CN111588925A

CN111588925A - Drainage device

Info

Publication number: CN111588925A
Application number: CN202010567413.3A
Authority: CN
Inventors: 周革
Original assignee: Paddy Field Medical And Health Industry Investment Group Co ltd
Current assignee: Shaanxi paddy Diagnostic Reagent Co.,Ltd.
Priority date: 2020-06-19
Filing date: 2020-06-19
Publication date: 2020-08-28

Abstract

The present disclosure relates to a drainage device, comprising: a drainage tube body (1); the air bag assembly (2) is arranged on the drainage tube body (1) and comprises a plurality of first air bags (21) and a plurality of second air bags (22), the first air bags (21) and the second air bags (22) are arranged along the circumferential direction of the drainage tube body (1), and the process of charging and releasing the working fluid of the first air bags (21) and the process of charging and releasing the working fluid of the second air bags (22) are mutually independent.

Description

Drainage device

Technical Field

The present disclosure relates to the field of medical equipment, and in particular, to a drainage device.

Background

Anastomotic fistulas are one of the serious complications after colorectal surgery, can cause serious infection in the abdominal cavity, thereby increasing the pain of patients, prolonging the hospitalization time, increasing the treatment cost, and leading to the death of patients in serious cases. In addition, anastomotic fistula after colorectal surgery may cause long-term complications of postoperative anastomotic stenosis, defecation dysfunction and the like of patients, thereby reducing the survival rate of the patients and affecting the quality of life.

The occurrence of anastomotic fistula after colorectal surgery is related to factors such as the nutritional status of the patient, the tension of the anastomotic stoma, the pressure in the intestinal lumen, the blood circulation of the anastomotic stoma, and the like. There is evidence that continued reduced pressure drainage in the rectum after surgery to lower the pressure in the intestinal lumen can significantly reduce the occurrence of anastomotic fistulas. The effective decompression drainage in the rectal cavity and the fixation of the decompression drainage matter are the prerequisite for success.

Disclosure of Invention

In one aspect of the present disclosure, there is provided a drainage device comprising:

a drainage tube body;

and the air bag assembly is arranged on the drainage tube body and comprises a plurality of first air bags and a plurality of second air bags, the first air bags and the second air bags are arranged along the circumferential direction of the drainage tube body, and the processes of charging and releasing the working fluid of the first air bags and the processes of charging and releasing the working fluid of the second air bags are mutually independent.

In some embodiments, the first balloon and the second balloon are alternately arranged along the circumference of the drainage tube body.

In some embodiments, the balloon assembly is located at an end of the drainage tube body on a first side in the axial direction, the adjacent first balloon and the second balloon are attached to each other in the expansion state, and a groove located on the first side is formed between the first balloon and the second balloon.

In some embodiments, the drainage device further comprises:

the first inflation pipe is positioned in the pipe wall of the drainage pipe body and comprises a first annular pipe section and a first straight pipe section, the first annular pipe section is respectively communicated with the plurality of first air bags, and the first straight pipe section is communicated with the first annular pipe section and extends along the axial direction of the drainage pipe body;

the second inflating tube is located in the tube wall of the drainage tube body and comprises a second annular tube section and a second straight tube section, the second annular tube section is communicated with the second air bags respectively, and the second straight tube section is communicated with the second annular tube section and extends in the axial direction of the drainage tube body.

In some embodiments, the drainage device further comprises:

the outer fixing seat is arranged on the drainage tube body and is configured to be in a state that the drainage tube body is inserted into a cavity of a human body, and the outer fixing seat and the air bag assembly are respectively arranged on the outer side and the inner side of a cavity opening of the cavity of the human body and are used for fixing and limiting the drainage tube body along the axial direction of the drainage tube body.

In some embodiments, the drainage device further comprises:

the first inflating tube is positioned in the tube wall of the drainage tube body and is respectively communicated with the plurality of first air bags;

the second inflation tube is positioned in the tube wall of the drainage tube body and is respectively communicated with the plurality of second air bags;

the third charging pipe is provided with a first part which is positioned in the outer fixed seat and communicated with the first charging pipe and a second part which is communicated with the first part and led out from the outer fixed seat;

and the fourth charging pipe is provided with a third part which is positioned in the outer fixed seat and communicated with the second charging pipe and a fourth part which is communicated with the third part and led out from the outer fixed seat.

In some embodiments, the drainage device further comprises:

a first pressure bladder in communication with a second portion of the third inflation tube configured to inject a working fluid into the plurality of first bladders via the third inflation tube and the first inflation tube;

a second pressure bladder in communication with a fourth portion of the fourth inflation tube configured to inject a working fluid into the plurality of second bladders via the fourth inflation tube and the second inflation tube.

In some embodiments, the drainage device further comprises:

a fluid guide device in communication with the second portion of the third and fourth inflation tubes, respectively, configured to guide the working fluid to alternately flow into the plurality of first balloons and the plurality of second balloons in a preset cycle according to a set program.

In some embodiments, the drainage device further comprises:

and the drainage container is positioned on one side of the outer fixed seat far away from the air bag component, and forms detachable connection with one end of the drainage tube body far away from the air bag component.

In some embodiments, the drainage container comprises a flexible drainage bag.

In some embodiments, the drainage container has a connection port which is connected with one end of the drainage tube body far away from the balloon assembly in an inserted manner, and the cross-sectional area of the bottom of the drainage container is larger than that of the connection port.

In some embodiments, the external fixation seat comprises:

a tube connecting part connected with the drainage tube;

the first fixing part and the second fixing part are respectively connected to two sides of the pipe body connecting part along the longitudinal direction, and the transverse width of the first fixing part is larger than that of the second fixing part.

In some embodiments, the lateral width of the outer fixing seat gradually decreases in a direction from the first fixing portion to the second fixing portion, and an end portion of the first fixing portion on a side away from the pipe connecting portion and an end portion of the second fixing portion on a side away from the pipe connecting portion are arc-shaped.

In some embodiments, the surfaces of the first fixing portion and the second fixing portion adjacent to one side of the airbag module are concave cambered surfaces relative to the airbag module.

In some embodiments, the first fixing portion is configured to abut against the perineum and the skin from the perineum to the anus of the human body in a state where the drainage tube body is inserted into the rectum, and the second fixing portion is configured to abut against the coccyx of the human body and the skin from the coccyx to the anus in a state where the drainage tube body is inserted into the rectum.

In some embodiments, the drainage device further comprises:

the first flushing injection pipe is at least partially positioned in the pipe wall of the drainage pipe body and comprises a third annular pipe section and a third straight pipe section, the third annular pipe section is positioned on one side, far away from the outer fixing seat, of the drainage pipe body, and the third straight pipe section is communicated with the third annular pipe section and extends in the axial direction of the drainage pipe body;

the second flushing injection pipe is provided with a fifth part which is positioned in the outer fixed seat and is communicated with the first flushing injection pipe and a sixth part which is communicated with the fifth part and is led out from the outer fixed seat;

wherein the third annular tube section is circumferentially provided with a plurality of openings configured to spray a washing liquid or a liquid medicine outward.

In some embodiments, the external fixation seat comprises: with the body connecting portion that the drainage body is connected and vertically connect respectively the first fixed part and the second fixed part of the both sides of body connecting portion, the second washes the injection pipe the second inflating pipe with the fourth inflating pipe is all in the tip that first fixed part kept away from body connecting portion one side is outwards drawn forth.

In some embodiments, the outer fixing seat is adjustable in position relative to the drainage tube body in the axial direction of the drainage tube body.

In some embodiments, the length of the drainage tube body is 50-60 mm, and/or the inner diameter of the drainage tube body is 15mm, and/or the wall thickness of the drainage tube body is 1.5 mm.

In some embodiments, the balloon assembly is located at an end of the catheter body on a first axial side, and the balloon assembly is flush with or extends beyond the end of the catheter body at least in the expanded state.

In some embodiments, the outer fixing seat is located at an end of the drainage tube body on a second side in the axial direction, and the second side end of the drainage tube body does not exceed a farthest end of a side, away from the balloon assembly, of the outer fixing seat in the axial direction.

In some embodiments, the material of the outer holder is transparent.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure.

The present disclosure may be more clearly understood from the following detailed description, taken with reference to the accompanying drawings, in which:

fig. 1 is a perspective view of a drainage device according to some embodiments of the present disclosure;

fig. 2 and 3 are each a schematic structural view of some embodiments of a drainage device according to the present disclosure from different perspectives;

FIG. 4 is a schematic perspective view of the internal structure of some embodiments of a drainage device according to the present disclosure;

fig. 5 is a schematic structural view of a first inflation tube, a second inflation tube, and a first irrigation syringe in some embodiments of a rectal drainage device according to the present disclosure.

It should be understood that the dimensions of the various parts shown in the figures are not drawn to scale. Further, the same or similar reference numerals denote the same or similar components.

Detailed Description

Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. The description of the exemplary embodiments is merely illustrative and is in no way intended to limit the disclosure, its application, or uses. The present disclosure may be embodied in many different forms and is not limited to the embodiments described herein. These embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. It should be noted that: the relative arrangement of parts and steps, the composition of materials, numerical expressions and numerical values set forth in these embodiments are to be construed as merely illustrative, and not as limitative, unless specifically stated otherwise.

The use of "first," "second," and similar terms in this disclosure is not intended to indicate any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element preceding the word covers the element listed after the word, and does not exclude the possibility that other elements are also covered. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

In the present disclosure, when a specific device is described as being located between a first device and a second device, there may or may not be intervening devices between the specific device and the first device or the second device. When a particular device is described as being coupled to other devices, that particular device may be directly coupled to the other devices without intervening devices or may be directly coupled to the other devices with intervening devices.

All terms (including technical or scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs unless specifically defined otherwise. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate.

In the related art, the following several rectal decompression drainage methods are mainly adopted:

1. after the colorectal surgery, a doctor manually expands the anus for a plurality of times so as to achieve the purposes of reducing the rectal pressure of a patient and defecation without tension. The research shows that the mode has poor patient acceptance, increases the workload of doctors, causes limited operation because the operation part is close to the operation part, and has limited effect of reducing the pressure in the rectal cavity.

2. The balloon is fixed in the rectal cavity. This approach requires the use of balloon catheters, endotracheal intubation, and the like. The research shows that the air sac causes continuous compression on rectal mucosa, influences blood transportation of the rectal wall and can cause injury to the rectal mucosa. On the other hand, the pressure-reducing drainage tube in the device with the air bag is provided with an exposed part positioned outside the anus, so that the movement and the body position of a patient are limited, and the exposed part of the pressure-reducing drainage tube can be changed due to the fact that the exposed part cannot be fixed exactly, so that the position of the air bag in the rectal cavity is influenced, the rectal wall is inevitably pulled and displaced, and the healing of an operation part is influenced.

3. The anus is fixed by suturing. The research shows that the mode is not fixed exactly, the drainage tube is easy to bend and separate, and the position change of the exposed decompression drainage tube can affect the position of the decompression drainage tube in the rectal cavity to cause traction and displacement to the rectal wall. Also, the tubular structure located within the rectal cavity can cause significant pain and may cause infection at the suture fixation site.

4. And (5) fixing the external anal fixing object. Researches show that the mode does not conform to the human anatomy relation, and other fixtures such as fixing ropes, waist snares and the like are required, so that the comfort of a patient is poor. In addition, the mutual connection relationship of the external fixators is complex, the fixation is not exact, the exposed part outside the anus is large in size, the body position of a patient is limited, the position of the exposed part can indirectly influence the position of the internal part of the rectum, and the pull is caused to the rectal wall or the anastomotic orifice, so that the healing of the anastomotic orifice is influenced.

In view of this, the present disclosure provides a drainage device, which can reduce the pressure of the balloon assembly on the mucosa of the body lumen.

Fig. 1 is a perspective view of a drainage device according to some embodiments of the present disclosure. Referring to fig. 1 in conjunction with the block diagrams shown in fig. 2-5, in some embodiments, a drainage device comprises: a drainage tube body 1 and a balloon assembly 2. . The balloon assembly 2 is disposed on the catheter body 1 and includes a plurality of first balloons 21 and a plurality of second balloons 22.

In some embodiments, the airbag module 2 may be formed from a flexible, waterproof, and airtight material, such as polyvinyl chloride (PVC), for example. The plurality of first balloons 21 and the plurality of second balloons 22 included in the balloon assembly 2 are arranged along the circumferential direction of the catheter body 1. In fig. 1, the plurality of first balloons 21 and the plurality of second balloons 22 are radial to the catheter body 1 along the radially outer side of the catheter body 1, and are shaped like petals. The plurality of first and

second balloons

21 and 22 are capable of expanding in the radial direction as the volume of the internal working fluid increases and contracting in the radial direction as the volume of the internal working fluid decreases. The airbag module 2 can be inflated or released with a liquid or gaseous working fluid, such as air, water, oil, etc. Taking air as an example, by changing the inflation amount and air pressure in the airbag module 2 by inflating air to a part or all of the airbags of the airbag module 2, the part or all of the airbags can be expanded or contracted in the radial direction. The air bag component 2 in the contraction state is easy to enter the human body cavity (such as entering the rectum through the anus) along with the drainage tube body 1, and the air bag component 2 in the expansion state can support the cavity wall of the human body cavity (such as the cavity wall of the rectum intestinal cavity). In some application scenarios (e.g., post-operative or intra-operative rectal decompression drainage), the first balloon and the second balloon may be caused to respectively exhibit different degrees of expansion to create non-continuous localized compression of the luminal wall mucosa of the rectal cavity. In other application scenarios (e.g., local compression treatment of distal rectal bleeding or conservative treatment of colorectal lesions), all of the balloons in the balloon assembly 2 may be expanded to the same extent to inhibit distal rectal bleeding.

To facilitate independent control of the degree of expansion of the first and second balloons, in some embodiments, the process of inflating and releasing the working fluid from the plurality of first balloons 21 may be independent of the process of inflating and releasing the working fluid from the plurality of second balloons 22. For example, the plurality of first airbags 21 and the plurality of second airbags 22 are not communicated with each other.

Compared with a plurality of annular air bags which are respectively arranged along the axial direction of the drainage tube body and are inflated alternately, in the embodiment, a plurality of first air bags and a plurality of second air bags which are mutually independent in the process of inflating and deflating working fluid are arranged along the circumferential direction of the drainage tube body, on one hand, the first air bags and the second air bags can be alternately inflated and released by the working fluid, and the continuous local compression on the mucosa of the cavity wall can be avoided when the human body cavity is supported; on the other hand, a plurality of air bags are arranged in the circumferential direction, a longer drainage tube body is not needed, and the risk of damage to the cavity wall caused by the longer part of the drainage tube body in the human cavity is reduced or avoided.

In fig. 1, the plurality of first balloons 21 and the plurality of second balloons 22 are located at the same position in the axial direction of the catheter body 1. In addition, the number of the first airbags 21 may be the same as or different from the number of the second airbags 22, for example, 6 each.

In order to ensure the uniformity of the local support of the air bag assembly 2 to the body cavity, the first air bag 21 (i.e. the white air bag in fig. 1) and the second air bag 22 (i.e. the gray air bag in fig. 1) can be alternately arranged along the circumferential direction of the drainage tube body 1, i.e. the first air bag 21, the second air bag 22, the first air bag 21 and the second air bag 22 … … are arranged in sequence along one circumferential direction (clockwise or counterclockwise).

By setting the process of charging and discharging the working fluid of the plurality of first air cells 21 and the process of charging and discharging the working fluid of the plurality of second air cells 22 to be independent of each other, it is possible to effectively prevent the occurrence of mutual interference between the flow rate or pressure control of the working fluid inside the first air cells 21 and the second air cells 22.

Referring to fig. 1 and 3, in some embodiments, the balloon assembly 2 is located at the end of the drainage tube body 1 on the first side in the axial direction, the adjacent first balloon 21 and the second balloon 22 are attached to each other in the expanded state, and a groove 27 on the first side is formed between the first balloon 21 and the second balloon 22. In fig. 1, an inner concave groove 27 can be formed between each set of adjacent first and

second bladders

21 and 22 in the circumferential direction. The groove 27 can effectively guide the content in the body cavity to flow to the mouth of the drainage tube body at the center, thereby improving the drainage effect.

Referring to fig. 1-5, in some embodiments, the drainage device further comprises an outer fixing base 3. The outer fixing seat 3 is arranged on the drainage tube body 1, and can be in the state that the drainage tube body 1 is inserted into a human cavity, and the air bag component 2 is respectively arranged on the outer side and the inner side of a cavity opening of the human cavity along the axial direction of the drainage tube body 1 to fix and limit the drainage tube body 1.

For example, when drainage device was applied to the rectum drainage, drainage body 1 inserted the rectum lower extreme through the anus, and gasbag subassembly 2 and outer fixing base 3 can be respectively the anus inboard is followed with the outside the axial of drainage body 1 is right drainage body 1 fixes spacingly to realize the dual fixed of rectum intracavity and anus outside, make fixed more definite, accord with human anatomy structure and physiology function more, make the patient more comfortable, and reduce clinical medical staff's work load. In addition, other auxiliary fixing devices can be omitted, so that the stability and the fixing position of the drainage device are not easily influenced by the limb movement of the patient, and the limb movement and the body position of the patient are not easily influenced.

In some embodiments, the catheter body 1 can be made of polyurethane material. The material has good human body tolerance, can bear the extrusion of the orifice of a plurality of human body orifices without obvious deformation, thereby ensuring that the cavity of the drainage tube body 1 keeps unobstructed. For example, when the drainage tube body 1 is applied to rectal drainage, the drainage tube body can not deform obviously under the pressure of internal and external sphincters of an anus, so that the internal pressure of a rectal cavity is effectively reduced, a low-pressure environment is created for colorectal surgery, the healing of an anastomotic stoma is promoted, and the occurrence probability of anastomotic fistula is reduced.

The catheter body 1 may be retained in use at the distal end of a body lumen (i.e. the end adjacent to the orifice of the lumen), for example the lower end of the rectum adjacent to the anus. By fixing the balloon assembly within the body lumen, the tubular structure arrangement at the proximal end of the body lumen (i.e., the end distal from the lumen opening) can be eliminated. Thus, in some embodiments, no tubular structure is provided at the proximal end of the drainage tube body 1 located in the body cavity, so that the drainage tube body is shorter, the drainage resistance is smaller, and the surgical site in the body cavity cannot be injured by traction and displacement.

Referring to fig. 2, in some embodiments, the balloon assembly 2 is located at an end of the catheter body 1 on a first side in the axial direction, and the balloon assembly 2 is flush with or beyond the end of the catheter body 1 at least in the expanded state. In other words, the highest position of the balloon assembly 2 in the expanded state is not lower than the upper end of the catheter body 1 in the z-axis direction in fig. 2. This effectively avoids damage to the cavity wall mucosa from the tubular structure above the balloon assembly 2.

In fig. 2, the outer fixing base 3 can be arranged at the end of the drainage tube body 1 along the second side of the axial direction, i.e. at the lower end of the drainage tube body 1 along the z-axis direction in fig. 2. And the second side end of the drainage tube body 1 does not exceed the farthest end of the side of the outer fixed seat 3 far away from the air bag component 2 along the axial direction. In other words, the lowest position of the outer fixing base 3 is not lower than the lower end of the drainage tube body 1. Therefore, the drainage device of the embodiment has no tubular structure outside the orifice of the cavity, so that the patient can move freely without influencing the stability and the fixed part of the drainage device. In other embodiments, the lower end of the drainage tube body 1 may slightly protrude downward relative to the lowest end of the outer fixing base 3.

Taking the rectal operation as an example, since the length of the anal canal of different patients is different, medical personnel can determine the length of the anal canal through digital diagnosis or instruments and select a drainage device with a corresponding specification and a proper drainage tube length. In some embodiments, the length of the drainage tube body 1 can be selected to be 50-60 mm to meet the requirement of rectal drainage.

In some embodiments, the fixing position between the outer fixing base 3 and the drainage tube body 1 is adjustable in the axial direction of the drainage tube body 1. For example, set up a plurality of gears on drainage tube body 1, outer fixing base 3 can follow drainage tube body 1's axial displacement position to pass through modes fixed connection such as joint, screw connection with drainage tube body 1 on the gear that corresponds. Accordingly, a recognizable scale can be provided on the catheter body 1.

In some embodiments, the internal diameter of drainage tube body 1 is 10 ~ 20mm, and optional 15mm makes the drainage more unobstructed through the lumen internal diameter of accessible broad, can reduce the uncomfortable sense that the patient used drainage device moreover. In order to accommodate, for example, an inflation tube or a flushing injection tube in the tube wall, in some embodiments, the wall thickness of the drainage tube body 1 may be set to 1-2 mm, optionally 1.5 mm.

Referring to FIG. 3, in some embodiments, the balloon assembly 2 has a maximum diameter D of 28-38 mm in the expanded state. Referring to FIG. 2, in some embodiments, the height H of the balloon assembly 2 in the axial direction of the catheter body 1 is 6-12 mm, optionally 10 mm. In addition, in some embodiments, the balloon assembly 2 is flush with or higher than the end of the catheter body 1 at least in the expanded state. For example, in fig. 4, the highest position of the balloon assembly 2 in the expanded state is flush with the top end of the catheter body 1, so that the catheter body 1 does not have a tubular structure above the balloon assembly.

Referring to fig. 4 and 5, in some embodiments, the drainage device further comprises a first inflation tube 23 and a second inflation tube 24. The first and

second perfusion tubes

23, 24 are located in the wall of the catheter body 1. The first inflation tube 23 comprises a first annular tube section 23a and a first straight tube section 23b, the first annular tube section 23a is respectively communicated with the plurality of first air cells 21, and the first straight tube section 23b is communicated with the first annular tube section 23a and extends along the axial direction of the drainage tube body 1. The second inflation tube 24 includes a second annular tube section 24a and a second straight tube section 24b, the second annular tube section 24a communicates with the plurality of second cells 22, respectively, and the second straight tube section 24b communicates with the second annular tube section 24a and extends in the axial direction of the catheter body 1.

In fig. 5, the first annular tube section 23a is provided with a plurality of openings in the circumferential direction, and can communicate with a plurality of first air cells 21 arranged at intervals in the circumferential direction through the plurality of openings, respectively. The second annular tube section 24a is provided with a plurality of openings in the circumferential direction, and can communicate with a plurality of second airbags 22 arranged at intervals in the circumferential direction, respectively, through the plurality of openings. The first annular section 23a and the second annular section 24a can be located at different positions in the axial direction of the drainage tube body 1.

Referring to fig. 4, in some embodiments, the drainage device further comprises: a third charging pipe 25 and a fourth charging pipe 26. The third charging pipe 25 has a first portion 25a located in the outer holder 3 and communicating with the first charging pipe 23, and a second portion 25b communicating with the first portion 25a and led out of the outer holder 3. The fourth charging pipe 26 has a third portion 26a located in the outer fixing base 3 and communicated with the second charging pipe 24, and a fourth portion 26b communicated with the third portion 26a and led out from the outer fixing base 3.

In fig. 4, the first straight section 23b of the first charge pipe 23 is connected with the first portion 25a of the third charge pipe 25. In some embodiments, the first and

third inflation tubes

23, 25 may be integrally formed. In fig. 4, the second straight tube section 24b of the second charging tube 24 is connected with the third portion 26a of the fourth charging tube 26. In some embodiments, the second and

fourth inflation tubes

24, 26 may be integrally formed.

The lengths of the second part 25b and the fourth part 26b of the third inflation tube 25 and the fourth inflation tube 26 respectively led out from the outer fixing seat 3 can be set according to needs, for example, the lengths are set to be led out to the abdomen of a patient, so that the operation of medical staff is convenient. The working fluid can enter the first balloon 21 through the third inflation tube 25 and the first inflation tube 23 and enter the second balloon 22 through the fourth inflation tube 25 and the second inflation tube 24. The driving of the working fluid can be performed in the second and

fourth portions

25b and 26b of the third and fourth fluid-filled

tubes

25 and 26, respectively, which are led out of the outer fixed seat 3.

Referring to fig. 1-4, in some embodiments, the drainage device further comprises: a first pressure bladder 27 and a second pressure bladder 28. The first pressure measurement cell 27 communicates with the second portion 25b of the third inflation tube 25, and the working fluid can be injected into the plurality of first cells 21 through the third inflation tube 25 and the first inflation tube 23. The second pressure bladder 28 communicates with the fourth portion 26b of the fourth inflation tube 26, and is capable of injecting the working fluid into the plurality of second bladders 22 through the fourth inflation tube 26 and the second inflation tube 24. The first pressure bladder 27 and the second pressure bladder 28 herein function as a driving means for the working fluid to enable the operation of charging the working fluid. The operator may manually squeeze the first pressure bladder 27 or the second pressure bladder 28 to effect the fluid filling operation.

Sealing heads can be respectively arranged on the first pressure measuring air bag and the second pressure measuring air bag to maintain the pressure of working fluid in the first air bag and the second air bag, and when the sealing head of any one of the first pressure measuring air bag and the second pressure measuring air bag is started, the release of the working fluid in the corresponding first air bag or the corresponding second air bag can be realized. In addition, the first pressure measuring air bag and the second pressure measuring air bag can measure the pressure of the working fluid, so that the inflation and the deflation of the working fluid of the first air bag and the second air bag are controlled more accurately, and the expansion degree of the air bag assembly is estimated better.

To simplify manual operation and improve automation and ease of use of the drainage device, in some embodiments, the drainage device may further comprise: a fluid direction device. The fluid guiding device is in communication with the second portion 25b of the third inflation tube 25 and the fourth portion 26b of the fourth inflation tube 26, respectively, and is configured to guide the working fluid to alternately flow into the plurality of first air cells 21 and the plurality of second air cells 22 according to a preset cycle according to a set program.

In some embodiments, the fluid guiding device may include an air pump, an air valve and a microprocessor or controller, and the air valve and the air pump are controlled by the microprocessor or controller to implement the alternate inflation and deflation operations of the plurality of first air cells 21 and the plurality of second air cells 22 according to a preset period. The fluid guide device is used for automatically filling the first air bag and/or the second air bag with the working fluid or releasing the working fluid in the first air bag and/or the second air bag, and the working parameters of the working fluid, such as pressure, flow and the like, can be detected.

Referring to fig. 1 and 2, in some embodiments, the drain device further comprises a drain container 4. The drainage container 4 is located the outer fixing base 3 is far away from one side of gasbag subassembly 2, and with drainage tube body 1 is kept away from the one end of gasbag subassembly 2 forms the connection that can install and remove. The drainage container 4 is connected with the drainage tube body 1, so that the internal fluid of the rectum, such as the content in the intestinal cavity of the rectum or the liquid medicine after flushing the intestinal wall, can be conveniently collected.

In some embodiments, the drainage container 4 includes a de flexible drainage bag made of a flexible material (e.g., plastic or silicone, etc.) so as not to affect the position (e.g., sitting or standing position, etc.) of the patient.

Referring to fig. 2, in some embodiments, the drainage container 4 has a connection port that is plugged into an end of the drainage tube body 1 remote from the balloon assembly 2. The connecting port can adopt an annular plug-in type structure, and the outer diameter of the connecting port can be less than or equal to the inner diameter of the drainage tube body 1 so as to be inserted into the lower end of the drainage tube body 1. The length of the connecting port can be 10-30 mm, for example 20mm, so as to form stable and reliable connection with the drainage tube body 1. The cross-sectional area of the bottom of the drainage container 4 is larger than the cross-sectional area of the connection port. In thatThe bottom width W of the drainage container 4 can be seen in fig. 2₅Is greater than the width W of the connecting port₄The gradually-wide structure of the drainage container can effectively reduce the resistance of pressure reduction drainage.

In some embodiments, the material of the outer fixing base 3 is transparent so as to facilitate the medical staff to observe the inside of the body cavity. For example, but not limited to, the outer fixing base 3 can be made of transparent silicone. The transparent silica gel material is softer, can increase patient's acceptance and compliance, makes things convenient for patient's free activity to shorten recovery time, reduce the complication because of lying in bed for a long time and producing.

Referring to fig. 1-4, in some embodiments, the external fixation base 3 comprises: a tube connecting portion 31, a first fixing portion 32, and a second fixing portion 33. The tube connecting portion 31 is connected to the drainage tube 1. Referring to fig. 1-4, the z-axis is parallel to the axis of the catheter body, and the x-axis and the y-axis are both parallel to the z-axis and the x-axis is parallel to the y-axis. In some embodiments, the y-axis extends perpendicular to the sagittal plane of the human body, the x-axis extends perpendicular to the coronal plane of the human body, and the z-axis extends perpendicular to the cross-sectional plane of the human body. The extending direction of the x-axis is defined as the longitudinal direction of the outer fixing base 3, and the extending direction of the y-axis is defined as the transverse direction of the outer fixing base 3. The first fixing portion 32 and the second fixing portion 33 are respectively connected to both sides of the pipe body connecting portion 31 in a longitudinal direction.

When the drainage device is applied to rectal drainage, the first fixing portion 32 is configured to abut against the perineum of the human body and the skin from the perineum to the anus in a state that the drainage tube body 1 is inserted into the rectum. The second fixing portion is configured to abut against the coccyx of the human body and the skin of the coccyx to the anus in a state where the drainage tube body 1 is inserted into the rectum.

The first fixing part and the second fixing part are respectively fixed on the front side and the rear side of the human body, so that the drainage tube body is more firmly fixed. Referring to fig. 2, in order to better conform to the anatomical and physiological structure of the human body, the surfaces of the first fixing portion 32 and the second fixing portion 33 adjacent to one side of the airbag module 2 may be concave and arc relative to the airbag module 2. In fig. 1 and 2, the first fixing portion 32 and the second fixing portion 33 are bent toward the balloon module 2 with respect to a connecting portion between the catheter body 1 and the body connecting portion 31. This allows the external fixation base 3 to assume an anchor-like configuration, allowing the patient to move freely without affecting the stability and fixation of the drainage device.

Referring to fig. 3, in some embodiments, the lateral width W of the first fixing portion 32₁Is larger than the transverse width W of the second fixing part 33₂. The structure described above is more conformable to human anatomy and physiology, resulting in better fixation and increased patient comfort. For example, in FIG. 3, W₁Is 30mm, W₂Is 10 mm. The length of the outer fixing base 3 in the second direction x may be 90mm, and the thickness of the outer fixing base 3 is 5 mm.

In fig. 3, the transverse width of the outer fixing base 3 gradually decreases from the first fixing portion 32 to the second fixing portion 33, and both the end of the first fixing portion 32 away from the pipe connecting portion 31 and the end of the second fixing portion 33 away from the pipe connecting portion 31 are arc-shaped. The structure not only conforms to the anatomy and physiological structure of the human body, but also is more comfortable for the patient to use. In some application scenarios, it is necessary to introduce a medical liquid for treatment or a cleaning solution for cleaning into a body lumen, for example, to introduce a medical liquid into a rectum after operation or to flush the inside of a rectum. Accordingly, referring to fig. 1-5, in some embodiments, the drainage device further comprises a first irrigation syringe 51 and a second irrigation syringe 52. At least part of the first irrigation syringe 51 is located in the wall of the drainage tube body 1. The first flushing injection tube 51 comprises a third annular tube section 51a and a third straight tube section 51b, the third annular tube section 51a is positioned on one side of the drainage tube body 1 far away from the outer fixed seat 3, and the third straight tube section 51b is communicated with the third annular tube section 51a and extends along the axial direction of the drainage tube body 1.

The third annular pipe section 51a is provided with a plurality of holes 54 in a circumferential direction, and the plurality of holes 54 are configured to spray the washing liquid or the liquid medicine outward. In some embodiments, a spray head may also be disposed over each of the apertures 54. The flushing and medicine injection operation is performed through the plurality of openings 54 formed in the third annular tube section 51a, so that the body cavity can be flushed or filled more fully. The number of the open pores can be set according to the requirement, for example, 4-8 open pores are set, and 6 open pores can be selected. The plurality of apertures 54 may be equally spaced circumferentially. In other embodiments, the plurality of apertures 54 may be circumferentially non-equally spaced.

Referring to fig. 2, in some embodiments, the third annular tube segment 51a is located axially outward of an end of the catheter body 1, such as over the top end of the catheter body 1 in fig. 2. Referring to fig. 4, in other embodiments, the third annular tube 51a is located within the wall of the drainage tube body 1 and adjacent to the top end of the drainage tube body 1, and the top end of the drainage tube body 1 is also provided with a plurality of openings respectively aligned with the plurality of openings 54 of the third annular tube 51a, so that the working fluid entering the third annular tube 51a can be sprayed upwards through the openings 54 and the openings at the top end of the drainage tube body 1.

The second flushing and injecting tube 52 has a fifth portion 52a located inside the outer fixed seat 3 and communicating with the third straight tube section 51b, and a sixth portion 52b communicating with the fifth portion 52a and led out of the outer fixed seat 3. In some embodiments, the second irrigation syringe 52 and the first irrigation syringe 51 may be integrally formed.

The sixth portion 52b of the second flushing and medicine injecting tube 52, which is led out from the outer fixed seat 3, can be connected with a device for supplying flushing liquid or medicine liquid so as to inject the flushing liquid or medicine liquid into the body cavity.

Referring to fig. 1 and 4, in some embodiments, the second irrigation and injection tube 52, the second inflation tube 24 and the fourth inflation tube 26 are all led out at the end of the first fixing portion 32 on the side away from the tube connecting portion 31. So as to facilitate the operation of medical personnel.

Referring to fig. 4 and 5, in some embodiments, at least a portion of the first irrigation infusate tube 51 is disposed with the first and

second infusion tubes

23, 24 within the wall of the catheter body 1. In fig. 5, the third straight tube section 51b of the first flushing syringe 51 is closely adjacent to the first straight tube section 23b of the first filling tube 23 and the second straight tube section 24b of the second filling tube 24, so as to simplify the manufacturing process. The third annular tube section 51a is parallel to the first annular tube section 23a and the second annular tube section 24a and is arranged at intervals along the axial direction of the drainage tube body 1. In other embodiments, the third straight tube section 51b is not immediately adjacent to the first and second

straight tube sections

23b, 24b at a different angular position.

With reference to the foregoing embodiments of the drainage device of the present disclosure, an example of applying the drainage device to a post-rectal procedure is described below.

The clinician may first perform a digital rectal exam to assess the length of the anal canal, thereby selecting a drainage device of appropriate dimensions. The air bag assembly of the drainage device is inflated through the pressure measuring air bag so as to detect the inflation quantity and the expansion degree of the air bag assembly, and then the air in the air bag assembly is evacuated.

The patient is positioned at the lithotomy position, the second fixing part of the outer fixing seat is opposite to the position of the coccyx tip, the first fixing part is opposite to the position of the perineum, and the drainage tube body is placed into the lower end of the rectum through the anus. Observing the intrarectal condition and the indwelling position through the lower end opening of the drainage tube body, inflating one of the first balloon and the second balloon, inflating the other of the first balloon and the second balloon after a period of time (for example, 12 hours), and deflating the originally inflated balloon. The alternation can improve the local pressure condition of the rectum intestinal wall.

After the drainage device is fixed exactly, the flexible drainage bag is inserted into an opening at the lower end of the drainage tube body and is used for receiving the content in the rectum. When the flexible drainage bag needs to be replaced, the connecting port can be directly pulled out from the lower end opening of the drainage tube body, and a new flexible drainage bag is replaced. When the drainage device needs to be removed, all gas in the air bag assembly is pumped out, and then the air bag assembly is slowly taken out from the outer edge of the anus.

When bleeding occurs distally to the rectum, the first and second balloons may be inflated simultaneously to achieve pressurized hemostasis. When the conservative treatment of the anastomotic fistula of the colorectal injury is carried out, the enema and the treatment medicine can be instilled through the flushing medicine injection tube, and the treatment effect can be evaluated through the property of the drainage matter in the flexible drainage bag.

Thus, various embodiments of the present disclosure have been described in detail. Some details that are well known in the art have not been described in order to avoid obscuring the concepts of the present disclosure. It will be fully apparent to those skilled in the art from the foregoing description how to practice the presently disclosed embodiments.

Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the foregoing examples are for purposes of illustration only and are not intended to limit the scope of the present disclosure. It will be understood by those skilled in the art that various changes may be made in the above embodiments or equivalents may be substituted for elements thereof without departing from the scope and spirit of the present disclosure. The scope of the present disclosure is defined by the appended claims.

Claims

1. A drainage device, comprising:

a drainage tube body (1);

the air bag assembly (2) is arranged on the drainage tube body (1) and comprises a plurality of first air bags (21) and a plurality of second air bags (22), the first air bags (21) and the second air bags (22) are arranged along the circumferential direction of the drainage tube body (1), and the process of charging and releasing the working fluid of the first air bags (21) and the process of charging and releasing the working fluid of the second air bags (22) are mutually independent.

2. The drainage device according to claim 1, characterized in that the first balloons (21) and the second balloons (22) are arranged alternately in the circumferential direction of the catheter body (1).

3. The drainage device according to claim 2, characterized in that the balloon assembly (2) is arranged at the end of the drainage tube body (1) on the first side in the axial direction, the adjacent first balloon (21) and the second balloon (22) are mutually attached in the expansion state, and a groove (27) on the first side is formed between the first balloon (21) and the second balloon (22).

4. The drainage device of claim 1, further comprising:

the first inflation pipe (23) is positioned in the pipe wall of the drainage pipe body (1), the first inflation pipe (23) comprises a first annular pipe section (23a) and a first straight pipe section (23b), the first annular pipe section (23a) is respectively communicated with the first air bags (21), and the first straight pipe section (23b) is communicated with the first annular pipe section (23a) and extends along the axial direction of the drainage pipe body (1);

the second inflating tube (24) is located in the tube wall of the drainage tube body (1), the second inflating tube (24) comprises a second annular tube section (24a) and a second straight tube section (24b), the second annular tube section (24a) is communicated with the second air bags (22) respectively, and the second straight tube section (24b) is communicated with the second annular tube section (24a) and extends along the axial direction of the drainage tube body (1).

5. The drainage device of claim 1, further comprising:

the outer fixing seat (3) is arranged on the drainage tube body (1) and is configured to be in a state that the drainage tube body (1) is inserted into a human body cavity, and the outer fixing seat and the inner fixing seat are respectively arranged on the outer side and the inner side of a cavity opening of the human body cavity along the axial direction of the drainage tube body (1) to fix and limit the drainage tube body (1).

6. The drainage device of claim 5, further comprising:

the first inflation tube (23) is positioned in the tube wall of the drainage tube body (1) and is respectively communicated with the first air bags (21);

the second inflation tube (24) is positioned in the tube wall of the drainage tube body (1) and is respectively communicated with the second air bags (22);

a third charging pipe (25) which is provided with a first part (25a) positioned in the outer fixed seat (3) and communicated with the first charging pipe (23) and a second part (25b) communicated with the first part (25a) and led out from the outer fixed seat (3);

and the fourth charging pipe (26) is provided with a third part (26a) which is positioned in the outer fixed seat (3) and communicated with the second charging pipe (24) and a fourth part (26b) which is communicated with the third part (26a) and led out from the outer fixed seat (3).

7. The drainage device of claim 6, further comprising:

a first pressure bladder (27) in communication with the second portion (25b) of the third inflation tube (25) configured to inject a working fluid into the plurality of first bladders (21) via the third inflation tube (25) and the first inflation tube (23);

a second pressure bladder (28) in communication with a fourth portion (26b) of the fourth inflation tube (26) and configured to inject a working fluid into the plurality of second bladders (22) via the fourth inflation tube (26) and the second inflation tube (24).

8. The drainage device of claim 6, further comprising:

a fluid guiding device, communicating with the second portion (25b) of the third flow tube (25) and the fourth portion (26b) of the fourth flow tube (26), respectively, configured to guide the working fluid to alternately flow into the plurality of first balloons (21) and the plurality of second balloons (22) according to a preset cycle according to a set program.

9. The drainage device of claim 5, further comprising:

the drainage container (4) is located one side of the air bag component (2) is kept away from the outer fixing seat (3), and the drainage container is connected with one end, far away from the air bag component (2), of the drainage tube body (1) in a detachable mode.

10. The drainage device according to claim 9, characterized in that the drainage container (4) comprises a flexible drainage bag.

11. The drainage device according to claim 9, characterized in that the drainage container (4) has a connection port which is plugged with one end of the drainage tube body (1) which is far away from the balloon assembly (2), and the cross-sectional area of the bottom of the drainage container (4) is larger than that of the connection port.

12. The drainage device according to claim 5, characterized in that said external fixation seat (3) comprises:

a tube connecting part (31) connected to the drainage tube (1);

the first fixing part (32) and the second fixing part (33) are respectively connected to two sides of the pipe body connecting part (31) along the longitudinal direction, and the transverse width of the first fixing part (32) is larger than that of the second fixing part (33).

13. The drainage device according to claim 12, characterized in that the lateral width of the outer fixing base (3) is gradually reduced in a direction from the first fixing portion (32) to the second fixing portion (33), and an end portion of the first fixing portion (32) on a side away from the tube connecting portion (31) and an end portion of the second fixing portion (33) on a side away from the tube connecting portion (31) are formed in a circular arc shape.

14. The drainage device according to claim 12, characterized in that the surfaces of the first and second fixing portions (32, 33) adjacent to the balloon component (2) are concavely curved with respect to the balloon component (2).

15. The drainage device according to claim 12, characterized in that said first fixing portion (32) is configured to abut against the perineum and the skin from the perineum to the anus of the human body in a state where said drainage tube body (1) is inserted into the rectum, and said second fixing portion (33) is configured to abut against the coccyx and the skin from the coccyx to the anus of the human body in a state where said drainage tube body (1) is inserted into the rectum.

16. The drainage device of claim 6, further comprising:

the first flushing injection pipe (51) is at least partially positioned in the pipe wall of the drainage pipe body (1), the first flushing injection pipe (51) comprises a third annular pipe section (51a) and a third straight pipe section (51b), the third annular pipe section (51a) is positioned on one side, away from the outer fixed seat (3), of the drainage pipe body (1), and the third straight pipe section (51b) is communicated with the third annular pipe section (51a) and extends in the axial direction of the drainage pipe body (1);

a second flushing and medicine injecting tube (52) which is provided with a fifth part (52a) positioned in the outer fixed seat (3) and communicated with the third straight tube section (51b) and a sixth part (52b) communicated with the fifth part (52a) and led out from the outer fixed seat (3);

wherein the third annular pipe section (51a) is provided with a plurality of openings (54) in a circumferential direction, the plurality of openings (54) being configured to spray the washing liquid or the liquid medicine outward.

17. The drainage device according to claim 16, characterized in that said external fixation seat (3) comprises: with body connecting portion (31) that drainage body (1) is connected and vertically connect respectively first fixed part (32) and second fixed part (33) of the both sides of body connecting portion (31), the second washes injection pipe (52) second fill the flow tube (24) with fourth fill flow tube (26) and all are in first fixed part (32) are kept away from the tip of body connecting portion (31) one side is outwards drawn forth.

18. The drainage device according to claim 5, characterized in that the outer fixing base (3) is adjustable in position relative to the drainage tube body (1) in the axial direction of the drainage tube body (1).

19. The drainage device according to claim 1, characterized in that the length of the drainage tube body (1) is 50-60 mm, and/or the inner diameter of the drainage tube body (1) is 15mm, and/or the wall thickness of the drainage tube body (1) is 1.5 mm.

20. The drainage device according to claim 1, characterized in that the balloon assembly (2) is located at the end of the drainage tube body (1) on the first side in the axial direction, the balloon assembly (2) being flush with the end of the drainage tube body (1) or extending beyond the end of the drainage tube body (1) at least in the expanded state.

21. The drainage device according to claim 5, characterized in that the outer fixing base (3) is located at the end of the second side of the drainage tube body (1) in the axial direction, and the end of the second side of the drainage tube body (1) does not exceed the farthest end of the side of the outer fixing base (3) away from the balloon assembly (2) in the axial direction.

22. The drainage device according to claim 5, characterized in that the material of the outer fixing base (3) is transparent.