Patent Description:
This application also claims priority to <CIT>.

The present disclosure generally relates to medical devices and procedures, and particularly, devices configured to be delivered and placed in a patient's body for the treatment of pelvic floor disorder and methods thereof.

Pelvic organ prolapse is an abnormal descent or herniation of the pelvic organs. A prolapse may occur when muscles and tissues in the pelvic region become weak and can no longer hold the pelvic organs in place correctly.

Treatment for symptoms of the pelvic organ prolapse can include changes in diet, weight control, and lifestyle. Treatment may also include surgery, medication, and use of grafts to support the pelvic organs.

Sacrocolpopexy is one such surgical technique that may be used to repair pelvic organ prolapse. This can be performed using an open abdominal technique or with the use of minimally invasive surgery, such as laparoscopy or robotic-assisted surgery. The technique includes suspension of the apical portion of vagina (or sometimes the vaginal cuff after hysterectomy) using an implant such that the technique tries to recreate the natural anatomic support.

In some cases, a Y-shaped implant may be used to treat vaginal vault prolapse during the sacrocolpopexy procedure. The Y-shaped implant aids vaginal cuff suspension to the sacrum and provides long-term support. The procedure can be minimally invasive (laparoscopic sacral colpopexy) or traditional (open sacral colpopexy). Also, in some cases, different anatomical locations inside a patient's body for example, vagina, uterus, and sacrum may be involved in repair of the pelvic organ prolapse. For example, at least a portion of the implant may be attached to an anterior vaginal wall, and a posterior vaginal wall in some cases. These anatomical locations have different biological attributes and behave differently. Therefore, the implant may not conform to the varying behavior of the different anatomical locations where the implant portions are attached. One reason for matching biomechanical properties of tissue with an implant is to promote tissue viability. In some cases, when an implant supports a higher force than the tissue attached to it, the tissue atrophies. In some cases this may lead to breakdown in the tissue structure as well as pain for patient.

Thus, there is a need for an implant that has different properties at different locations along the implant. Additionally, in light of the above, there is a need for an improved implant that can be fabricated to conform to varying behavior of different anatomical locations inside a patient's body.

In a background example, the application discloses an implant. The implant may include a first flap and a second flap. The first flap may further include a first portion, a second portion and a transition region. The first portion may be configured to be attached proximate a sacrum. The second portion may be configured to be attached to an anterior vaginal wall. The transition region lies between the first portion and the second portion. The second flap may be fabricated such that a portion of the second flap is configured to be attached to a posterior vaginal wall. The implant may be configured such that a value corresponding to a biomechanical parameter defining a biomechanical attribute of the portion of the first flap attaching to the anterior wall is different from a value of the biomechanical parameter defining the biomechanical attribute of the portion of the second flap attaching to the posterior wall.

The present invention relates to a tubular implant as set forth in the appended claims. The tubular implant includes a first portion, a second portion, and a transition region. The first portion of the tubular implant can be configured to be attached proximate a sacrum. The transition region can extend from the first portion. The second portion can extend from the transition region monolithically. The second portion includes a first section and a second section and two slits provided laterally in the second portion configuring the first section as apart from the second section at a proximal end. The tubular implant further includes a lumen defined within the first and second portions of the tubular implant. The tubular implant can be configured such that the first section is configured to be attached to an anterior vaginal wall, and the second section is configured to be attached to a posterior vaginal wall. A value corresponding to a biomechanical parameter defining a biomechanical attribute of the first section and a value of the bio-mechanical parameter defining the biomechanical attribute of the second section are different from each other. The biomechanical attribute of the first section is configured to emulate biomechanical properties of the anterior vaginal wall of the patient and the biomechanical attribute of the second section is configured to emulate biomechanical properties of the posterior vaginal wall of the patient. The biomechanical attribute is one of the following: elasticity, viscoelasticity, viscohyperelasticity, anisotropicity, resistance to creep and stiffness; and a knit structure of the first section is different from a knit structure of the second section.

In a background example, the application discloses a method for placing an implant in a body of a patient. The method includes inserting the implant inside the body. The method further includes attaching a portion of the implant to an anterior vaginal wall, wherein the portion attaching to the anterior vaginal wall defines a first value of a biomechanical parameter defining a biomechanical attribute. The method further includes attaching a portion of the implant to a posterior vaginal wall. The portion attaching to the posterior vaginal wall defines a second value of the biomechanical parameter such that the second value corresponding to the portion attaching to the posterior wall is different from the first value corresponding to the portion attaching to the anterior wall.

A tubular mesh implant comprising a lumen is known from the document <CIT>. <CIT> discusses a prosthetic strip made from layers of a material made from biocompatible polymer fibres with a central and two lateral zones, the central zone having a greater elasticity than the lateral zones. <CIT>, <CIT>, and <CIT> each discuss different types of prosthetic knit fabrics to be used for implants. <CIT> discusses a device comprising a filiform suspension cord, and at least two anchoring parts connected to the ends of this cord, having a flexible and openworked structure, capable of adapting to the configuration of the respective implantation walls. <CIT> discusses a multi-arm implantable devices designed to provide support to the bulbar urethral region of a patient experiencing incontinence.

The invention and the following detailed description of certain embodiments, thereof, may be understood with reference to the following figures. <FIG> and <FIG> do not represent embodiments of the invention:.

Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Further, the terms and phrases used herein are not intended to be limiting, but to provide an understandable description of the invention.

The terms "a" or "an," as used herein, are defined as one or more than one. The term "another," as used herein, is defined as at least a second or more. The terms "including" and/or "having", as used herein, are defined as comprising (i.e., open transition).

In general, the disclosure is directed to systems, methods, and devices for treating vaginal prolapse. However, the disclosure may be equally employed for other treatment purposes such as pelvic organ prolapse or other pelvic disorders such as incontinence. As described below in various illustrative embodiments, the disclosure provides systems, methods, and devices employing a medical device configured to deliver or place an implant within a patient's body to support pelvic organs and deliver a fluid such as a medication inside the body such as to the implant site for the treatment of pelvic organ prolapse or other pelvic disorders.

The term patient may be used hereafter for a person who benefits from the medical device or the methods disclosed in the present disclosure. For example, the patient may be a person whose body is operated with the use of the medical device disclosed by the present disclosure in a surgical treatment. For example, in some embodiments, the patient may be a human female, human male or any other mammal.

The terms proximal and distal described in relation to various devices, apparatuses, and components as discussed in the subsequent text of the present disclosure are referred to with a point of reference. The point of reference, as used in this description, is a perspective of an operator. The operator may be a surgeon, a physician, a nurse, a doctor, a technician, and the like who may perform the procedure of delivery and placement of the bodily implants into the patient's body as described in the present disclosure. The term proximal refers to an area that is closest to the operator. The term distal refers to an area that is farthest from the operator.

<FIG> is a schematic diagram of an implant <NUM>. The implant <NUM> can include a first flap <NUM>. The first flap <NUM> can include a first portion <NUM>, a second portion <NUM> and a transition region <NUM>. In an embodiment, the implant <NUM> can be used for the treatment of a pelvic floor disorder. In some embodiments, the implant <NUM> can be used to suspend various bodily locations in a body of a patient. For example, in some embodiments, the implant <NUM> can be used to suspend a pelvic organ of a patient's body. In some embodiments, the implant <NUM> can be a part of a retropubic incontinence sling. In some embodiments, the implant <NUM> can be configured to be delivered by way of a transvaginal approach or a transobturator approach or vaginal pre-pubic approach or a laparoscopic approach or can be delivered through other approaches and positioned at various locations within a patient's body.

The first portion <NUM> defines a first side <NUM>, a second side <NUM>, a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be attached to or extend from the transition region <NUM> of the first flap <NUM>. The distal portion <NUM> can be configured to be attached to a first bodily tissue. In some embodiments, the first bodily tissue can be a sacrum or tissue proximate a sacrum of a patient. In some embodiments, the first bodily tissue can be any one of lumbar vertebra, tail bone, and ileum portion of hip bone inside the patient's body. In some embodiments, the first bodily tissue can be any other location inside the patient's body.

The first portion <NUM> defines a length L1 along the first side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The first portion <NUM> defines a length L2 along the second side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the length L1 can be equal to the length L2. In some embodiments, the length L1 can be different from the length L2. The first portion <NUM> defines a width W1 extending between the first side <NUM> and the second side <NUM>. In some embodiments, the width W1 can remain constant from the proximal portion <NUM> to the distal portion <NUM>.

The first bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The first portion <NUM> can be configured to define a set of biomechanical attributes or biomechanical properties so as to emulate the biomechanical behavior of the first bodily tissue, where at least a portion of the first portion <NUM> is required to be attached, in the defined set of physical conditions. The biomechanical attributes for the first bodily tissue can be defined by a first set of values of respective biomechanical parameters associated with each of the biomechanical attributes. For example, in some embodiments, the biomechanical attribute can be elasticity and a corresponding biomechanical parameter can be modulus of elasticity which can be defined by a numerical value. While the use of a modulus (such as a modulus of elasticity) is used to measure a biomechanical parameter, it should be understood that the biomechanical parameter of the bodily tissue may also be directly measured. For example, in some embodiments, the elasticity of the bodily tissue maybe measured (without using a modulus). In some embodiments, the biomechanical attribute can be stiffness. In some embodiments, the biomechanical attribute can be strength. In some embodiments, the biomechanical attribute can be resistance to creep. In various embodiments, the biomechanical attributes of the first portion <NUM> can be defined for example by defining one or more of shape, size, fabrication method, structure, profile, knit structure, pore size, material of fabrication, fiber orientation, and the like. In some embodiments, for example, the congruence between the biomechanical behavior of the first bodily tissue and the first portion <NUM> can be achieved by varying the shape of the first portion <NUM>. For example, the first portion <NUM> can have a square, rectangular, triangular or any other shape, which can facilitate the first portion <NUM> in closely equating the biomechanical behavior of the first bodily tissue. Adding apertures or reinforcements at specific sites along the implant can affect the biomechanical properties. Utilizing materials with properties that change over time, such as biodegradable materials, can adjust specific biomechanical properties over time. Coatings on specific portions of the implant may be used to influence the biomechanical properties, for example but reducing the elasticity of the coated portion.

In some embodiments, the biomechanical attributes of the first portion <NUM> can be defined by a first type of knit structure (not shown here and explained later). In some embodiments, the first type of knit structure can be defined by first type of knitting pattern (not shown here and explained later). In some embodiments, the first type of knit structure can be defined by a first type of pore construct. In some embodiments, the first type of knit structure can be defined by weaving the knit with a required and defined tension. For example, the first knitting pattern can be woven tightly or loosely to define required type of knitting pattern. In some embodiments, the first knitting pattern characterized by biomechanical properties of high elastic modulus and stiffness can facilitate holding onto the first bodily tissue such as a sacrum in the correct anatomical location. The different ways of achieving the desirable biomechanical attributes for the first portion <NUM> of the first flap <NUM> can be used in isolation or in combination. It must be appreciated that though the above ways of defining the required biomechanical attributes are used for mesh-based implants <NUM> including a knit pattern, the implant <NUM> can be fabricated as a planar structure. In such embodiments, the biomechanical attributes of the first portion <NUM> of the first flap <NUM> of the implant <NUM> can be defined for example by the material used in fabrication of the first portion <NUM>, shape and size of the portion, and the like without limitations. For example, a rigid medical grade polymer can be used for fabricating the first portion <NUM> thereby defining the biomechanical attribute of rigidity for the first portion <NUM> to a desired value.

The second portion <NUM> defines a first side <NUM>, and a second side <NUM>, a proximal portion <NUM> and a distal portion <NUM>. The distal portion <NUM> can be attached to or extend from the transition region <NUM> of the first flap <NUM>. The proximal portion <NUM> can be configured to be attached to a second bodily tissue. In some embodiments, the second bodily tissue can be an anterior vaginal wall inside a patient's body. In some embodiments, the second bodily tissue can be at least one of a posterior vaginal wall, a uterus, and a vaginal apex. In some embodiments, the second bodily tissue can be any other location inside the patient's body.

The second portion <NUM> defines a length L3 along the first side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The second portion <NUM> defines a length L4 along the second side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the length L3 can be equal to the length L4. In some embodiments, the length L3 can be different from the length L4. The second portion <NUM> defines a width W2 extending between the first side <NUM> and the second side120. In some embodiments, the width W2 can remain constant from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the width W2 can differ from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the second portion <NUM> is fabricated such that the width W2 of the second portion <NUM> is greater than the width W1 of the first portion <NUM>. In some embodiments, the second portion <NUM> can define a trapezoidal shape such that the width W2 at the proximal portion <NUM> is substantially greater than the width W2 at the distal portion <NUM>. In some embodiments, the second portion <NUM> can have a polygonal shape. In some embodiments, the second portion <NUM> can have a square, rectangular, triangular or any other shape.

The second bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The behavior exhibited by the second bodily tissue can be different than the behavior exhibited by the first bodily tissue. The second portion <NUM> can be configured to define the biomechanical attributes or biomechanical properties so as to emulate the biomechanical behavior of the second bodily tissue in the defined set of physical conditions. The biomechanical attributes can be defined by a second set of values of respective biomechanical parameters associated with each of the biomechanical attributes. Consequently, the second portion <NUM> may be defined to exhibit values of the biomechanical attributes, different than the values of the biomechanical attributes of the first portion <NUM>, in accordance with the second bodily tissue where at least a portion of the second portion <NUM> of the first flap <NUM> may be attached. It must be appreciated that in some embodiments, only one or more but not all of the first set of values biomechanical attributes and the second set of values differ in terms of their values of parameters defining the respective attributes. For example, the modulus of elasticity may be same for the first portion <NUM> and the second portion <NUM> but any other parameter for other attribute such as resistance to creep may be different. In some other embodiments, all the attributes of the first portion <NUM> and the second portion <NUM> may differ in terms of their numerical values of parameters defining the respective attributes.

In some embodiments, the second set of values associated with the biomechanical attributes can be different along different directions for the same fixed set of physical conditions even for the same attribute. For example, in some embodiments, a value of a parameter P defining an attribute T along a first direction A1 can be different from a value of the parameter P defining the attribute T along a second direction A2. In some embodiments, the first direction A1 can be a longitudinal direction and the second direction A2 can be a transverse direction.

It must be appreciated that the biomechanical behavior of the bodily tissues and the biomechanical attributes of the various portions of the implant <NUM> may change owing to change in physical conditions. Therefore, for the purpose of comparing the various biomechanical behaviors and the biomechanical attributes, a reasonably sufficient amount of similarity in physical conditions may be assumed to an extent that a change in the conditions creates an ignorable influence. However, in other embodiments, the physical conditions may vary and measurement of the biomechanical behavior and the attributes may accordingly be calibrated so as to compare the various values associated with the various attributes in light of the required characteristics at the required locations. For example, the stiffness of the first portion <NUM> and the second portion <NUM> may be different initially during fabrication but since the physical conditions at the respective bodily tissues may be different, therefore the initial values of the stiffness may not remain same after placement. This change due to variation in the physical conditions may be considered while defining the attributes of the respective portions of the implant <NUM> so as to achieve the desired set of attributes with the desired set of values.

In some embodiments, the biomechanical attributes can include elasticity and a corresponding biomechanical parameter can be modulus of elasticity. In some embodiments, the biomechanical attribute can be viscoelasticity. In some embodiments, the biomechanical attribute can be viscohyperelasticity. In some embodiments, the biomechanical attribute can be anisotrophicity. In various embodiments, the biomechanical attributes of the second portion <NUM> can be defined by defining one or more of shape, size, fabrication method or structure, profile, knit structure, pore size, material of fabrication, and the like. In some embodiments, for example, the congruence between the biomechanical behavior of the second bodily tissue and the second portion <NUM> can be achieved by varying the shape of the second portion <NUM>. For example, the trapezoidal shape of the second portion <NUM> can conform to shape of the second bodily tissue such as the anterior vaginal wall inside a patient's body.

In some embodiments, the biomechanical attributes of the second portion <NUM> can be defined a second type of knit structure (not shown here and explained later). In some embodiments, the second type of knit structure can be defined by second type of knitting pattern (not shown here and explained later). In some embodiments, the second type of knit structure can be defined by weaving the knit (or knitting) with a required and defined tension. For example, the anterior vaginal wall shows biomechanical behavior of anisotrophicity, with bias toward more elongation along a transverse direction, therefore, the second type of knitting pattern can be selected so as to be more elastic along a longitudinal direction as compared to the transverse direction.

In some embodiments, the second type of knit structure can be defined by a second type of pore construct. In some embodiments, the second type of pore construct is different from the first type of pore construct. In some embodiments, the second pore construct includes a larger pore size as compared to a pore size of the first pore construct. In some embodiments, the difference in pore constructs of the first and second portions <NUM> and <NUM> can be achieved by weaving a mesh with different pore sizes. In some embodiments, the difference in pore constructs for the first and second portions <NUM> and <NUM> can be achieved by extruding or knitting a single pore size mesh and heat setting the pores to set a different pore size for the first and second portions <NUM> and <NUM> as illustrated and described by later figures. The second pore construct can define the second set of values of the biomechanical attributes of the second portion <NUM>. In an embodiment, the second pore construct can define larger pore sizes as compared to the remaining portion of the implant <NUM>. In some embodiments, the second pore construct can be fabricated to exhibit biomechanical attributes of high flexibility and elongation to a particular strain level and high stiffness after the particular stain level is reached. Such a strain behavior may closely emulate the biomechanical behavior of the vaginal wall for example the anterior vaginal wall. Therefore, the second pore structure defines the biomechanical attributes so as to conform to the biomechanical behavior of the second bodily tissue that is the vaginal wall.

In some embodiments, the values associated with the biomechanical attributes can be defined by a material used for fabricating the second portion <NUM>. For example, a viscoelastic medical grade polymer can be used for fabricating the second portion <NUM> thereby defining a value for the biomechanical attribute of viscoelasticity for the second portion <NUM>. In some embodiments, an anisotropic medical grade polymer can be used for achieving a desired value of anisotropicity. In some embodiments, a creep resistant medical grade polymer can be used for achieving a desired value of creep resistance.

In some embodiments, the first bodily tissue can be stiffer and the second bodily tissue can be flexible, therefore the first portion <NUM> in such cases can be configured with the biomechanical attributes congruent with high stiffness and the second portion <NUM> with high flexibility. Similarly, in other embodiments, other attributes may be associated according to the behavior of the respective bodily tissues. The different ways of achieving the desirable values for the biomechanical attributes for the first portion <NUM> and the second portion <NUM> as discussed above can be used in isolation or in combination.

In some embodiments, for example, the second bodily tissue can be the anterior vaginal wall. Various examples of attributes possibly needed to be considered for defining the portions of the first flap <NUM> that are attached to the anterior vaginal wall can without limitations be viscoelasticity, viscohyperelasticity, resistance to creep and anisotropy, and the like.

The first flap <NUM> further includes the transition region <NUM> as mentioned above. The transition region <NUM> defines a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> of the transition region <NUM> can be coupled to or extend from the distal portion <NUM> of the second portion <NUM>. The distal portion <NUM> of the transition region <NUM> can be coupled to or extend from the proximal portion <NUM> of the first portion <NUM>. In some embodiments, the transition region <NUM> may define a third type of knit structure (not shown here and explained later) that monolithically joins the first portion <NUM> and the second portion <NUM>. In some embodiments, the third knit structure may define a third type of pore construct (not shown here and explained later). In some embodiments, the first flap <NUM> can be formed by suturing together the first portion <NUM> and the second portion <NUM>. In such cases, the transition region <NUM> includes sutures tying the first portion <NUM> and the second portion <NUM>.

In some embodiments, the implant <NUM> further includes a second flap (not shown in <FIG>). The second flap can include a first portion, a second portion and a transition region. The first portion and the transition region of the second flap can function the same way as that of the first flap <NUM> and can be defined in a similar manner. The first portion can be attached to the first bodily tissue proximate to a location where the first portion <NUM> of the first flap <NUM> is attached. The second portion of the second flap can be configured to be attached to a third bodily tissue. In some embodiments, the third bodily tissue can be a posterior vaginal wall inside a patient's body. The third bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The second portion can define the biomechanical attributes so as to emulate the biomechanical behavior of the third bodily tissue, where at least a portion of the first portion of the second flap is required to be attached, in the defined set of physical conditions. The biomechanical attributes can be defined by a third set of values corresponding to respective biomechanical parameters associated with the biomechanical attributes. The second portion of the second flap can be configured so that at least one of the biomechanical parameters of the second portion <NUM> of the first flap and the second portion of the second flap differ in their numerical values. For example, the stiffness behavior of the anterior vaginal wall can be different from the posterior vaginal wall; therefore the second portion <NUM> of the first flap <NUM> and the second portion of the second flap can be fabricated to exhibit stiffness attributes different from each other.

In some embodiments, the implant <NUM> can be configured such that each of the first flap <NUM> and the second flap define stripes of material and can be configured to be attached separately to bodily locations. In some embodiments, each of the first flap <NUM> and the second flap are constructed from a single piece of material. In some embodiments, the first flap <NUM> and the second flap are fabricated independent of each other. In some embodiments, the implant <NUM> can be formed from a mesh material. In some embodiments, the implant can be formed from a non-mesh material.

In some embodiments, the implant <NUM> can be Y-shaped. The Y-shaped implant can include three portions - a first portion configured to be attached to the sacrum or tissues proximate the sacrum, a second portion configured to be attached to the anterior vaginal wall, a third portion configured to be attached to the posterior vaginal wall. In some embodiments, the Y-shaped implant <NUM> can be fabricated so as to include either of the first flap <NUM> and the second flap as described above and another flap which may be either a conventional strip of implant material or any of the first flap and the second flap above. For example, in an embodiment, the Y-shaped implant can be fabricated by using the first flap and the second flap and coupling them together to provide a Y-shape to the implant. During fabrication a portion of the first and/or second flaps may be removed to configure the implant in the Y-shape. For example, at least one of the first portion of the first flap and the first portion of the second flap can be removed. In another embodiment, the Y-shaped implant can be fabricated by using one of the first flap and the second flap and another conventional flap such that the conventional flap can be coupled to the other of the first or the second flap to configure the implant in the Y-shape. In still another embodiment, the Y-shape can be achieved by using various portions of the first flap and the second flap and a conventional implant strip. In some embodiments, the biomechanical attributes of the three portions of the Y-shaped implant can be defined based on the biomechanical behavior of the three locations of the body where the three portions of the implant are configured to be attached. In other embodiments, the implant has a shape other than a Y-shape. For example, the implant could be rectangular, square, or any other shape. Additionally, in some embodiments, the implant has more than one portion, such as more than one separate portion. For example, the implant may have two, three or more separate portions or pieces.

In some embodiments, the implant <NUM>, or the first flap <NUM> or the second flap can be cut from a prefabricated structure including the first portion <NUM> with the first type of knit structure and the second portion <NUM> with the second type of knit structure. In some embodiments, the implant <NUM> can be fabricated by coupling different strips of materials each defining a set of biomechanical attributes congruent with biomechanical behavior of respective anatomical locations where they are placed inside a patient's body. The strips can take a shape such as linear or planar, curvilinear, curved, or any other shape.

In some embodiments, the first flap <NUM> and the second flap can be monolithically defined as a single piece such as in the form of a tubular structure (not shown here and explained later). The tubular structure can include a first portion, a transition region and a second portion. The first portion can be configured to be attached proximate the sacrum inside a patient's body. In some embodiments, the first portion can be similar to the first portion of the first flap described above in terms of biomechanical attributes. The transition region extends from the first portion. In some embodiments, the second portion of the tubular structure can function in a manner similar to the way the second portion of the first flap and the second portion of the second flap together perform. For example, an upper circumferential section of the second portion of the tubular structure can function similar to the function of the second portion of the first flap and the lower circumferential section of the tubular structure can function similar to the second portion of the second flap. In an embodiment, the second portion of the tubular structure can be configured to be cut by an operator to convert it into two sections. The sections though may still be joined at a medial portion or proximate the transition region. In some embodiments, two slits may be provided along two lateral edges of the tubular structure to define the two flaps for the two different bodily tissues. The slits can be made by an operator or may be pre-fabricated.

In some embodiments, the procedure of placing the implant <NUM> within a body can be performed after performing hysterectomy and removal of uterus from the body. In some other embodiments, the implant <NUM> can be placed even when the uterus is intact. The first flap <NUM> and the second flap can be attached inside the patient's body through various attachment elements or means. In some embodiments, the attachment elements include, without limitations, sutures, adhesives, bonding agents, mechanical fasteners (e.g. a medical grade plastic clip), staples, and the like. In some embodiments, the implant <NUM> can be sutured to bodily tissues with the use of a suturing device such as a Capio™ (as sold and distributed by Boston Scientific Corporation) and the like. In some embodiments, the implant <NUM> can be delivered inside a patient's body using any suitable insertion tool such as a needle or any other device. In some embodiments, a dilator may be attached to the implant <NUM> to deliver the implant <NUM> inside the patient's body.

In various embodiments, as discussed above, the implant <NUM> is made of a single piece of material. In some embodiments, the material is synthetic. In some embodiments, the implant <NUM> includes a polymeric mesh body. Exemplary polymeric materials are polypropylene, polyester, polyethylene, nylon, PVC, polystyrene, and the like. In some other embodiments, the implant <NUM> includes a polymeric planar body without mesh cells. In some embodiments, the implant <NUM> is made of a mesh body made of a non-woven polymeric material. An example of the mesh, out of which the implant <NUM> is formed, can be Polyform® Synthetic Mesh developed by the Boston Scientific Corporation. The Polyform® Synthetic Mesh is made from uncoated monofilament macro-porous polypropylene. Typically, the surface of the implant <NUM> is made smooth to avoid/reduce irritation on adjacent body tissues during medical interactions. Additionally, the implant <NUM> is stretchable and flexible to adapt movements along the anatomy of the human body and reduce suture pullout. Furthermore, softness, lightness, conformity, and strength are certain other attributes that can be provided in the implant <NUM> for efficient tissue repair and implantation. In some embodiments, the implant <NUM> can be made of natural materials such as biologic material or a cadaveric tissue and the like. In some embodiments, the implants can be cut, stamped, shaped, or otherwise molded into a shape. Exemplary biologic materials are bovine dermis, porcine dermis, porcine intestinal sub mucosa, bovine pericardium, a cellulose based product, cadaveric dermis, and the like. Accordingly, the in some embodiments, the structures are not knit structures. Rather, in some cases the structures are cut, stamped, or molded from sheets of material for example.

In some embodiments, different portions of the implant may be configured to display or have different biomechanical profiles. For example, in some embodiments portions of the implant may include a coating, such as a silicone coating that may impart or provide elasticity factors to the portions of the implant. The coating may also secure or help prevent the fibers or filaments of the implant from moving with respect to each other. In some embodiments, the coating may be configured to degrade or partially degrade once disposed within the body of the patient. In some embodiments, portions of the implant may be annealed or softened with respect to other portions of the implant. The annealing or softening can be done in patterns to provide or impart anisotropic characteristics. For example, in some embodiments, heat, radiation, or chemicals may be used to anneal or soften portions of the implant.

In some embodiments, some filaments of the implant can be treated with glue or an adhesive or can be welded to an adjacent filament. Such gluing or welding can provide different characteristics to the different portions of the implant. In some embodiments, different materials may be used to form the different portions of the implant. The different materials may be configured to display and provide different characteristics to the different portions of the implant. In some embodiments, the different portions of the implant may include more filaments or more twists or have a different weave pattern.

In some embodiments, the implant includes a reinforcing fiber or a plurality of reinforcing fibers. The reinforcing fiber or fibers may be disposed at specific locations or extend along a particular direction to provide different characteristics to the different portions of the implant.

In some embodiments, the implant includes flat or planar sheets of material. The sheets of material may have different pore quantities or distributions to provide different characteristics at different portions of the implant. In some embodiments, the implant may include laminated materials. For example, a mesh material may be coupled to or otherwise disposed adjacent to a sheet material. Additionally, one sheet material may be coupled to or otherwise disposed adjacent to another sheet material.

In some embodiments, a portion or portions of the implant may be weakened to provide different characteristics to different portions of the implant. For example, in some embodiments, portions of the implants may be notched, scored, or shaved (or apertures may be formed) to introduce weakness or to weaken different portions of the implant.

In some embodiments, the implant includes a sheet of material that has a property or a mechanical parameter that varies. For example, in one embodiment, the sheet of material has a property or biomechanical property, such as ability to stretch, of one value at a first location on the sheet of material and has the property or mechanical parameter of another value at different location on the sheet of material. In some embodiments, the property or mechanical parameter varies along a length of the sheet of material. In some embodiments, the property or mechanical parameter is the stiffness of the material, the ability to flex or stretch, or any other property or mechanical parameter.

In some embodiments, the varying of the property or mechanical parameter is accomplished by varying the knit pattern of the sheet of material. In other words, in some embodiments, the single sheet of material may have different properties or mechanical parameter at different locations because of or at least in part because of different knit patters or knit densities at the different locations along the sheet of material. For example, the sheet of material may have a first knit pattern at a first location on the sheet of material and a second knit pattern at a second location on the sheet of material.

In some embodiments, the weight or density of the sheet of material is greater than or equal to <NUM> grams per square meter (g/m<NUM>). For example, the weight of the material may be between <NUM> and <NUM>/m<NUM>. In other embodiments, the weight of the material is greater than <NUM>/m<NUM>. In yet other embodiments, the weight of the material is less than <NUM>/m<NUM>. In some embodiments, the weight of the material varies at different locations on the sheet of material. For example, in some embodiments, the weight of the material may be greater than <NUM>/m<NUM> at one location and less than <NUM>/m<NUM> at another location.

<FIG> is a perspective view of a first flap <NUM> of a medical implant <NUM> for placement over an anterior wall of a vagina inside a patient's body. The first flap <NUM> can include a first portion <NUM>, a second portion <NUM> and a transition region <NUM>.

The first portion <NUM> defines a first side <NUM>, a second side <NUM>, a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be attached to or extend from the transition region <NUM> of the first flap <NUM>. The distal portion <NUM> can be configured to be attached to a first bodily tissue. In some embodiments, the first bodily tissue can be a sacrum inside a patient's body. The first portion <NUM> defines a length L5 along the first side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The first portion <NUM> defines a length L6 along the second side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the length L5 can be equal to the length L6. The first portion <NUM> defines a width W3 extending between the first side <NUM> and the second side <NUM>. In some embodiments, the width W3 can remain constant from the proximal portion <NUM> to the distal portion <NUM>.

In some embodiments, the first flap <NUM> can be configured so that the first portion <NUM> can be attached to the sacrum or tissues proximate the sacrum and the remaining portion of the first flap <NUM> can be attached to the anterior vaginal wall in order to provide support to the anterior vaginal wall.

The first bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The first portion <NUM> can be configured to define a set of biomechanical attributes or biomechanical properties so as to emulate the biomechanical behavior of the first bodily tissue, where at least a portion of the first portion <NUM> is required to be attached, in the defined set of physical conditions. The biomechanical attributes can be defined by a first set of values of respective biomechanical parameters associated with the biomechanical attributes. For example, in some embodiments, the biomechanical attribute can be elasticity and a corresponding biomechanical parameter can be modulus of elasticity, which can be defined by a numerical value. In some embodiments, the biomechanical attribute can be stiffness. In some embodiments, the biomechanical attribute can be strength. In some embodiments, the biomechanical attribute can be resistance to creep. In various embodiments, the biomechanical attributes of the first portion <NUM> can be defined by defining one or more of shape, size, fabrication method or structure, profile, knit structure, pore size, material of fabrication, and the like. In some embodiments, for example, the congruence between the biomechanical behavior of the first bodily tissue and the first portion <NUM> can be achieved by varying the shape of the first portion <NUM>. For example, the first portion <NUM> can have a square, rectangular, triangular or any other shape, which can facilitate the first portion <NUM> in closely equating the biomechanical behavior of the first bodily tissue.

In some embodiments, the values of the biomechanical attributes of the first portion <NUM> can be defined by a first type of knit structure <NUM>. In some embodiments, the first type of knit structure <NUM> can be defined by a first type of knitting pattern <NUM>. In some embodiments, the first type of knit structure <NUM> can be defined by weaving the knit with a required and defined tension. For example, the first type of knitting pattern <NUM> can be woven tightly or loosely to define a required type of knitting pattern. In some embodiments, the first type of knitting pattern <NUM> characterized by biomechanical properties of high elastic modulus and stiffness can hold bodily tissue such as a vaginal tissue in the correct anatomical location. In some embodiments, the first type of knit structure <NUM> can be defined by a first type of pore construct <NUM>. The first type of pore construct <NUM> includes a plurality of pores <NUM>. The first type of pore construct <NUM> can be fabricated to define biomechanical attributes conforming to biomechanical behavior of the first bodily tissue by varying the first type knit structure <NUM>, and the pore construct <NUM>. The different ways of achieving the desirable biomechanical attributes for the first portion <NUM> of the first flap <NUM> can be used in isolation or in combination. In some embodiments, the knit structure includes knitting, weaving, braiding, twisting, tying, or any combination thereof. Utilizing materials with properties that change over time, such as biodegradable materials, can adjust specific biomechanical properties over time. Coatings on specific portions of the implant may be used to influence the biomechanical properties, for example but reducing the elasticity of the coated portion.

It must be appreciated that though the above ways of defining the required biomechanical attributes are used for mesh-based implants <NUM> including a knit pattern, the implant <NUM> can be fabricated as a planar structure. In such embodiments, the biomechanical attributes of the first portion <NUM> of the first flap <NUM> can be defined for example by the material used in fabrication of the first portion <NUM>, shape and size of the portion, and the like without limitations. For example, a rigid medical grade polymer can be used for fabricating the first portion <NUM> thereby defining the biomechanical attribute of rigidity for the first portion <NUM> to a desired value.

The second portion <NUM> defines a first side <NUM>, and a second side <NUM>, a proximal portion <NUM> and a distal portion <NUM>. The distal portion <NUM> can be attached to or extend from the transition region <NUM> of the first flap <NUM>. The proximal portion <NUM> can be configured to be attached to the second bodily tissue. In some embodiments, the second bodily tissue can be an anterior vaginal wall inside a patient's body.

The second portion <NUM> defines a length L7 along the first side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The second portion <NUM> defines a length L9 along the second side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the length L7 can be different from the length L9. The second portion <NUM> defines a width W4 extending between the first side <NUM> and the second side <NUM>. In some embodiments, as illustrated, the width W4 can differ from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the second portion <NUM> is fabricated such that the width W4 is greater than the width W3 of the first portion <NUM>. In some embodiments, the second portion <NUM> can define a trapezoidal shape such that the width W4 at the proximal portion <NUM> is substantially greater than the width W4 at the distal portion. The second portion is configured to be attached and provide support to a second bodily tissue.

The second bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The behavior exhibited by the second bodily tissue can be different than the behavior exhibited by the first bodily tissue. The second bodily tissue can be configured to define a set of biomechanical attributes or biomechanical properties so as to emulate the biomechanical behavior of the second bodily tissue in the defined set of physical conditions. The biomechanical attributes can be defined by a second set of values of respective biomechanical parameters associated with each of the biomechanical attributes. The second set of values can be different from the first set of values. Consequently, the second portion <NUM> may be defined to exhibit values of the biomechanical attributes, different than the values of the biomechanical attributes of the first portion <NUM>, in accordance with the second bodily tissue where at least a portion of the second portion <NUM> of the first flap <NUM> may be attached. It must be appreciated that in some embodiments, only one or more but not all of the first set of values biomechanical attributes and the second set of values differ in terms of their values of parameters defining the respective attributes. For example, the modulus of elasticity may be same for the first portion <NUM> and the second portion <NUM> but any other parameter for other attribute such as resistance to creep may be different. In some other embodiments, all the attributes of the first portion <NUM> and the second portion <NUM> may differ in terms of their values of parameters defining the respective attributes. The values of the various parameters provide mathematical measures of the respective parameters.

In some embodiments, the second set of values associated with the biomechanical attributes can be different along different directions for the same fixed set of physical conditions even for the same attribute. For example, in some embodiments, a value of a parameter P defining an attribute T along a first direction B1 can be different from a value of the parameter P defining the attribute T along a second direction B2. In some embodiments, the first direction B1 can be a longitudinal direction and the second direction B2 can be a transverse direction. Therefore, a parameter may differ in its value in different directions, in some embodiments. For example, modulus of elasticity of various portions of the first flap <NUM> may differ in different directions, in some embodiments. This may be important to match the biomechanical behavior of bodily tissues that may exhibit different levels of elasticity in different directions. Also, the second set of values associated with the biomechanical attributes can vary with a variation in the set of physical conditions. However, in some embodiments, the physical conditions may vary and measurement of the biomechanical behavior and the attributes may accordingly be calibrated so as to compare the various values associated with the various attributes in light of the required characteristics at the required locations. In some embodiments, the first direction B1 and the second direction B2 do not align along the axes of the implant. Additionally, in some embodiments, B1 and B2 are not disposed orthogonal or perpendicular to one another.

In some embodiments, the biomechanical attributes can include elasticity and a corresponding biomechanical parameter can be modulus of elasticity. In some embodiments, the biomechanical attribute can be viscoelasticity. In some embodiments, the biomechanical attribute can be viscohyperelasticity. In some embodiments, the biomechanical attribute can be anisotropicity. In various embodiments, the biomechanical attributes of the second portion <NUM> can be defined by defining one or more of shape, size, fabrication method or structure, profile, knit structure, pore size, material of fabrication, and the like. In some embodiments, for example, the congruence between the biomechanical behavior of the second bodily tissue and the second portion <NUM> can be achieved by varying the shape of the second portion <NUM>. For example, the trapezoidal shape of the second portion <NUM> can conform to the shape of the second bodily tissue such as the anterior vaginal wall. The trapezoidal shape can be provided to the second portion <NUM> to emulate a taper of an outer vaginal canal. In some embodiments, at the widest end, the width W4 can range from <NUM> - <NUM>. In some embodiments, at the narrowest end, the width W4 can range from <NUM> - <NUM>. The lengths L6 or L8 of the trapezoid can range from <NUM> - <NUM> based on the linear length of the vagina.

In some embodiments, the values of the biomechanical attributes of the second portion <NUM> can be defined by a second type of knit structure <NUM>. In some embodiments, the second type of knit structure can be defined by a second type of knitting pattern <NUM>. In some embodiments, the second type of knit structure <NUM> can be defined by weaving the knit with a required and defined tension. For example, the anterior vaginal wall shows biomechanical behavior of anisotrophicity, with bias toward more elongation along a transverse direction such as the direction B1, therefore, the second type of knitting pattern <NUM> can be selected so as to be more elastic along a longitudinal direction such as the direction B2 as compared to the transverse direction.

In some embodiments, the second type of knit structure <NUM> can be defined by a second type of pore construct <NUM>. In some embodiments, the second type of pore construct <NUM> is different from the first type of pore construct <NUM>. The second type of pore construct <NUM> includes a plurality of pores <NUM>. In some embodiments, the difference in pore construct for the first portion <NUM> and the second portion <NUM> can be achieved by weaving or knitting a mesh with different pore sizes. In some embodiments, the difference in pore constructs <NUM> and <NUM> of the first portion <NUM> and the second portion <NUM> can be achieved by extruding or knitting a single pore size mesh and heat setting the pores to set a different pore size for the first portion <NUM> and the second portion <NUM> as illustrated and described by later figures. The second pore construct <NUM> can define the second set of values of the biomechanical attributes of the second portion <NUM>. In an embodiment, the second pore construct <NUM> can define larger pore sizes as compared to the remaining portion of the first flap <NUM>. In some embodiments, the second pore construct <NUM> can be fabricated to exhibit biomechanical attributes of high flexibility and elongation to a particular strain level and high stiffness after a particular stain level is reached. Such a strain behavior closely emulates the biomechanical behavior of the anterior vaginal wall.

In some embodiments, one or more of the biomechanical attributes can be defined by a material used for fabricating the second portion <NUM>. For example, a viscoelastic medical grade polymer can be used for fabricating the second portion <NUM> thereby defining a value for the biomechanical attribute of viscoelasticity for the second portion <NUM>. In some embodiments, an anisotropic medical grade polymer (or the fabrication of such material) can be used for achieving a desired value of anisotropicity. In some embodiments, a creep resistant medical grade polymer can be used for achieving a desired value of creep resistance.

Generally, the anterior vaginal wall can be viscohyperelastic. The second portion therefore can be defined such that it exhibits high viscoelasticity. In some embodiments, the biomechanical parameters can have different values in different directions. For example, the biomechanical parameters may have different values in the first direction B1 than in the second direction B2.

The values of the biomechanical parameters defining the biomechanical behavior of the anterior vaginal wall may vary under different load conditions. For example, in some embodiments, the stiffness of the anterior vaginal wall at a low strain along the direction B1 can range from <NUM> - <NUM> MegaPascal (MPa). In some embodiments, the stiffness of the anterior vaginal wall at a high strain along the direction B1 can range from <NUM> - <NUM> MPa, In some embodiments, the stiffness the anterior vaginal wall at the low strain along the direction B2 can range from <NUM> - <NUM> MPa. In some embodiments, the stiffness of the anterior vaginal wall along the direction B2 at the high strain can range from <NUM> - <NUM> MPa. The stiffness behaviors of the anterior vaginal wall are further explained in detail in conjunction with <FIG>. Therefore, in some embodiments, the second portion <NUM> of the first flap <NUM> can be fabricated so as to define a set of values of the biomechanical parameter of stiffness that can conform to the values defining the biomechanical behavior of the anterior vaginal wall under similar load conditions.

The first flap <NUM> further includes the transition region <NUM> as mentioned above. The transition region <NUM> defines a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be coupled to or extend from the distal portion <NUM> of the second portion <NUM>. The distal portion <NUM> can be coupled to or extend from the proximal portion <NUM> of the first portion <NUM>. In some embodiments, the transition region <NUM> may define a third type of knit structure <NUM> that monolithically joins the first portion <NUM> and the second portion <NUM>. In some embodiments, the third knit structure <NUM> may define a third type of pore construct <NUM>. In some embodiments, the first flap <NUM> can be formed by suturing together the first portion <NUM> and the second portion <NUM>. In such cases, the transition region <NUM> includes sutures tying the first portion <NUM> and the second portion <NUM>.

<FIG> is a perspective view of a second flap <NUM> of the medical device <NUM> for placement over a posterior wall of a vagina inside a patient's body. The first flap <NUM> and the second flap <NUM> can collectively form the medical implant <NUM>. The second flap <NUM> can include a first portion <NUM>, a second portion <NUM> and a transition region <NUM>.

The first portion <NUM> defines a first side <NUM>, a second side <NUM>, a proximal portion <NUM> and a distal portion314. The proximal portion <NUM> can be attached to or extend from the transition region <NUM> of the second flap <NUM>. The distal portion <NUM> can be configured to be attached to a first bodily tissue. In some embodiments, the first bodily tissue can be a sacrum or tissues proximate the sacrum. The first portion <NUM> defines a length L9 along the first side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The first portion <NUM> defines a length L10 along the second side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the length L9 can be equal to the length L10. The first portion <NUM> defines a width W5 extending between the first side <NUM> and the second side <NUM>. In some embodiments, the width W5 can remain constant from the proximal portion <NUM> to the distal portion <NUM>.

In some embodiments, the second flap <NUM> can be configured so that the first portion <NUM> can be attached to the sacrum and the remaining portion of the implant <NUM> can be attached to the posterior vaginal wall in order to provide support to the posterior vaginal wall. The first bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The first portion <NUM> can be configured to define a set of biomechanical attributes or biomechanical properties so as to emulate the biomechanical behavior of the first bodily tissue, where at least a portion of the first portion <NUM> is required to be attached, in the defined set of physical conditions. The first portion <NUM> of the second flap <NUM> can be fabricated similar to the first portion <NUM> of the first flap <NUM> as described in <FIG>. The attributes of the first portion <NUM> of the second flap <NUM> can be defined in a manner similar to the attributes of the first portion <NUM> of the first flap <NUM>.

The second portion <NUM> defines a first side <NUM>, and a second side <NUM>, a proximal portion <NUM> and a distal portion <NUM>. The distal portion <NUM> can be attached to or extend from the transition region <NUM> of the second flap <NUM>. The proximal portion <NUM> can be configured to be attached to a third bodily tissue. In some embodiments, the third bodily tissue can be the posterior vaginal wall.

The second portion <NUM> defines a length L11 along the first side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The second portion <NUM> defines a length L12 along the second side <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the length L11 can be different from the length L12. The second portion <NUM> defines a width W6 extending between the first side <NUM> and the second side <NUM>. In some embodiments, as illustrated, the width W6 can differ from the proximal portion <NUM> to the distal portion <NUM>. In some embodiments, the second portion <NUM> is fabricated such that the width W6 is greater than the width W5 of the first portion <NUM>. In some embodiments, the second portion <NUM> can define a trapezoidal shape such that the width W6 at the proximal portion <NUM> is substantially greater than the width W6 at the distal portion <NUM>.

The third bodily tissue exhibits a definite biomechanical behavior in a defined set of physical conditions. The behavior exhibited by the third bodily tissue can be different than the behavior exhibited by the first bodily tissue or the second bodily tissue. The third bodily tissue can be configured to define the biomechanical attributes or biomechanical properties so as to emulate the biomechanical behavior of the third bodily tissue in the defined set of physical conditions. The biomechanical attributes can be defined by a third set of values of respective biomechanical parameters associated with the biomechanical attributes. In some embodiments, the third set of values can be different from the first set of values of the biomechanical attributes. In some embodiments, the third set of values can be different from the second set of values of the biomechanical attributes. Consequently, the second portion <NUM> may be defined to exhibit biomechanical attributes, different than the biomechanical attributes of the first portion <NUM>, in accordance with the third bodily tissue where at least a portion of the second portion <NUM> may be attached. The second portion <NUM> may be defined to exhibit biomechanical attributes, different than the biomechanical attributes of the first portion <NUM> from the first flap <NUM>.

In some embodiments, the third set of values associated with the biomechanical attributes can be different along different directions for the same fixed set of physical conditions even for the same attribute. For example, in some embodiments, a value of a parameter P defining an attribute T along a first direction C1 can be different from a value of the parameter P defining the attribute T along a second direction C2. In some embodiments, the first direction C1 can be a longitudinal direction and the second direction C2 can be a transverse direction. Also, the third set of values associated with the biomechanical attributes can vary with a variation in the set of physical conditions. In some embodiments, the third set of values can be different from the first set of values associated with the biomechanical attributes under the same fixed set of physical conditions.

In some embodiments, the biomechanical attribute can include elasticity and a corresponding biomechanical parameter can be modulus of elasticity. In some embodiments, the biomechanical attribute can be viscoelasticity. In some embodiments, the biomechanical attribute can be viscohyperelasticity. In some embodiments, the biomechanical attribute can be anisotropicity. In various embodiments, the biomechanical attributes of the second portion <NUM> can be defined by defining one or more of shape, size, fabrication method or structure, profile, knit structure, pore size, material of fabrication, and the like. In some embodiments, for example, the congruence between the biomechanical behavior of the third bodily tissue and the second portion <NUM> can be achieved by varying the shape of the second portion <NUM>. For example, the trapezoidal shape of the second portion <NUM> can conform to shape of the posterior vaginal wall.

In some embodiments, the values of the biomechanical attributes of the second portion <NUM> can be defined by a fourth type of knit structure <NUM>. In some embodiments, the fourth type of knit structure <NUM> can be defined by a fourth type of knitting pattern <NUM>. In some embodiments, the fourth type of knit structure <NUM> can be defined by weaving the knit with a required and defined tension. For example, the posterior vaginal wall shows biomechanical behavior of anisotrophicity, with biasness (or being biased) toward more elongation along the direction C1, therefore, the fourth type of knitting pattern <NUM> can be selected to be more elastic along the direction C2 as compared to the direction C1.

In some embodiments, the fourth type of knit structure <NUM> can be defined by a fourth type of pore construct <NUM>. In some embodiments, the fourth type of pore construct <NUM> is different from the first type of pore construct <NUM> and the second type of pore construct <NUM> of <FIG>. The fourth type of pore construct <NUM> includes a plurality of pores <NUM>. The difference in pore construct for the first portion <NUM> and the second portion <NUM> can be achieved as described in <FIG>. The fourth type of pore construct <NUM> can be configured to conform to biomechanical properties of the posterior vaginal wall.

In some embodiments, one or more of the biomechanical attributes can be defined by the third set of values associated with the biomechanical attributes for the second portion <NUM>. In an embodiment, the third set of values may be defined by a material used for fabricating the second portion <NUM>. For example, a viscoelastic medical grade polymer can be used for fabricating the second portion <NUM> thereby defining a desired value of viscoelasticity for the second portion <NUM>. In some embodiments, an anisotropic medical grade polymer can be used for achieving a desired value of anisotropicity. In some embodiments, a creep resistant medical grade polymer can be used for achieving a desired value of creep resistance.

The posterior vaginal wall can have high visco-hyper elasticity. Therefore, the second portion <NUM> can have a high value of viscohyperelasticity under a fixed set of stress conditions. In some embodiments, the value of the biomechanical parameter can be different for the first direction C1 and the second direction C2 for the posterior vaginal wall. The value of the biomechanical parameter would be different for a set of high load conditions and a set of low load conditions for the posterior vaginal wall. For example, in some embodiments, the stiffness of the posterior vaginal wall at a low strain along the direction C1 can range from <NUM> - <NUM> MegaPascal (MPa). In some embodiments, the stiffness of the posterior vaginal wall at a high strain along the direction C1 can range from <NUM> - <NUM> MPa. In some embodiments, the stiffness of the posterior vaginal wall at the low strain along the direction C2 can range from <NUM> - <NUM> MPa. In some embodiments, the stiffness of the posterior vaginal wall along the direction C2 at the high strain can range from <NUM> - <NUM> MPa. These values indicate an anisotropic behavior and stiffness variation along different directions and different physical conditions for posterior vaginal wall. The stiffness behaviors of the posterior vaginal wall are explained in detail by <FIG>. Therefore, in some embodiments, the second portion <NUM> of the second flap <NUM> can be fabricated so as to define a set of values of the biomechanical parameter of stiffness that can conform to the values defining the biomechanical behavior of the posterior vaginal wall under similar load conditions. The second portion <NUM> can be fabricated such that the set of values of the biomechanical parameter can be different from the set of values for the same biomechanical parameter of the second portion <NUM> of the first flap <NUM>.

The second flap <NUM> further includes the transition region <NUM> as mentioned above. The transition region <NUM> defines a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be coupled to or extend from the distal portion <NUM> of the second portion <NUM>. The distal portion <NUM> can be coupled to or extend from the proximal portion <NUM> of the first portion <NUM>. In some embodiments, the transition region <NUM> defines a fifth type of knit structure <NUM> that monolithically joins the first portion <NUM> and the second portion <NUM>. The fifth type of knit structure <NUM> defines a fifth pore construct <NUM>. In some embodiments, the third knit structure <NUM> may define a third type of pore construct <NUM>.

In some embodiments, the second flap <NUM> can be made out of a single strip of material. In some embodiments, the second flap <NUM> can be formed by suturing together the first portion <NUM> and the second portion <NUM>. In such cases, the transition region <NUM> includes sutures tying the first portion <NUM> and the second portion <NUM>.

<FIG> is a perspective view of a medical implant <NUM> including a plurality of flaps for placement over the first bodily tissue, the second bodily tissue and the third bodily tissue inside a patient's body. The plurality of flaps may include a first flap <NUM>, a second flap <NUM>, and a third flap <NUM>. The plurality of flaps can be joined together at a transition region <NUM> to form a Y-shaped implant as illustrated in the <FIG>. In some embodiments, there may not be any transition regions such as the transition region <NUM> and the first, second, and third flaps can directly be coupled with the use of sutures or any other coupler.

The first flap <NUM> defines a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be attached to or extend from the transition region <NUM> of the medical implant <NUM>. The distal portion <NUM> can be configured to be attached to the first bodily tissue as described with reference to <FIG>. The first flap <NUM> can be configured to define the first set of values corresponding to the biomechanical parameters as explained in <FIG> for emulating biomechanical behavior of first bodily tissue for example the sacrum, or tissue proximate the sacrum.

The second flap <NUM> defines a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be attached to or extend from the transition region <NUM> of the medical implant <NUM>. The distal portion <NUM> can be configured to be attached to the second bodily tissue as described with reference to <FIG>. The second flap <NUM> can be configured to define the second set of values corresponding to the biomechanical parameters as explained in <FIG> for emulating biomechanical behavior of the second bodily tissue for example, the anterior vaginal wall.

The third flap <NUM> defines a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> can be attached to or extend from the transition region <NUM> of the medical implant <NUM>. The distal portion <NUM> can be configured to be attached to the third bodily tissue as described with reference to <FIG>. The third flap <NUM> can be configured to define the third set of values corresponding to the biomechanical parameters as explained in <FIG> for emulating biomechanical behavior of third bodily tissue, for example, the posterior vaginal wall.

In some embodiments, the first flap <NUM>, the second flap <NUM> and third flap <NUM> can be fabricated independent of each other. The first flap <NUM>, the second flap <NUM> and the third flap <NUM> can be tied together with a suture <NUM> at the transition region <NUM> to form the medical implant <NUM>. In some embodiments, the three flaps <NUM>, <NUM>, and <NUM> exhibit different biomechanical attributes owning to different biomechanical properties of anatomical locations that each of the three flaps <NUM>, <NUM>, and <NUM> are configured to be attached to.

As mentioned above, the biomechanical properties of the posterior wall of vagina, the anterior wall of vagina and the sacrum or tissues proximate the sacrum inside a patient's body are different from each other; therefore in some embodiments the flaps of the medical implant <NUM> are fabricated with a pore construct and knit structure that can closely mimic biomechanical attributes of the anatomical locations inside the patient's body. For example, the first flap <NUM> can have a knit structure <NUM> similar to the first knit structure <NUM> of the first portion <NUM> of the first flap <NUM> from <FIG> so as to be biomechanically congruent with the first bodily tissue. The second flap <NUM> can have a knit structure <NUM> similar to the second knit structure <NUM> of the second portion <NUM> of the first flap <NUM> from <FIG> so as to be biomechanically congruent with the second bodily tissue. The third flap <NUM> can have a knit structure <NUM> similar to the fourth knit structure <NUM> of the second flap <NUM> from <FIG> so as to be biomechanically congruent with the third bodily tissue. Upon placement, the first flap <NUM>, the second flap <NUM>, and the third flap <NUM> can act as three different arms that can be configured to support the pelvic organs like the anterior vaginal wall, the posterior vaginal wall and the sacrum by attaching the implant <NUM> at three distinct bodily locations. The three arms can be movable with respect to one another to conform to the shape of the target anatomical location of attachment inside the body. The three arms can take a shape such as linear/planar, curvilinear, curved, or any other shape.

In some embodiments, for example, the medical implant <NUM> can be formed by tying together the second portion <NUM> of the first flap <NUM>, the second portion <NUM> of the second flap <NUM> and the first portion <NUM> or <NUM> from either the first flap <NUM> or the second flap <NUM>. In such cases, the three portions mentioned above conform to the biomechanical attributes of the second bodily tissue, the third bodily tissue and the first bodily tissue respectively.

In some embodiments, a Y-shaped mesh as illustrated in <FIG> may be formed of two sheets of material. One sheet of material may be coupled, such as via a suture or other coupling member or mechanism, to the other sheet of material to form a Y shape. In some embodiments, one of the sheets of material may have properties or mechanical parameters that vary along a length of the sheet of material.

For example, in one embodiments, a first sheet of material may be placed in the body of the patient such that it extends from the sacrum (or tissues proximate the sacrum) of the patient to a vaginal wall of the patient (or tissue proximate a vaginal wall), such as the posterior vaginal wall of the patient. The portion of the first sheet of material that is coupled to the sacrum (or to tissue proximate the sacrum) may have a first value for a property or mechanical parameter. The portion of the first sheet of material that is coupled to the vaginal wall may have a different value for the property or mechanical parameter. In some embodiments, the property or mechanical parameter is stretchiness or ability to stretch. In some embodiments, the portion of the first sheet of material that is coupled to the sacrum (or to tissues proximate the sacrum) is less stretchy (has less ability to stretch) than the portion of the sheet of material that is coupled to the vaginal wall.

In some embodiments, the second sheet of material that is coupled to the first sheet of material is configured to be coupled to another vaginal wall, such as an anterior portion of the vaginal wall (or tissues proximate such vaginal wall). In some embodiments, the second sheet of material has the same value for the property or mechanical parameter as the portion of the first sheet of material that is coupled to the vaginal wall.

In some embodiments, the first sheet of material may be rectangular, square, or any other shape. In some embodiments, the first sheet of material may be cut or reshaped by the user or the physician. In some embodiments, the first sheet of material is rectangular in shape and is <NUM> by <NUM> in size. In other embodiments, the first sheet of material is larger than <NUM> by <NUM>. In yet other embodiments, the first sheet of material is smaller than <NUM> by <NUM>. In some embodiments, half of the first sheet of material is formed such that it has a first value for a property or mechanical parameter and the other half of the first sheet of material is formed such that it has a second value for the property or mechanical parameter. For example, in some embodiments, a <NUM> by <NUM> portion of the first sheet of material may have the first value for the property or mechanical parameter and another <NUM> by <NUM> portion of the first sheet of material may have the second value for the property or mechanical parameter. In other embodiments, more or less than half of the first sheet of material has the first value for the property or mechanical parameter. Accordingly, less or more than half of the first sheet of material has the second value for the property or mechanical parameter.

In some embodiments, the portion of the first sheet of material that is coupled to the vaginal wall of the patient may be formed of a knit structure that has a high elongation (or is configured to elongate or stretch) at loads in the range of between <NUM> and <NUM> pounds of pressure. For example, the knit structure may be configured to stretch when placed under loads of <NUM> to <NUM> pounds per square cm. In other embodiments, the portion of the first sheet of material that is coupled to the vaginal wall of the patient may be formed of a structure that is configured to elongate at higher amounts of pressure.

In some embodiments, a portion of the first sheet of material is formulated or configured to promote tissue ingrowth. For example, in some embodiments, the first portion of the first sheet of material is configured to promote tissue ingrowth. In some embodiments, the second portion of the first sheet of material is configured to promote tissue ingrowth.

<FIG> is a perspective view of a medical implant <NUM> formed as a tubular structure <NUM>.

The tubular structure <NUM> of the medical implant includes a first portion <NUM>, a second portion <NUM>, and a transition region <NUM>. The transition region <NUM> is formed from intersection of the first, and the second <NUM>, and <NUM> of the tubular structure <NUM> of the medical implant <NUM>. The medical implant <NUM> defines a proximal portion <NUM>, a distal portion <NUM> and a lumen <NUM> extending from the proximal portion <NUM> to the distal portion <NUM>. The medical implant <NUM> defines a length L13 from the proximal portion <NUM> to the distal portion <NUM>. The medical implant includes the second portion <NUM> at the proximal portion <NUM> of the medical implant. The second portion can a first section <NUM> and a second section <NUM> and two slits 518A and 518B extending laterally along the length L13 of the medical implant <NUM>. In some embodiments, the proximal portion <NUM> includes two slits extending laterally along the length L13 and into the lumen <NUM> of the medical implant <NUM>. The slits 518A and 518B can configure first section <NUM> as apart from the second section <NUM> at a proximal end <NUM> of the medical implant <NUM>. The medical implant <NUM> can be configured so that each of the first portion <NUM>, the first section <NUM> and the second section <NUM> can define a set of biomechanical attributes, which can be congruent with the sacrum or tissues proximate the sacrum, the anterior vaginal wall and the posterior vaginal wall respectively. The congruency can be achieved by any of the methods described with reference to <FIG>.

The first portion <NUM> can define a knit structure <NUM> formed of a pore construct <NUM>. In some embodiments, the pore construct <NUM> can define a pore size so as to accommodate values of the biomechanical attributes the first bodily tissue. The first section <NUM> can define a knit structure <NUM> formed of a pore construct <NUM>. In some embodiments, the pore construct <NUM> can define a pore size so as to accommodate values of the biomechanical attributes the second bodily tissue. The second section <NUM> can define a knit structure <NUM> formed of a pore construct <NUM>. In some embodiments, the pore construct <NUM> can define a pore size so as to accommodate values of the biomechanical attributes the third bodily tissue. In some embodiments, the knit structure <NUM> of the first portion <NUM> is different from the knit structure <NUM> and the knit structure <NUM> of the first section <NUM> and the second section <NUM> of the second portion <NUM>. In some embodiments, the knit structure <NUM> of the first section <NUM> is different from the knit structure <NUM> of the second section <NUM>. In some embodiments, the varying knit structure is formed by varying the knit structure in the course of a pore.

In some embodiments, the first portion <NUM> can be configured for attaching to the sacrum, the first section <NUM> to the anterior vaginal wall and the second section <NUM> to the posterior vaginal wall. In some embodiments, a value corresponding to a biomechanical parameter defining a biomechanical attribute of the first section <NUM> attaching to the anterior vaginal wall is different from a value of the same biomechanical parameter of the second section <NUM> attaching to the posterior vaginal wall. For example, the value of elasticity can be different for the first section <NUM> and the second section <NUM> under similar strain conditions.

In some embodiments, the medical implant <NUM> can be formed from a process of extrusion. The pore constructs <NUM>, <NUM>, and <NUM>, in such cases can be the same. The medical implant can then be provided a heat treatment and different portions of the medical implant <NUM> can be heat set to different pore sizes. For example, the pore construct <NUM> can remain in a closed position without application of heat as illustrated in <FIG>. The second portion <NUM> can be manually stretched to bring the medical implant <NUM> in an open position as illustrated in <FIG>. This can increase a pore size of the pore constructs <NUM> and <NUM>. The pore construct <NUM> and the pore construct <NUM> can remain in an open position on application of heat over the first section <NUM> and the second section <NUM>. The first section <NUM> and the second section <NUM> may each be given heat treatment for setting different pore sizes so as to facilitate defining biomechanical attributes emulating biomechanical behavior of the anterior and posterior vaginal walls respectively.

In some embodiments, the medical implant <NUM> can be fabricated so that the first portion <NUM> includes the knit structure <NUM> and the pore construct <NUM> as described for the first flap <NUM>, the second portion <NUM> includes the knit structure <NUM> and the pore construct <NUM> as described for the first flap <NUM> and the third portion <NUM> includes the knit structure <NUM> and the pore construct <NUM> as described for the second flap <NUM>.

<FIG> is an exemplary graphical representation of relationship between stress applied on a vaginal tissue and resulting elongation in the vaginal tissue due to the applied stress. A medical implant can be fabricated to conform to the changes resulting in the vaginal tissue due to applied stress. The medical implant can be any of the medical implants <NUM>, <NUM>, <NUM>, and <NUM>. The vaginal tissue is generally viscoelastic or viscohyperelastic. The vaginal tissue can experience large deformation under small loads as shown. Therefore, in some embodiments, the medical implant is configured to experience varying levels of deformation under varying loads. The vaginal tissue stress-strain or load vs (or compared to) elongation relationship can follow a non-linear curve as illustrated. The curve has a first linear phase at low loads / stresses. At low levels of load, the strains or elongations are high defining a low stiffness attribute of the implant. The curve includes a second phase defined by a transition phase after an inflection point where it transitions from one linear phase to a third phase such that the curve is sharper in the third phase. The third phase defines a region of relatively lower elongation even under an application of relatively higher loads as compared to the first phase. That is to say that that after the load increases after a limit defined by the inflection point, there is lesser elongation with every unit change in load. This defines a property of high stiffness of the implant at higher loads. The unit change in elongation with every unit change in load decreases thereafter till it reaches a level that there is almost negligible elongation in the implant even at increased loads. The implant thus behaves as a stiff member. Therefore, the medical implant can be configured to define the attributes congruent with the stress-strain or load vs (or compared to) elongation relationship of the vaginal tissue. In some embodiments, the portion of the medical implant attaching to the anterior or posterior portion of the vagina can be so configured that it experiences large deformations over small loads until the inflection point is achieved. As the load is increased beyond the inflection point, the medical implant portion attached to the anterior vaginal wall or posterior vaginal wall starts exhibiting high stiffness and very less (negligible) deformation.

As mentioned with respect to <FIG> and <FIG> above, in some cases the vaginal wall may be anisotropic in nature; therefore, it experiences different elongations in different directions. For example, the vaginal wall in a traverse direction is generally more elastic than in a longitudinal direction. Therefore, it may be desirable to configure the medical implant to exhibit values of the biomechanical attributes defined to emulate the varying elongation behavior of the vaginal wall in different directions. <FIG> is a graphical representation of a comparison of an exemplary attribute, elongation, of the vaginal tissue in the transverse direction and the longitudinal direction. A shown, the elongation of the vaginal tissue in the transverse direction is much lesser than the elongation in the longitudinal direction.

Referring to the graphical representations of <FIG> that depict the characteristics and behavior of a vaginal tissue, the portions of the medical implant that are attached to vaginal tissues are configured to behave accordingly in order to emulate the behavior of the vaginal tissues such as the anterior and posterior vaginal walls. For example, in some embodiments, the portions of the implant that attach to the anterior vaginal wall can be configured to define different stiffness characteristics at different levels of loads on the implant portions. Similarly, the implant portions that attach to the posterior vaginal wall can be configured to define different characteristics in different directions such as the transverse direction and the longitudinal direction and for different load values.

In some embodiments, stiffness at the low strain or deformation phase can range from <NUM> - <NUM> MPa for the anterior vaginal wall in the longitudinal direction. In some embodiments, stiffness at the high strain or deformation phase can range from <NUM> - <NUM> MPa for the anterior vaginal wall in the longitudinal direction. In some embodiments, stiffness at a low strain or deformation phase can range from <NUM> - <NUM> MPa for the posterior vaginal wall in the longitudinal direction. In some embodiments, stiffness at a high strain or deformation phase can range from <NUM> - <NUM> MPa for the posterior vaginal wall in the longitudinal direction. In some embodiments, stiffness at the low strain or deformation phase can range from. <NUM> MPa for the anterior vaginal wall in the traverse direction. In some embodiments, stiffness at the high strain or deformation phase can range from. <NUM> MPa for the anterior vaginal wall in the traverse direction. In some embodiments, stiffness at the low strain or deformation phase can range from <NUM> - <NUM> MPa for the posterior vaginal wall in the traverse direction. In some embodiments, stiffness at the high strain or deformation phase can range from <NUM> - <NUM> MPa for the posterior vaginal wall in the traverse direction. The values of stiffness detailed here are a guide for vaginal tissues generally. The values of stiffness can be different depending on disease state, age, or any other influencing factor. Therefore, the implant can be made / designed accordingly to be configured for emulating the biomechanical behavior of the vaginal tissue in accordance with the desired characteristic behavior.

<FIG> is a perspective view of the medical implant <NUM>, including the first flap <NUM> and the second flap <NUM> of <FIG> and <FIG> respectively, placed inside a patient's body, in accordance with an embodiment of the invention. The body portions of the patient such as the vagina V, the anterior vaginal wall AVW, the posterior vaginal wall PVW, a urethra U, and the sacrum S are illustrated in <FIG>. <FIG> illustrates a method <NUM> for placing an implant in a patient's body. The method <NUM> is described below in conjunction with <FIG>, <FIG>, <FIG>, <FIG>, and <NUM>-<NUM>. The medical implant <NUM> including the first flap <NUM> and the second flap <NUM> is used as an exemplary embodiment to illustrate and discuss the method <NUM>. However, it must be appreciated that other implants such as the medical implant <NUM> and the medical implant <NUM> as discussed above can also be employed equally.

The method <NUM> includes inserting the first flap <NUM> of the medical implant <NUM> inside the body at step <NUM>. In some embodiments, the first flap <NUM> can be inserted inside the patient's body through a laparoscopic approach. In some embodiments, the method <NUM> includes creating an abdominal incision for delivering the medical implant inside the body laparoscopically.

The method <NUM> further includes attaching the first portion <NUM> of the medical implant <NUM> at the sacrum S inside the patient's body. The first portion <NUM> can be configured to define the biomechanical attributes so as to emulate the biomechanical behavior of the sacrum S in a defined set of physical conditions. The biomechanical attributes can be defined by the first set of values of respective biomechanical parameters associated with the biomechanical attributes.

The method <NUM> further includes attaching the second portion <NUM> of the first flap <NUM> to the anterior vaginal wall AVW at step <NUM>. The anterior vaginal wall AVW is known to exhibit properties of viscoelasticity, anisotropy, and viscohyperelasticity. The second portion <NUM> can be configured to emulate the biomechanical behavior of the anterior vaginal wall AVW and define viscoelasticity, anisotropy, and viscohyperelasticity. The second portion <NUM> can define the biomechanical attributes that can be defined by the second set of values of respective biomechanical parameters associated with the biomechanical attributes as explained by way of <FIG>. The first flap <NUM> is configured so that the first set of values is different from the second set of values. The difference in values can be attributed to the difference in the biomechanical behavior of the sacrum S and the anterior vaginal wall AVW. In some embodiments, the portion attaching to the anterior wall is formed monolithically with the first portion <NUM> and the transition region <NUM> as discussed above. It must be appreciated that any conventionally known or practiced methods or devices may be used for attaching the medical implant at any location inside the patient's body.

The method <NUM> further includes placing the second flap <NUM> of the medical implant <NUM> over the posterior vaginal wall PVW at step <NUM> as described below.

The first portion <NUM> can be configured to define the biomechanical attributes so as to emulate the biomechanical behavior of the sacrum S in a defined set of physical conditions. The biomechanical attributes can be defined by the first set of values of respective biomechanical parameters associated with the biomechanical attributes. The first set of values for the first portion <NUM> from the first flap <NUM> can be same as those for the first portion <NUM> from the second flap <NUM>.

The posterior vaginal wall PVW is known to exhibit properties of viscoelasticity, anisotropy, and viscohyperelasticity. The second portion <NUM> can be configured to emulate the biomechanical behavior of the posterior vaginal wall PVW and define viscoelasticity, anisotropy, and viscohyperelasticity. The second portion <NUM> can define the biomechanical attributes that can be defined by the third set of values of respective biomechanical parameters associated with the biomechanical attributes as explained by way of <FIG>. The second portion <NUM> can be configured to define the biomechanical attributes congruent to the biomechanical behavior of the posterior vaginal wall. The medical implant <NUM> can be fabricated so that second flap <NUM> is configured to have the third set of values corresponding to the biomechanical attributes to be different from the second set of values corresponding to the first flap <NUM>. Therefore, the second portion <NUM> of the first flap <NUM> used for attaching to the anterior vaginal wall AVW defines a different set of values corresponding to a biomechanical parameter than the set of values corresponding to the same biomechanical parameter for the second portion <NUM> of the second flap <NUM> attaching to the posterior vaginal wall. In this way, the properties of the first flap <NUM> and the second flap <NUM> are different and congruent with respect to the portions the first flap <NUM> and the second flap <NUM> are attached to. In some embodiments, the portion attaching to the posterior vaginal wall PVW is formed monolithically with the first portion <NUM> and the transition region <NUM> as discussed above. It must be appreciated that any conventionally known or practiced methods or devices may be used for attaching the medical implant at any location inside the patient's body. In some embodiments, the tow flaps can be independent from each other and may collectively enable the medical implant <NUM> in emulating biomechanical behavior of the anterior vaginal wall AVW, posterior vaginal wall PVW and the sacrum S inside a patient's body.

In some embodiments, the method <NUM> further includes cutting an unwanted portion of the medical implant <NUM> after placing in the body. In some embodiments, the method <NUM> further includes closing the abdominal incision or any other incision created for method <NUM>.

In some embodiments, the method <NUM> can be used for treatment of a pelvic floor disorder, in accordance with an embodiment of the present invention. The implant can be a dual knit mesh. The dual knit mesh material can be a polymer mesh, a polypropylene material, a bio-absorbable material, or any other preferred material. The knit structure defined by each of the implants <NUM>, <NUM>, and <NUM> can be any knit structure that emulates the biomechanical properties of the vagina in the wide body region and provides stiffness in the stem region. The implant can be sold as a separate dual knit mesh and a standard mesh. The implant can be used for vaginal prolapse to suspend the vagina to the sacral promontory or the sacrum after a hysterectomy termed as Sacrocolpopexy or any other disorders. The implant can be placed into the body by laparoscopic or any other means.

In some embodiments, an implant includes a first flap and a second flap. The first flap has a first portion configured to be attached proximate a sacrum; a second portion configured to be attached to an anterior vaginal wall; and a transition region lying between the first portion and the second portion. The second flap includes a portion configured to be attached to a posterior vaginal wall. A value corresponding to a biomechanical parameter defining a biomechanical attribute of the portion of the first flap attaching to the anterior wall is different from a value of the biomechanical parameter defining the biomechanical attribute of the portion of the second flap attaching to the posterior wall.

In some embodiments, the implant may be configured to help suspend or provide support to a portion of the body of the patient. For example, the implant may be used to provide support to a vagina of a patient. In other embodiments, the implant is configured to suspend or provide support to other portions of the body, such as a portion of the gastrointestinal tract of the patient, a bladder of the patient, or a rectum of the patient.

In some embodiments, an implant includes a first end portion, a second end portion and a body in between the ends. The first end portion has a biomechanical attribute that is different in value than the same biomechanical attribute at the second end portion.

In some embodiments, the first portion of the first flap defines a first type of knit structure. In some embodiments, the second portion of the first flap defines a second type of knit structure. In some embodiments, the first type of knit structure includes pores that are smaller in cross sectional profile than the pores in the second type of knit structure. In some embodiments, a width of the second portion is substantially more or greater than a width of the first portion of the first flap. In some embodiments, the second portion includes a proximal end and a distal end, the distal end being proximate the transition region, wherein the width of the second portion varies from the proximal end to the distal end of the second portion. In some embodiments, the varying second width along the second portion defines a trapezoidal shape of the second portion. In some embodiments, the transition region defines a third type of knit structure. In some embodiments, each of the first and the second flaps defines a planar shape and are configured to be attached separately to bodily locations. In some embodiments, each of the value of the biomechanical parameter defining the biomechanical attribute of the portion of the first flap attaching to the anterior wall and the value of the biomechanical parameter defining the biomechanical attribute of the portion of the second flap attaching to the posterior wall is different from a value of the biomechanical parameter of the first portion attaching proximate the sacrum.

In some embodiments, the biomechanical attribute is elasticity and the biomechanical parameter is a modulus of elasticity. In some embodiments, the biomechanical attribute is viscoelasticity. In some embodiments, the biomechanical attribute is viscohyperelasticity. In some embodiments, the biomechanical attribute is anisotropicity. In some embodiments, the biomechanical attribute is resistance to creep. In some embodiments, the biomechanical attribute is stiffness.

In some embodiments, the second flap includes a first portion defining a width and configured to be attached proximate the sacrum; a second portion defining a width and configured to be attached to the posterior vaginal wall; and a transition region lying between the first portion and the second portion and monolithically joining the first portion and the second portion.

In some embodiments, the first flap and the second flap are constructed from a single piece of material. In some embodiments, the first flap and the second flap are fabricated independent of each other. In some embodiments, each of the first flap and the second flap are fabricated from a linear strip of material such that the transition region of each of the first flap and the second flap extends monolithically from each of the first portion, and the second portion.

In some embodiments, a tubular implant includes a first portion of the tubular implant configured to be attached proximate a sacrum; a transition region extending from the first portion; a second portion of the tubular implant and extending from the transition region monolithically and including a first section and a second section and two slits provided laterally in the second portion configuring the first section as apart from the second section at a proximal end; and a lumen defined within the first and second portions of the tubular implant. The first section is configured to be attached to an anterior vaginal wall, and the second section is configured to be attached to a posterior vaginal wall.

In some embodiments, a knit structure of the first portion is different from a knit structure of the second portion. In some embodiments, a knit structure of the first section is different from a knit structure of the second section of the section portion. In some embodiments, a value corresponding to a biomechanical parameter defining a biomechanical attribute of the first section wall is different from a value of the biomechanical parameter of the second section.

In some embodiments, a method for placing an implant in a body of a patient, the method includes inserting the implant inside the body; attaching a portion of the implant to an anterior vaginal wall, wherein the portion attaching to the anterior vaginal wall defines a first value of a biomechanical parameter defining a biomechanical attribute; attaching a portion of the implant to a posterior vaginal wall, wherein the portion attaching to the posterior vaginal wall defines a second value of the biomechanical parameter such that the second value corresponding to the portion attaching to the posterior wall is different from the first value corresponding to the portion attaching to the anterior wall.

In some embodiments, the method includes creating an abdominal incision for delivering the implant inside the body laparoscopically. In some embodiments, the portions attaching to the anterior wall, and the posterior wall define regions of a tubular structure of the implant. In some embodiments, the tubular structure includes a portion configured to be attached proximate a sacrum, the method further comprising attaching the portion proximate the sacrum.

In some embodiments, the portion attaching to the anterior wall is formed monolithically with a second portion configured to be attached proximate a sacrum and a transition region between the portion attaching to the anterior wall and the second portion attaching proximate the sacrum, the method further comprising attaching the second portion proximate the sacrum. In some embodiments, the portion attaching to the posterior wall is formed monolithically with a second portion configured to be attached proximate a sacrum and a transition region between the portion attaching to the posterior wall and the second portion attaching proximate the sacrum, the method further comprising attaching the second portion proximate the sacrum.

In some embodiments, the method includes cutting an unwanted portion of the implant after placing in the body. In some embodiments, the method includes closing the abdominal incision and other incisions.

Claim 1:
A tubular implant (<NUM>) comprising:
a first portion (<NUM>) of the tubular implant (<NUM>) configured to be attached proximate a sacrum, the first portion (<NUM>) defining a first lumen;
a second portion (<NUM>) of the tubular implant (<NUM>), the second portion (<NUM>) defining a second lumen, the second lumen directly extending from the first lumen, the second portion (<NUM>) including a proximal end portion and a distal end portion, the proximal end portion being adjacent to the first portion (<NUM>), the second portion (<NUM>) including a first section (<NUM>) and a second section (<NUM>) and two slits (518A, 518B) separating the first section (<NUM>) and the second section (<NUM>), the two slits (518A, 518B) extend substantially entirely from the proximal end portion to the distal end portion,
a transition region (<NUM>) defined by an intersection of the first portion (<NUM>), the first section (<NUM>), and the second section (<NUM>), the two slits (518A, 518B) extending to the transition region (<NUM>),
wherein a value corresponding to a biomechanical parameter defining a biomechanical attribute of the first section (<NUM>) and a value of the biomechanical parameter defining the biomechanical attribute of the second section (<NUM>) are different from each other,
wherein the first section (<NUM>) is configured to be attached to an anterior vaginal wall, and the second section (<NUM>) is configured to be attached to a posterior vaginal wall,
wherein the biomechanical attribute of the first section (<NUM>) is configured to emulate biomechanical properties of the anterior vaginal wall of the patient and the biomechanical attribute of the second section (<NUM>) is configured to emulate biomechanical properties of the posterior vaginal wall of the patient;
wherein the biomechanical attribute is one of the following: elasticity, viscoelasticity, viscohyperelasticity, anisotropicity, resistance to creep and stiffness;
wherein a knit structure (<NUM>) of the first section (<NUM>) is different from a knit structure (<NUM>) of the second section (<NUM>).