CN106344094B - Digestive tract lesion wound surface sealing telescopic clamp - Google Patents

Abstract

The invention relates to a telescopic clip for sealing wounds of gastrointestinal lesions, which belongs to the field of medical instruments. It consists of four rods, hinge holes are provided at both ends of the rods, and the hinge holes of two adjacent rods are respectively connected by hinge axes a~d to form a parallelogram clip; two corresponding hinge axes b on the parallelogram clip One ends of b and d are respectively connected with the two operating cables of the gastroscope, and the other ends of the hinge axes b and d are provided with a clamping structure; The clamping structure at the other end is opened; the two operating cables are controlled to make the hinge shafts b and d move toward each other until they touch each other, and the clamping structure at the other end of the hinge shafts b and d is closed to realize the sealing and clamping of the digestive tract lesion. It effectively expands the diameter of the wound that can be completely closed; within the range of 45°~135°, it can effectively pull the mucous membrane of the oral side and anal side of the wound, and improve the sealing speed.

Description

Digestive canal lesion wound sealing telescopic clip

technical field

The invention relates to the field of medical devices, in particular to a telescopic clip for sealing wounds of gastrointestinal lesions.

Background technique

With the continuous development of our country's society and economy, people's living standards continue to improve, but at the same time people's life pressure is also increasing, fast-paced lifestyles lead to irregular diets for most people, long-term heavy drinking, etc. As a result, the number of patients with digestive tract tumors in my country has increased year by year in recent years. The carcinogenic factors of gastrointestinal tumors are mainly caused by the unhealthy lifestyle of patients, such as eating too fast, eating irregularly, long-term consumption of high-fat, repeatedly heated food, mildewed food, rough food and irritating food, and drinking a lot of alcohol for a long time Wait. The main symptoms of gastrointestinal tumors are abdominal pain, bloating, stomach discomfort and persistent indigestion, black stools or bloody stools, alternating constipation and diarrhea, and thin stools; foreign body sensation when swallowing, choking sensation when eating, unknown The reasons are prolonged fever, anemia, etc.; fatigue, yellow skin and mucous membranes, greasy feeling, low back pain, etc. These symptoms are common in daily life and are easy to be ignored by people. Once patients are found to have gastrointestinal tumors, most of them are already highly differentiated. Here comes the heavy burden.

Clinically, digestive endoscopy is a commonly used endoscopic examination method in clinical practice. It can complete the oral cavity, esophagus, stomach, jejunum, ileum, and the entire colon and rectum through different types of mirrors such as gastroscopy, colonoscopy, and enteroscopy. Through endoscopy, the tumors and precancerous lesions of digestive tract diseases can be clearly observed, and most of the lesions can be treated with endoscopic minimally invasive treatment. Simple and rapid endoscopic treatment can avoid the huge trauma caused by traditional open surgery, make the operation minimally invasive, and change the existing diagnosis and treatment mode.

In recent years, ESD, as an emerging endoscopic technique, has allowed more gastrointestinal lesions to be resected endoscopically. In the past, although EMR had a good effect on early-stage gastrointestinal tumors confined to the mucosa, it was difficult to completely remove them with a diameter > 2 cm. Lesions, their incomplete resection and the possibility of recurrence are greatly increased. Compared with EMR, ESD can control the size and shape of the resected tissue, completely remove larger gastrointestinal lesions, reduce residual lesions and recurrence rates, and can also resect ulcerated lesions. For lesions with ESD indications, such as differentiated adenocarcinoma in the gastric mucosa without lymph node metastasis and ulcers, squamous cell carcinoma of the esophageal mucosa lamina propria, etc., ESD treatment can be performed without traditional laparotomy or laparotomy. Thoracic surgery, thereby reducing the trauma, reducing the incidence of surgery-related complications, improving the quality of life of patients, reflecting the advantages of minimally invasive treatment. Another thing that needs attention is iatrogenic gastrointestinal perforation. Iatrogenic (due to endoscopy and surgery) digestive tract perforation/defect and pathogenic perforation (such as digestive tract ulcer, etc.) are clinical emergencies. If not closed in time, secondary pleural and peritoneal infection may occur, and even life-threatening.

With the continuous development of endoscope and auxiliary equipment, the progress of endoscopic treatment technology has been promoted, but it has also caused many artificial wall stomas. For example, accidental perforation during digestive endoscopy, perforation after dilation of digestive system stenosis surgery, tearing and perforation caused by air sac dilation and achalasia of the cardia, perforation during gastrointestinal mucosal polypectomy, and natural orifice endoscopic surgery (natural perforation caused by orifice transluminal endoscopic surgery, NOTES). Among them, after endoscopic treatment of endoscopic sphincterotomy (EST), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) Accidental perforation is the main perforation of the gastrointestinal tract, which can be divided into acute and chronic according to the time of occurrence; it can be divided into large, medium, small and occult perforation according to the diameter of the perforation; it can also be divided into upper gastrointestinal and lower gastrointestinal perforation according to different parts. Tract perforation; according to the predictability of perforation, it can be divided into therapeutic and complicated perforation. In order to achieve good results in the treatment and prognosis of perforation, different treatment methods should be selected for different types. Clinically, many conditions can also lead to pathogenic gastrointestinal perforation and defect, such as Boerhaave syndrome, gastrointestinal ulcers, benign and malignant tumors, and some such as swallowing fish bones, sharp animal bones, and metal foreign bodies penetrating the gastrointestinal tract. Surgical closure of gastrointestinal perforations and defects is the traditional clinical treatment. In 1990, Mouret et al. and Nathanson et al. first reported laparoscopic ulcer perforation repair, and laparoscopic perforation repair gradually replaced traditional surgery.

Endoscopic interventional minimally invasive treatment is widely used in clinic, and the development of endoscopic equipment and its accessories is also changing with each passing day. Among them, the new technology of endoscopic treatment of digestive tract perforation and defect has also emerged as the times require, and different methods determine the different prognosis of treatment. Compared with traditional surgical closure, the closure of perforation or defect under endoscopy can not only shorten the treatment time, is convenient and fast, but also has less trauma, good painlessness, and reduces unnecessary accidents and various complications during the operation. Bring good news to patients and hospitals.

At present, the most widely used clinical technique is metal clip closure. Titanium clips, as a gradually mature endoscopic minimally invasive treatment method, are increasingly valued by endoscopic and gastroenterologists. However, there are still many problems in the clinical application of metal clips, such as insufficient mastery of hemostatic clip operation skills, inability to clip the full thickness of the intestinal wall, selection of clip types, and indications for patients, all of which need further research and discussion to be resolved. There is an urgent clinical need for this simple and effective suture technique under direct vision of the endoscope to provide reliable technical support for the wider development of a variety of new endoscopic minimally invasive treatments, and to make endoscopic minimally invasive diagnosis and treatment techniques more effective. to play. The indications of endoscopic titanium metal clips have also gradually expanded from the initial simple local gastrointestinal hemostatic treatment to closing gastrointestinal perforation and fistula, fixing catheter or probe in the gastrointestinal tract, and preoperative marking, etc. Endoscopic equipment has successfully carried out more endoscopic minimally invasive treatments. Simple metal clip closure operation In 1993, the first clinical case of endoscopic application of metal clips to close acute perforation in the digestive cavity was reported, which opened a research window leading to closure defects in the digestive tract cavity. Since then, researches and clinical cases of related metal clip perforation and defect repair in endoscopic treatment have appeared in various literatures, but the safety and effectiveness of this new technology have always been controversial. Compared with the traditional surgical method, simple metal clip closure surgery is more difficult to operate, but it is worth noting that the technology can be developed, as well as its good effectiveness and safety, and it is gradually being replaced by endoscopic full-thickness resection ( EFR) practitioners fancy and adopt. Usually, one or more metal clips can be used to close the perforation well. However, for perforations with relatively large diameters, since the metal clip itself has a certain diameter limit, the perforation cannot be completely closed at one time. At this time, multiple metal clips can be used to close the perforation gradually from both ends of the perforation to the middle. According to related reports, up to 22 titanium clips are used abroad to complete the closure of mucosal defects. The results of an animal experiment using metal clips to suture full-thickness gastric wall defects showed that compared with traditional surgical suturing of gastric wall defects, the application of metal clip closure technology has obvious advantages. It can not only achieve clinical healing in a shorter time, but is also relatively safe reliable.

Titanium clips combined with nylon rope closure technology, clinically for the deep and large wounds left after gastrointestinal tumor or polypectomy, especially for the endoscopic suture of gastrointestinal defects after EFR, nylon rope combined with nylon rope is often used. A purse-string suture-like technique composed of titanium clips. The specific operation process is as follows: ①Using an endoscope with two clamp channels, insert the nylon rope and metal titanium clip into the endoscopic treatment forceps; A metal clip anchors the placed nylon rope; ③Then clamp the proximal nylon rope with a second metal titanium clip, and then fix it at the proximal edge of the digestive canal wall defect; ④Pull the nylon rope together to close the wound ⑤Repeat the above steps, using multiple nylon ropes, until the wound is completely sutured. It should be noted that some patients with severe pneumothorax need to be closely observed during the operation or after the operation. If necessary, the right upper quadrant can be punctured to relieve abdominal distension.

For OTSC (over the scope clip) closure technology is a new type of suturing device for closing gastrointestinal defects. When in use, the instrument is first placed on the transparent cap at the front end of the endoscope, and the metal clip similar to the bear's claw is "released" by pulling through the preset thread, similar to the commonly used ligation. During the specific operation, a large-caliber forceps is first sent out from the biopsy channel close to the perforation, and then the forceps are deployed to grasp the tissue around the defect, pulled into the transparent cap, and then "release" the clamping device. The forceps teeth then engage the tissue, closing the perforation or some surgical margins. For some perforations with full-thickness defects, it can also be closed, and has a better healing effect. At present, more and more literatures have proved that the OTSC system is more effective and convenient in the treatment of digestive tract defects\perforation, with fewer complications and high safety factor. The OTSC system has been recognized in clinical practice for its clinical value in closing 10-30 mm defects in the alimentary canal. The OTSC system has been successfully tested in animal models, demonstrating its effectiveness in closing full-thickness perforations of the digestive tract. Studies have also shown that the healing effect of the OTSC system for closed colonic perforation is similar to that of traditional suturing instruments and conventional stapler techniques. The disadvantages are that the price is extremely expensive, the operation is relatively complicated, and it has high technical requirements for the operating endoscopist.

Endoscopic treatment is favored by doctors and patients for its unique advantages of minimally invasive, efficient, convenient and fast, and it is gradually being widely used clinically. Based on the various methods available for closing acute perforation of the digestive tract, we have concluded the following conclusions: ① The early methods are low in cost, limited in the treatment site or diameter, and are suitable for closure of specific sites or small perforations; ② The latest methods The therapeutic effect of the OTSC system is superior to other types of closure effects, but the operation is complicated and the price is very expensive, so it is not suitable for promotion and application in hospitals at all levels.

Contents of the invention

The purpose of the present invention is to provide a stretch clip for sealing wounds of digestive tract lesions, which solves the above-mentioned problems in the prior art. On the basis of emphasizing on retaining the original safety and effectiveness, the present invention achieves a good sealing and suturing effect, makes it more suitable for large-area perforation closure and wound repair, and reduces medical expenses, so as to be better applied and popularized in clinic. The present invention will continue to broaden the application range of endoscopic closure of digestive tract perforation and defect technology, provide better therapeutic effect, and bring endoscopic treatment to a new level.

Above-mentioned purpose of the present invention is achieved through the following technical solutions:

The wound sealing telescopic clip for gastrointestinal lesions, a new type of closed telescopic clip with a working angle of 45°~135°, realizes clipping of the distal end of the wound (the distance from the distal end of the intestinal endoscope). In the present invention, two corresponding hinge shafts on the parallelogram mechanism are respectively connected to two operating cables of the gastroscope, and the relative movement between the two hinge shafts is controlled by the two operating cables to realize the wound sealing clamp for gastrointestinal lesions. hold. Its structure includes four rods 1, the two ends of the rods 1 are respectively provided with hinge holes, and the hinge holes of two adjacent rods are respectively connected by hinge axis a2, hinge axis b3, hinge axis c4, and hinge axis d5, forming a parallelogram Clip; two corresponding hinge shafts b3 and one end of the hinge shaft d5 on the parallelogram clip are respectively connected with two operating cables 8 of the gastroscope, and the other ends of the hinge shaft b3 and the hinge shaft d5 are provided with clips The holding structure 6; by controlling the two operating cables 8, the hinge axis b3 and the hinge axis d5 move away from each other, and the clamping structure 6 at the other end of the hinge axis b3 and the hinge axis d5 is opened; control the two operating cables 8 The hinge axis b3 and the hinge axis d5 are moved towards each other until they touch each other, and the clamping structure 6 at the other end of the hinge axis b3 and the hinge axis d5 is closed, so as to realize the sealing and clamping of the digestive tract lesion.

The hinge shaft b3 is connected to one of the two operation cables 8 through the fork structure 7, the width of the fork structure 7 is larger than the diameter of the hinge shaft b3; the hinge shaft d5 is directly connected to the other operation cable.

The hinge hole and the hinge axis a2, hinge axis b3, hinge axis c4, and hinge axis d5 are clearance fits to ensure that the four bars of the parallelogram clip respectively wind around the hinge axis a2, hinge axis b3, hinge axis c4, and hinge axis. The shaft d5 rotates, and the length of each rod of the parallelogram clip is less than 30mm, so as to meet the requirement of the quadrilateral mechanism working in the intestinal tract and complete the telescopic function of the clip.

The beneficial effects of the present invention are:

1. Based on the classic wound sealing method, during the sealing process, the diameter of the wound that can be completely sealed is effectively enlarged.

2. By elastically adjusting the length of the clamp arm, the relationship between the plane of the anal end of the wound under the colonoscope and the clamping plane of the telescopic clamp is established.

3. Adjust the operating handle to change the opening angle of the telescopic clip, so that it can effectively pull the mucous membrane on the oral side and anal side of the wound within the range of 45°~135°, and improve the sealing speed.

4. When this device is used for sealing, it is only necessary to ensure that the anal arm of the clip is against the surrounding mucosa of the wound, and the side arm of the clip mouth is stretched to pull the mucosa on the side of the wound to seal it. There is no need to adjust the mirror body, which is more convenient for practical application.

The present invention utilizes two corresponding hinge shafts on the parallelogram mechanism to form clips, which are respectively connected with two operating cables of the gastroscope, so as to realize effective sealing of huge wounds and ensure larger sealing diameter and suturing force, especially for diameter It can achieve a unique sealing effect on the huge large intestine wound of 20-35mm.

Description of drawings

The accompanying drawings described here are used to provide a further understanding of the present invention, and constitute a part of the application. The schematic examples and descriptions of the present invention are used to explain the present invention, and do not constitute improper limitations to the present invention.

Fig. 1 is a structural representation of the present invention;

Fig. 2 is a schematic side view of Fig. 1;

Fig. 3 is a schematic diagram of the connection between the hinge shaft of the present invention and the operation cable through the fork structure;

Fig. 4 is a schematic side view of Fig. 3;

Fig. 5 is a schematic diagram of the present invention using operating cables to control the relative movement of two hinge shafts (expanded state);

Figure 6 is a schematic side view of Figure 5;

Fig. 7 is a schematic diagram of controlling the relative movement (clamping state) of two hinge shafts by using an operating cable in the present invention;

FIG. 8 is a schematic side view of FIG. 7 .

In the figure: 1. rod; 2. hinge axis a; 3. hinge axis b; 4. hinge axis c; 5. hinge axis d; 6. clamping structure; 7. fork-shaped structure; 8. operation cable.

Detailed ways

The detailed content of the present invention and its specific implementation will be further described below in conjunction with the accompanying drawings.

Referring to Fig. 1 to Fig. 8, the telescopic clip for sealing wounds of digestive tract lesions of the present invention is connected to two operating cables of the gastroscope by using two corresponding hinge shafts on the parallelogram mechanism, and through these two operating wires The cable controls the relative movement between the two hinge axes to realize the sealing and clamping of the gastrointestinal lesions. It includes four rods 1, and the two ends of the rods 1 are respectively provided with hinge holes, and the hinge holes of the two adjacent rods are respectively passed through the hinge The axis a2, the hinge axis b3, the hinge axis c4, and the hinge axis d5 are connected to form a parallelogram clip; two corresponding hinge axes b3 and one end of the hinge axis d5 on the parallelogram clip are connected with the two operating lines of the gastroscope respectively. The other end of the hinge shaft b3 and the hinge shaft d5 is connected with a clamping structure 6; by controlling the two operating cables 8, the hinge shaft b3 and the hinge shaft d5 move in opposite directions, and the hinge shaft b3 and the hinge shaft The clamping structure 6 at the other end of d 5 is opened; the two operating cables 8 are controlled to make the hinge axis b3 and the hinge axis d 5 move toward each other until they touch each other, and the clamping structure 6 at the other end of the hinge axis b3 and the hinge axis d 5 is closed. Realize the closure and clamping of digestive tract lesions.

The hinge shaft b3 is connected to one of the two operation cables 8 through the fork structure 7, the width of the fork structure 7 is larger than the diameter of the hinge shaft b3; the hinge shaft d5 is directly connected to the other operation cable. The fork-shaped structure avoids interference between the operating cables and the hinge shaft.

The hinge hole and the hinge axis a2, hinge axis b3, hinge axis c4, and hinge axis d5 are clearance fits to ensure that the four bars of the parallelogram clip respectively wind around the hinge axis a2, hinge axis b3, hinge axis c4, and hinge axis. The shaft d5 is rotatable, and the length of each rod of the parallelogram clip is less than 30mm, so as to meet the requirements of the quadrilateral mechanism working in the intestinal tract and complete the telescopic function of the clip.

See Figures 1 to 8, when in use, the parallelogram clip is placed in the duct of the forceps by connecting with the gastroscope operation cable in the open state, and arrives near the wound of the digestive tract lesion along with the gastroscope; The quadrilateral clip moves to the wound surface of the lesion; the two operating cables are respectively controlled to move the hinge axis b and the hinge axis d connected thereto until the two hinge axes b and d are in contact. d The clamping structure on the other side clamps the diseased wound surface.

The invention can effectively expand the diameter of the completely closed wound surface. This novel wound sealing telescopic clip is based on a parallelogram mechanism. One end of two corresponding hinge shafts on the mechanism is respectively connected with two operating cables of the gastroscope, and the other end of the hinge shaft is made into a clamping structure. The parallelogram clip is placed in the duct of the forceps through the connection with the gastroscope operating cable in the open state, and reaches the vicinity of the gastrointestinal lesion wound with the gastroscope, and uses two operating cables to control the relative movement between the two hinge shafts to realize healing of the gastrointestinal lesion wound. Closed grip. The invention adopts a parallelogram mechanism to realize the expansion and contraction of the clip, and the fork-shaped structure connecting the hinge shaft and the operation cable avoids the interference between the operation cable and the hinge shaft during clamping, and effectively expands the diameter of the wound that can be completely closed.

The above descriptions are only preferred examples of the present invention, and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made to the present invention shall be included within the protection scope of the present invention.

Claims (2)

1. A retractable clip for sealing wounds of gastrointestinal lesions, characterized in that it includes four rods (1), hinge holes are respectively provided at both ends of the rods (1), and the hinge holes of two adjacent rods pass through the hinge shafts respectively. a (2), hinge axis b (3), hinge axis c (4), and hinge axis d (5) are connected to form a parallelogram clip; hinge axis b (3), hinge axis d ( 5) are respectively connected to the two operating cables (8) of the gastroscope, and the other ends of the hinge shaft b (3) and the hinge shaft d (5) are provided with a clamping structure (6); by controlling the two operating wires The cable (8) moves hinge axis b (3) and hinge axis d (5) in opposite directions, and the clamping structure (6) at the other end of hinge axis b (3) and hinge axis d (5) opens; Operate the cable (8) to move the hinge axis b (3) and hinge axis d (5) towards each other until they touch each other, and the clamping structure (6) at the other end of the hinge axis b (3) and hinge axis d (5) is closed to realize Sealing and clamping of digestive tract lesions; The hinge shaft b (3) is connected to one of the two operating cables (8) through a fork-shaped structure (7), and the width of the fork-shaped structure (7) is larger than the diameter of the hinge shaft b (3); the hinge shaft d(5) is directly connected to another operating cable. 2. The retractable clip for sealing wounds of gastrointestinal lesions according to claim 1, characterized in that: the hinge hole is connected with hinge axis a (2), hinge axis b (3), hinge axis c (4), and hinge axis There is a gap fit between d(5) to ensure that the four bars of the parallelogram clip rotate around the hinge axis a(2), hinge axis b(3), hinge axis c(4) and hinge axis d(5) respectively, parallel The length of each rod of the quadrilateral clip is less than 30mm, so as to meet the requirement of the quadrilateral mechanism working in the intestinal tract and complete the telescopic function of the clip.