Fistula implant

Abstract

The fistula implant comprises a spiral body, a suture line and a line anchor, the spiral body is provided with a near end and a far end, the near end is provided with a first opening end, the far end is close to tissue and is provided with a second opening end, a through hollow cavity is formed between the first opening end and the second opening end, and the suture line is arranged in the hollow cavity. The suture line and the line anchor are connected together in a sliding mode, and the line anchor is arranged in the mode that after the suture line is tensioned, the length of the section of the line anchor is shortened, the line diameter of the section of the line anchor is enlarged to be in a knot shape, and the first opening end is blocked. The fistula implant can tightly block a fistula, and liquid leakage and failure caused by gaps are not prone to occurring.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical apparatus and instruments, and particularly relates to a fistula implant. BACKGROUND

[0002] An anal fistula is an abnormal infectious fistula between the anal canal and rectum and the skin around the anus, which is usually caused by infection of the crypt gland of the anus and formed after abscess rupture or incision and drainage. The symptoms of anal fistula include repeated discharge of purulent secretions or fecal water from the external orifice. The perianal skin may thicken, become red, and sometimes gas is discharged from the external orifice. Treatment of anal fistula usually requires surgery, and the surgical methods are various, including anal fistula incision, anal fistula resection, anal fistula enucleation, anal fistula thread treatment, etc. The choice of operation should be determined according to whether the anal fistula involves the anal sphincter and the extent of involvement.

[0003] Anal fistula incision is usually suitable for inter-sphincter fistula and low trans-sphincteric fistula, and the success rate can reach 90%. This is a simple and effective surgical method, but there may be postoperative complications such as fecal incontinence or recurrence of anal fistula. Anal fistula resection has the same effect as anal fistula incision, but may cause greater damage, longer healing time, and certain risk of anal incontinence, and is not suitable for deep fistula; it is only suitable for patients with superficial and poor fistula patency. Anal fistula thread treatment is suitable for anal fistula involving more sphincter muscles, which can reduce the risk of fecal incontinence caused by sphincter muscle disconnection. Compared with the first two operations, thread treatment can effectively reduce complications. This method of trying to retain the sphincter with a thread has been used for many years and is still the preferred method used by surgeons. However, the existing thread method cannot block the fistula for a long enough time to ensure its complete healing, and often the blockage is not tight enough, and the excretions can re-enter the pipeline, leading to abscess formation and re-fistulization.

[0004] Therefore, it is a technical problem to be solved by those skilled in the art to provide a fistula implant that is tightly blocked and less likely to form secondary liquid leakage and infection. UTILITY MODEL CONTENT

[0005] The utility model provides a fistula implant which can tightly block the fistula and will not fail again due to liquid leakage caused by the remaining gap.

[0006] To solve the above technical problems, the technical scheme provided by the utility model is:

[0007] A fistula implant, comprising: a fistula implant, characterized by comprising: a helix body having a proximal end and a distal end, the proximal end being provided with a first open end, the distal end being close to a tissue and provided with a second open end, and the first open end and the second open end having a hollow cavity passing therebetween, a suture and a wire anchor being slidably connected together, the wire anchor being arranged such that when the suture is pulled tight, the length of this section of the wire anchor is shortened and the diameter of the wire anchor is expanded into a knot shape, and the first open end is blocked.

[0008] Further, the proximal end face is provided with a through hole communicating with the hollow cavity, the wire anchor is woven into a shape, at least one section of the middle of the suture is woven into a core-in-sheath structure section with the wire anchor, and the two ends of the suture respectively extend out from the two ends of the wire anchor; one end of the suture passes through the through hole and is fixed at the through hole by a knot, and the other end is a free end.

[0009] Further, the outer diameter of the helix body is the same along the length between the proximal end and the distal end.

[0010] Further, the inner diameter of the helix body tapers from the distal end to the proximal end.

[0011] Further, the outer wall of the helix body is provided with an anti-backflow structure.

[0012] Further, the anti-backflow structure is a convex structure, and the convex structure comprises one or more of a barb, a hook, an arrow, or a fishhook-shaped structure.

[0013] Further, the anti-backflow structure is a concave structure, and the concave structure comprises a groove or a channel.

[0014] Further, the surface of the anti-backflow structure is roughened.

[0015] Further, the distal end of the helix body is a cutting tip.

[0016] Further, the suture and the wire anchor are connected by threading to form a threading structure section.

[0017] Further, the threading structure section is folded and expanded into a knot when the suture is pulled tight.

[0018] The beneficial effects of this invention are as follows: The fistula implant of this invention uses a shrinkable, knot-forming braided structure combined with a spiral. After implantation, the suture anchor shrinks into a knot to seal the first opening of the spiral. In other words, the spiral and suture anchor completely block the connection between the rectum and the fistula, effectively preventing feces from re-entering the fistula and causing reinfection, abscess formation, and secondary fistula surgery, thus ensuring the reliability of the surgery and postoperative healing. The spiral, suture anchor, and suture are all made of absorbable material, which can be absorbed by the body after healing, avoiding secondary removal. Simply pulling the suture anchor to form a knot and seal the first opening is simple and convenient. Attached Figure Description

[0019] Figure 1 This is a structural diagram of the fistula implant of this utility model;

[0020] Figure 2 This is a structural diagram showing the connection between the suture and the suture anchor in the fistula implant of this utility model;

[0021] Figure 3 This is an overall structural diagram of the driver and fistula implant of this utility model;

[0022] Figure 4 This is a structural diagram of the connection between the driver and the fistula implant of this utility model.

[0023] The reference numerals in the figures include:

[0024] 100—Chromosome 110—Proximal end 120—Distal end

[0025] 111—First opening end; 121—Second opening end; 112—Through hole

[0026] 130—Hollow cavity; 140—Anti-reverse structure; 200—Line anchor.

[0027] 300—Suture 400—Driver Detailed Implementation

[0028] To make the technical problems, technical solutions, and beneficial effects of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.

[0029] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0030] It should be understood that the terms "length", "width", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate directions or positions based on the directions or positions shown in the drawings, and are used only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0031] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined as "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "multiple" is two or more, unless otherwise explicitly specified.

[0032] The present application provides a fistula implant, which has a structure as shown in Figure 1 、 Figure 3 and Figure 4 , mainly comprising a spiral body 100, a wire anchor 200 and a suture 300. The spiral body 100 has a proximal end 110 and a distal end 120, the proximal end 110 is close to the driver 400 and is provided with a first open end 111; the distal end 120 is close to the tissue and is provided with a second open end 121; the first open end 111 and the second open end 121 have a through hollow cavity 130 therebetween. A through hole 112 is provided on the end face of the proximal end 110 of the spiral body 100, and the through hole 112 is through the hollow cavity 130. The distal end 120 of the spiral body 100 is a cutting tip, which is used to be inserted into the bulk tissue around the fistula. The outer edge of the spiral body 100 is provided with an engaging part (not shown in the figure), which is used to engage with the driver 400 to make the spiral body 100 rotate into the fistula under the driving of the driver 400. A back-rolling prevention structure 140 is provided on the outer periphery of the spiral body 100, which can be a convex structure, such as a barb, a hook, an arrow or a fishhook structure; the back-rolling prevention structure 140 can also be a concave structure, such as a groove, a notch or a trench. The surface of the back-rolling prevention structure 140 is roughened to increase the friction and prevent the back-rolling phenomenon during implantation or the post-implantation migration phenomenon after the implant is implanted.

[0033] The structural relationship between the wire anchor 200 and the suture 300 is as shown in Figure 2As shown, the line anchor 200 is a flexible fixing component, is a braided structure, and can slide relative to the suture 300, and at least a section of the suture 300 is braided with the line anchor 200 to form a core-sheath structure section. The core-sheath structure section is a section in which the suture 300 passes through the inside of the braided line anchor 200, and when the line anchor 200 is contracted relative to the suture 300, the length of this section of the line anchor 200 is shortened and the diameter is expanded into a knot after the suture 300 is pulled tight. Two ends of the suture 300 extend out of two ends of the line anchor 200, respectively, one end of which passes through the through hole 112 and is fixed outside the through hole 112 by a knot, and the other end extends out of the hollow cavity 130 and is a free end. Therefore, the line anchor 200 can be contracted into a knot by pulling the suture 300 to achieve the effect of plugging the first opening end 111, and the end of the suture 300 as the free end can be used as a drainage line in the fistula and extended to the external opening of the fistula.

[0034] The suture 300 and the line anchor 200 are connected by insertion to form an insertion structure section, and the insertion structure section is folded and expanded into a knot when the suture 300 is pulled tight. The free end of the suture 300 has an anchoring structure for anchoring the line body in place, which can be a barb, a hook or a knot, and in some cases, the free end of the suture 300 as the drainage line is embedded in the sphincter complex through the anchoring structure.

[0035] The cross section of the helical body 100 can be one or more of a circle, an ellipse, a triangle or a polygon.

[0036] In the utility model, the helical body 100, the line anchor 200 and the suture 300 are all made of bioabsorbable materials, and after being implanted in the fistula, the absorbable materials are gradually degraded and absorbed by the human body after the pipeline is gradually healed, so that the harm caused by secondary removal can be avoided.

[0037] As shown in FIG. 1, the helical body 100 is a helical body with a hollow cavity 130, and the line anchor 200 is arranged in the hollow cavity 130. Figure 1 and Figure 3As shown, the helix 100 of the implant includes an outer diameter that is substantially constant and an inner diameter that tapers from the proximal end 110 to the distal end 120. The proximal end 110 of the implant is the largest coil and, with the proper outer boundary initially, it encircles the tissue defect. As the implant is advanced, the proximal end 110 provides a larger surface area to effectively anchor the implant. Each subsequent coil provides (in addition to) anchoring and compression functions. The smallest coil toward the distal end 120 provides the greatest amount of tissue compression. As the implant is transformed into tissue, each coil further compresses the captured tissue toward the center of the tissue defect, effectively fully compressing the surrounding tissue inward. The close proximity of the tissue allows the tissue to heal together. This compression provides an effective seal against the pressure created in the rectum and prevents fecal matter from passing into the fistula, thereby preventing reinfection. The smaller diameter of the implant coil prevents the captured tissue from separating and prevents the healing process from failing or foreign matter from entering the tissue defect.

[0038] In a specific surgical procedure, the implant is first delivered into the tissue by the driver 400 such that the helix 100 of the implant rotates into the tissue of the fistula and radially inwardly compresses the surrounding tissue such that the surrounding tissue is squeezed into the hollow cavity 130 with the proximal end 110 of the helix 100 at the internal opening of the fistula (i.e., at the connection to the rectum), then the suture 300 is pulled tight such that the line anchor 200 is contracted into a mass and plugs at the second open end 121, at which point the internal opening of the fistula has been completely sealed off and liquid from the rectum can no longer flow into the fistula, preventing reinfection and re-fistulization. The free end of the suture 300 is then outside the external opening of the fistula for draining liquid from the fistula.

[0039] The above merely provides a preferred embodiment of the present application, and for those skilled in the art, many changes can be made to the specific implementation and application range according to the idea of the present application, as long as these changes do not deviate from the concept of the present application, and all of these changes are within the protection scope of the present application.

Claims

1. A fistula implant, characterized in that, Comprising: a helix (100) having a proximal end (110) and a distal end (120), the proximal end (110) is provided with a first open end (111), the distal end (120) is provided with a second open end (121) close to the tissue, and the first open end (111) and the second open end (121) have a hollow cavity (130) passing through therebetween, the suture line (300) and the line anchor (200) are slidably connected together, the line anchor (200) is arranged to be shortened in length and enlarged in diameter into a knot shape to block the first open end (111) after the suture line (300) is pulled tight.

2. The fistula implant of claim 1, wherein, The proximal end (110) is provided with a through hole (112) communicating with the hollow cavity (130), the line anchor (200) is woven into a shape, at least one section of the suture line (300) is woven into a core structure section with the line anchor (200), and the two ends of the suture line (300) extend out from the two ends of the line anchor (200) respectively; one end of the suture line (300) passes through the through hole (112) and is fixed at the through hole (112) by a knot, and the other end is a free end.

3. The fistula implant of claim 2, wherein, The outer diameter of the helix (100) is the same along the length direction between the proximal end (110) and the distal end (120).

4. The fistula implant of claim 3, wherein, The inner diameter of the helix (100) tapers from the distal end (120) to the proximal end (110).

5. The fistula implant of claim 4, wherein, The outer wall of the helix (100) is provided with an anti-backup structure (140).

6. The fistula implant of claim 5, wherein, The anti-backup structure (140) is a convex structure, which includes one or more of barbs, hooks, arrows or fishhook-shaped structures.

7. The fistula implant of claim 5, wherein, The anti-backup structure (140) is a concave structure, which includes a groove or a groove.

8. The fistula implant of claim 6, wherein, The surface of the anti-backup structure (140) is roughened.

9. The fistula implant of claim 8, wherein, The distal end (120) of the helix (100) is a cutting tip.

10. The fistula implant of claim 2, wherein, The suture line (300) and the line anchor (200) are connected by insertion to form an insertion structure section; the insertion structure section is folded and expanded into a knot when the suture line (300) is pulled tight.

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