A biomaterial anal fistula plug

Abstract

The utility model discloses a kind of biological material fistula plugs, comprising: conical body, including conical side wall, hollow cavity, open end and closed end;Conical plug body, the conical plug body is set in the hollow cavity of the conical body, for carrying therapeutic drug;Wherein, the taper of the conical plug body and conical body is same.The double-layer conical tube structure of the utility model can make traditional Chinese medicine effective components continuously act on wound cavity surface, improve perianal local wound microcirculation, promote the absorption of inflammation, can promote postoperative wound healing, improve wound healing quality, and can prevent infection.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and more specifically, to a biomaterial fistula plug. Background Technology

[0002] An anal fistula is a chronic infected tract connecting the perianal skin and the rectum / anal canal. It is an inevitable result of the healing of perianal abscesses and is a common benign anal disease. However, due to the deep location of high-level complex anal fistulas, the surgical wound is large and deep, leading to longer hospital stays, increased hospitalization costs, and prolonged wound healing time. Daily dressing changes and perianal wound care are required, severely impacting patients' work and daily lives. Furthermore, with the growth of granulation tissue, wound edema, and postoperative defecation, feces and wound secretions easily accumulate in the wound, affecting healing time. Cleaning foreign objects and secretions during dressing changes causes severe pain and discomfort for patients. More seriously, it can lead to weakened anal function and even incontinence, severely impacting patients' quality of life and mental health. Therefore, reducing postoperative pain, accelerating wound healing, and preserving anal function and postoperative quality of life are the main issues to be addressed after surgery for high-level complex anal fistulas.

[0003] Traditional Chinese medicine offers a rich array of treatments for anal fistulas, including herbal fumigation, herbal thread placement, external herbal application, rectal administration, acupuncture, and moxibustion. These treatment concepts and methods provide a wealth of innovative approaches for modern anal fistula treatment. In modern surgical treatment of anal fistulas, procedures fall into two main categories: sphincter-preserving techniques, such as fibrin glue sealing, fistula plugs, and rectal mucosal flaps; and sphincter-damaging techniques, including thread cutting, fistula incision, and fistula excision. Generally, sphincter-damaging techniques have a higher success rate but are accompanied by a higher rate of anal incontinence. Conversely, sphincter-preserving techniques have a slightly lower success rate but minimal impact on anal function. Utility Model Content

[0004] The purpose of this disclosure is to address the technical problems in related technologies by providing a biological patch for anal fistula repair. This patch is manufactured using biomaterials derived from composite traditional Chinese medicine. It utilizes porcine small intestinal submucosa material, which is already widely used, as a base material to construct a special structure. Combined with the effective components of traditional Chinese medicine, a high-quality and inexpensive anal fistula plug is obtained. After implantation, this plug allows the traditional Chinese medicine to continue to exert its effects, promoting fistula regeneration and repair, improving the success rate of anal fistula treatment, and effectively preserving anal function. This is of great significance for changing the current status of minimally invasive anal fistula treatment devices in my country, improving patient treatment outcomes and quality of life, and reducing medical expenses. The specific solution is as follows:

[0005] This disclosure provides a biomaterial anal fistula plug, comprising: a conical body, including...

[0006] The conical sidewall, hollow cavity, open end, and closed end; a conical plug, which is fitted inside the hollow cavity of the conical body to hold a therapeutic drug; wherein the conical plug has the same taper as the conical body.

[0007] In some embodiments, after the conical plug is fitted inside the conical body, the bottom of the conical plug is flush with the open end of the conical body.

[0008] In some embodiments, the biomaterial fistula plug further includes:

[0009] The first thread is located at the open end of the conical body and is fixedly connected to the conical sidewall.

[0010] In some embodiments, the length of the first filament is greater than the axial height of the conical body.

[0011] In some embodiments, the biomaterial fistula plug further includes:

[0012] At least one second thread is fixedly connected to the side wall of the conical body.

[0013] In some embodiments, the number of the second thread is 2-4.

[0014] In some embodiments, the biomaterial fistula plug further includes:

[0015] At least one auxiliary connector is disposed on the side wall of the conical main body.

[0016] In some embodiments, the number of auxiliary connectors is 2-4.

[0017] In some embodiments, the conical plug is a sponge-like biomaterial.

[0018] In some embodiments, the biomaterial is an extracellular matrix source material; and / or, the biomaterial further includes traditional Chinese medicine components.

[0019] Compared with related technologies, the above-described solutions of this disclosure have at least the following beneficial effects:

[0020] The fistula plug containing the traditional Chinese medicine SIS in this application has a double-layered conical structure, which facilitates its implantation into the fistula tract during surgery and its easy fixation to the patient's wound, thus improving the convenience of the operation.

[0021] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description

[0022] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure. It is obvious that the drawings described below are merely some embodiments of this disclosure, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort. In the drawings:

[0023] Figure 1 This is a schematic diagram of the conical body of a biomaterial fistula plug, as shown in some embodiments.

[0024] Figure 2 This is a schematic diagram of the overall structure of a biomaterial fistula plug, as shown in some embodiments.

[0025] Figure 3 This is a schematic diagram of the overall structure of a biomaterial fistula plug, as shown in some embodiments.

[0026] Figure 4 This is a scanning electron microscope image of a biomaterial fistula plug.

[0027] Figure label:

[0028] Conical body 10, conical sidewall 11, hollow cavity 12, open end 13, closed end 14, conical plug 20, first thread 30, second thread 31, auxiliary connector 40. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of this disclosure clearer, the disclosure will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0030] The terminology used in the embodiments of this disclosure is for the purpose of describing particular embodiments only and is not intended to limit the disclosure. The singular forms “a,” “the,” and “the” as used in the embodiments of this disclosure and the appended claims are also intended to include the plural forms, unless the context clearly indicates otherwise; “multiple” generally includes at least two, and other quantifiers are similarly intended.

[0031] It should be understood that although the terms first, second, third, etc. may be used to describe… in the embodiments of this disclosure, these… should not be limited to these terms. These terms are only used to distinguish…. For example, first… may also be referred to as second… without departing from the scope of the embodiments of this disclosure, and similarly, second… may also be referred to as first…. Furthermore, the terms “first,” “second,” “third,” etc. are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0032] It should be understood that the term "and / or" as used herein is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, and B alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship. The singular forms "a," "the," and "the" are also intended to include the plural forms unless the context clearly indicates otherwise.

[0033] It is further understood that the terms “center,” “longitudinal,” “lateral,” “front,” “rear,” “up,” “down,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this embodiment and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0034] In the description of this disclosure, it should be noted that, unless otherwise expressly specified and limited, the terms "connected" or "linked" should be interpreted broadly. For example, it can refer to a fixed connection, a detachable connection, or an integral connection; it can refer to a mechanical connection or an electrical connection; it can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0035] Depending on the context, the words “if” or “suppose” as used here can be interpreted as “when” or “in response to determination” or “in response to detection.” Similarly, depending on the context, the phrases “if determination” or “if detection (of the stated condition or event)” can be interpreted as “when determination” or “in response to determination” or “when detection (of the stated condition or event)” or “in response to detection (of the stated condition or event).”

[0036] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0037] like Figures 1-2 As shown, this disclosure provides a biomaterial fistula plug, wherein the biomaterial is an extracellular matrix source material, specifically a porcine small intestinal submucosa material. The fistula plug includes a conical body 10, which comprises a conical sidewall 11, a hollow cavity 12, an open end 13, and a closed end 14. The conical body 10 is formed by curling a sheet-like biomaterial. The biomaterial fistula plug also includes a conical plug body 20, which is fitted within the hollow cavity 12 of the conical body 10 to hold therapeutic drugs. The conical plug body 20 has the same taper as the conical body 10. In some embodiments, the conical plug body 20 is a sponge-like biomaterial.

[0038] The biomaterial is decellularized porcine small intestinal submucosa matrix material (SIS). SIS is an extracellular matrix-derived material that removes genetic material and immunogenic substances from xenogeneic animals through a decellularization process while preserving the three-dimensional microstructure of the extracellular matrix. It is completely degraded and absorbed after implantation, exhibiting good biocompatibility, tissue regeneration induction, biodegradability, and anti-infection capabilities. This product is used in the treatment of anal fistulas, stimulating and supporting tissue reconstruction and repair at the damaged site, effectively promoting fistula wound healing and protecting anal function.

[0039] In some embodiments, the conical body 10 is made of an extracellular matrix material, which can provide tissue repair support for the fistula tract during intersphincteric fistula ligation. In a preferred embodiment, the material of the conical body 10 is an extracellular matrix material that has been cryogenically pulverized in liquid nitrogen, swollen in acetic acid solution, emulsified to obtain collagen slurry, and then molded using a model.

[0040] The conical main body is an extracellular matrix source material. The prepared collagen slurry is used to fabricate a conical scaffold material through a molding process, ensuring the material's key physical properties such as mechanical properties and porosity, and avoiding compression of the material's three-dimensional structure.

[0041] In a preferred embodiment, the conical plug 20 is a sponge structure, and the material of the conical plug 20 is an extracellular matrix source material that can carry traditional Chinese medicine. After the hollow cavity 12 is filled with the sponge structure conical plug 20, it can carry traditional Chinese medicine for treatment, and the conical plug 20 will preferentially degrade, thereby releasing the effective components of traditional Chinese medicine into the fistula.

[0042] In a preferred embodiment, the material of the conical plug 20 includes extracellular matrix source material and effective components of traditional Chinese medicine. The extracellular matrix source collagen slurry carrying the effective components of traditional Chinese medicine is injected into the hollow cavity 12 of the conical body 10 and freeze-dried to form an extracellular matrix source material sponge structure. The sponge structure plug will preferentially degrade, thereby releasing the effective components of traditional Chinese medicine into the fistula.

[0043] The conical plug 20 is a sponge filler formed from extracellular matrix material carrying traditional Chinese medicine. A collagen slurry containing the effective components of traditional Chinese medicine is poured into the conical body and freeze-dried. The resulting sponge structure retains its internal porous structure and will not collapse or create cavities within the conical body.

[0044] In a preferred embodiment, the plug is disposed inside the conical body, which can effectively achieve the sustained release effect of the effective ingredients of traditional Chinese medicine and reduce the impact on anal function.

[0045] In some embodiments, after the conical plug 20 is fitted inside the conical body 10, the bottom of the conical plug 20 is flush with the opening end 13 of the conical body 10.

[0046] In some embodiments, the biomaterial fistula plug further includes a first thread 30, which is disposed at the open end 13 of the conical body 10 and fixedly connected to the conical sidewall 11. During the operation, the fistula plug can be pulled into the puncture sinus tract by pulling the first thread 30. The first thread 30 is made of a biodegradable extracellular matrix-derived material.

[0047] In some embodiments, the length of the first thread 30 is greater than the axial height of the conical body 10 in order to provide a pullable structure.

[0048] In some embodiments, the biomaterial fistula plug further includes at least one second thread 31, which is fixedly connected to the conical body sidewall 11. In some embodiments, the number of second threads is 2-4. By providing the second thread 31 on the conical body sidewall 11, the orientation of the biomaterial fistula plug can be adjusted by pulling.

[0049] In some embodiments, such as Figure 3As shown, the biomaterial fistula plug further includes at least one auxiliary connector 40, which is disposed on the sidewall 11 of the conical main body. In some embodiments, the number of auxiliary connectors 40 is 2-4. The auxiliary connectors 40 are used to assist in fitting against the sidewall of the wound. The material of the auxiliary connectors 40 is a biodegradable extracellular matrix-derived material.

[0050] In some embodiments, the biomaterial is an extracellular matrix source material; and / or, the biomaterial further includes traditional Chinese medicine components.

[0051] Figure 4 This is a scanning electron microscope image of a biomaterial fistula plug. The fistula plug was prepared by rolling up a SIS membrane. The collagen fibers of the SIS material remained intact and undamaged. When using the biomaterial fistula plug of this application, firstly, the perianal area is disinfected with povidone-iodine. A small radial incision is made at the ischioanal fossa, close to the anal verge. A catheter is inserted and cut open. The biomaterial fistula plug is then placed into the fistula tract along the catheter. The position of the fistula plug is adjusted using the first and second sutures. Finally, the fistula plug is fixed to the affected area using an auxiliary connector.

[0052] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems or apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.

[0053] The above embodiments are only used to illustrate the technical solutions of this disclosure, and are not intended to limit it. Although this disclosure has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this disclosure.

Claims

1. A biomaterial fistula plug, characterized in that: include: The conical body includes conical sidewalls, a hollow cavity, an open end, and a closed end; A conical plug, which is fitted inside the hollow cavity of the conical body, is used to hold therapeutic drugs; The conical plug has the same taper as the conical body. The biomaterial fistula plug further includes: a first thread, disposed at the open end of the conical body and fixedly connected to the conical sidewall.

2. The biomaterial fistula plug according to claim 1, characterized in that, After the conical plug is fitted inside the conical body, the bottom of the conical plug is flush with the open end of the conical body.

3. The biomaterial fistula plug according to claim 1, characterized in that, The length of the first filament is greater than the height of the axis of the conical body.

4. The biomaterial fistula plug according to claim 1, characterized in that, The biomaterial fistula plug also includes: At least one second thread is fixedly connected to the side wall of the conical body.

5. The biomaterial fistula plug according to claim 4, characterized in that, The number of the second thread is 2-4.

6. The biomaterial fistula plug according to claim 1, characterized in that, The biomaterial fistula plug also includes: At least one auxiliary connector is disposed on the side wall of the conical main body.

7. The biomaterial fistula plug according to claim 6, characterized in that, The number of auxiliary connectors is 2-4.

8. The biomaterial fistula plug according to claim 1, characterized in that, The conical plug is a sponge-like biomaterial.

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