Anti-blocking and anti-extrusion anal fistula flushing and drainage thread hanging device

Abstract

The invention discloses an anti-blocking and anti-extrusion anal fistula flushing and drainage thread hanging device, and belongs to the technical field of medical instruments. The device comprises a flexible pipe body which is sequentially divided into a liquid injection connecting section, a special-shaped flushing function section and a closed locking section in the axial direction. The cross section of the special-shaped flushing functional section is of a non-circular special-shaped structure, the special-shaped flushing functional section comprises a central flushing channel, a plurality of supporting parts which protrude outwards in the radial direction and a plurality of flow guide parts which are sunken inwards in the radial direction, and the flow guide parts extend in the axial direction to form longitudinal flow guide grooves; a lateral spraying hole communicated with the central flushing channel is formed in the valley bottom position of the flow guide part; and the support part forms a height difference relative to the orifice position of the lateral injection hole. And the tail end of the closed locking section and the liquid injection connecting section can form a mechanically-locked closed loop. The problems that a drainage tube is easy to flatten and side holes are easy to block are solved through the special-shaped section structure, meanwhile, knotting-free rapid closing is achieved, and the drainage tube is suitable for thread hanging treatment of high-position complex anal fistula.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a flushing and drainage device for anorectal surgery, more particularly to a drainage and thread integration device with active flushing, anti-clogging and anti-extrusion functions, which can be used in high-complexity anal fistula thread treatment and can achieve rapid closure and fixation. BACKGROUND

[0002] Anal fistula is one of the common diseases in anorectal surgery, which is usually formed after the rupture or incision and drainage of perianal abscess. For high-complexity anal fistula (fistula tube passing through the internal and external sphincter), direct incision will damage the sphincter and cause anal incontinence. Therefore, the "thread treatment" is commonly used in clinical practice. This treatment uses thread material to form a closed loop through the fistula tube, which plays a role in chronic cutting and continuous drainage.

[0003] The current clinical use of anal fistula thread material mainly has the following defects:

[0004] 1) Solid material (such as rubber band, silk thread) has single function: although it has mechanical cutting effect, it lacks internal passage and can only rely on passive drainage around the thread body, which cannot actively flush the pus in the deep part, corner or blind end of the fistula tube, resulting in a long healing period.

[0005] 2) Ordinary hollow drainage tube has poor anti-extrusion ability: the existing thin-walled soft tube with circular cross-section is easily collapsed and occluded in the opposite direction when passing through the sphincter due to the continuous contraction of the sphincter (the contraction pressure can exceed 150 mmHg), resulting in drainage failure.

[0006] 3) Side hole is prone to "adhesion blockage": the side hole of the existing drainage tube is usually directly opened on the surface of the tube wall. Under the action of negative pressure or tissue pressure in the body, the outer surface of the tube wall is tightly attached to the granulation tissue, directly blocking the side hole, so that the flushing liquid cannot be sprayed out and the drainage liquid cannot be sucked in.

[0007] 4) Connection operation is complicated and uncomfortable: traditional thread treatment needs to be manually knotted to form a closed loop, which takes a long time (about 3-5 minutes), and the knot is large in size and has sharp corners, which can easily irritate the perianal skin after operation, causing pain and secondary infection.

[0008] Although there are some special cross-section drainage tubes (such as cross-shaped groove drainage tube) in the prior art, they are usually designed for abdominal or thoracic drainage and are not specially designed for the "loop closure", "sphincter high-pressure environment" and "repeated opening and closing flushing" required by anal fistula thread treatment. Therefore, it is of great clinical significance to develop a special device that integrates active flushing, anti-extrusion, anti-clogging and rapid closure. SUMMARY

[0009] The purpose of this invention is to provide an anal fistula irrigation and drainage hanging device that is resistant to blockage and compression, solving the problems of drainage tube blockage due to pressure, side hole blockage, and cumbersome hanging operation.

[0010] To achieve the above objectives, the present invention adopts the following technical solution: a fistula irrigation and drainage hanging device that prevents blockage and compression, comprising a flexible tube body, wherein the flexible tube body is divided into an injection connection section, an irregularly shaped irrigation function section and a closing locking section in sequence along the axial direction.

[0011] The irregularly shaped flushing section includes a central flushing channel and multiple outwardly radially protruding support portions and multiple inwardly radially recessed guide portions alternately arranged along the circumference of the central flushing channel. The cross-section of the irregularly shaped flushing section is non-circular. The support portions extend axially along the flexible tube to form an anti-compression skeleton, and the guide portions extend axially to form external guide grooves. At least one lateral injection hole is provided at the bottom of the valley of the guide portion, and the lateral injection hole is connected to the central flushing channel. A radial height difference H is formed between the radial apex of the support portion and the orifice position of the lateral injection hole at the corresponding valley of the guide portion. This height difference H is configured to maintain a guide gap between the lateral injection hole and the external tissue by utilizing the supporting effect of the support portion when the flexible tube is compressed by external tissue.

[0012] As a preferred embodiment, the height difference H ranges from 0.3 mm to 1.0 mm; more preferably from 0.4 mm to 0.8 mm.

[0013] As a preferred embodiment, the injection connection section is a hollow tubular structure; the closing locking section is a solid structure with one or more enlarged protrusions at its end; in use, the end of the closing locking section can be inserted into and held in the inner cavity of the injection connection section by means of the elastic deformation of the material, thereby forming a mechanically locked closed loop.

[0014] As a preferred embodiment, the end of the closing locking section is conical or bullet-shaped, and the maximum outer diameter of the end is greater than the inner diameter of the injection connection section.

[0015] As a preferred embodiment, the number of the support portions (6) is 3 to 6, and each support portion (6) is evenly distributed along the circumference. More preferably, the number of the support portions is 3, and the cross-section of the irregular flushing functional section has a clover-shaped structure.

[0016] As a preferred embodiment, the diameter of the lateral injection hole is 0.15 mm to 0.30 mm.

[0017] As a preferred embodiment, the lateral injection holes are arranged in a linear array along the axial direction of the guide portion; the diameter of each lateral injection hole in the linear array is the same; or, the diameter of each lateral injection hole gradually increases along the liquid flow direction.

[0018] As a preferred embodiment, the flexible tube is made of medical-grade silicone or thermoplastic polyurethane with a Shore hardness of 50A to 75A. Preferably, the elastic material has a Shore hardness of 60A to 70A.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1) Structural anti-clogging: Utilizing the radial height difference H generated by the "peak-valley" structure, the lateral injection holes are "hidden" at the bottom of the valley in the guide section. The support section, like a tent pole, supports the surrounding tissue, artificially creating physical gaps and completely eliminating the phenomenon of tissue adhering to the wall and clogging the side holes.

[0021] 2) Active anti-compression: The solid support section acts as an anti-compression skeleton, which can prevent the tube from collapsing even under strong contraction of the anal sphincter, ensuring that the central flushing channel is unobstructed.

[0022] 3) High-efficiency drainage: The external drainage channel utilizes the capillary siphon principle and low flow resistance to guide the pus to drain smoothly and avoid accumulation.

[0023] 4) Rapid closure and repeated flushing: The plug-in connection achieved by interference fit shortens the closure time to a few seconds, and the connection is smooth and knot-free, which greatly improves patient comfort; the loop can be repeatedly opened for flushing after the operation, which is simple to operate. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the overall structure of the anti-blockage and anti-squeezing anal fistula irrigation and drainage hanging thread device provided in an embodiment of the present invention.

[0025] Figure 2 for Figure 1 A magnified schematic diagram of the cross-section of the irregularly shaped flushing functional section.

[0026] Figure 3 This is a cross-sectional view of the connection point when the device of the present invention is in a closed and locked state.

[0027] Explanation of reference numerals in the attached drawings: 1—Injection connection section; 2—Irregularly shaped flushing functional section; 3—Closed locking section; 301—Locking head; 4—Side injection hole; 5—Guiding part (valley bottom / groove); 6—Support part (peak top / skeleton); 7—Central flushing channel; H—Radial height difference. Detailed Implementation

[0028] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0029] Example 1: The overall structure and anti-clogging design of the device are as follows Figure 1 and Figure 2 As shown, the present invention provides an anti-blockage and anti-compression anal fistula irrigation and drainage hanging device, which is mainly composed of an integrally molded medical silicone flexible tube. The tube is divided into three sections along its length: a liquid injection connection section 1, a special-shaped irrigation function section 2, and a closing and locking section 3.

[0030] The irregularly shaped flushing functional section 2 is the core part of this invention, and its cross-section is non-circular, resembling a clover leaf (e.g., ...). Figure 2 (As shown). This cross-section consists of three circumferentially distributed support sections 6 and three guide sections 5 located between the support sections. The support sections 6 are solid (or thick-walled) structures that bulge outwards and extend axially along the tube body. Their function is similar to the tread blocks of a car tire or the columns of a building, primarily used to withstand the radial pressure from the anal sphincter and prevent the central flushing channel 7 from closing. The guide sections 5 are inwardly recessed areas with three longitudinal grooves forming along the axial direction. Several lateral jet holes 4 are formed at the deepest point (i.e., the valley bottom) of the guide sections 5, and these holes communicate with the internal central flushing channel 7. (As shown) Figure 2 As shown, there is a radial height difference H between the apex (peak) of the support portion 6 and the outer surface of the lateral jet hole 4 at the bottom of the guide portion 5. In this embodiment, H is set to 0.6 mm. When the device is inserted into the fistula, the surrounding granulation tissue or sphincter muscle presses against the apex of the support portion 6. Due to the height difference H, the tissue is suspended above the guide portion 5 and cannot contact the lateral jet hole 4 at the bottom. This forms a natural "anti-clogging safety zone".

[0031] It is important to note that if H < 0.3 mm, soft granulation tissue can easily become trapped in the groove and cover the orifice, causing blockage; if H > 1.0 mm, the overall outer diameter of the tube will be too large, increasing the difficulty of threading and causing a foreign body sensation for the patient. Therefore, 0.3-1.0 mm is the optimal range for balancing anti-blockage performance and minimally invasive comfort. A more preferred range is 0.4-0.8 mm.

[0032] Example 2: Side Hole Arrangement and Flushing Function

[0033] The side injection holes 4 are arranged in a linear array along the axial direction of the guide section 5. The hole diameter is designed to be 0.2 mm. In a preferred embodiment, the hole diameter gradually increases along the liquid flow direction (away from the injection end) (e.g., from 0.20 mm to 0.30 mm) to balance the fluid pressure drop in the pipe, ensure the injection force at the distal end, and achieve uniform flushing of the entire pipe section.

[0034] Example 3: Quick-closing locking structure

[0035] like Figure 1 and Figure 3 As shown, the injection connection section 1 is a standard circular hollow silicone tube that can be connected to the syringe tip. The locking closure section 3 is a solid structure with a bullet-shaped bulge 301 at its end. The maximum outer diameter of the bulge 301 (e.g., 2.5 mm) is slightly larger than the inner diameter of the injection connection section 1 (e.g., 2.0 mm). It can be a conical or bullet-shaped structure, etc.

[0036] Instructions for use: During the procedure, after inserting the device through the fistula, the doctor simply pinches the locking segment 3 and forcefully inserts its end into the cavity of the infusion connection segment 1. Due to the elasticity of the silicone material, the two components achieve an interference fit, such as... Figure 3 As shown.

[0037] The advantages of this connection method are:

[0038] No knotting required: Eliminates the tedious process of hand-tying knots, reducing the time from 3-5 minutes to just a few seconds.

[0039] Smooth transition: The outer diameter of the connection changes gradually, without the hard lumps of traditional knots, greatly reducing friction and pain to the anus.

[0040] Reversible operation: During postoperative irrigation, the loop can be opened by forcefully pulling it out for irrigation. After irrigation, it can be reinserted and locked, making it suitable for treatment cycles lasting several weeks.

[0041] Example 4: Selection of Material Hardness

[0042] The main body of this device is made of medical-grade silicone, with a Shore hardness controlled between 60A and 70A.

[0043] Rigidity selection criteria: The resting pressure of the anal sphincter is approximately 40-80 mmHg, while the contraction pressure can reach over 150 mmHg. If the rigidity is below 50A, the tube is too soft, and the supporting part 6 is easily deformed under pressure, leading to passage closure. If the rigidity is above 75A, the tube is too rigid, like a hard rod passing through the anus, causing severe pain for the patient when sitting, standing, or walking, and easily cutting and damaging normal tissue. The rigidity range of 60A-70A provides sufficient pressure resistance while maintaining good flexibility and biocompatibility.

[0044] Example 5: Manufacturing Process

[0045] This device is preferably manufactured using liquid silicone injection molding or extrusion molding combined with secondary molding. A transition zone of approximately 5-10 mm is provided between the liquid injection connection section 1 and the irregularly shaped flushing functional section 2. The cross-section of this area smoothly transitions from a circular shape to a clover shape to avoid stress concentration that could lead to breakage.

[0046] Working principle and usage status of the device

[0047] The working principle and operation status of the device of the present invention in practical applications are as follows:

[0048] In use, the closing locking section 3 of the device serves as a guide end, traversing the tissue along the fistula path. Once the device is in place, the enlarged protrusion of the closing locking section 3 is inserted into the inner cavity of the injection connection section 1. Because the outer diameter of the enlarged protrusion is larger than the inner diameter of the injection connection section, the two utilize the elasticity of the silicone material to achieve an interference fit, thereby quickly forming a mechanically locked closed loop without the need for manual knotting.

[0049] When flushing is required, external force pulls out the locking section 3, opening the loop. An external flushing device (such as a syringe) is tightly connected to the injection connection section 1 and liquid is injected. The liquid is transported through the central flushing channel 7 to the irregularly shaped flushing functional section 2 and ejected from the lateral spray hole 4 at the bottom of the guide section 5. If the device is compressed by external tissue (such as a sphincter), the support section 6 supports the tissue, ensuring that the flushing fluid can be ejected from the lateral spray hole 4 and discharged along the longitudinal groove formed by the guide section 5. After flushing, simply inserting the locking section 3 back into the injection connection section 1 restores the locked state.

[0050] The above description is merely a preferred embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A clog-resistant and compression-resistant anal fistula irrigation and drainage hanging device, characterized in that, The system includes a flexible tube body, which is divided axially into an injection connection section (1), a shaped flushing functional section (2), and a closing and locking section (3). The shaped flushing functional section (2) includes a central flushing channel (7) and multiple outwardly radially protruding support parts (6) and multiple inwardly radially recessed guide parts (5) arranged alternately along the circumference of the central flushing channel (7). The cross-section of the shaped flushing functional section (2) is a non-circular shaped structure. The support parts (6) extend axially to form a support skeleton, and the guide parts (5) An external guide groove is formed by extending along the axial direction; at least one lateral spray hole (4) is provided at the bottom of the guide part (5), and the lateral spray hole (4) is connected to the central flushing channel (7); a radial height difference H is formed between the radial apex of the support part (6) and the orifice of the lateral spray hole (4) at the bottom of the guide part (5), and the height difference H is configured to maintain the guide gap between the lateral spray hole (4) and the external tissue by utilizing the supporting effect of the support part (6) when subjected to external tissue compression.

2. The apparatus according to claim 1, characterized in that, The radial height difference H ranges from 0.3 mm to 1.0 mm.

3. The apparatus according to claim 1, characterized in that, The injection connection section (1) is a hollow tubular structure; the closing locking section (3) is a solid structure with one or more enlarged protrusions at its end; in use, the end of the closing locking section (3) can be inserted into and held in the inner cavity of the injection connection section (1) by means of the elastic deformation of the material, thereby forming a mechanically locked closed loop.

4. The apparatus according to claim 3, characterized in that, The end of the closed locking section (3) is conical or bullet-shaped, and the maximum outer diameter of the end is greater than the inner diameter of the injection connection section (1).

5. The apparatus according to claim 1, characterized in that, The number of the support parts (6) is 3 to 6, and each support part (6) is evenly distributed along the circumference.

6. The apparatus according to claim 5, characterized in that, The number of the support parts (6) is 3, and the cross-section of the irregular flushing functional section (2) is clover-shaped.

7. The apparatus according to claim 1, characterized in that, The diameter of the lateral injection hole (4) is 0.15 mm to 0.30 mm.

8. The apparatus according to claim 1 or 7, characterized in that, The lateral injection holes (4) are arranged in a linear array along the axial direction of the guide portion (5); the diameter of each lateral injection hole (4) in the linear array is the same; or, the diameter of each lateral injection hole (4) gradually increases along the liquid flow direction.

9. The apparatus according to claim 1, characterized in that, The flexible tube is made of an elastic material with a Shore hardness of 50A to 75A.

10. The apparatus according to claim 9, characterized in that, The elastic material includes medical-grade silicone, thermoplastic polyurethane, or a composite material of the two; the liquid injection connection section (1), the irregular flushing function section (2), and the closing locking section (3) are integral injection molded structures.

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