Fistula treatment device

Abstract

The present invention relates to devices and related methods for treating fistula, such as anal fistula or rectal vaginal fistula, generally comprising an elongated body of seton and tissue growth promoting matrix material, where the elongated body is adapted to be positioned within the fistula, in one aspect of the invention, the elongated body is configured to be positioned within the fistula. The elongated body includes a plurality of protrusions positioned on at least one outer surface of the elongated body. In another aspect of the invention, the device includes one or more connection points positioned along the length of the elongated body, where the one or more connection points are configured to connect the elongated body to another hanging line.

Description

Technical Field

[0001] The present invention relates to devices and related methods for treating fistulas such as anal or rectovaginal fistulas. Generally, the device includes an elongate body of a seton and a tissue growth promoting matrix material, wherein the elongate body is adapted to be placed within a fistula tract. In one aspect of the present invention, the elongate body includes a plurality of protrusions located on at least one outer surface of the elongate body. In another aspect of the present invention, the device includes one or more connection points positioned along the length of the elongate body, wherein the one or more connection points are configured to connect the elongate body to other setons. Background Art

[0002] An anal fistula, also known as an anorectal fistula, is an abnormal passage formed between the anal wall and the skin around the anus (usually perianal skin). An anal fistula typically originates from an infection of the anal glands within the anal canal. If the anal glands become infected, an abscess may form deep within the skin around the anus, which requires surgical drainage. After drainage, a passage may form between the drainage site and the anal wall, resulting in an anal fistula. A fistula causes intermittent discharge symptoms and generally does not heal without treatment or surgical intervention. An anal fistula is also a common feature of inflammatory bowel disease, particularly ulcerative colitis and Crohn's disease.

[0003] “Open” fistulotomy is a conventional surgery for treating anal fistulas, which involves separating the tissue between the fistula and the skin to promote tissue regeneration and thus promote fistula healing. The disadvantage of this surgery is that it causes discomfort and scarring, and usually results in a certain degree of urinary incontinence.

[0004] In another treatment method, a seton is used that is passed through a fistula tract by a fistula probe. The seton is preferably made of silicon or rubber and is usually passed through the eye of the fistula probe. The probe is then passed through the fistula tract, pulling the seton so that it passes through the entire length of the fistula. When the probe reaches the anal wall, the probe is passed through the anus and then removed from the seton, so that the two loose ends of the seton can be tied together to form a loop, thereby forming a “seton stitch”. The seton stitch usually either remains in place for a long time to help drain any discharge from the fistula or is tightened to produce a slow fistulotomy, i.e., cutting the tissue on the surface layer of the fistula.

[0005] If the seton stitch remains in place for a long time to help drain any discharge from the fistula, the results may vary. In particular, if the fistula is stenotic and / or the discharge is viscous, drainage is often inadequate, which can prolong and / or worsen any infection. Persistent infection makes definitive treatment difficult and less successful.

[0006] A novel method for treating fistulas is described in patent application WO2011 / 151659. This method uses a seton stitch to fix a tissue growth promoter (such as a fibrin plug) inside the fistula. Thus, this method allows and encourages the fistula to heal internally, rather than just draining. In addition, as described above, this method avoids the main drawbacks associated with fistulotomy. Therefore, it can be seen that this new method represents a significant advancement in the clinical treatment of fistulas.

[0007] Patent application WO 2011 / 151659 also describes a device suitable for the new method. For example, in one embodiment, a device is described that includes a fistula plug fixed to a seton, where the seton passes through a hole in the center of the fistula plug. In another embodiment, a fistula plug sutured to a seton is described. Patent application WO 2014 / 023962 describes other devices for the new method.

[0008] However, there is still a need for devices that can better fix tissue growth promoters inside the fistula, making it easier for end users to treat complex fistulas, and / or improving manufacturing cost - effectiveness.

[0009] The present invention seeks to provide a device that meets some or all of the above - mentioned needs. Summary of the Invention

[0010] According to a first aspect of the present invention, there is provided a device suitable for treating a fistula, where the fistula includes a fistula tract, and the device includes a seton and an elongate body of a tissue growth - promoting matrix material, where the elongate body is adapted to be positioned inside the fistula tract, and the elongate body includes a plurality of protrusions located on at least one outer surface of the elongate body.

[0011] In one embodiment of the first aspect of the present invention, the elongate body has a longitudinal axis. Generally, one or more of the plurality of protrusions are located on an outer surface parallel to or substantially parallel to the longitudinal axis of the elongate body. More typically, two or more of the plurality of protrusions are located on an outer surface parallel to or substantially parallel to the longitudinal axis of the elongate body.

[0012] The plurality of protrusions may be located on a single outer surface of the elongate body or on two or more outer surfaces. Generally, each outer surface on which the plurality of protrusions are located is parallel to or substantially parallel to the longitudinal axis of the elongate body. For example, in one embodiment, the elongate body includes a first outer surface and a second outer surface, where the first outer surface and the second outer surface are both parallel to or substantially parallel to the longitudinal axis of the elongate body, and a first plurality of protrusions are located on the first outer surface and a second plurality of protrusions are located on the second outer surface.

[0013] In one embodiment, each outer surface on which each of the plurality of protrusions is located includes 2 - 200 protrusions. More typically, each outer surface on which the plurality of protrusions is located includes 5 - 100 protrusions, or 10 - 60 protrusions. More typically, each outer surface on which the plurality of protrusions is located includes 30 - 50 protrusions.

[0014] The plurality of protrusions may be distributed uniformly or non - uniformly on each outer surface on which they are located. The plurality of protrusions may be distributed over all or part of each outer surface on which they are located. Generally, the plurality of protrusions is distributed substantially uniformly on all of the respective outer surfaces on which they are located.

[0015] In one embodiment, the distance (dp) between the highest points of each adjacent protrusion on each outer surface on which the plurality of protrusions is located is 0.1 - 20 mm. Generally, the distance (dp) between the highest points of each adjacent protrusion is 0.2 - 10 mm. More typically, the distance (dp) between the highest points of each adjacent protrusion is 0.5 - 5 mm. More typically, the distance (dp) between the highest points of each adjacent protrusion is 1 - 3 mm.

[0016] In one embodiment, the height of each protrusion among the plurality of protrusions is 0.1 - 5 mm. More typically, the height of each protrusion among the plurality of protrusions is 0.5 - 3 mm. More typically, the height of each protrusion among the plurality of protrusions is 0.8 - 1.5 mm. It is understood that, as described in the present application, the height of the protrusion refers to the maximum distance (hp) that the protrusion extends upward from the adjacent lowest point on the surface, and hp is measured perpendicular to the surface on which the protrusion is formed.

[0017] In one embodiment, the width of each protrusion among the plurality of protrusions is 0.1 - 10 mm. More typically, the width of each protrusion among the plurality of protrusions is 0.5 - 5 mm. More typically, the width of each protrusion among the plurality of protrusions is 1 - 3 mm. It is understood that, as described in the present application, the width of the protrusion refers to the maximum distance (wp) that the protrusion extends between two adjacent lowest points, and wp is measured parallel to the surface on which the protrusion is formed.

[0018] Each protrusion among the plurality of protrusions may have the same or different sizes. Generally, each protrusion among the plurality of protrusions has substantially the same size. More typically, each protrusion among the plurality of protrusions has the same size.

[0019] Each of the plurality of protrusions may have the same or different shapes. For example, the shape of each of the plurality of protrusions may be circular or dome-shaped, cylindrical, conical, square or cuboid, or triangular, triangular prism-shaped or pyramid-shaped. Generally, each protrusion includes at least one point. In one embodiment, the shape of each of the plurality of protrusions is conical, triangular, triangular prism-shaped or pyramid-shaped. Generally, the shape of each of the plurality of protrusions is substantially the same. More typically, the shape of each of the plurality of protrusions is the same.

[0020] In one embodiment, each lowest point between adjacent protrusions is not pointed or V-shaped. For example, each lowest point between adjacent protrusions may be, for example, curved or circular so as to form a concave curve between the highest points of each adjacent protrusion.

[0021] The shape of the elongate body may be cylindrical, conical or prismatic. The prism may be regular or irregular. For example, the shape of the elongate body may be cylindrical, conical, triangular prismatic, square prismatic, rectangular prismatic, pentagonal prismatic or hexagonal prismatic. In these embodiments, one or more of the plurality of protrusions are generally located on one or more sides of the cylindrical, conical or prismatic shape. Any edges or corners formed between the end faces and one or more sides of the cylindrical, conical or prismatic shape may optionally be chamfered.

[0022] The plurality of protrusions may be formed of a material that is the same as or different from the material of the elongate body of the tissue growth promoting matrix material. Generally, the plurality of protrusions are formed of a substance including one or more biodegradable materials, examples of which will be discussed below. Generally, the plurality of protrusions are formed of a material that is the same as the material of the elongate body.

[0023] In one embodiment, the elongate body and the plurality of protrusions are an integral structure.

[0024] The elongate body may be defined as having a longitudinal axis (x) and two other axes (y) and (z), which are perpendicular to each other and both perpendicular to the longitudinal axis (x). When so defined, the maximum length of the elongate body measured along the x-axis is greater than the maximum width and maximum height of the elongate body measured along the y-axis and z-axis, respectively.

[0025] Generally, the maximum length of the elongate body measured along the x-axis is 2 to 30 times greater than the greater of the maximum width and maximum height of the elongate body measured along the y-axis and z-axis, respectively. More typically, the maximum length of the elongate body is 5 to 15 times greater than the greater of the maximum width and maximum height of the elongate body. More typically, the maximum length of the elongate body is 8 to 12 times greater than the greater of the maximum width and maximum height of the elongate body.

[0026] In one embodiment, the maximum length of the elongate body measured along the x-axis is 10 - 200 mm. Typically, the maximum length of the elongate body is 30 - 150 mm. More typically, the maximum length of the elongate body is 50 - 100 mm.

[0027] In one embodiment, the greater of the maximum width and the maximum height of the elongate body measured along the y-axis and the z-axis respectively is 3 - 20 mm. Typically, the greater of the maximum width and the maximum height of the elongate body is 4 - 15 mm. More typically, the greater of the maximum width and the maximum height of the elongate body is 5 - 10 mm.

[0028] In one embodiment, the elongate body is an elongate sheet of tissue growth promoting matrix material. In such an embodiment, the elongate sheet can be defined such that when laid flat, it has a longitudinal axis (x) and two other axes (y) and (z) that are perpendicular to each other and both perpendicular to the longitudinal axis (x). Typically, when laid flat, the y-axis is parallel to the plane of the sheet and the z-axis is perpendicular to the plane of the sheet. When so defined, the maximum length of the elongate sheet measured along the x-axis is greater than the maximum width of the elongate sheet measured along the y-axis, and the maximum width of the elongate sheet measured along the y-axis is greater than the maximum height (i.e., thickness) of the elongate sheet measured along the z-axis.

[0029] Typically, the maximum length of the elongate sheet measured along the x-axis is 2 - 30 times greater than the maximum width of the elongate sheet measured along the y-axis. More typically, the maximum length of the elongate sheet is 5 - 15 times greater than the maximum width of the elongate sheet. More typically, the maximum length of the elongate sheet is 8 - 12 times greater than the maximum width of the elongate sheet.

[0030] Typically, the maximum width of the elongate sheet measured along the y-axis is 5 - 50 times greater than the maximum height or thickness of the elongate sheet measured along the z-axis. More typically, the maximum width of the elongate sheet is 10 - 30 times greater than the maximum height or thickness of the elongate sheet. More typically, the maximum width of the elongate sheet is 15 - 20 times greater than the maximum height or thickness of the elongate sheet.

[0031] In one embodiment, the maximum length of the elongate sheet measured along the x-axis is 10 - 200 mm. Typically, the maximum length of the elongate sheet is 30 - 150 mm. More typically, the maximum length of the elongate sheet is 50 - 100 mm.

[0032] In one embodiment, the maximum width of the elongate sheet measured along the y-axis is 3 - 20 mm. Typically, the maximum width of the elongate sheet is 4 - 15 mm. More typically, the maximum width of the elongate sheet is 5 - 10 mm.

[0033] In one embodiment, the maximum height or thickness of the elongated sheet measured along the z-axis is 0.1 - 2 mm. Generally, the maximum height or thickness of the elongated sheet is 0.2 - 1 mm. More typically, the maximum height or thickness of the elongated sheet is 0.3 - 0.5 mm.

[0034] Generally, the shape of the elongated sheet of the tissue growth promoting matrix material is substantially rectangular, trapezoidal or oval. More typically, the shape of the elongated sheet of the tissue growth promoting matrix material is substantially rectangular or trapezoidal. Most typically, the shape of the elongated sheet of the tissue growth promoting matrix material is substantially rectangular. When the shape of the elongated sheet is substantially rectangular or trapezoidal, the corners of the rectangle or trapezoid can optionally be rounded or chamfered.

[0035] In the case where the elongated body is the elongated sheet of the tissue growth promoting matrix material, in one embodiment, a plurality of protrusions are located on at least one outer edge surface of the elongated sheet. It can be understood that when referring to the elongated sheet, the term "outer edge surface" refers to the outer surface formed in at least one dimension that is parallel to or substantially parallel to the thickness of the sheet (i.e., the z-axis defined above).

[0036] Generally, one or more of the plurality of protrusions are located on the outer edge surface parallel to or substantially parallel to the longitudinal axis of the elongated sheet. In such an embodiment, it can be seen that the outer edge surface extends in the directions of the x-axis and z-axis defined above. More typically, two or more of the plurality of protrusions are located on the outer edge surface parallel to or substantially parallel to the longitudinal axis of the elongated sheet.

[0037] The plurality of protrusions can be located on a single outer edge surface of the elongated sheet or on two or more outer edge surfaces. Generally, each outer edge surface on which the plurality of protrusions are located is parallel to or substantially parallel to the longitudinal axis of the elongated body. For example, in one embodiment, the elongated sheet includes a first outer edge surface and a second outer edge surface, wherein both the first outer edge surface and the second outer edge surface are parallel to or substantially parallel to the longitudinal axis of the elongated sheet, wherein a first plurality of protrusions are located on the first outer edge surface, and a second plurality of protrusions are located on the second outer edge surface.

[0038] In one embodiment, the elongated sheet does not include any protrusions on any surface parallel to or substantially parallel to the x-axis and y-axis, i.e., any surface parallel to or substantially parallel to the plane of the sheet when the sheet is laid flat.

[0039] In the case where a plurality of protrusions are located on at least one outer edge surface of the elongated sheet, the plurality of protrusions can be formed by cutting the outer edge of the elongated sheet. For example, the elongated sheet can be cut to have one or more crenellated or serrated outer edges. Generally, the elongated sheet is cut to have one or more serrated outer edges.

[0040] Thus, in an exemplary embodiment of the first aspect of the present invention, the present invention provides a device suitable for treating a fistula, wherein the fistula includes a fistula tract, and wherein the device includes a thread and an elongated sheet of tissue growth promoting matrix material, wherein the elongated sheet is adapted to be positioned within the fistula tract, and wherein the elongated sheet includes a first outer edge surface and a second outer edge surface, wherein when the elongated sheet is laid flat, both the first outer edge surface and the second outer edge surface are parallel or substantially parallel to the longitudinal axis of the elongated sheet, wherein the first plurality of protrusions includes serrations formed on the first outer edge surface, and wherein the second plurality of protrusions includes serrations formed on the second outer edge surface.

[0041] According to the first aspect of the present invention, the thread can be fixed to the elongated body or the elongated sheet of the tissue growth promoting matrix material.

[0042] In one embodiment, the thread passes through the elongated body or the elongated sheet of the tissue growth promoting matrix material. Generally, the thread passes through the elongated body or the elongated sheet in a direction parallel or substantially parallel to the longitudinal axis of the elongated body or the elongated sheet. Generally, the thread passes through the elongated body or the elongated sheet in a direction coaxial or substantially coaxial with the longitudinal axis of the elongated body or the elongated sheet.

[0043] The elongated body or the elongated sheet can be defined as including a first end and a second end, and the longitudinal axis extends from the first end to the second end. Generally, when the thread passes through the elongated body or the elongated sheet of the tissue growth promoting matrix material, a portion of the thread extends beyond at least the first end or the second end of the elongated body or the elongated sheet. More typically, a first portion of the thread extends beyond the first end of the elongated body or the elongated sheet, and a second portion of the thread extends beyond the second end.

[0044] When the thread passes through the elongated body or the elongated sheet of the tissue growth promoting matrix material, the thread is typically fixed to the elongated body or the elongated sheet to prevent the elongated body or the elongated sheet from sliding along the thread. For example, the thread can be fixed to the elongated body or the elongated sheet by glue, knots, heat bonding, and / or welding. In one embodiment, when the thread passes through the elongated body or the elongated sheet, the thread is fixed to the elongated body or the elongated sheet by one or more knots to prevent the elongated body or the elongated sheet from sliding along the thread. Generally, in such an embodiment, the thread is fixed to the elongated body or the elongated sheet by a first knot near the first end of the elongated body or the elongated sheet, the thread passes through the elongated body or the elongated sheet such that a first portion of the thread extends beyond the first end of the elongated body or the elongated sheet, a second portion of the thread extends beyond the second end, and the thread is fixed to the elongated body or the elongated sheet by a second knot near the second end of the elongated body or the elongated sheet.

[0045] In one embodiment, the tie line is fixed to the elongate sheet by a first knot near the first end of the elongate sheet. The tie line passes through the elongate sheet such that a first portion of the tie line extends beyond the first end of the elongate sheet, a second portion of the tie line extends beyond the second end, and the tie line is fixed to the elongate sheet by a second knot near the second end of the elongate sheet. The elongate sheet is wound or folded at the first and second ends, and the first and second knots are tied such that the loops of each knot surround the respective wound or folded portions of the elongate sheet.

[0046] In another embodiment, the elongate sheet may be formed in the form of a first layer and a second layer comprising a tissue growth promoting material, wherein the first layer and the second layer are attached to each other to form the elongate sheet, and the tie line is sandwiched between the first layer and the second layer. Thereby, a tie line passing through the elongate sheet of the tissue growth promoting material is produced. The first layer, the second layer, and the tie line may be fixed to each other, for example, by glue, knots, heat bonding, and / or welding.

[0047] In another embodiment, the tie line is connected to one side of an elongate body or an elongate sheet of a tissue growth promoting matrix material. For example, the tie line may be connected to one side of the elongate body or the elongate sheet by means of glue, knots, heat bonding, and / or welding. Generally, in such an embodiment, the tie line is connected to one side of the elongate body or the elongate sheet such that the tie line extends in a direction parallel to or substantially parallel to the longitudinal axis of the elongate body or the elongate sheet. Generally, in such an embodiment, a portion of the tie line extends beyond at least the first end or the second end of the elongate body or the elongate sheet. More typically, a first portion of the tie line extends beyond the first end of the elongate body or the elongate sheet, and a second portion of the tie line extends beyond the second end.

[0048] In another embodiment, the suture is connected to one end of an elongate body or an elongate sheet of the tissue growth promoting matrix material. In another embodiment, the suture is connected to one end of an elongate body or an elongate sheet of the tissue growth promoting matrix material. In another embodiment, the elongate body or elongate sheet is defined to include a first end and a second end, and a longitudinal axis extends from the first end to the second end. A first suture is connected to the first end of the elongate body or elongate sheet, and a second suture is connected to the second end of the elongate body or elongate sheet. When a suture is connected to one or both ends of the elongate body or elongate sheet, the suture can be connected, for example, by means of glue, knots, heat bonding, and / or welding. In one embodiment, the suture is connected to one end of the elongate body of the tissue growth promoting matrix material by a knot. In another embodiment, the suture is connected to one end of the elongate sheet of the tissue growth promoting matrix material by a knot, wherein the elongate sheet is wound or folded and the knot is tied such that the loop of the knot surrounds the corresponding wound or folded portion of the elongate sheet. For example, the first suture can be connected to the first end of the elongate sheet by a first knot, and the second suture can be connected to the second end of the elongate sheet by a second knot, wherein the elongate sheet is wound or folded at the first end and the second end, and the first and second knots are tied such that the loop of each knot surrounds the corresponding wound or folded portion of the elongate sheet.

[0049] According to a second aspect of the present invention, the present invention provides a device suitable for treating a fistula, wherein the fistula includes a fistula tract, wherein the device includes a suture and an elongate body of a tissue growth promoting matrix material, wherein the elongate body is adapted to be positioned within the fistula tract, and wherein the device includes one or more connection points positioned along the length of the elongate body, wherein the one or more connection points are configured to connect the elongate body to another suture.

[0050] Each connection point can be in the form of a loop, a circle, a clip, a connector, or other form configured to connect the elongate body to another suture. The type of each connection point can be the same or different. Generally, each connection point is of the same type of connection point.

[0051] In one embodiment of the second aspect of the present invention, the form of each connection point is a connection loop. In other words, the device includes one or more connection loops positioned along the length of the elongate body, wherein the one or more connection loops are configured to connect the elongate body to another suture. Generally, the one or more connection loops are configured such that another suture can be tied to the device through one or more loops.

[0052] Unless otherwise specified, the term "loop" as used in this application does not include a discontinuous or broken loop.

[0053] Each connection loop can have the same or different sizes. Generally, each connection loop has substantially the same size. More typically, each connection loop has the same size.

[0054] In one embodiment, the inner circumference of each connecting ring is 3 - 30 mm. Typically, the inner circumference of each connecting ring is 5 - 20 mm. More typically, the inner circumference of each connecting ring is 6 - 15 mm.

[0055] In one embodiment of the second aspect of the present invention, the device includes 2 - 50 connection points or connecting rings positioned along the length of the elongate body. Typically, the device includes 5 - 30 connection points or connecting rings positioned along the length of the elongate body. More typically, the device includes 10 - 20 connection points or connecting rings positioned along the length of the elongate body.

[0056] In one embodiment of the second aspect of the present invention, the elongate body includes a first end and a second end, and a longitudinal axis extends from the first end to the second end.

[0057] Typically, one or more connection points or connecting rings are located on an outer surface parallel to or substantially parallel to the longitudinal axis of the elongate body. More typically, two or more connection points or connecting rings are located on an outer surface parallel to or substantially parallel to the longitudinal axis of the elongate body.

[0058] The connection points or connecting rings can be located on a single outer surface of the elongate body or on two or more outer surfaces. Typically, each outer surface on which the connection points or connecting rings are located is parallel to or substantially parallel to the longitudinal axis of the elongate body. For example, in one embodiment, the elongate body includes a first outer surface and a second outer surface, wherein the first outer surface and the second outer surface are both parallel to or substantially parallel to the longitudinal axis of the elongate body, wherein one or more connection points or connecting rings are located on the first outer surface, and wherein one or more connection points or connecting rings are located on the second outer surface.

[0059] In one embodiment, each outer surface on which one or more connection points or connecting rings are located includes 1 - 25 connection points or connecting rings. More typically, each outer surface on which one or more connection points or connecting rings are located includes 3 - 15 connection points or connecting rings. More typically, each outer surface on which one or more connection points or connecting rings are located includes 5 - 10 connection points or connecting rings.

[0060] The elongate body of the second aspect of the present invention can be defined as having a longitudinal axis (x) and two additional axes (y) and (z) that are perpendicular to each other and both perpendicular to the longitudinal axis (x). When so defined, the maximum length of the elongate body measured along the x - axis is greater than the maximum width and maximum height of the elongate body measured along the y - axis and z - axis, respectively.

[0061] Typically, the maximum length of the elongate body measured along the x-axis is 2 to 30 times greater than the greater of the maximum width and the maximum height of the elongate body measured along the y-axis and the z-axis, respectively. More typically, the maximum length of the elongate body is 5 to 15 times greater than the greater of the maximum width and the maximum height of the elongate body. Even more typically, the maximum length of the elongate body is 8 to 12 times greater than the greater of the maximum width and the maximum height of the elongate body.

[0062] In one embodiment, the maximum length of the elongate body measured along the x-axis is 10 to 200 mm. Typically, the maximum length of the elongate body is 30 to 150 mm. More typically, the maximum length of the elongate body is 50 to 100 mm.

[0063] In one embodiment, the greater of the maximum width and the maximum height of the elongate body measured along the y-axis and the z-axis, respectively, is 3 to 20 mm. Typically, the greater of the maximum width and the maximum height of the elongate body is 4 to 15 mm. More typically, the greater of the maximum width and the maximum height of the elongate body is 5 to 10 mm.

[0064] In one embodiment, the elongate body is an elongate sheet of a tissue growth promoting matrix material. In such an embodiment, the elongate sheet can be defined such that when laid flat, it has a longitudinal axis (x) and two other axes (y) and (z) that are perpendicular to each other and both perpendicular to the longitudinal axis (x). Typically, when laid flat, the y-axis is parallel to the plane of the sheet and the z-axis is perpendicular to the plane of the sheet. When so defined, the maximum length of the elongate sheet measured along the x-axis is greater than the maximum width of the elongate sheet measured along the y-axis, and the maximum width of the elongate sheet measured along the y-axis is greater than the maximum height (i.e., thickness) of the elongate sheet measured along the z-axis.

[0065] Typically, the maximum length of the elongate sheet measured along the x-axis is 2 to 30 times greater than the maximum width of the elongate sheet measured along the y-axis. More typically, the maximum length of the elongate sheet is 5 to 15 times greater than the maximum width of the elongate sheet. Even more typically, the maximum length of the elongate sheet is 8 to 12 times greater than the maximum width of the elongate sheet.

[0066] Typically, the maximum width of the elongate sheet measured along the y-axis is 5 to 50 times greater than the maximum height or thickness of the elongate sheet measured along the z-axis. More typically, the maximum width of the elongate sheet is 10 to 30 times greater than the maximum height or thickness of the elongate sheet. Even more typically, the maximum width of the elongate sheet is 15 to 20 times greater than the maximum height or thickness of the elongate sheet.

[0067] In one embodiment, the maximum length of the elongate sheet measured along the x-axis is 10 to 200 mm. Typically, the maximum length of the elongate sheet is 30 to 150 mm. More typically, the maximum length of the elongate sheet is 50 to 100 mm.

[0068] In one embodiment, the maximum width of the elongated sheet measured along the y-axis is 3 - 20 mm. Typically, the maximum width of the elongated sheet is 4 - 15 mm. More typically, the maximum width of the elongated sheet is 5 - 10 mm.

[0069] In one embodiment, the maximum height or thickness of the elongated sheet measured along the z-axis is 0.1 - 2 mm. Typically, the maximum height or thickness of the elongated sheet is 0.2 - 1 mm. More typically, the maximum height or thickness of the elongated sheet is 0.3 - 0.5 mm.

[0070] Typically, the shape of the elongated sheet of the tissue growth promoting matrix material is substantially rectangular, trapezoidal, or oval. More typically, the shape of the elongated sheet of the tissue growth promoting matrix material is substantially rectangular or trapezoidal. Most typically, the shape of the elongated sheet of the tissue growth promoting matrix material is substantially rectangular. When the shape of the elongated sheet is substantially rectangular or trapezoidal, the corners of the rectangle or trapezoid can optionally be rounded or chamfered.

[0071] The connection points or connection rings can be distributed uniformly or non-uniformly on each outer surface on which they are located.

[0072] In one embodiment of the second aspect of the present invention, the connection points or connection rings are distributed uniformly or substantially uniformly along the entire length of the elongated body. For example, the connection points or connection rings can be positioned on a first line along the length of the first outer surface of the elongated body and on a second line along the length of the second outer surface of the elongated body, wherein, on each line, the connection points or connection rings are distributed uniformly or substantially uniformly along the entire length of the elongated body.

[0073] In the case where the elongated body is an elongated sheet of tissue growth promoting matrix material, in one embodiment, one or more connection points or connection rings are located on a surface parallel or substantially parallel to the x-axis and y-axis, i.e., any surface parallel or substantially parallel to the plane of the sheet when the sheet is laid flat. Typically in such an embodiment, one or more connection points or connection rings are located on a first surface parallel or substantially parallel to the x-axis and y-axis, and one or more connection points or connection rings are located on a second surface parallel or substantially parallel to the x-axis and y-axis. Thus, for example, one or more connection points or connection rings can be located on the first side of the elongated sheet, and one or more connection points or connection loops can be located on the second side of the elongated sheet.

[0074] According to the second aspect of the present invention, a suture can be fixed to the elongated body or elongated sheet of the tissue growth promoting matrix material.

[0075] In one embodiment, the suture is passed through the elongate body or elongate sheet of the tissue growth promoting matrix material. Generally, the suture is passed through the elongate body or elongate sheet in a direction parallel to or substantially parallel to the longitudinal axis of the elongate body or elongate sheet. Generally, the suture is passed through the elongate body or elongate sheet in a direction coaxial or substantially coaxial with the longitudinal axis of the elongate body or elongate sheet.

[0076] The elongate body or elongate sheet may be defined as including a first end and a second end, with the longitudinal axis extending from the first end to the second end. Generally, when the suture is passed through the elongate body or elongate sheet of the tissue growth promoting matrix material, a portion of the suture extends beyond at least the first end or the second end of the elongate body or elongate sheet. More typically, a first portion of the suture extends beyond the first end of the elongate body or elongate sheet, and a second portion of the suture extends beyond the second end.

[0077] When the suture is passed through the elongate body or elongate sheet of the tissue growth promoting matrix material, the suture is typically fixed to the elongate body or elongate sheet to prevent the elongate body or elongate sheet from sliding along the suture. For example, the suture can be fixed to the elongate body or elongate sheet by glue, knots, heat bonding, and / or welding. In one embodiment, when the suture is passed through the elongate body or elongate sheet, the suture is fixed to the elongate body or elongate sheet by one or more knots to prevent the elongate body or elongate sheet from sliding along the suture. Typically in such an embodiment, the suture is fixed to the elongate body or elongate sheet by a first knot near the first end of the elongate body or elongate sheet, the suture is passed through the elongate body or elongate sheet such that a first portion of the suture extends beyond the first end of the elongate body or elongate sheet, a second portion of the suture extends beyond the second end, and the suture is fixed to the elongate body or elongate sheet by a second knot near the second end of the elongate body or elongate sheet.

[0078] In one embodiment, the suture is fixed to the elongate sheet by a first knot near the first end of the elongate sheet, the suture is passed through the elongate sheet such that a first portion of the suture extends beyond the first end of the elongate sheet, a second portion of the suture extends beyond the second end, and the suture is fixed to the elongate sheet by a second knot near the second end of the elongate sheet, wherein the elongate sheet is wound or folded at the first end and the second end, and the first knot and the second knot are tied together such that the loop of each knot surrounds the corresponding wound or folded portion of the elongate sheet.

[0079] In another embodiment, the elongate sheet may be formed in the form of a first layer and a second layer comprising the tissue growth promoting material, wherein the first layer and the second layer are attached to each other to form the elongate sheet, and wherein the suture is sandwiched between the first layer and the second layer. Thereby resulting in a suture passing through the elongate sheet of the tissue growth promoting material. The first layer, the second layer, and the suture may be fixed to each other by, for example, glue, knots, heat bonding, and / or welding.

[0080] In another embodiment, the tie line is connected to one side of an elongate body or an elongate sheet of the tissue growth promoting matrix material. For example, the tie line can be connected to one side of the elongate body or the elongate sheet by means of glue, knot, thermal bonding, and / or welding. Generally in such an embodiment, the tie line is connected to one side of the elongate body or the elongate sheet such that the tie line extends in a direction parallel to or substantially parallel to the longitudinal axis of the elongate body or the elongate sheet. Generally in such an embodiment, a portion of the tie line extends beyond at least the first end or the second end of the elongate body or the elongate sheet. More typically, a first portion of the tie line extends beyond the first end of the elongate body or the elongate sheet, and a second portion of the tie line extends beyond the second end.

[0081] In another embodiment, the tie line is connected to one end of an elongate body or an elongate sheet of the tissue growth promoting matrix material. In another embodiment, wherein the elongate body or the elongate sheet is defined as including a first end and a second end, and the longitudinal axis extends from the first end to the second end. A first tie line is connected to the first end of the elongate body or the elongate sheet, and a second tie line is connected to the second end of the elongate body or the elongate sheet. When the tie line is connected to one or both ends of the elongate body or the elongate sheet, the tie line can be connected, for example, by means of glue, knot, thermal bonding, and / or welding. In one embodiment, the tie line is connected to one end of an elongate body or an elongate sheet of the tissue growth promoting matrix material by a knot. In another embodiment, the tie line is connected to one end of an elongate sheet of the tissue growth promoting matrix material by a knot, wherein the elongate sheet is wound or folded, and the knot is tied such that the loop of the knot surrounds the corresponding wound or folded portion of the elongate sheet. For example, the first tie line can be connected to the first end of the elongate sheet by a first knot, and the second tie line can be connected to the second end of the elongate sheet by a second knot, wherein the elongate sheet is wound or folded at the first end and the second end, and the first knot and the second knot are tied such that the loop of each knot surrounds the corresponding wound or folded portion of the elongate sheet.

[0082] In one embodiment of the second aspect of the present invention, each connection point or connection loop is directly fixed to the tie line. Generally in such an embodiment, the tie line passes through an elongate body or an elongate sheet of the tissue growth promoting matrix material. For example, each connection point or connection loop can be glued, tied, or welded to the tie line. In one embodiment, each connection point is provided in the form of a connection loop, wherein each connection loop is tied to the tie line. Each connection loop can be formed by including a material the same as or different from the tie line material. Generally, each connection loop is made by including a material the same as the tie line material.

[0083] In another embodiment of the second aspect of the present invention, each connection point is provided in the form of a connection loop, wherein each connection loop is formed by a ligature. Typically in such an embodiment, the ligature passes through the elongate body or elongate sheet of the tissue growth promoting matrix material. In one embodiment, the entire inner circumference of each connection loop is defined by the ligature. In another embodiment, the inner circumference of each connection loop is defined in part by the ligature and in part by the tissue growth promoting matrix material of the elongate body or sheet.

[0084] When the ligature passes through the elongate body or elongate sheet of the tissue growth promoting matrix material, the ligature can be a thread, and the path of this thread is as follows: the ligature extends beyond the first end of the elongate body or sheet, passes through the elongate body or sheet and re-enters the elongate body or sheet, thereby forming a connection loop outside the elongate body or sheet, optionally passing through the elongate body or sheet and re-entering the elongate body or sheet one or more times, thereby forming one or more additional connection loops, and then leaving the elongate body or sheet to extend beyond the second end of the elongate body or sheet.

[0085] In an exemplary embodiment of the second aspect of the present invention, the present invention provides a device suitable for treating a fistula, wherein the fistula includes a fistula tract, and wherein the device includes a ligature and an elongate sheet of tissue growth promoting matrix material, wherein the elongate sheet is adapted to be positioned within the fistula tract, wherein the elongate sheet includes a first end and a second end, and its longitudinal axis extends from the first end to the second end, wherein the ligature extends beyond the first end of the elongate sheet, repeatedly passes from the first side of the elongate sheet to the second side, and then passes through the second side of the elongate sheet and back to the first side, thereby forming a plurality of connection loops on alternating sides along the length of the elongate sheet, wherein the ligature optionally passes from the first side of the elongate sheet back to the second side, and wherein the ligature leaves the elongate sheet and extends beyond the second end of the elongate sheet, and wherein the plurality of connection loops are configured to tie the elongate sheet to one or more additional ligatures.

[0086] Typically in such an exemplary embodiment, when the sheet is laid flat, the first side of the elongate sheet forms a surface parallel to or substantially parallel to the x-axis and the y-axis, and when the sheet is laid flat, the second side of the elongate sheet forms a relative surface parallel to or substantially parallel to the x-axis and the y-axis.

[0087] Typically, in such an exemplary embodiment, the ligature is fixed to the elongate sheet by a first knot located near the first end of the elongate sheet, and the ligature is fixed to the elongate sheet by a second knot located near the second end of the elongate sheet. Typically, the elongate sheet is wound or folded at the first end and the second end, and the first knot and the second knot are tied together such that the loops of each knot surround the corresponding wound or folded portion of the elongate sheet.

[0088] In one embodiment, the device of the first aspect of the present invention is also the device of the second aspect of the present invention. Thus, in one embodiment, the present invention provides a device suitable for treating a fistula, wherein the fistula includes a fistulous tract, wherein the device includes an elongated body of a seton and a tissue growth promoting matrix material, wherein the elongated body is suitable for placement within the fistulous tract, wherein the elongated body includes a plurality of protrusions located on at least one outer surface of the elongated body, and wherein the device includes one or more connection points positioned along the length of the elongated body, wherein the one or more connection points are configured to connect the elongated body to another seton.

[0089] In an exemplary embodiment, the present invention provides a device suitable for treating a fistula, wherein the fistula includes a fistulous tract, wherein the device includes an elongated sheet of a seton and a tissue growth promoting matrix material, wherein the elongated sheet is suitable for positioning within the fistulous tract, and wherein the elongated sheet includes a first end and a second end, a first outer edge surface and a second outer edge surface, wherein when the elongated sheet is laid flat, a longitudinal axis extends from the first end to the second end, wherein when laid flat, both the first outer edge surface and the second outer edge surface are parallel or substantially parallel to the longitudinal axis of the elongated sheet, wherein the first plurality of protrusions includes serrations formed on the first outer edge surface, wherein the second plurality of protrusions includes serrations formed on the second outer edge surface, wherein the seton extends beyond the first end of the elongated sheet, repeatedly passes through the first side of the elongated sheet to the second side, and then passes through the second side of the elongated sheet back to the first side, a plurality of connecting loops along alternating sides of the length of the elongated sheet, optionally, after the seton passes through the first side of the elongated sheet back to the second side and then leaves the elongated sheet to extend beyond the second end of the elongated sheet, and wherein the plurality of connecting loops are configured to tie the elongated sheet to one or more additional setons.

[0090] Generally, the devices of the first and second aspects of the present invention are configured such that the device can form a loop, wherein the loop has a sufficient length to pass through the fistulous tract and connect outside the fistulous tract. Preferably, the loop includes part or all of the seton and part or all of the elongated body or elongated sheet. Preferably, the loop can be used to fix the elongated body or elongated sheet within the fistulous tract.

[0091] In one embodiment of the first or second aspect of the present invention, the elongated body or elongated sheet is flexible. Optionally, the elongated body or elongated sheet is also elastic, for example, by applying a force, the elongated body or elongated sheet can be deformed from a substantially linear or substantially planar position to a non-linear or non-planar position respectively, but will return to the substantially linear or substantially planar position after the applied force is removed.

[0092] The tissue growth promoting matrix material according to the first or second aspect of the present invention can be defined as a substance or structure that can act as a framework on and / or through which tissue can grow. Generally, tissue can grow on and through the framework.

[0093] In one embodiment of the first or second aspect of the present invention, the tissue growth promoting matrix material comprises a micro-framework, i.e., the framework structure is not visible to the naked eye. In another embodiment of the first or second aspect of the present invention, the tissue growth promoting matrix material comprises a macro-framework, i.e., the framework structure is visible to the naked eye. The tissue growth promoting matrix material can also comprise a mixture of a macro-framework and a micro-framework. For example, the macro-framework can be made of, coated with, or embedded in the micro-framework.

[0094] In one embodiment of the first or second aspect of the present invention, the tissue growth promoting matrix material comprises a framework, wherein the framework comprises a plurality of fibers. The fibers can be woven or non-woven. The fibers can be interconnected in an ordered or disordered structure. In one embodiment of the first or second aspect of the present invention, the tissue growth promoting matrix material comprises a framework, wherein the framework comprises a plurality of fibers, wherein the fibers are interconnected in a non-woven disordered structure.

[0095] In an alternative embodiment, the framework can comprise a porous structure, such as a spongy structure. The porous structure can be micro or macro.

[0096] When the framework comprises a plurality of fibers, generally, the average diameter of the fibers is 0.1 - 50 μm. More typically, the average diameter of the fibers is 1 - 10 μm. More typically, the average diameter of the fibers is 1.5 - 4 μm.

[0097] When the fibers are interconnected in an ordered or disordered structure, generally, the fibers are interconnected to form a porous structure. For example, the tissue growth promoting matrix material can comprise a framework, wherein the framework comprises a plurality of fibers, wherein the fibers are interconnected in a non-woven disordered porous structure. When the fibers are interconnected to form a porous structure, generally, its average pore size is 1 - 100 μm. More typically, the average pore size is 2 - 35 μm. More typically, the average pore size is 8 - 25 μm.

[0098] The average fiber diameter and the average pore size can be determined by scanning electron microscopy. Hixon et al. describe suitable determination methods in "Electrospinning", Volume 1, pages 31 - 45, 2017. Unless otherwise specified, the term "pore size" as used in this application refers to the maximum internal dimension of a given pore (i.e., the longest internal linear span), and the term "average pore size" is the arithmetic mean of the pore sizes of at least 10 randomly selected pores.

[0099] The tissue growth promoting matrix material can be composed of materials including biological or abiotic materials or mixtures thereof. Preferably, the material can promote tissue remodeling and / or be remodelable. Preferably, the material can promote angiogenesis.

[0100] In a preferred embodiment of the present invention, the tissue growth promoting material is biocompatible. The term "biocompatible material" as used in this application refers to a material that has no unacceptable adverse effects on the subject to be treated (such as a human or other animal). When in contact with the subject to be treated for preferably at least 2 weeks, more preferably at least 4 weeks, and most preferably at least 6 weeks, the biocompatible material will not have unacceptable adverse effects on the subject to be treated.

[0101] In one embodiment of the present invention, the tissue growth promoting matrix material is composed of materials including biological materials and / or their synthetic equivalents. Generally in such an embodiment, the biological materials and / or their synthetic equivalents are fibrous. Generally in such an embodiment, the tissue growth promoting matrix material includes a framework, wherein the framework includes a plurality of fibers, and wherein the fibers are composed of materials including biological materials and / or their synthetic equivalents.

[0102] The biological material can be xenogeneic, allogeneic (such as cadaveric), autologous, or a mixture thereof. Generally, when the tissue growth promoting matrix material is composed of substances including biological materials, the biological materials are processed and / or purified, preferably such that the biological materials are acellular.

[0103] Substances suitable for providing a framework for tissue growth include fibrin; collagen, such as type I, type II, type III, type IV, or type V collagen; other extracted collagen extracellular matrix (ECM) materials, such as submucosal tissue (such as intestinal submucosa, bladder submucosa, or uterine submucosa), fascia tissue, renal capsule tissue, dermal tissue (such as dermal collagen), dura mater, pericardial tissue, serosa, peritoneum, basement membrane layer, amnion, omentum, etc.

[0104] In this application, "fibrin" refers to a polymer formed from substances including fibrin monomers, which monomers themselves are formed by treating fibrinogen with thrombin.

[0105] Other substances suitable for providing a framework for tissue growth include fibrous biological materials or their synthetic equivalents that have been crosslinked, for example using crosslinking agents such as dialdehydes, polyepoxides, dichloroalkanes, etc., to obtain materials such as albumin crosslinked with glutaraldehyde. Crosslinking can also be achieved through the reaction of chemical groups in the fibrous biological materials or their synthetic equivalents, for example through dehydration, formation of disulfide bonds, etc.

[0106] In a typical embodiment of the present invention, the tissue growth promoting matrix material is constituted by a substance including a biodegradable material (such as a biodegradable polymer). The biodegradable material can be a single biodegradable material, or a mixture or composition of one or more biodegradable materials. Similarly, the biodegradable polymer can be a single biodegradable polymer, or a mixture or composition of one or more biodegradable polymers. Generally in such an embodiment, the tissue growth promoting matrix material includes a framework, wherein the framework includes a plurality of fibers, and wherein the fibers are constituted by a substance including a biodegradable material.

[0107] Alternatively or additionally, the tissue growth promoting matrix material can be constituted by a substance including a non - biodegradable material (such as a non - biodegradable polymer).

[0108] In the present application, a "biodegradable material" refers to a material that decomposes when in contact with a biological fluid or system (such as plasma, skin, or sphincter). Similarly, a "biodegradable polymer" refers to a polymer that undergoes hydrolysis when in contact with a biological fluid or system (such as plasma, skin, or sphincter). A "fully biodegradable" polymer is a polymer in which at least one covalent bond in each connection between the constituent monomer units is capable of undergoing hydrolysis when in contact with a biological fluid or system. Preferably, after or during decomposition, the material or polymer is absorbed into the body, that is, the biodegradable material or polymer is also bioabsorbable.

[0109] In contrast, a "non - biodegradable" material or polymer refers to a material or polymer that does not substantially decompose or hydrolyze when in contact with a biological fluid or system.

[0110] In an embodiment of any aspect of the present invention, a "biodegradable" material or polymer decomposes or hydrolyzes when in contact with an aqueous solution having a pH of 5 - 9, typically 6 - 8, and more typically about 7.

[0111] Generally, a "biodegradable" material or polymer decomposes or hydrolyzes when in contact with a biological fluid or system at a rate such that it takes on average at least 10 days for such a material or polymer to degrade into its constituent non - biodegradable parts and / or constituent monomer units. More typically, it takes on average at least 20 days, at least 30 days, at least 40 days, or at least 50 days for such a material or polymer to degrade into its constituent non - biodegradable parts and / or constituent monomer units. Most typically, it takes on average at least 60 days for such a material or polymer to degrade into its constituent non - biodegradable parts and / or constituent monomer units.

[0112] Typically, a "biodegradable" material or polymer will decompose or hydrolyze when in contact with a biological fluid or system at a rate such that it takes, on average, less than 400 days for such material or polymer to degrade into its constituent non - biodegradable moieties and / or constituent monomer units. More typically, it takes, on average, less than 200 days for such material or polymer to degrade into its constituent non - biodegradable moieties and / or constituent monomer units. Most typically, it takes, on average, less than 100 days for such material or polymer to degrade into its constituent non - biodegradable moieties and / or constituent monomer units.

[0113] Biodegradable polymers suitable for the present invention include, but are not limited to, polyesters such as polylactic acid (polylactide), polyglycolic acid (polyglycolide), polycaprolactone, polycaprolactone diol, and polycaprolactone triol; polyanhydrides such as polysebacic acid, polyadipic acid, poly(fumaric anhydride), polystyrene - dicarboxylic anhydride, and poly[1,6 - bis(p - carboxyphenoxy)hexane]; polyphosphates such as poly[1,4 - bis(2 - hydroxyethyl) - terephthalic acid - co - ethoxyphosphate]; polyphosphazenes such as poly(bis(1,4 - dioxolanyl)phosphazene), poly(bis[4 - carboxyphenoxy]phosphazene), and poly - [bis(1 - (ethoxycarbonyl) - 2 - phenylethylamino)phosphazene]; polyethers such as polypropylene oxide and polyethylene glycol; other synthetic polymers such as polycarbonates, polycyanoacrylates, polydioxanone, poly(1,5 - dioxepan - 2 - one), polyamino acids, polyamides, polyhydroxybutyrate, polyhydroxyvalerate, poly(ester amide), polyvinylpyrrolidone, polyurethanes, poly(alkylene succinate), polymalic acid, poly(alkylene oxalate), polyorthocarbonates, polyorthoesters, polyamines, polyhydroxycellulose, polyvinyl alcohol, polyacetals, polyketones, and cyclodextrins; natural polymers such as albumin, chitin, chitosan, collagen, dextran, fibrin, fibrinogen, gelatin, polysaccharides, carrageenan, tragacanth, gum arabic, xanthan gum, and poly(alginic acid); and any combination thereof.

[0114] The biodegradable polymers may also include copolymers of any of the above, including alternating copolymers, periodic copolymers, random copolymers, and block copolymers. Examples of such copolymers include polylactic-co-glycolic acid, poly(lactide-co-glycolide), poly(lactide-co-caprolactone), poly(lactide-co-caprolactone-co-glycolide), poly[(lactic acid-co-ethylene glycol)-co-ethoxy phosphate], poly[(1,6-bis(p-carboxyphenoxy)hexane)-co-sebacate], poly(hydroxybutyrate-co-hydroxyvalerate), poly[1,4-bis(2-hydroxyethyl)terephthalate-co-ethoxy phosphate]-co-1,4-bis(2-hydroxyethyl)terephthalate-co-terephthalate, poly(ethylene glycol)-poly(caprolactone) methyl ether block copolymer, poly(ethylene glycol)-poly(lactic acid) methyl ether block copolymer, poly(ethylene glycol) methyl ether-poly(lactic acid)-poly(lactic acid) block copolymer, poly(ethylene oxide)-poly(caprolactone) block copolymer, poly(ethylene oxide)-poly(lactic acid) block copolymer, poly(caprolactone)-poly(tetrahydrofuran)-poly(caprolactone) block copolymer, poly(lactic acid)-poly(ethylene glycol)-poly(lactic acid) block copolymer, poly(ethylene oxide)-polypropylene block copolymer, and any combination thereof.

[0115] The non-biodegradable polymers suitable for the present invention include cellulose, such as cellulose ethers, ethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethyl methyl cellulose, methyl cellulose, cellulose acetate, and their derivatives and copolymers. Other suitable non-biodegradable polymers include polyalkylenes, polyacrylates, polymethacrylates, polyvinylpyrrolidone, polyoxyethylene, polyoxyethylene-polypropylene copolymers, polymethyl methacrylate, polybutyl methacrylate, polysiloxanes, shellac, acrylic and methacrylic polymers and their copolymers.

[0116] In exemplary embodiments of the first and second aspects of the present invention, the tissue growth promoting matrix material includes a framework, wherein the framework includes a plurality of fibers, and wherein the fibers are made of a material including a biodegradable polymer. Typically in such embodiments, the fibers are made of a material including a biodegradable and bioabsorbable polymer. For example, the fibers may be made of a material including a biodegradable polyester, which is optionally selected from polylactic acid (polylactide), polyglycolic acid (polyglycolide), polycaprolactone, polycaprolactone diol, polycaprolactone triol, and their copolymers. More typically, in such embodiments, the fibers are made of a material including a biodegradable polyester selected from polylactic acid (polylactide), polyglycolic acid (polyglycolide), and their copolymers. Most typically, the fibers are made of a material including polylactic acid such as poly-L-lactic acid (PLLA).

[0117] In one aspect of the above-described embodiments, the tissue growth promoting matrix material comprises a framework, wherein the framework comprises a plurality of fibers, wherein the fibers are interconnected in a non-woven disordered porous structure, and wherein the fibers are made of a material comprising a biodegradable polymer, such as all of the polymers listed above. Generally in this aspect of the embodiment, the tissue growth promoting matrix material is prepared by electrospinning a polymer solution to form the framework. For example, such an electrospinning method is described in patent application WO 2007 / 132186, the entire content of which is incorporated herein by reference.

[0118] Optionally, the tissue growth promoting matrix material of the first or second aspect of the present invention can be coated or impregnated with one or more tissue growth promoters and / or one or more other agents. Exemplary tissue growth promoters include growth factors such as basic fibroblast growth factor (FGF-2), transforming growth factor β (TGF-β), epidermal growth factor (EGF), chondrogenic growth factor (CDGF), platelet-derived growth factor (PDGF), insulin-like growth factors I and II (IGF-I and IGF-II), interferons (such as interferon α, β, γ), etc. Other agents can be selected from anti-inflammatory drugs, antibacterial agents, immunomodulators or combinations thereof. Examples of suitable agents are listed on pages 13-19 of patent application WO 2011 / 151659, the entire content of which is incorporated herein by reference.

[0119] In any embodiment of any aspect of the present invention, preferably, the suture and / or the entire device is made of a substance comprising a biocompatible material. For example, the suture can be made of a substance comprising a flexible material such as rubber, silicone, silk, a flexible plastic such as polypropylene, etc. Generally, the suture is made of a material comprising a flexible plastic.

[0120] In one embodiment of the first or second aspect of the present invention, the suture is made of a substance comprising one or more biodegradable materials such as biodegradable polymers. Examples of suitable biodegradable polymers are listed above. Generally, the suture is made of a material comprising one or more biodegradable and bioabsorbable polymers. Generally, the suture is made of a material comprising one or more biodegradable polyesters, which are optionally selected from polylactic acid (polylactide), polyglycolic acid (polyglycolide), polycaprolactone, polycaprolactone diol, polycaprolactone triol and copolymers thereof.

[0121] In an embodiment of the first or second aspect of the present invention, the ligature comprises a braided cord coated with at least one layer of coating. Generally in such an embodiment, the ligature comprises a braided cord composed of a first biodegradable polymer and at least one coating, wherein the coating comprises a second biodegradable polymer and optionally a fatty acid, a fatty acid ester or a salt thereof. Generally, both the first biodegradable polymer and the second biodegradable polymer are biodegradable polyesters, optionally selected from polylactic acid (polylactide), polyglycolic acid (polyglycolide), polycaprolactone, polycaprolactone diol, polycaprolactone triol and copolymers thereof. The first biodegradable polymer and the second biodegradable polymer may be the same or different. Generally, the first biodegradable polymer and the second biodegradable polymer are different. In one example, the first biodegradable polymer is selected from polylactic acid (polylactide), polyglycolic acid (polyglycolide) and copolymers thereof, and the second biodegradable polymer is selected from polyglycolic acid (polyglycolide), polycaprolactone, polycaprolactone diol, polycaprolactone triol and copolymers thereof. Generally, the first biodegradable polymer is a copolymer of glycolide and lactide, more preferably a copolymer of glycolide and L-lactide. Generally, such a copolymer comprises about 80-95 mol% of glycolide and about 5-20 mol% of L-lactide. Most preferably, the copolymer comprises about 90 mol% of glycolide and about 10 mol% of L-lactide. Generally, the second biodegradable polymer is a copolymer of glycolide and caprolactone. Generally, the fatty acid, fatty acid ester or salt thereof is a lactate of a fatty acid or a salt thereof. More typically, the fatty acid, fatty acid ester or salt thereof is a stearoyl lactate, such as stearoyl-2-lactate or a salt thereof. Most typically, the fatty acid, fatty acid ester or salt thereof is calcium stearoyl-2-lactate. A coated braided cord comprising a copolymer of glycolide and lactide as the first biodegradable polymer, a copolymer of glycolide and caprolactone as the second biodegradable polymer, and calcium stearoyl-2-lactate as the fatty acid, fatty acid ester or salt thereof is commercially available under the trade name Polysorb TM commercially available and can be used as the ligature of the first or second aspect of the present invention.

[0122] Generally, any part of the ligature and / or the elongate body or elongate sheet to be placed in the fistula does not contain exposed metal. More typically, any part of the ligature and / or the elongate body or elongate sheet to be placed in the fistula does not contain metal. Most typically, the device of the first or second aspect of the present invention does not contain metal.

[0123] The ligature is elongate in shape. Generally, in any embodiment of any aspect of the present invention, the total length of the ligature and the elongate body or elongate sheet (e.g., when the ligature passes through the elongate body or elongate sheet) is 100-1000 mm. More typically, the total length of the ligature and the elongate body or elongate sheet is 200-800 mm. More typically, the total length of the ligature and the elongate body or elongate sheet is 400-600 mm.

[0124] In one embodiment, the cross-section of the suspension wire is approximately polygonal (e.g., approximately rectangular, pentagonal, hexagonal, heptagonal or octagonal). In another embodiment, the cross-section of the suspension wire is approximately circular.

[0125] Generally, the maximum width or diameter of the cross-section of the suspension wire is 0.05 - 6 mm. More typically, the maximum width or diameter of the cross-section is 0.1 - 4 mm. Generally, the minimum width or diameter of the cross-section of the suspension wire is 0.2 - 2 mm. More typically, the minimum thickness or diameter of the cross-section is 0.3 - 0.5 mm.

[0126] The third aspect of the present invention provides a method of manufacturing the device of the first and / or second aspect of the present invention, the method comprising the step of connecting a suspension wire to an elongate body or an elongate sheet.

[0127] In one embodiment of the third aspect of the present invention, the method is a method of manufacturing the device of the first aspect of the present invention. Generally in such an embodiment, the method comprises the steps of forming a plurality of protrusions on at least one outer surface of the elongate body and then connecting the elongate body to the suspension wire. More typically, the method comprises the steps of cutting an elongate sheet of tissue growth promoting matrix material from a larger sheet of tissue growth promoting matrix material, forming the elongate sheet with one or more crenellated or serrated outer edges, and then connecting the elongate sheet to the suspension wire.

[0128] In one embodiment of the third aspect of the present invention, the method is a method of manufacturing the device of the second aspect of the present invention. Generally in such an embodiment, the step of connecting the suspension wire to the elongate body or the elongate sheet comprises passing the suspension wire through and out of the elongate body or the elongate sheet to form one or more connecting loops.

[0129] In an exemplary embodiment of the third aspect of the present invention, the method comprises the following steps:

[0130] (i) cutting an elongate sheet of tissue growth promoting matrix material from a larger sheet of tissue growth promoting matrix material, optionally forming the elongate sheet with one or more crenellated or serrated outer edges, the outer edges extending in a direction parallel to or substantially parallel to the longitudinal axis of the elongate sheet;

[0131] (ii) folding the elongate sheet in alternating directions to form a bellows-like fold, wherein the creases of the bellows-like fold extend in a direction perpendicular to or substantially perpendicular to the longitudinal axis of the elongate sheet;

[0132] (iii) passing the suspension wire through the bellows-like folded elongate sheet, optionally with the aid of a needle, such that the suspension wire passes through the elongate sheet multiple times;

[0133] (iv) Stretch the accordion-folded elongated sheet along the length direction of the suspension line; and

[0134] (v) Optionally, tie or otherwise fix the suspension line to the elongated sheet to prevent the elongated sheet from sliding along the suspension line.

[0135] In steps (ii) and (iii), sharp wrinkles or creases in the elongated sheet should generally be avoided.

[0136] The fourth aspect of the present invention provides a device according to the first and / or second aspect of the present invention for medical use. Generally, the device is used for treating fistulas, such as anal fistulas or rectovaginal fistulas. Generally, such treatment includes inserting the device into the fistula tract. Generally, such treatment includes forming a loop with the device, wherein the loop passes through the fistula tract and is connected outside the fistula tract. More typically, the loop is used to fix an elongated body or an elongated sheet within the fistula tract.

[0137] According to the fifth aspect of the present invention, the present invention provides a method for treating a fistula, including using the device according to the first and / or second aspect of the present invention. Generally, the fistula is an anal fistula or a rectovaginal fistula. Generally, the method includes inserting the device into the fistula tract. Generally, the method includes forming a loop with the device, wherein the loop passes through the fistula tract and is connected outside the fistula tract. More typically, the loop is used to fix an elongated body or an elongated sheet within the fistula tract.

[0138] As used in this application, "fistula" refers to any abnormal passage or communication through the body between two epithelial surfaces, including those that occur naturally, such as due to infection, due to injury (such as due to puncture), and those that are artificial, such as due to surgery or body piercing.

[0139] In one embodiment of any aspect of the present invention, the fistulas to be treated are selected from:

[0140] (i) Body piercing or skin-to-skin fistulas;

[0141] (ii) Anal or anorectal fistulas, which can be anatomically classified into intra-sphincter fistulas, trans-sphincter fistulas, supra-sphincter fistulas, or extra-sphincter fistulas;

[0142] (iii) Rectovaginal fistulas, such as vulvar fistulas, vaginal fistulas, rectovestibular fistulas, abdominovestibular fistulas, or rectovestibular fistulas, wherein rectovaginal fistulas can be anatomically classified into sub-sphincter fistulas, trans-sphincter fistulas, or supra-sphincter fistulas;

[0143] (iv) Rectoprostatic fistulas;

[0144] (v) Gastrointestinal fistulas, such as tracheoesophageal fistulas, gastrocutaneous fistulas, ileocutaneous fistulas, colocutaneous fistulas, rectocutaneous fistulas, colovaginal fistulas, or gastrointestinal vascular fistulas;

[0145] (vi) Urinary fistulas, such as urethrocutaneous fistulas, urethrovaginal fistulas, urethrovesical fistulas, vesicovaginal fistulas, rectovesical fistulas or rectourethral fistulas; or

[0146] (vii) Fistulas comprising any combination of the above-mentioned fistulas, such as rectovesicovaginal fistulas.

[0147] Typically, the fistulas described are complete (i.e., both ends open on the mucous membrane or outer surface of the body). A complete fistula can be external (i.e., between a hollow organ and the outer surface of the body) or double-mucosal (i.e., both ends open on the mucous membrane surface of the body).

[0148] In one embodiment, the fistula is simple (i.e., does not contain blind tubes and contains only one opening at each end of the tube). However, optionally, the fistula includes blind tubes and / or is complex (i.e., includes more than two openings due to the bifurcation of the tube). An example of a complex fistula is a horseshoe fistula (both ends of the fistula open on the outer surface of the body, and the third end opens into a hollow organ such as the anal canal).

[0149] In one embodiment of the fourth or fifth aspect of the present invention, the fistula to be treated is complex, and the device at least complies with the second aspect of the present invention. Typically, in such an embodiment, the treatment or method comprises the following steps:

[0150] (i) Fixing another seton to the connection point or connection loop of the device of the second aspect of the present invention, optionally, wherein the other seton forms part of another device of the first and / or second aspect of the present invention;

[0151] (ii) Inserting the combined device and the other seton (or another device) into the branch tract of the complex fistula such that one or more elongate bodies or elongate sheets are located within the branch fistula, and causing the first end of the device seton to protrude from the first opening at the first end of the branch fistula, the second end of the device seton to protrude from the second opening at the second end of the branch fistula, and one end of the other seton to protrude from the third opening at the third end of the branch fistula; and

[0152] (iii) Fixing two or more of the protruding ends of the setons to each other, for example, tying the protruding ends together to form one or more knots.

[0153] Typically, the fistula to be treated is selected from anal fistulas or rectovaginal fistulas. More typically, the fistula is an anal fistula.

[0154] Typically, the patient to be treated in any of the foregoing aspects of the present invention is a human. Typically, the patient to be treated requires such treatment. Optionally, the patient may also suffer from an inflammatory bowel disease, such as Crohn's disease.

[0155] To avoid doubt, any embodiment of any given aspect of the present invention can be used in combination with any other embodiment of the same aspect of the present invention, whenever possible. In addition, whenever possible, it should be understood that any preferred or optional embodiment of any aspect of the present invention should also be considered as a preferred or optional embodiment of any other aspect of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0156] Figure 1 A perspective view showing the device of the present invention, which device includes an elongated sheet of a suture and a tissue growth promoting matrix material.

[0157] Figure 2 Showing Figure 1 A perspective view of the device, showing the longitudinal axis and various dimensions of the device.

[0158] Figure 3 Showing Figure 1 A perspective view of the device in a non-linear position.

[0159] Figure 4 Showing Figure 1 A top view of the device.

[0160] Figure 5 Showing Figure 1 A side view of the device.

[0161] Figure 6 Showing Figure 1 An enlarged top view of the end of the elongated sheet of the device.

[0162] Figure 7 Showing Figure 1 An enlarged top view of the end of the elongated sheet of the device, but having crenellated protrusions.

[0163] Figure 8 Showing Figure 1 An enlarged side view of the end of the elongated sheet of the device.

[0164] Figure 9 Showing Figure 1 A side view of the method of manufacturing the device.

[0165] Figure 10 Showing Figure 1 A schematic view of the device placed in a simple anal fistula.

[0166] Figure 11 A perspective view showing the device of the present invention, which device is connected to another device of the present invention by a connecting ring.

[0167] Figure 12 Showing Figure 11 A schematic view of the ligating device placed in a complex anal fistula.

[0168] Reference Numerals:

[0169] Device 101

[0170] Thread 102

[0171] First part of the thread 102a

[0172] Second part of the thread 102b

[0173] Thread part 102c

[0174] Elongated thin sheet of tissue growth promoting matrix material 103

[0175] First plurality of protrusions 104

[0176] Second plurality of protrusions 105

[0177] First end of the elongated thin sheet 106

[0178] Second end of the elongated thin sheet 107

[0179] First knot 108

[0180] Second knot 109

[0181] First double - thickness region 110

[0182] Second double - thickness region 111

[0183] First side of the elongated thin sheet 112

[0184] Second side of the elongated thin sheet 113

[0185] Part of the side of the elongated thin sheet 113a

[0186] Position on the elongated thin sheet 114

[0187] Position on the elongated thin sheet 115

[0188] Position on the elongated thin sheet 116

[0189] Linking ring 117

[0190] Linking ring 118

[0191] Linking ring 119

[0192] Linking ring 120

[0193] Linking ring 121

[0194] Linking ring 122

[0195] Position on the elongated thin sheet 123

[0196] Inner circumference of the connecting ring 124

[0197] Crease 125

[0198] Crease 126

[0199] Compressed elongated thin sheet 127

[0200] Connecting ring 128

[0201] Connecting ring 129

[0202] Probe 130

[0203] Fistula 131

[0204] First opening 132

[0205] Second opening 133

[0206] Anal canal 134

[0207] Knot 135

[0208] Connecting ring of the first device 136

[0209] Complex fistula 137

[0210] First opening 138

[0211] Second opening 139

[0212] Third opening 140

[0213] Anal canal 141

[0214] Fistula branch 142

[0215] First probe 143

[0216] Second probe 144

[0217] Knot 145

[0218] Another device 201

[0219] Seton of another device 202

[0220] Elongated thin sheet of tissue growth promoting matrix material of another device 203

[0221] Knot 204

[0222] Multiple protrusions of another device 205

[0223] Connecting ring of another device 236

[0224] Crenellated protrusion 704

[0225] 705 castellations

[0226] 901 needle Detailed implementation manners

[0227] Now, embodiments of the present invention will be described only by way of example with reference to the accompanying drawings. The device of the present invention is particularly suitable for treating fistulas, such as anal or rectovaginal fistulas. Depending on the different fistulas to be treated, it may be necessary and / or essential to pre-treat the fistula before using the device of the present invention. The device of the present invention includes an elongate body of a tissue growth promoting matrix material. For example, if the fistula is severely infected, it may be necessary to insert a drainage seton according to the prior art methods described above. The drainage seton can optionally incorporate antibiotics and / or anti-inflammatory drugs to help reduce the degree of infection. Alternatively, it may be preferably to insert a device including a fistula stent, such as the device described in WO 2014 / 023962, instead.

[0228] After a period of time, the drainage seton or the fistula stent can be removed before inserting the device of the present invention including the elongate body of the tissue growth promoting matrix material.

[0229] Optionally, before inserting the device of the present invention, the fistula tract can be cleaned, for example, by spraying water and / or using a suitable brush.

[0230] Now refer to Figure 1 、 4 and 5, which illustrate a device 101 according to an embodiment of the present invention. The device includes a seton 102 and an elongate body 103 of a tissue growth promoting matrix material. The elongate body can be regarded as a rectangular prism provided by a sheet of tissue growth promoting matrix material. Therefore, the elongate body can be regarded as an elongate thin sheet 103 of the tissue growth promoting matrix material.

[0231] As Figure 2 shown, when laid flat and unfolded, it can be seen that the device and the elongate thin sheet have a longitudinal axis x, which extends longitudinally through the seton 102 and the elongate thin sheet 103 of the tissue growth promoting matrix material. As shown in the figure, it can also be seen that the device has a y-axis perpendicular to the longitudinal x-axis and parallel to the plane of the thin sheet, and a z-axis perpendicular to the x-axis and the y-axis.

[0232] It can be understood that, as Figure 1 and Figure 2 shown, in this application, all references to the longitudinal axis and related dimensions and sizes refer to the device when laid flat in the unfolded position, and the dimensions are measured in such a position unless otherwise specified. However, it can be understood that both the seton 102 and the elongate thin sheet of the tissue growth promoting material are flexible and can be adopted in a variety of positions, as Figure 3 shown.

[0233] As described in the Summary of the Invention, the dimensions of the elongate body or sheet 103 and the suture 102 depend on the fistula to be treated. However, typically, the maximum length l1 of the elongate sheet 103 measured along the x-axis (see Figure 4 ) is about 75 mm, the maximum width w of the elongate sheet measured along the y-axis (see Figure 4 ) is about 7.5 mm, and the maximum height or thickness h measured along the z-axis (see Figure 5 ) is about 0.4 mm. Similarly, the maximum width or diameter of the suture 102 is typically about 0.35 mm (see Figure 4 ), and the suture is selected such that the total length l2 of the device 101 (see Figure 4 ) is about 475 mm. In the illustrated embodiment, the cross-section of the suture is approximately circular, but it should be understood that other cross-sectional shapes are possible.

[0234] In the described embodiment, the tissue growth promoting matrix material of the elongate sheet 103 includes a framework, wherein the framework includes a plurality of fibers, and wherein the fibers are interconnected in a non-woven disordered structure. These fibers are formed of poly-L-lactic acid (PLLA), which is a biodegradable, biocompatible, and bioabsorbable polymer. The matrix material is purchased from Neotherix Limited and is formed by electrospinning a solution of the polymer in 1,1,1,3,3,3-hexafluoropropan-2-ol (HFIP), thereby producing a material having a fiber diameter of 2 - 3 μm and an average pore size of about 10 μm. As described above, while other tissue growth promoting matrix materials may be used, electrospun biodegradable polymers such as the exemplified polymers are preferably used, as these polymers can promote tissue ingrowth and drainage due to their large surface area and porosity, and at the same time the polymer fibers degrade over time and are absorbed and ultimately excreted by the body, thus having excellent tissue growth promoting properties.

[0235] In the described embodiment, the suture 102 includes a braided cord having an outer coating. The braided cord is formed of a poly(lactide-co-glycolide) (PLGA) copolymer in which the lactide content is about 10 mol% and the glycolide content is about 90 mol%. The outer coating is formed by mixing a poly(ε-caprolactone-co-glycolide) copolymer with calcium stearoyl-2-lactate. Again, this copolymer is biodegradable, biocompatible, and bioabsorbable. Such a suture is commercially available and is a suture with the trademark Polysorb TM . While sutures made of other materials may be used, such a coated braided cord combines the advantages of strength and flexibility, while being smooth enough for easy use and biodegradable, thus avoiding subsequent surgical removal.

[0236] Returning to Figure 1, it can be seen that the elongated body or sheet 103 includes a first plurality of protrusions 104 located on a first outer edge surface that is substantially parallel to the longitudinal axis x of the elongated sheet, and a second plurality of protrusions 105 located on a second outer edge surface that is also substantially parallel to the longitudinal axis x of the elongated sheet. Generally, about 40 protrusions are provided in the first plurality of protrusions 104, and about 40 protrusions are provided in the second plurality of protrusions 105. The protrusions and the elongated sheet 103 are of an integral structure and are provided in the form of serrations formed by correspondingly cutting the outer edge of the elongated sheet. As Figure 6 shown, the distance dp between the highest points of each adjacent protrusion is typically about 2 mm, the width or maximum distance (wp) that each protrusion extends between two adjacent lowest points is typically about 2 mm, and the height or maximum distance (hp) that each protrusion extends from the adjacent lowest point on the surface is typically about 1 mm.

[0237] When the device is inserted into the fistula, the protrusions 104, 105 can be used to clamp or insert into the inner wall of the fistula. Therefore, the protrusions can be used to prevent the rotational movement of the elongated body or sheet 103 within the fistula and prevent lateral or sideward movement to prevent the elongated body or sheet 103 from slipping out of the fistula. Since the protrusions help to hold the elongated body or sheet 103 in a single position relative to the surrounding tissue of the fistula, tissue ingrowth is promoted.

[0238] It can be understood that the shape of the protrusions does not have to be triangular or serrated. For example, it can be in the form of crenellations as shown by the protrusions 704 and 705 in Figure 7 . Other shapes are described in the Summary of the Invention section. However, advantageously, each protrusion includes at least one point that can be used to better clamp or insert into the inner wall of the fistula.

[0239] As Figure 6 and Figure 7 shown, the lowest points between adjacent protrusions 105, 705 are V-shaped ( Figure 6 ) or have a square profile with a sharp inner angle ( Figure 7 ). However, it may be necessary to ensure that each lowest point between adjacent protrusions is not sharp or V-shaped. For example, each lowest point between adjacent protrusions can be curved or rounded, for example, in order to form a concave curve between the highest points of each adjacent protrusion. Thereby minimizing the tear-promoting points.

[0240] As Figure 1 , 4As best shown in FIGS. 5, the suspension wire 102 passes through the elongated sheet 103 such that a first portion 102a of the suspension wire 102 extends beyond a first end 106 of the elongated sheet 103, a second portion 102b of the suspension wire 102 extends beyond a second end 107, and the suspension wire 102 spans the entire length of the elongated sheet 103. Since, in use, the elongated sheet 103 is placed in the fistula and the first and second portions 102a and 102b are tied together outside the fistula to form a loop or a suspension stitch, this configuration means that the fixation relies entirely on the strong suspension wire for strength and not on a potentially weaker material such as a tissue growth promoting matrix material. Thus, a more robust fixation is achieved.

[0241] The elongated sheet 103 folds back on itself at the first end to form a double-thickness region 110 of the sheet. A first knot 108 is tied around the folded portion 110 of the elongated sheet with the suspension wire. Similarly, the elongated sheet 103 folds back on itself at the second end to form another double-thickness region 111 of the sheet. A second knot 109 is tied around the folded portion 111 of the elongated sheet with the suspension wire. It will be appreciated that these two knots prevent the elongated sheet 103 from sliding along the suspension wire 102. Additionally, by folding or winding the elongated sheet, a stronger connection is formed, enabling a surgeon or care practitioner to forcibly pull on the first or second portion (102a or 102b) of the suspension wire while minimizing the risk of tearing the elongated sheet 103. The same folding or winding also minimizes the risk of the elongated sheet 103 tearing in situ due to the daily strain and stress imposed by patient movement.

[0242] In the illustrated embodiment, the shape of the elongated sheet 103 of the tissue growth promoting matrix material is substantially rectangular (see particularly the top view of the device 101 in FIG. Figure 4 ), with right angles formed at the corners of the rectangle at the first end 106 and the second end 107. However, it may be necessary to ensure that the corners of the rectangle are rounded or chamfered to facilitate insertion of the device into the fistula.

[0243] Turning to Figure 5, As can be seen along the path of the hanging line 102 starting from the first knot 108, the hanging line passes through the first side 112 of the elongated sheet 103 at position 114 to reach the second side 113, then passes back through the second side 113 at position 115, and then passes back through the first side 112 at position 116, and so on along the length of the elongated sheet. By doing so, it can be seen that in a direction substantially parallel to the longitudinal x-axis, a plurality of connecting loops 117, 118, 119, 120, 121, 122 are formed, which are alternately located on two sides along the length of the elongated sheet. As shown in the figure, it can be seen that before the second knot 109, the hanging line 102 passes through the first side 112 of the elongated sheet 103 at position 123 for the last time to reach the second side 113. However, this is not important. The last pass through the elongated sheet can also be from the second side to the first side. It should be understood that Figure 5 , 8 and the hanging line 102 shown in FIG. 9 are loose lines, which is for best demonstrating the path through the elongated sheet 103 and the connecting loops 117, 118, etc. However, in practice, usually before tying the first and second knots 108, 109, the hanging line 102 and the elongated sheet 103 are tightened so that the hanging line lies flat on the surfaces 112, 113 of the elongated sheet 103.

[0244] In the illustrated embodiment, the distances between the positions 114, 115, 116, etc. where the hanging line passes through the elongated sheet are substantially equal. Therefore, the connecting loops 117, 118, 119, 120, 121, 122, etc. are distributed substantially uniformly along the entire length of the elongated sheet, and the sizes of each connecting loop are substantially the same. However, it should be understood that an alternating spacing can be used to change the distribution and size of the connecting loops. Similarly, in Figure 1 the illustrated embodiment, there are seven connecting loops on the first side of the elongated sheet and eight connecting loops on the second side, so there are a total of 15 connecting loops along the length of the elongated sheet. However, it can also be understood that the number of connecting loops on each side and in total can vary.

[0245] The plurality of connecting loops 117, 118, 119, 120, 121, 122 are configured to tie the elongated sheet to one or more other hanging lines. As Figure 8 shown, the inner peripheral portion of the connecting loop 117 is formed by the hanging line portion 102c and partly by the portion 113a on the side of the elongated sheet 103. Therefore, the inner periphery associated with the connecting loop 118 is shown by the thick line 124. The inner periphery is advantageously selected such that the end user can pass another hanging line through the connecting loop and tie it relatively easily while preventing substantial lateral movement of the tied other hanging line. To achieve this, the inner periphery is usually 10 mm.

[0246] Now turning to Figure 1In the method of manufacturing the device shown, it will be understood that this is typically carried out in a factory and then delivered to a surgeon or other end user. The elongate sheet 103 can be cut from a larger sheet of tissue growth promoting matrix material. Typically, serrations or crenellations are cut while cutting the elongate sheet from the larger sheet, so that multiple elongate sheets can be cut with minimal waste, especially if the same cut is used to form serrations or crenellations on multiple elongate sheets. The cutting method is not limited and can include, for example, die cutting, laser cutting or cutting with scissors.

[0247] In Figure 9 In a particularly effective manufacturing method shown, the elongate sheet 103 can be folded in alternating directions to form a bellows fold, where the creases 125, 126 of the bellows fold extend in a direction perpendicular or substantially perpendicular to the longitudinal x-axis of the elongate sheet. Then, the bellows-folded sheet can be compressed to obtain a compressed elongate sheet 127. Then, as Figure 9 (b) shows, the suture 102 can be passed through the compressed elongate sheet 127 in a direction substantially parallel to the x-axis. As shown, a needle 901 can be used to assist in passing the suture through the compressed elongate sheet 127, but it should be understood that other ways of forming holes, such as punching or drilling, are also possible. Then, as Figure 9 (c) shows, the compressed elongate sheet 127 can be stretched outwards in opposite directions along the length of the suture 102. As Figure 9 (d) shows, once stretched out, an elongate sheet 103 with multiple connecting loops 128, 129 formed by the suture 102 is provided. Then, as described above, the ends of the elongate sheet can be folded and the suture fixed in the first and second knots at each end. In this way, multiple connecting loops can be created in one operation, thus facilitating automated or batch manufacturing.

[0248] When folding and compressing the elongate sheet 103, it may be necessary to ensure that the creases 125, 126 or wrinkles are not sharp. For example, during the folding and compression steps (a)-(c), a wrinkle or crease can be formed around a temporary support roller (not shown) placed inside the wrinkle or crease 125, 126. Thereby avoiding the formation of permanent creases in the elongate sheet 103.

[0249] Alternatively, the bellows-folded elongate sheet can be formed by compressing the elongate sheet 103 between an upper former and a lower former. Typically, the upper former and the lower former are shaped to have corresponding mating surfaces to allow the formation of a bellows fold when the elongate sheet 103 is clamped between the two formers. For example, the mating surfaces can be configured such that the elongate sheet adopts a shape approximating a sine wave extending in a direction parallel to the longitudinal axis x of the elongate sheet. Thereby avoiding the generation of sharp creases or wrinkles in the elongate sheet.

[0250] A longitudinal guiding channel can be formed through a plurality of component channels in two formers. The longitudinal guiding channel can be configured such that when the elongated sheet 103 is clamped between the two formers, a piercing tool such as a needle or a drill bit can pass through the guiding channel to form a series of holes extending along the length of the sheet in the elongated sheet. Then, the upper former and the lower former can be removed, and then the suspension wire 102 can be passed through these holes to form connecting loops 128, 129. Alternatively, each of the upper former and the lower former can be divided into at least two parts that cooperate around the component channels. In such an embodiment, the piercing tool can connect the suspension wire 102 and pass through the elongated sheet 103 along the longitudinal guiding channel. Then, these parts of the upper former and the lower former can be separated, and the suspension wire 102 can pass through the elongated sheet 103 multiple times, thereby forming connecting loops 128, 129, as Figure 9 (d) shows. Then, the suspension wire 102 and the elongated sheet 103 can be tightened, and the suspension wire can be fixed to the suspension wire using, for example, a knot as described above.

[0251] The device of the present invention can be used to treat simple or complex fistulas, especially simple or complex anorectal or rectovaginal fistulas. Generally, the device of the present invention can be inserted when the patient is awake, for example, using a local anesthetic. That is to say, these devices can also be inserted under general anesthesia.

[0252] For the treatment of simple fistulas, usually a single device according to the present invention is used. Referring to Figure 10 (a), which shows a patient with a fistula 131 extending from a first opening 132 located on the outer surface of the patient's buttock or perianal skin to a second opening 133 located within the anal canal 134. A surgeon or a nursing practitioner can, with the help of a probe 130, insert a device 101 including a suspension wire 102 and an elongated sheet 103 through the first opening 132 into the fistula 131. Then, as Figure 10 shown by the arrow in (a), the first end of the probe and the suspension wire are manipulated to pass through the fistula 131, out of the second opening 133, and out of the patient's body through the anal canal 134. In this way, the elongated sheet 103 can be positioned within the fistula 131, where the first end of the suspension wire extends out of the anal canal 134 from the second opening 133, and the second end of the suspension wire extends out of the first opening 132. Then the probe can be removed, and the two ends of the suspension wire can be tied together to form a knot 135, as Figure 10 (b) shows, and the elongated sheet 103 is fixed within the fistula by a suspension wire stitch.

[0253] As described above, from Figure 10As can be clearly seen in (b), when the protrusions 104, 105 are in place, they may clamp or insert into the inner wall of the fistula 131. Thus, the protrusions can be used to prevent rotational movement of the elongate sheet 103 within the fistula and to prevent its lateral or side-to-side movement, to prevent the elongate sheet 103 from slipping out of the fistula due to the rotation of the suture stitches.

[0254] In addition, although the elongate sheet is flexible, it can have a degree of elasticity. In use, to assist in feeding the elongate sheet 103 into the fistula 131, a surgeon or healthcare practitioner will typically form the sheet into a grooved or V-shaped configuration, with the bottom of the groove or V extending along a line generally the same as the suture, i.e., extending parallel to the previously defined longitudinal axis of the device. If the sheet has elasticity, then once placed within the fistula, it will have a tendency to unfurl or spread out, thereby creating an outward pressure on the protrusions that enter the fistula wall, thus facilitating its fixation. Further, by forming the elongate sheet 103 into a grooved or V-shaped configuration, with the bottom of the groove or V extending along a line generally the same as the suture, it can be seen that once in place, any attempt to rotate the elongate sheet 103 about the suture will cause one of the two sets of protrusions 104, 105 to cut into the inner wall of the fistula 131 in a direction opposite to the attempted direction of rotation, regardless of whether the elongate sheet is rotated clockwise or counterclockwise and regardless of whether the elongate sheet has elasticity. Thus, it can be seen that the plurality of protrusions are very effective in maintaining the tissue growth promoting matrix material in a constant position relative to the inner wall of the fistula. Thereby encouraging tissue ingrowth.

[0255] To treat a longer fistula, or a fistula with a non-uniform inner diameter, two or more devices of the present invention can be tied end-to-end, e.g., such that one end of the elongate sheet of the first device of the present invention is very close to or adjacent to one end of the elongate sheet of the second device of the present invention. The elongate sheets of the first and second devices of the present invention can have different widths (w) to correspond to different inner diameters of a given fistula.

[0256] The plurality of attachment points or loops make the device particularly suitable for treating complex fistulas. As Figure 11As shown, the ligature 202 of another device 201 of the present invention can be tied to the connecting loop 136 of the first device 101 of the present invention to form a knot 204. The other device includes an elongated sheet 203 and a protrusion 205 of the tissue growth promoting matrix material as described above. It can be understood that although the other device 201 is connected via the shown connecting loop 136, the other device can alternatively be connected to any additional connecting loop on the first device 101. In addition, although not shown, other devices of the present invention can be connected to the combined bundling device via the same connecting loop 136, another connecting loop on either side of the first device 101, or a connecting loop 236 on another device 201. In all cases, the end user can select the sizes of the first device 101, the other device 201, and any other devices according to the fistula to be treated. Therefore, it can be understood that almost infinite variations are possible, and a surgeon or care practitioner can connect any number of devices together in almost any configuration to match the structure and degree of branching of the complex fistula to be treated.

[0257] Go to Figure 12 , which shows inserting Figure 11 the combined bundling device into a complex fistula. Referring to Figure 12 (a), which shows a patient with a complex fistula 137 that extends from a first opening 138 on the outer surface of the patient's buttock or perianal skin to a second opening 139 within the anal canal 141 and further extends through a branch 142 to a third opening 140 also on the outer surface of the patient's buttock or perianal skin.

[0258] With the help of a first probe 143, a surgeon or care practitioner can pass the first end of the ligature 102 of the first device 101 through the anal canal 141 and into the fistula 137 through the second opening 139. Then, as shown by the arrow in Figure 12 (a), the first probe 143 and the first end of the ligature 102 are manipulated to pass through the fistula 137 and out of the first opening 138. Similarly, with the help of a second probe 144, the first end of the ligature 202 of another device 201 tied to the first device 101 can pass through the anal canal 141 and enter the fistula 137 via the second opening 139. Then, as shown by the arrow in Figure 12 (a), the second probe 144 and the first end of the ligature 202 are manipulated to pass through the branch 142 of the fistula 137 and protrude from the third opening 140.

[0259] In this way, the elongated sheet 103 of the first device can be positioned within the fistula 137, with the first end of the thread 102 extending out of the anal canal 141 through the second opening 139, and the second end of the thread 102 extending out through the first opening 138. As previously described, another device 201 is connected to the connecting loop of the first device 101 by a knot 204, and the elongated sheet 203 is positioned to extend through the length of the fistula branch 142 such that one end of the thread 202 of the other device 201 protrudes from the third opening 140. After removing all the probes, the two ends of the thread 102 and the loose ends of the thread 202 can be tied into a knot 145, and the elongated sheets 103 and 203 are fixed within the two branches of the fistula 137 by the thread stitches as shown in Figure 12 (b).

[0260] It can be understood that since the thread 202 of the other device is directly tied to the thread 102 of the first device, the final fixation of such an in-situ combined thread stitch and the two elongated sheets 103 and 203 will be very firm. In addition, the two elongated sheets 102 and 203 may also include a plurality of protrusions 105 and 205 in the form of serrated or crenellated edges, thus contributing to the fixation as previously described.

[0261] The device and method can be optimally adjusted by a surgeon or a care practitioner according to the specific fistula to be treated. For example, the insertion method of the device of the present invention is not limited to Figure 10 and Figure 12 the ways shown, and other insertion techniques can be easily adopted or envisioned. For example, referring to Figure 12 , before the first device 101 is connected to the second device 201 through the connecting loop, the first device 101 and the second device 201 can be first inserted into the corresponding branches of the tracheal fistula.

[0262] Although the embodiments of the present invention have been shown and described, those skilled in the art will understand that the above description should be regarded only as a description of the preferred embodiments. These examples are not intended to limit the scope of the present invention. Various modification schemes and embodiments can be made without departing from the scope and spirit defined by the claims of the present invention.

Claims

1. A device suitable for treating a fistula, Among them, The fistula includes a fistulous tract, wherein the device includes a ligature and an elongate body of tissue growth promoting matrix material, wherein the elongate body is adapted to be positioned within the fistulous tract, and wherein the elongate body includes a plurality of protrusions positioned on at least one outer surface of the elongate body.

2. The apparatus according to claim 1, wherein Each outer surface on which the plurality of protrusions are positioned is parallel or substantially parallel to the longitudinal axis of the elongate body.

3. The device according to claim 1 or 2, wherein The height of each protrusion among the plurality of protrusions is 0.5 - 3 mm, and the width is 0.5 - 5 mm.

4. The device according to any one of the preceding claims, wherein, The shape of each protrusion among the plurality of protrusions is conical, triangular, triangular prismatic or pyramidal.

5. The device according to any one of the preceding claims, wherein, The elongate body and the plurality of protrusions are an integral structure.

6. The apparatus according to any of the preceding claims, wherein, The elongate body is an elongate thin sheet of tissue growth promoting matrix material.

7. The apparatus according to claim 6, wherein, The plurality of protrusions are positioned on at least one outer edge surface of the elongate body, wherein the outer edge surface is parallel or substantially parallel to the longitudinal axis of the elongate body.

8. A device suitable for treating a fistula, Among them, The fistula includes a fistulous tract, wherein the device includes a ligature and an elongate thin sheet of tissue growth promoting matrix material, wherein the elongate thin sheet is adapted to be positioned within the fistulous tract, wherein the elongate thin sheet includes a first outer edge surface and a second outer edge surface, wherein when the elongate thin sheet is laid flat, both the first outer edge surface and the second outer edge surface are parallel or substantially parallel to the longitudinal axis of the elongate thin sheet, wherein the first plurality of protrusions includes serrations formed on the first outer edge surface, and wherein the second plurality of protrusions includes serrations formed on the second outer edge surface.

9. A device suitable for treating a fistula, Among them, The fistula includes a fistulous tract, wherein the device includes a ligature and an elongate body of tissue growth promoting matrix material, wherein the elongate body is adapted to be positioned within the fistulous tract, wherein the device includes one or more connection points positioned along the length of the elongate body, wherein the one or more connection points are configured to connect the elongate body to another ligature.

10. The apparatus according to claim 9, wherein The elongate body is an elongate thin sheet of tissue growth promoting matrix material.

11. The device according to claim 9 or 10, wherein, Each connection point is provided in the form of a connection loop, optionally, wherein the inner circumference of each connection loop is 5 - 20 mm.

12. The apparatus according to claim 11, wherein, The ligature passes through the elongate body or the elongate thin sheet of tissue growth promoting matrix material, wherein each connection loop is directly fixed to the ligature, or each connection loop is formed by the ligature.

13. A device suitable for treating a fistula, Among them, The fistula includes a fistulous tract, wherein the device includes a ligature and an elongate thin sheet of tissue growth promoting matrix material, wherein the elongate thin sheet is adapted to be positioned within the fistulous tract, wherein the elongate thin sheet includes a first end and a second end, and its longitudinal axis extends from the first end to the second end, wherein the ligature extends beyond the first end of the elongate thin sheet, repeatedly passes through the first side of the elongate thin sheet to the second side, and then passes through the second side of the elongate thin sheet and back to the first side, thereby forming a plurality of connection loops on alternating sides along the length of the elongate thin sheet, wherein the ligature optionally passes back from the first side of the elongate thin sheet to the second side, and wherein the ligature exits the elongate thin sheet and extends beyond the second end of the elongate thin sheet, wherein the plurality of connection loops are configured to tie the elongate thin sheet to one or more additional ligatures.

14. The apparatus according to claim 13, wherein, The suture is fixed to the elongate sheet by a first knot near the first end of the elongate sheet, and the suture is fixed to the elongate sheet by a second knot near the second end of the elongate sheet. Optionally, wherein the elongate sheet is wound or folded at the first and second ends to tie the first and second knots such that the loops of each knot surround the corresponding wound or folded portion of the elongate sheet.

15. The apparatus according to any of the preceding claims, wherein, The tissue growth promoting matrix material comprises a framework, wherein the framework comprises a plurality of fibers. Optionally, wherein the fibers are interconnected in a non-woven disordered structure.

16. The apparatus according to claim 15, wherein, The fibers are made of a material comprising a biodegradable polymer such as a biodegradable polyester.

17. The apparatus according to claim 16, wherein, The fibers are made of a material comprising poly-L-lactic acid.

18. The device according to any of the preceding claims, wherein, The suture is made of a material comprising one or more biodegradable polymers.

19. A method of manufacturing an apparatus according to any of the preceding claims, the method comprising the step of attaching a suture to an elongate body or an elongate sheet.

20. The production method according to claim 19, wherein, The manufacturing method comprises the following steps: (i) cutting an elongate sheet of the tissue growth promoting matrix material from a larger sheet of the tissue growth promoting matrix material, optionally such that the elongate sheet has one or more castellated or serrated outer edges that extend in a direction parallel or substantially parallel to the longitudinal axis of the elongate sheet; (ii) folding the elongate sheet in alternating directions to form an accordion fold, wherein the creases of the accordion fold extend in a direction perpendicular or substantially perpendicular to the longitudinal axis of the elongate sheet; (iii) passing the suture through the accordion-folded elongate sheet, optionally with the aid of a needle, such that the suture passes through the elongate sheet a plurality of times; (iv) stretching the accordion-folded elongate sheet along the length of the suture; and (v) optionally tying or otherwise fixing the suture to the elongate sheet to prevent the elongate sheet from sliding along the suture.

21. A method of treating a fistula, the method comprising using an apparatus according to any of claims 1-19.

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