WO2025149768A1

WO2025149768A1 - Soft tissue prosthesis for repairing sunken anus

Info

Publication number: WO2025149768A1
Application number: PCT/IB2024/050142
Authority: WO
Inventors: Ehsan MERAT; Simin SAMANI
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-01-08
Filing date: 2024-01-08
Publication date: 2025-07-17
Anticipated expiration: 2026-07-08

Abstract

A soft tissue prosthesis for repairing sunken anus comprising a curved support layer and a curved tubular structure. The curved tubular structure may comprise an elastomeric exterior cover and an internal lumen filled with an elastomer gel. The curved tubular structure may be coupled to one side of the curved support layer further apart from a peripheral edge of the curved support layer such that a peripheral zone may be defined between the peripheral edge of the curved support layer and the elastomeric exterior cover of the curved tubular structure. The curved tubular structure may be extended longitudinally along the one side of the curved support layer from a first end to a second end of the curved support layer.

Description

SOFT TISSUE PROSTHESIS FOR REPAIRING SUNKEN ANUS

TECHNICAL FIELD

[0001] The present disclosure generally relates to an exemplary soft tissue prosthesis for repairing sunken anus, and more particularly to an exemplary soft tissue prosthesis for repairing sunken anus in mares.

BACKGROUND

[0002] Pelvic conformation of mares plays a crucial role in reproductive health, as a significant number of mares experiencing reproductive issues often exhibit a flattened croup, elevated tailhead, and a downward incline in the pelvis. Mare’s sunken anus may be linked to the formation of a shelf on the dorsal aspect of the vulva, resulting in a risk of fecal contamination in vagina. Sunken anus may manifest in mares of any age but is frequently observed in older or undernourished individuals, leading to a sunken anus that results in the elevation of upper vulva into a horizontal alignment. Previous foalings may cause injuries to cervix and vagina, potentially enabling the infiltration of infections beyond these anatomical structures. Meanwhile, mares exhibiting inadequate body condition or young fillies in optimal racing form but lacking perineal fat frequently display suboptimal perineal conformation, increasing their susceptibility to pneumovagina.

[0003] Upon identifying irregular perineal conformation, a veterinarian may assess and determine an optimal intervention. In numerous cases, applying a Caslick suture may prove effective in resolving concerns related to both air and fecal contamination, ultimately restoring fertility. For instances involving more pronounced anatomical abnormalities, more extensive interventions such as perineal reconstructive surgery or perineal body transection may be required. Surgical procedures may give rise to diverse complications, including formation of gaps between vulvar lips, potential for trauma during foaling caused by a closed vulva, and thickening of sutures with each replacement of Caslick sutures. Thus, there is need to develop less invasive techniques for treating sunken anus in mares.

SUMMARY

[0004] This summary is intended to provide an overview of the subject matter of the present disclosure, and is not intended to identify essential elements or key elements of the subject matter, nor is it intended to be used to determine the scope of the claimed implementations. Its sole purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description that is presented later. The proper scope of the present disclosure may be ascertained from the claims set forth below in view of the detailed description below and the drawings.

[0005] One or more exemplary embodiments describe an exemplary soft tissue prosthesis for repairing sunken anus. In an exemplary embodiment, an exemplary prosthesis may comprise an exemplary curved support layer and an exemplary curved tubular structure. In an exemplary embodiment, an exemplary curved tubular structure may comprise an exemplary silicone exterior cover and an exemplary internal lumen filled with an exemplary cohesive silicone gel. In an exemplary embodiment, an exemplary curved tubular structure may be coupled to one side of an exemplary curved support layer further apart from peripheral edge of an exemplary curved support layer such that an exemplary peripheral zone may be defined between peripheral edge of an exemplary curved support layer and an exemplary silicone exterior cover.

[0006] In an exemplary embodiment, an exemplary curved tubular structure may be extended longitudinally along an exemplary one side of curved support layer from a first end to a second end of an exemplary curved support layer. In an exemplary embodiment, an exemplary curved tubular structure may comprise a same first height at exemplary first and second endings of an exemplary curved tubular structure. In an exemplary embodiment, an exemplary curved tubular structure may further comprise an exemplary second height at a middle of an exemplary curved tubular structure that may be more than an exemplary first height at exemplary first and second endings of an exemplary curved tubular structure.

[0007] This Summary may introduce a number of concepts in a simplified format; the concepts are further disclosed within the “Detailed Description” section. This Summary is not intended to configure essential/key features of the claimed subject matter, nor is intended to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The novel features which are believed to be characteristic of the present disclosure, as to its structure, organization, use and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawings in which a presently preferred embodiment of the present disclosure will now be illustrated by way of example. It is expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the present disclosure. Embodiments of the present disclosure will now be described by way of example in association with the accompanying drawings in which:

[0009] FIG. 1A illustrates a perspective view of an exemplary prosthesis for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure;

[00010] FIG. IB illustrates a front view of an exemplary prosthesis for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure;

[00011] FIG. 1C illustrates a bottom view of an exemplary prosthesis for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure;

[00012] FIG. ID illustrates a top view of an exemplary prosthesis for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure; [00013] FIG. IE illustrates a rear view of an exemplary prosthesis for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure;

[00014] FIG. IF illustrates a side view of an exemplary prosthesis for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure;

[00015] FIG. 2 illustrates transverse cross-sectional view of an exemplary prosthesis, consistent with one or more exemplary embodiments of the present disclosure;

[00016] FIG. 3 illustrates a dorsal view of an exemplary mare with two exemplary incisions at 4 and 8 o’clock around rectum, consistent with one or more exemplary embodiments of the present disclosure;

[00017] FIG. 4 illustrates a surface view of exemplary incisions at 4 and 8 o’clock with an exemplary prosthesis subcutaneously implanted at perineal region of an exemplary mare, consistent with one or more exemplary embodiments of the present disclosure; and

[00018] FIG. 5 illustrates a dorsal view of an exemplary mare after implanting an exemplary prosthesis at perineal region and suturing exemplary incisions at 4 and 8 o’clock, consistent with one or more exemplary embodiments of the present disclosure.

DETAILED DESCRIPTION

[00019] In the following detailed description, numerous specific details are set forth by way of examples to provide a thorough understanding of the relevant teachings related to the exemplary embodiments. However, it should be apparent that the present teachings may be practiced without such details. In other instances, well known methods, procedures, components, and/or circuitry have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings.

[00020] The following detailed description is presented to enable a person skilled in the art to make and use the methods and devices disclosed in one or more exemplary embodiments of the present disclosure. For purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the present disclosure. However, it will be apparent to one skilled in the art that these specific details are not required to practice the disclosed exemplary embodiments. Descriptions of specific exemplary embodiments are provided only as representative examples. Various modifications to the exemplary implementations will be plain to one skilled in the art, and the general principles defined herein may be applied to other implementations and applications without departing from the scope of the present disclosure. The present disclosure is not intended to be limited to the implementations shown, but is to be accorded the widest possible scope consistent with the principles and features disclosed herein.

[00021] The occurrence of reproductive failure in mares, due to sunken anus, may pose a significant challenge for an attending veterinarian. Identifying and addressing numerous factors contributing to conception failure or challenges in maintaining pregnancy to term may often be straightforward in diagnosis and amenable to effective treatment. In certain instances, a combined approach involving both medical intervention and surgical procedures may be required to attain a favorable outcome. Sunken anus may manifest at any age, although it is more frequently observed in older or underweight mares. In such cases, anus undergoes a concave deformation, causing an upper part of vulva to adopt a horizontal orientation. Insufficient vulvar seal in mares poses a risk of air aspiration and subsequent vaginal contamination, potentially leading to subfertility through the progression of vaginitis to cervicitis and acute endometritis. Age-related trauma and decreased muscular tone may compromise vulvar seal, increasing a mare's vulnerability to pneumovagina or 'wind sucking.' Additionally, vulvar inclination due to anus recession or poor labial muscular tone may elevate the risk of ascending reproductive tract infections. Deficiencies in vulvar conformation, whether congenital (though rare) or acquired, may result from vulvar stretching post-multiple foaling, perineal injuries during foaling or breeding, or poor body condition in older, thin mares. [00022] Disclosed herein is an exemplary soft tissue prosthesis for repairing sunken anus. In an exemplary embodiment, an exemplary soft tissue prosthesis may be used for repairing sunken anus in various mammals including, but not limited to, horses, cattle, pigs, sheep and goats, canines, and felines. Unlike procedures such as Caslick sutures, an exemplary soft tissue prosthesis may require only one surgical intervention. This may significantly reduce the overall stress and recovery time for an exemplary subject mammal (e.g., a mare) compared to multiple surgeries, leading to a quicker recovery period. This advantage may be particularly attractive to horse owners looking for solutions that minimize downtime and enable a faster return to regular activities. Furthermore, an exemplary soft tissue prosthesis may be designed to provide a customized fit for each individual case, ensuring optimal effectiveness based on variations in anatomy. The need for only one surgical procedure may contribute to a more cost-effective solution compared to multiple interventions required in traditional approaches. This may appeal to horse owners seeking economical yet effective treatments for their animals.

[00023] Referring to the figures, FIG. 1A illustrates a perspective view of prosthesis 100 for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure. FIG. IB illustrates a front view of prosthesis 100 for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure. FIG. 1C illustrates a bottom view of prosthesis 100 for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure. FIG. ID illustrates a top view of prosthesis 100 for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure. FIG. IE illustrates a rear view of prosthesis 100 for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure. FIG. IF illustrates a side view of prosthesis 100 for repairing sunken anus, consistent with one or more exemplary embodiments of the present disclosure. In further detail with respect to FIGs. 1A-F, prosthesis 100 may include curved support layer 102 and curved tubular structure 104, both having a U-shaped profile. In an exemplary embodiment, curved tubular structure 104 may be coupled to first side 106a of curved support layer 102 further apart from peripheral edge 108 of curved support layer 102. In an exemplary embodiment, curved tubular structure 104 may longitudinally extend along first side 106a of curved support layer 102, from first end 110a to second end 110b of curved support layer 102. In an exemplary embodiment, curved support layer 102 may have a thickness between about 0.7 mm and 1.3 mm. Meanwhile, in an exemplary embodiment, curved tubular structure 104 may have a diameter between about 13 mm and 17 mm.

[00024] In an exemplary embodiment, details of curved tubular structure 104 are illustrated in context of elements presented in FIG. 2. FIG. 2 illustrates transverse cross-sectional view 200 of prosthesis 100, consistent with one or more exemplary embodiments of the present disclosure. In further detail with respect to transverse cross-sectional view 200, in an exemplary embodiment, curved tubular structure 104 may comprise elastomeric exterior cover 202 and internal lumen 204 that may be filled with an exemplary elastomer gel. In an exemplary embodiment, elastomeric exterior cover 202 may include, but is not limited to, an exemplary silicone exterior cover. In an exemplary embodiment, internal lumen 204 may be filled with an exemplary cohesive silicone gel and/or an exemplary highly cohesive silicone gel.

[00025] In an exemplary embodiment, “silicone gel” may include repeating silicon-oxygen (Si-O) units, forming an exemplary polymer structure. Exemplary building blocks of silicone polymers may be siloxane units, which may consist of a silicon atom (Si) linked to oxygen atoms (O). "Cohesive silicone gel" may refer to a type of silicone gel that may possess a high degree of internal cohesion or molecular bonding. In the context of medical prosthetics, cohesive silicone gel may be employed as a filling material in breast implants and other exemplary soft tissue implants. In cohesive silicone gel, exemplary siloxane units may be arranged in a way that gives a high degree of internal cohesion to an exemplary material. Arrangement and cross-linking of siloxane units may contribute to a gel's stability, consistency, and resistance to deformation. In an exemplary embodiment, “highly cohesive silicone gel” may refer to an exemplary viscous cohesive silicone composed primarily of a polymeric cohesive gel. In an exemplary embodiment, an exemplary cross -linked polymeric silicone gel may be recognized as an inert material due to its robust durability and thermal stability, maintaining a consistent chemical and elastic properties. An exemplary cross-linked polymeric silicone gel may incorporate about 1-2% (w/w) low molecular weight (LMW) silicones, including hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecamethylcyclohexasiloxane, and tetradecamethylcycloheptasiloxane.

[00026] In an exemplary embodiment, an exemplary silicone exterior cover (i.e., elastomeric exterior cover 202) may include an exemplary medical-grade silicone. In an exemplary embodiment, “medical-grade silicone” may refer to a pourable two-component elastomer that may undergo a curing process, resulting in a translucent silicone rubber formation at a temperature level between about 20 °C and 25 °C (i.e., room temperature). In an exemplary embodiment, an exemplary elastomer component of an exemplary medical-grade silicone may comprise dimethylsiloxane polymer, reinforcing silica, and a platinum catalyst. Meanwhile, an exemplary curing agent component of an exemplary medical-grade silicone may include dimethylsiloxane polymer, an exemplary inhibitor, and a siloxane crosslinker. In an exemplary embodiment, manufacturing of medical-grade elastomer may adhere to precise specifications, ensuring compliance with rigorous quality standards specifically tailored for medical applications. In further detail with respect to prosthesis 100, elastomeric exterior cover 204 may be made of an exemplary medical-grade silicone with a specific gravity between about 1.08 and 1.14, durometer shore A between about 19 and 68, tensile strength between about 7.5 MPa and 10 MPa, and elongation between about 400% and 890%.

[00027] With continued reference to FIGs. 1A-F, prosthesis 100 may further include peripheral zone 112 (see FIG. ID) defined between peripheral edge 108 and elastomeric exterior cover 202 of curved tubular structure 104. In an exemplary embodiment, peripheral zone 112 may have a diameter between about 4 mm and 6 mm. In an exemplary embodiment, following the insertion of prosthesis 100 into perineal region of a mammal subject (ensuring that second side 106b of curved supporting layer 102 is in contact with perineal muscles), peripheral zone 112 may be surgically affixed to internal muscles within a perineal region of an exemplary mammalian subject (e.g., an exemplary mare). In an exemplary embodiment, surgically affixing peripheral zone 112 of prosthesis 100 may include suturing peripheral zone 112 to an exemplary internal muscles including, but not limited to, superficial transverse perineal muscles, deep perineal muscles, and levator ani muscles within perineal region of an exemplary mammal subject (e.g., an exemplary mare) to fix prosthesis 100 in perineum, situated between opening of vagina and rectum.

[00028] In an exemplary embodiment, an exemplary height of curved tubular structure 104, from base 114 to top 116, may vary along the length of curved tubular structure 104. In an exemplary embodiment, prosthesis 100 may be produced in different sizes with respect to individual properties of an exemplary mammal subject (e.g., mares) including but not limited to size, length, and slope of croup in different breeds, and angle of declination of vulva (i.e., effective vulva length). As illustrated in FIG. IB, in an exemplary embodiment, curved tubular structure 104 may have a same first height at first and second endings (118a and 118b, respectively), which are labeled as hi and hi', respectively. Meanwhile, in an exemplary embodiment, curved tubular structure 104 may have an exemplary second height (labeled as I12) at middle 120 of curved tubular structure 104 that may be more than an exemplary first height (hi and hi'). In an exemplary embodiment, diameter of prosthesis 100 may be determined based on an exemplary distance between first end 110a and second end 110b of curved support layer 102, which is labeled as “d” in FIG. IB. Table 1 bellow shows exemplary amounts of hi, hi', I12, and d with respect to mares’ effective vulva length. Table 2:

Exemplary amounts of first height (hi, hi') and second height (I12) of an exemplary curved tubular structure 104, and diameter (d) of prosthesis 100 with respect to an exemplary mare’s effective vulva length and rectal diameter, consistent with one or more exemplary embodiments of the present disclosure.

[00029] In an exemplary embodiment, prosthesis 100 may be produced by: forming an exemplary medical-grade silicone shell comprising curved support layer 102 and elastomeric exterior cover 202, and injecting an exemplary highly cohesive silicone gel into an exemplary medical-grade silicone shell. In an exemplary embodiment, forming an exemplary medical-grade silicone shell may include an exemplary process including: i) obtaining an exemplary plastic mold corresponding to an exemplary shape of curved support layer 102 and elastomeric exterior cover 202 of prosthesis 100; ii) affixing an exemplary plastic mold horizontally, with respect to the ground, on an exemplary variable speed rotator; iii) pouring an exemplary solution of medicalgrade silicone into an exemplary plastic mold while mixing using an exemplary variable speed rotator (e.g., at an exemplary speed of about 1-30 rpm) to generate an exemplary uniform and dried silicone texture; iv) curing an exemplary dried medical-grade silicone by placing an exemplary plastic mold (containing an exemplary dried medical-grade silicone) in an exemplary oven set at a temperature level of about 750 °C; and v) extracting an exemplary medical-grade silicone shell leaving an exemplary aperture on an exemplary cured medical-grade silicone for injection of highly cohesive silicone gel.

[00030] In an exemplary embodiment, injecting an exemplary highly cohesive silicone gel into an exemplary medical-grade silicone shell may include an exemplary process including: i) injecting an exemplary volume of highly cohesive silicone gel (determined based on an exemplary size of prosthesis 100 as set forth in Table 1) into an exemplary medical-grade silicone shell through an exemplary aperture on an exemplary medical-grade silicone, e.g., using an exemplary precision injection device; ii) de-airing an exemplary highly cohesive silicone gel by placing an exemplary filled medical-grade silicone shell into an exemplary vacuum machine and decreasing air pressure from 760 mmHg to 5 mmHg; iii) filling an exemplary void resulting from the expulsion of air bubbles within an exemplary highly cohesive silicone gel with additional highly cohesive silicone gel; iv) and securely sealing an exemplary aperture of medical-grade silicone shell, e.g., through an exemplary process of heat sealing or vulcanization. “Heat sealing” or “vulcanization” may refer to applying heat to a silicone material, causing it to melt and bond, effectively closing an exemplary aperture. In an exemplary process of heat sealing/vulcanization, heat may be applied to an exemplary medical-grade silicone shell using a heat-sealing machine that may ensure uniform sealing without compromising the integrity of an exemplary silicone shell. In an exemplary embodiment, securely sealing an exemplary aperture of medical-grade silicone shell may further include applying an exemplary compatible sealing agent or adhesive to an exemplary aperture, creating a secure and durable bond upon curing.

[00031] FIG. 3 illustrates dorsal view 300 of mare 302 with two exemplary incisions at 4 and 8 o’clock (304a and 304b, respectively) around rectum 306, consistent with one or more exemplary embodiments of the present disclosure. FIG. 4 illustrates surface view 400 of exemplary incisions at 4 and 8 o’clock (304a and 304b, respectively) with prosthesis 100 subcutaneously implanted at perineal region of mare 302, consistent with one or more exemplary embodiments of the present disclosure. FIG. 5 illustrates dorsal view 500 of mare 302 after implanting prosthesis 100 at perineal region and suturing incisions at 4 and 8 o’clock (304a and 304b, respectively), consistent with one or more exemplary embodiments of the present disclosure. In further detail with respect to dorsal view 300, in an exemplary embodiment, prosthesis 100 may be used to repair sunken anus in mares (e.g., mare 302). To repair sunken anus, subsequent to administration of epidural anesthesia in mare 302, two exemplary incisions at 4 and 8 o’clock (304a and 304b, respectively) may be performed on mare’s skin at 4 and 8 o’ clock positions around rectum 306 (i.e., at perineal region between rectum 306 and opening of vagina 308). Subsequently, a subcutaneous channel may be meticulously established between exemplary incisions 304a and 304b without compromising the integrity of anal sphincter. In an exemplary embodiment, the deliberate absence of skin incisions along the path of fecal discharge may minimize the likelihood of postoperative infections.

[00032] In further detail with respect to surface view 400, in an exemplary embodiment, subsequent to establishing a subcutaneous channel between exemplary incisions 304a and 304b, prosthesis 100 may be inserted from one of exemplary incisions 304a and 304b in either a clockwise or counterclockwise orientation into an exemplary created subcutaneous channel. In an exemplary embodiment, prosthesis 100 may be inserted into perineal region of mare 302 such that second side 106b (see FIG. 1C) of curved supporting layer 102 is in contact with perineal muscles. Subsequently, secure fixation of prosthesis 100 to exemplary internal muscles within perineal region of mare 302 may be achieved by applying a few basic stitches along peripheral zone 112 of prosthesis 100. In an exemplary embodiment, as illustrated in dorsal view 500, exemplary incisions 304a and 304b may be sutured utilizing an exemplary suturing technique, such as interrupted sutures. Given that exemplary incision 304a and 304b may be positioned away from an exemplary path of defecation, the likelihood of infection at an exemplary operative site may be significantly diminished.

[00033] While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications may be made therein and that the subject matter disclosed herein may be implemented in various forms and examples, and that the teachings may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all applications, modifications and variations that fall within the true scope of the present teachings.

[00034] Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. [00035] The scope of protection is limited solely by the claims that now follow. That scope is intended and should be interpreted to be as broad as is consistent with the ordinary meaning of the language that is used in the claims when interpreted in light of this specification and the prosecution history that follows and to encompass all structural and functional equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of Sections 101, 102, or 103 of the Patent Act, nor should they be interpreted in such a way. Any unintended embracement of such subject matter is hereby disclaimed.

[00036] Except as stated immediately above, nothing that has been stated or illustrated is intended or should be interpreted to cause a dedication of any component, step, feature, object, benefit, advantage, or equivalent to the public, regardless of whether it is or is not recited in the claims.

[00037] It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. An element proceeded by “a” or “an” does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[00038] Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[00039] It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study, except where specific meanings have otherwise been set forth herein. Relational terms such as “first” and “second” and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.

[00040] The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it may be seen that various features are grouped together in various implementations. This is for purposes of streamlining the disclosure, and is not to be interpreted as reflecting an intention that the claimed implementations require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed implementation. Thus, the following claims are hereby incorporated into the

Detailed Description, with each claim standing on its own as a separately claimed subject matter. [00041] While various implementations have been described, the description is intended to be exemplary, rather than limiting and it will be apparent to those of ordinary skill in the art that many more implementations and implementations are possible that are within the scope of the implementations. Although many possible combinations of features are shown in the accompanying figures and discussed in this detailed description, many other combinations of the disclosed features are possible. Any feature of any implementation may be used in combination with or substituted for any other feature or element in any other implementation unless specifically restricted. Therefore, it will be understood that any of the features shown and/or discussed in the present disclosure may be implemented together in any suitable combination. Accordingly, the implementations are not to be restricted except in light of the attached claims and their equivalents. Also, various modifications and changes may be made within the scope of the attached claims.

Claims

What is claimed is:

1. A soft tissue prosthesis for repairing sunken anus, comprising: a curved support layer; and a curved tubular structure comprising a silicone exterior cover and an internal lumen filled with a cohesive silicone gel, wherein the curved tubular structure is coupled to one side of the curved support layer further apart from a peripheral edge of the curved support layer such that a peripheral zone is defined between the peripheral edge of the curved support layer and the silicone exterior cover of the curved tubular structure, the curved tubular structure longitudinally extending along the one side of the curved support layer from a first end to a second end of the curved support layer; wherein the curved tubular structure comprises a same first height at first and second endings of the curved tubular structure, and a second height at a middle of the curved tubular structure that is more than the first height at the first and second endings of the curved tubular structure.

2. The soft tissue prosthesis of claim 1, wherein the curved support layer may have a thickness between 0.7 mm and 1.3 mm.

3. The soft tissue prosthesis of claim 1, wherein the peripheral zone may have a diameter between 4 mm and 6 mm.

4. The soft tissue prosthesis of claim 1, wherein the first height is between 2 cm and 3 cm.

5. The soft tissue prosthesis of claim 1, wherein the second height is between 4 cm and 6 cm.

6. The soft tissue prosthesis of claim 1, wherein a distance between the first end and the second end of the curved support layer is between 6 cm and 12 cm.

7. The soft tissue prosthesis of claim 1, wherein the curved tubular structure has a diameter between 13 mm and 17 mm.

8. A soft tissue prosthesis for repairing sunken anus, comprising: a curved support layer; and a curved tubular structure comprising an elastomeric exterior cover and an internal lumen filled with an elastomer gel, wherein the curved tubular structure is coupled to one side of the curved support layer further apart from a peripheral edge of the curved support layer such that a peripheral zone is defined between the peripheral edge of the curved support layer and the elastomeric exterior cover of the curved tubular structure, the curved tubular structure longitudinally extending along the one side of the curved support layer from a first end to a second end of the curved support layer.

9. The soft tissue prosthesis of claim 8, wherein the curved tubular structure comprises a same first height at first and second endings of the curved tubular structure, and a second height at a middle of the curved tubular structure that is more than the first height at the first and second endings of the curved tubular structure.

10. The soft tissue prosthesis of claim 8, wherein the curved support layer may have a thickness between 0.7 mm and 1.3 mm.

11. The soft tissue prosthesis of claim 8, wherein the peripheral zone may have a diameter between 4 mm and 6 mm.

12. The soft tissue prosthesis of claim 9, wherein the first height is between 2 cm and 3 cm.

13. The soft tissue prosthesis of claim 9, wherein the second height is between 4 cm and 6 cm.

14. The soft tissue prosthesis of claim 8, wherein a distance between the first end and the second end of the curved support layer is between 6 cm and 12 cm.

15. The soft tissue prosthesis of claim 8, wherein the curved tubular structure has a diameter between 13 mm and 17 mm.