastric band using the extension of present suture. Figure 9 is a perspective view of a suture projection extension according to a further embodiment. Figure 10 is a perspective view of a suture projection extension according to an alternative embodiment. Figures 1 1, 12, 13 and 14, respectively, show a perspective view of a balloon, a perspective view of a belt, a cross-sectional view of a gastric band and a perspective view of the gastric band in accordance with another embodiment of the present invention. Figures 15 and 16, respectively, show a perspective view of a gastric band and a cross-sectional view of the gastric band according to an alternative embodiment of the present invention. Figure 17 is a cross-sectional view of a gastric band according to another embodiment of the present invention. Figures 18, 9, 20 and 21, respectively, show a perspective view of a belt, a perspective view of a balloon, a cross-sectional view of a gastric band and a perspective view of the gastric band in accordance with still another embodiment of the present invention. Figures 22 to 31 show various embodiments of a balloon-like gastric band with different locations of the delivery tube.

Figures 32 to 43 show various embodiments of suture overhang extensions with different attachment structures.

DESCRIPTION OF THE PREFERRED MODALITIES The detailed embodiments of the present invention are described in this section. However, it should be understood that the embodiments described are only an example of the present invention, which can be represented in various ways. Therefore, the details described herein will not be construed as limiting, but only as the basis for the claims and teachings to one skilled in the art of how to make and / or use the present invention. Referring to Figures 1 and 2, a removable suture projection extension 100 for use in conjunction with a gastric band 10 is described. The extension 100 is designed to improve the use of gastric bands 10 and helps to utilize the secure closure mechanism of the gastric band 20. In particular, the extension 100 provides a mechanism to assist the passage of the first secure closure element 22 of the secure closure mechanism 20 through the second secure closure element 26 of the closure mechanism secure 20, either by screwing or pushing the first secure closure element 22 through the second secure closure element 26 or by inserting a fastener through the second secure closure element 26, holding the tip of the extension 1 12, Y pushing it back through the second secure closure element 26 to close it. To attach the extension 100 to the gastric band 10, the lashing strap strip 108 of the extension 100 is threaded through an opening 38 in the tip of the secure locking mechanism 20. This strap of the lanyard 108 is then glued the rest of the extension 100 within a coupling notch 1 10. According to an alternative embodiment, and referring to Figure 10, the extension 300 can be provided with a bag 31 1 placed at the end of the coupling notch 310, in which the tie strap strip 308 can be attached. The extension 100 is easily removed or cut from the gastric band 10 once the gastric band 10 is properly placed and secured around the stomach, minimizing in this way the risk of edges of the "sharp" bands if the band were cut by itself. To remove the extension 100, the tie strap strip 108 is cut between the opening 38 in the tip 36 of the gastric band 20 and the coupling notch 1 10 containing the attached tie strap strip 108. This allows the extension 100 is removed in one piece, leaving the gastric band 100 completely intact without "sharp" band edges at all. The extension 100 may additionally be provided with a recess 109 (see Figure 2) on the extension 100 for inserting scissors between the tip 36 of the gastric band 20 and the tie strap strip 108 to facilitate the best cutting of the extension 100. The extension 100 is removed in its entirety from the body after it has been cut from the gastric band 10. The extension 100 also allows for the creation of a temporary closure that allows adjustment around the stomach prior to the final closure of the secure closure mechanism 20. Although a preferred embodiment has the cut extension for removal of a single part of the body from the gastric band , an alternative embodiment could involve leaving the extension in place in the gastric band and using the provisional closure (i.e., the retaining element 1 14, 214 which is described below in greater detail) as an additional permanent closure position for Use with different stomach sizes. In practice, and with reference to Figure 3, the extension of present suture projection 00 is secured to the first end 14 of gastric band 10 adjacent to the first secure closure element 22 to form a single band / extension functional unit. Hereafter, the gastric band 10, with the extension 100 secured to it, is inserted behind the stomach. The first secure closing element 22 of the secure locking mechanism 20, as well as the extension 100, are then pushed or pulled through the second secure closing element 26 of the secure locking mechanism 20. The addition of the protrusion extension of present suture 100 provides a longer region for holding and manipulating the first secure closure element 22, as it is made passing around the stomach and through the second secure closure element 26. According to a preferred embodiment, and as will be discussed below in greater detail, the extension of suture projection 100 is an elongated elastomeric component which is attached to the first end of the suture. of the gastric band 10 to assist in matching and closing the first secure closure element 22 with the second secure closure element 26. The extension 100 is preferably attached to a projection 24 on the first end 14 of the gastric band 10 for keep extension 100 in place. The extension 100 can be removed with a cut through the tie strap strip 108 on the extension 100 and incorporates an open recess or recess, eg, a bowl-like feature 106, for coupling the first end 14 of gastric band 10 and extension 100 closed together as they move as an integral unit. More specifically, and as will be appreciated in greater detail based on the following description, the projection 24 of the gastric band 10 is placed within the recess 106 of the extension 100 and is securely and firmly attached thereto, using a strip of mooring strap 108. In addition, and in accordance with the preferred embodiment, the second end of the extension may include a suture loop 105 for compatibility with a device similar to Goldfinger 150. As will surely be appreciated by those skilled in the art, the similar device a Goldfinger 150 helps to pass the gastric band 20 through the retro-gastric tunnel. Alternatively, for those surgeons who use other devices to pass the gastric band 20 through the retro-gastric tunnel, the holding section, or flat tip 1 12, of the extension 100 is also compatible with these bandpass devices. In general, a Goldfinger instrument is an articulation bandpass device used to perform a sharp dissection behind the stomach before passing the gastric band. This is articulated and fed behind the stomach. At the tip of the Goldfinger instrument, there is a notch that can trap a suture loop. Once the suture is caught, the Goldfinger instrument is pulled out of the retro-gastric tunnel and the suture loop pulls the band with it. Alternatively, to facilitate use with these other bandpass devices, a length of the extension may be round (similar to a pipe) behind the flat tip, such that the extension is easier to orient. The 100 removable extension is designed to be used with a variety of gastric bands. By way of example, the extension is designed to be used with the gastric banding as described in the U.S. Patent Application. No. 1 / 182,072, filed July 15, 2005, entitled "LATCHING DEVICE FOR GASTRIC BAND", which is incorporated herein by reference. In general, and referring to Figures 4, 5 and 5a, the gastric band 10 includes a band body 12 having a first end 14 and a second opposite end 16. The band body 12 and the secure closing mechanism 20 are preferably made from silicone. Although, and as will be discussed below in greater detail, the gastric band is a balloon-like gastric band, the present secure closure mechanism can be used in conjunction with a variety of band structures without departing from the spirit of the present invention. As mentioned briefly above, the gastric band 10 is formed and sized to circumscribe the stomach in a predetermined location, reducing the size of the stomach. The gastric band 10 employs a flexible secure closure mechanism 20 with the ability to close and open without destroying the secure closure mechanism 20 or the significant reduction in holding capacities after reclosing. The first and second extremes 14, 16, respectively, act as both male and female elements, depending on the direction of movement and the attempt to close or open the secure closure mechanism 20 of the present gastric band 10. The first end 14, includes a frame element, or first secure closure element 22, generally composed of a frame formed as hollow crescent with a projection 24 for clamping and pulling through the ring element, or second secure closing element 26, composed of a semicircular opening 30 on the second end 16. The crescent frame of the first secure closure element 22 collapses as it is pulled or pushed through the security element. ring 26 by a fastener. The ring element 26 includes a tongue 28, such that the frame member 22 slides through the semicircular opening 30 and below the tongue 28 during secure closure. Once the frame element 22 passes the tongue 28, the papers change. The first end 14 functions as a female component when the frame member 22 elastically returns to its original shape and is allowed to slide back over the second end 16 (now a male component) and over the tongue 28. Therefore , the frame element 22, functions as both a male component and a female component during the operation of the secure closing mechanism 20 and the ring element 26 functions as both a male and female component during the operation of the secure closing mechanism 20, that is, the frame member 22 functions as a male component during insertion through the ring element 26 and as a female component thereafter when the tongue 28 is seated therein. It is achieved by opening it using fasteners to pull the first end 14 forward, away from the second end 16, by removing the tongue of the frame member 22. The M-shape of the frame member 22 allows it to collapse and move under the tongue 28 and through the ring element 26. More particularly, the frame member 22 at the first end 14 of the gastric band 10, is generally a half-moon-shaped frame with an open, wide end 32 that is tapered towards a narrow end 34 adjacent to the tip 36 of the first end 14. The frame member 22 is substantially hollow and is formed from a material, e.g., silicone, which permits compression and expansion thereof. Referring to Figure 5a, the frame member 22 is formed with an outer surface substantially formed as M 23a, when viewed from the wide end 32 thereof. That is, the outer surface of the frame member 22 has a profile substantially formed as M, while the interior surface of the frame member 22 adjacent the wide end 32 has a substantially smooth semicircular profile. The unique M-shaped profile has been found to improve flexibility and control as the frame member 22 is passed through the ring element 26. Additionally, the inclusion of the M-shape at the wide end 32 of the frame member 22 allows for easy opening, since it will be easier and more controllable by the one that compresses frame element 22. Frame member 22 slides through ring element 26 as discussed above. Hereinafter, the center 54 of the wide end M-shaped 32 returns to its original shape and fits over the tongue 28. When the gastric band 10 is not securely closed, the frame member 22 is pulled forward away from the ring element 26 and the M-shaped frame element 22 allows it to move under the tongue 28 and through the ring element 26. The shape The preformed shape of the frame member 22 not only acts as a guiding feature for the tongue 28 to slide over the frame member 22 during the secure non-closed position, but also allows the frame member 22 to slide more easily from the frame element 22. return through the opening 30 of the ring element 26. An opening 38 is formed within the projection 24, adjacent the tip 36 of the first end 14 and the narrow end 34 of the frame element 22. The opening 38 is formed and sized to receive a suture or fastener commonly used in the installation of the gastric banding. Additionally, the projection 24 is formed with the projections 49 which help to hold the projection 24 during closure and opening. Also, at the first end 14, although on the opposite side of the frame member 22 from the opening 38 and adjacent the wide end 32 of the frame member 22 is a rearwardly extending fastener 51. The fastening element 51 is formed and sized to allow dual direction access to close and open the secure locking mechanism 20. More particularly, the fastening element 51 includes the projections 56 along the upper and lower surfaces 53, 55 thereof. These projections facilitate the attachment of the same along a first directional orientation. The fastening element 51 is further formed with an "hourglass" shape having a reinforced central section 57. The reinforced central section 57 allows for fastening in a second steering orientation.

The secure closure of the frame element 22 with the ring element 26 is achieved by ensuring that after the frame member 22 is compressed while passing through the ring element 26, the frame member 22 returns to its original shape and the wide end 32 of the frame element 22 is supported with the first edge 46 of the ring element 26. The secure closure is further improved by providing the ring element 26 with a tongue 28 extending from the ring element 26 away from the tip 50 of the second end 16. The tongue 28 is formed and sized to settle within the wide end 32 of frame member 22 after the frame member 22 has passed through the ring element 26 and the gastric band 10 is stretched as the first and second ends 14, 16 are located towards each other with the frame member 22 deforming to move back through the ring element 26 towards a position not locked safe. With this in mind, the tongue 28 can be oriented downwardly such that it slides with the frame member 22 in a convenient and reliable manner. The tongue 28 may be of a different color to provide an indication of whether the secure locking mechanism 20 is properly closed. The clamping of the second end 16 is further improved by providing a forwardly facing clamping element 58, ie, a clamping element facing the tip 50 of the second end 16.

The forwardly facing fastener 58 is formed and sized to allow access in a dual direction to close and open the secure locking mechanism 20. More particularly, the fastening element 58 includes projections 59 along the upper and lower surfaces of the fastener. background 62, 64, of the same. These projections 59 facilitate fastening thereof along a first directional orientation. The fastening element 58 is further formed with an "hourglass" shape having a reinforced center section 60. The reinforced central section 60 allows for fastening in a second steering orientation. The clamping element 58 is formed and sized to receive and center the frame member 22 as it passes through the ring element 26. The clamping member 58 also helps to compress the frame member 22 as it passes to the frame member 22. Through the ring element 26. According to a preferred embodiment of the present invention, the gastric band is a balloon-like gastric band as shown in Figures 1 to 16. With this in mind, the gastric band 410, is generally composed of a reinforcing belt 412 to which an elongated balloon 414 is secured. The belt 412 includes a first end 416 and a second end 418 to which the first and second secure closure elements 422, 426 are respectively secured. The belt 412, additionally it includes an interior surface 428 and an exterior surface 430. The exterior surface 430 is substantially smooth and forms a portion substantial of the outer surface 431 of the gastric band 410 when secured around the patient's stomach. The inner surface 428 of the belt 412 is formed and sized for attachment to the outer surface 438 of the balloon 414. With respect to the balloon 414, it also includes a first end 432, a second end 434, an interior surface 436 and an exterior surface 438. The interior surface 436 is substantially smooth and is formed and dimensioned to engage the stomach of the patient when the gastric band 410 is secured thereto. The outer surface 438 of the balloon 414 is formed and sized to engage the inner surface 428 of the belt 412. Referring to Figures 1 to 16, the belt 412 and the balloon 414 can be respectively coupled by either molding or molding. separately with subsequent adhesive bond (similar numbers are used for the different modalities). Regardless of the manufacturing technique, the outer surface 438 of the balloon 414 is formed with a slot 439 formed and sized to receive the belt 412. Referring to Figures 15 and 16, where the belt 412 is adhesively attached to the balloon 414, the slot 439 is formed with a glue hole 439a formed and sized to receive a small amount of adhesive without adversely affecting the placement of the belt 4 2 within the slot 439.

According to an alternative embodiment, and referring to Figure 17, this contemplates that the balloon 4 4 'and the belt 412' that can be coupled by adding a layer of uncured material 412 '(similar in composition to the components) between the balloon 414 'and the belt 412', and heal them together. Additionally, a reinforcing structure layer 415 '(mesh, different material, or silicone material with a higher durometer) is contained within the uncured material layer 413'. This reinforcing structure 415 'is encapsulated within the device from the assembly and cure, and provides an additional structure or mechanical properties different to the product. Additionally, and referring to Figures 18 to 21, still an additional gastric band construction 410"is contemplated in accordance with the present invention, In accordance with this embodiment, the belt 412" is secured along an inner surface 417"of the balloon 414", with the outer surface 428"of the balloon 414" forming the exposed outer surface 430"of the gastric band 410". As with the embodiments described above, the inner surface 417"is formed with a groove 439" formed and sized to receive the belt 412. "The secure positioning of the belt 412" within the groove 439"is achieved by providing a glue hole 439"a, along the slot 439" and a retaining rivet 439b "along the length of the slot 439." The glue hole 439a "is substantially similar to that used in accordance with the embodiment described with reference to Figures 16 and 1 7.

As the retaining rivet 439b ", the slot 439" is constructed with inwardly directed projections, opposed 439c "formed and sized to engage the belt 412", and temporarily retain the belt 412"within the slot 430", while that the glue used to attach the belt 412"and the balloon 414" is cured during the gluing operation. More particularly, the inwardly directed projections 439c "are formed and sized to wrap around the belt 412" in a form that holds it within the slot 439c. "In accordance with a preferred embodiment, the 412" belt is placed within the balloon. 414"in the following manner: Belt 412" is threaded through one of the balloon openings 433", 435" at either end 432", 434" of the balloon 414. "The retaining rivet 439b, specifically the 439c projections "over slot 439 of balloon 414" temporarily hold the components together while being attached by means of a long needle inserted between balloon 414"and belt 412." Alternatively, it is contemplated that the balloon may be molded on the belt In accordance with the preferred embodiments, and as briefly stated above, the balloon and the belt can be secured together, by either adhesive bond, co-molding, over molding or mechanical connection (for example, coupling sleeves), which secures the balloon and the belt in a way that results in the coupling of these different gastric band components. When the belt and the balloon are overmoulded, a plug 415 could be used to close the outlet of the core in the balloon for overmolding and the plug could be integral with the gastric band structure (see Figure 14). As will surely be appreciated by those skilled in the art, co-molding is essentially the same procedure as over-molding, although materials of different properties are injected into the mold at the same time. As with over-molding, co-molding requires a plug to close the core outlet in the balloon. Regardless of how the product is molded or assembled, the belt and balloon components may consist of the same or different materials (hardness tester, filling materials such as BaS04, Ti02, dyes, etc.). Additionally, features within the same component (ie, closure features or end covers) may vary in composition. These characteristics can be adhered to the rest of the product with adhesives, mechanical fastening (ie pressure adjustments), welding, co-molding or over molding. Although the belt is described as being secured to an outer surface of the balloon, it is contemplated that the belt may be internal or external to the surface of the balloon or integrated within the balloon, without departing from the spirit of the present invention. For assembly methods that allow the adhesion of different components (ie bond by adhesives, mechanical connection, over molding), the unique belt and balloon components can be combined to provide variable configurations. For example, belts with different locking mechanisms can be exchanged with balloons of different lengths to provide the possibility of multiple product combinations. The balloon 414 is constructed to improve contact with the stomach wall when applied to it. With this in mind, and as will be discussed below in greater detail, the balloon 414 is constructed as a high volume, low pressure, previously curved balloon. The balloon 414 is constructed to maintain a soft and flexible surface (low pressure) when applied to the stomach tissue. Balloon 414 is also constructed to provide 360 degree coverage to prevent perforations or discontinuities of tissue in the shape of the stomach, and, therefore, may employ the balloon construction described in the U.S. Patent Application. Commonly owned, Serial No. 1 1 / 182,070, entitled "GASTRIC BAND WITH MATING END PROFILES", filed on 07/15/2005, which is incorporated herein by reference. The balloon 414 is additionally constructed in such a way that it reaches its fully inflated and circular configuration with minimal "bends". Additionally, balloon 414 is constructed to exhibit no folds or bends (single axis, no double axes) when all fluid is evacuated therefrom.

With the foregoing in mind, the balloon 414 employed according to a preferred embodiment of the present application, is constructed of an elastomeric material. Due to the design of this balloon, it does not inflate or expand in a manner that causes tension in the balloon when it is full during the adjustment of the gastric band. Instead, balloon 414 is adapted to receive a large volume of fluid under a relatively low pressure. In this regard, balloon 414 receives fluid during application, although it does not inflate or expand in a traditional manner creating tension along the walls of balloon 414. In other words, when balloon 414 is filled to the recommended volume for achieve maximum stomach restriction, there is no expansion of balloon material. Instead, balloon 414 fills up to a certain percentage its total theoretical volume (ie, maximum fill volume). Because the balloon 414 is not filled even near its maximum filling volume, it remains at low pressure, allowing the balloon 414 to conform to the stomach instead of the stomach to a rigid balloon. According to a preferred embodiment of the present invention, balloon 414 is designed with a maximum capacity of between about 10 cc and about 18 cc, and preferably 18 cc, although it will be completely filled to function in accordance with the present invention to achieve smaller stoma size with from about 9 cc to about 12 cc, and preferably 9 cc. By providing a balloon 414, which is not in its capacity when properly filled to function, the softness and conformity of the Balloon is improved. Although the specific volumes are described according to a preferred embodiment of the present invention, those skilled in the art will appreciate that the filling volumes can be varied without departing from the spirit of the present invention. Additionally, balloon 414 is manufactured in such a way that it exhibits a curved configuration when it is not under stress. Although a variety of curvatures are possible within the spirit of the present invention, the curved configuration is designed to provide a radius of curvature of about 1.27 cm to about 3.81 cm. Additionally, it is contemplated that the balloon may have a varying radius as it extends around its length. In general, the curvature of the balloon is designed to approximate the curvature required to locate the first and second secure closure elements 422, 426 in approach or contact when the balloon 414 is not deflected and is left to assume the relaxed configuration. By manufacturing the balloon 414 with an inherent curvature, the folds created from the application of fluid are substantially decreased. With this in mind, the belt is previously curved in a similar manner to reduce bending and to approximate the first and second secure closure elements 422, 426. As will be appreciated by those skilled in the art, belt 412 is constructed to have approximately a curvature equal to that of balloon 414, such that undesirable tension is reduced between belt 412 and balloon 414. Additionally, and in Considering the previously curved nature of the belt 412, the belt 412 easily conforms to the outer surface of the stomach and the belt 412. The contact with the stomach tissue is further improved by providing the balloon 414 with a concave cross section along the the interior surface of the balloons 436. This cross-sectional configuration helps facilitate the evacuation and straightening of the same. Implementing the structural criteria indicated above, the balloon 414 deflates without folds or protuberances forming on the interior surface 436 of the balloon 414, a low pressure balloon and previously curved 414 is achieved and the balloon 414 changes shape when it is filled ( filling bag closure). As it changes shape, the balloon 414 is constructed in such a way that it has a relatively wider and flat cross section before being filled along a cross section that is transverse to the longitudinal axis of the balloon 414. When the balloon 414 is subsequently filled during application to the stomach of a patient, the cross-sectional shape of the balloon 414 changes to that of a rounder balloon exhibiting a narrower cross-section with a greater distance between the inner and outer surfaces 436, 430 Of the same. With this in mind, it is further contemplated that the cross section of the balloon may be molded into a rounded rectangular shape, wherein the "corners" provide support, distribute the shape change and reduce folds. Providing a balloon, which is wide and flat before filling, reduces the distance between the inner surface of the balloon and the belt. This reduces the last profile of the gastric band and improves the ability of the gastric band to be easily delivered for deployment. As will be appreciated by those skilled in the art, a supply tube is used to connect the inner cavity of the gastric band balloon to a source of pressurized fluid. The use of the tube with a remote fluid source allows controlled inflation and deflation of the balloon in a predetermined manner. The exact position of the tube is important in the sense that the surgeon does not want the tubing to be a visual obstruction during closure and / or other manipulation of the gastric band. Additionally, once the gastric banding is completed, the tube should not irritate the surrounding tissue (for example, sticking directly to the liver or spleen). Surgeons also do not want to push the tube through a retro-gastric tunnel, because they can not easily see if the tissue is being damaged. The tube should also have the ability to act as a secure attachment location for gastric band manipulation, the tube should not deform at the junction of the gastric band and prevent fluid flow, and the location of the tube should facilitate the step of the band through a small trocar. With this in mind, and in accordance with various preferred embodiments of the present invention, different tube placements when referring to Figures 22 to 31. As each of these modalities shows, the tube is placed at one end of the gastric band. It has been discovered that with the placement of the tube at one end of the gastric band, the forces on the tube, the gastric band and ultimately the stomach are reduced. This placement also improves the ability of the tube and gastric band to flex for insertion and expansion to its original shape during deployment. Referring to Figure 22, tube 540 is oriented to exit gastric band 510 from the outer surface thereof. According to a preferred embodiment of this design, the tube 540 is positioned in such a manner that it leaves the outer surface 531 of the gastric band 510 just below a longitudinally extending median line 542 of the gastric band 510. The tube 540 it is positioned in such a way that it is free from obstructions of the secure closure mechanism 520 and is angled obliquely relative to the longitudinal axis (according to a preferred embodiment at an angle of approximately 34 °) of the gastric band 510 for Allow easy insertion through a trocar. Referring to Figure 23, the tube 640 is molded on the second end 634 of the balloon 614. In particular, the tube 640 is molded at the end of the balloon 614, and is integrated into the shape of the balloon. As with the previous embodiment, the tube 640 is oriented obliquely relative to the longitudinal axis of the gastric band 610 and is similarly positioned below a longitudinal line extending longitudinally. of the gastric band 610. The compensation allows the ends of the balloon 632, 634 to be without interference from the tube 640. A further embodiment is shown with reference to Figure 24, wherein the tube 740 leaves the balloon 714 off the lateral side 744, that is, a bottom surface of balloon 714 as it is placed within the patient. The entry point of the tube 740 is substantially aligned with the second secure closure element 726 in relation to the longitudinal axis of the gastric band 710. As with the previous embodiments, the tube 740 is oriented obliquely relative to the longitudinal axis of the gastric band 710. As shown in Figures 25 and 26, the tube connection 840 is integrated in one of the sides of the secure closure elements. In accordance with the described embodiment, it is integrated in the second secure closure element 826, although it is contemplated that it could be integrated with the first secure closure element 822 without departing from the spirit of the present invention. The tube 840 enters the second secure closure element 826 and extends therethrough into the body of the balloon 814. Once the tube 840 is inside the body of the balloon 814, it angles toward the centerline (or line mean 842) of balloon 814 for uniform saline flushing. The tube 840 is also oriented obliquely relative to the longitudinal axis of the gastric band 810 and is similarly positioned below a longitudinally extending median line 842 of the gastric band 810. The compensation allows that the ends of the balloon 832, 834 to meet without interference from the tube 840. Still other embodiments are shown with reference to Figures 27 and 28, respectively. According to an embodiment as shown in Figure 27, the tube 940 is molded into the plug 946 used to cover the core portion of the balloon 914. According to the other embodiment shown in Figure 28, the tube 1040 is molded as an integral portion of the second secure closure element 1026. The fluid passage, therefore, extends through the tube 1040, in the passages 1048 formed in the second secure closure element 1026 and ultimately in the balloon 1014. More particularly, once the tube 1040 enters a bridge of the second secure closure element 1026 (i.e., where the second secure closure element 1026 defines the opening), it is separated in a bifurcated tube 1052 that enters to the balloon 1014 by means of both walls 1054 of the opening 1030 of the second secure closing element 1026. Still another embodiment is shown in Figures 29 and 30, where the tube 1 140 is integrated into one of the sides of the mechanism. e secure closure 1 120, preferably, the second secure closure element 126. The tube 1 140, then moves through a fold 156 from the rear of the second secure closure element 1 126, to allow a low entry angle inside the balloon 1 1 14.

Referring to Figure 31, the inlet of the tube 1240 is integrated within the belt 1212 (and more particularly, the second secure closure element 1226) to allow separate molding of the belt 1212 and the balloon 1214. By being attached to the second element of 1226 secure closure, tube 1240 could be used to find the location of secure closure mechanism 1220 once the implant has been encapsulated in the fibrous tissue. As with the above embodiments, the tube 1240 is oriented obliquely relative to the longitudinal axis of the gastric band 1210 and is similarly positioned below a longitudinally extending median line 1242 of the gastric band 1210. The compensation allows that the ends of globe 1234 are without interference from tube 1240. Additionally, any of the pipe configurations described with reference to Figures 22 to 31, it could incorporate some type of tension release element to reduce fatigue as the pipe flexes back and forth in the body. Such tension release could be achieved by placing a length of thicker material at the point of pipe entry into the balloon (see, for example, number 1 156 in Figure 29, shown similarly, though not indicated in the Figure). 31). The length of the thicker material allows the pipe to take a longer curve as it is bent away from the junction between the pipe and the globe. In other words, this length of material that has been thickened increases the stiffness of the pipe in this region to allow the pipe It flexes without deforming and moves the point of flexion beyond the vulnerable junction between the band, the balloon and the pipe. The tension release element could preferably be made of silicone, although other materials (plastics, metals, etc.) could also be used. Also, in all these embodiments, the pipe could be connected either to the belt or to the balloon by any of the multiple manufacturing methods, such as over molding or assembly and bonding. Although the present invention is described for use in conjunction with gastric bands, those skilled in the art will appreciate that the above intention is equally applicable to other types of bands that can be implanted. For example, the bands used for the treatment of fecal incontinence. One of said bands is described in the U.S. Patent. No. 6,461, 292. The bands can also be used to treat urinary incontinence. One of said bands is described in the Patent Application Publication of E.U.A. No. 2003/0105385. The bands can also be used to treat cardiacgia and / or acid reflux. One of said bands is described in the U.S. Patent. No. 6,470,892. The bands can also be used to treat impotence. One of said bands is described in the Patent Application Publication of E.U.A. No. 2003/01 14729. Referring to Figures 1 and 2, the extension 100 includes an elongate body member having a first end 102 and a second end 104. The first end 102 includes an open recess 106 formed and sized for receive the tab 24 of the first element of secure closure 22 at the first end 14 of the gastric band 10. The first end 102 of the extension 100 is additionally provided with a tie strap 108. The tie strap 108 is formed and sized to pass through the opening 38 formed in the projection 24 and the last joint within the mating groove 1 10 formed in the outer surface of the first end 102 of the extension 100. In this sense, the fastening strap strip 108 extending from the extension 100 it creates a loop through the projection 24 which easily couples the first end of the extension 100 to the first secure closure element 22 for selective joining and separation. The second end 104 of the extension 100 includes a clamping section 1 12 formed and sized to facilitate clamping it as the extension 100 is passed through the ring element 26 and the gastric band 10 is applied around the stomach of the patient. Additionally, there is a suture loop 105 to achieve compatibility with the Goldfinger 150 instruments as discussed above and the holding section, or flat end 12 of the extension 100 is compatible with other bandpass devices. Between the first end 102 and the second end 104 of the extension 100 a laterally extending retaining element 1 14 is formed. The retaining element 1 13 is semi-circular when viewed along a flat, transverse section. The retaining element 1 14 is tapered to extend halfway extending towards the first end 102 of the extension 100 in a shape that creates a surface on which the ring element 26 can slide during the secure closure for the provisional joining of the extension 100 to the ring element 26. The tapered creates a coupling surface 1 18, which holds the element of ring 26 between the first elongate end 102 of the extension 100 and the retaining element 14 when the first end 102 of the extension 100 is temporarily securely locked to the ring element 26. Although an extension with a recess and a member of an extension was previously described, Withholding according to a preferred embodiment, extension may take other forms without departing from the spirit of the present invention. For example, and in accordance with another preferred embodiment shown with reference to Figure 9, the extension element 200 includes an elongate body member having a first end 202 and a second end 204. The first end 202 includes bag recesses, attachments, more particularly a bag 206 formed and sized to fully receive the projection 24 of the first secure closure element 22 at the first end 14 of the gastric band 10. The first end 202 of the extension element 200 is additionally provided with a strap of mooring 208. The mooring strap strip 208 is formed and sized to pass through the opening 38 formed in the projection 24 and the last link within the mating groove 210 formed in the outer surface of the first end 202 of the mating element. extension 200. In this form, the first end 202 of the extension element 200 can be securely and selectively and selectively separated from the first secure closure element 22. The second end 204 of the extension member 200 includes a series of projections 202 formed and sized to facilitate fastening thereof as the extension member 200 is made passing through the ring element 26 and the gastric band 10 is applied around the stomach of the patient. The second end 204 also includes a suture loop 205 extending therefrom. Between the first end 202 and the second end 204 of the extension element 200 a laterally extending retaining element 214 is formed. The retaining element 214 includes first and second coupling elements 216, 218. The coupling elements 216, 218 they are tapered to widen as they extend towards the first end 202 of the extension element 200 in a shape that creates a surface on which the ring element 26 can slide during the secure closure for the provisional connection of the extension element 200. to the ring element 26 before completing the secure closure of the gastric band 10, the secure closing mechanism 20 (after the extension element 200 is separated from the gastric band 10). The taper creates opposite mating surfaces 220, 222, which maintain the ring element 26 between the first elongated end 202 of the extension element 200 and the coupling elements 216, 218 when the first end 202 of the extension element 200 is closed temporarily secure the ring element 26.

Regardless of the construction of the extension used in accordance with the gastric band, it is important that the extension be easily accessed for removal with a small possibility of error. The two keys grant that the removal of an extension rotates around an ability of the surgeon to identify the extension, in particular, that part of the extension that requires manipulation for the removal of the extension, and proceeds to remove the extension in accordance with the removal mechanism used. With this in mind, various modalities have been developed to ensure unobstructed viewing and convenient cutting. Any of the modalities described below may incorporate a visual indicator such as a color (on either the entire extension, the tie strap or only the region to be cut) or a visible suture to indicate to the surgeon that this is a separate component of the gastric band that must be removed. Additionally, these modalities also provide various means in which the extension can be attached to the gastric band (tie strap, suture, etc.). More particularly, and with reference to Figures 32, 33, 35 and 36, the extension 1300 adjacent the first end 1302 thereof or the tie strap strip 1508, 1608 of extension 1500, 1600 is provided with one or more raises 1330, 1530, 1630 at a location adjacent to the open coupling notch or bag 1310 within which the tie strap strip 1308, 1508, 1608 of extension 1300, 1500, 1600 will be placed. Providing an increase or ramp 1330, 1530, 1630 in this position (or, either at the first end of the extension or on the tie strap strip), the tie strap strip 1308, 1508, 1608 is held above the first end 1302 and the surgeon has the ability to visualize easily the location of the tie band strip 1308, 1508, 1608. The location of the raise or ramp 1330, 1530, 1630 is in a position adjacent to the point at which the tie strap strip 1308, 1508, 1608 will be cut for the removal of extension 1300, 1500, 1600 and therefore, provide the surgeon with a visual indicator such as the cutting location. According to the modality shown with reference to Figure 35, two increases 1530a, 1530b are wrapped completely around the tie strap strip 508 and define an area in which a surgeon must cut the tie strap strip 1508. In addition to improving the display of the tie strap strip, in each of the modalities, the ramps arise from the lashing strap slightly above the gastric band, increase the space between the lashing strap and the gastric band to provide an improved passage to place the scissors therein to cut the strap and tie up and ultimately remove the extension. The display of the cutting location according to this embodiment is improved by providing a hole or notch 1332, 1432, 1532 along the tie strap strip 1308, 1408, 1508 (see Figures 32, 33, 34). and 35). In particular, and referring to Figures 32, 33 and 43, the suture loop at the second end of the extension 1300, 2200 is continuous through the body of the extension 1300, 2200 with suture 1334, 2234 extending through tie strap strip 1308, 2208 and functions as a reinforcement element. However, a portion of the suture 1334, 2234 is exposed along the tie strap strip 1308, 2208 at a predetermined location such that when the tie strap strip 1308, 2208 is passed through from the opening 38 of the gastric band projection 24 and is wrapped around the gastric band 10 to secure the two components together, the hole 1332, 2232 is placed in the desired location for cutting. Similarly, and as seen in Figures 34 and 35, the lashing strap strip 1408, 1508 may have a localized region that is smaller than the remainder of the lashing strap 1408, 1508 allowing one-step cutting. only. More particularly, the localized region is preferably a notch 1432, 1532 formed along the tie strap strip 1408, 1508. Additionally, because the hole or notch 1432, 1532 easily differentiates based on its physical appearance of rest of the lashing strap 1408, 1508, a surgeon can easily identify the location that requires cutting. It is contemplated that, the design of either the notch or the hole could be used in conjunction with the increase described above with reference to Figures 32, 33, 36, 42 and 43, although these designs could actually be employed without the increase in where certain design considerations are dictated.

Other embodiments are described with reference to Figures 37, 39 and 40. These embodiments employ a stiffening element, for example, a suture 1734, 1934 to assist in the connection of extension 1700, 1900 to the tip of the gastric band. In an affliction (see Figure 37), the suture 1734 holds the tie strap strip 1708 down from the body thereof. As such, and instead of cutting the tie strap strip 1708 by itself, as described above with reference to the various embodiments, the lock suture 1734 is cut to thereby release the tie strap strip 1708 for the removal of extension 1700. Alternatively, the suture can be used to tie the strip and therefore secure the lashing strap to the extension without the aid of adhesives. Although a suture is described as a reinforcing element according to a preferred embodiment, other reinforcing structures, eg, mesh, can be used within the spirit of the present invention. In another related embodiment shown in Figures 39 and 40, the suture material of the suture loop 1905 extends to travel along the length of the extension 1900, such that the suture material 1934 extends from the first end 1902 of the extension 1900 (substantially replacing the lashing strap of the above embodiments). This allows the extension 1900 to wrap a suture 1934 through an opening 38 in the tip of the gastric band 10 and engage a projection 1936 extending from the first end 1902 of the extension 1900. In addition to securing the gastric band in a reliable and convenient manner, this modality provides additional benefits in the sense that suture 1934 now has a loop at first end 1902 and second end 1904 at extension 1900. This increases the strength of the 1900 extension because the suture can not pull the extension regardless of the failure of the extension material. Referring to Figure 38, another embodiment is described. In accordance with this embodiment, the tip 1812 of the gastric band 1810 is seated within the recess 1806 formed in the extension 1800. However, the recess 1806 and the tip 1812 of the gastric band 1810 include a snap-fit feature that provides a semi-mechanical closing mechanism between the gastric band 1810 and the extension 1800. Said modality could improve the ability of the extension 1800 to drive and guide the tip 1812 of the gastric band 1810 in harmony without twisting or turning it. Said semi-mechanical closure mechanism could be used in conjunction with other tie-down securing configurations as a means to provide redundant securing which ensures the extension of the gastric band. Additionally, this embodiment contemplates that it may have a suture 181 1 around the tip 1812 of the gastric band 1810 and the recess 1806 of the extension 1800 (similar to Figure 37) to compress the region where the pressure fitting tip 1812 fits within recess 1806 of extension 1800. When the surgeon cuts and removes the surrounding suture 181 1, the surgeon can then expand the flexible silicone extension 1800 over the snap-fit tip 1812 on the front of the projection to separate the 1800 extension of the gastric band 1810 in one piece. Additionally and with reference to Figure 41, a suture 2034 is used in a similar manner to ensure extension 2000 to the gastric band. However, the projection 2036 to which extension 2000 is secured, is designed in such a way that it can be disengaged. Therefore, when you want to remove the 2000 extension, you only need to remove the 2036 projection to free the 2000 extension and in this way you do not need to make any cuts. Referring to Figure 42, another mode is described. In accordance with this embodiment, the lashing strap 2108 of the extension 2100 is elongated to allow placement of the glue 2138 to be moved to a forward position on the open recess 2106 of the extension 2100. This allows the lanyard strap 2108 of the extension 2100 to be cut on the line 2140 to remove the extension 2100. More particularly, the open recess 2106 includes a front end 2106a positioned toward the midline of the extension 2100 and a rear position 2106b positioned near the first end 2102 of the extension 2100. The glue position 2138 is at its front end 2106a. This is still a one-piece removal, only the length of the location for the cut has changed. This mode allows the lashing strap 2108 to tilt for improved access with scissors or other tools when the front part of the extension is bent upwards because the tie strap is only stuck at one end 2106a. According to still another embodiment, and referring to Figure 43, a flange or plug 2242 is placed at a present point along the length of the lashing strap 2208. This allows the hole 2232 to be placed on the lashing strap. 2208 in relation to the position of the extension 2200 wherein the suture 2243 needs to be cut and to prevent the suture from contacting the gastric band hole during the pulling of the band. The plug 2242 is positioned to engage the projection surrounding the opening, in such a manner as to limit the extent to which the tie strap 2208 can pass therethrough. The portion of the lanyard 2208 adjacent the plug 2242 can be tapered and the section that is positioned within the gastric band opening can be longer in cross section to provide a snug fit with the hole in the gastric band. As with the previous embodiments, the lashing strap will include a hole or section with notch for the identification and cutting of the same. Additionally, the suture loop is fully displaced through the extension and can be used by tying it within a knot that is molded into the elongated section of the plug, such that it improves the strength of the extension lanyard. It will be readily apparent to those skilled in the art that the above invention has equal applicability for other types of implantable bands. For example, the bands are used for the treatment of fecal incontinence. One of said bands is described in the U.S. Patent. 6,461, 292 which is incorporated herein by reference. The bands can also be used to treat urinary incontinence. One of said bands is described in the U.S. Patent Application. 2003/0105385 which is incorporated herein by reference. The bands can also be used to treat cardiacgia and / or acid reflux. One of said bands is described in the U.S. Patent. 6,470,892 which is incorporated herein by reference. The bands can also be used to treat impotence. One of said bands is described in the U.S. Patent Application: A. 2003/0114729 which is incorporated herein by reference. Although the preferred embodiments have been shown and described, it should be understood that it is not intended to limit the present invention to said description, but instead, is intended to encompass all modifications and alternative constructions that are within the spirit and scope of the invention. present invention.

Claims (3)

NOVELTY OF THE INVENTION CLAIMS

1 .- A method to implant a surgically implantable band, said method comprises the steps of: a. providing a band comprising an elongate body member including a first end with a first secure closure element positioned therein, and a second end with a second secure closure element positioned thereon; said first secure closure element has a suture projection extending therefrom, said extension suture projection has a fixed suture thereto, said second end has a securing section placed therein formed and sized to facilitate the clamping thereof as the gastric band extension passes through the second secure closure element; b. placing said band around an anatomical structure, said band securely closing around said structure by placing said extension of suture projection through said second secure closure element and thereafter coupling said first and second secure closure elements; c. removing said extension of suture from said band.

2. The method according to claim 1, further characterized in that said step of removing said extension from suture projection from said band comprises the step of removing said suture projection extension as a single piece.

3. The method according to claim 1, further characterized in that said step of placing said suture projection extension through said second secure closure element comprises pulling said extension of suture projection through said second closure element. insurance.