CN111450392B

CN111450392B - Multi-level fistula dilatation puncture drainage tube with balloon

Info

Publication number: CN111450392B
Application number: CN202010393197.5A
Authority: CN
Inventors: 张�诚; 杨玉龙
Original assignee: Shanghai East Hospital
Current assignee: Shanghai East Hospital
Priority date: 2020-05-11
Filing date: 2020-05-11
Publication date: 2025-01-14
Anticipated expiration: 2040-05-11
Also published as: CN111450392A

Abstract

The present invention provides a multi-stage fistula expansion type puncture drainage tube with a balloon, comprising a drainage tube and an inner core, wherein the drainage tube comprises a head, a balloon part, a body and a tail; a channel I is arranged in the head, and the balloon part comprises a drainage tube I with channels II and III arranged therein and a head end balloon; channels IV, V, VI, VII and VIII are arranged in the body; the outer wall of the body is sleeved with overlapping balloons I, II and III; channels IX, X, XI, XII and XIII are arranged in the tail; connectors I, II, III and IV are arranged on the wall of the tail tube, and connector V is arranged in the middle of the bottom; the tail end of the inner core is cooperatively connected with connector V; the inner core is inserted into the channel in connector V and passes through channel I. The present invention can increase the expansion range of the fistula, reduce the number of replacement times of the drainage tube, shorten the course of the disease, and has low manufacturing cost.

Description

Multi-stage fistula dilation type puncture drainage tube with saccule

Technical Field

The invention relates to the technical field of minimally invasive medical technology and surgical instruments, in particular to a multi-stage fistula expansion type puncture drainage tube with a balloon, which is a minimally invasive surgical instrument for treating biliary tract diseases after percutaneous transhepatic biliary tract puncture and fistula expansion or for treating biliary tract diseases by expanding percutaneous transhepatic biliary tract puncture fistula.

Background

Gall bladder and intrahepatic and extrahepatic calculus are common diseases, and can induce complications such as acute and chronic cholecystitis, cholangitis, obstructive jaundice, biliary tract tumor and the like. The traditional treatment mode of gall-stone is that the gall-stone is cut off from the abdomen and the liver leaves are cut off, and then the technology of laparoscope and choledochoscope is developed increasingly today, and the gall-stone is cut off from the gall-stone under the laparoscope and the gall-stone is explored and removed from the gall-stone is an important means for the treatment of the gall-stone.

Either the cholecystectomy and lithotomy under laparoscope or the biliary tract exploration and lithotomy should be performed under general anesthesia. For the elderly and high-risk patients who cannot tolerate the risk of general anesthesia and patients who accept multiple open-abdominal operations, percutaneous liver gall bladder and bile duct puncture drainage can be adopted firstly, then fistula is gradually expanded, and when the fistula is expanded to more than 16Fr, a choledochoscope can be placed through the fistula to enter the gall bladder and the lithotripter in the tube for stone extraction. Fistula expansion includes two modes, one is to expand the fistula by using hard expansion tubes of different types in one operation, but the mode still needs to be completed in a general anesthesia state, complications such as bleeding, liver abscess, biliary leakage and the like are easy to occur, and the other is to intermittently replace biliary tract drainage tubes of thicker types, the mode does not need anesthesia, but the interval between the two operations is longer, so that the disease treatment time is longer. If the interval time is shorter or a thicker drainage tube is selected, the pain of a patient is increased, and the difficulty of placing the drainage tube is also increased.

Disclosure of Invention

According to the method, hard dilating tubes of different types are used for dilating fistulae in one operation, but the method still needs to be completed in a general anesthesia state, complications such as hemorrhage, liver abscess, biliary leakage and the like are easy to occur, and a biliary tract drainage tube of a thicker type is intermittently replaced, so that anesthesia is not needed, but the interval between two operations is longer, so that the disease treatment time is longer, if the interval time is shorter or a thicker type drainage tube is selected, the pain of a patient is increased, and the technical problem of the difficulty of tube placement is also increased. The device is mainly used for directly penetrating into a bile duct or a gall bladder through skin by local anesthesia, complications such as abdominal pain and the like caused by bile entering the abdominal cavity in the conventional penetration process are avoided, the head end balloon at the front end of the drainage tube is used for preventing the drainage tube from shifting, the multi-balloon design is adopted, the expansion range of the fistula tract is enlarged, the frequency of replacing the drainage tube is reduced, the course of disease is shortened, the body multi-balloon is fixed in a telescopic manner, each balloon is gradually filled from inside to outside, the gradual expansion of the fistula tract can be realized, the risk of rapid expansion and tearing bleeding of the fistula tract is reduced, and the pain response is small.

The invention adopts the following technical means:

The multi-stage fistula dilation type puncture drainage tube with the balloon comprises a drainage tube and an inner core, wherein the drainage tube comprises a head part, a balloon part, a body part and a tail part which are connected with each other in sequence from beginning to end;

the head part is conical and is a single-channel drainage tube, and a channel I is arranged in the head part;

The balloon part comprises a drainage tube I and a head end balloon sleeved on the outer wall of the drainage tube I, wherein the drainage tube I is a double-channel drainage tube, a channel II communicated with the channel I and a channel III communicated with the head end balloon are arranged in the drainage tube I, and the proximal end of the channel III is a blind end;

The body is a five-channel drainage tube, a channel IV, a channel V, a channel VI, a channel VII and a channel VIII which are communicated with the channel II are arranged in the five-channel drainage tube, and the head ends of the channel V, the channel VI and the channel VII are blind ends;

The outer wall of the body part is concave, a telescopic balloon I, a telescopic balloon II and a telescopic balloon III are sequentially sleeved from inside to outside, two ends of the balloon I, the balloon II and the balloon III are conical, and the middle body is cylindrical;

The tube wall of the body is provided with a through hole I, a through hole II and a through hole III which are respectively communicated with the channel V, the channel VI and the channel VII, and the head ends of the channel V, the channel VI and the channel VII are respectively communicated with the balloon I, the balloon II and the balloon III;

the tail part is a five-channel drainage tube, a channel IX, a channel X, a channel XI, a channel XII and a channel XIII are arranged in the five-channel drainage tube, the channel IX is communicated with the channel IV, the channel XIII is communicated with the channel VIII, and the channel X, the channel XI and the channel XII are respectively communicated with the channel V, the channel VI and the channel VII;

The pipe wall of the tail part is provided with a single-channel connector I, a single-channel connector II, a single-channel connector III and a single-channel connector IV which are respectively communicated with the tail ends of the channel X, the channel XI, the channel XII and the channel XIII;

The surfaces of the connector I, the connector II, the connector III, the connector IV and the connector V are respectively provided with a single-channel valve, the surface is provided with a spiral groove;

The tail end of the inner core is provided with a connecting cap, the inner wall of the connecting cap is provided with a spiral groove I, the spiral groove I is connected with the spiral groove of the outer wall of the connector V in a matched mode, and the body of the inner core is inserted into a channel in the connector V and penetrates out of the channel I.

Further, the inner core is a supporting tube, or a combination of a puncture needle and the supporting tube;

The two sides of the head end of the supporting tube are provided with resistance blocks, the resistance blocks are connected with the inner wall of the channel I in a matched mode, the supporting tube is a single-channel metal tube, the body of the supporting tube is cylindrical, the tail end of the supporting tube is provided with a connecting cap I which is a single-channel connecting cap, and the inner wall of the connecting cap I is provided with a spiral groove I which is connected with the spiral groove of the outer wall of the connector V in a matched mode.

Further, when the inner core is a supporting tube, the connecting cap is the connecting cap I, and the supporting tube is connected with the connector V through the matching connection of the spiral groove I and the spiral groove.

Further, when the inner core is a combination of a puncture needle and a supporting tube, a spiral groove II is formed in the outer wall of the connecting cap I on the supporting tube, a connecting cap II is arranged at the tail end of the puncture needle, a spiral groove III is formed in the inner wall of the connecting cap II, the spiral groove III is connected with the spiral groove II in a matched mode, and a middle body of the puncture needle is arranged in a channel of the supporting tube;

the connecting cap is a combination of the connecting cap I and the connecting cap II;

the top of the puncture needle is conical, and the middle body is cylindrical.

Further, the length of the drainage tube is 60-100 cm, the outer diameter is 7Fr, and the inner diameter is 5Fr.

Further, the maximum diameter of the head end saccule is 1cm when the head end saccule is filled, and the head end saccule is oval after being filled;

the upper end and the lower end of the head end saccule are respectively fixed with the wall of the drainage tube I through a metal ring I and a metal ring II.

Further, the length of the balloon I is 30-60 cm, the balloon II is 1cm longer than the balloon I, the balloon III is 1cm longer than the balloon II, and the expansion diameters of the balloon I, the balloon II and the balloon III are 8Fr, 10Fr and 12Fr or 14Fr, 16Fr and 18Fr respectively;

The head ends of the balloon I, the balloon II and the balloon III are flush and are fixed with the body pipe wall through a metal ring III;

The tail ends of the balloon I, the balloon II and the balloon III are respectively fixed with the body pipe wall through a metal ring IV, a metal ring V and a metal ring VI.

Further, the connector I is connected with an injector or a pressure pump, and physiological saline containing contrast agent is injected to fill the head end saccule;

the connector II is connected with an injector or a pressure pump, physiological saline containing contrast agent is gradually injected, and the balloon I is slowly filled to expand the fistula;

the connector III and the connector IV are connected with an injector or a pressure pump, physiological saline containing contrast agent is gradually injected, the balloon II and the balloon III are slowly filled, and the balloon II and the balloon III with larger diameters are used for expanding fistula;

The connector V is connected with a drainage bag for draining bile.

The blind end is that the head end of the water injection and gas injection channel is L-shaped and is connected with the saccule cavity through a side wall hole formed in the wall of the drainage tube.

Compared with the prior art, the invention has the following advantages:

1. the multi-stage fistula expansion type puncture drainage tube with the balloon has low manufacturing cost, can be directly punctured into a bile duct or a gall bladder through skin under local anesthesia, simplifies the operation flow, does not need to additionally use a guide wire and a puncture needle, saves the operation time and the medical cost, avoids complications such as abdominal pain caused by bile entering the abdominal cavity in the conventional puncture process, and can also expand the fistula of a percutaneous transhepatic duct puncture way.

2. The model of the multi-stage fistula expanding puncture drainage tube with the balloon is 7Fr, and the multi-stage fistula expanding puncture drainage tube with the balloon is easy to be placed into a fistula.

3. The multi-stage fistula expanding puncture drainage tube with the balloon has the function of preventing the drainage tube from shifting.

4. The multi-stage fistula expanding puncture drainage tube with the balloon adopts the multi-balloon design, so that the fistula expanding range is enlarged, the frequency of replacing the drainage tube is reduced, and the course of the disease is shortened.

5. According to the multi-stage fistula expanding puncture drainage tube with the balloon, the body multi-balloon is fixed in a telescopic manner, each balloon is gradually filled from inside to outside, the fistula can be expanded step by step, the risk of rapid fistula expansion, tearing and bleeding is reduced, and pain response is small.

6. The multi-stage fistula expanding puncture drainage tube with the balloon has the advantages that each balloon has a fixed diameter, the expanded diameter can be achieved under smaller pressure, the pressure requirement is small, the operation is simple, and the manufacturing cost is low.

In summary, the technical scheme of the invention can solve the problems that in the prior art, hard dilating tubes of different types are used for dilating fistulae in one operation, but the method still needs to be completed in a general anesthesia state, complications such as hemorrhage, liver abscess, biliary leakage and the like are easy to occur, and biliary tract drainage tubes of thicker types are intermittently replaced, and anesthesia is not needed, but the interval between the two operations is longer, so that the disease treatment time is longer, and if the interval time is shorter or thicker type drainage tubes are selected, the pain of patients is increased, and the difficulty of tube placement is also increased.

Based on the reasons, the invention can be widely popularized in the fields of minimally invasive medical technology, surgical instruments and the like.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings may be obtained according to the drawings without inventive effort to a person skilled in the art.

Fig. 1 is a schematic structural view of a multi-stage fistula expanding type puncture drainage tube with balloon in example 1 of the invention.

Fig. 2 is a schematic structural view of a multi-stage fistula-dilating drainage tube with balloon in example 2 of this invention.

FIG. 3 is a schematic view of the structure of a drainage tube according to an embodiment of the present invention.

FIG. 4 is a cross-sectional view taken along line A-A in FIG. 3.

Fig. 5 is a sectional view of the view B-B of fig. 3.

Fig. 6 is a cross-sectional view of fig. 3C-C.

Fig. 7 is a sectional view of D-D in fig. 3.

Fig. 8 is a sectional view of fig. 3E-E.

Fig. 9 is a cross-sectional view of F-F in fig. 3.

Fig. 10 is a sectional view of fig. 3G-G.

Fig. 11 is a schematic view showing the structure of a puncture needle according to an embodiment of the present invention.

Fig. 12 is a schematic structural view of a support tube according to an embodiment of the present invention.

Fig. 13 is a schematic view of a multi-stage balloon fistula-dilating puncture drainage tube in an operational state (head end balloon filling) in accordance with an embodiment of the invention.

Fig. 14 is a schematic view of a multi-stage balloon fistula-dilating puncture drainage tube in an operational state (head end balloon and balloon I inflated) in accordance with an embodiment of the invention.

Fig. 15 is a schematic view of a multi-stage balloon fistula-dilating puncture drainage tube in an operational state (head end balloon, balloon I and balloon II filling) in accordance with an embodiment of the invention.

Fig. 16 is a schematic view of a multi-stage balloon fistula-dilating puncture drainage tube in an operational state (head end balloon, balloon I, balloon II, and balloon III filling) in accordance with an embodiment of the invention.

In the figure, 1, a head part, 2, a balloon part, 3, a body part, 4, a tail part, 5, a puncture needle, 6 and a supporting tube;

11. channel I, 21, drainage tube I, 22, head end saccule, 23, channel II, 24, channel III, 25, side hole, 26, metal ring I, 27, metal ring II;

31. Channel IV, 32, channel V, 33, channel VI, 34, channel VII, 35, channel VIII, 36, balloon I, 37, balloon II, 38, balloon III, 39, metal ring III, 310, metal ring IV, 311, metal ring V, 312, metal ring VI;

41. Channel IX, 42, channel X, 43, channel XI, 44, channel XII, 45, channel XIII, 46, connector I, 47, connector II, 48, connector III, 49, connector IV, 410, connector V, 411, syringe or pressure pump.

Detailed Description

It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other. The invention will be described in detail below with reference to the drawings in connection with embodiments.

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. The following description of at least one exemplary embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the present invention. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.

The relative arrangement of the components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless it is specifically stated otherwise. Meanwhile, it should be clear that the dimensions of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail, but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values. It should be noted that like reference numerals and letters refer to like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.

In the description of the present invention, it should be understood that the azimuth terms such as "front, rear, upper, lower, left, right", "transverse, vertical, horizontal", and "top, bottom", etc., are generally based on the azimuth or positional relationships shown in the drawings, and are merely for convenience of describing the present invention and simplifying the description, and these azimuth terms do not indicate or imply that the apparatus or elements to be referred to must have a specific azimuth or be constructed and operated in a specific azimuth, and thus should not be construed as limiting the scope of the present invention in that the azimuth terms "inside and outside" refer to inside and outside with respect to the outline of each component itself.

Spatially relative terms, such as "above," "upper" and "upper surface," "above" and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or structures would then be oriented "below" or "beneath" the other devices or structures. Thus, the process is carried out, the exemplary term "above" may be included. Upper and lower. Two orientations below. The device may also be positioned in other different ways (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

In addition, the terms "first", "second", etc. are used to define the components, and are only for convenience of distinguishing the corresponding components, and the terms have no special meaning unless otherwise stated, and therefore should not be construed as limiting the scope of the present invention.

1-16, The invention provides a multi-stage fistula expanding puncture drainage tube with a balloon, which comprises a drainage tube and an inner core, wherein the drainage tube comprises a head part 1, a balloon part 2, a body part 3 and a tail part 4 which are connected with each other in sequence from beginning to end;

the head 1 is conical and is a single-channel drainage tube, and a channel I11 is arranged in the head;

The balloon part 2 comprises a drainage tube I21 and a head end balloon 22 sleeved on the outer wall of the drainage tube I21, wherein the drainage tube I21 is a double-channel drainage tube, a channel II23 communicated with the channel I11 and a channel III24 communicated with the head end balloon 22 are arranged in the drainage tube I21, the channel III24 is arranged between the channel II23 and the inner wall of the drainage tube I21, the proximal end of the channel III24 is a blind end (the proximal end is one end close to the head 1), two oval side holes 25 (the distal end is one end far away from the head 1) are arranged on the wall of the distal end of the drainage tube I21, and the two side holes 25 are communicated with the channel I11 and are used for discharging bile;

The body 3 is a five-channel drainage tube, a channel IV31, a channel V32, a channel VI33, a channel VII34 and a channel VIII35 which are communicated with the channel II23 and the channel III24 are arranged in the five-channel drainage tube, the channel V32, the channel VI33, the channel VII34 and the channel VIII35 are arranged between the channel IV31 and the inner wall of the body 3 drainage tube, and the head ends of the channel V32, the channel VI33 and the channel VII34 are blind ends;

The outer wall of the body part 3 is concave, three telescopic plastic balloons are wrapped, the balloon I36, the balloon II37 and the balloon III38 are respectively arranged from inside to outside in sequence, two ends of the balloon I36, the balloon II37 and the balloon III38 are conical, and the middle body is cylindrical;

the pipe wall of the body 3 is provided with a through hole I, a through hole II and a through hole III which are respectively communicated with the channel V32, the channel VI33 and the channel VII34, and the head ends of the channel V32, the channel VI33 and the channel VII34 are respectively communicated with the balloon I36, the balloon II37 and the balloon III 38;

The tail 4 is a five-channel drainage tube, a channel IX41, a channel X42, a channel XI43, a channel XII44 and a channel XIII45 are arranged in the five-channel drainage tube, the channel IX41 is communicated with the channel IV31, the channel XIII45 is communicated with the channel VIII35, the channel X42, the channel XI43 and the channel XII44 are respectively communicated with the channel V32, the channel VI33 and the channel VII34, the channel X42, the channel XI43, the channel XII44 and the channel XIII45 are arranged between the channel IX41 and the inner wall of the tail 4 drainage tube, and the tail ends of the channel X42, the channel XI43, the channel XII44 and the channel XIII45 are blind ends;

The pipe wall of the tail part 4 is provided with a single-channel connector I46, a connector II47, a connector III48 and a connector IV49 which are respectively communicated with the tail ends of the channel X42, the channel XI43, the channel XII44 and the channel XIII45, and the middle part of the bottom end of the tail part 4 is provided with a connector V410 communicated with the channel IX 41;

The surfaces of the connector I46, the connector II47, the connector III48, the connector IV49 and the connector V410 are respectively provided with a single-channel valve, and the surfaces of the connectors are provided with spiral grooves;

The tail end of the inner core is provided with a connecting cap, the inner wall of the connecting cap is provided with a spiral groove I, the spiral groove I is connected with the spiral groove on the outer wall of the connector V410 in a matched mode, and the body of the inner core is inserted into a channel in the connector V410 and penetrates out of the channel I11.

The inner core is a combination of a puncture needle 5 and a supporting tube 6, or the supporting tube 6;

The two sides of the head end of the supporting tube 6 are provided with resistance blocks, the resistance blocks are connected with the inner wall of the channel I in a matched mode, the supporting tube 6 is a single-channel metal tube, the body of the supporting tube is cylindrical, the tail end of the supporting tube 6 is provided with a connecting cap I which is a single-channel connecting cap, and the inner wall of the connecting cap I is provided with a spiral groove I which is connected with the spiral groove of the outer wall of the connector V410 in a matched mode.

When the inner core is the supporting tube 6, the connecting cap is the connecting cap I, and the supporting tube 6 is connected with the connector V410 through the cooperation connection of the spiral groove I and the spiral groove.

When the inner core is a combination of a puncture needle 5 and a supporting tube 6, a spiral groove II is formed in the outer wall of a connecting cap I on the supporting tube 6, a connecting cap II is arranged at the tail end of the puncture needle 5, a spiral groove III is formed in the inner wall of the connecting cap II, the spiral groove III is connected with the spiral groove II in a matched mode, and a middle body of the puncture needle 5 is arranged in a channel of the supporting tube 6;

the top of the puncture needle 5 is conical, and the middle body is cylindrical.

The length of the drainage tube is 60-100 cm, the outer diameter is 7Fr, and the inner diameter is 5Fr.

The maximum diameter of the head end balloon 22 is 1cm when the head end balloon 22 is filled, and the head end balloon 22 is oval after being filled;

the upper end and the lower end of the head end saccule 22 are respectively fixed with the tube wall of the drainage tube I21 through a metal ring I26 and a metal ring II 27.

The length of the balloon I36 is 30-60 cm, the balloon II37 is 1cm longer than the balloon I36, the balloon III38 is 1cm longer than the balloon II37, and the expansion diameters of the balloon I36, the balloon II37 and the balloon III38 are respectively 8Fr, 10Fr and 12Fr, or 14Fr, 16Fr and 18Fr;

the head ends of the balloon I36, the balloon II37 and the balloon III38 are flush and are fixed with the pipe wall of the body 3 through a metal ring III 39;

The tail ends of the balloon I36, the balloon II37 and the balloon III38 are respectively fixed with the wall of the body 3 through a metal ring IV310, a metal ring V311 and a metal ring VI 312.

Example 1

The multi-stage fistula expanding type puncture drainage tube with the balloon can directly perform percutaneous hepatobiliary tract and gall bladder puncture, and simultaneously expand the fistula, and comprises a drainage tube and an inner core, wherein the drainage tube comprises a head part 1, a balloon part 2, a body part 3 and a tail part 4 which are connected with one another in sequence from beginning to end.

The balloon part 2 comprises a drainage tube I21 and a head end balloon 22 sleeved on the outer wall of the drainage tube I21, wherein the drainage tube I21 is a double-channel drainage tube, a channel II23 communicated with the channel I11 and a channel III24 communicated with the head end balloon 22 are arranged in the drainage tube I, the channel III24 is arranged between the channel II23 and the inner wall of the drainage tube I21 (as shown in figures 5-6), the proximal end of the channel III24 is a blind end (the proximal end refers to the end close to the head 1), two oval side holes 25 (the distal end refers to the end far away from the head 1) are arranged on the wall of the distal end of the drainage tube I21, and the two side holes 25 are communicated with the channel I11 and are used for discharging bile;

The body 3 is a five-channel drainage tube, a channel IV31, a channel V32, a channel VI33, a channel VII34 and a channel VIII35 which are communicated with the channel II23 and the channel III24 are arranged in the five-channel drainage tube, the channel V32, the channel VI33, the channel VII34 and the channel VIII35 are arranged between the channel IV31 and the inner wall of the body 3 drainage tube (as shown in figures 7-9), and the head ends of the channel V32, the channel VI33 and the channel VII34 are blind ends;

The balloon catheter comprises a balloon body 3, and is characterized in that a through hole I, a through hole II and a through hole III are formed in the catheter wall of the balloon body 3 and are respectively communicated with a channel V32, a channel VI33 and a channel VII34, wherein the catheter wall is a catheter wall wrapped by the balloon body 3, the head ends of the channel V32, the channel VI33 and the channel VII34 are respectively communicated with a balloon I36, a balloon II37 and a balloon III38, the head end of the channel V32 is communicated with the balloon I36 through the through hole I, the head end of the channel VI33 is communicated with the balloon II37 through the through hole II, and the head end of the channel VII34 is communicated with the balloon III38 through the through hole III;

The tail 4 is a five-channel drainage tube, a channel IX41, a channel X42, a channel XI43, a channel XII44 and a channel XIII45 are arranged in the five-channel drainage tube, the channel IX41 is communicated with the channel IV31, the channel XIII45 is communicated with the channel VIII35, the channel X42, the channel XI43 and the channel XII44 are respectively communicated with the channel V32, the channel VI33 and the channel VII34, the channel X42, the channel XI43, the channel XII44 and the channel XIII45 are arranged between the channel IX41 and the inner wall of the tail 4 drainage tube (as shown in figure 10), and the tail ends of the channel X42, the channel XI43, the channel XII44 and the channel XIII45 are blind ends;

The inner core is a combination of a puncture needle 5 and a supporting tube 6, as shown in fig. 1.

The outer wall of the connecting cap I on the supporting tube 6 is provided with a spiral groove II, the tail end of the puncture needle 5 is provided with a connecting cap II, the inner wall of the connecting cap II is provided with a spiral groove III, the spiral groove III is connected with the spiral groove II in a matching way, and the middle body of the puncture needle 5 is arranged in a channel of the supporting tube 6;

The length of the drainage tube is 100cm, the outer diameter is 7Fr, and the inner diameter is 5Fr.

The length of the balloon I36 is 60cm, the balloon II37 is 1cm longer than the balloon I36, the balloon III38 is 1cm longer than the balloon II37, and the expansion diameters of the balloon I36, the balloon II37 and the balloon III38 are respectively 8Fr, 10Fr and 12Fr;

After the percutaneous puncture of the device is placed at the appointed position of the bile duct under the guidance of ultrasound, the puncture needle 5 and the supporting tube 6 are withdrawn, the connector I46 is connected with the injector or the pressure pump 411, and the head end saccule 22 (placed into the biliary tract and used for fixing and preventing the drainage tube from shifting) is filled with physiological saline containing contrast agent. The connector II47 is connected with a syringe or a pressure pump 411, the physiological saline containing contrast agent is gradually injected, the balloon I36 is slowly filled to expand the fistula, then the connector III48 and the connector IV49 are connected with the syringe or the pressure pump 411, the physiological saline containing contrast agent is gradually injected, the balloon II37 and the balloon III38 are slowly filled, and the balloon II37 and the balloon III38 with larger diameters are used to expand the fistula (the balloon I36, the balloon II37 and the balloon III38 are put into the fistula). The connector V410 is connected with a drainage bag for draining bile. The invention can directly implement percutaneous hepatobiliary tract and gall bladder puncture, and simultaneously expand fistula, can increase the fistula expansion range, reduce the replacement frequency of the drainage tube and shorten the course of disease, and has low manufacturing cost.

Example 2

In the embodiment, the fistula of the percutaneous transhepatic duct puncture way is expanded to form a multi-stage fistula expansion type drainage tube with a balloon, and the multi-stage fistula expansion type drainage tube comprises a drainage tube and an inner core, wherein the drainage tube comprises a head part 1, a balloon part 2, a body part 3 and a tail part 4 which are connected with each other in sequence from beginning to end;

The inner core is a support tube 6, as shown in figure 2.

The connecting cap is the connecting cap I, and the supporting tube 6 is connected with the connecting head V410 through the matching connection of the spiral groove I and the spiral groove.

The length of the drainage tube is 60cm, the outer diameter is 7Fr, and the inner diameter is 5Fr.

The length of the balloon I36 is 30cm, the balloon II37 is 1cm longer than the balloon I36, the balloon III38 is 1cm longer than the balloon II37, and the expansion diameters of the balloon I36, the balloon II37 and the balloon III38 are 14Fr, 16Fr and 18Fr respectively;

The device is placed into an expanding part under the guidance of the guide wire, is connected with a syringe or a pressure pump 411 through a connector I46 after being placed into the expanding part, is injected with a head end saccule 22 (placed into biliary tract, plays a fixing role and prevents the drainage tube from shifting) containing contrast agent physiological saline or air, and closes the connector I46. The connector II47 is connected with the injector or the pressure pump 411, the saline containing contrast agent is gradually injected, the cylindrical expansion air sac is slowly filled to expand the fistula, the connector III48 and the connector IV49 are connected with the injector or the pressure pump 411, the saline containing contrast agent is gradually injected, the balloon II37 and the balloon III38 are slowly filled, the balloon II37 and the balloon III38 with larger diameters are used for expanding the fistula (the balloon I36, the balloon II37 and the balloon III38 are placed into the fistula), and the connector V410 is connected with the drainage bag to drain bile. By adopting the scheme of the invention for expanding the fistula in the percutaneous transhepatic duct puncture way, the fistula expansion range can be increased, the replacement frequency of the drainage tube can be reduced, the course of the disease can be shortened, and the manufacturing cost of the invention is low.

It should be noted that the above embodiments are merely for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the above embodiments, it should be understood by those skilled in the art that the technical solution described in the above embodiments may be modified or some or all of the technical features may be equivalently replaced, and these modifications or substitutions do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the present invention.

Claims

1. A multi-stage fistula expansion puncture drainage tube with a balloon, characterized in that it comprises: a drainage tube and an inner core, wherein the drainage tube comprises a head (1), a balloon part (2), a body (3) and a tail (4) which are sequentially connected to each other from the beginning to the end;

The head (1) is conical and is a single-channel drainage tube, and is provided with a channel I (11) therein;

The balloon portion (2) comprises a drainage tube I (21) and a head end balloon (22) sleeved on its outer wall, wherein the drainage tube I (21) is a double-channel drainage tube, provided with a channel II (23) communicating with the channel I (11) and a channel III (24) communicating with the head end balloon (22), wherein the proximal end of the channel III (24) is a blind end; two elliptical side holes (25) are provided on the distal end wall of the drainage tube I (21), and the two side holes (25) are both connected with the channel I (11) for discharging bile;

The body (3) is a five-channel drainage tube, which is provided with a channel IV (31), a channel V (32), a channel VI (33), a channel VII (34) connected to the channel II (23) and a channel VIII (35) connected to the channel III (24), and the head ends of the channel V (32), the channel VI (33) and the channel VII (34) are blind ends;

The outer wall of the body (3) is concave and wrapped with three overlapping plastic balloons, which are sequentially connected from the inside to the outside with overlapping balloons I (36), balloon II (37) and balloon III (38), wherein both ends of the balloons I (36), balloon II (37) and balloon III (38) are conical, and the middle body is cylindrical;

The tube wall of the body (3) is provided with a through hole I, a through hole II and a through hole III, which are respectively connected to the channel V (32), the channel VI (33) and the channel VII (34); the head ends of the channel V (32), the channel VI (33) and the channel VII (34) are respectively connected to the balloon I (36), the balloon II (37) and the balloon III (38);

The tail portion (4) is a five-channel drainage tube, which is provided with a channel IX (41), a channel X (42), a channel XI (43), a channel XII (44) and a channel XIII (45); the channel IX (41) is connected to the channel IV (31), the channel XIII (45) is connected to the channel VIII (35), the channel X (42), the channel XI (43) and the channel XII (44) are connected to the channel V (32), the channel VI (33) and the channel VII (34) respectively; the tail ends of the channel X (42), the channel XI (43), the channel XII (44) and the channel XIII (45) are blind ends;

The tube wall of the tail portion (4) is provided with single-channel connectors I (46), II (47), III (48) and IV (49), which are respectively connected to the tail ends of the channel X (42), the channel XI (43), the channel XII (44) and the channel XIII (45); the middle part of the bottom end of the tail portion (4) is provided with a connector V (410) which is connected to the channel IX (41);

The surfaces of the connectors I (46), II (47), III (48), IV (49) and V (410) are all provided with single-channel valves and spiral grooves;

A connecting cap is provided at the tail end of the inner core, and a spiral groove I is provided on the inner wall of the connecting cap. The spiral groove I cooperates with the spiral groove on the outer wall of the connecting head V (410). The body of the inner core is inserted into the channel in the connecting head V (410) and passes through the channel I (11).

2. The multi-stage fistula expansion puncture drainage tube with a balloon according to claim 1, characterized in that the inner core is a support tube (6), or a combination of a puncture needle (5) and a support tube (6);

Resistance blocks are provided on both sides of the head end of the support tube (6), and the resistance blocks are connected in cooperation with the inner wall of the channel I; the support tube (6) is a single-channel metal tube, and the body is cylindrical; a connecting cap I is provided at the tail end of the support tube (6), which is a single-channel connecting cap; the inner wall of the connecting cap I is provided with the spiral groove I that is connected in cooperation with the spiral groove on the outer wall of the connecting head V (410).

3. The multi-stage fistula expansion puncture drainage tube with a balloon according to claim 2 is characterized in that when the inner core is a support tube (6), the connecting cap is the connecting cap I, and the support tube (6) is connected to the connecting head V (410) through the matching connection between the spiral groove I and the spiral groove.

4. The multi-stage fistula expansion puncture drainage tube with a balloon according to claim 2, characterized in that when the inner core is a combination of a puncture needle (5) and a support tube (6), the outer wall of the connecting cap I on the support tube (6) is provided with a spiral groove II, the tail end of the puncture needle (5) is provided with a connecting cap II, the inner wall of the connecting cap II is provided with a spiral groove III, the spiral groove III is matched and connected with the spiral groove II, and the middle body of the puncture needle (5) is placed in the channel of the support tube (6);

The top of the puncture needle (5) is in a cone shape, and the middle body is in a column shape.

5. The multi-stage fistula expansion puncture drainage tube with a balloon according to claim 1 or 2, characterized in that the drainage tube has a length of 60 to 100 cm, an outer diameter of 7 Fr, and an inner diameter of 5 Fr.

6. The multi-stage fistula expansion puncture drainage tube with a balloon according to claim 5, characterized in that the maximum diameter of the head end balloon (22) when filled is 1 cm, and the head end balloon (22) is elliptical after being filled;

The upper and lower ends of the head end balloon (22) are fixed to the wall of the drainage tube I (21) via a metal ring I (26) and a metal ring II (27) respectively.

7. The multi-stage fistula expansion puncture drainage tube with balloons according to claim 5, characterized in that the length of the balloon I (36) is 30 to 60 cm, the balloon II (37) is 1 cm longer than the balloon I (36), the balloon III (38) is 1 cm longer than the balloon II (37), and the expanded diameters of the balloon I (36), the balloon II (37) and the balloon III (38) are 8 Fr, 10 Fr and 12 Fr, or 14 Fr, 16 Fr and 18 Fr, respectively;

The head ends of the balloons I (36), II (37) and III (38) are flush and are all fixed to the wall of the body (3) via a metal ring III (39);

The tail ends of the balloon I (36), balloon II (37) and balloon III (38) are fixed to the tube wall of the body (3) via metal ring IV (310), metal ring V (311) and metal ring VI (312), respectively.

8. The multi-stage fistula expansion puncture drainage tube with a balloon according to claim 5, characterized in that the connector I (46) is connected to a syringe or a pressure pump (411), and a physiological saline containing a contrast agent is injected to fill the balloon (22) at the head end;

The connector II (47) is connected to a syringe or a pressure pump (411), and physiological saline containing contrast agent is gradually injected to slowly fill the balloon I (36) to expand the fistula;

The connector III (48) and the connector IV (49) are connected to a syringe or a pressure pump (411), and physiological saline containing contrast agent is gradually injected to slowly fill the balloon II (37) and the balloon III (38), and the balloon II (37) and the balloon III (38) with a larger diameter are used to expand the fistula;

The connector V (410) is connected to a drainage bag to drain bile.