Multi-level fistula dilatation puncture drainage tube with balloon

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

Technical Field

[0001] The present invention relates to the field of minimally invasive medical technology and surgical instrument technology, and in particular to a multi-stage fistula expansion puncture drainage tube with a balloon, which is a minimally invasive surgical instrument used for percutaneous transhepatic bile duct puncture and fistula expansion to treat biliary system diseases, or a minimally invasive surgical instrument used for expanding percutaneous transhepatic bile duct puncture fistula to treat biliary system diseases. Background Art

[0002] Gallbladder and intrahepatic bile duct stones are common diseases that can induce complications such as acute and chronic cholecystitis, cholangitis, obstructive jaundice, and biliary tumors. The traditional treatment for gallstones is open cholecystectomy and hepatic lobectomy. With the increasing development of laparoscopic and choledochoscopy techniques, laparoscopic cholecystolithotomy and bile duct exploration and lithotomy have become important means of treating gallstones.

[0003] Whether it is laparoscopic cholecystolithotomy or biliary exploration and lithotripsy, it needs to be performed under general anesthesia. For elderly and high-risk patients who cannot tolerate the risks of general anesthesia, as well as patients who have undergone multiple laparotomies, percutaneous transhepatic gallbladder and bile duct puncture and drainage can be performed first, followed by gradual dilation of the fistula. When the fistula is dilated to more than 16Fr, a choledochoscope can be inserted through the fistula to enter the gallbladder and duct for lithotripsy and stone removal. There are two ways to dilate the fistula. One is to use different types of hard dilation tubes to dilate the fistula in one operation, but this method still needs to be completed under general anesthesia, which is prone to complications such as bleeding, liver abscess, and bile leakage. The other is to intermittently replace a thicker type of bile duct drainage tube. This method does not require anesthesia, but the interval between the two operations is long, resulting in a longer treatment time for the disease. If the interval is short or a thicker type of drainage tube is selected, it will not only increase the patient's pain, but also increase the difficulty of catheterization. Summary of the invention

[0004] According to the above-mentioned, different types of hard dilation tubes are used to dilate the fistula in one operation, but this method still needs to be completed under general anesthesia, which is prone to complications such as bleeding, liver abscess, and bile leakage; intermittent replacement of thicker bile duct drainage tubes does not require anesthesia, but the interval between two operations is long, resulting in a long treatment time for the disease. If the interval is short or a thicker drainage tube is selected, it not only increases the patient's pain, but also increases the technical problem of the difficulty of catheterization, and provides a multi-stage fistula dilation puncture drainage tube with a balloon. The present invention mainly uses the device to directly puncture the bile duct or gallbladder through the skin under local anesthesia to avoid complications such as abdominal pain caused by bile entering the abdominal cavity during conventional puncture; the head end balloon at the front end of the drainage tube prevents the displacement of the drainage tube; the multi-balloon design is adopted to increase the scope of fistula expansion, reduce the number of times the drainage tube is replaced, and shorten the course of the disease; the multi-balloons in the body are fixed in an overlapping manner, and each balloon is gradually filled from the inside to the outside, which can achieve step-by-step expansion of the fistula, reduce the risk of rapid expansion of the fistula, tearing and bleeding, and have a small pain reaction.

[0005] The technical means adopted by the present invention are as follows:

[0006] A multi-stage fistula expansion 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 part which are sequentially connected to each other from the beginning to the end;

[0007] The head is conical and is a single-channel drainage tube with channel I provided therein;

[0008] The balloon part includes a drainage tube I and a head-end balloon sleeved on its outer wall. The drainage tube I is a double-channel drainage tube, which is provided with a channel II connected to the channel I and a channel III connected to the head-end balloon. The proximal end of the channel III is a blind end. Two elliptical side holes are provided on the distal wall of the drainage tube I. Both side holes are connected to the channel I for discharging bile.

[0009] The body is a five-channel drainage tube, which is provided with channel IV, channel V, channel VI, channel VII connected to the channel II and channel VIII connected to the channel III, and the head ends of the channel V, channel VI and channel VII are blind ends;

[0010] The outer wall of the body is concave, and is inset with overlapping balloons I, II and III in sequence from the inside to the outside. Both ends of the balloons I, II and III are conical, and the middle body is cylindrical.

[0011] The tube wall of the body is provided with through holes I, II and III, which are respectively connected to 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 connected to the balloon I, the balloon II and the balloon III;

[0012] The tail portion is a five-channel drainage tube, which is provided with channel IX, channel X, channel XI, channel XII and channel XIII, the channel IX is connected with the channel IV, the channel XIII is connected with the channel VIII, the channel X, channel XI and channel XII are connected with the channel V, channel VI and channel VII respectively; the tail ends of the channel X, channel XI, channel XII and channel XIII are blind ends;

[0013] The tube wall of the tail portion is provided with single-channel connectors I, II, III and IV, which are respectively connected to the tail ends of the channels X, XI, XII and XIII; the middle of the bottom end of the tail portion is provided with a connector V connected to the channel IX;

[0014] The surfaces of the connectors I, II, III, IV and V are all provided with single-channel valves, and the surfaces are provided with spiral grooves;

[0015] 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. The body of the inner core is inserted into the channel in the connecting head V and passes through the channel I.

[0016] Further, the inner core is a support tube, or a combination of a puncture needle and a support tube;

[0017] Resistance blocks are provided on both sides of the head end of the support tube, and the resistance blocks are connected with the inner wall of the channel I; the support tube is a single-channel metal tube, and the body is cylindrical; the tail end of the support tube is provided with a connecting cap I, 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 with the spiral groove on the outer wall of the connecting head V.

[0018] Further, when the inner core is a support tube, the connecting cap is the connecting cap I, and the support tube is connected to the connecting head V through the matching connection between the spiral groove I and the spiral groove.

[0019] Furthermore, when the inner core is a combination of a puncture needle and a support tube, the outer wall of the connecting cap I on the support tube is provided with a spiral groove II, the tail end of the puncture needle 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, and the middle body of the puncture needle is placed in the channel of the support tube;

[0020] The connecting cap is a combination of the connecting cap I and the connecting cap II;

[0021] The top of the puncture needle is in a cone shape, and the middle body is in a column shape.

[0022] Furthermore, the drainage tube has a length of 60 to 100 cm, an outer diameter of 7 Fr, and an inner diameter of 5 Fr.

[0023] Furthermore, the maximum diameter of the head end balloon when inflated is 1 cm, and the head end balloon is elliptical when inflated;

[0024] The upper and lower ends of the head end balloon are fixed to the wall of the drainage tube I through a metal ring I and a metal ring II respectively.

[0025] Further, the length of the balloon I is 30 to 60 cm, the balloon II is 1 cm longer than the balloon I, the balloon III is 1 cm longer than the balloon II, and the expanded diameters of the balloon I, the balloon II and the balloon III are 8 Fr, 10 Fr and 12 Fr, or 14 Fr, 16 Fr and 18 Fr, respectively;

[0026] The head ends of the balloons I, II and III are flush and are all fixed to the tube wall of the body by a metal ring III;

[0027] The tail ends of the balloons I, II and III are fixed to the tube wall of the body through metal rings IV, V and VI respectively.

[0028] Furthermore, the connector I is connected to a syringe or a pressure pump, and a physiological saline solution containing a contrast agent is injected to fill the head end balloon;

[0029] The connector II is connected to a syringe or a pressure pump, and physiological saline containing contrast agent is gradually injected to slowly fill the balloon I to expand the fistula;

[0030] The connector III and the connector IV are connected to a syringe or a pressure pump, and physiological saline containing contrast agent is gradually injected to slowly fill balloon II and balloon III, and the larger diameter balloon II and balloon III are used to expand the fistula;

[0031] The connector V is connected to a drainage bag to drain bile.

[0032] The blind end mentioned above refers to the L-shaped head end of the water injection and gas injection channel, which is connected to the balloon cavity through the side wall hole opened in the wall of the drainage tube.

[0033] Compared with the prior art, the present invention has the following advantages:

[0034] 1. The multi-stage fistula expansion puncture drainage tube with a balloon provided by the present invention has a low manufacturing cost. The device can be directly punctured through the skin into the bile duct or gallbladder under local anesthesia, which simplifies the operation process and does not require the use of additional guide wires and puncture needles, saving operation time and medical costs, and avoiding complications such as abdominal pain caused by bile entering the abdominal cavity during conventional puncture; it can also expand the fistula of the percutaneous transhepatic bile duct puncture route.

[0035] 2. The multi-stage fistula expansion puncture drainage tube with balloon provided by the present invention is of 7Fr model and can be easily inserted into the fistula.

[0036] 3. The multi-stage fistula expansion puncture drainage tube with a balloon provided by the present invention has a balloon at the head end that can prevent the drainage tube from shifting.

[0037] 4. The multi-stage fistula expansion puncture drainage tube with balloon provided by the present invention adopts a multi-balloon design, which increases the range of fistula expansion, reduces the number of times the drainage tube needs to be replaced, and shortens the course of the disease.

[0038] 5. The multi-stage fistula expansion puncture drainage tube with balloons provided by the present invention has multiple balloons fixed in an overlapping manner, and each balloon is gradually filled from the inside to the outside, which can achieve step-by-step expansion of the fistula, reduce the risk of tearing and bleeding due to rapid expansion of the fistula, and have a small pain response.

[0039] 6. The multi-stage fistula expansion puncture drainage tube with balloons provided by the present invention has each balloon with a fixed diameter, and can reach the expansion diameter under relatively low pressure, has low pressure requirements, is simple to operate, and has low manufacturing costs.

[0040] In summary, the technical solution of the present invention can solve the problem of using different types of hard dilation tubes to dilate fistulas in one operation in the prior art, but this method still needs to be completed under general anesthesia, which is prone to complications such as bleeding, liver abscess, and bile leakage; intermittent replacement of thicker biliary drainage tubes does not require anesthesia, but the interval between the two operations is long, resulting in a longer disease treatment time. If the interval is short or a thicker drainage tube is selected, it not only increases the patient's pain, but also increases the difficulty of catheterization.

[0041] Based on the above reasons, the present invention can be widely promoted in the fields of minimally invasive medical technology and surgical instruments. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0043] Figure 1 It is a schematic structural diagram of a multi-stage fistula expansion type puncture drainage tube with a balloon in Example 1 of the present invention.

[0044] Figure 2 It is a schematic structural diagram of a multi-stage fistula expansion type drainage tube with a balloon in Example 2 of the present invention.

[0045] Figure 3 It is a schematic diagram of the structure of the drainage tube in a specific embodiment of the present invention.

[0046] Figure 4 for Figure 3 Middle AA section view.

[0047] Figure 5 for Figure 3 Middle BB cross-section.

[0048] Figure 6 for Figure 3 Middle CC section.

[0049] Figure 7 for Figure 3 Middle DD section view.

[0050] Figure 8 for Figure 3 Middle EE section view.

[0051] Fig. 9 for Figure 3 Middle FF cross-section.

[0052] Fig.10 for Figure 3 Middle GG cross-section.

[0053] Fig.11 It is a schematic diagram of the structure of the puncture needle in a specific embodiment of the present invention.

[0054] Fig.12 It is a schematic diagram of the structure of the support tube in a specific implementation manner of the present invention.

[0055] Fig.13 It is a schematic diagram of a multi-stage fistula expansion type puncture drainage tube with a balloon in a working state (the balloon at the head end is filled) in a specific embodiment of the present invention.

[0056] Fig.14 It is a schematic diagram of a multi-stage fistula expansion type puncture drainage tube with a balloon in a working state in a specific embodiment of the present invention (the head end balloon and balloon I are filled).

[0057] Fig.15 It is a schematic diagram of a multi-stage fistula expansion type puncture drainage tube with balloons in a working state in a specific embodiment of the present invention (the head end balloon, balloon I and balloon II are filled).

[0058] Fig.16 It is a schematic diagram of a multi-stage fistula expansion type puncture drainage tube with balloons in a working state in a specific embodiment of the present invention (the head end balloon, balloon I, balloon II and balloon III are filled).

[0059] In the figure: 1, head; 2, balloon; 3, body; 4, tail; 5, puncture needle; 6, support tube;

[0060] 11. Channel I; 21. Drainage tube I; 22. Head end balloon; 23. Channel II; 24. Channel III; 25. Side hole; 26. Metal ring I; 27. Metal ring II;

[0061] 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;

[0062] 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

[0063] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0064] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0065] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprising" and / or "including" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0066] Unless otherwise specifically stated, the relative arrangement of the parts and steps described in these embodiments, the numerical expressions and numerical values ​​do not limit the scope of the present invention. At the same time, it should be clear that, for ease of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be regarded as part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0067] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention: the directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0068] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below their position devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0069] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0070] like Figure 1-16As shown, 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 1, a balloon part 2, a body 3 and a tail 4 which are sequentially connected to each other from the head to the tail;

[0071] The head 1 is conical and is a single-channel drainage tube, and is provided with a channel I 11 therein;

[0072] The balloon portion 2 includes a drainage tube I 21 and a head-end balloon 22 sleeved on its outer wall. The drainage tube I 21 is a double-channel drainage tube, which is provided with a channel II 23 connected to the channel I 11 and a channel III 24 connected to the head-end balloon 22. The channel III 24 is placed between the channel II 23 and the inner wall of the drainage tube I 21. The proximal end of the channel III 24 is a blind end (the proximal end refers to the end close to the head 1). Two elliptical side holes 25 are provided on the distal wall of the drainage tube I 21 (the distal end refers to the end away from the head 1). The two side holes 25 are both connected to the channel I 11 for discharging bile.

[0073] The body 3 is a five-channel drainage tube, which is provided with a channel IV31, a channel V32, a channel VI33, a channel VII34 connected to the channel II23, and a channel VIII35 connected to the channel III24. The channels V32, VI33, VII34, and VIII35 are placed between the channel IV31 and the inner wall of the drainage tube of the body 3, and the head ends of the channels V32, VI33, and VII34 are blind ends.

[0074] The outer wall of the body 3 is concave, and is wrapped with three overlapping plastic balloons, which are respectively balloon I 36, balloon II 37 and balloon III 38 from the inside to the outside. Both ends of the balloons I 36, balloon II 37 and balloon III 38 are conical, and the middle body is cylindrical;

[0075] The tube wall of the body 3 is provided with through holes I, II and III, which are respectively connected to 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 connected to the balloon I36, the balloon II37 and the balloon III38;

[0076] 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 respectively connected to the channel V 32, the channel VI 33 and the channel VII 34; the channel X 42, the channel XI 43, the channel XII 44 and the channel XIII 45 are placed between the channel IX 41 and the inner wall of the drainage tube of the tail portion 4; the tail ends of the channels X 42, the channel XI 43, the channel XII 44 and the channel XIII 45 are blind ends;

[0077] 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 connected to the channel IX 41;

[0078] The surfaces of the connector I46, connector II47, connector III48, connector IV49 and connector V410 are all provided with single-channel valves, and the surfaces are provided with spiral grooves;

[0079] 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 V410 and is connected; the body of the inner core is inserted into the channel in the connecting head V410 and passes through the channel I11.

[0080] The inner core is a combination of a puncture needle 5 and a support tube 6, or a support tube 6;

[0081] Resistance blocks are provided on both sides of the head end of the support tube 6, and the resistance blocks are connected with the inner wall of the channel I; the support tube 6 is a single-channel metal tube, and the main body is cylindrical; the tail end of the support tube 6 is provided with a connecting cap I, which is a single-channel connecting cap; the inner wall of the connecting cap I is provided with the spiral groove I which is connected with the spiral groove on the outer wall of the connecting head V410.

[0082] When the inner core is the support tube 6, the connecting cap is the connecting cap I, and the support tube 6 is connected to the connecting head V410 through the matching connection between the spiral groove I and the spiral groove.

[0083] 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;

[0084] The connecting cap is a combination of the connecting cap I and the connecting cap II;

[0085] The top of the puncture needle 5 is in a cone shape, and the middle body is in a column shape.

[0086] The drainage tube has a length of 60 to 100 cm, an outer diameter of 7 Fr, and an inner diameter of 5 Fr.

[0087] The maximum diameter of the head end balloon 22 when filled is 1 cm, and the head end balloon 22 is elliptical when filled;

[0088] The upper and lower ends of the head end balloon 22 are fixed to the wall of the drainage tube I 21 through a metal ring I 26 and a metal ring II 27 respectively.

[0089] 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;

[0090] The head ends of the balloons I 36, II 37 and III 38 are flush and fixed to the wall of the body 3 by a metal ring III 39;

[0091] The tail ends of the balloons I 36 , II 37 and III 38 are fixed to the wall of the body 3 via metal rings IV 310 , V 311 and VI 312 , respectively.

[0092] Example 1

[0093] The multi-stage fistula expansion puncture drainage tube with balloon in this embodiment can directly implement percutaneous transhepatic bile duct and gallbladder puncture and expand the fistula at the same time, including: a drainage tube and an inner core, and the drainage tube includes a head 1, a balloon part 2, a body 3 and a tail 4 which are connected to each other from head to tail.

[0094] The head 1 is conical and is a single-channel drainage tube, and is provided with a channel I 11 therein;

[0095] The balloon portion 2 includes a drainage tube I 21 and a head end balloon 22 sleeved on its outer wall. The drainage tube I 21 is a double-channel drainage tube, which is provided with a channel II 23 connected to the channel I 11 and a channel III 24 connected to the head end balloon 22. The channel III 24 is placed between the channel II 23 and the inner wall of the drainage tube I 21 (such as Figure 5-6As shown), the proximal end of the channel III 24 is a blind end (the proximal end refers to the end close to the head 1); two elliptical side holes 25 are provided on the distal wall of the drainage tube I 21 (the distal end refers to the end away from the head 1), and the two side holes 25 are connected to the channel I 11 for discharging bile;

[0096] The body 3 is a five-channel drainage tube, which is provided with a channel IV31, a channel V32, a channel VI33, a channel VII34 connected to the channel II23, and a channel VIII35 connected to the channel III24. The channel V32, the channel VI33, the channel VII34 and the channel VIII35 are placed between the channel IV31 and the inner wall of the drainage tube of the body 3 (such as Figure 7-9 As shown), the head ends of the channels V32, VI33 and VII34 are blind ends;

[0097] The outer wall of the body 3 is concave, and is wrapped with three overlapping plastic balloons, which are respectively balloon I 36, balloon II 37 and balloon III 38 from the inside to the outside. Both ends of the balloons I 36, balloon II 37 and balloon III 38 are conical, and the middle body is cylindrical;

[0098] The tube wall of the body 3 is provided with through holes I, II and III, which are respectively connected with the channel V32, the channel VI33 and the channel VII34; the tube wall is the tube wall on the body 3 wrapped by the balloon; the head ends of the channel V32, the channel VI33 and the channel VII34 are respectively connected with the balloon I36, the balloon II37 and the balloon III38; wherein the head end of the channel V32 is connected with the balloon I36 through the through hole I, the head end of the channel VI33 is connected with the balloon II37 through the through hole II, and the head end of the channel VII34 is connected with the balloon III38 through the through hole III;

[0099] 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 channel X 42, the channel XI 43, the channel XII 44 and the channel XIII 45 are placed between the channel IX 41 and the inner wall of the drainage tube of the tail portion 4 (such as Fig.10 The tail ends of the channel Ⅹ42, the channel Ⅺ43, the channel Ⅻ44 and the channel ⅩIII45 are blind ends;

[0100] 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 connected to the channel IX 41;

[0101] The surfaces of the connector I46, connector II47, connector III48, connector IV49 and connector V410 are all provided with single-channel valves, and the surfaces are provided with spiral grooves;

[0102] 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 V410 and is connected; the body of the inner core is inserted into the channel in the connecting head V410 and passes through the channel I11.

[0103] The inner core is a combination of a puncture needle 5 and a support tube 6. Figure 1 shown.

[0104] Resistance blocks are provided on both sides of the head end of the support tube 6, and the resistance blocks are connected with the inner wall of the channel I; the support tube 6 is a single-channel metal tube, and the main body is cylindrical; the tail end of the support tube 6 is provided with a connecting cap I, which is a single-channel connecting cap; the inner wall of the connecting cap I is provided with the spiral groove I which is connected with the spiral groove on the outer wall of the connecting head V410.

[0105] 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 matched and connected with the spiral groove II, and the middle body of the puncture needle 5 is placed in the channel of the supporting tube 6;

[0106] The connecting cap is a combination of the connecting cap I and the connecting cap II;

[0107] The top of the puncture needle 5 is in a cone shape, and the middle body is in a column shape.

[0108] The drainage tube has a length of 100 cm, an outer diameter of 7 Fr, and an inner diameter of 5 Fr.

[0109] The maximum diameter of the head end balloon 22 when filled is 1 cm, and the head end balloon 22 is elliptical when filled;

[0110] The upper and lower ends of the head end balloon 22 are fixed to the wall of the drainage tube I 21 through a metal ring I 26 and a metal ring II 27 respectively.

[0111] The length of the balloon I 36 is 60 cm, the balloon II 37 is 1 cm longer than the balloon I 36, and the balloon III 38 is 1 cm longer than the balloon II 37. 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, respectively;

[0112] The head ends of the balloons I 36, II 37 and III 38 are flush and fixed to the wall of the body 3 by a metal ring III 39;

[0113] The tail ends of the balloons I 36 , II 37 and III 38 are fixed to the wall of the body 3 via metal rings IV 310 , V 311 and VI 312 , respectively.

[0114] After the device is percutaneously inserted into the designated position of the bile duct under ultrasound guidance, the puncture needle 5 and the support tube 6 are withdrawn, the connector I 46 is connected to the syringe or pressure pump 411, and the saline containing contrast agent is injected to fill the head end balloon 22 (put into the bile duct to fix it and prevent the drainage tube from shifting). The connector II 47 is connected to the syringe or pressure pump 411, and the saline containing contrast agent is gradually injected, and the balloon I 36 is slowly filled to expand the fistula. Then, the syringe or pressure pump 411 is connected through the connector III 48 and the connector IV 49, and the saline containing contrast agent is gradually injected, and the balloons II 37 and III 38 are slowly filled. The larger diameter balloons II 37 and III 38 are used to expand the fistula (the balloons I 36, II 37 and III 38 are put into the fistula). The connector V 410 is connected to the drainage bag to drain bile. The present invention can directly implement percutaneous transhepatic bile duct and gallbladder puncture and simultaneously dilate the fistula, thereby increasing the dilation range of the fistula, reducing the number of drainage tube replacements, shortening the course of the disease, and the present invention has low production cost.

[0115] Example 2

[0116] In this embodiment, the fistula tract of the percutaneous transhepatic bile duct puncture route is expanded, and a multi-stage fistula tract expansion type drainage tube with a balloon is provided, comprising: a drainage tube and an inner core, wherein the drainage tube comprises a head 1, a balloon part 2, a body part 3 and a tail part 4 which are sequentially connected to each other from the head to the tail;

[0117] The head 1 is conical and is a single-channel drainage tube, and is provided with a channel I 11 therein;

[0118] The balloon portion 2 includes a drainage tube I 21 and a head-end balloon 22 sleeved on its outer wall. The drainage tube I 21 is a double-channel drainage tube, which is provided with a channel II 23 connected to the channel I 11 and a channel III 24 connected to the head-end balloon 22. The channel III 24 is placed between the channel II 23 and the inner wall of the drainage tube I 21. The proximal end of the channel III 24 is a blind end (the proximal end refers to the end close to the head 1). Two elliptical side holes 25 are provided on the distal wall of the drainage tube I 21 (the distal end refers to the end away from the head 1). The two side holes 25 are both connected to the channel I 11 for discharging bile.

[0119] The body 3 is a five-channel drainage tube, which is provided with a channel IV31, a channel V32, a channel VI33, a channel VII34 connected to the channel II23, and a channel VIII35 connected to the channel III24. The channels V32, VI33, VII34, and VIII35 are placed between the channel IV31 and the inner wall of the drainage tube of the body 3, and the head ends of the channels V32, VI33, and VII34 are blind ends.

[0120] The outer wall of the body 3 is concave, and is wrapped with three overlapping plastic balloons, which are respectively balloon I 36, balloon II 37 and balloon III 38 from the inside to the outside. Both ends of the balloons I 36, balloon II 37 and balloon III 38 are conical, and the middle body is cylindrical;

[0121] The tube wall of the body 3 is provided with through holes I, II and III, which are respectively connected with the channel V32, the channel VI33 and the channel VII34; the tube wall is the tube wall on the body 3 wrapped by the balloon; the head ends of the channel V32, the channel VI33 and the channel VII34 are respectively connected with the balloon I36, the balloon II37 and the balloon III38; wherein the head end of the channel V32 is connected with the balloon I36 through the through hole I, the head end of the channel VI33 is connected with the balloon II37 through the through hole II, and the head end of the channel VII34 is connected with the balloon III38 through the through hole III;

[0122] 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 respectively connected to the channel V 32, the channel VI 33 and the channel VII 34; the channel X 42, the channel XI 43, the channel XII 44 and the channel XIII 45 are placed between the channel IX 41 and the inner wall of the drainage tube of the tail portion 4; the tail ends of the channels X 42, the channel XI 43, the channel XII 44 and the channel XIII 45 are blind ends;

[0123] 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 connected to the channel IX 41;

[0124] The surfaces of the connector I46, connector II47, connector III48, connector IV49 and connector V410 are all provided with single-channel valves, and the surfaces are provided with spiral grooves;

[0125] 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 V410 and is connected; the body of the inner core is inserted into the channel in the connecting head V410 and passes through the channel I11.

[0126] The inner core is a support tube 6, such as Figure 2 shown.

[0127] Resistance blocks are provided on both sides of the head end of the support tube 6, and the resistance blocks are connected with the inner wall of the channel I; the support tube 6 is a single-channel metal tube, and the main body is cylindrical; the tail end of the support tube 6 is provided with a connecting cap I, which is a single-channel connecting cap; the inner wall of the connecting cap I is provided with the spiral groove I which is connected with the spiral groove on the outer wall of the connecting head V410.

[0128] The connecting cap is the connecting cap I, and the supporting tube 6 is connected to the connecting head V410 through the matching connection between the spiral groove I and the spiral groove.

[0129] The drainage tube has a length of 60 cm, an outer diameter of 7 Fr, and an inner diameter of 5 Fr.

[0130] The maximum diameter of the head end balloon 22 when filled is 1 cm, and the head end balloon 22 is elliptical when filled;

[0131] The upper and lower ends of the head end balloon 22 are fixed to the wall of the drainage tube I 21 through a metal ring I 26 and a metal ring II 27 respectively.

[0132] The length of the balloon I 36 is 30 cm, the balloon II 37 is 1 cm longer than the balloon I 36, and the balloon III 38 is 1 cm longer than the balloon II 37. The expanded diameters of the balloon I 36, the balloon II 37, and the balloon III 38 are 14 Fr, 16 Fr, and 18 Fr, respectively;

[0133] The head ends of the balloons I 36, II 37 and III 38 are flush and fixed to the wall of the body 3 by a metal ring III 39;

[0134] The tail ends of the balloons I 36 , II 37 and III 38 are fixed to the wall of the body 3 via metal rings IV 310 , V 311 and VI 312 , respectively.

[0135] Under ultrasound or X-ray monitoring, a guide wire is inserted through the original drainage tube, the guide wire is retained and the original drainage tube is withdrawn, and the device is inserted under the guidance of the guide wire. After the device is inserted into the expansion site, the syringe or pressure pump 411 is connected through the connector Ⅰ46, and physiological saline containing contrast agent or air is injected to fill the head end balloon 22 (which is placed in the bile duct to fix it and prevent the drainage tube from shifting), and the connector Ⅰ46 is closed. The connector II47 is connected to a syringe or a pressure pump 411, and a contrast-containing saline solution is gradually injected, and the cylindrical expansion balloon is slowly filled to expand the fistula. The connector III48 and the connector IV49 are connected to a syringe or a pressure pump 411, and a contrast-containing saline solution is gradually injected, and the balloon II37 and the balloon III38 are slowly filled, and the balloon II37 and the balloon III38 with a larger diameter are used to expand the fistula (the balloon I36, the balloon II37 and the balloon III38 are placed in the fistula); the connector V410 is connected to a drainage bag to drain bile. The scheme of expanding the fistula through the percutaneous transhepatic bile duct puncture route of the present invention can increase the expansion range of the fistula, reduce the number of drainage tube replacements, shorten the course of the disease, and the present invention has low manufacturing cost.

[0136] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A multi-stage fistula expansion puncture drainage tube with a balloon, characterized in that: include: A drainage tube and an inner core, wherein the drainage tube comprises a head portion (1), a balloon portion (2), a body portion (3) and a tail portion (4) which are sequentially connected to each other from head to tail; 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, characterized in that: When the inner core is a support tube (6), the connection cap is the connection cap I, and the support tube (6) is connected to the connection 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 connecting cap is a combination of the connecting cap I and the connecting cap II; 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 when 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 a balloon 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) to inject physiological saline containing contrast agent to fill the head end balloon (22); 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.

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