WO2016052826A1

WO2016052826A1 - Plastic stent

Info

Publication number: WO2016052826A1
Application number: PCT/KR2015/003780
Authority: WO
Inventors: 권창일; 김길수; 류재우; 신경민
Original assignee: (주) 태웅메디칼
Priority date: 2014-09-29
Filing date: 2015-04-15
Publication date: 2016-04-07
Also published as: KR20160037487A; JP2018501824A

Abstract

The present invention relates to a plastic stent that is inserted into a lesion, which has become narrow on account of a tumor or disease in a bile duct, a pancreatic duct, etc. of a human body, in order to widen the lesion. The plastic stent comprises: a body part (10) that is particularly a plastic shape-memory tube and has an inlet (11) and an outlet (12) formed in the upper and lower ends thereof for the inflow and outflow of a body fluid; an upper support part (20) that has a spiral shape and is formed on the upper portion of the body part (10) to support the body part (10) so as to prevent the stent from being separated from an installation position in a human body; and a lower discharge part (30) formed on the lower portion of the body part (10), wherein the lower discharge part is wound and bent in a circular shape. The upper support part (20) can prevent the plastic stent from piercing a tissue to damage or perforate the tissue when being inserted into, and installed in, a lesion and can maximize the contact area with the internal tissue to enhance a support force, thereby effectively preventing the plastic stent from being separated from the installed state, and the lower discharge part (30) can also prevent a perforation and blockage of the lower portion due to food, etc. and can make a body fluid smoothly flow.

Description

Plastic stent

The present invention relates to a plastic stent inserted into a lesion area narrowed by a tumor or a disease in a bile duct or pancreatic duct of the present invention to widen the lesion area, and in particular, an upper support part having a spiral shape on an upper part of a trunk formed of a plastic tube to remember the shape. When inserting into the lesion site, stab the tissue to prevent the damage or perforation of the tissue and improve the support capacity by maximizing the contact area with the internal tissue, thereby effectively preventing the positional deviation in the installation state, as well as forming the lower discharge portion at the bottom The present invention relates to a plastic stent that prevents clogging of the lower part by food and the like and provides a smooth distribution of body fluids.

In general, problems such as biliary or pancreatic ducts or other internal parts of the human body have narrowed pipelines due to tumors or diseases, thereby preventing the smooth flow of body fluids.

In this case, a plastic stent is used. The plastic stent widens the narrowed channel such as the bile duct, the pancreatic duct, or the inside of the human body, thereby facilitating the distribution of body fluids.

Conventional plastic stent is a plastic tube to remember the shape as shown in Figure 1 to form a body (1) having an inlet hole (1a), the outlet hole (1b) for the inflow and outflow of body fluid at the top and bottom, The upper and lower portions of the torso 1 are formed with pig tail-shaped bends 2 and 2 'to prevent the bends from being displaced from the installation state by being supported by a pipe in the endurance.

In addition, the bent portion (2) (2 ') was formed to assist the inflow and outflow of body fluid by forming an auxiliary inlet hole (2a) and an auxiliary outlet hole (2'a).

However, the conventional plastic stent has a curved portion (2) (2 ') of the upper body and the lower part of the body (1) due to a tumor or disease in the bile or pancreatic duct with a guide wire or catheter inserted therein. It will be inserted into the narrowed lesion.

Since the inserted plastic stent is made of a shape memory material, the upper and lower bends (2) and (2 ') of the trunk (1) are restored to the pig tail shape from the straight shape and are supported by the ducts of the bile or pancreatic ducts. Maintaining the state, as well as widening the narrowed conduit due to the tumor or disease, the inlet hole (1a), the outlet hole (1b) of the upper and lower body, and the secondary inlet hole (2a) and secondary outflow of the bent portion (2) (2 ') The fluid is passed through the ball (2'a) and becomes available for circulation.

However, the conventional plastic stent has the following problems.

First, the end of the bent portion (2) (2 ') of the bile duct or pancreatic tube during the process of restoring the pig's upper and lower portions of the bent portion (2) (2') into the bile duct or pancreatic duct and restoring to a pig tail shape again. There was a problem of stabbing the tracheal tissue to damage or puncture the tissue.

Second, the upper and lower bent portion (2) (2 ') of the stent is simply formed in the shape of a pig tail, so the contact area is small in the ducts of the bile or pancreatic ducts, so the support strength is weak, so that the installation state is not firmly maintained at the lesion site. There was a problem that easily escaped.

In particular, when the stent is released from the bile duct or pancreatic duct, the lower part of the stent protrudes toward the duodenum, causing the problem that the bottom of the stent is punctured by the duodenum.

Third, when the stent is inserted into the duct of the bile duct or the pancreatic duct, the body fluid is discharged through the upper and lower inlet holes 1a, the outlet hole 1b, the auxiliary inlet hole 2a, and the auxiliary outlet hole 2'a. The secondary inlet hole (2a) and the secondary outlet hole (2 'a) is formed on the side of the bone tail (2) (2') of the pig tail shape (pipe direction side rather than the channel direction) of the body fluid There was a problem that the distribution of body fluids becomes more difficult when the lower outflow hole 1b of the stent is blocked by food or the like that passes through the duodenum due to poor distribution.

The present invention has been invented to solve the problems of the prior art as described above, by forming a spiral upper support portion on the upper portion of the body formed of a plastic tubular body to remember the shape of the tissue to insert into the lesion site It prevents damage or perforation and maximizes the contact area with the internal structure to improve the bearing capacity, which effectively prevents the positional deviation from the installation state, as well as the rounded or bent straight shape or the straight lower shape. The purpose is to form a discharge portion to prevent the blockage of the lower portion by food and the like and to provide a smooth flow of body fluids.

An object of the present invention is to further provide an auxiliary inlet hole, an auxiliary outlet hole between the upper support portion and the lower discharge portion, the upper support portion and the body to more smoothly provide inflow and outflow of body fluids.

The object of the present invention is to form the body in a spiral structure to more effectively prevent the positional deviation in the installation state.

The present invention aims to further prevent the damage or perforation of the tissue by puncturing the tissue when inserted into the lesion site to form a round protrusion by gathering the upper end of the upper support and the lower outlet end of the body.

The present invention forms a body having an inlet hole and an outlet hole for the inflow and outflow of the body fluid in the upper and lower parts of the plastic tube to remember the shape, the spiral shape to support to prevent the departure from the body installation position on the upper portion of the body The upper support and the lower portion of the bent in a round shape, or a straight bent shape or a straight shape of the lower discharge portion is characterized in that it is configured.

The upper support portion of the spiral shape is formed in a triangular shape, the upper portion is narrower and wider toward the lower, the inverted triangular shape is wider and narrower toward the lower, or the upper portion is narrow and the center is wider and the lower portion is narrow again It is characterized by the composition.

The upper support portion and the lower discharge portion is characterized in that at least one or more auxiliary inlet hole, the secondary outlet hole penetrating toward the upper and lower portions for the smooth inflow and outflow of body fluids.

The auxiliary inlet hole and the auxiliary outlet hole is characterized in that it is formed by forming any one of a circular hole, an elliptical hole and a long hole.

The present invention is characterized by further forming an auxiliary inlet hole between the upper support and the body.

The present invention is characterized in that the upper support portion and the lower discharge portion of the body is configured to form a round protrusion by rounding the end portion.

The body of the present invention is characterized in that it is formed in a spiral structure.

The present invention forms an upper support portion of a spiral shape, such as an inverted triangle shape, a triangle shape or a rhombus shape, on the upper part of the body formed of a plastic tubular body that remembers the shape, and punctures the tissue during insertion into the lesion site to damage or puncture the tissue. It prevents the concern and maximizes the contact area with the internal tissue to improve the bearing capacity, which effectively prevents the positional deviation from the installation state, and also forms a curved or straight bottom discharge part at the bottom. It prevents the blockage of the lower part by food and the like and provides a smooth distribution of body fluids, so that it has an excellent use efficiency and safety.

In addition, an additional inlet hole and an auxiliary outlet hole may be further formed between the upper support part and the lower discharge part, the upper support part and the body to provide the inflow and outflow of body fluid more smoothly, and the body may also be formed in a spiral structure. It prevents the deviation of the position more effectively, as well as forming the round protrusions by gathering the upper end of the upper support and the lower discharge end of the body into a round protrusion to further prevent damage to the tissue or perforation by stabbing the tissue when installing into the lesion site. Will have the effect.

1 is a front view showing a conventional plastic stent.

Figure 2 is a perspective view showing an embodiment of the present invention stent.

3 is a front view of FIG. 2;

4 and 5 are perspective views to which other embodiments of the lower discharge part are applied in FIG. 2.

6 and 7 are front views to which other embodiments of the upper support in FIG. 2 are applied.

8, 9 and 10 are top plan views showing various embodiments of the secondary inlet hole, secondary outlet hole of the present invention stent.

Figure 11 is a front view of the main portion showing another embodiment of the top and bottom of the stent of the present invention.

12 is a perspective view showing another embodiment of the present invention stent.

Figure 13 is a front view showing another embodiment of the present invention stent.

14 and 15 is a front view showing the main portion showing the installation use state of the stent of the present invention

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Plastic stent of the present invention is to facilitate the communication of body fluids by inserting into the narrowed lesion area due to tumors or diseases in the bile duct or pancreatic duct of the human body to widen the lesion site.

That is, as shown in Figures 2 to 13 to form a body (10) having an inlet hole 11, the outlet hole 12 for the inflow and outflow of the body fluid in the upper and lower portions of the plastic tube to remember the shape, In order to support the body to be prevented from being separated from the installation position on the upper portion of the body 10, it is formed by forming the upper discharge portion 30 of the spiral shape and the lower discharge portion 30 of the shape bent in a circular shape.

Since the spiral upper support part 20 is spirally dried, the support force is increased by maximizing the contact area with internal tissues such as bile ducts or pancreatic ducts, as shown in FIG. On the contrary, as shown in FIG. 6, the upper portion is formed in an inverted triangle shape that is wider and becomes narrower toward the lower portion, or in FIG. 7, the upper portion is formed in a rhombus shape that is narrower, the center is wider, and the lower portion is narrower, or various other shapes. It can be formed into a spiral shape.

In addition, the lower outlet portion 30 may also be variously formed in a straight shape as shown in FIG. 4 or a straight shape as shown in FIG. In the case of forming a curved shape than a straight line or a rounded shape, the blockage of the lower outflow hole 12 may be minimized.

In addition, the upper support part 20 and the lower outlet part 30 further include at least one auxiliary inlet hole 21 and an auxiliary outlet hole 32 penetrating upward and downward for smooth inflow and outflow of body fluids. It can be configured.

At this time, the auxiliary inlet hole 21 and the auxiliary outlet hole 32 may be formed in various forms such as a circular hole, an elliptical hole, a long hole, of course.

In addition, it is preferable to further form an auxiliary inlet hole 22 between the upper support portion 20 and the body 10, as shown in Figure 12, which is formed in the upper support portion in the upper support portion 20 of the spiral shape This is to allow the excess body fluid not flowing through the ball 21 to flow between the upper support 20 and the torso 10.

And the upper support portion 20 and the lower discharge portion 30 of the body 10 has an end portion excluding the inlet hole 11 and the outlet hole 12 can be inserted into the guide wire or catheter as shown in FIG. In order to prevent the perforation or damage of the tissues gathered round the round protrusion 13 is formed.

In addition, the body 10 may also be formed by forming a spiral structure (10a) to maintain the installed state in the installation position as shown in FIG.

As an unexplained symbol, 100 represents a liver 200, a gallbladder, 210 a bile duct, 220 a lesion site, 300 a pancreas, and 400 a duodenum.

Next will be described the operation and action of the present invention configured as described above.

First, the guide wire (guide wire) is passed through the narrowed lesion, and then placed through the body 10 of the plastic stent through the guide wire on the opposite side and pushed with a push catheter to the lesion site along the guide wire (push catheter) Inserted to reach the lesion or in the state in which the body of the plastic stent 10 is inserted into the pusher catheter (the pre-mounted torso of the plastic stent in the catheter), the pusher catheter to reach the lesion site along the guide wire It is.

That is, the body 10 of the plastic stent is inserted into the lesion region 120 narrowed by the tumor or disease in the bile duct or the pancreatic duct, as shown in FIGS. 14 and 15.

In this way, the body 10 of the plastic stent inserted into the narrowed lesion part 220 of the human body ensures a passage through which body fluid can flow, as well as the upper support part 20 and the lower part of the upper and lower parts of the body 10. It is possible to maintain the installation state while the unit 30 is restored to the original shape memorized.

In particular, the upper support portion 20 of the body 10 is formed in a spiral shape, for example, a triangular shape of which the upper part is narrower and wider toward the lower part as shown in FIG. 3, or conversely, the upper part is wider and lower as shown in FIG. 6. The upper support portion 20 is formed in the shape of an inverted triangle that becomes narrower toward the top, or in FIG. 7 and in the shape of a rhombus that is narrow in the upper part, wide in the center, and narrow in the lower part, or spiral shape of various other shapes. In addition, the contact area with the internal tissue of the pancreatic duct is maximized, as well as the tension is supported in all directions to increase the supporting force, thereby maintaining the installation state firmly.

In addition, since the upper support portion 20 is inserted into an expanded state when the installation is inserted into the lesion area 120 narrowed due to the tumor or disease in the bile duct or the pancreatic duct, the insertion is completed and then spirally dried and restored to a spiral shape again. The end of the upper support 20 will not puncture internal tissues such as bile ducts or pancreatic ducts to prevent problems such as damage or puncture of tissues of the bile ducts or pancreatic ducts as in the prior art.

In addition, since the upper support portion 20 firmly maintains the installation state at the lesion site 120, the lower discharge portion 30 protrudes into the duodenum 400 as in the prior art, so that the end of the lower discharge portion 30 is duodenum 400 To prevent perforation).

In addition, the lower discharge part 30 may be formed in various ways such as a straight shape as well as a rounded shape or a straight shape bent in a straight shape such that the lower support part 30 may protrude from the duodenum 400. End of the) is not in contact with the internal tissue to prevent tissue damage or perforation problem, as well as the food passing through the duodenum flows back into the outlet hole 12 of the lower outlet to prevent the problem that the outlet hole 12 is blocked. It will ensure a smooth distribution of body fluids.

In addition, the plastic stent of the present invention is a secondary inlet hole 21, auxiliary outlet hole formed in various forms such as a circular hole, an elliptical hole, a long hole in the upper support portion 20 and the lower discharge portion 30 of the body (10) Since 32 is formed in a plurality of penetrating toward the upper and lower side rather than the side, the body fluid inside the bile duct or the pancreatic duct smoothly flows in and out.

That is, even if the inlet hole 11, the outlet hole 12 of the upper and lower ends of the body 10 is blocked, the auxiliary inlet hole 21, the auxiliary outlet hole 32 provides a smooth inflow and outflow of body fluids Will be done.

In addition, the auxiliary inlet hole 22 is further formed between the upper support part 20 and the body 10 to prevent the body fluid from flowing through the auxiliary inlet hole 21 from the upper support part 20 having a spiral shape. It will be introduced through the secondary inlet hole 22 between the upper support portion 20 and the body 10 to provide a more smooth distribution of body fluids.

In addition, the plastic stent of the present invention because the body 10 itself is also formed in a spiral structure (10a) to support the tension in the state installed in the lesion site, such as bile ducts or pancreatic ducts to further prevent the departure of the installation position to maintain a solid installation state Will be.

And the body 10 of the plastic stent, the upper and lower end portions are rounded to form a round protrusion 13 by excluding the inlet hole 11 and the outlet hole 12 to form a round protrusion (13) or separated into the human body When it comes in contact with the tissue inside the human body as well as to prevent the damage or perforation of the tissue as in the conventional as well as to minimize the pain of the patient.

Therefore, the plastic stent of the present invention forms a spiral-like upper support portion such as a triangular shape, an inverted triangle shape or a rhombus shape on the upper part of the body formed of a plastic tubular body that remembers the shape and punctures the tissue during insertion into the lesion site. It prevents the possibility of damage or perforation, and maximizes the contact area with the internal tissue to improve the bearing capacity.It effectively prevents the positional deviation from the installation state. By forming the lower discharge portion to prevent the lower blockage by food and the like and to provide a smooth flow of body fluids.

In particular, the upper support portion and the lower discharge portion, the auxiliary inlet hole, the auxiliary outlet hole is further formed between the upper support and the body to provide a smooth inflow and outflow of body fluid, the upper end of the upper support and the lower outlet portion of the body It is gathered in a round shape to form a round protrusion to insert the lesion into the site of the puncture tissue to prevent further damage or perforation of the tissue.

* Description of the sign *

10: Torso

11: inlet hole

12: outflow hole

13: round protrusion

20: upper support

21,22: secondary inlet hole

32: secondary outlet

30: lower outlet

Claims

Plastic body to remember the shape to form a body 10 having an inlet hole 11, the outlet hole 12 for the inflow and outflow of the body fluid in the upper and lower, the body installation position on the upper portion of the body (10) Plastic stent, characterized in that formed by forming a lower discharge portion 30 of the shape bent in a circular roll on the lower and the upper support portion 20 of the spiral shape so as to prevent the departure from.
Plastic body to remember the shape to form a body 10 having an inlet hole 11, the outlet hole 12 for the inflow and outflow of the body fluid in the upper and lower, the body installation position on the upper portion of the body (10) Plastic stent, characterized in that formed by forming a spiral upper support portion 20 and the lower discharge portion 30 of the shape bent in a straight line to prevent the departure from.
Plastic body to remember the shape to form a body 10 having an inlet hole 11, the outlet hole 12 for the inflow and outflow of the body fluid in the upper and lower, the body installation position on the upper portion of the body (10) Plastic stent, characterized in that by forming a spiral-like upper support portion 20 and the lower discharge portion 30 of the straight shape so as to prevent the departure from.
The method according to claim 1 or 2 or 3,

The spiral shaped upper support portion 20 is a plastic stent, characterized in that formed in a triangular shape that the upper portion is narrower and wider toward the lower portion.
The method according to claim 1 or 2 or 3,

The spiral upper support portion 20 is a plastic stent, characterized in that formed by forming an inverted triangular shape is wider and narrower toward the bottom.
The method according to claim 1 or 2 or 3,

The spiral upper support portion 20 is a plastic stent, characterized in that formed in a rhombus shape of the upper portion is narrow, the center is wide and the lower portion is narrow again.
The method according to claim 1 or 2 or 3,

The upper support portion 20 and the lower discharge portion 30 is formed by forming at least one or more auxiliary inlet hole 21, secondary outlet hole 32 penetrating toward the upper and lower portions for the smooth inflow and outflow of body fluids Plastic stent, characterized in that.
The method of claim 7, wherein

The auxiliary inlet hole 21 and the auxiliary outlet hole 32 is a plastic stent, characterized in that formed by forming any one of a circular hole, an elliptical hole and a long hole.
The method according to claim 1 or 2 or 3,

Plastic stent, characterized in that formed by further forming an auxiliary inlet hole (22) between the upper support (20) and the body (10).
The method according to claim 1 or 2 or 3,

The upper support portion 20 and the lower discharge portion 30 of the body (10) is a plastic stent, characterized in that the rounded end portion is rounded to form a round projection (13).
The method according to claim 1 or 2 or 3,

The body 10 is a plastic stent, characterized in that formed by forming a spiral structure (10a).