US20200113570A1 - Gastroesophageal reflux treatment system, method, and device - Google Patents

Abstract

A gastroesophageal reflux preventer and related methods are provided. The gastroesophageal reflux preventer may include an absorbable material able to be placed in contact with a body organ and configured to induce a scarification of the body organ in response to absorption by the body organ of the material. In this manner, a proximate sphincter may be tightened, such as to ameliorate reflux through a gastroesophageal sphincter.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S)
• This application claims priority to and the benefit of U.S. Prov. Pat. App. No. 62/744,538 entitled “GASTROESOPHAGEAL REFLUX TREATMENT SYSTEM, METHOD, AND DEVICE,” naming Moises Jacobs as inventor, and filed on Oct. 11, 2018, the contents of which are hereby incorporated herein by reference in their entirety for any purpose.
FIELD
• The present disclosure relates generally to a medical device, and more specifically to a gastroesophageal reflux treatment system, method, and device.
BACKGROUND
• Many individuals suffer from gastroesophageal reflux. Efforts have been made to treat gastroesophageal reflux. Many treatment modalities exhibit significant complications, are complex, and/or are very expensive. Thus there exists a need for improved systems, methods, and devices for treatment of gastroesophageal reflux.
SUMMARY
• The forgoing features and elements may be combined in various combinations without exclusivity, unless expressly indicated herein otherwise. These features and elements as well as the operation of the disclosed embodiments will become more apparent in light of the following description and accompanying drawings.
• Embodiments of gastroesophageal reflux treatment systems, methods, and devices are disclosed. For instance, an implantable gastroesophageal reflux treatment device may include a gastroesophageal reflux preventer and a closure mechanism emplaceable proximate to an organ. In various embodiments, at least a portion of the gastroesophageal reflux preventer is absorbable by a human body. In various embodiments, at least a portion of the gastroesophageal reflux preventer is configured to induce a scar pattern upon absorption by the human body. By structuring the gastroesophageal reflux preventer to induce a desired scar pattern upon absorption, tightening of a sphincter may be induced responsive to the scarring, thereby ameliorating gastroesophageal reflux through the sphincter. Thus, a gastroesophageal reflux treatment system, method, and device may include the planned inducement of scarring in a pattern corresponding to a structure of a gastroesophageal reflux preventer as disclosed herein.
• A gastroesophageal reflux preventer is provided. The gastroesophageal reflux preventer includes an elongate portion of an absorbable material having a first end and a second end. The gastroesophageal reflux preventer includes a support string having a first portion extending outwardly from the first end and having a second portion extending outwardly from the second end. The gastroesophageal reflux preventer also includes a closure mechanism configured to retain at least a portion of the elongate portion in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of the elongate portion.
• A further gastroesophageal reflux preventer is provided. The further gastroesophageal reflux preventer may include a plurality of nodes including pieces of an absorbable mesh material linked together by a support string. The support string may have a first portion extending outwardly from a first end of the plurality of nodes linked together and may have a second portion extending outwardly from a second end of the plurality of nodes linked together. Moreover, the gastroesophageal reflux preventer may have a closure mechanism configured to retain at least a portion of the plurality of nodes in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of at least one node of the plurality of nodes.
• A method of making a gastroesophageal reflux preventer is provided. The method may include providing an elongate portion of an absorbable material having a first end and a second end. The method may also include providing a support string having a first portion extending outwardly from the first end and having a second portion extending outwardly from the second end. The method may also include providing a closure mechanism attached to the support string and configured to retain at least a portion of the elongate portion in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of the elongate portion.
• A method of reducing leakage of a body fluid through a gastroesophageal sphincter is provided. In various embodiments, the method includes resting an elongate portion of a gastroesophageal reflux preventer against at least one of a stomach and an esophagus proximate to the gastroesophageal sphincter. The method may further include retaining at least a portion of the elongate portion in contact with the at least one of the stomach and the esophagus by encircling at least one of the elongate portion and a support string extending outwardly from the elongate portion about the at least one of the stomach and the esophagus and engaging a closure mechanism attached to the support string. In various embodiments, engaging the closure mechanism includes knotting together (i) a first portion of the support string extending outwardly from a first end of the elongate portion and (ii) a second portion of the support string extending outwardly from a second end of the elongate portion.
• A further gastroesophageal reflux preventer is provided. The gastroesophageal reflux preventer may include an elongate portion and a closure mechanism. The elongate portion may be of an absorbable material having a first end and a second end. The closure mechanism may be a knotting together of the first end and the second end to retain at least a portion of the elongate portion in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of the elongate portion.
BRIEF DESCRIPTION OF THE DRAWINGS
• The subject matter of the present disclosure is particularly pointed out and distinctly claimed in the concluding portion of the specification. A more complete understanding of the present disclosure, however, may best be obtained by referring to the detailed description and claims when considered in connection with the drawing figures, wherein like numerals denote like elements.
• FIG. 1A illustrates a block diagram of a gastroesophageal reflux treatment device installed proximate to a gastroesophageal sphincter of a stomach and with an elongate portion extending 360 degrees around an esophagus, according to various embodiments;
• FIG. 1B illustrates a block diagram of a gastroesophageal reflux treatment device installed proximate to a gastroesophageal sphincter of a stomach and with an elongate portion extending less than 360 degrees around an esophagus, according to various embodiments;
• FIG. 2 illustrates an example gastroesophageal reflux treatment device having a sheathed preventer, in accordance with various embodiments;
• FIG. 3 illustrates an example gastroesophageal reflux treatment device having a perforated sheathed preventer, in accordance with various embodiments;
• FIG. 4 illustrates an example gastroesophageal reflux treatment device having a sectioned sheathed preventer, in accordance with various embodiments;
• FIG. 5 illustrates an example gastroesophageal reflux treatment device having an embodiment of a linked node preventer with trapezoidal nodes, in accordance with various embodiments;
• FIG. 6 illustrates an example gastroesophageal reflux treatment device having an embodiment of a linked node preventer with rounded nodes, in accordance with various embodiments;
• FIG. 7A illustrates an example gastroesophageal reflux treatment device having an embodiment of a linked node preventer with spherical nodes, in accordance with various embodiments;
• FIG. 7B illustrates an example gastroesophageal reflux treatment device having an embodiment of a linked node preventer with annular nodes, in accordance with various embodiments;
• FIG. 8 illustrates an example gastroesophageal reflux treatment device having a sheet preventer, in accordance with various embodiments;
• FIG. 9 illustrates an example gastroesophageal reflux treatment device having a perforated sheet preventer, in accordance with various embodiments;
• FIG. 10 illustrates an example gastroesophageal reflux treatment device having a one-side notched sheet preventer, in accordance with various embodiments;
• FIG. 11 illustrates an example gastroesophageal reflux treatment device having a dual-side notched sheet preventer, in accordance with various embodiments;
• FIG. 12 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to a trapezoidal cross-section, in accordance with various embodiments;
• FIG. 13 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to a concave cross-section, in accordance with various embodiments;
• FIG. 14 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to a convex cross-section, in accordance with various embodiments;
• FIG. 15 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to a flattened cross-section, in accordance with various embodiments;
• FIG. 16 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to an oval cross-section, in accordance with various embodiments;
• FIG. 17 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to an round cross-section, in accordance with various embodiments;
• FIG. 18 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to a stranded cross-section, in accordance with various embodiments;
• FIG. 19 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to a t-shape cross-section, in accordance with various embodiments;
• FIG. 20 illustrates an example gastroesophageal reflux treatment device with a cross-sectional profile corresponding to an L-shape cross-section, in accordance with various embodiments;
• FIG. 21 illustrates an example gastroesophageal reflux treatment device with a closure mechanism corresponding to a bow knot closure, in accordance with various embodiments;
• FIG. 22 illustrates an example gastroesophageal reflux treatment device with a closure mechanism corresponding to a square knot closure, in accordance with various embodiments;
• FIG. 23 illustrates an example gastroesophageal reflux treatment device with a closure mechanism corresponding to an inward clasp closure, in accordance with various embodiments;
• FIG. 24 illustrates an example gastroesophageal reflux treatment device with a closure mechanism corresponding to an outward clasp closure, in accordance with various embodiments;
• FIG. 25 illustrates an example gastroesophageal reflux treatment device with a closure mechanism corresponding to a one-way insertion closure, in accordance with various embodiments;
• FIG. 26 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having annular nodes, in accordance with various embodiments;
• FIGS. 27-28 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having a sheathed preventer and a one-way insertion closure, in accordance with various embodiments;
• FIG. 29 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having a sheathed preventer including spaced nodes, and a one-way insertion closure, in accordance with various embodiments;
• FIG. 30 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having a sectioned sheathed preventer, in accordance with various embodiments;
• FIG. 31 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having a braided multi-strand preventer, in accordance with various embodiments;
• FIG. 32 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having a chain-link multi-strand preventer, in accordance with various embodiments;
• FIG. 33 illustrates a round link of a chain-link multi-strand preventer, in accordance with various embodiments;
• FIG. 34 illustrates a stretched link of a chain-link multi-strand preventer, in accordance with various embodiments;
• FIG. 35 illustrates a trapezoidal link of a chain-link multi-strand preventer, in accordance with various embodiments;
• FIG. 36 illustrates an example gastroesophageal reflux treatment device with a gastroesophageal reflux preventer having a bangle preventer, in accordance with various embodiments;
• FIG. 37 illustrates an example bendable section of a bangle preventer, in accordance with various embodiments;
• FIG. 38 illustrates an example hinged section of a bangle preventer, in accordance with various embodiments;
• FIG. 39 illustrates an example closure mechanism of a bangle preventer including a knot, in accordance with various embodiments;
• FIG. 40 illustrates an example closure mechanism of a bangle preventer including an abutment closure, in accordance with various embodiments; and
• FIGS. 41-42 illustrate an example gastroesophageal reflux treatment device having a sheathed preventer with nestable ends, in accordance with various embodiments.
DETAILED DESCRIPTION
• The detailed description of exemplary embodiments herein makes reference to the accompanying drawings, which show exemplary embodiments by way of illustration. While these exemplary embodiments are described in sufficient detail to enable those skilled in the art to practice embodiments of the disclosure, it should be understood that other embodiments may be realized and that logical changes and adaptations in design and construction may be made in accordance with this invention and the teachings herein. Thus, the detailed description herein is presented for purposes of illustration only and not limitation. The scope of the disclosure is defined by the appended claims. For example, the steps recited in any of the method or process descriptions may be executed in any order and are not necessarily limited to the order presented. Furthermore, any reference to singular includes plural embodiments, and any reference to more than one component or step may include a singular embodiment or step. Also, any reference to attached, fixed, connected or the like may include permanent, removable, temporary, partial, full and/or any other possible attachment option. Additionally, any reference to without contact (or similar phrases) may also include reduced contact or minimal contact.
• Furthermore, any reference to singular includes plural embodiments, and any reference to more than one component or step may include a singular embodiment or step. Surface shading lines may be used throughout the figures to denote different parts but not necessarily to denote the same or different materials.
• In various example embodiments, a 5 mm circumference rounded solid meshed absorbable material of different lengths (e.g., 5 cm, 6 cm, 7 cm, and/or 8 cm in length, or any other desired length) with sutures protruding at each end is provided. In various instances a single suture protrudes at each end. The single sutures can be tied to each other to close a circle when placed around the gastroesophageal junction. The mesh may loosely lie around the esophagus, so that when the ends are tied, the mesh by itself does not constrict the esophagus.
• The absorbable material may be synthetic absorbable surgical suture, such as a monofilament prepared from a copolymer of glycolide and epsilon-caprolactone. For example, the absorbable material may be poliglecaprone 25, Monocryl® available from Ethicon, and/or the like. Moreover, the absorbable material may be a synthetic absorbable surgical suture such as may be formed of a copolymer made from 90% glycolide and 10% L-lactide. For example, the absorbable material may be polyglactin 910, Vicryl® available from Ethicon, and/or the like. In various embodiments, the absorbable material may be prepared from the polyester, poly (p-dioxanone). For example, the absorbable material may be polydioxanone, PDS® II available from Ethicon, and/or the like. One may appreciate that in further embodiments, the absorbable material may be any suitable material identified by a skilled artisan.
• Alternatively, the round solid mesh may be of longer length, but it may have a hollow inner diameter through which an absorbable suture passes and slides, so that the solid mesh can be cut away/separated from the inner suture at predetermined lengths or at any desired lengths, making a “one size fits all” implantable gastroesophageal reflux treatment device for different esophageal circumferences. The protruding sutures may be loosely tied, creating a loose circle of mesh around the esophagus, and any excess suture is cut away.
• In various embodiments, the implantable gastroesophageal reflux treatment device, such as the rounded solid absorbable mesh, is placed between the posterior vagus nerve and around the outer wall of the esophagus at the gastroesophageal junction below the diaphragm. Any hiatal hernias may be repaired if present thus returning the gastroesophageal junction to its normal anatomic position if possible, at the same time that the implantable gastroesophageal reflux treatment device is emplaced.
• Subsequently, scar tissue induced by the mesh, enhances closure of the sphincter of the gastroesophageal junction as the mesh is absorbed. In this manner, reflux through the sphincter is ameliorated.
• Further aspects, features, and embodiments are disclosed herein below with reference to specific drawings. For example, turning attention now toFIGS. 1A-1B, an implantable gastroesophageal reflux treatment device1 is illustrated. The implantable gastroesophageal reflux treatment device1 includes agastroesophageal reflux preventer6 and aclosure mechanism15 emplaceable proximate to an organ, such as a stomach4. Thegastroesophageal reflux preventer6 may be an elongate portion of absorbable material that is retained in place by theclosure mechanism15 for at least a period of time during which at least a portion of thegastroesophageal reflux preventer6 dissolves and/or is absorbed by the body. Unexpectedly, a resultant scar induced proximate to the area of contact by thegastroesophageal reflux preventer6 against the stomach4 causes tightening of the stomach4 in the area of the resultant scar, improving functioning of a sphincter. The elongate portion may be positioned to at least partially encircle an esophagus at or near the junction of the esophagus to the stomach, so that the resultant scar is proximate to the gastroesophageal sphincter.
• In various embodiments, the resultant scar induced proximate to the area of contact has a size and shape (a profile) carefully tuned by tuning of the geometry of the gastroesophageal reflux preventer. For instance, a scar may be 360 degrees around an esophagus, such as may be generated by agastroesophageal reflux preventer6 shown inFIG. 1A, or may be less than 360 degrees around an esophagus, such as may be generated by agastroesophageal reflux preventer6 shown inFIG. 1B. For instance, in various instances, thegastroesophageal reflux preventer6 may have an elongate portion extending 270 degrees or another length less than 360 degrees around an esophagus, as shown inFIG. 1B. In further instances, thegastroesophageal reflux preventer6 may have an elongate portion extending 360 degrees around the esophagus, as shown inFIG. 1A. A scar may be continuous, or may be discontinuous. The size, shape, and spacing of the local scar segments of a discontinuous scar may be set according to a scarring profile of beads, sections, or other features of thegastroesophageal reflux preventer6. For instance, reduced esophageal motility may be caused by acid over time stiffening an esophagus. For a patient with reduced esophageal motility, a continuous 360 degree scar encircling the esophagus may excessively tighten the gastroesophageal sphincter, or otherwise be non-recommended. Thus, scar profiles may be tailored from patient to patient.
• The implantable gastroesophageal reflux treatment device1 may have a variety of configurations. For instance, differentgastroesophageal reflux preventers6 may combine withdifferent closure mechanisms15. Various configurations ofgastroesophageal reflux preventers6 may have differentcross-sectional profiles7, such as those shown inFIGS. 12-20. Various configurations ofclosure mechanisms15 may include embodiments such as those shown inFIGS. 21-25.
• Thegastroesophageal reflux preventers6 may include a variety of configurations of absorbable materials and also include asupport string3. Thesupport string3 may comprise a string made of absorbable material, such as an absorbable suture. Thesupport string3 may extend from the ends of the variousgastroesophageal reflux preventers6 discussed herein. Thesupport string3 may be connectable to itself such as via aclosure mechanism15. For example, thesupport string3 extending from one end may be tied with thesupport string3 extending from the other end into a knot. In various instances, thesupport string3 passes through device, for instance, through an elongate portion of absorbable material, and extends from each end. In further instances, thesupport string3 comprises two segments, with a first segment attached to a first end of the device (e.g., to an elongate portion of absorbable material) and a second segment attached to a second end of the device (e.g., to the elongate portion of absorbable material). Moreover, while reference is made to asupport string3 throughout, such reference is for convenience, and in various embodiments, thesupport string3 is a shorthand description of a portion of the elongate portion aspect of thegastroesophageal reflux preventer6. For instance, rather than knotting an outwardly extendingsupport string3 to retain thegastroesophageal reflux preventer6, thesupport string3 may be a shorthand description for knotting together the ends of the elongate portion of thegastroesophageal reflux preventer6, and no separate string aspect may be provided.
• With specific attention now toFIGS. 2-11, and 41-42, various embodiments ofgastroesophageal reflux preventers6 are now discussed. For instance,FIG. 2 depicts agastroesophageal reflux preventer6 comprising an elongate portion configured as a sheathed preventer8. A sheathed preventer8 may include atubular portion9. Atubular portion9 may comprise a tube made from an absorbable material. In various embodiments, thetubular portion9 comprises a 5 mm circumference rounded solid meshed absorbable material. Moreover, thetubular portion9 may be flexible, for instance, a cylindrical member may be readily deformable, such as lying in flat layers when rested against a surface. In further embodiments, thetubular portion9 comprises a rigid shape. Thetubular portion9 may have a cross-section, such as a cylindrical, ovoid, or any other cross-section. Various cross-sectional profiles are depicted herein inFIGS. 12-20 (cross-sectional profiles7). Moreover, thecross-sectional profile7 of thetubular portion9 may adapt to at least partially correspond to a shape of an organ that thetubular portion9 is resting against.
• The absorbable material may be synthetic absorbable surgical suture, such as a monofilament prepared from a copolymer of glycolide and epsilon-caprolactone. For example, the absorbable material may be poliglecaprone 25, Monocryl® available from Ethicon, and/or the like. Moreover, the absorbable material may be a synthetic absorbable surgical suture such as may be formed of a copolymer made from 90% glycolide and 10% L-lactide. For example, the absorbable material may be polyglactin 910, Vicryl® available from Ethicon, and/or the like. In various embodiments, the absorbable material may be prepared from the polyester, poly (p-dioxanone). For example, the absorbable material may be polydioxanone, PDS® II available from Ethicon, and/or the like. One may appreciate that in further embodiments, the absorbable material may be any suitable material identified by a skilled artisan.
• In various instances, the sheathed preventer8 is filled. In further instances, the sheathed preventer8 is hollow. A sheathed preventer8 may be filled with a same or similar solid meshed absorbable material. The filling may be continuous, or may be intermittent. For instance,FIG. 29 depicts an elongate portion configured as sheathed preventer8 further comprising spacednodes58. Spacednodes58 may include locally filled regions of the sheathed preventer8. Spacednodes58 may have a size, shape, and spacing corresponding to a scarring profile chosen based on a given patient's degree of reduction of esophageal motility. In this manner the shape and extent of scarification may be selected to promote patient-specific desired therapeutic effects.
• With specific attention toFIGS. 41-42, there is provided agastroesophageal reflux preventer6 comprising an elongate portion configured as a nestable sheathedpreventer200. A nestable sheathedpreventer200 may include a nestabletubular portion203. A nestabletubular portion203 may comprise a tube made from an absorbable material. The nestabletubular portion203 may have a non-constant diameter, for instance alarger portion206 may have a greater diameter than asmaller portion205. Thelarger portion206 andsmaller portion205 may be opposite ends of the nestabletubular portion203. Thesmaller portion205 may be insertable into aninternal passage209 of thelarger portion206 and retained therein by one ormore suture207. Thus, theclosure mechanism15 may comprise asuture207 passing into theinternal passage209 to retain thesmaller portion205 therein. The nestabletubular portion203 may have a cross-section, such as a cylindrical, ovoid, or any other cross-section. Various cross-sectional profiles are depicted herein inFIGS. 12-20 (cross-sectional profiles7). Moreover, thecross-sectional profile7 of the nestabletubular portion203 may adapt to at least partially correspond to a shape of an organ that the nestabletubular portion203 is resting against.
• With reference toFIG. 1A-3, thegastroesophageal reflux preventer6 may comprise an elongate portion configured as a perforated sheathedpreventer10. The perforated sheathedpreventer10 may include similar features as the sheathed preventer8 discussed above. Moreover, thegastroesophageal reflux preventer6 may also, in addition to the perforated sheathedpreventer10, include asupport string3 as discussed. However, the perforated sheathedpreventer10 may include a perforatedtubular portion11 which, though similar to the sheathed preventer8, may also include one or more set of perforations defined through the perforatedtubular portion11. Sets of perforations may be spaced at different stations along the length of the perforatedtubular portion11. The perforatedtubular portion11 may be separated, such as by tearing or cutting at one or more set of perforations. In this manner, the perforated sheathedpreventer10 may be “one size fits all” meaning that the length of the perforated sheathedpreventer10 may be readily shortened to correspond to a desired geometry. For instance, thegastroesophageal reflux preventer6 may be shortened during a surgical installation so that it corresponds to a circumference of a specific patient's esophagus. Moreover, a length of the perforatedtubular portion11 may be shortened independently of asupport string3 extending therethrough. Thus, the scarring profile may be tailored to a patient's needs. For instance, by extending only 270 degrees or some other extent less than 360 degrees around an esophagus, the perforatedtubular portion11 may cause a scarring profile tailored to a particular patient's degree of esophageal motility.
• In various instances, the perforated sheathedpreventer10 is filled. In further instances, the perforated sheathedpreventer10 is hollow. A filled perforated sheathedpreventer10 may be filled with a same or similar solid meshed absorbable material. The filling may be continuous, or may be intermittent. For instance,FIG. 29 depicts a sheathed preventer8 further comprising spacednodes58. Similar spacednodes58 may be provided for perforated sheathedpreventer10. Spacednodes58 may include locally filled regions of a perforated sheathedpreventer10.
• With reference toFIGS. 1A-B and4, thegastroesophageal reflux preventer6 may comprise an elongate portion configured as a sectionedsheath preventer12. A sectionedsheath preventer12 may be analogous to a sheathed preventer8, but divided into sections. Thus, a sectionedsheath preventer12 may include a plurality of sectionedtubular portions13. A sectionedtubular portion13 may comprise a tube made from an absorbable material. In various embodiments, the sectionedtubular portion13 comprises a rounded solid meshed absorbable material. The plurality of sectionedtubular portions13 may be curved so as to each comprise an arcuate tube. The plurality of sectionedtubular portions13 may be rigid. In further instances, the plurality of sectionedtubular portions13 may be flexible. Moreover, each of the plurality of sectionedtubular portions13 may have open or closed ends, or one open end and one closed end, may be filled, may be hollow, or may be partially filled or partially hollow. Sectionedtubular portions13 may have a size, shape, and spacing corresponding to a scarring profile chosen based on a given patient's degree of reduction of esophageal motility. In this manner the shape and extent of scarification may be selected to promote patient-specific desired therapeutic effects.
• The absorbable material may be synthetic absorbable surgical suture, such as a monofilament prepared from a copolymer of glycolide and epsilon-caprolactone. For example, the absorbable material may be poliglecaprone 25, Monocryl® available from Ethicon, and/or the like. Moreover, the absorbable material may be a synthetic absorbable surgical suture such as may be formed of a copolymer made from 90% glycolide and 10% L-lactide. For example, the absorbable material may be polyglactin 910, Vicryl® available from Ethicon, and/or the like. In various embodiments, the absorbable material may be prepared from the polyester, poly (p-dioxanone). For example, the absorbable material may be polydioxanone, PDS® II available from Ethicon, and/or the like. One may appreciate that in further embodiments, the absorbable material may be any suitable material identified by a skilled artisan.
• With reference toFIGS. 1A-B and5, thegastroesophageal reflux preventer6 may comprise an elongate portion configured as a linkednode preventer14. A linkednode preventer14 may comprise a plurality of modules of absorbable material that are connected together by one or more string linking module to module. For example, a linkednode preventer14 may comprise one or moretrapezoidal node16.Trapezoidal node16 may comprise a trapezoidally shaped block of absorbable material. With reference toFIG. 6, linkednode preventer14 may comprise one or more rounded node17. A rounded node17 may comprise a trapezoidally shaped block of absorbable material with one or more edge and/or corner that is rounded. With reference toFIG. 7A, linkednode preventer14 may comprise one or morespherical node18. Aspherical node18 may comprise a spherically shaped block of absorbable material. With reference toFIG. 7B, linkednode preventer14 may comprise one or moreannular node19. Anannular node19 may comprise an annularly shaped block of absorbable material defining an aperture. Moreover, the various nodes described herein may, in certain embodiments, be curved so as to each comprise an arcuate node. In various instances, the nodes may be rigid, whereas in further instances, the nodes may be flexible. The curve may correspond to a curve of a surface of an organ, such as a curved surface of an esophagus.
• With reference toFIGS. 1A-B and8, in various instances, thegastroesophageal reflux preventer6 comprises an elongate portion configured as asheet preventer20. Asheet preventer20 may comprise a strip of absorbable material. The strip of absorbable material may be tie-able at the ends. For example, the strip of absorbable material may have a first end and a second end. The first end may be an opposite end of the strip from the second end. The first end and second end may be tie-able ends101. Thus, theclosure mechanism15 may be integral with thesheet preventer20. For shorthand ease of reference, the tie-able ends101 may be referred to herein as portions of a support string, though no string may be provided and thesheet preventer20 may be a one piece apparatus.
• With reference toFIGS. 1A-B and9, thegastroesophageal reflux preventer6 may comprise an elongate portion configured as aperforated sheet preventer22. Theperforated sheet preventer22 may include similar features as thesheet preventer20 discussed above. However, theperforated sheet preventer22 may include aperforated sheet portion23 which, though similar to thesheet preventer20, may also include one or more set ofperforations25 defined through theperforated sheet portion23. Sets ofperforations25 may be spaced at different stations along the length of theperforated sheet portion23. Theperforated sheet portion23 may be separated, such as by tearing or cutting, at one or more set ofperforations25. In this manner, theperforated sheet portion23 may be “one size fits all” meaning that the length of theperforated sheet portion23 may be readily shortened to correspond to a desired geometry. For instance, thegastroesophageal reflux preventer6 may be shortened during a surgical installation so that it corresponds to a circumference of a specific patient's esophagus, or a desired scarring profile depending on a patient's physiology, esophageal motility, treatment objectives, etc.
• With reference toFIGS. 1A-B and10, thegastroesophageal reflux preventer6 may comprise an elongate portion configured as a one-side notchedsheet preventer24. The one-side notchedsheet preventer24 may include similar features as thesheet preventer20 discussed above. However, the one-side notchedsheet preventer24 may include a notchedsheet portion27 which, though similar to thesheet preventer20, may also includefirst edge notches29.First edge notches29 are spaced apart notches along a first edge.First edge notches29 may be spaced at different stations along the length of the notchedsheet portion27. The notchedsheet portion27 may be separated, such as by tearing or cutting, at one or morefirst edge notches29. In this manner, the notchedsheet portion27 may be “one size fits all” meaning that the length of the notchedsheet portion27 may be readily shortened to correspond to a desired geometry. For instance, thegastroesophageal reflux preventer6 may be shortened during a surgical installation so that it corresponds to a circumference of a specific patient's esophagus, or a desired scarring profile depending on a patient's physiology, esophageal motility, treatment objectives, etc.
• With reference toFIGS. 1A-B and11, thegastroesophageal reflux preventer6 may comprise an elongate portion configured as a dual-side notchedsheet preventer26. The dual-side notchedsheet preventer26 may include similar features as thesheet preventer20 discussed above. However, the dual-side notchedsheet preventer26 may include a notchedsheet portion27 which, though similar to thesheet preventer20, may also includefirst edge notches29 and also includessecond edge notches31.First edge notches29 are spaced apart notches along a first edge of the notchedsheet portion27.First edge notches29 may be spaced at different stations along the length of the notchedsheet portion27.
• Second edge notches31 are spaced apart notches along a second edge of the notchedsheet portion27 opposite thefirst edge notches29.Second edge notches31 may be spaced at different stations along the length of the notchedsheet portion27. In various embodiments, thefirst edge notches29 and thesecond edge notches31 are spaced apart along their respective first and second edges of the notchedsheet portion27 such that eachfirst edge notch29 corresponds to asecond edge notch31 at a same station along the length of the notchedsheet portion27. Moreover, the notchedsheet portion27 may be separated, such as by tearing or cutting, at one or morefirst edge notches29 and at one of the one or moresecond edge notches31. For instance, a tear or cut may be started at afirst edge notch29 and end at asecond edge notch31. Alternatively, a tear or cut may be started at asecond edge notch31 and may end at afirst edge notch29. In this manner, the notchedsheet portion27 may be “one size fits all” meaning that the length of the notchedsheet portion27 may be readily shortened to correspond to a desired geometry. For instance, thegastroesophageal reflux preventer6 may be shortened during a surgical installation so that it corresponds to a circumference of a specific patient's esophagus, or a desired scarring profile depending on a patient's physiology, esophageal motility, treatment objectives, etc.
• Having introduced various embodiments ofgastroesophageal reflux preventer6, attention is shifted toFIGS. 1A-B and12-20 for a discussion of variouscross-sectional profiles7 that several of the differentgastroesophageal reflux preventers6 discussed herein may include. For example, section lines A-A are depicted inFIGS. 12-20 corresponding to a section view A-A. The section view A-A corresponds to across-sectional profile7 of the various differentgastroesophageal reflux preventers6. Thus, with reference toFIGS. 12-20, one may appreciate that in different embodiments, differentcross-sectional profiles7 may be adopted.
• For example, thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of an elongate portion configured as atubular portion9 of a sheathed preventer8. Thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of an elongate portion configured as a perforatedtubular portion11 of a perforated sheathedpreventer10. Thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of an elongate portion configured as a sectionedtubular portion13 of a sectioned sheath preventer12 (and different sectionedtubular portions13 of a same sectionedsheath preventer12 may have different cross-sectional profiles7). Thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of a node of an elongate portion configured as linkednode preventer14, including atrapezoidal node16, a rounded node17, aspherical node18, and/or anannular node19. Different nodes of a linkednode preventer14 may have differentcross-sectional profiles7. Thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of an elongate portion configured as asheet portion21 of asheet preventer20. Thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of an elongate portion configured as aperforated sheet portion23 of aperforated sheet preventer22. Thecross-sectional profiles7 discussed herein may comprise a cross-sectional shape of an elongate portion configured as a notchedsheet portion27 of a one-side notchedsheet preventer24. Thecross-sectional profiles7 discussed herein may comprise an elongate portion configured as a cross-sectional shape of a notchedsheet portion27 of a dual-side notchedsheet preventer26. In addition, different portions or aspects of agastroesophageal reflux preventer6 may have differentcross-sectional profiles7, for instance, thecross-sectional profile7 of agastroesophageal reflux preventer6 may change from location to location. Thecross-sectional profile7 may correspond to a desired scarring profile.
• More specifically, with reference toFIGS. 1A-B and12, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise atrapezoidal cross-section28. Atrapezoidal cross-section28 may comprise a rectangle. In further instances, atrapezoidal cross-section28 may comprise a square. Atrapezoidal cross-section28 may comprise a parallelogram. Atrapezoidal cross-section28 may comprise a rhombus. Atrapezoidal cross-section28 may comprise a trapezoid or quadrilateral or any four sided shape as desired. Moreover, the corners of thetrapezoidal cross-section28 may include acute angles, obtuse angles, right angles, curves, chamfers, and/or other features as desired.
• More specifically, with reference toFIGS. 1A-B and13, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise a concave cross-section30. A concave cross-section30 may comprise one or more arc. The one or more arc may be positioned to provide at least one surface of thegastroesophageal reflux preventer6 that is concave. When rested against an organ, such as a stomach and/or esophagus, the concavity faces the organ, such that the concavity corresponds to a gap between the organ and at least a portion of the concave surface of thegastroesophageal reflux preventer6. The gap is disposed between two regions of lesser gap and/or greater contact between the concave surface of thegastroesophageal reflux preventer6 and the organ.
• Furthermore, now with reference toFIGS. 1A-B and14, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise aconvex cross-section32. Aconvex cross-section32 may comprise one or more arc. The one or more arc may be positioned to provide at least one surface of thegastroesophageal reflux preventer6 that is convex. When rested against an organ, such as a stomach and/or esophagus, the convexity faces the organ. In various embodiments, the convexity corresponds to a gap between the organ and at least a portion of the convex surface of thegastroesophageal reflux preventer6. For example, the gap may be disposed on opposite sides an intermediate region of lesser gap and/or greater contact between the convex surface of thegastroesophageal reflux preventer6 and the organ.
• Moreover, in various embodiments the convexity corresponds to a profile of an organ. For example, an esophagus and a stomach may connect together. Body tissue proximate to the junction may have a curve, such as so that the esophagus wall transitions along a curvature to a stomach wall. The convexity may correspond to the shape of a union of an esophagus and a stomach. The convexity may correspond to a profile of an organ. In this manner, the surface of the convexity may rest against a corresponding surface of a body organ. Thus, aconvex cross-section32 may be said to nest against a curve of a body organ.
• Directing attention now toFIGS. 1A-B and15, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise aflat cross-section34. For example, aflat cross-section34 may include at least one planar surface. In various embodiments, one or more edge of the planar surface is rounded, such as to ameliorate force concentrations between an edge of the planar surface and body organ.
• Shifting focus now toFIGS. 1A-B and16, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise anoval cross-section36. Theoval cross-section36 may comprise a continuous arc of varying radius. Theoval cross-section36 may have a longer diameter and a shorter diameter. The longer diameter may facilitate improved contact area between a body organ and thegastroesophageal reflux preventer6 and the shorter diameter may facilitate correspondence of a profile of a portion of theoval cross-section36 to a corresponding surface of a body organ, such as to be said to nest against a curve of a body organ. In this manner, the shorter diameter may correspond to a shape of a union of an esophagus and a stomach, while the longer diameter may correspond to an improved contact area between a stomach and thegastroesophageal reflux preventer6.
• With reference toFIGS. 1A-B and17, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise around cross-section38. For example, theround cross-section38 may comprise a continuous arc of constant radius. Theround cross-section38 may facilitate improved contact area between a union of an esophagus and a stomach, for instance, theround cross-section38 may comprise a diameter selected to facilitate nesting of theround cross-section38 against a curve of a body organ, such as a shape of a union of an esophagus and a stomach.
• Agastroesophageal reflux preventer6 may include multiple portions of material that are collected together such as strands collected into a rope, strands collected into a braid, and/or similar. For instance, agastroesophageal reflux preventer6 may have across-sectional profile7 as shown inFIG. 18. With reference toFIGS. 1A-B and18, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise multiple cross-sections of multiple portions of material that are collected together to form thegastroesophageal reflux preventer6. For instance, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise a collection of round strands to form a larger cord-like strand, for instance, a collection of round cross-sections assembled to provide a strandedcross-section40. While the strandedcross-section40 shows a collection of strands that itself approximates the shape of the constituent strands, in further instances, the cross-section of each strand and the collection of the strands may be dissimilar. For instance, strands with a round cross-section (FIG. 17) may be assembled into a strandedcross-section40 that approximates a trapezoidal cross-section28 (FIG. 12).
• With reference toFIGS. 1A-B and19, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise a t-shape cross-section42. For example, the cross-section may include at least two arms joining at an angle. In various instances, t-shape cross-section42 comprises two arms bisecting at a right angle. Stated differently, t-shape cross-section42 may comprise four arms extending outwardly from a junction wherein each arm is at a right angle to at least two other such arms and parallel to at least one other such arm. One may appreciate that the different arms may be of different lengths, and may be at angles other than right angles with respect to each other, for instance, a t-shape cross-section42 may resemble an X-shape, in further embodiments.
• In further instances, across-sectional profile7 of agastroesophageal reflux preventer6 may comprise an L-shape cross-section44, such as is depicted inFIG. 20. With reference toFIGS. 1A-B and20, an L-shape cross-section44 may comprise two arms joining at an angle. In various instances, the L-shape cross-section44 may comprise two arms extending outwardly from a junction where the two arms join at a right angle. One may appreciate that the arms may be of different lengths, and may be at angles other than a right angle with respect to each other, for instance, L-shape cross-section44 may resemble a V-shape, in further embodiments.
• Having introduced a variety of embodiments ofgastroesophageal reflux preventers6 comprising a variety of configurations, attention is now directed to the previously mentioned closure mechanism15 (FIG. 1). Various differentgastroesophageal reflux preventers6 may includevarious closure mechanisms15 in order to retain thegastroesophageal reflux preventer6 to an organ, such as an esophagus and/or stomach. In various instances, theclosure mechanism15 does not connect thegastroesophageal reflux preventer6 in direct fixation to the organ, but captures thegastroesophageal reflux preventer6 in loose proximity to the organ. For instance, opposite ends of an aspect of thegastroesophageal reflux preventer6 may be tied about an esophagus, retaining thegastroesophageal reflux preventer6 in proximity to the esophagus but not requiring suturing directly to the esophagus.
• With reference toFIGS. 1A-B and21-25, a few example embodiments of aclosure mechanism15 are provided. For example, with reference toFIGS. 1A-B and21, aclosure mechanism15 may comprise aknot5. Aknot5 may be formed in asupport string3 as mentioned herein, or aknot5 may be formed in opposite ends of a portion such as atubular portion9, perforatedtubular portion11, sectionedtubular portion13, and or the previously mentioned tie-able ends101 (seeFIGS. 1A-19) that have been discussed.
• Aknot5 may comprise abow knot closure46. For instance, as shown inFIG. 21, abow knot closure46 may be tied such that a bow knot is formed, such as to facilitate easy release of theknot5 for later removal and/or adjustment. With reference toFIG. 22, aknot5 may comprise asquare knot closure48, such that a square knot is tied.
• Turning attention toFIG. 23, aclosure mechanism15 may comprise aninward clasp closure50. For instance, apin47 may be provided to be received into aslot49 attached to thepin47 such as by deformation and snap fitting, or by friction fitting, and/or the like. The combination of thepin47 andslot49 may be disposed inwardly of the closed outer boundary (e.g., inwardly of the outward edge of the elongate portion) of thegastroesophageal reflux preventer6 when thepin47 andslot49 are connected. In further instances, and as shown inFIG. 24, aclosure mechanism15 may comprise anoutward clasp closure52. Anoutward clasp closure52 may include asimilar pin47 andslot49 aspect, however, the combination of thepin47 andslot49 may be disposed outwardly of the closed inner boundary (e.g., outward of the inner edge of the elongate portion) of thegastroesophageal reflux preventer6 when thepin47 andslot49 are connected.
• Finally, and with reference toFIGS. 1A-B and25, a one-way insertion closure54 may be provided. Aclosure mechanism15 comprising a one-way insertion closure54 may provide for easy closure by medical personnel during installation of thegastroesophageal reflux preventer6, but may resist opening following installation, so as to facilitate reliable emplacement without migration in a living body.
• For example, agastroesophageal reflux preventer6 may include asupport string3 mentioned elsewhere herein. Thesupport string3 may have two ends extending oppositely from thegastroesophageal reflux preventer6. The one-way insertion closure54 may include a thickenedtab57 attached proximate to a first end of thesupport string3, and a slottedreceiver53 attached proximate to a second end of thesupport string3 opposite the first end.
• A thickenedtab57 may comprise a portion of asupport string3, or a separate member attached to the end of thesupport string3, that is thicker than thesupport string3. In various embodiments, the thickenedtab57 is only partially thicker than thesupport string3. For example, the thickenedtab57 may be tapered such that a tip of the thickenedtab57 is thinner than a root of the thickenedtab57 where the root is the end of the thickenedtab57 closest to thesupport string3 and the tip is the end of the thickenedtab57 cantilevered distally farthest from thesupport string3. In various embodiments, the thickenedtab57 may be cone-shaped. Thus the thickenedtab57 may be self-aligning with a slottedreceiver53, so that the thin tip readily inserts into a portion of a slottedreceiver53, and as the thickenedtab57 is inserted further into the slottedreceiver53, the thickenedtab57 progressively fills the slottedreceiver53. The thickenedtab57 may be sized to progressively become larger than a corresponding aperture in the slottedreceiver53, such that the thickenedtab57 is compressed during insertion into an aperture of the slottedreceiver53, and following passage through the aperture of the slottedreceiver53, uncompresses to become larger than the aperture, such that the thickenedtab57 is restricted from passing oppositely through the aperture and disconnecting therefrom.
• The slottedreceiver53 may comprise a portion of asupport string3, or a separate member attached to an end of thesupport string3. The slottedreceiver53 may be a spaced node58 (FIG. 29), or a sectionedtubular portion13 of a sectioned sheath preventer12 (FIG. 4), or a node of a linked node preventer14 (FIGS. 5-7B), or may be an aperture of asheet portion21 of a sheet preventer20 (FIG. 8), or may be an aperture of aperforated sheet portion23 of a perforated sheet preventer22 (FIG. 9) or may be an aperture of a notchedsheet portion27 of a one-side notched sheet preventer24 (FIG. 10) or of a dual-side notched sheet preventer26 (FIG. 11). The slottedreceiver53 may comprise an annular node19 (FIGS. 7B, 26) of a linked node preventer14 (FIGS. 7B, 26) defining an aperture through an annulus. The thickenedtab57 may be insertable through theannular node19.Annular nodes19 may be positioned along the support string so that a variety of options for insertion of the thickenedtab57 are available. In this manner, the length of thegastroesophageal reflux preventer6 may be tailored to a specific patient's needs, and thenexcess support string3 and/or excessannular nodes19 may be cut free and removed.
• Having introduced various configurations ofgastroesophageal reflux preventers6, various examples of different embodiments that combine subsets of features will now be discussed. Turning first toFIG. 26, agastroesophageal reflux preventer6 may include a linkednode preventer14 withannular nodes19 spaced apart along asupport string3. Thesupport string3 has two ends that may be tied about an esophagus. Alternatively, thesupport string3 may have aclosure mechanism15 comprising a one-way insertion closure54 with a thickenedtab57 at one end of thesupport string3 and a slottedreceiver53 provided by anannular node19 at the other end of thesupport string3. In various embodiments, medical personnel installing thegastroesophageal reflux preventer6 may select from among multiple differentannular nodes19, so as to size thegastroesophageal reflux preventer6 to a specific patient's specific anatomy. The excessannular nodes19 andexcess support string3 remaining after insertion of a thickenedtab57 into a slottedreceiver53 may be cut free and removed from a patient's body.
• Turning now toFIGS. 27 and 28, another embodiment includes a sheathed preventer8 in combination with aclosure mechanism15 comprising a one-way insertion closure54. Atubular portion9 of a sheathed preventer8 may have asupport string3 extending through it, and/or havingseparate support string3 portions attached to opposite ends thereof. A one-way insertion closure54 may include a thickenedtab57 from one end of thesupport string3 and a slottedreceiver53 from another end of thesupport string3. In various instances, the slottedreceiver53 may be an annulus defining an aperture to receive the thickenedtab57, such as anannular node19.
• A further embodiment is depicted inFIG. 29. For instance, a sheathed preventer8 has been discussed elsewhere herein, however, in various embodiments a sheathed preventer8 includes spacednodes58 included as a part of atubular portion9 having asupport string3 extending through it, and/or havingseparate support string3 portions attached to opposite ends thereof. The sheathed preventer8 may be combined with aclosure mechanism15 comprising a one-way insertion closure54. A one-way insertion closure54 may include a thickenedtab57 from one end of thesupport string3 and a slottedreceiver53 from another end of thesupport string3. In various instances, the slottedreceiver53 may be an annulus defining an aperture to receive the thickenedtab57, such as anannular node19.
• Yet a further embodiment is depicted inFIG. 30 wherein a sectionedsheath preventer12 is provided in connection withsupport string3 and aclosure mechanism15 comprising aknot5.
• With reference toFIG. 31, agastroesophageal reflux preventer6 comprising a braidedmulti-strand preventer160 is provided. Agastroesophageal reflux preventer6 may include an elongate portion configured as a braidedmulti-strand preventer160. The braidedmulti-strand preventer160 may comprise multiple strands of absorbable material that are braided together. In various instances, the multiple strands may be a same material as asupport string3 discussed elsewhere herein. The braidedmulti-strand preventer160 may comprise a first strand161-1, a second strand161-2, and any number N of strands, such as an N^thstrand161-n. Asupport string3 may, in various embodiments, be omitted.
• With reference toFIG. 32-35,gastroesophageal reflux preventer6 comprising an elongate portion configured as a chain-link preventer180 is provided. The chain-link preventer180 may comprise multiple links of absorbable material that are joined as a chain. The links may have different shapes. For example, a link may be round, such as around link182, or may be elliptical or otherwise stretched as astretched link184, or may be trapezoidal, as atrapezoidal link186, or may be any shape as desired. For instance, the links may be herringbone, Figaro, ball, belcher, trace, box, snake, curb, wheat link, rope, rolo, popcorn, or any link style as desired.
• Finally, and with reference toFIG. 36-40, agastroesophageal reflux preventer6 comprising an elongate portion configured as a bangle preventer190 is provided. A bangle preventer190 comprises a first portion192 comprising a curved member of absorbable material and a second portion194 comprising a curved member of absorbable material, the first portion192 and the second portion194 joined by aflexible portion198. Theflexible portion198 further may comprise absorbable material. For instance, a score line of the first portion192 and/or the second portion194 may facilitate a bending of the first portion192 and second portion194 relative to each other, thereby providing theflexible portion198. In various embodiments,flexible portion198 comprises abendable section197 such as may have a greater flexibility and/or elasticity than at least one of the first portion192 and/or second portion194. In further embodiments,flexible portion198 comprises ahinge199, so that at least one of the first portion192 and the second portion194 may be pivoted.
• The first portion192 and the second portion194 may be joinable together by aclosure mechanism15. In various embodiments, theclosure mechanism15 comprises anabutment closure195. For instance, the first portion192 and the second portion194 may at least partially abut proximate to an end of the first portion192 and an end of the second portion194. The abutting region may be sutured together, or may be magnetically attracted together, or may comprise mechanically interlocking features, etc.
• Various benefits and advantages have been described herein with regard to specific embodiments. Furthermore, the connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system. However, the benefits, advantages, and any elements that may cause any benefit or advantage to occur or become more pronounced are not to be construed as critical, required, or essential features or elements of the disclosure. The scope of the disclosure is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” Moreover, where a phrase similar to “at least one of A, B, or C” is used in the claims, it is intended that the phrase be interpreted to mean that A alone may be present in an embodiment, B alone may be present in an embodiment, C alone may be present in an embodiment, or that any combination of the elements A, B and C may be present in a single embodiment; for example, A and B, A and C, B and C, or A and B and C.
• The foregoing features and elements may be combined in various combinations without exclusivity, unless expressly indicated otherwise. These features and elements as well as the operation thereof will become more apparent in light of the following description and the accompanying drawings. It should be understood, however, the following description and drawings are intended to be exemplary in nature and non-limiting.
• Systems, methods and apparatus are provided herein. In the detailed description herein, references to “various embodiments”, “one embodiment”, “an embodiment”, “an example embodiment”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments.
• Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112(f), unless the element is expressly recited using the phrase “means for.” As used herein, the terms “comprises”, “comprising”, or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

Claims (27)

1. A gastroesophageal reflux preventer comprising:

an elongate portion of an absorbable material having a first end and a second end;

a support string having a first portion extending outwardly from the first end and having a second portion extending outwardly from the second end; and

a closure mechanism configured to retain at least a portion of the elongate portion in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of the elongate portion.

2. The gastroesophageal reflux preventer according toclaim 1, wherein the closure mechanism comprises a knot connecting the first portion of the support string to the second portion of the support string.

3. The gastroesophageal reflux preventer according toclaim 1, wherein the closure mechanism comprises an inward clasp closure comprising a pin attached to the first portion of the support string and a slot attached to the second portion of the support string to receive the pin, wherein the inward clasp closure is disposed inwardly of an outward edge of the elongate portion of the gastroesophageal reflux preventer when the pin and the slot are engaged.

4. The gastroesophageal reflux preventer according toclaim 1, wherein the closure mechanism comprises an outward clasp closure comprising a pin attached to the first portion of the support string and a slot attached to the second portion of the support string to receive the pin, wherein the outward clasp closure is disposed outwardly of an inner edge of the elongate portion of the gastroesophageal reflux preventer when the pin and the slot are engaged.

5. The gastroesophageal reflux preventer according toclaim 1, wherein the closure mechanism comprises a one-way insertion closure comprising a thickened tab attached to the first portion of the support string and slotted receiver attached to the second portion of the support string to receive the thickened tab.

6. The gastroesophageal reflux preventer according toclaim 1, wherein the elongate portion comprises a sectioned tubular portion having a plurality of sections spaced apart along a length of the support string.

7. The gastroesophageal reflux preventer according toclaim 1, wherein the elongate portion comprises a tube through which the support string passes.

8. The gastroesophageal reflux preventer according toclaim 1, wherein the elongate portion comprises a tube wherein the support string extends from ends of the tube but does not pass internally through the tube.

9. The gastroesophageal reflux preventer according toclaim 1, wherein the elongate portion comprises a perforated tubular portion having spaced apart perforations such that the perforated tubular portion may be provided at an overall desired length by separating at least one perforation.

10. A gastroesophageal reflux preventer comprising:

a plurality of nodes comprising pieces of an absorbable mesh material linked together by a support string;

the support string having a first portion extending outwardly from a first end of the plurality of nodes linked together and having a second portion extending outwardly from a second end of the plurality of nodes linked together; and

a closure mechanism configured to retain at least a portion of the plurality of nodes in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of at least one node of the plurality of nodes.

11. The gastroesophageal reflux preventer according toclaim 10, wherein a knotted portion of the first portion and the second portion of the support string comprises the closure mechanism.

12. The gastroesophageal reflux preventer according toclaim 10, wherein a plurality of nodes extend no more than 270 degrees around a portion of a body organ, wherein the support string extends a remaining 90 degrees around a portion of the body organ.

13. The gastroesophageal reflux preventer according toclaim 10, wherein the at least one node comprises an annular node defining an aperture.

14. The gastroesophageal reflux preventer according toclaim 13, wherein the closure mechanism comprises a one-way insertion closure comprising a thickened tab attached to the first portion of the support string and a slotted receiver attached to the second portion of the support string to receive the thickened tab, the slotted receiver comprising the annular node defining the aperture and the thickened tab receivable into the aperture.

15. The gastroesophageal reflux preventer according toclaim 10, wherein the closure mechanism comprises a knot connecting the first portion of the support string to the second portion of the support string.

16. The gastroesophageal reflux preventer according toclaim 10, wherein the closure mechanism comprises a pin attached to the first portion of the support string and a slot attached to the second portion of the support string to receive the pin.

17. The gastroesophageal reflux preventer according toclaim 10, wherein the closure mechanism comprises a one-way insertion closure comprising a thickened tab attached to the first portion of the support string and slotted receiver attached to the second portion of the support string to receive the thickened tab.

18. A method of making a gastroesophageal reflux preventer comprising:

providing an elongate portion of an absorbable material having a first end and a second end;

providing a support string having a first portion extending outwardly from the first end and having a second portion extending outwardly from the second end; and

providing a closure mechanism configured to retain at least a portion of the elongate portion in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of the elongate portion.

19. The method of making the gastroesophageal reflux preventer according toclaim 18, wherein providing the closure mechanism includes providing an inward clasp closure comprising a pin attached to the first portion of the support string and a slot attached to the second portion of the support string to receive the pin, wherein the inward clasp closure is disposed inwardly of an outward edge of the elongate portion of the gastroesophageal reflux preventer when the pin and the slot are engaged.

20. The method of making the gastroesophageal reflux preventer according toclaim 18, wherein providing the closure mechanism includes providing an outward clasp closure comprising a pin attached to the first portion of the support string and a slot attached to the second portion of the support string to receive the pin, wherein the outward clasp closure is disposed outwardly of an inner edge of the elongate portion of the gastroesophageal reflux preventer when the pin and the slot are engaged.

21. The method of making the gastroesophageal reflux preventer according toclaim 18, wherein providing the closure mechanism includes providing a one-way insertion closure comprising providing a thickened tab attached to the first portion of the support string and providing a slotted receiver attached to the second portion of the support string to receive the thickened tab.

22. The method of making the gastroesophageal reflux preventer according toclaim 18, wherein the elongate portion comprises a sectioned tubular portion having a plurality of sections spaced apart along at least a portion of length of the support string.

23. The method of making the gastroesophageal reflux preventer according toclaim 22, wherein the at least the portion of length of the support string comprises no more than 270 degrees around at least a portion of a body organ when installed in a body.

24. The method of making the gastroesophageal reflux preventer according toclaim 18, further including passing the support string through the elongate portion.

25. The method of making the gastroesophageal reflux preventer according toclaim 18, further including providing spaced apart perforations along the elongate portion.

26. A method of reducing leakage of a body fluid through a gastroesophageal sphincter comprising:

resting an elongate portion of a gastroesophageal reflux preventer against at least one of a stomach and an esophagus proximate to the gastroesophageal sphincter; and

retaining at least a portion of the elongate portion in contact with the at least one of the stomach and the esophagus by encircling at least one of the elongate portion and a support string extending outwardly from the elongate portion about the at least one of the stomach and the esophagus and engaging a closure mechanism;

wherein engaging the closure mechanism comprises knotting together (i) a first portion of the support string extending outwardly from a first end of the elongate portion and (ii) a second portion of the support string extending outwardly from a second end of the elongate portion.

27. A gastroesophageal reflux preventer comprising:

an elongate portion of an absorbable material having a first end and a second end; and

a closure mechanism comprising a knotting together of the first end and the second end to retain at least a portion of the elongate portion in contact with a body organ during at least a portion of a scarification of the body organ in response to absorption by the body organ of the elongate portion.

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