Gallstone removing device

Abstract

The invention discloses a gallstone removing device. The gallstone removing device comprises a mesh tubular stent and a stent conveying system, wherein the mesh tubular stent is formed by interweaving one or more weaving wires; the mesh tubular stent comprises a stent main body, and a stent far end and a stent near end positioned at two ends of the stent main body; when the mesh tubular stent is in a released state, the diameter of the stent far end is larger than or equal to that of the stent body, and the diameter of the stent near end is larger than or equal to that of the stent body. After the far end of the stent is released, the diameter of the stent is larger than the inner diameter of a gallbladder duct and the inner diameter of a total bile duct, a funnel-shaped structure completely attached to the wall of the bile duct can be formed, calculus in the gallbladder can be sucked into the funnel-shaped structure at a time by combining an in-vitro negative pressure suction device, finally the calculus is removed from a biliary tract system, and a calculus removing net basket does not need to enter and exit from the gallbladder repeatedly. The gallbladder and the bile duct are prevented from being damaged; the stent adopting the degradable silk can be fully degraded in a biliary tract system within three months and does not need to be taken out through a secondary operation, and complications are avoided.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a gallbladder stone removal device. Background Technology

[0002] See appendix Figure 1 As shown, the gallbladder is located below the liver. A normal gallbladder is about 8-12 cm long, 3-5 cm wide, and has a capacity of about 30-60 ml. The cystic duct is a slender tube connecting the gallbladder and the common bile duct. It is about 3-5 cm long and has an inner diameter of about 3-4 mm. Its main function is to transport bile stored in the gallbladder to the common bile duct and then into the intestines to participate in digestion.

[0003] See appendix Figure 2 As shown, gallstones are stones that form within the gallbladder, primarily caused by changes in the composition of bile and bile stasis. Gallstones are a common condition that can lead to a series of complications, with common symptoms including right upper quadrant pain and bloating. Most patients can relieve pain with medication, but when stones exceed 2 cm, the gallbladder wall is calcified, or stones are accompanied by gallbladder polyps, surgical removal of the gallbladder is necessary to alleviate symptoms, improve quality of life, and prevent future gallbladder cancer due to chronic inflammation. Gallbladder removal surgery has disadvantages such as significant trauma and slow postoperative recovery. Because the gallbladder is a vital digestive and immune organ, gallbladder removal can cause many side effects, such as indigestion, diarrhea, bloating, bile reflux gastritis, common bile duct stone formation, and even a significant increase in the risk of colon cancer. Theoretically, gallbladder-preserving stone removal is the optimal clinical treatment for gallstones. Extracorporeal shock wave lithotripsy (ESWL) or laser lithotripsy not only damages the gallbladder but also requires repeated lithotripsy of the same area, often leading to adhesions between the stones and surrounding tissues, ultimately requiring surgical intervention. Given the gallbladder's contractile function, establishing a temporary passage between the gallbladder and common bile duct can potentially clear small gallstones within a month. However, this temporary passage should not be maintained for extended periods, as reflux from the intestines and common bile duct can cause gallbladder infection and inflammation. In summary, a perfect gallbladder stone removal system requires: 1) an instrument capable of minimally invasive access to the gallbladder; 2) a device for minimally invasive and efficient removal of gallstones; and 3) a temporary passage between the gallbladder and common bile duct.

[0004] Patent documents "CN206714791U" and "CN113384346A" respectively disclose a clamp body for taking gallstones under laparoscope and a laparoscope gallbladder-preserving lithotripsy stone taking cannula, which is used in the process of first crushing large gallbladder stones by using a special device, and then taking out the crushed stones, so as to complete the taking out operation of gallbladder stones, but such device has the following defects: 1. The clamp body holding the stones needs to be taken out from the gallbladder for many times, which is easy to cause damage to the gallbladder and increase the pain of the patient; 2. In the process of crushing large stones by the clamp body, small stone particles fall into the gallbladder and still need to be removed in subsequent surgery.

[0005] Based on the above clinical pain points, a high-efficiency gallbladder stone removing device is designed to solve the above problems.

[0006] It should be noted that the above introduction to the technical background is only for the convenience of clearly and completely describing the technical scheme of the present application and facilitating the understanding of those skilled in the art. The above technical scheme cannot be considered as known to those skilled in the art only because it is described in the background section of the present application. SUMMARY

[0007] In order to overcome the above-mentioned deficiencies in the prior art, the purpose of the present application is to provide a gallbladder stone removing device.

[0008] In order to achieve the above purpose and other related purposes, the technical scheme provided by the present application is: a gallbladder stone removing device, which comprises a net tube-shaped stent formed by one or more interwoven wires; the net tube-shaped stent comprises a stent main body and stent distal ends and stent proximal ends located at both ends thereof; when the net tube-shaped stent is in a released state, the diameters of the stent distal ends and the stent proximal ends are both greater than or equal to the diameter of the stent main body. When the interwoven wires are made of degradable materials, the net tube-shaped stent can be completely absorbed after completing the clinical function. It should be noted that "multiple" in the present scheme includes two.

[0009] Further, the stent distal ends are released in a funnel-shaped or spherical crown structure in the gallbladder, and the stent proximal ends are released in a straight pipe or spherical crown in the common bile duct or duodenum. It should be noted that the shape of the stent proximal end in the released state includes but is not limited to a straight pipe, a spherical crown, and can also be a drum or other shapes that meet the functional requirements.

[0010] It should be noted that the funnel shape in the present scheme refers to the interwoven net structure formed by the gradually increasing diameter of the stent distal end in the direction away from the stent main body. The spherical crown in the present scheme refers to a large spherical crown shape containing a spherical center. The drum shape in the present scheme refers to a drum-shaped profile formed by the maximum diameter of the middle part of the stent proximal end and the gradual shrinkage along the axial direction to both ends.

[0011] Further, when weaving, the weaving wires are interwoven / back and forth interwoven in a spiral feeding manner along the axial direction.

[0012] Further, when the number of weaving wires is greater than or equal to two, the weaving wires located at both ends of the mesh tubular stent are in an open structure without connection or a closed structure with two-by-two fixation. It should be noted that in the closed structure, the two-by-two fixation of the weaving wires includes but is not limited to welding, riveting, crimping, bonding (using medical-grade biocompatible adhesive), and can also be other fixation modes that meet the functional requirements of the stent.

[0013] In the open structure, the end points of the weaving wires are in an unconnected state, and the advantage of this structure is low processing cost, but the mechanical properties of the mesh tubular stent at both ends are deviated, and looseness is prone to occur; in the closed structure, the end points of the weaving wires are in a welded or riveted fixed state, and the advantage of this structure is that the mechanical properties of the mesh tubular stent at both ends are stable, but the processing cost is high.

[0014] Further, the material of the weaving wires includes but is not limited to magnesium alloy, iron (base) alloy, zinc alloy, molybdenum alloy, nickel-titanium alloy, cobalt-chromium alloy, polyglycolide, polylactic acid, polyglycolide-lactide, or polycaprolactone. In a specific embodiment, the material of the degradable metal wire includes but is not limited to magnesium alloy, iron alloy, zinc alloy, or molybdenum alloy.

[0015] Further, the mesh tubular stent is provided with a high-molecular film layer, and the high-molecular film layer at least covers the distal end portion of the mesh tubular stent in the axial direction; the mesh tubular stent can form a sealed and smokeable tube cavity structure completely adhered to the bile duct wall in the released state. The material of the high-molecular film layer includes but is not limited to polyglycolide, polylactic acid, polyglycolide-lactide, polycaprolactone, silicone, or polyurethane.

[0016] Further, the mesh tubular stent and / or the high-molecular film layer are loaded with drugs. The surface of the stent and the high-molecular film layer can be loaded with therapeutic drugs, for example, antibiotics, anti-platelet drugs, anti-inflammatory drugs, drugs for promoting endothelialization, or anti-tissue proliferation drugs, etc.

[0017] Further, the diameter of the weaving wire is 0.05-0.5 mm; the length of the mesh tubular stent in the released state is 20-200 mm, and the diameter of the stent is 3-20 mm. In a specific embodiment, the surface of the degradable metal wire can be passivated as required.

[0018] Further, the cross-sectional shape of the weaving wire is at least one of a circular shape, an elliptical shape, and a rectangular shape. The cross-sectional shape of the weaving wire includes but is not limited to a combination of one or more of a circular shape, an elliptical shape, and a rectangular shape.

[0019] Further, the present application also includes a stent delivery system for delivering the mesh tubular stent, which comprises an inner tube and an outer tube sleeved on the inner tube, and a receiving cavity for compressively receiving the mesh tubular stent is defined between the inner tube and the outer tube. A handle is arranged at the proximal end of the inner tube, and a soft head extending out of the receiving cavity is arranged at the distal end of the inner tube, and a stent recovery buckle is arranged at the end of the inner tube close to the soft head, and the proximal end of the outer tube is connected with the handle. When the outer tube moves towards the handle, the mesh tubular stent is gradually exposed out of the receiving cavity and released, and the inner diameter of the released mesh tubular stent is greater than the outer diameter of the outer tube.

[0020] It should be noted that the proximal end refers to the end entering the human body first and close to the handle in the direction of stent implantation into the human body, and the distal end refers to the end entering the human body last and close to the soft head of the delivery system in the direction of stent implantation into the human body.

[0021] Further, the outer tube is composed of an outer layer, an intermediate layer and an inner layer sleeved from outside to inside, the intermediate layer is a mesh tubular structure or a spring structure woven by metal wires, the material hardness of the distal end of the outer tube is less than or equal to the material hardness of the main body of the outer tube, the inner diameter of the outer tube is 1-7 mm, and the outer diameter of the outer tube is 2-10 mm.

[0022] Due to the use of the above technical solutions, the present application has the following beneficial effects compared with the prior art: Compared with the instruments used in clinical practice and the published invention applications, the gallbladder stone removal device of the present application has the following advantages: (1) The distal end of the stent delivery system of the present application is relatively soft and has good anti-bending performance, and can enter the tortuous cystic duct, thereby avoiding excessive expansion and damage to the cystic duct.

[0023] (2) After the distal end of the stent of the present application is released, the diameter of the stent is greater than the inner diameter of the cystic duct, and a structure completely adhering to the wall of the bile duct can be formed, and in combination with an external negative pressure suction device, the gallbladder stones can be suctioned into the structure at one time, and finally removed from the biliary system, without the need to use a traditional stone removal basket to enter and exit the gallbladder multiple times, thereby avoiding damage to the gallbladder and bile duct.

[0024] (3) The diameters of the two ends of the stent of the present application are greater than the diameter of the main body of the stent, and the stent will not be displaced.

[0025] (4) The stent made of degradable material of the present application can be completely degraded in the biliary system in about three months, without the need for a second operation to remove it, thereby not only reducing the cost of surgery, but also avoiding serious complications such as cholangitis and pancreatitis. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 Anatomical illustration of gallbladder, bile duct and duodenum; Figure 2 Illustration of gallbladder stone; Figure 3 Illustration of gallbladder stone removal stent of the present application (both distal and proximal diameters are larger than the main body diameter); Figure 4 Illustration of stent delivery system of the present application; Figure 5 Illustration of inner tube and its related structure of the present application; Figure 6 Illustration of outer tube structure of the present application; Figure 7 Illustration of gallbladder stone removal by external suction pump after the distal end of the stent of the present application is released; Figure 8 Illustration of gallbladder stone removal stent of the present application (both distal and proximal ends are spherical); Figure 9 Illustration of gallbladder stone removal stent of the present application (distal diameter is larger than the main body diameter); Figure 10 Illustration of gallbladder stone removal stent of the present application as a temporary stent left in the cystic duct; In the above drawings, 1, distal end of the stent; 2, main body of the stent; 3, proximal end of the stent; 4, outer tube; 5, inner tube; 6, stent recovery buckle; 7, soft head; 8, handle; 9, inner layer; 10, middle layer; 11, outer layer. DETAILED DESCRIPTION

[0027] The embodiments of the present application will be described in detail by the following specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the contents disclosed in the specification.

[0028] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "arrangement", "installation", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrally connected, it can be mechanically connected, or it can be electrically connected, it can be directly connected, or it can be indirectly connected through an intermediate medium, it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0029] The preferred embodiments of the present application will be described in detail below with reference to the drawings, so that the advantages and features of the present application can be more easily understood by those skilled in the art, and the protection scope of the present application can be more clearly and explicitly defined.

[0030] Referring to the drawingsFigure 3 , attached Figure 8 and attached Figure 9 As shown in the drawings, the gallbladder stone removal device of the present application comprises a mesh tube stent, which is interwoven by one or more woven wires; the mesh tube stent comprises a stent body 2 and a stent distal end 1 and a stent proximal end 3 at both ends thereof; when the mesh tube stent is in a released state, the diameter of the stent distal end 1 is greater than or equal to the diameter of the stent body 2, and the diameter of the stent proximal end 3 is greater than or equal to the diameter of the stent body 2. The woven wire is made of degradable material, and after the clinical function is completed, the mesh tube stent can be completely absorbed. The stent distal end 1 is in a funnel shape or a spherical crown structure in the released state of the stent, and the stent proximal end 3 is in a straight pipe shape, a spherical crown shape or a drum shape in the released state of the stent.

[0031] It should be noted that the straight pipe shape in the present embodiment refers to a pipe shape structure with the same diameter as the stent body 2. The funnel shape in the present embodiment refers to a woven mesh structure in which the diameter of the stent distal end 1 gradually increases in the direction away from the stent body 2. The spherical crown shape in the present embodiment refers to a large spherical crown shape containing a spherical center. The drum shape in the present embodiment refers to a drum-like profile formed by gradually tapering the middle part of the stent proximal end 3 along the axial direction to both ends. In specific embodiments, the shape of the stent distal end 1 in the released state of the stent is not limited to the funnel shape or the spherical crown shape, and the shape of the stent proximal end 3 in the released state of the stent is not limited to the straight pipe shape, the spherical crown shape or the drum shape.

[0032] When weaving, the woven wires are interwoven / back and forth interwoven in the axial direction in a spiral feeding manner. It should be noted that when the woven wires are interwoven, the woven wires in the same diameter section are fed at a constant pitch, which can ensure that the mesh holes of the section are uniformly expanded, improve the support stability, and the overall structure is more stable in supporting the bile duct. When the number of woven wires is greater than or equal to two, the woven wires at both ends of the mesh tube stent are in an open structure or a closed structure welded or riveted fixedly. In the open structure, the end points of the woven wires are in an unconnected state, and the advantage of this structure is low processing cost, but the mechanical properties of the two ends of the mesh tube stent are deviated, and loose is easy to occur. As shown in the drawings, in the closed structure, the end points of the woven wires are in a welded fixed state, and the advantage of this structure is that the mechanical properties of the two ends of the mesh tube stent are stable, but the processing cost is high. Figure 3

[0033] Based on this, in some embodiments, the material of the woven wire includes but is not limited to degradable metals such as magnesium alloy, iron (base) alloy, zinc alloy or molybdenum alloy.

[0034] ​In some embodiments, the surface of the mesh-tube stent is provided with a polymer film layer, and the material of the polymer film layer includes, but is not limited to, polyglycolide, polylactic acid, polyglycolide-lactide, polycaprolactone, silica gel or polyurethane. It should be noted that the polymer film layer on the surface of the mesh-tube stent covers at least the distal end portion in the axial direction, and in specific embodiments, the polymer film layer on the surface of the mesh-tube stent can cover: the distal end of the stent, the distal end of the stent + part of the main body of the stent, the distal end of the stent + the main body of the stent, the distal end of the stent + part of the proximal end of the stent, the distal end of the stent + the proximal end of the stent (i.e. the full length of the stent in the axial direction). The coated mesh-tube stent can form a sealed and smokeable tube cavity structure that completely adheres to the bile duct wall in the released state.

[0035] The mesh-tube stent and / or the polymer film layer are loaded with drugs. The surface of the stent and the polymer film layer can be loaded with therapeutic drugs, for example, antibiotics, anti-platelet drugs, anti-inflammatory drugs, drugs for promoting endothelialization, or anti-tissue proliferation drugs, etc., such as rapamycin, paclitaxel, cilostazol, ticlopidine, triptolide and dexamethasone, etc. In some embodiments, the diameter of the braided wire is 0.05-0.5 mm; in specific embodiments, the diameter of the braided wire can be 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm or 0.5 mm. The surface of the degradable metal wire can be passivated according to specific clinical requirements, and after the surface is passivated, a dense protective film can be formed to delay degradation. The length of the mesh-tube stent is 20-200 mm; in specific embodiments, the length of the mesh-tube stent can be 20 mm, 50 mm, 100 mm, 120 mm, 150 mm or 200 mm. The diameter of the mesh-tube stent in the released state is 3-20 mm; in specific embodiments, the diameter of the mesh-tube stent in the released state can be 3 mm, 5 mm, 8 mm, 12 mm, 16 mm or 20 mm. The cross-sectional shape of the braided wire is at least one of circular, elliptical, rectangular, etc. In specific embodiments, the cross-sectional shape of the braided wire includes, but is not limited to, one or a combination of circular, elliptical, rectangular, etc.

[0036] In order to successfully implant the mesh-tube stent into the lesion site, the present application also provides a stent delivery system, as shown in FIG. 4, which includes a stent delivery device 1 and a mesh-tube stent 2. Figure 4 and FIG. 4 Figure 5As shown, the stent delivery system comprises an inner tube 5 and an outer tube 4, which are sleeved one inside the other, and a receiving cavity for compressively receiving the mesh stent is defined between the inner tube 5 and the outer tube 4; a handle 8 is arranged at the proximal end of the inner tube 5, a soft tip 7 is arranged at the distal end of the inner tube 5, the inner tube 5 is provided with a stent recovery buckle 6 at the end close to the soft tip 7, and the proximal end of the outer tube 4 is connected with the handle 8; when the outer tube 4 moves towards the handle 8, the mesh stent gradually emerges from the receiving cavity and is released, and the inner diameter of the mesh stent after being released is greater than the outer diameter of the outer tube 4.

[0037] Referring to the accompanying drawings Figure 6 As shown, the outer tube 4 is composed of an outer layer 11, an intermediate layer 10 and an inner layer 9 which are sleeved one inside the other from outside to inside, and the outer tube 4 has a three-layer composite structure: the outer layer 11 (contacting tissue), the intermediate layer 10 (reinforcing layer) and the inner layer 9 (sliding layer). The intermediate layer 10 is a mesh tube structure or a spring structure woven by metal wires; the material hardness of the distal end of the outer tube 4 is less than or equal to that of the main body of the outer tube 4; the inner diameter of the outer tube 4 is 1-7 mm, and in specific embodiments, the inner diameter of the outer tube 4 can be 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm or 7 mm; and the outer diameter of the outer tube 4 is 2-10 mm, and in specific embodiments, the outer diameter of the outer tube 4 can be 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm or 10 mm.

[0038] It should be noted that, in some embodiments, the material of the inner layer 9 includes but is not limited to polytetrafluoroethylene and high-density polyethylene; the material of the metal wires for weaving the intermediate layer 10 includes but is not limited to stainless steel, nickel-titanium memory alloy and cobalt-chromium alloy; and the material of the outer layer 11 includes but is not limited to polyurethane, nylon or modified nylon PEBAX, and in some specific embodiments, the material of the outer layer 11 can be made of more than one kind of material (non-chemical mixing), such as being made of two kinds of materials respectively and then being spliced, so as to realize different hardnesses of the distal end and the proximal end. The Shore hardness of the material of the outer layer 11 at the distal end of the outer tube 4 is 40A-50A (A scale), the Shore hardness of the main body of the outer tube 4 is 90A-40D, and the Shore hardness of the proximal end of the outer tube 4 is 50D-85D (D scale). Among them, 90A≈38D and 40D≈90A (ASTM D2240 standard is quoted). The distal end of the outer tube 4 adopts soft Shore 40A-50A material to ensure the flexibility for passing through the tortuous biliary tract; the proximal end adopts hard Shore 50D-85D material to ensure the transmission of the pushing force, and the main body of the outer tube 4 adopts hard Shore 38D-40D material to realize the stiffness transition (ASTM D2240 standard is quoted).

[0039] This invention relates to a biliary stent and its delivery system, constructed from biodegradable metal wires with diameters at both ends larger than the main body diameter. Even after deployment of no more than 90% of the stent's total length, it can still be retrieved into the delivery system. The distal end 1 or the entire length of the stent can be covered with a biodegradable polymer membrane. When only the distal end of the stent is deployed, it forms a funnel-shaped structure that completely conforms to the bile duct wall. Combined with an external negative pressure suction device or needle, gallstones in the gallbladder can be drawn into the funnel-shaped structure in one go. The stones can then be removed from the gallbladder and biliary system by withdrawing the delivery system. The device can also remove bile duct stones, including those in the common bile duct. After the gallbladder and bile duct stones are removed, the distal end of the stent delivery system carrying the biliary stent is placed into the gallbladder. The distal end 1 of the stent is released into the gallbladder, the main body 2 into the cystic duct, and the proximal end 3 into the common bile duct, forming a temporary channel from the gallbladder to the common bile duct. Depending on clinical needs, a longer biliary stent can be deployed with its distal end 1 in the gallbladder, its main body 2 in the common bile duct, and its proximal end 3 in the junction of the duodenum and bile duct, forming a temporary channel from the gallbladder to the duodenum. This facilitates the emptying of residual stones from the gallbladder and biliary system into the duodenum. The biodegradable fibers and biodegradable membrane that make up the biliary stent will completely degrade within three months of placement, eliminating the need for a second surgery to remove the stent.

[0040] Example 1: See appendix Figure 3 As shown, in this embodiment, the number of braided filaments is 24; the diameter of the braided filaments is 0.05 mm; the surface treatment of the braided filaments is passivation; the material of the braided filaments is magnesium alloy; the diameter of the distal end 1 of the support is 12 mm, the diameter of the main body 2 of the support is 8 mm, the diameter of the proximal end 3 of the support is 8 mm, and the braided filaments at both ends of the support are fixed by welding in pairs; the surface coating of the support is: the distal end 1 of the support is covered with a biodegradable polymer film. The shape of the distal end 1 of the support is drum-shaped; the shape of the proximal end 3 of the support is crown-shaped.

[0041] After passivation treatment, a dense protective film forms on the surface of magnesium alloy wire, which helps to delay degradation.

[0042] See appendix Figure 4 As shown, the support delivery system of this invention includes an outer tube 4, an inner tube 5, a support retrieval buckle 6, a flexible head 7, and a handle 8. The outer tube 4 is a composite structure tube with an inner diameter of 2.5 mm, an outer diameter of 3.5 mm, a flexible distal end, high rigidity in the main body, and high rigidity in the proximal end.

[0043] See appendix Figure 5As shown, the outer tube 4 of the stent delivery system is a three-layer structure: from the outside to the inside, it includes an outer layer 11, an intermediate layer 10 and an inner layer 9. The material of the inner layer 9 is polytetrafluoroethylene, which can make the surface of the inner layer 9 very smooth, facilitating the relative sliding with the inner tube 5; the intermediate layer 10 is a woven mesh structure woven with stainless steel wires; the material of the outer layer 11 is PEBAX with a hardness of 35D from the distal end to the proximal end, PEBAX with a hardness of 45D, PEBAX with a hardness of 55D, PEBAX with a hardness of 63D, PEBAX with a hardness of 72D and nylon with a hardness of 85D. The structure of the catheter distal end is good in flexibility, so even if a high-pressure balloon is not used for dilation of the cystic duct, it can also enter the gallbladder.

[0044] First, the doctor pushes the guide wire into the cystic duct by means of the digestive endoscope and its auxiliary instruments, and after withdrawing the digestive endoscope, pushes the distal end of the stent delivery system of the embodiment into the gallbladder. The doctor holds the handle 8 of the stent delivery system with one hand and slowly withdraws the outer tube 4 of the stent delivery system with the other hand, releases the stent distal end 1 of the embodiment in the gallbladder, while the stent body 2 and the stent proximal end 3 are still left in the outer tube 4 of the stent delivery system (the body and the proximal end are still constrained in the outer tube 4), forming an auxiliary channel from the gallbladder to the duodenum. Figure 7 The funnel-shaped structure (funnel-shaped suction cavity) shown can be combined with an external negative pressure suction device (such as a suction pump) to suck the gallstones in the gallbladder into the funnel-shaped structure formed by the stent distal end 1 at one time, at which time the stent delivery system is slowly withdrawn, so that the gallstones in the gallbladder are removed out of the gallbladder and the bile duct, and finally released into the duodenum, and the gallstones can be excreted out of the body through the intestinal tract.

[0045] If a clinical access stent needs to be left in the gallbladder and the bile duct of a patient, after the doctor removes various gallstones, the distal end of the stent delivery system is pushed into the gallbladder, the doctor holds the handle 8 of the stent delivery system with one hand and slowly withdraws the outer tube 4 of the stent delivery system with the other hand, gradually releasing the stent distal end 1 of the embodiment in the gallbladder, the stent body 2 in the common bile duct and the stent proximal end 3 at the junction of the duodenum and the common bile duct, forming a temporary channel from the gallbladder to the duodenum, which is beneficial to the emptying of residual stones in the gallbladder and the biliary system into the duodenum. The diameter of the stent distal end 1 of the embodiment is greater than the diameter of the stent body 2, so the stent cannot move out of the gallbladder, which can avoid the displacement of the stent. After the stent is placed in the gallbladder and the bile duct, the degradable membrane of the stent distal end 1 and the degradable wires constituting the stent begin to degrade gradually, and all the biliary stents are degraded completely in about three months, avoiding the secondary surgery of replacing the stent.

[0046] Embodiment two: Referring to the accompanying drawings, the stent delivery system of the embodiment is used to remove the gallstones in the gallbladder and the bile duct. Figure 8In the embodiment, the number of braided wires is 16, the wire diameter is 0.1 mm, the wire surface treatment is none, the braided wire material is molybdenum alloy, the diameter of the stent distal end 1 is 15 mm, the diameter of the stent body 2 is 10 mm, the diameter of the stent proximal end 3 is 15 mm, and the state between the braided wires at the two ends of the stent is welded and fixed.

[0047] The shape of the stent distal end 1 is a spherical cap, and the shape of the stent proximal end 3 is a spherical cap.

[0048] The stent without a covering passage in the embodiment can be used for patients without large gallbladder stones. The outer tube 4 in the embodiment is used as a catheter, which is a large-diameter catheter with an inner diameter of 3 mm, an outer diameter of 4 mm, and a soft distal end. The material of the inner layer 9 is polytetrafluoroethylene, which can make the surface of the inner layer 9 very smooth. The intermediate layer 10 is a spring mesh structure woven with stainless steel wires. The material of the outer layer 11 gradually changes from the distal end to the proximal end, and the hardness of the PEBAX is 35D, 45D, 55D, 63D, and 75D nylon, respectively.

[0049] The doctor uses the traditional scheme to crush the gallbladder stones (in vivo or in vitro), and then pushes the outer tube 4 of the stent delivery system into the gallbladder along the guide wire. The handle 8 at the proximal end of the catheter is connected to a negative pressure suction device, which can suction the small stones in the gallbladder into the inner cavity of the stent delivery catheter at one time. Then the catheter is withdrawn from the patient's body, and compressed air is used to blow the stones in the inner cavity of the stent delivery catheter. Finally, the stent distal end 1 of the embodiment can be released in the gallbladder, the stent body 2 can be released in the common bile duct, and the stent proximal end 3 can be released at the junction of the duodenum and the common bile duct, forming a temporary channel from the gallbladder to the duodenum, which is beneficial to the emptying of residual gallbladder and biliary system stones into the duodenum. After the stent is placed in the gallbladder and bile duct, the degradable wire gradually begins to degrade, and all the degradable wires are completely degraded in about three months, avoiding the second operation of replacing the stent.

[0050] Embodiment three: The device of the embodiment can not contain a passage stent, which is suitable for patients with small and few gallbladder stones.

[0051] The stent delivery outer tube 4 in the embodiment is a large-diameter catheter with an inner diameter of 4 mm, an outer diameter of 5 mm, and a soft distal end. The material of the inner layer 9 is polytetrafluoroethylene, which can make the surface of the inner layer 9 very smooth. The intermediate layer 10 is a woven mesh structure woven with stainless steel wires. The material of the outer layer 11 gradually changes from the distal end to the proximal end, and the hardness of the PEBAX is 35D, 45D, 55D, 63D, and 75D nylon, respectively.

[0052] The doctor first inserts a guidewire into the gallbladder using a traditional method. Following the guidewire, the distal end of the stone aspiration tube (outer tube 4) in this embodiment is pushed into the gallbladder. The proximal handle 8 of the stone aspiration tube is connected to a negative pressure suction device, which can aspirate small gallstones from the gallbladder into the tube's lumen in one go. While withdrawing the stone aspiration tube, the doctor continues to use the external negative pressure suction device to gradually draw stones from the bile duct (common bile duct) into the tube. Finally, the stone aspiration tube is withdrawn from the patient's body, thus efficiently and minimally invasively removing gallstones and bile duct stones.

[0053] Example 4: See appendix Figure 8 As shown, in this embodiment, the number of braided filaments is 1; the surface treatment of the braided filaments is none; the material of the metal wire is zinc alloy; the diameter of the distal end 1 of the support is 15mm; the diameter of the main body 2 of the support is 10mm; the diameter of the proximal end 3 of the support is 15mm; the surface coating of the support is a biodegradable polymer film covering the entire length of the support.

[0054] The shape of the distal end 1 of the stent is spherical; the shape of the proximal end 3 of the stent is spherical.

[0055] In this embodiment, the outer tube 4 of the stent delivery system is a conduit with an inner diameter of 2 mm and an outer diameter of 3 mm; the inner layer 9 is made of polytetrafluoroethylene, which makes the surface of the inner layer 9 very smooth; the middle layer 10 is a braided mesh structure made of nickel-titanium alloy wire; for removing stones from the common bile duct, the outer tube 4 does not need a soft distal end. In this embodiment, the material of the outer tube 4 from distal end to proximal end is PEBAX with a Shore hardness of 63D, PEBAX with a Shore hardness of 72D, and nylon with a hardness of 85D.

[0056] Firstly, the doctor pushes the guide wire into the common bile duct by using the digestive endoscope and its auxiliary instruments. After the digestive endoscope is withdrawn, the distal end of the stent delivery system of the embodiment is pushed into the proximal end of the stone in the common bile duct. The doctor holds the handle 8 of the stent delivery system with one hand and slowly withdraws the outer tube 4 of the stent delivery system with the other hand, so as to release the distal end 1 of the stent of the embodiment, while the stent body 2 and the proximal end 3 of the stent are still left in the outer tube 4 of the stent delivery system, and a funnel-shaped structure completely adhered to the wall of the bile duct can be formed. In combination with the external negative pressure suction device, the bile duct stone can be suctioned into the funnel-shaped structure formed by the distal end 1 of the stent at one time. At this time, the stent delivery system is slowly withdrawn, so that the stone can be removed out of the bile duct and finally released into the duodenum, and the gallstones can be discharged out of the body through the intestinal tract. Finally, the operation mode similar to that of the first embodiment can be used to gradually release the distal end 1 and the stent body 2 of the stent of the embodiment in the common bile duct and release the proximal end 3 of the stent in the duodenum, so as to form a temporary channel from the common bile duct to the duodenum, which is beneficial to the emptying of the residual stones in the entire biliary system. The diameter of the distal end 1 of the stent of the embodiment is greater than that of the stent body 2, and the stent cannot move out of the gallbladder, thereby avoiding the displacement of the stent. After the biliary stent is placed in the common bile duct, the distal end degradable membrane and the degradable wire constituting the stent gradually begin to degrade, and the entire stent is completely degraded in about three months, thereby avoiding the secondary surgery of replacing the stent.

[0057] Embodiment Five Referring to FIG. 5, in the embodiment, the number of braided wires is 1; the surface treatment of the braided wire is none; the metal wire material is iron-based alloy; the diameter of the distal end 1 of the stent is 15 mm; the diameter of the stent body 2 is 10 mm; the diameter of the proximal end 3 of the stent is 15 mm; and the state between the wires at the two ends of the stent is naturally closed. Figure 9

[0058] The shape of the distal end 1 of the stent is spherical cap; and the shape of the proximal end 3 of the stent is straight pipe.

[0059] The outer tube 4 of the stent delivery system of the embodiment is a catheter with an inner diameter of 2 mm and an outer diameter of 3 mm; the material of the inner layer 9 of the outer tube 4 is polytetrafluoroethylene, which can make the surface of the inner layer 9 very smooth; the intermediate layer 10 of the outer tube 4 is a braided mesh structure woven by a nickel-titanium alloy wire; and the material of the outer layer 11 of the outer tube 4 is PEBAX with a hardness of 35D, PEBAX with a hardness of 45D, PEBAX with a hardness of 55D, PEBAX with a hardness of 63D, PEBAX with a hardness of 72D, and nylon with a hardness of 85D from the distal end to the proximal end in sequence.

[0060] ​First, the doctor with the help of digestive endoscopy and its auxiliary instruments, the guide wire into the cystic duct, after the withdrawal of digestive endoscopy, the distal end of the stent delivery system of the embodiment is pushed into the gallbladder, the doctor holds the handle 8 of the stent delivery system with one hand, and slowly withdraws the outer tube 4 of the stent delivery system with the other hand, releases the distal end 1 of the stent of the embodiment, and the stent body 2 and the proximal end 3 of the stent are still left in the outer tube 4 of the stent delivery system, forming a funnel-shaped structure. Combined with the external negative pressure suction device, the gallbladder stones can be sucked into the funnel-shaped structure formed by the distal end 1 of the stent at one time, at this time, the stent delivery system is slowly withdrawn, the gallbladder stones in the gallbladder can be removed out of the gallbladder and the bile duct, and finally released into the duodenum, and the gallstones can be excreted out of the body through the intestinal tract. Finally, the operation mode similar to example one can be used to gradually release the distal end 1 of the stent of the embodiment in the gallbladder, the stent body 2 in the cystic duct, and the proximal end 3 in the common bile duct, as shown in Figure 10 , forming a temporary channel from the gallbladder to the common bile duct, which is beneficial to the emptying of residual stones in the gallbladder. The diameter of the distal end 1 of the stent of the embodiment is greater than the diameter of the stent body 2, and the stent will not move out of the gallbladder to avoid displacement of the stent. After the stent is placed in the gallbladder and the bile duct, the distal end degradable membrane and the degradable wire constituting the stent gradually begin to degrade, and the entire stent is degraded in about three months, avoiding the second operation of replacing the stent.

[0061] The above embodiments are only for illustrating the technical concept and characteristics of the present application, the purpose is to let the person skilled in the art understand the content of the present application and implement it, and cannot limit the protection scope of the present application, any equivalent changes or modifications made according to the spirit and essence of the present application should be covered within the protection scope of the present application.

Claims

1. A gallbladder stone removal device, characterized by: The net tube-shaped stent comprises a stent body (2) and a stent distal end (1) and a stent proximal end (3) at both ends of the stent body (2); when the net tube-shaped stent is in a released state, the diameter of the stent distal end (1) is greater than or equal to the diameter of the stent body (2), and the diameter of the stent proximal end (3) is greater than or equal to the diameter of the stent body (2); The stent distal end (1) is released in a straight tube shape, a funnel shape or a spherical crown shape in the gallbladder, and the stent proximal end (3) is released in a straight tube shape or a spherical crown shape in the common bile duct or the duodenum; The surface of the net tube-shaped stent is provided with a high polymer film layer, and the high polymer film layer at least covers the distal end part of the net tube-shaped stent in the axial direction; the net tube-shaped stent in the released state can form a completely fitted and sealed smokeable tube cavity structure with the bile duct wall. During weaving, the weaving wires are interwoven / back and forth interwoven in a spiral feeding manner in the axial direction; when the number of weaving wires is greater than or equal to two, the weaving wires at both ends of the net tube-shaped stent are in an open structure or a closed structure.

2. The gallbladder stone removal device according to claim 1, characterized in that: The material of the weaving wire is magnesium alloy, iron alloy, zinc alloy, molybdenum alloy, nickel-titanium alloy, cobalt-chromium alloy, polyglycolide, polylactic acid, polyglycolide-lactide or polycaprolactone.

3. The gallbladder stone removal device of claim 1, wherein: The material of the high polymer film layer is polyglycolide, polylactic acid, polyglycolide-lactide, polycaprolactone, silica gel or polyurethane.

4. The gallbladder stone removal device of claim 1, wherein: The net tube-shaped stent and / or the high polymer film layer are loaded with drugs.

5. The gallbladder stone removal device according to claim 4, characterized in that: The diameter of the weaving wire is 0.05-0.5 mm; the length of the net tube-shaped stent in the released state is 20-200 mm, and the diameter is 3-20 mm.

6. The gallbladder stone removal device of claim 1, wherein: The cross-sectional shape of the weaving wire is at least one of a circular shape, an elliptical shape and a rectangular shape.

7. The gallbladder stone removal device of claim 1, wherein:

8. The gallbladder stone removal device according to any one of claims 1 to 7, further comprising a stent delivery system for delivering the net tube-shaped stent, characterized in that: The stent delivery system comprises an inner tube (5) and an outer tube (4) sleeved on the inner tube (5), and a containing cavity for compressively accommodating the net tube-shaped stent is defined between the inner tube (5) and the outer tube (4); The proximal end of the inner tube (5) is provided with a handle (8), the distal end of the inner tube (5) is provided with a soft head (7) protruding out of the containing cavity, and a stent recovery buckle (6) is arranged on the inner tube (5) close to the soft head (7); the proximal end of the outer tube (4) is connected with the handle (8); When the outer tube (4) moves towards the handle (8), the net tube-shaped stent is gradually exposed out of the containing cavity and released, and the inner diameter of the net tube-shaped stent after being released is greater than the outer diameter of the outer tube (4). ​ 9. The gallbladder stone removal device according to claim 8, characterized in that: The outer tube (4) is composed of an outer layer (11), an intermediate layer (10) and an inner layer (9) which are sequentially sleeved from outside to inside, the intermediate layer (10) is a mesh tube structure or a spring structure woven by metal wires; the material hardness of the distal end of the outer tube (4) is less than or equal to the material hardness of the main body of the outer tube (4); the inner diameter of the outer tube (4) is 1-7mm, and the outer diameter of the outer tube (4) is 2-10mm.

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