Metal support for intestinal canal anastomosis and anastomotic leakage
The metal stent, designed with a double-layer metal mesh and drainage tube, solves the problems of stent displacement and mucosal friction in anastomotic leakage of the digestive tract, achieving efficient drainage of secretions and anastomotic healing, and reducing the risk of complications.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHANGHAI RUIFAN MEDICAL TECHNOLOGY CO LTD
- Filing Date
- 2025-04-18
- Publication Date
- 2026-05-15
AI Technical Summary
In current treatments for anastomotic leaks in the digestive tract, metal stents are prone to displacement, mucosal friction leads to edema, secretions accumulate, and negative pressure suction devices suffer from friction damage and blockage, all of which affect the healing outcome.
A double-layer metal mesh support is designed, with a silicone coating and pores between the inner and outer mesh layers. Combined with a drainage tube, it forms a negative pressure or water/air injection channel to promote the discharge of secretions and reduce mucosal friction and blockage.
It effectively reduces mucosal irritation, improves the efficiency of secretion drainage, promotes the healing of anastomoses and leaks, reduces the risk of complications, and avoids secondary surgery.
Smart Images
Figure CN224235606U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and more specifically, to a metal stent for intestinal anastomosis and anastomotic leakage. Background Technology
[0002] Gastrointestinal obstruction is common in gastroenterology and gastrointestinal surgery. According to the location of the obstruction, it can be divided into esophageal obstruction, gastric obstruction, duodenal obstruction, small bowel obstruction, colonic obstruction, and rectal obstruction. According to the benign or malignant nature of the obstruction, it can be analyzed as benign obstruction and malignant obstruction. According to the time of onset, it can be classified as acute obstruction, subacute obstruction, and chronic obstruction. According to the nature of the obstruction, it can be classified as mechanical obstruction, dynamic obstruction, and strangulated obstruction.
[0003] Removing the cause of obstruction, resecting the affected organ, and performing gastrointestinal anastomosis are routine surgical procedures for treating gastrointestinal obstruction. The use of anastomotic devices has greatly simplified organ anastomosis, but complications such as anastomotic leakage and bleeding are still common. For patients in the acute phase, to reduce the incidence of complications, a gastrointestinal stoma is often performed, allowing the anastomosis and reduction of digestive organs to occur after the organ edema subsides. A gastrointestinal stoma not only requires cumbersome nursing care, affecting daily life and work, but the secondary surgery to complete the anastomosis and reduction of digestive organs further increases the patient's financial burden and physical suffering.
[0004] Silicone-coated fully covered nickel-titanium alloy stents have been widely used in the treatment of bile leaks. By sealing the leak through the stent wall, bile leakage can be stopped, thus promoting healing. These fully covered stents have also been used to treat gastrointestinal perforations and anastomotic leaks. However, under gastrointestinal peristalsis, cylindrical fully covered stents are prone to displacement, losing their ability to seal the leak and limiting their clinical application. To reduce stent displacement, fully covered stents are designed in a dumbbell shape. However, fluid secreted by the gastrointestinal mucosa and the leak tends to accumulate in the central depression of the stent, which not only hinders leak healing but can also lead to further aggravation of the anastomotic leak.
[0005] To facilitate the drainage of secretions accumulated in the recesses of metal stents, VAC Stent Company has applied for a negative pressure suction stent (patent number: WO2024170414A1). This stent is a dumbbell-shaped, fully covered metal stent with a polyurethane foam insert in the recessed area. A vacuum tube connects the foam to the recessed surface of the metal stent. Continuous negative pressure suction through the vacuum tube removes various secretions, inflammatory mediators, and pus filtered by the polyurethane foam, thereby promoting the healing of the leakage site. The aforementioned negative pressure suction stent still has the following problems: 1. The gastrointestinal mucosa is in close contact with the polyurethane sponge, and the friction between the polyurethane sponge and the gastrointestinal mucosa can lead to gastrointestinal mucosal edema and promote the production of secretions; 2. The polyurethane sponge has a filtering effect on the gastrointestinal mucosa and the fluid secreted from the leak, and lumps of necrotic tissue or purulent coating will be deposited on the surface and in the gaps of the polyurethane sponge, gradually reducing the negative pressure drainage effect; 3. During continuous negative pressure suction, digestive juices in the gastrointestinal tract at both ends of the stent will enter the groove of the metal stent through the gap between the metal stent and the gastrointestinal mucosa, and the damage of digestive juices to the leak tissue is not conducive to the closure of the leak; 4. The outer sheath of the stent release device has a raised protective pad, which is not conducive to the application of the stent in surgical procedures. Utility Model Content
[0006] In response to the aforementioned technical problems, a metal stent for intestinal anastomosis and anastomotic leakage is provided.
[0007] The technical means adopted in this utility model are as follows:
[0008] A metal stent for intestinal anastomosis and anastomotic leakage includes: a metal stent, a drainage tube, and a stent release device. Before release, the metal stent is placed in the stent release device. After release, the metal stent is dumbbell-shaped, including a first raised section and a second raised section at both ends and a grooved section in the middle. The grooved section is located between the first raised section and the second raised section.
[0009] The grooved section is a double-layer metal mesh, including an inner metal mesh and an outer metal mesh, with a space between the inner metal mesh and the outer metal mesh;
[0010] Both the inner and outer surfaces of the metal bracket are covered with a silicone coating. The silicone coating on the outer metal mesh has multiple circular holes that are connected to the space.
[0011] The drainage tube is connected to the groove section, and the interior of the drainage tube is in communication with the space.
[0012] Furthermore, the metal support is woven from nickel-titanium alloy wire, and the plurality of circular holes are distributed on the silicone coating between the meshes of the outer metal mesh.
[0013] Furthermore, one side of the drainage tube passes between the inner and outer metal meshes, is located within the space and is in close contact with the inner metal mesh, and the other side of the drainage tube is led out from the inner cavity of the second raised section, wherein the drainage tube located within the space is arranged along the length of the entire groove section.
[0014] Furthermore, the drainage tube may be a single tube or two tubes.
[0015] Furthermore, the single drainage tube is a suction drainage tube, and the outlet end of the suction drainage tube is connected to an external negative pressure device through a negative pressure suction connector. The tube wall of the suction drainage tube is provided with multiple first side holes, which are used to connect the suction drainage tube and the space.
[0016] Furthermore, the single drainage tube is a dual-channel tube, with an internal suction channel and a water injection channel. The tube wall of the dual-channel tube has multiple second side holes and multiple third side holes. The multiple second side holes are connected to the suction channel and the space, and the multiple third side holes are connected to the water injection channel and the space. The outlet end of the dual-channel tube is connected to a negative pressure suction connector and an air injection connector. The negative pressure suction connector is connected to the suction channel and to an external negative pressure device, and the air injection connector is connected to the water injection channel and to an external water injection pipe.
[0017] Furthermore, the drainage tube is a double tube, comprising a suction tube and a flushing tube, both of which are single-channel tubes. The suction tube is connected to an external negative pressure device via a negative pressure suction connector, and the flushing tube is connected to an external water injection pipe via an air injection connector. The flushing tube is straight or annular. The suction tube has multiple fourth side holes on its wall, which are used to connect the suction tube to the space. The flushing tube has multiple fifth side holes on its wall, which are used to connect the flushing tube to the space.
[0018] Furthermore, the suction tube and the flushing tube are symmetrically arranged with respect to the center of the metal support.
[0019] Furthermore, the stent release device includes an outer sheath and a pusher, the pusher being inserted into the interior of the outer sheath, and the metal stent being sleeved on the pusher and located inside the outer sheath before release.
[0020] Furthermore, the head end of the outer sheath may or may not be covered with a silicone protective ring, and the tail end of the outer sheath is provided with a first handle;
[0021] The head end of the pusher has a conical structure, and a limiting structure is provided on the tube wall of the pusher. Before the metal bracket is released, it is sleeved between the conical structure and the limiting structure. The tail end of the pusher is provided with a second handle.
[0022] Compared with the prior art, the present invention has the following advantages:
[0023] 1. The intestinal anastomosis and anastomosis leakage metal stent provided by this utility model adopts a double-layer metal mesh and has a silicone membrane, which can reduce the irritation of the digestive tract mucosa and reduce the production of secretions.
[0024] 2. The intestinal anastomosis and anastomosis leak metal stent provided by this utility model has a circular hole in the silicone membrane in the middle of the outer metal mesh. The fluid secreted by the gastrointestinal mucosa and the leak can enter between the two metal meshes through the circular hole and be sucked out by the negative pressure drainage tube, which can promote the healing of the anastomosis and the leak.
[0025] 3. The intestinal anastomosis and anastomotic leakage metal stent provided by this utility model forms a relatively closed space between the two layers of metal mesh. The outer mesh membrane has larger pores, which can promote the discharge of large pieces of pus and necrotic tissue, resulting in higher drainage efficiency.
[0026] 4. The intestinal anastomosis and anastomosis leak metal stent provided by this utility model is equipped with a water / air injection channel or a separate drainage tube. Water or air enters the space between the two layers of metal mesh and is then led out through the negative pressure suction tube to form a closed loop. The flowing water or air can continuously flush the gastrointestinal mucosa and the leak, promote the discharge of gastrointestinal mucosa or leak secretions, and at the same time reduce the blockage rate of the suction tube side hole.
[0027] 5. The intestinal anastomosis and anastomotic leakage metal stent provided by this utility model has a silicone ring at the head end. When assembled into a long release device, it can be inserted through the digestive tract for the treatment of anastomotic leakage or digestive tract perforation. Alternatively, a stent without a silicone ring at the head end can be assembled into a short release device and inserted through a digestive tract stoma for surgical protection of the anastomosis without the need for a gastrointestinal stoma.
[0028] Based on the above reasons, this utility model can be widely promoted in fields such as medicine. Attached Figure Description
[0029] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0030] Figure 1 This is a schematic diagram of a metal stent for intestinal anastomosis and anastomotic leakage according to the present invention, wherein the head end of the stent release device is wrapped with a silicone protective ring.
[0031] Figure 2 This is a schematic diagram of another structure of the intestinal anastomosis and anastomotic leakage metal stent of this utility model, wherein the head end of the stent release device is not covered with a silicone protective ring.
[0032] Figure 3 This is a schematic diagram of the structure of the metal bracket connecting a single suction and drainage tube according to the present invention.
[0033] Figure 4 This is a schematic diagram of the structure of the metal bracket connecting a single dual-channel tube according to the present invention.
[0034] Figure 5 This is a schematic diagram of the structure of the metal bracket connecting the two drainage tubes of this utility model.
[0035] Figure 6 for Figure 3 A sectional view.
[0036] Figure 7 for Figure 4 A sectional view.
[0037] Figure 8 for Figure 5 A sectional view.
[0038] Figure 9 This is a cross-sectional view of the metal bracket of this utility model.
[0039] Figure 10 This is a cross-sectional view of the single suction and drainage tube of this utility model.
[0040] Figure 11 This is a cross-sectional view of the single-tube dual-channel pipe of this utility model.
[0041] Figure 12 This is a schematic diagram of the outer metal mesh with circular holes of this utility model.
[0042] Figure 13 This is a schematic diagram of the inner metal mesh of this utility model.
[0043] In the diagram: 1. Metal support; 11. First raised section; 121. Inner metal mesh; 122. Outer metal mesh; 123. Circular hole; 13. Second raised section; 21. Outer sheath; 22. Pusher; 23. Silicone protective ring; 3. Drainage tube. Detailed Implementation
[0044] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.
[0045] This utility model provides a metal stent for intestinal anastomosis and anastomotic leakage, comprising: a metal stent, a drainage tube 3, and a stent release device. Before release, the metal stent is placed within the stent release device. After release, the metal stent takes on a dumbbell shape with raised ends and a double-layered metal mesh in the middle. The metal stent includes a first raised section 11 and a second raised section 13 at both ends, and a grooved section in the middle, located between the first raised section 11 and the second raised section 13. The grooved section is a double-layered metal mesh, including an inner metal mesh 121 and an outer metal mesh 122, with a space between them. The inner and outer surfaces of the metal stent are coated with a silicone coating. Multiple circular holes 123 are provided on the silicone coating in the middle of the outer metal mesh 122 at the grooved section, communicating with the space. The drainage tube 3 is connected to the grooved section, and its interior communicates with the space.
[0046] Preferably, the metal support is woven from nickel-titanium alloy wire, and multiple circular holes 123 are distributed on the silicone coating between the meshes of the outer metal mesh 122.
[0047] Preferably, one side of the drainage tube 3 passes between the inner metal mesh 121 and the outer metal mesh 122 of the groove section of the metal support 1, is located in the space and is close to the inner metal mesh 121, and the other side of the drainage tube 3 is led out from the inner cavity of the head end of the second raised section 13. The drainage tube 3 located in the space is arranged in the length direction of the entire groove section, that is, the length of the drainage tube 3 located in the space is the same as the length of the groove section.
[0048] Preferably, the drainage tube 3 is a single tube or a double tube.
[0049] Preferably, the single drainage tube 3 is a suction drainage tube, and the outlet end of the suction drainage tube is connected to an external negative pressure device through a negative pressure suction connector. The tube wall of the suction drainage tube is provided with a plurality of first side holes, which are used to connect the suction drainage tube and the space.
[0050] Preferably, the single drainage pipe 3 is a dual-channel pipe, with an internal suction channel and a water injection channel. The pipe wall of the dual-channel pipe is provided with multiple second side holes and multiple third side holes. The multiple second side holes are used to connect the suction channel and the space, and the multiple third side holes are used to connect the water injection channel and the space. The outlet end of the dual-channel pipe is connected to a negative pressure suction connector and an air injection connector. The negative pressure suction connector is connected to the suction channel and to an external negative pressure device, and the air injection connector is connected to the water injection channel and to an external water injection pipe.
[0051] Preferably, the drainage tube 3 is a double tube, which includes a suction tube and a flushing tube. Both the suction tube and the flushing tube are single-channel tubes. The suction tube is connected to an external negative pressure device through a negative pressure suction connector, and the flushing tube is connected to an external water injection pipe through an air injection connector. The flushing tube is straight or circular (i.e. spiral). The suction tube has multiple fourth side holes on its wall, which are used to connect the suction tube and the space. The flushing tube has multiple fifth side holes on its wall, which are used to connect the flushing tube and the space.
[0052] Preferably, the suction tube and the flushing tube are arranged symmetrically with respect to the center of the metal support.
[0053] Preferably, the stent release device includes an outer sheath 21 and a pusher 22. The pusher 22 is inserted into the outer sheath 21. Before the metal stent is released, it is sleeved on the pusher 22 and located inside the outer sheath 21.
[0054] Preferably, the head end of the outer sheath 21 is wrapped with or not wrapped with a silicone protective ring 23, and the tail end of the outer sheath 21 is provided with a first handle; the head end of the pusher 22 is tapered, and the tube wall of the pusher 22 is provided with a metal bracket limiting structure (an existing limiting structure can be used). Before the metal bracket 1 is released, it is sleeved between the tapered structure and the limiting structure, and the tail end of the pusher 22 is provided with a second handle.
[0055] After release, the metal stent of this invention can block leaks in the digestive tract or support anastomoses. Fluids secreted by the intestinal mucosa, blood vessels, and leak tissue can enter between the two metal stent meshes through the circular holes on the silicone coating of the outer metal mesh of the stent, and be sucked out by negative pressure. This can keep the anastomosis and leak clean and promote the healing of the anastomosis and leak. By continuously injecting water or air into the sealed space between the two metal meshes of the stent, the anastomosis mucosa and leak are constantly flushed. This not only promotes the discharge of inflammatory mediators secreted by the anastomosis and leak, but also reduces the blockage rate of the negative pressure drainage tube, thereby accelerating the healing of the anastomosis and leak.
[0056] Use of this utility model:
[0057] 1. Treatment of gastrointestinal perforation or anastomotic leakage
[0058] If a gastroscopy or colonoscopy reveals a perforation in the digestive tract or anastomotic leakage, a guidewire is inserted and advanced into the distal digestive tract. Guided by the guidewire, the metal stent is placed. The stent pusher (push tube) of the stent release device is secured, and the outer sheath is pulled back. The metal stent is gradually released from the outer sheath until it is completely released. The drainage tube is secured, and the stent release device is pulled back until it separates from the stent release device.
[0059] 1.1 Single suction drainage tube
[0060] The outlet of the suction drainage tube is connected to an external negative pressure device (existing equipment) through a negative pressure suction connector, which can intermittently or continuously suction out secretions that have entered between the two metal meshes.
[0061] 1.2 Single-channel dual-channel flushing drainage tube
[0062] The outlet of the dual-channel drainage tube is connected to an air injection connector and a negative pressure suction connector. Air or water is injected through the air injection connector and enters the cavity between the two metal meshes. The negative pressure suction connector is connected to the negative pressure suction tube to intermittently or continuously suck out the air, water and secretions between the two metal meshes.
[0063] 1.3 Dual single-channel flushing drainage tubes
[0064] An air or water is injected into a drainage tube through an air injection connector. The air or water flows into the cavity between two layers of metal mesh through the side hole of the drainage tube. A negative pressure suction tube is connected through a negative pressure suction connector to intermittently or continuously suck out the water and secretions in the cavity between the two layers of metal mesh.
[0065] 2. Acute phase intestinal anastomosis
[0066] For patients with acute intestinal obstruction, after resection of necrotic and stenotic intestinal segments, enterostomy is unnecessary; the edematous intestinal segments are directly anastomosed end-to-end. The intestinal wall is incised away from the anastomosis site, and the metal stent is inserted through the incision. The anastomosis site is located in the grooved section of the metal stent. The intestinal segments at both ends of the anastomosis are squeezed towards the center of the metal stent. The stent pusher of the stent release device is fixed, and the outer sheath is pulled back. The metal stent is gradually released from the outer sheath until it is completely released. The drainage tube is fixed, and the stent release device is pulled back until the drainage tube separates from the stent release device. At this point, the intestinal wall on the grooved section of the metal stent is folded, and the anastomosis is tension-free. Absorbable sutures are used to fix the intestinal wall to the raised tube walls at both ends of the metal stent to prevent stent displacement. The entire intestinal wall incision and the depressor muscle layer are sutured with absorbable sutures and fixed to the drainage tube. The drainage tube runs parallel to the intestinal wall, and the seromuscular layer is sutured to wrap the drainage tube. Finally, the drainage tube is brought out through a puncture in the abdominal wall, and the drainage tube is sutured to the abdominal wall to fix it. By using negative pressure suction, secretions from the gaps between the two metal mesh layers can be drawn out intermittently or continuously. Alternatively, air or water can be continuously injected into the gaps between the two metal mesh layers to dilute the secretions and promote their drainage.
[0067] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.
Claims
1. A metal stent for intestinal anastomosis and anastomotic leakage, characterized in that, include: Metal stent (1), drainage tube (3) and stent release device, the metal stent (1) is set in the stent release device before release, the metal stent (1) is dumbbell shaped after release, including a first raised section (11) and a second raised section (13) set at both ends and a groove section set in the middle, the groove section is set between the first raised section (11) and the second raised section (13); The groove section is a double-layer metal mesh, including an inner metal mesh (121) and an outer metal mesh (122), with a space between the inner metal mesh (121) and the outer metal mesh (122); The inner and outer surfaces of the metal bracket (1) are covered with a silicone coating. The silicone coating at the outer metal mesh (122) is provided with a plurality of circular holes (123), which are connected to the space. The drainage tube (3) is connected to the groove section, and the interior of the drainage tube (3) is in communication with the space.
2. The intestinal anastomosis and anastomotic leakage metal stent according to claim 1, characterized in that, The metal support (1) is woven from nickel-titanium alloy wire, and the plurality of circular holes (123) are distributed on the silicone coating between the meshes of the outer metal mesh (122).
3. The intestinal anastomosis and anastomotic leakage metal stent according to claim 1, characterized in that, One side of the drainage tube (3) passes between the inner metal mesh (121) and the outer metal mesh (122), is located in the space and is close to the inner metal mesh (121), and the other side of the drainage tube (3) is led out from the inner cavity of the second raised section (13), wherein the drainage tube (3) located in the space is arranged along the length of the entire groove section.
4. The intestinal anastomosis and anastomotic leakage metal stent according to claim 3, characterized in that, The drainage tube (3) can be a single tube or two tubes.
5. The intestinal anastomosis and anastomotic leakage metal stent according to claim 4, characterized in that, The single drainage tube (3) is a suction drainage tube. The outlet end of the suction drainage tube is connected to an external negative pressure device through a negative pressure suction connector. The tube wall of the suction drainage tube is provided with multiple first side holes, which are used to connect the suction drainage tube and the space.
6. The intestinal anastomosis and anastomotic leakage metal stent according to claim 4, characterized in that, The single drainage tube (3) is a dual-channel tube with an internal suction channel and a water injection channel. The tube wall of the dual-channel tube is provided with multiple second side holes and multiple third side holes. The multiple second side holes are connected to the suction channel and the space, and the multiple third side holes are connected to the water injection channel and the space. The outlet end of the dual-channel tube is connected to a negative pressure suction connector and an air injection connector. The negative pressure suction connector is connected to the suction channel and to an external negative pressure device, and the air injection connector is connected to the water injection channel and to an external water injection pipe.
7. The intestinal anastomosis and anastomotic leakage metal stent according to claim 4, characterized in that, The drainage tube (3) is double-ended, and the double-ended drainage tube (3) includes a suction tube and a flushing tube. Both the suction tube and the flushing tube are single-channel tubes. The suction tube is connected to an external negative pressure device through a negative pressure suction connector, and the flushing tube is connected to an external water injection pipe through an air injection connector. The flushing tube is straight or annular. The suction tube has multiple fourth side holes on its wall, which are used to connect the suction tube and the space. The flushing tube has multiple fifth side holes on its wall, which are used to connect the flushing tube and the space.
8. The intestinal anastomosis and anastomotic leakage metal stent according to claim 7, characterized in that, The suction tube and the flushing tube are symmetrically arranged around the center of the metal support (1).
9. The intestinal anastomosis and anastomotic leakage metal stent according to claim 1, characterized in that, The stent release device includes an outer sheath (21) and a pusher (22). The pusher (22) is inserted into the interior of the outer sheath (21). Before release, the metal stent (1) is sleeved on the pusher (22) and located inside the outer sheath (21).
10. The intestinal anastomosis and anastomotic leakage metal stent according to claim 9, characterized in that, The head end of the outer sheath (21) may or may not be covered by a silicone protective ring (23), and the tail end of the outer sheath (21) is provided with a first handle; The head end of the pusher (22) is tapered, and a limiting structure is provided on the tube wall of the pusher (22). Before the metal bracket (1) is released, it is sleeved between the tapered structure and the limiting structure. The tail end of the pusher (22) is provided with a second handle.