WO2016205834A1

WO2016205834A1 - Multi-size gastric bypass band and surgical method

Info

Publication number: WO2016205834A1
Application number: PCT/US2016/043015
Authority: WO
Inventors: Mathias Asongwe Lawrence Fobi; Steven Masterson
Original assignee: Mathias Asongwe Lawrence Fobi; Steven Masterson
Priority date: 2015-06-19
Filing date: 2016-07-19
Publication date: 2016-12-22

Abstract

A multi-size gastric bypass band intended to provide a stabilized stoma and to aid in the maintenance of weight loss in bariatric surgery patients includes a flexible band body formed, e.g., from silicone rubber, and a buckle fixedly attached to band body. The band body is molded with a partially circular or arcuate shape toward a buckle end to ease placement around a gastric pouch. Once placed around the gastric pouch, a tapered end of the band body is fed through the buckle to form a ring around the pouch. The band body includes a locking profile in the form of, e.g., a saw tooth profile, that engages with a locking tab of the buckle so the ring can be set to a plurality of diameters.

Description

MULTI-SIZE GASTRIC BYPASS BAND AND SURGICAL METHOD

FIELD

[0001] The embodiments described herein relate to devices for performing gastric bypass surgery for morbidly obese individuals, and more specifically, to a multi-size gastric bypass band and related surgical method.

BACKGROUND

[0002] There are multiple devices that are currently used to control the pouch and stoma size in gastric operations for obesity. The adjustable bands, including the LapBand™ and the Realize Band™, are intended to control the pouch size in unresected stomach pouches. These devices have an inflatable component that can be used to adjust the level of restriction the device creates on the pouch outlet. These devices are responsible for the restriction and weight loss from the operations.

[0003] The devices, including the GaBP Ring Autolock System™, MiniMizer Ring™, IOC Bypass Band™, A.M.I. B-Band™, etc., are intended to control the pouch and stoma sizes in gastric operations for obesity with partially resected stomachs. The GaBP Ring® device is a non-adjustable band that comes in multiple sizes. None of these devices are protected or available for market in the U.S.

[0004] The gastric pouch and stoma provide the restrictive mechanism of the gastric bypass and other gastric operations for obesity. A loss of restriction will occur as the size of the pouch and stoma increase with time, resulting in weight regain or inadequate weight loss.

[0005] It is desirable to provide improved systems and methods that provide for a stabilized stoma and to aid in the maintenance of weight loss in bariatric surgery patients.

SUMMARY

[0006] The embodiments described herein are directed to an annular restrictive device comprising a multi-size gastric bypass band that is intended to provide a stabilized stoma and to aid in the maintenance of weight loss in bariatric surgery patients. The multi-size band is designed for long- term implantation in the field of open or laparoscopic bariatric surgery. The multi-size band includes a flexible band formed, e.g., from a silicone rubber band. A buckle, which is formed from a more rigid or stiff material relative to the band material, such as, e.g., an acetyl thermoplastic material, is fixedly or permanently coupled to the band. The band is molded in a semi-circular shape to ease placement around the gastric pouch. Once placed around the gastric pouch, a first or tail end of the band having an elongate taper is fed through a mouth or entrance opening of the buckle to form a ring or a loop around the pouch. The band has a saw tooth profile that engages with a locking tab of the buckle (similar to a zip-tie) so the ring or loop can be set to one of a plurality of diameters (e.g., 3 diameters of about 22.5mm, 27.5mm and 32.5mm, and the like). Once the ring or loop diameter is set, the excess band at a first end can be cut off and removed from the patient. The band has a soft consistency that provides for patient comfort and safety and is white for ease of implantation and radiopaque for radiographic imaging. The acetyl buckle is smooth with rounded corners to prevent damage to patient tissues and is blue in color to contrast with white band and ease of implantation.

[0007] Further, objects and advantages of the invention will become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

[0009] FIGURE 1 is a perspective view of an embodiment of a multi-size gastric bypass band.

[0010] FIGURE 2 is an exploded assembly perspective view of the multi-size gastric bypass band shown in Figure 1 along with a buckle.

[0011] FIGURE 3 is a perspective view of fully assembled assembly of the multi-size gastric bypass band and the buckle shown in Figure 2 shown in an unlocked state.

[0012] FIGURE 4A is a perspective view of fully assembled assembly of the multi-size gastric bypass band and the buckle shown in Figure 2 shown in a locked state.

[0013] FIGURE 4B is a side view of fully assembled assembly of the multi-size gastric bypass band and the buckle shown in Figure 2 shown in a locked state.

[0014] FIGURE 5A is a perspective view of fully assembled assembly of the multi-size gastric bypass band and the buckle shown in Figure 2 shown in a locked state with an excess portion of the band removed.

[0015] FIGURE 5B is a side view of fully assembled assembly of the multi-size gastric bypass band and the buckle shown in Figure 2 shown in a locked state with an excess portion of the band removed. [0016] FIGURE 6 a perspective view of the buckle shown in Figures 2 and 3.

[0017] FIGURES 7 A and 7B are end plan views of the buckle.

[0018] FIGURE 8 is a top view of the buckle.

[0019] FIGURE 9 is a side section view of the buckle taken along line 7— 7 in Figure 6.

[0020] FIGURE 10 is a detail view of a buckle mounting section of the multi-size gastric bypass band taken along line 10 in Figure 1.

[0021] FIGURE 11 is a detail view of a locking tooth section of the multi-size gastric bypass band taken along line 11 in Figure 1.

DETAILED DESCRIPTION

[0022] The present subject matter is not limited to the particular embodiments described, as those are only examples and may, of course, vary. Likewise, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0023] The embodiments described herein with reference to the drawings provide an annular restrictive device comprising a multi-size gastric bypass band 10 that is intended to provide a stabilized stoma and to aid in the maintenance of weight loss in bariatric surgery patients. As depicted in Figures 1-3, the multi-size band 10 includes a flexible band body 11, which is formed from a flexible material, such as, e.g., a silicone rubber material or the like. A buckle 30, which is formed from a more rigid or a stiffer material relative to the material from which the band body 11 is formed, such as, e.g., an acetyl thermoplastic or the like, is coupled to the band body 11 at a mounting section 14 adjacent a first end of the band body 11. The band body 11 is molded in an arcuate or partial circular shape profile 12 toward the first or buckle 30 end of the band body 11 to ease placement around a gastric pouch. A second end 20, opposite the first end of the band body 11, includes a tapered profile to ease feeding the band body 11 through, around and between tissues of a patient. Once the first end and arcuate profile 12 of the band body 11 is placed around the gastric pouch, the tapered end 20 of the band body 11 is fed through the buckle 30 to form a ring or a loop 19 with a generally annular profile, as shown in Figures 4A and 4B, around the gastric pouch.

[0024] The band body 11 includes a locking profile 18 comprising a plurality of abutments or stops in the form of, such as, e.g., a saw tooth profile, to which the buckle 30 engages with in a manner similar to, e.g., the locking mechanism of a nylon cable tie or zip-tie. The locking profile 18 and buckle 30 enable the ring 19 to be set to one of a plurality of diameters (e.g., 3 diameters of about 22.5mm, 27.5mm and 32.5mm, or the like). Once the diameter of the ring 19 is set, as shown in Figures 5 A and 5B, the excess of the band body 11 extending from the locking profile 18 to the second end 20 of the band body 1 1 can be cut off and removed from the patient, leaving behind a tail portion 16 and/or one or more sections of the locking profile 18 of the band body 11.

[0025] Opposite the tail portion 16 and adjacent the buckle 30, the band body 11 includes a tongue portion 13 having an elongate, tapered, arcuate profile that facilitates formation of the radial or annular shape of the ring 19 formed in the band body 1 1 when in a locked state and provides a more continuous or smooth inner surface adjacent the tissue as the ends of the band body 11 overlap or spiral. During installation, the tongue portion 13 is gripped with forceps as the tail end 20 is inserted through the buckle 30.

[0026] The band body 1 1 has a soft consistency that provides for patient comfort and safety and is white for ease of implantation and radiopaque for radiographic imaging. The acetyl buckle 30 is smooth with rounded corners to prevent damage to patient tissues and is a different color, such as, e.g., blue, to contrast it with white band 10 and ease of implantation.

[0027] Turning to Figures 6 through 9, the buckle 30 includes a base 32, opposing side walls 33 and 34 extending upwardly from the base 32 and having rounded corners, a mouth or entrance end wall 36 extending between opposing side walls 33 and 34 and forming an opening or mouth 35 through which the tapered end 20 of the band body 11 is inserted, a resilient catch or locking tab 38 extending at an angle from the end wall 36 toward an exit end of the buckle and down toward the base 32. The coupling or attachment area between the locking tab 38 and the end wall 36 forming a living hinge 39.

[0028] The living hinge 39 of the locking tab 38 advantageously

• makes compression or displacement of the locking profile 18 (prong, abutment, or stop) unnecessary;

• enables a suffer or more rigid material to be used for the buckle 30;

• enables a thicker and/or more dense material to be used for the band body 1 1 of the band 10, which tends to cause the band body to form a more radial or annular shape as the ends of the band body 1 1 overlap or spiral in a locked state; and

• results in more secure lock.

[0029] As depicted in Figure 8, the mounting section 14 of the band 10 include a recess 15 sized and shaped to receive the base 32 of the buckle 30. [0030] Turning to Figure 9, an individual saw tooth of a saw tooth profile embodiment of the locking profile 18 of the band body 11 , includes a ramp guide portion 17b upon which the catch tab 38 is positioned and a stop surface 17c extending at a grazing angle to the vertical from the guide portion 17b and positioned to engage the catch tab 18 to prevent the band 10 from expanding radially.

[0031] In operation, the tapered end 20 of the band body 11 is fed through the mouth 35 of the buckle 30. The first ramp guide portion 17a positioned prior to the first saw tooth of a saw tooth embodiment of the locking profilel 8, engages the catch or locking tab 38 applying a sufficient force against the locking tab 38 to displace the tab 38 as the band 10 is advanced through the buckle 30 to a desired diameter. The force applied by the ramp guide portion 17a is applied as a moment about the living hinge 39 minimizing the force necessary to upwardly displace the tab 38 to insert the band body 11 through the buckle 30 and adjust the size of the band 10. Due to the angular orientation of the locking tab 38 and the stop surface 17c of the saw tooth profile 18, any force exerted to expand the diameter of the band 10 and effectively withdraw the band body 11 from the buckle 30 is applied to the locking tab 38 in a compression orientation. As a result, a much greater force is necessary to withdraw the band body 1 1 from the buckle 30 than the force required to insert and reduce the size of the band body 1 1.

[0032] The subject application is related to U. S. Patent Numbers 7,909,839 and 8,469,978, and the surgical method disclosed therein. U. S. Patent Numbers 7,909,839 and 8,469,978 are incorporated herein by reference as if set forth in full.

[0033] All features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such

combinations or substitutions are possible. Express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art upon reading this description.

[0034] In many instances entities are described herein as being coupled to other entities. It should be understood that the terms "coupled" and "connected" (or any of their forms) are used interchangeably herein and, in both cases, are generic to the direct coupling of two entities (without any non-negligible (e.g., parasitic) intervening entities) and the indirect coupling of two entities (with one or more non-negligible intervening entities). Where entities are shown as being directly coupled together, or described as coupled together without description of any intervening entity, it should be understood that those entities can be indirectly coupled together as well unless the context clearly dictates otherwise.

[0035] As used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0036] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the inventive scope of the claims by features, functions, steps, or elements that are not within that scope.

Claims

WHAT IS CLAIMED IS:

1. A multi-size gastric bypass band comprising

an elongate band body having a locking profile comprising a plurality of locking abutments, and

a buckle coupled to the band body adjacent a first end, wherein a second end of the band body opposite the first end is insertable through the buckle to form a radial loop, wherein the buckle lockingly engages an individual one of the plurality of locking abutments of the locking profile of the band body to set the radial loop to a predetermine size.

2. The band of claim 1 wherein the locking profile comprises a saw tooth shaped profile.

3. The band of claims 1 and 2 wherein the second end of the band body has a tapered profile.

4. The band of claims 1 and 2 wherein the buckle is lockable to the locking profile to set the radial loop of the band body to one of a plurality of predetermined diameters.

5. The band of claim 3 wherein the buckle is lockable to the locking profile to set the radial loop of the band body to one of a plurality of predetermined diameters.

6. The band of claims 1 through 5 wherein the buckle includes

a base,

opposing side walls extending upwardly from the base,

an entrance end wall extending between opposing side walls and forming an opening through which the band body is passed, and

a resilient catch tab extending at an angle from the end wall toward a front end of the buckle and down toward the base.

7. The band of claim 6 wherein the band body includes a mounting section for coupling the base of the buckle.

8. The band of claim 7 wherein the mounting section of the band body includes a recess sized and shaped to receive the base of the buckle.

9. The band of claims 1 through 8 wherein the locking profile comprising a saw tooth comprising a plurality of saw tooth profiles.

10. The band of claim 9 wherein an individual saw tooth of the plurality of saw tooth profiles includes a ramp guide portion upon which the catch tab is positioned and a stop surface extending from the guide portion and positioned to engage the catch tab to prevent the loop of band body from expanding radially.

11. The band of claims 1 through 10 wherein the band body is formed from a first material and the buckle is formed from a second material, wherein the second material is more rigid than the first material.

12. The band of claim 11 wherein the first material having a density causing the band body to form an annular or arcuate profile as the band body is spiraled.

13. The band of claim 11 wherein an attachment of the catch tab to the end wall forming a living hinge.

14. The band of claim 13 wherein the living hinge comprises a reduction of material at the attachment between the catch tab and the end wall.

15. The band of claim 13 wherein insertion of the band body through the buckle exerts a displacement force on the catch tab causing the catch tab to rotate about the living hinge, and wherein the withdrawal of the band body exerts a compression force on the catch tab.

16. The band of claim 15 wherein the compression force exceeds the displacement force.