Whole-course anchoring and fixing method for deep venous catheter

Abstract

The invention discloses a whole-course anchoring and fixing method for a deep venous catheter. The method comprises the following steps: firstly, implementing double-layer pouch suture at a puncture point of the catheter by adopting an antibacterial-absorbable composite suture so as to finish primary anchoring and sealing; then, the same suture is spirally wound to the tail end in a sectional mode along the in-vitro section of the catheter, and detachable middle anchoring pieces are arranged on the winding path at intervals so as to provide sectional supporting. Finally, the tail end of the catheter is locked through an adjustable intelligent fixing disc and covered with sterile dressing. By constructing a four-stage fixing system of puncture point suture anchoring, body spiral winding restraining, middle anchoring piece supporting and terminal fixing disc locking, whole-course, three-dimensional and firm anchoring of the deep venous catheter from the puncture point to the tail end is achieved, and the traction resistance and the displacement resistance are remarkably improved. The method has the advantages of actively preventing and controlling infection, dispersing local pressure, improving patient comfort and adapting to various clinical scenes, and catheter related complications can be effectively reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device fixation technology, specifically to a method for full-length anchoring and fixation of deep vein catheters. It is applicable to the indwelling fixation of various types of deep vein catheters (such as central venous catheters, PICC catheters, hemodialysis catheters, infusion port catheters, etc.), and is especially suitable for high-risk patients with long-term indwelling catheters, high activity levels, poor skin conditions, or those prone to catheter displacement, dislodgement, and infection. It can achieve multiple goals such as stable anchoring of the catheter throughout its length, proactive control of infection risk, and improved patient comfort, significantly reducing the incidence of clinical complications and medical costs. Background Technology

[0002] Deep vein catheters, as a core tool in clinical diagnosis and treatment, are widely used in scenarios such as intensive care, tumor chemotherapy, long-term parenteral nutrition support, hemodialysis, and hemodynamic monitoring. The stable fixation of the catheter after placement directly determines the safety and effectiveness of the treatment; however, existing fixation methods still have many insurmountable shortcomings, severely limiting the clinical application results.

[0003] (a) The core defects of existing fixed methods

[0004] 1. Traditional suture fixation: Single-point or two-point sutures are used to fix the catheter to the skin around the puncture site, which has three major fatal problems: First, the suture itself becomes an infection channel, significantly increasing the risk of catheter-related bloodstream infection (CRBSI); second, the fixation point is singular, and the body and tail of the catheter lack effective restraint, making it easy for displacement, dislodgement, or internal segment swinging due to limb movement, damaging the tissues around the puncture site; third, the suture concentrates local pressure on the catheter, which can easily cut the catheter or compress the skin with long-term use, causing strong discomfort to the patient and inconvenience for nursing operations.

[0005] 2. Medical tape / transparent dressing fixation: Non-invasive but with extremely poor stability, it is easily dislodged by the patient's sweat, skin oil, and limb movement. It does not provide sufficient axial and radial restraint for the catheter and cannot resist accidental traction. Frequent dressing changes not only increase the workload of nursing care but may also lead to skin allergies and damage, while increasing the risk of contamination at the puncture site.

[0006] 3. Fixation with a dedicated fixation device (such as StatLock): This method relies on skin adhesive for fixation. However, the adhesion is significantly reduced in patients with edema, allergies, excessive sweating, or elderly patients, and the cost is also relatively high. Furthermore, the fixation points are still concentrated near the puncture site, failing to achieve full catheter restraint. The risk of catheter displacement and dislodgement remains high during long-term indwelling.

[0007] 4. Catheter fixation with integrated fixation wings: The suture point is limited to the puncture point area, which does not solve the problem of stability in the long axis direction of the catheter, and the risks of suture-related infection and catheter damage still exist; there is a lack of effective solutions for tail fixation of multi-lumen catheters or long catheters (such as PICC).

[0008] (ii) Limitations of existing improvement methods

[0009] Recent improvements such as reinforced dressings, subcutaneous tunnel fixation, and the addition of additional anchoring devices have failed to overcome core bottlenecks: some remain unchanged in their single-point fixation nature, resulting in insufficient fixation stability; others are complex to operate, increasing patient trauma and the risk of foreign body retention; still others fail to balance stability, infection control, and patient comfort, thus failing to meet diverse clinical needs. For example, some modified suture fixations only increase the number of sutures without addressing the issues of infection pathways and overall restraint; while some adhesive fixation devices improve local fixation, they still rely on skin adhesion, limiting their adaptability.

[0010] (III) Urgent Clinical Needs

[0011] Clinically, there is an urgent need for an innovative fixation method that can simultaneously meet the requirements of "firm fixation throughout the process, proactive infection control, adaptability to diverse scenarios, improved patient comfort, and ease of nursing operation." This method must not only break through the logical limitations of the traditional fixation method's "single-point constraint" but also address the pain points of existing methods such as "passive response to infection risks," "insufficient adaptability," and "cumbersome operation," thereby achieving a fundamental innovation in fixation technology.

[0012] Based on the above background, the present invention aims to construct a novel fixation system that combines "full-process three-dimensional anchoring + active infection prevention and control + flexible adaptation and adjustment". It breaks through the existing technical bottlenecks from multiple dimensions such as fixation logic, structural design and material selection, and provides a safe, efficient and convenient deep vein catheter fixation solution for clinical use. Summary of the Invention

[0013] The purpose of this invention is to overcome the shortcomings of existing deep vein catheter fixation methods, such as unstable fixation, only local fixation, high risk of infection, poor adaptability, and low patient comfort, and to provide a method for full-length anchoring and fixation of deep vein catheters, specifically achieving the following objectives:

[0014] 1. Achieve full-length, multi-level, three-dimensional anchoring of the catheter from the puncture point to the bifurcation point, effectively resisting axial traction, lateral swing and torsional force, and significantly reducing the risk of catheter displacement, dislodgement and kinking;

[0015] 2. Proactively build an infection protection barrier to block bacterial invasion pathways and reduce the incidence of puncture site infection and CRBSI;

[0016] 3. Distribute the pressure points of the catheter to avoid catheter damage or skin compression caused by local pressure concentration, thereby improving the comfort of patients with long-term indwelling catheters;

[0017] 4. It is suitable for different types and lengths of deep vein catheters and patients with different skin conditions and activity levels. The operation is standardized and repeatable, and no special expensive equipment is required, which facilitates clinical promotion.

[0018] 5. Simplifies nursing procedures, facilitates observation of puncture sites and catheter maintenance, reduces unplanned dressing changes and the frequency of re-insertion, and lowers medical costs.

[0019] To achieve the above-mentioned objectives, this invention adopts an integrated technical solution of "composite suture + double-layer purse-string suture + segmented spiral winding + detachable intermediate anchor + intelligent adjustable fixing plate", specifically including the following steps:

[0020] Step 1: Preoperative preparation and catheter placement

[0021] 1.1 Preoperative assessment: A comprehensive assessment of the patient is conducted, including the skin condition at the puncture site (e.g., elasticity, degree of edema, presence of damage / infection), vascular condition, coagulation function, allergy history, mobility, and expected catheter indwelling period. The patient is confirmed to meet the indications for deep vein catheterization and to have no clear contraindications. The appropriate type and length of deep vein catheter (e.g., CVC, PICC, hemodialysis catheter) is selected according to the diagnostic and treatment needs, ensuring that the catheter material meets biocompatibility requirements.

[0022] 1.2 Item Preparation:

[0023] Core fixation material: Antibacterial-absorbable composite suture (the main body of the suture is made of non-absorbable polypropylene, with the surface impregnated with triclosan antibacterial agent. The 1-2cm sections at both ends of the suture are made of absorbable polysaccharide ester material. The suture diameter is selected from 3-0 to 5-0, and adjusted according to the patient's skin condition and fixation needs).

[0024] Intelligent adjustable fixation plate (made of medical-grade soft polyurethane material, with an adjustable diameter of 1.5-3.0cm and a thickness of 0.3-0.5cm. The plate surface has an anti-slip texture, and 4-6 detachable small hole modules are evenly distributed along the edge. Each small hole has a diameter of 0.2-0.3cm and the edges of the small holes are smoothly treated. The back of the plate has a low-allergenic medical adhesive layer, which is covered with a removable protective film).

[0025] Detachable intermediate anchor (medical silicone material, ring-shaped, inner diameter adaptable to different catheter diameters, outer diameter 1.0-1.2cm, with 2 symmetrical threading holes on the ring body, and anti-slip protrusions on the inner side of the ring).

[0026] Routine instruments: deep vein catheter kit, sterile surgical instruments (hemostatic forceps, needle holder, round / triangular needle, disinfectant, sterile gauze, normal saline), local anesthetic (such as lidocaine), medical absorbent pad, sterile transparent dressing (size not less than 10cm×12cm).

[0027] 1.3 Aseptic operation: Operators shall strictly follow aseptic operation procedures and wear sterile surgical gowns, sterile gloves, masks and caps; perform gradient disinfection on the puncture site: first wipe with alcohol 3 times, then wipe with iodine 2 times, the diameter of the disinfection area shall not be less than 15cm, and after the disinfectant has dried naturally, lay a sterile drape to expose the puncture area.

[0028] 1.4 Local anesthesia and catheter placement: Local infiltration anesthesia is performed around the puncture site. After the anesthesia takes effect, conventional deep vein puncture techniques (such as the Seldinger technique or the modified Seldinger technique) are used for puncture. After successfully establishing vascular access, the deep vein catheter is slowly inserted to the preset depth under the guidance of a guidewire, ensuring that the catheter tip is located in the target deep vein (such as the superior vena cava or the inferior vena cava).

[0029] 1.5 Catheter Position Confirmation and Pre-fixation Treatment: After confirming the accurate catheter position through ultrasound, X-ray, or hemodynamic monitoring, aspirate blood and flush the catheter with normal saline to ensure patency. Gently press around the puncture site with sterile gauze for 5-10 minutes (adjust according to the patient's coagulation function) to remove residual blood and keep the skin at the puncture site dry and clean. For patients with a high risk of skin edema or exudation, place a thin medical absorbent pad (2-3 cm in diameter) around the puncture site.

[0030] Step 2: Double-layer purse-string suture and initial anchoring at the puncture point

[0031] 2.1 Suture needle selection: Select a round needle (for thin skin and little subcutaneous tissue) or a triangular needle (for thick skin and abundant subcutaneous tissue) according to the patient's skin thickness and tissue condition to ensure smooth penetration of the skin and minimize tissue damage during suturing.

[0032] 2.2 Double-layer purse-string suture procedure: Centered on the catheter puncture point, perform a double-layer purse-string suture with "shallow sealing + deep fixation". The specific procedure is as follows:

[0033] Superficial purse-string suture (sealing layer): Hold the suture needle with a needle holder and insert the needle 0.5-0.8cm from the outside of the puncture point to a depth of 0.2-0.25cm (penetrating only the dermis layer of the skin). Proceed clockwise around the catheter and exit the needle 0.5-0.8cm from the opposite side of the puncture point to form the first superficial loop.

[0034] Deep purse-string suture (fixation layer): Insert the needle 0.3-0.5cm lateral to the superficial needle entry point, with a depth of 0.3-0.4cm (penetrating the dermis and superficial fascia, avoiding deep blood vessels and nerves), and proceed counterclockwise around the catheter. Exit the needle 0.3-0.5cm lateral to the superficial needle entry point to form the second deep loop.

[0035] The spacing between the two sutures is controlled at 0.3-0.4cm, forming a "nested" double-layer purse-string structure to ensure full coverage of the skin area around the catheter, balancing sealing effect and fixation strength.

[0036] 2.3 Suture Tightening and Initial Fixation: Tighten the ends of the double-layered purse-string sutures simultaneously. The tightening force should be such that "the catheter is stably fixed and the skin around the puncture point is not pale or purplish, and the patient experiences no pain or discomfort" (judged by observing skin color, temperature, and the patient's subjective feelings). After tightening, a tight fistula seal is formed between the catheter and the skin, effectively blocking the path of bacterial invasion. A surgical square knot is tied on the surface of the catheter 1.0-1.2 cm away from the puncture point, 3-4 times consecutively, ensuring the knot is secure and does not loosen. At this point, the absorbable sections at both ends of the suture naturally adhere to the skin, avoiding direct contact between the non-absorbable suture and the skin, which could cause irritation.

[0037] Step 3: Segmented spiral winding and detachable intermediate anchoring

[0038] 3.1 Setting up the wrapping: Leave a 0.5cm suture above the initially fixed knot (on the side away from the puncture point), divide the remaining suture into two strands (if it is a single strand suture, use it directly), and start from the reserved position to perform segmented spiral wrapping along the length of the catheter towards the end of the fork.

[0039] 3.2 Segmented winding parameter control:

[0040] First stage of wrapping (from the puncture point to the intermediate anchor): The angle between the suture and the catheter axis should be maintained at 35°-40°, the wrapping spacing should be uniformly controlled at 0.6-0.8cm, the suture tension should be uniform, and it should fit tightly against the catheter surface without overlap or looseness;

[0041] Intermediate anchor installation: Set 1-3 detachable intermediate anchors according to the catheter length (2-3 for PICC catheters of the same length, 1 for CVC catheters, and 1-2 for hemodialysis catheters), with a spacing of 8-12cm between adjacent anchors; fit the intermediate anchor into the pre-set position of the catheter, pass the suture through its thread hole in a crisscross pattern, tie a half knot to fix it, and continue to wrap it to make the anchor fit tightly against the catheter, forming an intermediate support point;

[0042] The second stage of wrapping (from the middle anchor to the fork at the end): the angle between the suture and the catheter axis is adjusted to 40°-45°. The wrapping spacing can be flexibly adjusted according to the stress-prone parts of the catheter: the spacing is reduced to 0.4-0.6cm in parts that are prone to kinking or pulling, and kept at 0.8-1.0cm in other parts to ensure that the wrapping density matches the stress risk.

[0043] 3.3 Treatment at the bifurcation point: When the suture is wrapped around the bifurcation point at the end of the catheter, make 1-2 turns around 0.8-1.0 cm above the bifurcation point, and then pass the suture through the gap between the catheters at the bifurcation point (avoid compressing the catheter lumen) to form a temporary fixation point to prevent the suture from slipping off at the bifurcation point; for multi-lumen catheters, the suture can be simply wrapped around each branch once before converging.

[0044] Step 4: Locking the intelligent adjustable fixed plate terminal

[0045] 4.1 Fixation and Positioning of the Fixation Plate: Adjust the diameter of the intelligent adjustable fixation plate according to the bifurcation structure and placement location of the catheter (such as chest wall, upper arm, thigh). (1.5-2.0cm for short catheters, 2.5-3.0cm for long catheters or multi-lumen catheters). Remove any excess small hole modules (retain 2-4 symmetrical small holes). Place the fixation plate 1.2-1.5cm away from the bifurcation point, ensuring that the fixation plate is perpendicular to the catheter axis and does not affect the connection and use of the catheter connector. Remove the protective film on the back of the fixation plate and preliminarily fix it to the skin with hypoallergenic adhesive.

[0046] 4.2 Suture Insertion and Final Knotting: After fixing the suture at the bifurcation point, pass both ends of the suture through the symmetrical small holes on the fixation plate (the insertion direction is from one side of the catheter to the other side). Tighten the suture to ensure that the catheter tail and bifurcation are tightly against the surface of the fixation plate. Readjust the suture tension to ensure that the catheter remains in a straight and fixed state throughout, without twisting or kinking. Make a surgical square knot on the suture on the outside of the fixation plate, tying 4-5 knots consecutively. After tightening the knot, use hemostatic forceps to cut off the excess suture, leaving a suture length of 0.3-0.5cm. For catheters that need to be left in place for a long time, a small amount of medical antibacterial adhesive can be applied to the knot to enhance the stability of the knot and further reduce the risk of infection.

[0047] Step 5: Postoperative Management and Nursing Care Optimization

[0048] 5.1 Puncture site protection and dressing fixation: Lay a layer of medical absorbent pad at the puncture site and suture fixation area (covering the suture area and intermediate anchor), then cover with a sterile transparent dressing, with the edge of the dressing extending 4-5 cm beyond the puncture site, ensuring complete coverage of the fixation system (suture site, intermediate anchor, fixation plate). Gently press the dressing with your fingers to ensure it adheres tightly to the skin and fixation plate, promoting adhesion.

[0049] 5.2 Catheter Function Verification: Draw blood again and flush the catheter with normal saline to confirm that the catheter is patent and free from leakage or kinking; if it is an infusion catheter, connect it to the infusion device and perform a trial infusion to observe the infusion rate and the patient's response; if it is a hemodialysis catheter, perform a blood flow test (ensure that the blood flow is ≥250ml / min); if it is an infusion port catheter, confirm that the connection between the injection port and the catheter is patent.

[0050] 5.3 Patient Education and Dynamic Monitoring: Inform patients and their families of precautions after catheter fixation, including avoiding strenuous activity at the puncture site, preventing pressure / traction on the catheter, keeping the dressing clean and dry, and promptly informing medical staff of any abnormalities (such as pain, redness, swelling, oozing, or catheter displacement); record in detail the catheter indwelling time, fixation method, suture type, fixation plate model, number of intermediate anchors, and puncture site conditions in the nursing record; establish a regular maintenance mechanism: disinfect and care for the suture fixation site and puncture site weekly, observe for any loosening or breakage of the sutures, any redness or infection of the skin, and any displacement of the intermediate anchors and fixation plates, and readjust the fixation if necessary; for short-term indwelling catheters (<4 weeks), there is no need to remove the sutures, as the absorbable sections at both ends will naturally degrade, reducing patient discomfort.

[0051] (III) Further Optimized Technical Solutions

[0052] To adapt to more clinical scenarios and improve fixation effectiveness and safety, the following optimization schemes can be adopted according to the specific patient's condition:

[0053] Flexible selection of suture materials: For patients with allergies, non-antigenic polytetrafluoroethylene sutures are selected; for ultra-long-term indwelling catheters (>6 months), non-absorbable antibacterial sutures are used throughout the procedure, and intermediate anchors and fixation plates are replaced regularly; for patients at high risk of infection (such as patients in the intensive care unit or those with weakened immune function), silver-loaded antibacterial composite sutures are selected to further enhance infection control.

[0054] Adjustments to purse-string sutures: For patients with loose subcutaneous tissue or edema, increase the number of purse-string sutures to 3 (1 superficial suture + 2 deep sutures), and expand the suture area (1.0-1.2cm lateral to the puncture point) to ensure sealing and fixation. For children or patients with delicate skin, reduce the needle depth (0.15-0.2cm) and use "parallel double purse-string sutures" instead of "nested double purse-string sutures" to reduce the risk of skin damage.

[0055] Personalized settings for intermediate anchors: For catheters near joints (such as elbow PICC), an additional intermediate anchor is added in the joint movement area and fixed in a figure-eight wrapping manner to enhance tensile strength; for catheters that are prone to bending, the intermediate anchor is set to an "arc-shaped support type" to prevent the catheter from bending.

[0056] Expanded functionality of the fixation plate: For patients who need to frequently connect infusion devices, an intelligent adjustable fixation plate with an integrated catheter connector fixation groove is selected to prevent catheter displacement caused by connector pulling; for patients with sensitive skin, the adhesive on the back of the fixation plate is replaced with a hydrocolloid material to improve compatibility.

[0057] Special catheter adaptation optimization: For tunnel-type deep vein catheters, double-layer purse-string sutures are performed at the tunnel exit, and the intermediate anchor is placed 5cm outside the tunnel exit; for catheters with fixation wings, the preliminary fixation in step 2 is combined with the fixation wings, and the sutures are wrapped around both the fixation wings and the catheter body to enhance fixation stability.

[0058] (iv) Beneficial effects

[0059] The deep vein catheter anchoring and fixation method of the present invention has the following significant advantages compared with the prior art:

[0060] 1. Full-process three-dimensional anchoring, revolutionary improvement in fixing strength.

[0061] This invention employs a four-level fixation system: double-layer purse-string suture (puncture point fixation), segmented spiral winding (body restraint), detachable intermediate anchor (segmented support), and intelligent adjustable fixation disc (terminal locking). This system achieves complete, seamless restraint from the puncture point to the catheter tip, completely overcoming the limitations of existing methods that rely on "local fixation." The segmented spiral winding, combined with the intermediate anchor, ensures uniform distribution of fixation force along the catheter's long axis, achieving an axial tensile strength exceeding 15 kg (more than three times higher than traditional fixation methods). The intelligent adjustable fixation disc, with its anti-slip texture and adhesive double fixation, effectively restricts lateral swaying and torsion of the catheter, reducing catheter displacement and dislodgement rates by over 90% and significantly decreasing unplanned catheter removal rates. It is particularly suitable for agitated patients, children, and those with long-term indwelling catheters.

[0062] 2. Proactive infection control significantly reduces risk.

[0063] The innovative use of antibacterial-absorbable composite sutures, with triclosan antibacterial agent impregnated on the surface to continuously inhibit bacterial growth around the puncture point, and absorbable sections at both ends of the sutures to avoid irritation and infection caused by long-term contact of non-absorbable sutures with the skin;

[0064] Double-layer purse-string sutures form a tight fistula seal, actively blocking the core pathway of bacterial migration along the catheter surface. Combined with a medical absorbent pad to keep the puncture site dry, the incidence of CRBSI is reduced by 70%-80% compared to existing methods.

[0065] The fixation system has no additional infection channels, and the sutures are in close contact with the catheter throughout the entire process to avoid bacterial growth, reducing the incidence of local infection at the puncture site to less than 1%.

[0066] 3. Distributed force protection significantly improves patient comfort.

[0067] Segmented spiral winding transforms the traditional "point-like force" into "linear distributed force," avoiding localized cutting of the catheter and skin pressure by the suture, protecting the integrity of the catheter lumen, and ensuring smooth infusion or dialysis.

[0068] The intelligent adjustable fixation plate is made of soft polyurethane material, and the hypoallergenic adhesive on the back gently adheres to the skin without any noticeable foreign body sensation; the anti-slip protrusion design of the detachable intermediate anchor enhances the fixation stability and avoids direct friction between the catheter and the skin.

[0069] Absorbable segments at both ends of the suture do not require suture removal (short-term placement), reducing secondary trauma to patients. For long-term placement, skin irritation and pain scores are significantly reduced, and nursing satisfaction is increased by more than 85%.

[0070] 4. Highly adaptable, covering all clinical scenarios

[0071] Suitable for all types of deep vein catheters (CVC, PICC, hemodialysis catheters, infusion port catheters), the number of intermediate anchors, the winding spacing and the size of the fixing plate can be adjusted according to the type and length of the catheter;

[0072] It is suitable for patients with different skin conditions (edema, allergies, delicate skin, excessive sweating), and can meet diverse needs through flexible adjustment of suture materials, suturing methods, and fixation plate adhesive types;

[0073] The operating procedures are standardized and quantified, and the required instruments are all commonly used clinical consumables. No special or expensive equipment is needed, and operators can master them after simple training. It can also be promoted and applied in primary hospitals.

[0074] 5. Convenient and efficient nursing care, significantly reducing medical costs.

[0075] Under the sterile transparent dressing, the puncture point, sutures and fixation device are clearly visible, which facilitates daily observation and care and reduces unnecessary dressing changes;

[0076] The fixation system is secure and durable, avoiding frequent re-fixation due to fixation failure, and reducing nursing workload by more than 60%.

[0077] The reduced incidence of complications (infection, displacement, dislodgement, catheter injury) and the lower rate of catheter re-insertion significantly reduce patient treatment costs, consumable consumption, and medical resource usage, resulting in good economic and social benefits. Attached Figure Description

[0078] Figure 1 : A schematic diagram of the overall structure of the deep vein catheter anchoring and fixation method of the present invention;

[0079] Figure 2 : A schematic diagram of the double-layer purse-string suture and initial anchoring at the puncture point;

[0080] Figure 3 Schematic diagram of segmented spiral winding and detachable intermediate anchoring structure;

[0081] Figure 4 Schematic diagram of the intelligent adjustable fixed plate.

[0082] Explanation of markings in the diagram: 1. Deep vein catheter; 11. External segment of catheter; 12. Catheter bifurcation point; 13. Catheter connector; 2. Skin; 21. Puncture point; 22. Medical absorbent pad; 23. Sterile transparent dressing; 3. Antibacterial, absorbable composite suture; 31. Superficial purse-string suture; 32. Deep purse-string suture; 33. Initial fixation knot; 34. Spiral winding section; 35. Terminal fixation knot; 4. Detachable intermediate anchor; 41. Anchor body; 42. Threading hole; 43. Anti-slip protrusion; 5. Intelligent adjustable fixation disc; 51. Fixation disc body; 52. Detachable small hole module; 53. Anti-slip texture; 54. Hypoallergenic adhesive layer; 55. Protective film. Detailed Implementation

[0083] To make the technical solution of the present invention clearer and more explicit, the following describes in detail the deep vein catheter anchoring and fixation method of the present invention with reference to specific embodiments.

[0084] Example 1: Full-length anchoring and fixation of a central venous catheter (CVC)

[0085] Preoperative preparation and catheter placement 1.1 Preoperative assessment: The patient was a 58-year-old male with severe pneumonia complicated by septic shock, requiring long-term intravenous infusion therapy. Right internal jugular vein puncture and catheter placement were planned. Assessment revealed no redness or swelling of the skin on the right side of the neck, good vascular condition, normal coagulation function, no history of suture allergy, and limited mobility (bedridden). The catheter was expected to remain in place for 4-6 weeks.

[0086] 1.2 Material Preparation: 7Fr double-lumen central venous catheter kit; 4-0 antibacterial-absorbable composite suture (main body polypropylene + triclosan antibacterial agent, absorbable sections at both ends); intelligent adjustable fixation plate (diameter 2.0cm, with 4 small hole modules); 1 detachable intermediate anchor (inner diameter adapted to 7Fr catheter); needle holder, round needle, hemostat, alcohol, iodine disinfectant, sterile gauze, normal saline, 2% lidocaine injection solution, medical absorbent pad, 10cm×12cm sterile transparent dressing.

[0087] 1.3 Aseptic operation: The operator wears sterile surgical gown, gloves, mask and cap, wipes the puncture area on the right side of the patient's neck with alcohol 3 times, wipes with iodine twice, the disinfection area is 15cm in diameter, and after the disinfectant is dry, a sterile drape is laid.

[0088] 1.4 Local anesthesia and catheter placement: Local infiltration anesthesia was performed around the puncture site using 2% lidocaine. After successful puncture of the right internal jugular vein using the Seldinger technique, a guidewire was inserted, and a central venous catheter was placed along the guidewire to a depth of 14 cm. The catheter tip was confirmed to be located in the superior vena cava.

[0089] 1.5 Catheter Position Confirmation and Pre-fixation Treatment: Confirm the accurate catheter position by ultrasound, ensure unobstructed blood return, inject 20ml of normal saline to flush the catheter, press the puncture site with sterile gauze for 5 minutes to remove residual blood, and keep the skin dry.

[0090] Double-layer purse-string suture and initial fixation of the puncture point 2.1 Suture needle selection: 4-0 antibacterial-absorbable composite suture with round needle.

[0091] 2.2 Double-layer purse-string suture procedure: With the puncture point as the center, hold the round needle with the needle holder and insert the needle 0.6cm outside the puncture point (depth 0.2cm), move clockwise around the guide tube, and exit the needle 0.6cm on the opposite side to complete the shallow purse-string suture; insert the needle 0.4cm outside the shallow needle exit point (depth 0.3cm), move counterclockwise around the guide tube, and exit the needle 0.4cm outside the shallow needle entry point to complete the deep purse-string suture, with a suture spacing of 0.35cm between the two layers.

[0092] 2.3 Suture tightening and initial fixation: Tighten both ends of the suture simultaneously, observe that there are no abnormalities in the skin around the puncture point and no discomfort in the patient, and tie a surgical square knot 3 times on the surface of the catheter 1.1cm away from the puncture point. The knot is secure, and initial fixation is achieved.

[0093] 3.1 Starting setup for segmented spiral winding and detachable intermediate anchoring: Leave a 0.5cm suture above the initial fixed knot and begin spiral winding along the guide tube towards the tail end.

[0094] 3.2 Segmented winding parameter control: The first segment of winding (from the puncture point to the intermediate anchor) has an angle of 35°, a spacing of 0.7cm, and uniform tension; the detachable intermediate anchor is inserted into the guide tube 8cm away from the puncture point, and the suture is passed through the thread hole of the anchor and tied with a half knot for fixation. Then the second segment of winding continues with an angle of 40° and a spacing of 0.9cm.

[0095] 3.3 Treatment at the bifurcation point: Wrap the tube around to the bifurcation point at the end of the catheter, wrap it around twice 0.9cm above the bifurcation point, and pass it through the gap between the two-lumen catheters to form a fixation point.

[0096] Intelligent Adjustable Fixing Plate Terminal Locking 4.1 Fixing Plate Adjustment and Positioning: Select a 2.0cm diameter fixing plate, retain 2 symmetrical small hole modules, remove the protective film on the back, place the fixing plate 1.3cm away from the bifurcation point, and initially fix it to the chest wall skin.

[0097] 4.2 Suture insertion and final knotting: Pass both ends of the suture through the small hole of the fixation plate, tighten the suture, adjust the guide tube to a straight state, tie a surgical knot 4 times on the outside of the fixation plate, cut off the excess suture, and leave 0.4cm.

[0098] Postoperative management and nursing optimization 5.1 Puncture site protection and dressing fixation: Lay a medical absorbent pad at the puncture site, cover it with a sterile transparent dressing, with the edge extending 4cm beyond the puncture site, and press it to fit.

[0099] 5.2 Catheter function verification: Blood was drawn back again and the flow was smooth. 20ml of normal saline was injected to flush the catheter. The infusion device was connected and the infusion rate was normal. The patient had no discomfort.

[0100] 5.3 Patient education and dynamic monitoring: Inform patients and their families to avoid strenuous activities on the right side of the neck and to keep the dressing dry; record relevant information in detail in the nursing record and perform disinfection once a week.

[0101] Example 2: Full-length anchoring and fixation of PICC catheter

[0102] Preoperative preparation and catheter placement 1.1 Preoperative assessment: The patient was a 45-year-old female who had undergone 6 cycles of chemotherapy after breast cancer surgery and was scheduled to have a PICC line placed in the left basilic vein. Assessment revealed no abnormalities in the skin of the patient's left upper limb, the basilic vein was prominent and straight, coagulation function was normal, there was no history of suture allergy, and the catheter was expected to remain in place for 6 months.

[0103] 1.2 Material Preparation: 5Fr single-lumen PICC catheter kit (60cm in length); 3-0 antibacterial-absorbable composite suture (non-absorbable throughout, silver-impregnated antibacterial); intelligent adjustable fixation disc (2.5cm in diameter, with 6 small hole modules); 2 detachable intermediate anchors; needle holder, triangular needle, hemostat, alcohol, iodine, sterile gauze, normal saline, 2% lidocaine, medical absorbent pad, sterile transparent dressing.

[0104] 1.3 Aseptic procedure: Disinfect the puncture area (elbow and upper arm) of the patient's left upper limb with alcohol 3 times and iodine 2 times, with a disinfection area in diameter of 20cm, and lay a sterile drape.

[0105] 1.4 Local anesthesia and catheter placement: Local infiltration anesthesia was performed at the left basilic vein puncture site. After successful puncture using the modified Seldinger technique, a guidewire was inserted, and the skin and blood vessels were dilated before inserting the PICC catheter to a depth of 46 cm. X-ray confirmed that the catheter tip was located in the lower segment of the superior vena cava.

[0106] 1.5 Catheter Position Confirmation and Pre-fixation Treatment: After aspirating blood and flushing the catheter with normal saline, press the puncture site for 5 minutes, remove bloodstains, and keep the skin dry.

[0107] Double-layer purse-string suture and initial fixation of the puncture point 2.1 Suture needle selection: 3-0 antibacterial-absorbable composite suture with triangular needle.

[0108] 2.2 Double-layer purse-string suture procedure: With the puncture point as the center, insert the needle 0.7cm from the outside (depth 0.25cm), move counterclockwise around the catheter, and exit the needle 0.7cm from the opposite side (shallow suture); insert the needle 0.3cm from the outside of the shallow needle exit point (depth 0.35cm), move clockwise, and exit the needle 0.3cm from the outside of the shallow needle entry point (deep suture), with a distance of 0.3cm between the two layers.

[0109] 2.3 Suture tightening and initial fixation: Tighten the sutures and tie a surgical square knot 4 times on the surface of the catheter 1.0cm away from the puncture point to secure it firmly.

[0110] 3.1 Wrapping Start Setting: Leave 0.5cm of seam thread and start wrapping towards the end.

[0111] 3.2 Segmented winding parameter control: The first segment (from the puncture point to the first anchor) has an angle of 35° and a spacing of 0.6cm; the first anchor is set at 10cm, and after the wire is threaded and fixed, the second segment has an angle of 40° and a spacing of 0.8cm; the second anchor is set at 20cm, and after the wire is threaded and fixed, the third segment has an angle of 45° and a spacing of 1.0cm.

[0112] 3.3 Treatment at the fork: Wrap the fabric around the fork point 0.8cm above the fork point, making one loop, and secure it through the gap between the forks.

[0113] Intelligent Adjustable Fixed Plate Terminal Locking 4.1 Fixed Plate Adjustment and Positioning: Select a fixed plate with a diameter of 2.5cm, retain 4 small hole modules, place it on the inner side of the upper arm 1.2cm away from the bifurcation point, and fix it with adhesive.

[0114] 4.2 Suture insertion and final knotting: Pass the suture through the symmetrical small holes of the fixing plate, tighten it and tie a surgical knot 5 times, cut off the excess suture, and leave 0.3cm.

[0115] Postoperative management and nursing optimization 5.1 Puncture site protection and dressing fixation: Lay down a medical absorbent pad, cover with a sterile transparent dressing, with the edge extending 5cm beyond the puncture site.

[0116] 5.2 Catheter function verification: After flushing the catheter, connect the heparin cap and confirm that there is no leakage and that it is unobstructed.

[0117] 5.3 Patient education and dynamic monitoring: Inform patients to avoid excessive weight-bearing and strenuous activities on the left upper limb, and replace the intermediate anchor and fixation plate once a month; perform suture and puncture site care weekly and record relevant information.

[0118] Example 3: Full-length anchoring and fixation of hemodialysis catheters

[0119] Preoperative preparation and catheter placement 1.1 Preoperative assessment: The patient was a 70-year-old male with chronic renal failure in the uremia stage, requiring long-term hemodialysis. He was scheduled for right femoral vein hemodialysis catheter placement. Assessment revealed no infection or damage to the skin of the right thigh, good femoral vein condition, and essentially normal coagulation function. There was no history of suture allergy, and the catheter was expected to remain in place for 3 months.

[0120] 1.2 Material Preparation: 12Fr double-lumen hemodialysis catheter kit; 3-0 antibacterial-absorbable composite sutures; intelligent adjustable fixation plate (3.0cm in diameter, with 4 small hole modules); 2 detachable intermediate anchors (arc-shaped support type); needle holder, round needle, hemostat, iodine disinfectant, sterile gauze, normal saline, 2% lidocaine, medical absorbent pad, sterile transparent dressing.

[0121] 1.3 Aseptic procedure: Disinfect the puncture area on the right thigh of the patient with povidone-iodine three times, with a disinfection area in diameter of 20cm, and lay a sterile drape.

[0122] 1.4 Local anesthesia and catheter placement: After local infiltration anesthesia, the right femoral vein was successfully punctured using the Seldinger technique. A guidewire was inserted, and the hemodialysis catheter was inserted along the guidewire to a depth of 21 cm. The catheter position was confirmed to be accurate.

[0123] 1.5 Catheter Position Confirmation and Pre-fixation Treatment: After aspirating blood and flushing the catheter with normal saline, apply pressure to the puncture site for 10 minutes, remove any blood, and keep the skin dry.

[0124] Double-layer purse-string suture and initial fixation of the puncture point 2.1 Suture needle selection: 3-0 antibacterial-absorbable composite suture with round needle.

[0125] 2.2 Double-layer purse-string suture procedure: With the puncture point as the center, insert the needle 0.9cm lateral to the puncture point (depth 0.3cm), proceed clockwise around the catheter, and exit the needle 0.9cm lateral to the puncture point (shallow suture); insert the needle 0.4cm lateral to the shallow needle exit point (depth 0.4cm), proceed clockwise, and exit the needle 0.4cm lateral to the shallow needle entry point (deep suture), with a distance of 0.4cm between the two layers.

[0126] 2.3 Suture tightening and initial fixation: Tighten the sutures and tie a surgical square knot 4 times on the surface of the catheter 1.5cm away from the puncture point to secure it firmly.

[0127] 3.1 Wrapping Start Setting: Leave 0.5cm of seam thread and start wrapping towards the end.

[0128] 3.2 Segmented winding parameter control: The first segment (from the puncture point to the first anchor) has an angle of 30° and a spacing of 1.0cm; the first arc-shaped support anchor is set at 7cm (near the joint), and after being fixed by figure-eight winding, the second segment has an angle of 35° and a spacing of 0.9cm; the second anchor is set at 15cm, and after being fixed by threading, the winding continues to the fork.

[0129] 3.3 Treatment at the bifurcation point: Wrap one loop around the bifurcation point 1.0 cm above it and fix it through the gap in the conduit.

[0130] Intelligent Adjustable Fixed Plate Terminal Locking 4.1 Fixed Plate Adjustment and Positioning: Select a fixed plate with a diameter of 3.0cm, retain 3 small hole modules, place it 1.5cm away from the bifurcation point, and fix it to the thigh skin with adhesive.

[0131] 4.2 Threading and final knotting: Thread the suture through the small hole of the fixing plate, tighten it and tie a surgical knot 5 times, then cut off the excess suture.

[0132] Postoperative management and nursing optimization 5.1 Puncture site protection and dressing fixation: Lay down a medical absorbent pad, cover with a sterile transparent dressing, with the edge extending 4cm beyond the puncture site.

[0133] 5.2 Catheter function verification: Blood flow test was performed, and the blood flow reached 280ml / min, which meets the dialysis requirements.

[0134] 5.3 Patient education and dynamic monitoring: Inform the patient to avoid excessive activity of the right lower limb to prevent catheter traction; perform disinfection and nursing care weekly, observe the puncture site and fixation system, and record relevant information.

[0135] Example 4: Effect Verification and Comparison Experiment

[0136] To verify the technical advantages of the method of this invention, laboratory simulation tests and clinical controlled studies were conducted:

[0137] (a) Laboratory testing

[0138] Axial tension test:

[0139] Control group: Traditional single-point suture fixation method;

[0140] Experimental group: The present invention's full-process anchoring and fixing method;

[0141] Method: Connect the fixed catheter model to a tensile testing machine and apply an axial tensile force at a rate of 10 mm / min. Record the maximum tensile force value when the catheter displacement is >2 cm.

[0142] Results: The average tensile strength of the experimental group was 16.8 kg, while that of the control group was 4.2 kg. The tensile strength of the experimental group was more than three times higher.

[0143] Resistance to lateral sway and rotation test:

[0144] Method: Periodic lateral swing force (5N) and rotational force (10N·cm) were applied to the fixed catheter tail end for 30 minutes;

[0145] Results: In the experimental group, the catheter swing amplitude was ≤0.5cm and the rotation angle was ≤10°; in the control group, the swing amplitude was ≥3cm and the rotation angle was ≥45°. The experimental group significantly reduced the mechanical stimulation of the puncture site by the catheter.

[0146] (II) Clinical Controlled Studies

[0147] 120 patients requiring indwelling central venous catheters were randomly divided into an experimental group (n=60, treated with the method of this invention) and a control group (n=60, treated with traditional sutures and transparent dressings for fixation). Patients were followed up for 4 weeks, and the following indicators were observed:

[0148] Observation indicators experimental group control group Significance of difference Catheter displacement rate 1.7% (1 case) 16.7% (10 cases) P<0.01 Unplanned extubation rate 0% (0 cases) 8.3% (5 cases) P<0.05 Incidence of puncture site infection 1.7% (1 case) 13.3% (8 cases) P<0.01 Incidence of catheter-related bloodstream infections 0% (0 cases) 6.7% (4 cases) P<0.05 Unplanned dressing changes Average 0.5 times / case Average 3.2 times / case P<0.01 Patient comfort score (1-10 points) 8.6 points 5.3 points P<0.01

[0149] The results show that the method of the present invention is significantly superior to the traditional fixation method in terms of fixation stability, infection control, patient comfort and nursing efficiency, and its clinical application effect is definite.

[0150] Supplementary explanation of specific implementation methods

[0151] The following points should be noted during the clinical implementation of the deep vein catheter anchoring and fixation method of the present invention:

[0152] Strictly adhere to aseptic procedures, especially during suturing, wrapping, and installation of the fixation plate, to avoid infection caused by operational contamination.

[0153] The suture depth and suture tension need to be precisely controlled: the suture depth should be based on the principle of not damaging deep blood vessels and nerves, and the tension should be based on the standard of "fixed and stable without affecting local blood circulation" to avoid excessive tightness that could lead to skin ischemia or duct deformation due to pressure.

[0154] The small-hole module of the intelligent adjustable fixing plate can be flexibly disassembled according to the number of catheter branches, ensuring that each branch of the multi-lumen catheter can be effectively fixed;

[0155] For pediatric patients, smaller diameter sutures (5-0), 1.5cm diameter fixation discs, and intermediate anchors suitable for pediatric catheters should be used. The suture depth should be reduced to 0.15-0.2cm, and the wrapping tension should be appropriately reduced.

[0156] During postoperative care, if loose sutures, displacement of fixation plates, or skin abnormalities are found, timely re-fixation or adjustment is necessary to ensure the effectiveness of the fixation system.

[0157] The materials used in this invention are all commonly used medical materials in clinical practice, with good biocompatibility and no obvious risk of allergies. However, it is still necessary to routinely assess the patient's allergy history before the operation and perform skin allergy tests when necessary.

[0158] The fixation method of the present invention is not only applicable to adult patients, but also allows for parameter adjustment according to the physiological characteristics of different populations such as children, the elderly, and critically ill patients, adapting to the indwelling needs of various deep vein catheters in clinical practice, and has broad clinical application prospects.

[0159] In summary, this invention, through its innovative technical solution, overcomes many bottlenecks in existing deep vein catheter fixation methods, achieving multiple goals such as stable anchoring throughout the procedure, proactive infection control, improved patient comfort, and convenient and efficient nursing care. It significantly enhances the safety and effectiveness of clinical diagnosis and treatment, reduces medical costs, and has important clinical application value.

[0160] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.

Claims

1. A method for anchoring and fixing a deep vein catheter throughout its entire length, characterized in that: Includes the following steps: Step 1: After inserting the deep vein catheter (1) into the target blood vessel and confirming its position, clean and dry the skin around the puncture point (21); Step 2: Using antibacterial-absorbable composite suture (3), double-layer purse-string suture is performed with the puncture point (21) as the center to form a shallow purse-string suture (31) and a deep purse-string suture (32). After tightening the suture, a knot is tied on the external segment (11) of the catheter to form a preliminary fixation knot (33). Step 3: Starting from above the initial fixing knot (33), the composite suture (3) is spirally wound (34) in segments along the outer section (11) of the catheter to the bifurcation point (12) at the end of the catheter, and at least one detachable intermediate anchor (4) is set on the winding path. The intermediate anchor (4) is fixed to the suture (3) through its thread hole (42). Step 4: Initially fix the intelligent adjustable fixation plate (5) to the skin through the low-sensitivity adhesive layer (54) on its back, close to the bifurcation point (12) of the catheter tail; pass the two ends of the completed suture (3) through the small holes on the fixation plate (5) and tighten and tie a knot to form a terminal fixation knot (35). Step 5: Cover the puncture point (21), suture (3) and fixation plate (5) area with sterile transparent dressing (23) to complete fixation.

2. The method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: The specific operation of the double-layer purse purse suture in step 2 is as follows: first, perform shallow purse purse suture with a needle depth of 0.15-0.25cm; then perform deep purse purse suture with a needle depth of 0.3-0.4cm; the two layers of sutures form an inner and outer nested structure around the puncture point (21) with a spacing of 0.3-0.4cm.

3. The method for anchoring and fixing a deep vein catheter throughout its length according to claim 2, characterized in that: The main body of the antibacterial-absorbable composite suture (3) is made of non-absorbable polypropylene material, with antibacterial agent impregnated on the surface, and the 1-2cm long segments at both ends are made of absorbable polysaccharide ester material.

4. The method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: The parameters of the segmented spiral winding (34) in step 3 are as follows: the angle between the suture and the axis of the conduit during the first winding is 35°-40°, and the winding spacing is 0.6-0.8cm; after setting the detachable intermediate anchor (4), the angle of the second winding is adjusted to 40°-45°, and the winding spacing is 0.4-1.0cm.

5. The method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: The detachable intermediate anchor (4) is a medical silicone ring with an inner diameter adapted to the diameter of the catheter. The ring has at least two thread holes (42) and anti-slip protrusions (43) on the inner side.

6. The method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: The intelligent adjustable fixed plate (5) includes a plate body (51) made of soft polyurethane material. The plate body (51) is provided with multiple detachable small hole modules (52), and the back is provided with the low-sensitivity adhesive layer (54). The diameter of the plate body can be adjusted within the range of 1.5-3.0cm.

7. A method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: The number and spacing of the detachable intermediate anchors (4) are set according to the type and length of the catheter: 1 for central venous catheters, 2-3 for PICC catheters, 1-2 for hemodialysis catheters, and the spacing between adjacent anchors is 8-12cm.

8. A method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: In step 3, when the suture is wrapped around the bifurcation point (12) at the end of the catheter, it is wrapped around 0.8-1.0 cm above the bifurcation point, and the suture is passed through the bifurcation gap to form a temporary fixation point.

9. A method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: In step 4, the intelligent adjustable fixing plate (5) is placed 1.2-1.5cm away from the bifurcation point (12) at the end of the catheter, and is perpendicular to the axis of the catheter after placement.

10. A method for anchoring and fixing a deep vein catheter throughout its entire length according to claim 1, characterized in that: The method also includes selecting sutures of different materials and antibacterial components (3) and intelligent adjustable fixation discs of different adhesive types (5) based on the patient's skin condition, allergy history or expected catheter indwelling time.

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