KR101604990B1 - Stent - Google Patents

Abstract

The present invention relates to a stent which is inserted into a hole formed in an organ to form a passage of fluid temporarily or permanently between different kinds of organs. The stent includes a cylindrical body having a predetermined diameter and a length, And a protruding portion formed on the protruding portion to prevent the protruding portion from being separated from the inserted organs, wherein the body is composed of a wire intertwined in a tube shape so as to allow elastic deformation and a coating film sealing the space between the wires .

Description

Stent {Stent}

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a stent, and more particularly, to a stent for insertion of a stent to form a passage capable of fluid movement between different types of stent.

A stent is a medical implant that is inserted into a human body to facilitate the flow of body fluids or to artificially form a fluid flow path. The stent may be divided into various types according to the use, material, and form. Depending on the purpose, stents for blood vessels inserted into narrowed blood vessels to smooth the blood circulation, stents for improving the stenosis of organs, Long-term stent. In addition, depending on the material of the stent, it may be classified into a metal stent or a plastic stent. The stent may be classified into a coating type or a non-coating type depending on whether a coating is formed.

The long-term stent is inserted into the narrowed body fluid tube to facilitate the movement of the body fluid, to form an artificial passage between the different types of organ in which the body fluid should be moved, or to form a temporary passage for discharging the liquid inside the cyst .

Fig. 1 is a diagram showing a main organ of the human body. 1, a liver 101, a pancreas 104, a gallbladder 105, and the like are positioned around a stomach 102 connected to the esophagus, and bile ducts 103, Bodies with certain functions move. Because of various reasons, the body fluid tube for the movement of body fluids is clogged, or the cyst that is formed inside the organ is enlarged, which can compress other organs and blood vessels. Endoscopic procedures can be used to treat the disease by inserting the stent into a specific part of the body. have.

A pancreatic pseudocyst is a typical example of gastrointestinal diseases as described above. Pancreatic pseudocysts are pancreatitis or pancreatic ducts that are not surrounded by epithelial cells due to damage to the pancreas. When the mass of pseudocysts is enlarged, it may cause closure due to obstruction of the bile duct and stomach duodenum. It may increase the portal pressure by blocking blood vessels such as the splenic vein or the portal vein. In severe cases, the caesarian cyst may burst from the peritoneal membrane, It also forms organs and fistulas. Non-surgical drainage or surgical procedures are the active methods of treatment of pseudocysts. One of them is the method of discharging body fluids using stent.

The gallbladder produces a pus and supplies it to the duodenum. For certain reasons, the body fluid tube that connects the gallbladder and the duodenum may become clogged. In this case, the pus can not be supplied to the duodenum. In this case, an artificial body fluid passage is formed between the gallbladder and the duodenum through a stent insertion procedure.

Korean Patent Laid-Open Publication No. 2013-0110421 discloses a prior art relating to a stent that forms a connection passage of body fluids in a heterogeneous organ. The above prior art document discloses a body part that is disposed across a through hole formed at each end of two or more different types of organs and provides a connecting passage for communicating different kinds of organs and a body part which is disposed in the connecting passage, And a flare part including a check valve for guiding the flow of the fluid and a flare part extending from both ends of the body part to the outside to prevent both ends of the body part from separating from the through hole. However, when the flare part touches the wall of the organs, the stent is blocked at the end of the stent, and the stent may not flow into the body part of the body fluid to be discharged.

Therefore, the first problem to be solved by the present invention is to provide a fluid flow passage fixed between heterogeneous organs, and even when the end of the stent is in contact with the wall of the organ, fluid flows into the internal passageway of the stent body In the stent.

A second problem to be solved by the present invention is to provide a stent securing a space in which a fluid can flow into an end portion of a stent because a coating film is not formed on a part of a wire constituting the stent.

In order to achieve the first object of the present invention, there is provided a stent which is inserted into a hole formed in an organ to form a passage of fluid temporarily or permanently between different kinds of organs, comprising: a cylindrical body And a protrusion formed on both ends of the body and extending outwardly to prevent the detachment of the inserted organs, wherein the body is configured to seal the space between the wire and the wire, And a coating layer.

According to an embodiment of the present invention, the protrusion may be resilient so as to be connected to the wire of the body so as to be entangled and to be folded in the direction of the central axis of the body of the body.

According to another embodiment of the present invention, the protrusion includes a first region of a closed structure that can seal a hole formed in an organ at an end of the body, a second region extending in the first region to a predetermined length, And a second region of a possible structure.

According to another embodiment of the present invention, the second region of the protrusion is formed of a plurality of protrusions whose inner width becomes narrower toward the outer side in the longitudinal direction of the body, a coating film is formed inside the protrusions, A space through which the fluid can pass may be formed between the projections.

According to another embodiment of the present invention, it is preferable that the lengths of the first region and the second region are in the range of 1: 2 to 2: 1.

In order to achieve the second object, the present invention provides a stent inserted into a hole formed in an organ to form a passage of fluid temporarily or permanently between dissimilar organs, the stent comprising: And a protrusion formed of a plurality of protrusions connected to the wire of the body and extending from the opposite ends of the body in the longitudinal direction and the radial direction of the body, Wherein a coating film for preventing the passage of the fluid is formed in the inside of the protrusion, and a coating film is not formed in a space between adjacent adjacent protrusions.

The stent of the present invention has the following effects.

1. The protrusion is formed at both ends of the body of the stent, so that the stent is prevented from being detached from the hole formed in the organ.

2. Of the protrusions formed at both ends of the body, since the coating film is formed entirely between the wires in the region near the body, it is possible to prevent leakage from occurring in the vicinity of the hole in the organ.

3. The protrusion is formed in the outer region of the protrusion, and since the coating film is formed only in a part of the area between the wires constituting the protrusion, the body fluid can flow into the body of the stent even when the end of the protrusion touches the wall of the organ have.

4. Because the body fluid can enter the stent even when the end of the stent touches the wall of the organ, the range of the stent insertion position for normal operation of the stent is widened, so that the possibility of failure of the stent insertion procedure can be minimized.

5. In the case of a stent connecting the intrahepatic bile duct with the stomach, a coating film is formed only on a part of the body, so bile can effectively enter the body in the branching region of the intrahepatic bile duct.

6. A stent connecting the intrahepatic bile duct with the stomach has a protrusion formed only at one end of the body so that the protruding portion can be inserted smoothly into the intrahepatic bile duct and the portion of the body inserted into the intrahepatic bile duct, It is possible to prevent the stent from coming out of the insertion position due to the friction with the wall.

Fig. 1 is a diagram showing a main organ of the human body.
FIG. 2 is a view showing a state in which a stent is inserted between the cysts of the stomach and the pancreas for the treatment of a pseudocyst.
FIG. 3 shows a shape in which a stent is inserted between the gallbladder and the duodenum.
Figure 4 shows a stent of the prior art.
Fig. 5 shows a configuration in which a stent is inserted between the stomach and the pancreatic cyst.
6 illustrates a stent according to an embodiment of the present invention.
Fig. 7 is a view for explaining the principle of fluid flow when the stent of the present invention abuts against a wall of an organ; Fig.
8 is a photograph of a stent according to an embodiment of the present invention.
Figure 9 illustrates a stent according to an embodiment of the present invention.
FIG. 10 illustrates a configuration in which a stent according to an embodiment of the present invention is inserted between an intrahepatic bile duct and a stomach.

The present invention relates to a stent which is inserted into a hole formed in an organ to form a passage of fluid temporarily or permanently between different kinds of organs. The stent includes a cylindrical body having a predetermined diameter and a length, And a protruding portion formed on the protruding portion to prevent the protruding portion from being separated from the inserted organs, wherein the body is composed of a wire intertwined in a tube shape so as to allow elastic deformation and a coating film sealing the space between the wires .

The stent of the present invention is interposed between different kinds of organs to temporarily or permanently form a passage through which the body fluids can move between the organs. In this case, transient means removal immediately after insertion or removal after a certain period of time, and the period of insertion of the stent may be several hours, several days, or several weeks, and the term "permanent" Quot; inserted " state.

Specifically, the stent of the present invention can be inserted between the pseudocyst of the stomach and the pancreas, and inserted between the gallbladder and the duodenum. In the former case, the fluid inside the pseudocyst can be inserted temporarily for the purpose of discharging the fluid through the stomach. In the latter case, it can be inserted permanently so that the fluid can move between the gallbladder and the duodenum.

The stent of the present invention can be inserted into a human body through an endoscopic procedure. The stent can be made of a wire capable of maintaining a predetermined shape and capable of elastic deformation, and a coating film for preventing leakage of body fluids. The wire may be made of a metal such as stainless steel, a shape memory alloy, a plastic material, or the like, and the coating film may be made of a polymer film such as silicone rubber. The stent of the present invention may be provided with a lasso in a configuration for removal after insertion into the human body.

The stent of the present invention can be manufactured by winding a wire in a primary processing frame and heat-treating the wire, and performing a detailed molding and heat treatment in a secondary processing frame. After the forming step of the wire, . The details of the formation of the stent and the formation of the coating film are well known to those skilled in the art, so a detailed description thereof will be omitted.

The contents of the stent insertion procedure, stent configuration, and function of the present invention will be described below with reference to the drawings.

FIG. 2 shows a stent inserted between the pseudocysts of the pancreas and the stomach for treating the pseudocyst. Referring to FIG. 2, a pseudocyst 104a is formed in the pancreas 104, and a stent 200 is inserted between the pseudocyst 104a and the stomach 102. The insertion of the stent is performed by forming holes in the gastric wall and the pseudocyst 104a through an endoscope, fixing the position by elastically deforming the stent between the holes. At this time, the space between the stent and the hole is sealed by the elasticity of the wall of the pseudocyst of the pancreas, and the fluid inside the pseudocyst can be discharged to the inside of the stent through the inside of the stent. If the fluid inside the pseudocyst is sufficiently drained, the stent can be removed through the procedure.

FIG. 3 shows a shape in which a stent is inserted between the gallbladder and the duodenum. Referring to FIG. 3, a stent 200 is inserted between the gallbladder 105 and the duodenum 103. In normal human organs, the gallbladder is connected to the duodenum through the bile duct. When the body fluid tube is clogged by disease, it is necessary to provide a path of body fluid between the gallbladder 105 and the duodenum 103 through an artificial method. At this time, a stent is used. The insertion of the stent is performed by forming holes in the membrane of the duodenum 103 and the membrane of the gallbladder 105 through the endoscope and inserting the stent through the hole. Since the distance between the gallbladder and the duodenum is generally longer than the distance between the stomach and the pancreas, the length of the stent for treating the pseudocyst shown in Fig. 2 is shorter than that of the biliary stent shown in Fig.

Figure 4 shows a stent of the prior art. Referring to FIG. 4, the stent 200 of the prior art includes a body 210 and a protrusion 220. The body 210 has a wire 212 that is elastically deformable and is formed into a cylindrical shape and a coating film 230 is formed in a space between the wires 212. The wire 212 is inserted into the endoscope apparatus and enlarged in diameter by elastic deformation to widen the passage. The coating film 230 allows the body fluid to pass through the body 210 without leakage. The protrusion 220 is formed at both ends of the body 210 in the longitudinal direction and the radial direction. The protrusion 220 functions to fix the position of the stent 220 so that the stent is not released after the stent is inserted into the hole formed in the organ membrane. The protrusion 220 is made of a wire and a coating film. The wire forming the protrusion can be entangled with the wire of the body and can be resilient so that it can be folded in the direction of the central axis of the body of the body. The protrusions may be formed of a plurality of protrusions, and the protrusions form protrusions at both ends of the body. The coating film 230 forming the projections is also formed inside the individual projections 220, but also between the adjacent projections.

As shown in FIG. 4, the prior art stent has a coating film formed between adjacent protrusions, so that the end of the protrusion is surrounded by the coating film. When the end portion of the stent is brought into contact with the wall surface of the organs by the above-described structure, a space between the wall of the organ and the protrusion is blocked to form a closed structure in which the fluid can not pass. This phenomenon will be explained in a procedure example of the pseudocyst of Fig.

Fig. 5 shows the shape in which the stent is inserted between the pseudocyst of the pancreas and the stomach. Referring to Fig. 5 (a), a stent 200 is inserted between the stomach 102 and the pseudocyst 104a generated in the pancreas 104. At this time, since the end of the stent 200 near the pseudocyst 104a is not completely different from the membrane of the pseudocyst 104a, the fluid inside the pseudocyst 104a is discharged to the inside of the stomach 102 through the stent body .

Referring to FIG. 5 (b), when the stent is inserted into the marginal portion of the pseudocyst 104a, the protrusion 220 of the stent 200 can come into contact with the membrane of the pseudocyst 104a. This phenomenon may occur when the stent is inserted into a stent having a constant length because the insertion position of the stent is not always constant and the position and size of the organ may be different from person to person. When the protrusion of the stent is in contact with the membrane of the pseudocyst, the protrusion pushes the membrane of the pseudocyst with a constant force, so that the membrane of the elastic pseudocyst blocks the entrance of the protrusion of the stent. Therefore, there is a problem that the fluid inside the pseudocyst that was intended to be discharged can not be introduced into the body of the stent. Such a problem with the conventional stent may occur not only in the pseudocyst but also in the stent connecting the gallbladder and the duodenum.

In the stent of the present invention, a coating film is formed inside each protrusion forming the protrusion, but a coating film is not formed between adjacent protrusions, thereby solving the problem caused in the conventional stent.

6 illustrates a stent according to an embodiment of the present invention. 6 (a) shows a stent for pseudocyst surgery, (b) shows a biliary duct forming stent, and (c) shows an enlarged view of the structure of the protruding portion.

Referring to FIG. 6 (a), the stent 300 includes a body 310 and a protrusion 320. The body 310 is formed in a cylindrical shape having a predetermined length and diameter, and is composed of a wire 312 interlaced to enable elastic deformation and a coating film 311 sealing a space between the wires. The wire 312 functions to maintain a cylindrical shape capable of elastic deformation, and the coating film 311 functions to prevent the body fluid from flowing out to the outside. The protrusions 320 are formed at both ends of the body 310 in the longitudinal direction and the radial direction. The plurality of protrusions form protrusions. The protrusions are formed in such a manner that after the stent is inserted into the hole formed in the membrane of the organ, So as to fix the position. The protrusion 320 is made of a wire and a coating film. The wire forming the protrusion can be entangled with the wire of the body and can be resilient so that it can be folded in the direction of the central axis of the body of the body. The protrusions may be formed of a plurality of protrusions, and the protrusions may form protrusions at both ends of the body, and the protrusions may have the same shape or different shapes. A coating film for preventing the passage of the fluid is formed inside the protrusion, and a coating film is not formed in the space between the adjacent protrusions. FIG. 6 (B) shows a stent for biliary duct formation, and has the same configuration except that the length of the body is longer than that of FIG. 6 (A).

Referring to FIG. 6 (c), the plurality of protrusions 320 are formed at the end of the body and have a width A that is wider than the diameter B of the body, so that the stent is not detached from the hole formed in the organ membrane do. The protrusion (C region) composed of the plurality of protrusions (320) includes a first region (D region) of a closed structure capable of sealing a hole formed in an organ at an end of the body and a second region And a second region (E region) of the structure which is elongated and capable of inflow of fluid.

The first region (region D) is a portion which starts to extend from the end of the body, and a coating film is continuously formed in the circumferential direction of the body up to a certain length in the longitudinal direction of the body. The coating film thus formed functions to seal the holes and projections formed in the membrane of the organ to prevent the body fluids from flowing out between different organs. In addition, the first region functions to prevent the protrusion from being detached from the hole formed in the membrane of the organ due to the elastic deformation of the protrusion too easily in the direction of the central axis of the body. If there is no first region extending for a predetermined length, it is easy for the individually formed projections to be elastically deformed in the direction of the central axis of the body. However, since the individual projections are formed in a partially overlapped form in the first region, It can be resistant to deformation.

The second region (region E) is a region in which a plurality of projections overlap each other, and protrusions having a shape of narrowing the inner width toward the outer side in the longitudinal direction of the body are formed outside. At this time, since no coating film is formed between adjacent projections, fluid such as body fluids can pass through the spaces therebetween.

It is preferable that the ratio of the lengths of the first region and the second region (the length of the D region: the length of the E region) is 1: 2 to 2: 1. If the length ratio between the first region and the second region is less than 1: 2, the length of the first region is too short so that the body fluid flows out between the hole formed in the membrane of the organ and the stent, If the length ratio between the first region and the second region exceeds 2: 1, the area of the void space formed between the adjacent projections is small, so that the space in which the fluid passes (The end of the projection touches the wall of the organ). In the drawings, the lengths of the first region and the second region are indicated in the front view of the stent. However, a proper numerical range of the length ratio between the first region and the second region is a ratio of the length in a state in which the projections are completely folded in the direction of the central axis of the body .

The number of the projections formed at both ends of the body is preferably 4 to 12, more preferably 5 to 7. If the number of the projections is less than 4, the projections are difficult to be folded in the direction of the central axis of the body. If the number of the projections is more than 12, the void space between the projections becomes smaller.

Fig. 7 is a view for explaining the principle of fluid flow when the stent of the present invention abuts against a wall of an organ; Fig. 7 (A) shows a case where the protrusion 320 of the stent of the present invention is located inside the pseudocyst 104a. At this time, the cold fluid in the pseudocyst 104a can be introduced into the body of the stent through a wide space formed between the protrusions and an empty space (region where no coating film is formed) formed between adjacent protrusions. 7 (B) shows a case where the stent projection 320 of the present invention is inserted in contact with the membrane of the pseudocyst 104a. In this case, the insertion position of the stent may be deviated from the center of the pseudocyst, or may occur in a patient who has organs with a short distance between the stomach and the pancreas. The plurality of protrusions 320 press the wall surface of the pseudocyst 104a and the end of the protrusion abuts against the wall surface. At this time, since a coating film is not formed in the space between the adjacent protrusions 320, the fluid inside the pseudocyst can be introduced into the body of the stent while securing a space for the fluid to pass through.

8 is a photograph of a stent according to an embodiment of the present invention. Fig. 8 (A) is a photograph of the stent viewed from the front, and Fig. 8 (B) is a photograph of the stent seen at an oblique angle. Referring to FIG. 8, the stent of the present invention includes a body 210 and a protrusion 220 formed of a wire 212 and a coating layer 211 interlaced. It can be seen that a coating film is formed inside the protrusion 220 and no coating film is formed in a space between adjacent protrusions.

Figure 9 illustrates a stent according to an embodiment of the present invention. Referring to FIG. 9, the stent 500 includes a body 510 and a protrusion 520 formed at one end of the body. The body 510 includes a wire 512 and a coating film 511. The coating film 511 is partially formed only on a part of the body 510. [ The region of the body where the coating film is formed is configured such that the fluid can not pass through from outside by the coating film and the region of the body where the coating film is not formed is configured to allow the fluid to pass through the wires. The area of the body where the coating film is formed and the area of the body where the coating film is not formed may have a predetermined length. The length of the area where the coating film is formed and the length of the area where the coating film is not formed is 1: 2 to 2: 1 . If the length of the region where the coating film is formed is too short, the length of the passage through which the fluid can pass can not be ensured and if the length of the region where the coating film is formed is too long, the bile can not pass through the wires of the body in the branched portion of the intrahepatic bile duct Occurs. The structure in which the coating film is not formed on a part of the stent body has another effect. The portion of the body inserted into the intrahepatic bile duct in which the coating film is not formed exerts the friction with the intrahepatic bile duct wall, . The description of the protrusion of the stent is the same as that described with reference to Figs. 6 and 7, and a description thereof will be omitted.

FIG. 10 illustrates a configuration in which a stent according to an embodiment of the present invention is inserted between an intrahepatic bile duct and a stomach. Referring to FIG. 10, the intrahepatic bile duct 106 and stomach 102 are connected by a stent 500. This stent insertion procedure is performed to artificially secrete the bile into the stomach 102 when the bile of the gallbladder 105 is blocked by the passage connecting the duodenum 103. The magnified portion in FIG. 10 is an enlarged view of a part of the entire drawing, and is shown at an angle as viewed from above in order to understand the insertion position of the stent. The stent 500 connects the stomach 102 and the intraluminal bile duct 106, and the protrusion formed at one end of the stent body prevents the stent from being detached from the upper hole. A coating film is formed on a part of the protrusion side of the body to provide a passage for transporting the bile of the intrahepatic bile duct upward. There is no coating on the contralateral side of the body, which functions to allow bile to enter the stent in the branching region of the intrahepatic bile duct. If a coating is formed on the entire stent body, the bile in the first branch can not enter the stent body, and only the bile in the second branch is introduced into the stent body through the opening formed at the end of the body. However, since the stent of the present invention has a coating film formed on only a part of the body, bile of the first branch can be introduced into the interior of the stent body even in the intrahepatic bile duct branching region of the body.

While the present invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Therefore, the embodiments described in the present invention are not intended to limit the scope of the present invention but to limit the scope of the present invention. The scope of protection of the present invention should be construed according to the claims, and all technical ideas within the scope of equivalents should be construed as falling within the scope of the present invention.

101: Liver 102: Above
103: duodenum 104: pancreas
104a: Pseudocysts 105: Gallbladder
106: intrahepatic bile duct 106a: 1st branch
106b: The second branch
200: stent 210: body
211: coating film 212: wire
220: projection 230: coating film
300: stent 310: body
311: Coating film 312: Wire
320: projection
400: stent 410: body
411: Coating film 412: Wire
420: projection
500: stent 510: body
511: Coating layer 512: Wire
520: projection

Claims (9)

delete delete delete delete delete delete A stent for use in a long-term stent for inserting bile between a branching region and a stomach of an intrahepatic bile duct,
A cylindrical body having a predetermined diameter and length to be inserted into the endoscope apparatus; And
A protrusion formed to extend outwardly from one end of the body and to prevent the stent from being detached from the hole formed on the body,
Wherein the body is made of stainless steel, a shape memory alloy or a plastic material capable of being elastically deformed so as to widen the passage so that the diameter of the stent is detached from the endoscope, and a space between the wires And a sealing film for sealing,
The body is provided with a first region in which a coating film is coated on the entire circumference of the body so that the fluid can not pass therethrough and a second region in which a coating film is not formed on the entire circumference of the body so that fluid can pass therethrough, And a second region for preventing the stent from escaping,
So that the bifurcations of the first branch and the second branch branched from each other in the branching region of the intra-hepatic biliary duct can be introduced into the stent , The length ratio of the first region and the second region is limited within a range of 1: 2 to 2: 1,
The protrusion has a first region of a closed structure capable of closing a hole formed at an end of the body and a second region of a structure extending in a predetermined length in the first region and capable of flowing fluid, 12 protrusions,
Wherein the first region is a superposed region between the projections, a coating film for preventing leakage leakage is formed in the first region, and a space through which the fluid can pass is formed as a non-superposed region between the projections in the second region,
Wherein the first region and the second region have a length ratio of 1: 2 to 2: 1 when the protrusions are completely folded in the direction of the central axis of the body. delete delete

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