An integrated negative pressure adsorption colon enema catheter, system and separation method

Abstract

The application discloses an integrated negative pressure adsorption colon enema catheter and belongs to the technical field of medical devices.The catheter body is internally provided with a main channel and a negative pressure channel which are parallel to each other and axially penetrate through.The main channel and the negative pressure channel are independent of each other and are not communicated with each other.A plurality of side holes which are communicated with the main channel are arranged on the distal end tube wall of the catheter body.An integrated longitudinal adsorption ridge is arranged on the outer wall of the catheter body in an axial direction and is spaced apart from each other.The side of the longitudinal adsorption ridge which is away from the center of the catheter body is provided with a central recessed area.The bottom surface of the central recessed area is axially provided with a plurality of negative pressure holes which are communicated with the negative pressure channel.A sponge core is embedded in the central recessed area.The technical scheme provided by the application can provide a colon deep enema catheter system which has strong adsorption force, good sealing performance, firm component anti-dropping performance, full non-invasive performance and safe withdrawal performance.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an integrated negative pressure adsorption colonic enema catheter, system, and separation method. Background Technology

[0002] For patients who require drug delivery to the deep colon (such as the transverse colon and descending colon), such as those with ulcerative colitis or those who require gut microbiota transplantation, the main clinical methods currently used are traditional enemas or transendoscopic transluminal transluminal (TET) techniques.

[0003] However, these treatments and related catheter devices have many limitations in clinical application, as detailed below.

[0004] Traditional enemas often fail to effectively deliver medication deep into the colon, resulting in short retention times and severely limiting their efficacy, thus failing to fully meet the treatment needs of deep intestinal diseases. While endoscopic intestinal techniques can achieve deep drug delivery, a key issue is the need to fix the catheter to the intestinal wall with metal clips under endoscopy. This invasive procedure can lead to irreversible damage to the intestinal mucosa. More seriously, the metal clips need to be released after treatment, requiring another colonoscopy, significantly increasing patient pain, surgical risks, and medical costs.

[0005] To address the issue of non-invasive alternatives to metal clips, existing technologies attempt to temporarily fix the catheter to the colonoscope using suction cups. However, since most existing suction cups are designed with flat or simple concave surfaces, they cannot fully conform to the curvature of the cylindrical body of the colonoscope, usually resulting in only partial line contact, leading to a small contact area and insufficient suction force. Especially in the fluid-filled and moist environment of the intestinal lumen, these suction cups are prone to negative pressure leakage and short pressure holding time, making the catheter easy to loosen during the delivery of the endoscope.

[0006] In addition, most existing enema catheters with special fixation functions or multi-chamber designs are assembled from multiple independent components (such as suction cups, tube bodies, and connectors). Their complex structure not only increases the potential risk of failure, but also makes the production and assembly process more complicated, driving up manufacturing costs and making it difficult to widely promote their use as disposable consumables in clinical practice. Summary of the Invention

[0007] The purpose of this invention is to provide a deep colonic enema catheter system with strong adsorption, good sealing, secure anti-detachment components, non-invasive operation, and safe withdrawal.

[0008] To achieve the above objectives, the present invention adopts the following technical solution: an integrated negative pressure adsorption colonic enema catheter, comprising a catheter body, wherein the catheter body is provided with a main channel and a negative pressure channel that are parallel to each other and axially penetrate each other, the main channel and the negative pressure channel are independent of each other and not connected to each other, and the distal end of the catheter body is provided with a plurality of side holes that communicate with the main channel. The outer wall of the catheter body is provided with integrated longitudinal adsorption ridges spaced along the axial direction. The side of the longitudinal adsorption ridge away from the center of the catheter body is provided with a central recessed area. The bottom surface of the central recessed area is provided with multiple negative pressure holes connected to the negative pressure channel along the axial direction. The central recessed area is inlaid with a sponge core, and the two sides of the longitudinal adsorption ridge bend inward to form an inward-fastening skirt for locking and fastening the edge of the sponge core.

[0009] As a further description of the above technical solution: when negative pressure is applied to the negative pressure channel, the sponge core is compressed inward and forms a longitudinal arc-shaped indentation between the two inner-fastening skirts. The radius of curvature of the compressed longitudinal arc-shaped indentation matches the curvature of the cylindrical outer surface of the colonoscope used in conjunction with it.

[0010] As a further description of the above technical solution: a sponge anchoring unit is also provided on the outer wall of the catheter body near the distal end. The sponge anchoring unit includes a memory foam surrounding the outside of the catheter body and a highly elastic film completely covering the outer layer of the memory foam. The two ends of the highly elastic film are fixedly connected to the outer wall of the catheter body to form a sealed chamber, and the wall of the catheter body is provided with micropores that connect the sealed chamber and the negative pressure channel.

[0011] As a further description of the above technical solution: the sponge anchoring unit is provided in multiple and is arranged in a distributed series along the axial direction of the conduit body. In its natural state, the sponge anchoring unit presents as a beaded spindle-shaped protrusion. When negative pressure is applied to the negative pressure channel, the memory foam is compressed and shrinks, causing the high-elasticity film to adhere tightly to the surface of the conduit body, so that the outer diameter of the sponge anchoring unit is reduced to be flush with the outer diameter of the conduit body.

[0012] As a further description of the above technical solution: the catheter body, longitudinal adsorption ridge and inner buckle skirt are integrally injection molded or extruded from flexible polymer material; The multiple side holes are arranged in a spiral staggered pattern along the circumferential and axial directions of the distal end of the catheter body, and the inner and outer edges of the side holes are provided with smooth chamfers; The catheter body is equipped with a Luer connector at its tail end. The main channel and the negative pressure channel are led out from the tail end of the catheter body in a Y-shaped bifurcation structure and connected to the corresponding Luer connectors respectively.

[0013] As a further description of the above technical solution: the surface of the catheter body 100 is provided with scale lines, the material of the catheter body 100 contains X-ray imaging marking lines, the main channel 11 can be configured with a built-in super-slippery guidewire, the guidewire is used to enhance the toughness of the catheter.

[0014] An integrated negative pressure adsorption colonic enema system includes an integrated negative pressure adsorption colonic enema catheter, a negative pressure source, a three-way switch, and an enema device; The negative pressure source is connected to the Luer connector at the end of the negative pressure channel of the conduit via a connecting pipe. The three-way switch is installed on the connecting pipeline. The three ports of the three-way switch are respectively connected to the negative pressure source, the negative pressure channel and the external atmosphere, and are used to control the opening and closing of the negative pressure channel and the pressure relief. The enema device is connected to the Luer connector at the end of the main channel of the catheter via a connecting pipe, and is used to infuse the intestine with a drug solution or suspension.

[0015] An in vivo separation method for an integrated negative pressure adsorption colonic enema system includes the following steps: Step S1: Initial fitting of the lens body: Before operation, place the catheter body along the longitudinal axis of the colonoscope so that the longitudinal arc-shaped indentation of the longitudinal adsorption spine is initially attached to the outer surface of the colonoscope, and the sponge core is wrapped and fixed by the inner buckle skirt. Step S2, negative pressure adsorption fixation: Turn on the negative pressure source and connect the negative pressure channel through the three-way switch. Under the action of negative pressure, the sponge core is significantly compressed and concave, so that the longitudinal adsorption ridge and the surface of the colonoscope form a high-intensity vacuum adsorption state, realizing the temporary integrated connection between the catheter and the colonoscope. Step S3, Combined introduction into the body cavity: While maintaining a preset negative pressure value, the colonoscope and the catheter body attached to its surface are slowly inserted into the deep intestine of the patient and delivered to the target site. During placement, the built-in super-slippery guidewire in the main channel allows the catheter to adhere better to the surface of the colonoscope. When withdrawing the catheter, the super-slippery guidewire can assist the catheter and prevent it from kinking due to being too soft. Step S4: Release negative pressure and separate the contents of the body. Once the catheter reaches the target position, the negative pressure source is cut off by adjusting the three-way switch, and the negative pressure channel is connected to the outside atmosphere. The sponge core loses the negative pressure restraint, elastically rebounds and reshapes itself into a convex shape, thereby breaking the vacuum adsorption state and generating thrust, so that the catheter body and colonoscope body are smoothly separated.

[0016] As a further description of the above technical solution: between step S3 and step S4, step S3.1, distal intestinal wall anchoring is also included: After the catheter body reaches the target position, the sponge anchoring unit releases negative pressure and absorbs liquid to expand. The memory foam elastically rebounds and stretches the highly elastic film, allowing it to recover its expansion to the preset outer diameter and press against the intestinal wall, thus completing the flexible anchoring of the catheter deep in the intestine. After the enema treatment is completed, the method for removing the catheter includes the following steps: The negative pressure channel is opened to draw out the fluid and air inside the sponge anchoring unit, causing the memory sponge and high elastic film to be compressed to the preset minimally invasive removal diameter; Under continuous negative pressure, the catheter body is slowly pulled outward. During this process, the inner folding skirts on both sides of the longitudinal adsorption ridge fold backward and adhere to the surface of the catheter body under the pressure and friction of the intestinal tissue, so as to reduce the surface protrusion resistance.

[0017] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: 1. This design uses a longitudinal arc-shaped indentation to form a surface contact with the mirror body with a curvature matching, which increases the contact area and enhances the adsorption force; at the same time, combined with the capillary effect and gap filling of the sponge core, it forms a more effective seal, prolongs the pressure holding time of the wet surface, and effectively prevents negative pressure leakage.

[0018] 2. The inward-fastening skirt-like wrapping structure and the elastic embedded design of the sponge form an anti-dislodgement structure, ensuring that the sponge remains firmly in place during negative pressure suction, internal friction, or withdrawal operations, eliminating the safety risk of foreign body residue in the body; in addition, the sponge, as a buffer layer, effectively avoids direct rigid contact between the catheter and the colonoscope, protecting the coating of the endoscope from wear.

[0019] 3. This system does not require the use of metal clips for fixation, achieving non-invasive placement throughout the entire process; after the negative pressure is released, the sponge core automatically rebounds due to the elastic memory effect, assisting the adsorption ridge in restoring its shape, thereby achieving rapid and natural separation of the catheter and the endoscope; during withdrawal, the smooth rounded corner design of the inner skirt and the forward folding mechanism ensure that the tube body fits tightly against the surface of the catheter, without snagging tissue or posing a risk of damaging the mucosa.

[0020] 4. The catheter body, adsorption ridge, inner skirt and longitudinal groove adopt a one-piece molding process, which makes the structure simple and clear and does not require complex connectors, thus greatly reducing manufacturing costs; at the same time, the inner skirt and longitudinal groove work closely with the sponge core to significantly improve adsorption performance. Attached Figure Description

[0021] Figure 1 A schematic diagram of the present invention is shown; Figure 2 The present invention is shown. Figure 1 Enlarged view of point A in the middle; Figure 3 A perspective view of the sponge core of the present invention is shown; Figure 4 A perspective view of the longitudinal adsorption ridge of the present invention is shown; Figure 5 A three-dimensional view of the colonoscope and longitudinal adsorption ridge of the present invention is shown; Figure 6 A perspective view of the longitudinal arc-shaped indentation of the present invention is shown; Figure 7 A cross-sectional view of the catheter body of the present invention is shown; Figure 8 A cross-sectional view of the longitudinal adsorption ridge of the present invention is shown; Figure 9 A schematic diagram of the side hole of the present invention is shown; Figure 10 A cross-sectional view of the sponge anchoring unit of the present invention is shown; Figure 11 The steps of the present invention are shown in the diagram; Figure 12 A schematic diagram of the method of using the present invention is shown; Figure 13 A schematic diagram of the method of using the longitudinal adsorption ridge of the present invention is shown; Figure 14 A schematic diagram of the method of using the sponge anchoring unit of the present invention is shown; Figure 15 A schematic diagram of the catheter body and catheter body separation method of the present invention is shown; Figure 16 A schematic diagram of the catheter safe removal method of the present invention is shown.

[0022] Legend: 100. Catheter body; 11. Main channel; 12. Negative pressure channel; 13. Side port; 200. Longitudinal adsorption ridge; 21. Negative pressure hole; 22. Sponge core; 23. Inward-fastening skirt; 24. Central recessed area; 25. Longitudinal arc-shaped indentation; 300. Sponge anchoring unit; 31. Memory foam; 32. Thin film; 33. Micropores; 400, Luer connector; 500. Colonoscopy. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] Example 1 Please see Figures 1-10 The present invention provides a technical solution: an integrated negative pressure adsorption colonic enema catheter, including a catheter body 100, which is the core part of the overall structure; the total length of the catheter body 100 is designed to be 150 to 220 cm, and the outer diameter is set to be 4 to 5 mm.

[0025] In a preferred embodiment, the catheter body 100 is integrally formed from a medical-grade flexible polymer material (such as medical silicone or soft polyurethane TUP) through an extrusion process. This material not only gives the catheter excellent flexibility, making it smoother and more reliable when working in the intestine, but also allows the thin 4 to 5 mm outer diameter design to easily pass through various physiological bends and narrow areas of the colon, significantly reducing patient discomfort.

[0026] To further reduce frictional resistance during insertion and withdrawal, the outer surface of the catheter body 100 is completely coated with a hydrophilic lubricating coating.

[0027] Combination Figure 2 , Figure 7 and Figure 9 As can be seen, the inner cavity structure of the catheter body 100 adopts an integral molding design, which has two parallel axial through channels, namely the main channel 11 and the negative pressure channel 12, which are independent of each other and do not communicate with each other.

[0028] The main channel 11, with a larger cross-section and an inner diameter of ≥2.0mm, is dedicated to efficiently and with low resistance transport of high-viscosity enema solutions or fecal microbial solutions, avoiding blockage by fluid particles. The negative pressure channel 12, with a smaller auxiliary inner diameter of ≥1.0mm, is dedicated to transmitting the negative pressure source at the tail end to multiple working units at the distal end of the catheter.

[0029] At the tail end of the catheter body 100 (i.e., the external part), the negative pressure channel 12 and the main channel 11 are led out in a Y-shaped bifurcation structure to effectively prevent interference between the two channels; Luer connectors 400 are fixedly installed at the tail ends of both channels by medical adhesive bonding or hot-melt process.

[0030] The Luer connector 400 at the end of the negative pressure channel 12 is used for airtight connection with a medical aspirator or negative pressure pump; the Luer connector 400 at the end of the main channel 11 is designed to connect to a high-capacity syringe or infusion pump, thereby achieving standardized interface operation.

[0031] Please combine Figure 8 and Figure 9 The distal end of the catheter body 100 has several side holes 13 on its tube wall. The side holes 13 penetrate the tube wall and are connected to the main channel 11.

[0032] The preferred design features multiple side holes 13 arranged in a spiral staggered pattern along the circumferential and axial directions of the end of the catheter body 100, with the inner and outer edges of each side hole 13 being rounded and chamfered. This staggered hole structure enables uniform spraying of the medication within a 360-degree range, effectively increasing the coverage area of ​​the enema and preventing infusion blockage caused by the side holes 13 being completely adhered to the intestinal mucosa during intestinal peristalsis. The rounded chamfer design also prevents mechanical damage to the intestinal mucosa.

[0033] In a preferred embodiment, the catheter body 100 is integrally formed from medical-grade flexible polymer material through an extrusion process; in order to further reduce the frictional resistance during insertion and withdrawal, the outer surface of the catheter body 100 is completely coated with a hydrophilic lubricating coating.

[0034] In addition, the catheter body 100 has graduated lines on its surface to facilitate visual observation of the insertion depth; X-ray imaging markers are added to the material of the catheter body 100 to facilitate precise positioning under imaging equipment; the main channel 11, as the main lumen with a large cross-section, is dedicated to efficiently and with low resistance delivering high-viscosity enema solutions or fecal bacteria solutions; the main channel 11 can be equipped with a built-in super-slippery guidewire, which can enhance the toughness of the catheter body 100.

[0035] Reference Figure 1 , Figure 3 , Figure 4 , Figure 5 and Figure 6 An integrated longitudinal adsorption ridge 200 is provided on the outer wall of the catheter body 100 at a distance of 3cm, 50cm and 100cm from the end.

[0036] The longitudinal adsorption ridge 200 extends along the axial direction of the catheter and is a streamlined protrusion with a length of 15 to 20 mm and a width of 6 to 8 mm. Each ridge is integrally injection molded with the catheter body 100 using the same soft material.

[0037] The two ends of the longitudinal adsorption ridge 200 are designed with gentle transition slopes, which greatly reduces the friction when the catheter slides in the intestinal lumen or in the endoscope channel; by setting these three longitudinal adsorption ridges 200 at different positions, it is ensured that the catheter body can be stably fixed to the colonoscope 500 at the head, middle and tail.

[0038] In terms of specific structure, the back of the longitudinal adsorption ridge 200 (the side away from the center of the duct) is designed with a central recessed area 24, with a recess depth of about 0.8 mm.

[0039] Three to five negative pressure holes 21 are evenly distributed along the axial direction on the bottom surface of the central recessed area 24. The diameter of these negative pressure holes 21 ranges from 0.3 to 0.8 mm, and they directly penetrate the conduit wall and are connected to the built-in negative pressure channel 12.

[0040] For example, two negative pressure holes 21 are opened in the adsorption ridges at the distal and proximal ends, and three negative pressure holes 21 are opened in the adsorption ridges in the middle section, so as to finely adjust the adsorption negative pressure field intensity at different positions.

[0041] A sponge core 22 is embedded in the central recessed area 24. The sponge core 22 completely fills the recessed area and protrudes slightly outward. The sponge core 22 is made of open-cell elastic sponge, such as medical polyurethane sponge with high porosity, and fully covers all negative pressure holes 21.

[0042] This design allows the three-dimensional porous structure of the sponge to convert the strong point-like negative pressure suction generated by the bottom negative pressure holes 21 into a large-area adsorption force on the sponge surface; in addition, the sponge also acts as a natural filter layer, effectively preventing intestinal fluid, mucus or tiny fecal particles from being sucked in, so as not to clog the negative pressure holes 21.

[0043] On both sides of the longitudinal adsorption ridge 200, the edges are bent inward and extended to form an integrated inner-fastening skirt 23. The inner-fastening skirt 23 is similar to a "claw" structure, which can tightly fasten the edge of the sponge core 22, thereby ensuring that the sponge core 22 will not be displaced or fall off when the catheter rubs and slides with the endoscope.

[0044] Please combine Figure 6 For reference, when the internal negative pressure compresses the sponge core 22, its surface will be concave downward, forming a longitudinal arc-shaped indentation 25; this longitudinal arc-shaped indentation 25 presents as a longitudinal arc groove sandwiched between the two inner-fastening skirt edges 23, and its radius of curvature after compression precisely matches the cylindrical outer surface of the colonoscope 500, thereby achieving a close fit and firm fixation between the two.

[0045] Specifically, the sponge core 22 is made of open-cell elastic sponge material, specifically medical polyvinyl alcohol sponge (PVA sponge) in this embodiment, with a compression set of no more than 10%; the thickness of the sponge core 22 is 0.5 to 1.0 mm (preferably 0.8 mm in this embodiment), the average microscopic pore size is 50 to 150 μm (preferably 80 to 120 μm in this embodiment), and the porosity is 70 to 90% (preferably 85% in this embodiment).

[0046] The inward buckle angle of the inward-buckled skirt hem 23 is designed to be 15 to 30°, preferably 20° in this embodiment. The inward buckle width extending laterally is 1.0 to 1.5 mm (preferably 1.2 mm in this embodiment), and the thickness of the skirt hem itself is 0.20 to 0.30 mm (preferably 0.23 mm in this embodiment).

[0047] The inner-fastening skirt 23 and the sponge core 22 are fitted with an interference fit of 0 to 0.1 mm to ensure a tight fit. In addition, in order to reduce mechanical stimulation to the intestinal wall, the inner-fastening skirt 23 is made of soft silicone with a low Shore A hardness (20 to 30, specifically 25 in this embodiment), and its exposed outer surface is processed into a smooth rounded corner structure with a corner radius of not less than 0.2 mm (preferably 0.3 mm in this embodiment).

[0048] The depth of the longitudinal arc-shaped indentation 25 is 0.3 to 0.6 mm (preferably 0.5 mm in this embodiment), and the radius of curvature of its surface is designed to be 5 to 6 mm (preferably 5.5 mm in this embodiment). Since the outer diameter of the circular body of the standard clinical colonoscope 500 is usually 10 to 11 mm, and the radius of curvature of its outer surface is exactly 5 to 5.5 mm, the geometric curvature of the longitudinal arc-shaped indentation 25 achieves a high-precision curvature match with the outer surface of the colonoscope 500.

[0049] Combination Figure 1 , Figure 7 and Figure 10 It can be seen that in the area 10 to 30 cm from the head of the catheter body, the so-called anchoring section, three sponge anchoring units 300 are arranged in series along the axial direction of the catheter.

[0050] These anchoring units are spaced 2cm apart, forming a distributed series design. Compared with traditional single large airbags, this design provides better flexibility, enhances adaptability to intestinal curvature, and achieves multi-point friction fixation.

[0051] The specific structure of the sponge anchoring unit 300 includes a memory foam 31 surrounding the outside of the conduit body 100, and a highly elastic film 32 completely covering the outer layer of the memory foam 31.

[0052] In its natural state, without negative pressure, these sponge anchoring units 300 appear as beaded spindle-shaped protrusions, with a single unit length of approximately 3.5 cm and an outer diameter that can reach 2.0 to 2.5 cm when expanded.

[0053] Among them, the memory foam 31 is made of medical foam, which has a very high compression ratio and strong rebound memory performance; the film 32 is made of silicone waterproof film with excellent elasticity; the two ends of the film 32 are completely sealed to the outer wall of the catheter body 100 by medical glue, forming a closed cavity inside that covers the memory foam 31.

[0054] The gas in the chamber can be connected to the negative pressure channel 12 through the micropores 33 on the conduit wall, thereby achieving pressure regulation.

[0055] The technical advantage of this structure is that when negative pressure is applied to the negative pressure channel 12, the air inside the membrane 32 will be drawn out, and the memory foam 31 will be compressed to the extreme, causing the membrane 32 to stick tightly to the surface of the conduit body 100, so that the outer diameter of the anchoring unit is reduced to ≤5mm, which is basically flush with the outer diameter of the conduit.

[0056] Therefore, it does not cause obstruction during the delivery of the catheter with the endoscope. After the negative pressure is released, the memory foam 31 is freed from restraint, quickly absorbs air and expands the membrane 32, restoring its expansion to an outer diameter of 2 to 2.5 cm. This shape can effectively achieve non-invasive and safe anchoring of the catheter in the deep intestine by forming a gentle and extensive physical friction with the intestinal wall mucosa.

[0057] Example 2 This embodiment designs a colonic enema system to work with an endoscope to achieve non-invasive insertion of the catheter body 100 into the deep part of the colon and infusion of medication.

[0058] The system includes an integrated negative pressure adsorption colonic enema catheter and its associated external equipment; specifically, the colonic enema system includes a catheter, a negative pressure source, a three-way switch, and an enema device.

[0059] Specifically, the catheter is an integrated negative pressure adsorption colonic enema catheter, which serves as the core component for entering the patient's intestines.

[0060] The catheter is equipped with an independent main channel 11 and a negative pressure channel 12, which are used for drug infusion and negative pressure conduction, respectively, to ensure clear division of functions.

[0061] The negative pressure source is connected to the Luer connector 400 of the negative pressure channel 12 of the conduit via a connecting tube, providing a stable and adjustable negative pressure suction.

[0062] The negative pressure source can be a medical portable negative pressure suction pump or a hospital central negative pressure interface; during endoscopic operation, the negative pressure source transmits negative pressure to the longitudinal adsorption ridge 200 on the surface of the catheter, so that it is firmly attached to the surface of the colonoscope 500.

[0063] The three-way switch is installed on the connecting pipe between the negative pressure source and the negative pressure channel 12 of the conduit. The interface of the three-way switch is connected to the negative pressure source, the negative pressure channel 12 of the conduit and the external atmosphere respectively. Its function is to control the opening and closing of the negative pressure passage and the depressurization.

[0064] When it is necessary to fix the catheter to the colonoscope 500, adjust the three-way switch to connect the negative pressure source and the negative pressure channel 12; when the catheter reaches the target position and needs to be separated from the colonoscope 500, cut off the negative pressure source and at the same time connect the negative pressure channel 12 to the atmosphere, quickly destroy the vacuum state of the adsorption structure, and achieve smooth separation of the catheter from the colonoscope 500.

[0065] The enema device is connected to the main channel 11 of the catheter via a connecting tube and is used to infuse medication. The enema device can be equipped with a medical enema bag, a large-capacity syringe, or a medical automatic infusion pump, depending on the needs.

[0066] After the catheter is inserted deep into the colon and the colonoscope is withdrawn 500, the enema device can accurately and safely deliver therapeutic drugs, nutrient solutions or fecal microbiota transplantation suspensions to the lesion site deep in the colon through the main channel 11.

[0067] The collaboration of all components ensures that the system can achieve non-invasive and rapid catheter insertion, while supporting convenient in vivo separation operations, further improving the efficiency and convenience of enema treatment.

[0068] Example 3 This embodiment provides a method for separating the endoscope and catheter in vivo, and also includes specific steps for subsequent catheter withdrawal, and is used in conjunction with the integrated negative pressure adsorption colonic enema catheter mentioned in the above embodiment.

[0069] Methods for catheter insertion with endoscope and in vivo separation from endoscope: Step 1, External assembly of the equipment: Before the procedure begins, the catheter body 100 is placed along the longitudinal axis of the colonoscope 500 and initially fixed to the outer surface of the colonoscope 500 by the longitudinal adsorption ridge 200 on the catheter body 100.

[0070] At this time, the inward-fastening skirts 23 on both sides of the longitudinal adsorption ridge 200 tightly wrap around the internal sponge core 22 to prevent it from coming off or turning over due to subsequent friction; at the same time, the longitudinal arc-shaped indentation 25 on the surface of the longitudinal adsorption ridge 200 forms a large-area fit with the arc surface of the colonoscope 500 body to ensure geometric fit.

[0071] Step 2, Enhance adsorption and fixation: Activate the negative pressure device connected to the catheter body 100 and adjust the negative pressure value to between -50 and -80 kPa. Under the sustained negative pressure, the sponge core 22 in the longitudinal adsorption ridge 200 is significantly compressed due to the expulsion of internal air, and the central part of the ridge is concave, forming a high-intensity vacuum adsorption state with the colonoscope 500 body, thereby achieving a temporary and firm connection between the catheter body 100 and the colonoscope 500.

[0072] Specifically, under negative pressure, the sponge core 22 collapses inward, causing the central part of the longitudinal adsorption ridge 200 to undergo a secondary deep indentation. At this time, the inward-fastening skirts 23 on both sides and the longitudinal arc-shaped indentation 25 deform together, so that the longitudinal arc-shaped indentation 25, which originally conforms to the curvature of the scope, is tightly engaged on the outer surface of the colonoscope 500.

[0073] Because the radius of curvature of the indentation (R=5 to 6 mm) and the curvature of the mirror body (R=5 to 5.5 mm) are maximized to achieve geometric fit, the traditional "line contact" of the suction cup is completely transformed into a large-area "surface contact", which increases the effective adsorption area and improves the overall adsorption and fixation force.

[0074] Meanwhile, the compressed sponge core 22 effectively fills the micro-rough gap between the suction cup edge and the mirror body through its micro-porous grid, preventing intestinal mucus or water from seeping in; the sponge itself can also absorb the trace amount of moisture remaining on the surface of the mirror body, forming a highly efficient gas-barrier "wet seal" layer at the contact interface by means of capillary effect.

[0075] This dual sealing mechanism significantly extends the pressure-holding time of traditional suction cups, which can only maintain pressure for about 5 seconds in a moist intestinal environment, to 1-2 minutes, fundamentally eliminating catheter slippage caused by air pressure leakage.

[0076] In addition, the sponge acts as a cushioning pad, preventing the edge of the soft silicone suction cup from directly rubbing against the expensive endoscope surface coating, thus protecting the lens and housing coating of the Colonoscope 500.

[0077] Under the same negative pressure, the micropores 33 of the distal anchoring section also evacuate the cavity inside the sponge anchoring unit 300, causing the memory foam 31 to shrink to its limit, forcing the highly elastic waterproof membrane 32 to adhere tightly to the tube wall, reducing the outer diameter of the anchoring unit to no more than 5mm, forming a completely compact and smooth streamlined structure, thereby eliminating insertion resistance.

[0078] Step 3, combined insertion into the body cavity: While maintaining the preset negative pressure value, the operator slowly inserts the colonoscope 500 and the catheter body 100 close to its surface into the patient's body cavity.

[0079] Guided by the endoscopic view, the catheter body 100 is precisely manipulated to deliver it to the target lesion site or the predetermined deep intestinal region, such as the ascending colon or cecum.

[0080] Because the outer side of the inward-fastening skirt 23 has a smooth, large rounded corner (R=0.3mm), it slides gently laterally against the intestinal mucosa during the advancement of the endoscope, without causing any sharp scratches, thus achieving non-invasive delivery throughout the entire process.

[0081] Step 4, distal intestinal wall fixation: After the catheter tip is precisely positioned in the lesion area, the operator maintains a negative pressure state of longitudinal adsorption spine 200 and first treats the distal anchoring segment.

[0082] The doctor manually rotated the three-way switch on the airway control subsystem to interrupt the negative pressure supply to that section, allowing it to communicate with the atmosphere, which caused the pressure in the sealed space within the sponge anchoring unit 300 to recover rapidly.

[0083] After the negative pressure is removed, the memory foam 31 expands rapidly due to its strong elastic memory properties, absorbs air (or liquid), and quickly pulls the outer high-elasticity waterproof film 32 outward to expand back to its original design diameter of 3cm, forming beaded protrusions.

[0084] Because the expanded diameter is larger than the inner diameter of the corresponding intestinal segment, the three series-connected sponge anchoring units 300 closely adhere to the colonic wall mucosa in a gentle physical manner with a large contact area and low pressure. They are firmly fixed in the intestinal lumen by the dispersed surface friction force, thus achieving safe and non-invasive anchoring of the distal end of the catheter in the body.

[0085] Step 5: Release the negative pressure to achieve separation: After confirming that the distal end of the catheter body 100 is successfully anchored, the negative pressure device is turned off and the negative pressure channel 12 is connected to the atmosphere to release the negative pressure.

[0086] At this time, the compressed sponge core 22 quickly returns to its original shape due to the loss of negative pressure restraint. Its elastic rebound force reshapes the longitudinal adsorption ridge 200 into a raised shape, thereby breaking the vacuum adsorption state and generating a gentle thrust, allowing the catheter body 100 to separate smoothly from the colonoscope 500.

[0087] Step 6, Endoscope withdrawal and catheter placement: After confirming that the catheter body 100 is completely separated from the colonoscope 500, the operator smoothly withdraws the colonoscope 500 from the patient's body cavity.

[0088] At this point, the catheter body 100 maintains its position with the help of the expanded sponge anchoring unit 300, and is independently placed deep in the intestinal lumen, providing an interventional channel for subsequent drug delivery or fecal microbiota transplantation.

[0089] Safe removal of catheter: When the patient has completed the enema treatment and the catheter body 100 needs to be safely removed from the body, the following specific steps should be followed: Step 1: Use negative pressure to purge the anchoring unit First, the negative pressure channel 12 of the catheter body 100 is opened. With the help of the strong suction of the negative pressure, the liquid and gas accumulated in the distal sponge anchoring unit 300 are completely discharged, causing the unit structure to shrink significantly.

[0090] Step 2: Confirm the shrinkage and remove it smoothly. Under continuous negative pressure, once the volume of the distal sponge anchoring unit 300 has significantly decreased and its outer diameter has been compressed to meet the standards for minimally invasive removal (≤5mm), the operator can begin to slowly pull the catheter body 100 outward with a stable and uniform force.

[0091] Step 3: Adaptive contraction to reduce resistance Throughout the entire removal process, the negative pressure channel 12 must remain open to keep the sponge core 22 inside the catheter body 100 in a fully compressed state. When the catheter body 100 passes through the intestinal bend or the anal sphincter, the inner folding skirts 23 on both sides of the longitudinal adsorption ridge 200 will automatically fold backward under the action of tissue pressure and friction, and closely adhere to the surface of the catheter body 100.

[0092] This design significantly reduces protrusions on the tube surface, effectively reducing frictional resistance during removal, thereby ensuring that the catheter body 100 can be removed smoothly, painlessly, and safely, avoiding mechanical damage to the delicate intestinal mucosa.

[0093] Specifically, when the tube passes through narrow anatomical sites of the highly tortuous intestine or through the tense contracting anal sphincter, the longitudinal adsorption ridges 200 protruding from the surface of the tube will be subjected to backward normal compressive stress and tangential frictional shear force from the intestinal tissue.

[0094] Because the inner folding skirt 23 is made of ultra-soft silicone with an extremely thin (0.23mm) thickness and extremely low Shore hardness (Shore A25), the two inner folding skirts 23 will undergo adaptive forward (backward) flexible flipping and folding under the mechanical drive of lateral tissue pressure.

[0095] This transforms the entire adsorption ridge into an extremely smooth, streamlined, low-resistance structure. Combined with the original smooth rounded corners (R=0.3mm) of the skirt edge, it enables a "feel-free" smooth passage through narrow body cavities.

[0096] This not only significantly reduces the frictional resistance during removal, but also fundamentally eliminates the serious clinical risk of irregular protruding parts snagging and tearing intestinal mucosal tissue, ensuring non-invasive safety throughout the entire insertion cycle.

[0097] Once the catheter is completely removed from the body, the operator checks the integrity of the catheter components and confirms that the sponge core 22 is undamaged and without residue, thus safely completing the entire enema treatment process.

[0098] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An integrated negative pressure adsorption colonic enema catheter, characterized in that: The catheter body (100) includes a main channel (11) and a negative pressure channel (12) that are parallel to each other and axially penetrate each other. The main channel (11) and the negative pressure channel (12) are independent of each other and do not communicate with each other. The distal wall of the catheter body (100) is provided with several side holes (13) that communicate with the main channel (11). The outer wall of the catheter body (100) is provided with an integrated longitudinal adsorption ridge (200) spaced along the axial direction. The longitudinal adsorption ridge (200) has a central recessed area (24) on the side away from the center of the catheter body (100). The bottom surface of the central recessed area (24) has a plurality of negative pressure holes (21) connected to the negative pressure channel (12) along the axial direction. The central recessed area (24) is inlaid with a sponge core (22), and the two sides of the longitudinal adsorption ridge (200) bend inward to form an inward-fastening skirt (23) for locking and fastening the edge of the sponge core (22).

2. The integrated negative pressure adsorption colonic enema catheter according to claim 1, characterized in that: When negative pressure is applied to the negative pressure channel (12), the sponge core (22) is compressed and indented inward, forming a longitudinal arc-shaped indentation (25) between the two sides of the inner-fastening skirt (23). The radius of curvature of the longitudinal arc-shaped indentation (25) after compression matches the curvature of the cylindrical outer surface of the colonoscope (500) used in conjunction with it.

3. The integrated negative pressure adsorption colonic enema catheter according to claim 1, characterized in that: A sponge anchoring unit (300) is also sleeved on the outer wall of the catheter body (100) near the distal end. The sponge anchoring unit (300) includes a memory foam (31) surrounding the outside of the catheter body (100) and a highly elastic film (32) completely covering the outer layer of the memory foam (31). The two ends of the highly elastic film (32) are fixedly connected to the outer wall of the catheter body (100) to form a sealed chamber. The catheter body (100) has micropores (33) on its wall that connect the sealed chamber to the negative pressure channel (12).

4. The integrated negative pressure adsorption colonic enema catheter according to claim 3, characterized in that: The sponge anchoring unit (300) is provided in multiple and is arranged in a distributed series along the axial direction of the conduit body (100). In its natural state, the sponge anchoring unit (300) presents as a beaded spindle-shaped protrusion. When negative pressure is applied to the negative pressure channel (12), the memory foam (31) is compressed and shrinks, causing the high elastic film (32) to adhere to the surface of the conduit body (100), so that the outer diameter of the sponge anchoring unit (300) is reduced to be flush with the outer diameter of the conduit body (100).

5. The integrated negative pressure adsorption colonic enema catheter according to claim 1, characterized in that: The catheter body (100), longitudinal adsorption ridge (200) and inner buckle skirt (23) are integrally injection molded or extruded from flexible polymer material; The multiple side holes (13) are arranged in a spiral staggered manner along the circumferential and axial directions of the distal end of the catheter body (100), and the inner and outer edges of the side holes (13) are provided with smooth chamfers; The catheter body (100) is provided with a Luer connector (400) at the tail end. The main channel (11) and the negative pressure channel (12) are led out at the tail end of the catheter body (100) in a Y-shaped bifurcation structure and are respectively connected to the corresponding Luer connector (400).

6. The integrated negative pressure adsorption colonic enema catheter according to claim 1, characterized in that: The surface of the catheter body (100) is provided with scale lines, and X-ray imaging marking lines are added to the material of the catheter body (100). The main channel (11) can be configured with a built-in super-slippery guidewire, which is used to enhance the toughness of the catheter.

7. An integrated negative pressure adsorption colonic enema system, characterized in that: Includes an integrated negative pressure adsorption colonic enema catheter, a negative pressure source, a three-way switch, and an enema device as described in any one of claims 1 to 6; The negative pressure source is connected to the Luer connector (400) at the end of the negative pressure channel (12) of the conduit via a connecting pipe; The three-way switch is installed on the connecting pipeline. The three ports of the three-way switch are respectively connected to the negative pressure source, the negative pressure channel (12) and the external atmosphere, and are used to control the opening and closing of the negative pressure channel and the pressure relief. The enema device is connected to the Luer connector (400) at the end of the main channel (11) of the catheter via a connecting pipe, and is used to infuse the intestine with a drug solution or suspension.

8. The in vivo separation method of the integrated negative pressure adsorption colonic enema system according to claim 7, characterized in that: Includes the following steps: Step S1: Initial fitting of the lens body: Before operation, the catheter body (100) is placed along the longitudinal axis of the colonoscope (500) so that the longitudinal arc-shaped indentation (25) on the back of the longitudinal adsorption spine (200) is initially attached to the outer surface of the colonoscope (500), and the sponge core (22) is wrapped and fixed by the inner buckle skirt (23). Step S2, negative pressure adsorption fixation: Turn on the negative pressure source and connect the negative pressure channel (12) through the three-way switch. Under the action of negative pressure, the sponge core (22) is significantly compressed and concave, so that the longitudinal adsorption ridge (200) and the surface of the colonoscope (500) form a high-intensity vacuum adsorption state, and realize the temporary integrated connection between the catheter and the colonoscope (500). Step S3, Combined introduction into the body cavity: While maintaining a preset negative pressure value, the colonoscope (500) and the catheter body (100) attached to its surface are slowly inserted into the deep intestine of the patient and delivered to the target site. During placement, the built-in super-slippery guidewire in the main channel (11) allows the catheter to adhere better to the surface of the colonoscope (500). When the catheter is withdrawn, the super-slippery guidewire can assist the catheter and prevent it from kinking due to being too soft. Step S4: Release negative pressure and separate the contents of the body. When the catheter reaches the target position, the negative pressure source is cut off by adjusting the three-way switch and the negative pressure channel (12) is connected to the outside atmosphere. The sponge core (22) loses the negative pressure restraint and elastically rebounds to restore and reshape the convex shape, thereby destroying the vacuum adsorption state and generating thrust, so that the catheter body (100) and the colonoscope (500) are smoothly separated.

9. The in vivo separation method of the integrated negative pressure adsorption colonic enema system according to claim 8, characterized in that: Between steps S3 and S4, step S3.1, distal intestinal wall anchoring, is also included: After the catheter body (100) reaches the target position, the sponge anchoring unit (300) releases negative pressure and absorbs liquid to expand. The memory sponge (31) elastically rebounds and stretches the high elastic film (32), allowing it to recover its expansion to the preset outer diameter and press against the intestinal wall, thus completing the flexible anchoring of the catheter deep in the intestine. After the enema treatment is completed, the method for removing the catheter includes the following steps: The negative pressure channel (12) is opened to draw out the fluid and air inside the sponge anchoring unit (300), causing the memory sponge (31) and the high elastic film (32) to be compressed to the preset minimally invasive removal diameter; Under continuous negative pressure, the catheter body (100) is slowly pulled outward. During this process, the inner folding skirts (23) on both sides of the longitudinal adsorption ridge (200) are folded backward and attached to the surface of the catheter body (100) under the pressure and friction of the intestinal tissue to reduce surface protrusion resistance.

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