Registration Certificate Number/Product Technical Requirements Number: National Medical Device Registration Approval No. 20243021179

Medical Device Manufacturing License Number: Sujiang Medical Device Production License No. 20240191

[Product Name] Single-use ligation clip

[Product Model Specifications] L, M, S

【Scope of Application】

Used for closing tubular tissue structures. Do not remove postoperatively.

【Structural Composition】

The ligation clip is made of homopolymer polyoxymethylene (POM); the base is made of acrylonitrile–butadiene–styrene (ABS) resin conforming to GB/T 12672-2009; the fixing cap is made of polypropylene (PP) plastic conforming to YY/T 0242-2007. The product is sterilized with ethylene oxide, intended for single use, and has a shelf life of three years.

【Instructions for Use】

Clinicians select the appropriate ligation clip based on the size and structure of the blood vessels and tissues. The procedure for its use is as follows:

(1) Place the clip-applier (without the clip), firmly grasp the clip-applier (without the clip), and accurately insert the head of the clip-applier (without the clip) into the base of the ligating clamp. Ensure that the head is perpendicular to the base, then gently press down on the clip-applier (without the clip) until you hear a distinct click. Do not force the clip-applier (without the clip) into the base or the upper part of the ligating clamp; the clip-applier (without the clip) should be able to enter and exit the base with ease.

(2) Remove the applicator clamp from the base (without the clip), ensuring that the ligating clip is securely held within the bite surface of the applicator clamp (without the clip) (as shown in Figure 1). The base must be held firmly to ensure that the ligating clip can be removed.

(3) During use, as shown in Figure 1, the single tooth of the positioning ligating clamp allows the user to visually confirm the structure being ligated;

(4) Position the ligating clip around the ligated blood vessel and body cavity tissue in a manner that provides a clear view of the locking mechanism; then, with the clip-applier (without the clip attached), engage the blood vessel and body cavity tissue to be ligated (as shown in Figure 2). Apply sufficient force to the handle of the clip-applier (without the clip) to ensure that the jaws close and the ligating clip is securely locked (as shown in Figure 3). Finally, release the handle of the clip-applier (without the clip) to allow the instrument to return to a fully open position and withdraw.

[Supporting equipment]

(1) For single-use ligating clamps, it is recommended to use the clamp applicators manufactured by our company (without clamps), as shown in Figure 4, and the clamp-removal forceps, as shown in Figure 5. Our company’s ligating clamps are compatible with the corresponding clamp applicators (without clamps) and clamp-removal forceps; please refer to the table below for details.

Ligation clamp specifications and models	Diameter of vascular and tissue ligature tubes	Corresponding clamp (without jaw) model specifications	Corresponding clamp model specifications
S	2mm～3mm	KS-S	KJS
M	3mm～5mm	KS-M	KJ-LM
L	5mm～8mm	KS-L	KJ-LM

Note: Prior to performing the procedure, verify that the ligation clip model and specifications match those of the clip applier (without clips). You may also check whether the color of the applier’s rotating handwheel matches the color of its base.

(3) Clamp-removal method: Place the ligature lock to be released into the clamp-removal forceps head, then apply pressure to the handle of the forceps. When the working surface of the forceps contacts the ligature clip, exert firm pressure on the forceps to deform the curved clamping arms of the clip until the locking mechanism disengages. Release the forceps; at this point, due to the inherent structural and material tension, the clamping arms of the ligature clip will spring open, thereby completing the release of the ligature clip.

【Contraindications】

(1) Ligating clips shall not be used as occlusive devices for tubal sterilization.

(2) Ligating clips shall not be used for ligation of the renal artery during laparoscopic donor nephrectomy.

(3) Individuals with hypersensitivity to the ingredients of this product; individuals with diffuse mucosal bleeding.

(4) In cases of cancerous ulcers requiring hemostasis at the vascular stump, the tissue at the lesion site is fragile, making it easy for ligating clips to dislodge.

(5) Patients in whom the bleeding site extends beyond the clamping length accommodated by tissue clips, or whose vascular diameter is too large for ligation clip devices.

(6) Patients with advanced malignant tumors exhibiting distant metastases, as well as those with immunosuppression or immunodeficiency.

(7) For gastrointestinal ulcers in which the vascular stump is located at the center of the lesion and covers an area greater than 3 cm², as well as for bleeding cases accompanied by severe tissue necrosis, hemostasis achieved with ligating clips is often suboptimal; even when the clips are applied with some difficulty, they tend to dislodge prematurely, leading to recurrence.

 

The ligation clip is made of homopolymer polyoxymethylene (POM); the base is made of acrylonitrile–butadiene–styrene (ABS) resin conforming to GB/T 12672-2009; the fixing cap is made of polypropylene (PP) plastic conforming to YY/T 0242-2007. The product is sterilized with ethylene oxide, intended for single use, and has a shelf life of three years.