Partially covered stent for biliary and pancreatic duct drainage notes procedure

Abstract

The application relates to a part-coated stent for biliary and pancreatic duct drainage Notes operation, which comprises an operating handle and a stent body, the tail end of the operating handle is provided with the stent body; one end of the stent body is provided with a first fixing ring; the right end of the first fixing ring is provided with a connecting stent, and the inside of the connecting stent and the first fixing ring is provided with a coating; the right end of the connecting stent is provided with a second fixing ring, and the upper end of the second fixing ring is cup-shaped, and the lower end extends outward in a trumpet shape. The application has the advantages that the shape design is reasonable, the trumpet mouth is enlarged in a stepped manner, the compliance is good, the fixation is firm, the part-coated stent design has the advantages of both the coated stent and the non-coated stent, compared with the prior art, the stent deployment process is simpler, the operation time and the requirement for re-intervention are significantly reduced, the occurrence of adverse events and the discomfort of patients are reduced, the risk of radiation exposure is reduced, and the stent with multiple specifications facilitates clinical operation of various requirements.

Description

[Technical Field]

[0001] This invention relates to the field of medical device technology, specifically to a partially covered stent for Notes procedure of bile and pancreatic duct drainage. [Background Technology]

[0002] Endoscopic retrograde cholangiopancreatography (ERCP) is currently the standard treatment for patients with unresectable malignant biliary obstruction. However, ERCP fails in 5%–10% of patients due to malignant duodenal obstruction, anatomical changes, inability to insert a catheter through the papilla, or stricture of the common bile duct, requiring other decompression methods such as percutaneous transhepatic biliary drainage (PTCD), surgical bypass, and EUS-guided biliary drainage (EUS-BD). PTCD drains bile externally, altering the normal metabolic pathway of bile, which can easily cause electrolyte disturbances and indigestion. The main complications of PTCD include infection, bleeding, bile leakage, stent migration or occlusion, catheter slippage, external catheter infection, and fistula, with an incidence rate as high as 33%. Therefore, EUS-BD has become a preferred option for biliary drainage after ERCP failure. EUS-BD is a minimally invasive procedure with high clinical success rates, multiple flexible access routes, no external tube placement, reduced risk of infection, rapid postoperative recovery, and significantly shorter hospital stays. If biliary stent placement leads to re-obstruction, interventional treatment can be performed again through a transmural fistula. However, EUS-BD requires a high level of operator skill, and common complications include bile leakage, bleeding, cholangitis, sepsis, and peritonitis. Less common complications include intraperitoneal stent displacement and fatal perforation.

[0003] EUS-BD commonly uses two types of scaffolds: covered scaffolds and non-covered scaffolds. The difference lies in the membrane structure on the covered scaffold. Covered scaffolds effectively prevent newly formed granulation tissue from passing through the metal scaffold, reducing the risk of embedding, but they also increase the risk of scaffold migration. Non-covered scaffolds are more prone to embedding than covered scaffolds. Various semi-covered scaffolds exist in existing technologies, but most are limited to a single specification and cannot meet the anatomical requirements of multiple access routes.

[0004] Chinese patent application CN210130977U discloses a semi-covered gastrobiliary anastomosis stent, comprising a gastric segment stent and a biliary segment stent integrally connected, both made of clinically acceptable metal materials. A gastric end fixation ring extends from the open end of the gastric segment stent, with the diameter of the fixation ring coaxial with the gastric segment stent. Both the gastric segment stent and the gastric end fixation ring are covered with a membrane. A biliary end fixation ring extends from the open end of the biliary segment stent, with the biliary end fixation ring coaxial with the biliary segment stent. The outer diameter of the biliary end fixation ring is smaller than that of the gastric end fixation ring. This invention can effectively prevent intraperitoneal bile leakage and the ingrowth of gastric segment tumor tissue and granulation tissue into the stent, while also preventing blockage of the biliary segment stent. It is particularly suitable for drainage of the upper and middle segments of the bile duct and the intrahepatic bile duct system. For patients who cannot undergo surgery or whose ERCP has failed, the clinical efficacy of internal drainage using this gastrobiliary anastomosis stent under EUS guidance is good. However, if the covered and uncovered positions of the device are not set properly, the lack of a covered position can easily lead to lumen adhesion, leakage, and stent migration. The stent maintaining its position will not cause pressure damage or proliferative tissue reaction.

[0005] In summary, there is an urgent need for a semi-covered stent that not only has anchoring devices at both ends, but also has a reasonable shape and covering position. The covering position prevents the growth of new granulation tissue through the mesh, making it easy to remove the snare tightened at the saddle. The setting of the non-covered position can further increase resistance and reduce the dislodgement of the semi-covered stent during the Notes procedure for bile and pancreatic duct drainage. [Summary of the Invention]

[0006] The purpose of this invention is to provide a semi-covered stent that not only has anchoring devices at both ends, but also rationally sets the shape and covering position of the stent. The covering position prevents the growth of new granulation tissue through the mesh, making it easy to remove using a snare tightened at the saddle. The setting of the non-covered position can further increase resistance and reduce the dislodgement of the semi-covered stent during the Notes procedure for bile and pancreatic duct drainage.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] A partially covered stent for Notes procedure of bile and pancreatic duct drainage includes an operating handle and a stent body. The stent body is located at the tail end of the operating handle. One end of the stent body is provided with a first fixing ring, which is an inwardly recessed circular ring. A connecting stent is provided at the right end of the first fixing ring, and both the connecting stent and the first fixing ring are covered with a membrane. A second fixing ring is provided at the right end of the connecting stent, and the upper end of the second fixing ring is cup-shaped, while the lower end extends outward in a trumpet shape, with a 135° angle between the upper and lower ends. The upper end is covered with a membrane, while the lower end is not covered with a membrane.

[0009] As a preferred example, the stent is divided into a pancreatic duct and a bile duct.

[0010] More preferably, the first fixing ring of the pancreatic duct has a maximum diameter of 10 mm, the connecting bracket has a minimum diameter of 4 mm, and a length of 5 cm, 7 cm, 9 cm, or 12 cm. The second fixing ring has a maximum diameter of 5 mm for the covered portion and a length of 10 mm for the uncovered portion, and a maximum diameter of 6 mm for the uncovered portion and a length of 4 mm.

[0011] More preferably, the first fixing ring of the bile duct has a maximum diameter of 20 mm, the connecting bracket has a minimum diameter of 8 mm, and the covering length is 5 cm, 7 cm, 9 cm or 12 cm. The second fixing ring has a maximum diameter of 10 mm and a length of 10 mm for the covered portion, and a maximum diameter of 12 mm and a length of 5 mm for the uncovered portion.

[0012] As a preferred example, the support body is a mesh support.

[0013] The advantages of this invention are:

[0014] 1. The present invention has a reasonable shape design, with the flared opening expanding in a stepped shape, which has good conformability and is firmly fixed. It is also fixed at both ends, and the exposed part plays an anchoring role. One end adopts a non-covered scaffold, while the other end and the whole body adopt a covered scaffold. The design of the covered and non-covered positions is reasonable. The setting of the non-covered structure can increase resistance and reduce detachment, preventing scaffold migration. The setting of the covered structure can prevent the growth of new granulation tissue through the mesh, making it easy to remove the snare tightened at the saddle. It also reduces lumen adhesion, scaffold embedding and leakage. Moreover, the scaffold maintains its position without causing pressure damage or proliferative tissue reaction.

[0015] 2. The present invention has a large diameter, which facilitates drainage operations. It also has stents of various specifications to meet various clinical needs. Compared with the existing technology, the stent deployment process is simpler, which significantly reduces the operation time and the need for re-intervention, reduces the occurrence of adverse events and patient discomfort, and reduces the risk of radiation exposure. [Attached Image Description]

[0016] Appendix Figure 1 This invention relates to the operating handle of a partially covered stent for the Notes procedure of bile and pancreatic duct drainage.

[0017] Appendix Figure 2 This invention relates to a partially covered stent for a Notes procedure for bile and pancreatic duct drainage (point B in the figure represents the uncovered stent).

[0018] Appendix Figure 3 This is a cross-sectional view of the stent body of a partially covered stent for the Notes procedure of bile and pancreatic duct drainage according to the present invention.

Detailed Implementation Methods

[0019] The present invention will now be further described with reference to the embodiments and the accompanying drawings.

[0020] The reference numerals and components involved in the accompanying drawings are shown below:

[0021] 1. Operating handle 2. Scaffold 21. First fixing ring 22. Connecting bracket 23. Second fixing ring

[0022] Example 1

[0023] Please see Figure 1 , Figure 2 and Figure 3 , Figure 1 This invention relates to the operating handle of a partially covered stent for the Notes procedure of bile and pancreatic duct drainage. Figure 2 This invention relates to a partially covered stent for the Notes procedure of bile and pancreatic duct drainage (the uncovered stent is marked at point B in the figure). Figure 3 This is a cross-sectional view of the stent body of a partially covered stent for the Notes procedure of bile duct and pancreatic duct drainage according to the present invention. The partially covered stent for the Notes procedure of bile duct and pancreatic duct drainage includes an operating handle 1 and a stent body 2, wherein the stent body is provided at the tail end of the operating handle, as shown... Figure 1 As shown, point A represents the bracket not being released. It is released by operating the handle. Figure 2 The support body 2 has a first fixing ring 21 at one end, and the first fixing ring 21 is in the shape of an inwardly recessed ring; the right end of the first fixing ring 21 has a connecting bracket 22, and both the connecting bracket 22 and the first fixing ring 21 are covered with a film; the right end of the connecting bracket 22 has a second fixing ring 23, and the upper end of the second fixing ring 23 is cup-shaped, the lower end extends outward into a trumpet shape, the upper and lower ends have a 135° corner, the upper end is covered with a film, and the lower end is not covered with a film.

[0024] In this embodiment, the stent body 2 is preferably divided into a pancreatic duct and a bile duct.

[0025] In this embodiment, the first fixing ring 21 of the pancreatic duct preferably has a maximum diameter of 10 mm, the connecting bracket 22 has a minimum diameter of 4 mm and a length of 5 cm, 7 cm, 9 cm or 12 cm, the second fixing ring 23 has a maximum diameter of 5 mm and a length of 10 mm for the covered portion, and a maximum diameter of 6 mm and a length of 4 mm for the uncovered portion.

[0026] In this embodiment, the first fixing ring 21 of the bile duct preferably has a maximum diameter of 20 mm, the connecting bracket 22 has a minimum diameter of 8 mm, and the covering length is 5 cm, 7 cm, 9 cm or 12 cm. The second fixing ring 23 has a maximum diameter of 10 mm and a length of 10 mm for the covered portion, and a maximum diameter of 12 mm and a length of 5 mm for the uncovered portion.

[0027] In this embodiment, the support body 2 is preferably a mesh support.

[0028] The method and principle of use of the present invention are as follows: When in use, the first fixing ring 21 is placed in the patient's stomach by operating the handle 1, and the second fixing ring 23 is placed in the patient's bile duct / pancreatic duct. The upper ends of the first fixing ring 21, the connecting bracket 22 and the second fixing ring 23 are covered with a membrane to prevent new granulation tissue from growing in through the mesh. The second fixing ring 23 has a special shape and the lower end is not covered with a membrane, so it has greater resistance and can achieve a good fixing effect.

[0029] It should be noted that the present invention has a reasonable shape design, with a stepped expansion of the flared opening, good conformability, and reliable fixation. Both ends are fixed, and the exposed portion acts as an anchor. One end uses a non-covered stent, while the other end and the entire body use a covered stent. The design of the covered and non-covered positions is reasonable. The non-covered structure increases resistance and reduces dislodgement, preventing stent migration. The covered structure prevents the growth of new granulation tissue through the mesh, making it easy to remove the snare tightened at the saddle. It also reduces lumen adhesion, stent embedding, and leakage. The stent maintains its position without causing pressure damage or proliferative tissue reaction. The large diameter facilitates drainage operations, and various stent sizes are available to meet diverse clinical needs. Compared to existing technologies, the stent deployment process is simpler, significantly reducing surgical time and the need for re-intervention, minimizing adverse events and patient discomfort, and lowering the risk of radiation exposure.

[0030] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the principle of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A partially covered stent for Notes procedure of bile and pancreatic duct drainage, comprising an operating handle and a stent body, characterized in that, The operating handle has a support body at its tail end; one end of the support body has a first fixing ring, which is an inwardly recessed ring. The first fixing ring has a left side and a right side, and a space is formed between the left side and the right side. The outer periphery of the left side of the first fixing ring is further away from the connecting bracket than the inner periphery. The right end of the first fixing ring has a connecting bracket, and both the connecting bracket and the first fixing ring have a film covering inside. The right end of the connecting bracket has a second fixing ring, which has a cup-shaped upper end and a small trumpet-shaped lower end that extends outward. The upper and lower ends are stepped and widened, with a corner angle of 135°. The upper end is film-covered and the lower end is not film-covered. Except for the lower end of the second fixing ring, all other parts of the support body are film-covered.

2. The partially covered stent for the Notes procedure of bile and pancreatic duct drainage according to claim 1, characterized in that, The stent is divided into the pancreatic duct and the bile duct.

3. The partially covered stent for the Notes procedure for bile and pancreatic duct drainage according to claim 2, characterized in that, The first fixing ring of the pancreatic duct has a maximum diameter of 10mm, the connecting bracket has a minimum diameter of 4mm, and a length of 5cm, 7cm, 9cm, or 12cm. The second fixing ring has a maximum diameter of 5mm for the covered portion and a length of 10mm for the uncovered portion, and a maximum diameter of 6mm for the uncovered portion and a length of 4mm.

4. The partially covered stent for the Notes procedure of bile and pancreatic duct drainage according to claim 2, characterized in that, The first fixing ring of the bile duct has a maximum diameter of 20mm, the connecting bracket has a minimum diameter of 8mm, and the covering length is 5cm, 7cm, 9cm or 12cm. The second fixing ring has a maximum diameter of 10mm and a length of 10mm for the covered portion, and a maximum diameter of 12mm and a length of 5mm for the uncovered portion.

5. The partially covered stent for the Notes procedure of bile and pancreatic duct drainage according to claim 1, characterized in that, The support structure is a mesh support.

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