An ultra-fine expandable anorectal administration device

Abstract

This utility model discloses an ultra-thin, expandable anorectal drug delivery device, comprising: a catheter for inserting into the anus and rectum, with a drug injection port at the front end of the catheter and a Luer lock connector fixedly connected to the rear end of the catheter; wherein, the catheter includes an inner tube layer, a middle tube layer, and an outer tube layer, the inner tube layer being connected to the drug injection port, the middle tube layer being wrapped around the outer side of the inner tube layer, an expansion member for increasing the tube diameter being provided between the inner wall of the middle tube layer and the outer wall of the inner tube layer, and a driving member being installed at the rear end of the catheter, the expansion member being controlled by the driving member, thereby changing the tube diameter through the use of the expansion member to achieve a better drug delivery effect, reduce secondary damage to the intestinal mucosa, improve patient treatment comfort, and ensure the safety of the entire drug delivery process.

Description

Technical Field

[0001] This utility model relates to the field of anorectal disease technology, specifically to an ultra-fine, expandable anorectal drug delivery device. Background Technology

[0002] In the medical field, rectal administration is an important treatment route and is widely used in the treatment of various diseases. In particular, for patients with anorectal diseases, enema therapy is one of the commonly used methods.

[0003] For general enemas, such as those used to relieve constipation and routine bowel cleansing, enema tubes with a diameter of 12-18 (approximately 4-6 mm) are commonly used. However, when dealing with specific diseases, such as inflammatory conditions like proctitis, or bleeding due to mucosal lesions, more stringent requirements are placed on the enema tube. For example, in the treatment of ulcerative proctitis with enemas, the rectal mucosa is already diseased and extremely fragile. In addition to some pre-mixed enema medications, patients often need to prepare their own enema solutions according to the doctor's orders. These solutions often have problems such as undissolved particles (e.g., mesalazine sustained-release granules) and high concentrations. In such cases, to achieve precise drug delivery, minimize irritation to the lesion site, and promote uniform local distribution of the drug, thinner enema tubes, such as those with a diameter of 8-12 (approximately 2.7-4 mm), are often used clinically.

[0004] Traditional enema catheters generally suffer from the drawback of being too large and rigid. During insertion into the patient's anus and rectum, they are highly susceptible to secondary damage to the already fragile intestinal mucosa, causing not only additional pain but also potentially worsening the condition. Although drug delivery connectors of different diameters have been introduced to the market, the key issue of effectively preventing blockage—a small diameter for insertion, a large diameter for drug delivery—remains unresolved. Existing patents often utilize expandable catheters that rely on an inflatable balloon to change the diameter. However, this method has significant drawbacks. Uniform inflation of the balloon during expansion is difficult to guarantee, potentially leading to excessive or insufficient expansion of the catheter in certain areas, affecting treatment efficacy. Furthermore, there is a high risk of rupture; if the balloon ruptures, treatment will be interrupted, potentially causing serious medical accidents. Utility Model Content

[0005] The purpose of this invention is to provide an ultra-thin, expandable anorectal drug delivery device to solve the problem that existing enema catheters are generally thick and rigid, which can easily cause secondary damage to the already fragile intestinal mucosa during insertion into the patient's anus and rectum. This not only causes additional pain to the patient but may also aggravate the condition.

[0006] To achieve the above objectives, the main technical solution adopted by this utility model includes: an ultra-fine expandable anorectal drug delivery device, comprising: a catheter for inserting into the anus and rectum, wherein the front end of the catheter has an injection port, and the tail end of the catheter is fixedly connected to a Luer lock connector; wherein the catheter includes an inner tube layer, a middle tube layer, and an outer tube layer, the inner tube layer is connected to the injection port, the middle tube layer is wrapped around the outer side of the inner tube layer, an expansion member for increasing the tube diameter is provided between the inner wall of the middle tube layer and the outer wall of the inner tube layer, and a driving member is installed at the tail end of the catheter, the expansion member being controlled by the driving member.

[0007] As a preferred technical solution, the injection port is provided in multiple forms, including a straight hole distributed at the center of the tail end of the catheter and side holes distributed on the side wall of the tail end.

[0008] As a preferred technical solution, the extension component is a spring skeleton, which is sleeved on the outer wall of the inner tube layer, and the inner side of the spring skeleton is fixedly connected to the outer wall of the inner tube layer, and the outer side is fixedly connected to the inner wall of the middle tube layer.

[0009] The drive unit includes a rotary rewind switch fixedly installed at the tail end of the conduit, and a pull rope is connected to the rotary rewind switch. The pull rope is fixedly connected to the front end of the spring frame.

[0010] As a preferred technical solution, the spring frame is provided with a plurality of positioning holes at intervals, the positioning holes are distributed on the left and right sides of the spring frame, and the plurality of positioning holes on one side are aligned axially.

[0011] At least two pull ropes are provided, and the two pull ropes are respectively movably inserted into the interior of the multiple positioning holes on both sides.

[0012] As a preferred technical solution, the inner tube layer is made of silicone material with a thickness of 0.1–0.3 mm;

[0013] The middle tube layer is a corrugated elastic silicone structure, and the outer tube layer is wrapped around the outer wall of the middle tube layer;

[0014] The middle tube layer is made of silicone and has a thickness of 0.1 to 0.2 mm.

[0015] As a preferred technical solution, the pull rope is a polyethylene pull rope.

[0016] As a preferred technical solution, the outer wall of the outer tube layer is provided with scale lines.

[0017] This utility model has at least the following beneficial effects:

[0018] This invention provides an ultra-fine, expandable anorectal drug delivery device. Operating a knob-type rewind switch at the end of the catheter rotates the internal winding reel, causing a pull cord fixedly connected to the reel to tighten from the front of the catheter towards the handle. The tightening force of the pull cord acts on the front of the spring frame. Because the pull cord moves through positioning holes on both sides of the spring frame, the tension is evenly transmitted to the spring frame, causing it to gradually unfold from a spiral folded state. The unfolding of the spring frame causes the inner and middle tube layers, which are fixedly connected to it, to expand radially. The middle tube layer is a corrugated elastic silicone structure; during expansion, its folds gradually extend, and the outer tube layer also stretches accordingly. This expands the catheter diameter from an initial small diameter to the required larger diameter, for example, from 2mm to 6mm, to meet different drug delivery needs. This reduces secondary damage to the intestinal mucosa, improves patient comfort, and ensures the safety of the entire drug delivery process. Attached Figure Description

[0019] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0020] Figure 1 This is a three-dimensional view of the ultra-fine, expandable anal and rectal drug delivery device of this utility model.

[0021] Figure 2 This is a schematic diagram of the middle tube structure of the ultra-fine expandable anal and rectal drug delivery device of this utility model;

[0022] Figure 3 This is a schematic cross-sectional view of the catheter of the ultra-fine expandable anorectal drug delivery device of this utility model;

[0023] Figure 4 This is a schematic diagram of the spring frame mounting structure of the ultra-fine expandable anal and rectal drug delivery device of this utility model.

[0024] Figure 5 This is a schematic diagram of the pull rope installation of the ultra-fine expandable anal and rectal drug delivery device of this utility model.

[0025] Explanation of icon numbers:

[0026] 1. Guide tube; 101. Inner tube layer; 102. Middle tube layer; 103. Outer tube layer; 2. Luer lock connector; 3. Knob rewind switch; 4. Spring frame; 401. Positioning hole; 5. Pull rope; 6. Injection hole; 7. Scale line. Detailed Implementation

[0027] The following will describe in detail the implementation of this application with reference to the accompanying drawings and embodiments, so that the implementation process of how this application uses technical means to solve technical problems and achieve technical effects can be fully understood and implemented accordingly.

[0028] Example

[0029] Please refer to Figures 1 to 5 As shown, this embodiment provides an ultra-thin, expandable anorectal drug delivery device, including: a catheter 1 for inserting into the anus and rectum, with a drug injection port 6 at the front end of the catheter 1 and a Luer lock connector 2 fixedly connected to the tail end of the catheter 1; wherein, the catheter 1 includes an inner tube layer 101, a middle tube layer 102, and an outer tube layer 103, the inner tube layer 101 is connected to the drug injection port 6, the middle tube layer 102 is wrapped around the outer side of the inner tube layer 101, an expansion member for increasing the tube diameter is provided between the inner wall of the middle tube layer 102 and the outer wall of the inner tube layer 101, a driving member is installed at the tail end of the catheter 1, and the expansion member is controlled by the driving member. By using the expansion member, the tube diameter of the catheter 1 can be changed to achieve a better drug delivery effect, reduce secondary damage to the intestinal mucosa, improve patient treatment comfort, and ensure the safety of the entire drug delivery process.

[0030] The injection port 6 has multiple holes, including a straight hole at the center of the tail end of the catheter 1 and side holes on the side wall of the tail end. The design of multiple injection ports 6 including straight holes and side holes allows the drug to be sprayed into the rectum from different directions and positions, which is beneficial to the more uniform distribution of the drug in the rectum.

[0031] The extension component is a spring frame 4, which is sleeved on the outer wall of the inner tube layer 101. The inner side of the spring frame 4 is fixedly connected to the outer wall of the inner tube layer 101, and the outer side is fixedly connected to the inner wall of the middle tube layer 102. The driving component includes a rotary rewind switch 3 fixedly installed at the tail end of the catheter 1. A pull rope 5 is connected to the rotary rewind switch 3, and the pull rope 5 is fixedly connected to the front end of the spring frame 4. By using the spring frame 4 as the extension component, it has good elasticity and deformability. Under the traction of the pull rope 5, the diameter of the tube can be effectively expanded. The rotary rewind switch 3 is easy to operate. Medical staff or patients can easily control the opening and closing of the pull rope by rotating the knob, thereby accurately adjusting the extension degree of the spring frame 4 and achieving precise control of the diameter of the catheter 1.

[0032] The spring frame 4 is provided with multiple positioning holes 401 at intervals, which are distributed on the left and right sides of the spring frame 4, with the multiple positioning holes 401 on one side being axially aligned. At least two pull ropes 5 are provided, and the two pull ropes 5 are respectively movably inserted into the multiple positioning holes 401 on both sides. By providing multiple positioning holes 401 at intervals on the spring frame 4 and by having at least two pull ropes 5 movably inserted into the positioning holes on both sides, the force on the spring frame 4 during the expansion process can be more uniform, avoiding problems such as inconsistent tube diameter expansion or torsion deformation of the spring frame 4 caused by uneven force. This ensures that the catheter 1 can maintain a circular cross-section during expansion, thereby operating more smoothly in the rectum. It also improves the stability and reliability of the device and extends the service life of the device.

[0033] The inner tube layer 101 is made of silicone with a thickness of 0.1–0.3 mm; the middle tube layer 102 is a corrugated elastic silicone structure; and the outer tube layer 103 wraps around the outer wall of the middle tube layer 102. The middle tube layer 102 is also made of silicone with a thickness of 0.1–0.2 mm. The thickness of the inner tube layer 101 is preferably 0.2 mm, and the thickness of the middle tube layer 102 is preferably 0.1 mm. By using a thinner silicone material for the inner tube layer 101, good flexibility is ensured, reducing irritation to the rectal mucosa, while still meeting the needs of drug delivery to a certain extent. The corrugated elastic silicone structure of the middle tube layer 102, combined with the spring skeleton 4, can better adapt to the expansion and contraction of the tube diameter. At the same time, its own elasticity can also play a certain protective role for the internal structure. The outer tube layer 103 wraps around the middle tube layer 102, and when contracted, it is wrapped with folds, leaving a smooth and traceless surface. The reasonable combination of three layers with different materials and thicknesses allows the catheter to have expandability while also taking into account flexibility, strength, and friendliness to the rectal mucosa.

[0034] Among them, the pull rope 5 is a polyethylene pull rope. The use of polyethylene pull rope has the advantages of high strength and corrosion resistance. It is not easy to break during long-term use and can stably transmit the pulling force of the knob rewind switch 3, ensuring reliable traction on the spring skeleton 4. At the same time, the polyethylene pull rope is relatively light, which will not add too much weight to the device and will not affect the flexibility of the catheter 1 in the rectum.

[0035] The outer wall of the outer tube layer 103 is provided with graduation lines 7. By providing graduation lines 7 on the outer wall of the outer tube layer 103, medical staff can accurately determine the depth of the catheter 1 inserted into the rectum during operation. Combined with positioning methods such as anoscope or ultrasound, the drug injection port 6 at the front end of the catheter 1 can be delivered to the lesion site more accurately, improving the accuracy of drug administration and avoiding the impact on treatment effect due to insertion that is too deep or too shallow, which helps to achieve precision medicine.

[0036] It is worth noting that the rotary winding switch 3 is a prior art structure disclosed in Chinese Patent Publication No. CN220654909U. Its specific structure and working principle will not be described in detail here. The end of the pull rope 5 of this device is connected to the coil of the rotary winding switch 3.

[0037] Working principle:

[0038] When using this device, paraffin oil can be evenly applied to the outer wall of the outer tube layer 103 of catheter 1 using a cotton ball to reduce resistance when the tube enters the intestine. Then, a syringe containing the prepared medication or a regular enema bag is tightly connected to the Luer lock connector 2 at the end of catheter 1, ensuring a secure connection and preventing leakage. Medical personnel then hold catheter 1 and slowly and gently insert its tip into the anus, using the graduations 7 on the outer wall of catheter 1, combined with an anoscope or ultrasound positioning, to accurately determine the insertion depth until the tip of catheter 1 reaches the target lesion location in the rectum. During this process, due to… The catheter 1 is initially in a narrow diameter state, and the inner tube layer 101 is made of silicone, which is thin and soft. The outer tube layer 103 has a smooth surface, which can effectively reduce irritation and damage to the intestinal mucosa. When the catheter 1 reaches the target position, the medical staff operates the knob rewind switch 3 installed at the tail end of the catheter 1 to start rotating the internal winding wheel. The pull rope 5, which is fixedly connected to the winding wheel, tightens from the front end of the catheter 1 towards the handle. The tightening force of the pull rope 5 acts on the front end of the spring frame 4. Since the pull rope 5 moves through the positioning holes 401 on both sides of the spring frame 4, it can evenly... The tension is transferred to the spring frame 4, causing it to gradually unfold from its spiral folded state. The unfolding of the spring frame 4 causes the inner tube layer 101 and the middle tube layer 102, which are fixedly connected to it, to expand radially. The middle tube layer 102 is a corrugated elastic silicone structure; during expansion, its folds gradually extend, and the outer tube layer 103 also stretches accordingly. This expands the diameter of the catheter 1 from its initial small diameter to the required larger diameter, for example, from 2mm to 6mm, to meet different drug delivery needs. Then, the drug injection operation can be performed. If a push injection method is used, the medical staff will slowly push the catheter. The drug-filled syringe connected to the Luer lock connector 2 accurately injects the drug into the lesion site in the rectum through the injection port 6. Due to the larger diameter of the expanded tube, the resistance during drug delivery is effectively reduced, avoiding blockage caused by drug particles or high concentration. After the drug is injected, the button on the knob rewind switch 3 is released, causing the winding wheel to rotate in the opposite direction. The pull rope 5 loosens, and the elasticity of the spring frame 4 and the middle tube layer 102 causes it to retract, restoring the diameter of the catheter 1 to its initial small diameter state. The medical staff slowly removes the catheter 1 from the patient's anus, completing the entire drug administration procedure.

[0039] The foregoing description illustrates and describes several preferred embodiments of the present invention. However, as previously stated, it should be understood that the present invention is not limited to the forms disclosed herein and should not be construed as excluding other embodiments. It can be used in various other combinations, modifications, and environments, and can be altered within the scope of the inventive concept described herein through the foregoing teachings or techniques or knowledge in related fields. Any modifications and variations made by those skilled in the art that do not depart from the spirit and scope of the present invention should be within the protection scope of the appended claims.

Claims

1. An ultra-fine expandable anorectal administration device, characterized by, include: A catheter (1) for inserting into the anus and rectum, wherein the front end of the catheter (1) is provided with a drug injection hole (6) and the tail end of the catheter (1) is fixedly connected to a Luer lock connector (2). The catheter (1) includes an inner tube layer (101), a middle tube layer (102), and an outer tube layer (103). The inner tube layer (101) is connected to the injection port (6). The middle tube layer (102) is wrapped around the inner tube layer (101). An expansion member for increasing the tube diameter is provided between the inner wall of the middle tube layer (102) and the outer wall of the inner tube layer (101). A driving member is installed at the tail end of the catheter (1), and the expansion member is controlled by the driving member.

2. An ultra-fine extendible anorectal administration device according to claim 1, characterized in that: The injection port (6) is provided with multiple holes, including a straight hole distributed at the center of the tail end of the catheter (1) and a side hole distributed on the side wall of the tail end.

3. An ultra-fine extendible anorectal administration device according to claim 1, characterized in that: The extension component is a spring frame (4), which is sleeved on the outer wall of the inner tube layer (101). The inner side of the spring frame (4) is fixedly connected to the outer wall of the inner tube layer (101), and the outer side is fixedly connected to the inner wall of the middle tube layer (102). The drive unit includes a rotary rewind switch (3) fixedly installed at the tail end of the conduit (1), and a pull rope (5) is connected to the rotary rewind switch (3). The pull rope (5) is fixedly connected to the front end of the spring frame (4).

4. An ultra-fine extendible rectal delivery device according to claim 3, wherein: The spring frame (4) is provided with a plurality of positioning holes (401) spaced apart. The positioning holes (401) are distributed on the left and right sides of the spring frame (4), and the plurality of positioning holes (401) on one side are aligned axially. At least two pull ropes (5) are provided, and the two pull ropes (5) are respectively movably inserted into the interior of the multiple positioning holes (401) on both sides.

5. The ultra-fine extendable anorectal administration device according to claim 1, characterized in that: The inner tube layer (101) is made of silicone and has a thickness of 0.1 to 0.3 mm. The middle tube layer (102) is a corrugated elastic silicone structure, and the outer tube layer (103) is wrapped around the outer wall of the middle tube layer (102); The middle tube layer (102) is made of silicone and has a thickness of 0.1 to 0.2 mm.

6. An ultra-fine extendible rectal delivery device according to claim 3, wherein: The pull rope (5) is a polyethylene pull rope.

7. An ultra-fine extendible rectal delivery device according to any one of claims 1 to 6, wherein: The outer wall of the outer tube layer (103) is provided with scale lines (7).

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