WO2022134814A1

WO2022134814A1 - Balloon guide tube kit and treatment apparatus

Info

Publication number: WO2022134814A1
Application number: PCT/CN2021/125603
Authority: WO
Inventors: 王雄伟; 陈石伟; 朱鑫建; 黄艳红; 张向阳
Original assignee: 微创优通医疗科技(嘉兴)有限公司; 微创优通医疗科技（上海）有限公司
Priority date: 2020-12-25
Filing date: 2021-10-22
Publication date: 2022-06-30
Also published as: CN114668957A; CN114668957B

Abstract

A balloon guide tube kit and a treatment apparatus. The treatment apparatus comprises a guide wire (100), a suction apparatus, and a balloon guide tube kit, and the balloon guide tube kit comprises a first balloon guide tube (1000) and a second balloon guide tube (2000). The first balloon guide tube (1000) comprises a first guide tube body (1100) and a first balloon (1200) sleeved on an outer surface of a distal end of the first guide tube body (1100); the second balloon guide tube (2000) comprises a second guide tube body (2100) and a second balloon (2200) sleeved on an outer surface of a distal end of the second guide tube body (2100); the second guide tube body (2100) is used for perfusing a contrast agent to a distal side of a first predetermined location of a target cavity, the first balloon (1200) expands at the first predetermined location and blocks the target cavity, preventing the contrast agent from flowing back to a proximal side of the first predetermined location; the second balloon (2200) passes through a second channel (1102) and reaches a second predetermined location located at a distal side of a first target location; the second balloon (2200) expands at the second predetermined location and supports the target cavity; and after the second balloon (2200) is withdrawn from the target cavity, the second channel (1102) is further used for performing suction on contents in the target cavity. The balloon guide tube kit has the advantages of a quick effect and a good curative effect when used for treating intestinal obstruction.

Description

Balloon Catheter Kits and Treatment Devices

technical field

The invention relates to the technical field of medical devices, in particular to a balloon catheter kit and a treatment device.

Background technique

Adhesive Intestinal Obstruction (Adhesive Intestinal Obstruction) refers to the failure of intestinal contents to pass and run smoothly in the intestine due to intestinal adhesions in the abdominal cavity caused by various reasons. When the passage of intestinal contents is blocked, a series of symptoms such as abdominal distension, abdominal pain, nausea and vomiting and defecation disorder can occur. Adhesive ileus can be treated non-surgically in some cases to relieve symptoms, but in most cases, recurrent or conservative treatment fails, and surgery is still required.

Adhesive ileus is mostly small bowel obstruction. Previous survey statistics show that the incidence of small intestinal obstruction is about 40% of the incidence of intestinal obstruction, of which 70% to 80% have a history of abdominal surgery. Adhesive intestinal obstruction is mostly manifested as simple intestinal obstruction, and a few are transformed into strangulated intestinal obstruction.

The non-surgical treatment method for adhesive small intestinal obstruction is mainly to insert an intestinal obstruction catheter into the patient's stomach through the nasal cavity, adjust the patient's position, make the intestinal obstruction catheter pass through the greater curvature of the stomach, and then enter the small intestine indwelling site, and then rely on the small intestine. The peristalsis of the ileus carries the ileus catheter to the site of obstruction. During the passage of the ileus catheter from the indwelling site to the obstruction site, a suction device is used to perform negative pressure suction to expel the intestinal contents from the ileus catheter. The texture of the currently used intestinal obstruction catheters is relatively soft. During the patient's catheter placement, especially when passing through the greater curvature of the stomach, the pylorus and the duodenal curvature, there are problems such as poor controllability, poor pushability, and inconvenient operation. Therefore, usually only the head end of the intestinal obstruction catheter can be indwelled to the duodenum, and then the intestinal obstruction catheter can be carried to the obstruction site by the peristalsis of the small intestine. During the entire treatment process, the intestinal obstruction catheter needs to be indwelled in the patient's body for 3 to 14 days. For patients with weak bowel movements, the indwelling time can even be as long as several months. This not only seriously affects the quality of life of patients, but also occupies hospital bed resources. Some patients even suffer from intestinal ischemia due to slow or no curative effect, leading to emergency surgery. In addition, in the event of multi-segment obstruction, obstructive angulation, etc., it is difficult to carry the intestinal obstruction catheter to the obstruction site only by the power of intestinal peristalsis to relieve the obstruction.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a balloon catheter kit and a treatment device. When using the balloon catheter kit to treat adhesive intestinal obstruction, the obstruction can be actively relieved without using the power of peristalsis of the small intestine, thereby improving the treatment effect and shortening the treatment time.

To achieve the above object, the present invention provides a balloon catheter kit, comprising a first balloon catheter and a second balloon catheter; wherein,

The first balloon catheter includes a first catheter body and a first balloon sleeved on the outer surface of the distal end of the first catheter body; the first catheter body is formed with mutually isolated first channels and a second channel in communication with the first balloon;

The second balloon catheter includes a second catheter body and a second balloon sleeved on the outer surface of the distal end of the second catheter body; the second catheter body is formed with mutually isolated third channels and a fourth channel, the third channel communicates with the second balloon;

The balloon catheter kit is configured such that the second channel is used for infusing a contrast medium distal to a first predetermined location within the target lumen, and the first balloon is used at the first predetermined location The target lumen is expanded and blocked to prevent the contrast agent from flowing back along the target lumen to the proximal side of the first predetermined position; the second balloon is used to pass through the first predetermined position. two channels, and reach a second predetermined position in the target lumen, the second predetermined position is located at the distal side of the first predetermined position; the second balloon is used for the second predetermined position expanding at the second predetermined position to support the target lumen; and, after the second balloon is withdrawn from the target lumen, the second channel is also used to aspirate the target the contents of the lumen.

Optionally, the first conduit body includes a first tube body and a second tube body, the first tube body is sleeved on the outside of the second tube body, and the hardness of the first tube body is smaller than that of the first tube body. The hardness of the second tube body.

Optionally, the first channel is provided between the first pipe body and the second pipe body, or the first channel is provided on the pipe wall of the first pipe body; the second pipe body The inner cavity of the tubular body constitutes the second channel.

Optionally, the second pipe body includes at least one reinforcing layer, and the hardness of the reinforcing layer is greater than that of the first pipe body.

Optionally, the reinforcing layer includes a spring structure or a pipe network structure.

Optionally, the second pipe body further comprises at least one lubricating layer, and the lubricating layer is arranged on the inner surface of the reinforcing layer.

Optionally, the first balloon catheter further includes a flexible tip disposed at the distal end of the first catheter body, and the outer surface of the flexible tip is flush with the outer surface of the first catheter body ; The hardness of the flexible head end is less than the hardness of the first conduit body.

Optionally, the flexible head end has a fifth channel axially passing through and communicating with the second channel;

A first stepped surface and a second stepped surface are formed on the inner surface of the fifth channel, and the second stepped surface is located at the distal end side of the first stepped surface;

The distal end face of the first tube body abuts against the proximal end face of the flexible head end; the distal end face of the reinforcing layer abuts against the first step face, and the distal end face of the lubricating layer abuts against the first step face. the second step surface; and/or,

The flexible head end is provided with a developing element.

Optionally, the first balloon catheter further includes a first connector disposed at the proximal end of the first catheter body; the first connector includes a first interface, a second interface and a third interface; the The first interface communicates with the first channel, and both the second interface and the third interface communicate with the second channel.

Optionally, the second conduit body includes a third tube body and a fourth tube body; the third tube body is sleeved on the outer surface of the fourth tube body, and the fourth tube body is a hypotube.

Optionally, the second balloon catheter further includes a second connector disposed at the proximal end of the second catheter body; the second connector includes a fourth interface and a fifth interface, the fourth interface In communication with the third channel, the fifth interface is in communication with the fourth channel.

Optionally, the outer diameter of the first balloon in the expanded state is 20mm˜40mm; and/or,

The outer diameter of the second balloon in an expanded state is 8 mm˜18 mm.

In order to achieve the above object, the present invention also provides a treatment device, comprising a guide wire, a suction device and the aforementioned balloon catheter kit, the guide wire is used to pass through the second channel or the In the fourth channel; the suction device is used for communicating with the second channel to suck the contents in the target cavity.

To achieve the above object, the present invention also provides a method for using the above-mentioned treatment device, comprising the following steps:

introducing the first balloon of the first balloon catheter into a first predetermined position in the target lumen;

inflating the first balloon and occluding the target lumen at the first predetermined position;

Using the second channel of the first catheter body to perfuse a contrast medium to the distal side of the first predetermined position to perform contrast;

introducing the second balloon of the second balloon catheter into a second predetermined position in the target lumen through the second channel, the second predetermined position being located on the distal side of the first predetermined position;

inflating the second balloon to support the target lumen at the second predetermined location;

withdrawing the balloon of the second balloon catheter out of the target lumen through the second channel;

The contents of the target lumen are aspirated using the second channel.

Compared with the prior art, the balloon catheter kit and the treatment device of the present invention have the following advantages:

The first and aforesaid balloon catheter kits include a first balloon catheter and a second balloon catheter; wherein, the first balloon catheter includes a first catheter body and is sheathed outside the distal end of the first catheter body a first balloon on the surface; a first channel and a second channel isolated from each other are formed on the first catheter body, the first channel communicates with the first balloon; the second balloon catheter includes a second catheter body and a second balloon sheathed on the outer surface of the distal end of the second catheter body; a third channel and a fourth channel isolated from each other are formed on the second catheter body, and the third channel in communication with the second balloon; the balloon catheter kit is configured such that the second channel is used to perfuse a contrast medium distal to a first predetermined location in the target lumen, and the first balloon for expanding and blocking the target lumen at the first predetermined position to prevent the contrast agent from flowing back along the target lumen to the proximal side of the first predetermined position; the second The balloon is used for passing through the second channel and reaching a second predetermined position in the target lumen, and the second predetermined position is located on the distal side of the first predetermined position; the second balloon is used for expanding at the second predetermined location to support the target lumen at the second predetermined location; and, after the second balloon is withdrawn from the target lumen, the second channel also Used to aspirate the contents of the target lumen. When using the balloon catheter kit to treat adhesive intestinal obstruction, first introduce the proximal end of the first balloon catheter into the small intestine, and make the first balloon reach the proximal end of the obstruction area (ie, the first predetermined position), The first balloon is then inflated, and a contrast agent is introduced from the second channel to facilitate the operator to observe the obstruction. At the same time, the second channel also serves as an introduction channel for the second balloon, so that the second balloon can smoothly reach the obstruction area (ie, the second predetermined position) along the second channel, and expand to open the obstruction After that, the second balloon can be withdrawn, and the intestinal contents can be aspirated using the first balloon catheter to actively relieve the intestinal obstruction. In other words, the balloon catheter kit provided by the present invention can deliver the second balloon on the second balloon catheter to the obstructed area without relying on the power of small bowel peristalsis when treating intestinal obstruction, so as to actively Relieving the obstruction can have a good effect even for patients with poor bowel motility, and greatly shorten the treatment time and reduce the impact on the patient's quality of life.

Second, the first conduit body includes a first tube body and a second tube body, the first tube body is sleeved on the outer surface of the second tube body, and the hardness of the first tube body is smaller than that of the first tube body The hardness of the second tube body. The second tube body is used to support the first tube body, so that when the first tube body passes through the target lumen (such as the digestive tract), bending is avoided, and the pushability and operability of the first tube body are improved. Controllability, while also reducing patient discomfort.

Description of drawings

The accompanying drawings are used for better understanding of the present invention and do not constitute an improper limitation of the present invention. in:

1 is a schematic structural diagram of a first balloon catheter of a balloon catheter kit provided by the present invention according to an embodiment;

2 is a schematic structural diagram of a second balloon catheter of a balloon catheter kit provided by the present invention according to an embodiment;

Fig. 3 is the A-A cross-sectional view of the second balloon catheter of the balloon catheter kit shown in Fig. 2;

Figures 4a to 4f are schematic diagrams of the process of using a balloon catheter kit according to an embodiment of the present invention for treating adhesive intestinal obstruction.

[reference number]:

1000 - the first balloon catheter;

1100 - the first catheter body;

1101 - the first channel, 1102 - the second channel;

1110 - the first pipe body;

1120 - the second body;

1121-enhancing layer, 1122-lubricating layer;

1200 - the first balloon;

1300 - flexible head end;

1310 - Fifth Channel;

1311 - the first step surface, 1312 - the second step surface;

1301 - developing element;

1400 - the first connector;

1410 - the first interface, 1420 - the second interface, 1430 - the third interface;

2000 - Second Balloon Catheter;

2100-Second catheter body;

2101 - the fourth channel;

2110 - the third body, 2120 - the fourth body;

2200 - the second balloon;

2300 - the second connector;

2310- the fourth interface, 2320- the fifth interface;

100 - Guide wire.

Detailed ways

The embodiments of the present invention are described below through specific specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention may also be practiced or applied in other and different embodiments. Various details in this specification can also be modified or changed in various ways without departing from the spirit of the present invention based on different viewpoints and applications. It should be noted that the diagrams provided in this embodiment are only to illustrate the basic concept of the present invention in a schematic way, so the drawings only show the components related to the present invention rather than the number, shape and size of the components in actual implementation. For drawing, the type, quantity and proportion of each component can be arbitrarily changed during actual implementation, and the layout of components may also be more complicated.

In addition, each embodiment of the following description has one or more technical features, but this does not mean that the person using the present invention must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. One or all of the technical features of the . In other words, under the premise of possible implementation, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in the multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents, and the plural forms "a plurality" include two or more referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "installed", "connected", "connected" shall be To be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two elements or the interaction relationship between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

The core idea of the present invention is to provide a balloon catheter kit including a first balloon catheter and a second balloon catheter. Wherein, the first balloon catheter includes a first catheter body and a first balloon sleeved on the outer surface of the distal end of the first catheter body; the first catheter body is formed with mutually isolated first A channel and a second channel, the first channel being in communication with the first balloon. The second balloon catheter includes a second catheter body and a second balloon sleeved on the outer surface of the distal end of the second catheter body; the second catheter body is formed with a third channel and a third channel isolated from each other. Four channels, the third channel communicates with the second balloon. The balloon catheter kit is configured such that the second channel is used for infusing a contrast medium distal to a first predetermined location within the target lumen, and the first balloon is used at the first predetermined location The target lumen is expanded and blocked to prevent the contrast agent from flowing back along the target lumen to the proximal side of the first predetermined position; the second balloon is used to pass through the first predetermined position. two channels, and reach a second predetermined position in the target lumen, the second predetermined position is located at the distal side of the first predetermined position; the second balloon is used for the second predetermined position at the second predetermined position expanding to support the target lumen at the second predetermined location. And, after the second balloon is withdrawn from the target lumen, the second channel is also used for suctioning the contents in the target lumen.

The "target lumen" described herein may be, for example, the digestive tract, the "first predetermined position" may be a designated position on the proximal side of the region where the obstruction in the small intestine occurs, and the "second predetermined position" may be the occurrence of The location of the bowel obstruction (ie, the area of obstruction). That is, the balloon catheter kit can be used to treat intestinal obstruction. Hereinafter, the use of the balloon catheter kit to treat intestinal obstruction will be used as an example for description, but it should not be construed to limit the present invention.

When using the balloon catheter kit to treat intestinal obstruction, the second channel of the first balloon catheter is used as the delivery channel of the second balloon catheter, so that the second balloon catheter can directly reach the intestine The obstructed area in the tract, and the dilation of the second balloon is used to actively relieve the obstruction. That is, the balloon catheter kit provided by the embodiment of the present invention does not need to use intestinal peristalsis to relieve obstruction, shorten the treatment time, and improve the therapeutic effect, and even for patients with weak intestinal peristalsis, it also has a better curative effect. .

Herein, the terms "proximal", "distal" are the relative orientation, relative position, orientation of elements or actions relative to each other from the perspective of the operator using the medical device, although "proximal", "distal" " is not limiting, but "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end that first enters the patient.

In order to make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. The same or similar reference numbers in the drawings represent the same or similar parts.

As shown in FIGS. 1 to 3 , an embodiment of the present invention provides a balloon catheter kit including a first balloon catheter 1000 and a second balloon catheter 2000 . The first balloon catheter 1000 includes a first catheter body 1100 and a first balloon 1200 sheathed on the outer surface of the distal end of the first catheter body 1100 . A first channel 1101 and a second channel 1102 isolated from each other are formed on the first catheter body 1100 , and the first channel 1101 communicates with the first balloon 1200 for injecting into the first balloon 1200 Fill with filler. The second channel 1102 can be used for threading a guide wire, injecting a contrast agent, and threading the second balloon catheter 2000 , so that the second channel 1102 penetrates along the axial direction of the first catheter body 1100 . extend. The second balloon catheter 2000 includes a second catheter body 2100 and a second balloon 2200 sheathed on the outer surface of the distal end of the second catheter body 2100 . A third channel (not shown in the figure) and a fourth channel 2101 are formed on the second conduit body 2100 . The third channel communicates with the second balloon 2200 for filling the second balloon 2200 with an inflation agent. The fourth channel 2101 can be used for passing a guide wire, so the fourth channel 2101 extends through the axial direction of the second catheter body 2100 .

When using the balloon catheter kit to treat intestinal obstruction, first introduce the distal end of the first balloon catheter 1000 into the target lumen (eg, the digestive tract), and make the first balloon 1200 reach the obstruction in the target lumen The proximal side of the region (ie, the first predetermined position). Then, filling agent is injected into the first balloon 1200 through the first channel 1101 to expand the first balloon 1200 and block the target lumen at this position. Subsequently, a contrast agent is injected from the second channel 1102 to the region where the obstruction occurs (ie, the distal side of the first predetermined position), so that the operator can observe the obstruction in the intestine through imaging equipment such as X-ray equipment. Afterwards, the distal end of the second balloon catheter 2000 is passed through the second channel 1102, and the second balloon 2200 is brought to the obstruction area. Next, filling agent is injected into the second balloon 2200 through the third channel, so as to expand the second balloon 2200 to support the target lumen (eg, intestinal tract) where the adhesion occurs. After that, the second balloon 2200 is withdrawn from the body along the third channel. Finally, the second channel 1102 is used as a suction channel to aspirate the contents of the target lumen to remove the obstruction.

That is, in the balloon catheter kit, the first balloon catheter 1000 is not only used to display the obstruction area and the obstruction situation in the intestinal tract in combination with the contrast agent, but the second lumen 1102 thereof is also used as the second balloon The introduction channel of the catheter 2000 to rapidly push the second balloon 2200 to the obstructed area to quickly and actively relieve the obstruction. Taking the target lumen as an example of the intestinal tract, compared with the traditional intestinal obstruction treatment method, there is no need to use the power of intestinal peristalsis to push the second balloon 2200, which shortens the treatment time and improves the treatment effect, especially for the intestinal tract. Patients with weak peristalsis still have better curative effect. In this embodiment, the outer diameter of the first balloon 1200 in the expanded state is 20 mm˜40 mm, and the outer diameter of the second balloon 2200 in the expanded state is 8 mm˜18 mm. Both the first balloon 1200 and the second balloon 2200 can be conventional balloons, and the materials thereof can be polymer materials such as TPU and Pebax.

In actual use, the first catheter body 1100 needs to have good pushability and bending resistance, so that it can smoothly enter the digestive tract and provide an introduction channel for the second balloon catheter 2000 . For this purpose, please refer to FIG. 1 . In this embodiment, the first conduit body 1100 includes a first tube body 1110 and a second tube body 1120 . The first tube body 1110 is sleeved outside the second tube body 1120 , and the hardness of the first tube body 1110 is smaller than the hardness of the second tube body 1120 . During the process of introducing the distal end of the first balloon catheter 1000 into the digestive tract, the first tubular body 1110 is in contact with the inner wall of the target lumen to reduce damage to the inner wall of the target lumen. The second tube body 1120 is inside the first tube body 1110, and provides a support force for the first tube body 1110, so that the first catheter body 1100 is not easily bent when passing through the digestive tract, thereby improving the first tube body 1110. Pushability and controllability of the catheter body 1110 and reduce discomfort to the patient.

Optionally, the first tube body 1110 can be made of a hydrophilic polymer material. The optional materials include but are not limited to TPU, Pebax, silica gel, etc., whose shore hardness can be between 86A-96A, such as 84A-95A, 85A-93A, 86A-92A, and its shore hardness can be, for example, 86A , 87A, 89A, 90A, 91A, 93A, 94A, 95A, 96A. The second tube body 1120 includes at least one reinforcing layer 1121, and the hardness of the reinforcing layer 1121 is greater than that of the first tube body 1110, so that the hardness of the second tube body 1120 is higher than that of the first tube body The hardness of the body 1110 is large. The shore hardness of the second pipe body 1120 may be between 60D-80D, such as 62D-78D, 63D-75D, and the shore hardness of the second pipe body 1120 may be 60D, 63D, 68D, 70D, 75D, 77D, 80D, etc.

Referring back to FIG. 1 , there may be a gap between the inner surface of the first tube body 1110 and the outer surface of the second tube body 1120 , and the gap may constitute the first channel 1101 . At the same time, the inner cavity of the second tube body 1120 constitutes the second channel 1102 . As mentioned above, the second channel 1102 is also used to pass through the second balloon catheter 2000, so the inner surface of the second tube body 1120 should be as smooth as possible to reduce the distance between the second tube body 1120 and the second ball. Friction between balloon catheters 2000. Therefore, the second pipe body 1120 preferably further includes at least one lubricating layer 1122 , and the lubricating layer 1122 is disposed on the inner surface of the reinforcing layer 1121 .

In an exemplary embodiment, the reinforcing layer 1121 may be a spring structure or a pipe mesh structure, and the lubricating layer 1122 may be connected by heat shrinkage. Specifically, the reinforcing layer 1121 and the lubricating layer 1122 can be formed separately, and then the lubricating layer 1122 is sleeved on a metal tube, and then the reinforcing layer 1121 is sleeved on the lubricating layer 1122. Then, a heat shrinkable tube is sleeved on the outer surface of the reinforcing layer 1121, and then the heat shrinkable tube is heated, so that the reinforcing layer 1121 and the lubricating layer 1122 are connected under the action of heat, and finally removed the heat shrinkable tube and the metal tube. Connecting the reinforcing layer 1121 and the lubricating layer 1122 by means of heat shrinking can enhance the bending resistance of the second tube body 1120. After the second tube body 1120 is connected to the first tube body 1110, The bending resistance of the first catheter body 1100 is enhanced.

The reinforcing layer 1121 can be made of either a metal material or a non-metallic material. Metal materials that can be used to make the reinforcing layer 1121 include but are not limited to stainless steel, nickel-titanium alloy, nickel alloy, and titanium alloy. Non-metallic materials that can be used to make the reinforcing layer 1121 include, but are not limited to, polyethylene, polypropylene or other polyolefin materials, polycarbonate, polyamide, polyoxymethylene, and ABS resin.

It should be noted that, in an alternative embodiment, the first channel may be formed by an inner cavity of a pipe material, and the pipe material may be disposed between the inner surface of the first pipe body and the second pipe body (not shown in the figure). Or the inner surface of the first tube body is in contact with the outer surface of the second tube body, and the first tube body is provided with a hole extending along its axial direction as the first channel (Fig. (not shown), at this time, the reinforcing layer and the first pipe body can also be connected by heat shrinkage.

Further, please continue to refer to FIG. 1 , the first balloon catheter 1000 further includes a flexible head end 1300 disposed at the distal end of the first catheter body 1100 , and the hardness of the flexible head end 1300 is smaller than that of the first catheter The stiffness of the body 1100 facilitates the advancement of the distal end of the first balloon catheter 1100 in the digestive tract until the first balloon 1200 is delivered to the first predetermined location. It can be understood that the hardness of the first catheter body 1100 is jointly determined by the hardness of the first tube body 1110 and the hardness of the second tube body 1120 . The “hardness of the flexible head end 1300 is smaller than the hardness of the first catheter body 1100 ” mentioned here means that the flexibility of the flexible head end 1300 is better than that of the first catheter body 1100 . It can also be understood that when the first channel 1101 extends through the axial direction of the first catheter body 1100 , the flexible tip 1300 also blocks the distal end of the first channel 1101 . In addition, the flexible tip 1300 is also preferably provided with a developing element 1301 for displaying the position of the flexible tip 1300 in the digestive tract.

Generally, at the junction of the flexible head end 1300 and the first conduit body 1100, the outer peripheral surface of the flexible head end 1300 is flush with the outer peripheral surface of the first conduit body 1100 to avoid the first ball The balloon catheter 1000 scratches the inner wall of the target lumen as it travels through the digestive tract. And, the flexible head end 1300 also has a fifth channel 1310 axially passing through and communicating with the second channel 1102 of the first catheter body 1100 .

Further, a first stepped surface 1311 and a second stepped surface 1312 are formed on the inner surface of the fifth channel 1310 , and the second stepped surface 1311 is located on the distal side of the first stepped surface 1312 . The distal end of the reinforcing layer 1121 of the second tube body 1120 is exposed outside the first tube body 1110 (that is, the distal end of the reinforcing layer 1121 is not covered by the first tube body 1110 ), so the The distal end of the lubricating layer 1122 is exposed outside the reinforcing layer 1121 (ie, the distal end of the lubricating layer 1122 is not covered by the reinforcing layer 1121 ). In this way, when the first catheter body 1100 and the flexible head end 1300 are assembled, the distal end face of the first tube body 1110 abuts against the proximal end face of the flexible head end 1300, the second The distal end of the tube body 1120 extends into the fifth channel 1310, the distal end surface of the reinforcing layer 1121 abuts on the first stepped surface 1311, and the distal end surface of the lubricating layer 1122 abuts against the first step surface 1311. on the second step surface 1312. The advantage of this arrangement is that the hardness at the junction of the first catheter body 1100 and the flexible head end 1300 is between the hardness of the first catheter body 1100 and the hardness of the flexible end head 1300 , that is, , the hardness between the first catheter body 1100 and the flexible end 1300 can be smoothly transitioned to improve the bending resistance of the first balloon catheter 1000 .

In addition, please continue to refer to FIG. 1 , the first balloon catheter 1000 further includes a first connector 1400 , and the first connector 1400 is disposed at the proximal end of the first catheter body 1100 . The first connector 1400 includes a first interface 1410, a second interface 1420 and a third interface 1430, wherein the first interface 1410 communicates with the first channel 1101, and the second interface 1420 communicates with the first interface 1420. All three ports 1430 communicate with the second channel 1102 . That is, the first interface 1410 is used for connecting with a syringe to fill the first balloon 1200 with filling agent, and the second interface 1420 can be used for the second balloon catheter 2000 to enter the first balloon 1200. In the second channel 1102, the third interface 1430 can be used to connect with a syringe to infuse a contrast agent or other liquid.

Next, please refer to FIG. 2 and FIG. 3 , the second catheter body 2100 of the second balloon catheter 2000 includes a third tube body 2110 and a fourth tube body 2120 . The third tube body 2110 is sheathed outside the fourth tube body 2120 . Optionally, a hole extending along the axial direction of the third pipe body 2110 is opened on the pipe wall of the third pipe body 2110 to serve as the third passage. The third tube body 2110 can be made of polymer materials such as PP or PC. The fourth tube body 2120 is preferably a metal hypotube, which ensures that the second conduit body 2100 has better pushability and bending resistance without increasing the outer diameter of the third tube body 2110 sex. The inner cavity of the fourth tube body 2120 constitutes the fourth channel 2101 .

Those skilled in the art can understand that the maximum outer diameter of the second balloon catheter 2000 should be smaller than the inner diameters of the second channel 1102 of the first catheter body 1100 and the fifth channel 1310 of the flexible tip 1300, so that the The second balloon catheter 2000 can pass through the second channel 1102 and the fifth channel 1310 smoothly. The length of the second conduit body 2100 should be greater than the length of the first conduit body 1100. In a specific implementation manner, the overall length of the first balloon catheter 1000 is 3 m, the outer diameter of the first catheter body 1100 is 5 mm˜7 mm, and the inner diameter of the second channel 1102 is 2 mm˜4 mm. The length of the second balloon catheter 2000 is greater than 3 m and may be less than 4 m, and the outer diameter of the second catheter body 2100 is 2 mm˜3 mm.

Further, the second balloon catheter 2000 further includes a second connector 2300 . The second connector 2300 is disposed at the proximal end of the second catheter body 2100 and includes a fourth interface 2310 and a fifth interface 2320 . The fourth interface 2310 communicates with the third channel for connecting with a syringe and filling the second balloon 2200 with filling agent. The fifth interface 2320 communicates with the fourth channel 2101 for introducing a guide wire.

Based on the same inventive concept, the present invention also provides a treatment device, which includes the aforementioned balloon catheter kit, guide wire and suction device. The guide wire is used to pass through the second channel or the fourth channel. The suction device is used for communicating with the second passage to suction the contents in the digestive tract (target lumen).

Further, the present invention also provides a method for using the treatment device, comprising the following steps:

The contents of the target lumen are aspirated using the second channel.

4a to 4f, a detailed description will be given below by taking the use of the treatment device to treat adhesive small bowel obstruction as an example.

First, perform the preparatory work. The stomach is decompressed through a gastric tube, the digestive tract is locally anesthetized, and the balloon catheter set and the guide wire 100 are wetted at the same time.

Next, the guide wire 100 is introduced into the stomach along the nasal cavity, through the pylorus, into the duodenum, and over the ligament of Trevor, as far as possible into the jejunum. This step can be done with the aid of an endoscope or a catheter.

Next, as shown in FIG. 4 a , the distal end of the first balloon catheter 1000 is introduced into the duodenum along the guide wire 100 (that is, the guide wire 100 is passed through the second balloon catheter 1000 ). channel), and continue to advance deep into the jejunum until the first balloon 1200 approaches the obstructed area (ie, the first balloon 1200 reaches the proximal side of the obstructed area). During this process, the position of the developing element on the flexible head end 1300 can be observed by the developing device, and then the position of the first balloon 1200 can be determined.

Next, as shown in FIGS. 4b and 4c , filling agent is injected into the first balloon 1200 through the first channel (not shown in FIG. 4b ), so that the first balloon 1200 is inflated to occlusion the intestinal tract. The filling agent can be, for example, sterile distilled water.

Next, the obstructed area is perfused with a contrast agent through the second channel (not shown in Figure 4c) so that the operator can observe the obstructed area on the imaging device. It should be noted that, in this step, if the intestinal tract is severely dilated due to obstruction, the second channel can be used to suction the intestinal contents first, so as to decompress the intestinal tract, which is helpful for angiography.

Next, referring to FIG. 4d, the distal end of the second balloon catheter 2000 is introduced into the intestine along the guide wire 100 (at this time, the second balloon catheter 2000 travels in the second channel, and the guide The wire 100 is threaded in the fourth channel), and the second balloon 2200 is threaded from the distal end of the second channel until the obstruction area is reached.

Next, referring to FIG. 4e , filling agent is injected into the second balloon 2200 through the third channel (not shown in FIG. 4e ), so that the second balloon 2200 is inflated and the bowel in the obstructed area is opened. road.

Next, the guide wire is withdrawn from the body, and the second balloon catheter is withdrawn from the body after the second balloon is deflated. That is, after this step is completed, only the first balloon catheter 1000 is partially located in the digestive tract (as shown in FIG. 4f ).

Finally, the second channel is connected to a suction device to aspirate the contents of the intestinal tract. It can be understood that during the process of sucking the intestinal contents, the first balloon can be in an expanded state or a contracted state, which is not limited in the present invention. And, a suction hole communicated with the second channel may be opened on the side wall of the first pipe body. When there is no suction hole on the side wall of the first tubular body, the contents in the intestinal tract can directly enter the fourth channel from the distal end of the fifth channel of the flexible head end.

When the operator determines that the obstruction is relieved, the first balloon catheter can be withdrawn from the body. If the obstruction is not completely relieved, the first balloon catheter may be indwelled in the body for several days depending on the situation, and then withdrawn from the body after the obstruction is relieved. Those skilled in the art can understand that the operator can judge whether the obstruction is relieved through angiography, and can also judge whether the obstruction is relieved according to the condition of the patient's condition.

In the technical solution provided by the present invention, angiography is performed assisted by the first balloon catheter in the balloon catheter kit to observe the obstruction in the patient, and at the same time, the second balloon catheter is constructed by using the second channel of the first balloon catheter The second balloon of the second balloon catheter can be quickly transported to the obstructed area, so as to support the intestinal tract adhered to the obstructed area, and then use the first balloon catheter to aspirate the intestinal contents. That is, when treating intestinal obstruction, the balloon catheter kit of the present invention solves the defects of slow effect, long wearing time, and even ineffectiveness for severe adhesive small intestinal obstruction caused by traditional intestinal obstruction catheters relying on intestinal peristalsis. Compared with open surgery, this treatment method has the advantages of less harm to patients and lower cost.

Although the present invention is disclosed above, it is not limited thereto. Various modifications and variations can be made in the present invention by those skilled in the art without departing from the spirit and scope of the invention. Thus, provided that these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

A balloon catheter kit, characterized in that it includes a first balloon catheter and a second balloon catheter; wherein,

The first balloon catheter includes a first catheter body and a first balloon sleeved on the outer surface of the distal end of the first catheter body; the first catheter body is formed with mutually isolated first channels and a second channel in communication with the first balloon;

The second balloon catheter includes a second catheter body and a second balloon sleeved on the outer surface of the distal end of the second catheter body; the second catheter body is formed with mutually isolated third channels and a fourth channel in communication with the second balloon;

The balloon catheter kit is configured such that the second channel is used for infusing a contrast medium distal to a first predetermined location within the target lumen, and the first balloon is used at the first predetermined location The target lumen is expanded and blocked to prevent the contrast agent from flowing back along the target lumen to the proximal side of the first predetermined position; the second balloon is used to pass through the first predetermined position. two channels, and reach a second predetermined position in the target lumen, the second predetermined position is located at the distal side of the first predetermined position; the second balloon is used for the second predetermined position at the second predetermined position expanding to support the target lumen at the second predetermined location; and, after the second balloon is withdrawn from the target lumen, the second channel is also used to aspirate the target lumen content of the Tao.
The balloon catheter kit according to claim 1, wherein the first catheter body comprises a first tube body and a second tube body, and the first tube body is sleeved outside the second tube body , and the hardness of the first tube body is smaller than the hardness of the second tube body.
The balloon catheter kit according to claim 2, wherein the first channel is arranged between the first tubular body and the second tubular body, or the first channel is arranged between the first tubular body and the second tubular body. on the wall of a pipe body; the inner cavity of the second pipe body constitutes the second channel.
The balloon catheter kit according to claim 2, wherein the second tube body comprises at least one reinforcing layer, and the hardness of the reinforcing layer is greater than that of the first tube body.
The balloon catheter kit according to claim 4, wherein the reinforcing layer comprises a spring structure or a tube mesh structure.
The balloon catheter kit according to claim 4, wherein the second tubular body further comprises at least one lubricating layer, and the lubricating layer is arranged on the inner surface of the reinforcing layer.
The balloon catheter kit according to claim 6, wherein the first balloon catheter further comprises a flexible tip, disposed at the distal end of the first catheter body, and the outer surface of the flexible tip is is flush with the outer surface of the first conduit body; the hardness of the flexible head end is smaller than that of the first conduit body.
The balloon catheter kit according to claim 7, wherein the flexible head end has a fifth channel axially passing through and communicating with the second channel;

A first stepped surface and a second stepped surface are formed on the inner surface of the fifth channel, and the second stepped surface is located at the distal end side of the first stepped surface;

The distal end face of the first tube body abuts against the proximal end face of the flexible head end; the distal end face of the reinforcing layer abuts against the first step face, and the distal end face of the lubricating layer abuts against the first step face. the second step surface; and/or,

The flexible head end is provided with a developing element.
The balloon catheter kit according to any one of claims 1-8, wherein the first balloon catheter further comprises a first connecting piece, which is arranged at the proximal end of the first catheter body; the The first connector includes a first interface, a second interface and a third interface; the first interface communicates with the first channel, and both the second interface and the third interface communicate with the second channel.
The balloon catheter kit according to claim 1, wherein the second catheter body comprises a third tube body and a fourth tube body; the third tube body is sleeved on the outer surface of the fourth tube body , the fourth tube body is a hypotube.
The balloon catheter kit according to claim 1, wherein the second balloon catheter further comprises a second connecting member disposed at the proximal end of the second catheter body; the second connecting member includes a second connecting member. Four interfaces and a fifth interface, the fourth interface communicates with the third channel, and the fifth interface communicates with the fourth channel.
The balloon catheter kit according to claim 1, wherein the outer diameter of the first balloon in an expanded state is 20mm˜40mm; and/or,

The outer diameter of the second balloon in an expanded state is 8 mm˜18 mm.
A treatment device, characterized in that it comprises a guide wire, a suction device and the balloon catheter kit according to any one of claims 1-12, the guide wire is used to pass through the second channel or in the fourth channel; the suction device is used for communicating with the second channel to suck the contents in the target cavity.