CN117122755A

CN117122755A - Esophageal fistula device

Info

Publication number: CN117122755A
Application number: CN202311197689.7A
Authority: CN
Inventors: 周海燕; 章宏; 李志刚; 金跃辉; 殷青; 陈建彬
Original assignee: Shanghai Chester Medical Devices Co ltd
Current assignee: Shanghai Chester Medical Devices Co ltd
Priority date: 2023-09-18
Filing date: 2023-09-18
Publication date: 2023-11-28
Also published as: WO2025060152A1

Abstract

The utility model relates to an esophageal fistula device, which comprises an esophageal fistula drainage tube and a sponge connected outside one end of the esophageal fistula drainage tube, and is characterized in that: also has a compression housing; the sponge is compressed, and then the sponge with the compressed diameter is placed into a compression shell; after the sponge of the compressed shell is delivered to the esophageal stoma, the compressed shell softens and ruptures, allowing the sponge at the esophageal stoma to re-expand. The utility model can lead the sponge for plugging the esophageal fistula to smoothly reach the focus, save operation time, reduce pain of patients, be beneficial to doctor operation, and simultaneously provide advantages of continuously removing pus, esophageal exudates, necrotic secretions and the like for the esophageal fistula, ensuring adequate drainage of the pus cavity and the like.

Description

Esophageal fistula device

Technical Field

The utility model relates to the field of medical appliances, in particular to an esophageal fistula device.

Background

How to effectively repair esophageal fistulae caused by esophageal perforation, rupture, postoperative anastomotic stoma fistula and the like is always a key problem in research in the field of digestive surgery, if the fistula can not be closed timely, the infection of the pustules and mediastinum can rapidly progress in a short period, finally, septic shock and multiple organ failure are combined, and the death risk is obviously increased. Up to now, there is no unified, standardized clinical treatment guideline for the treatment of esophageal fistulae. Although there is a relevant expert consensus for asymptomatic and smaller esophageal fistulae, namely "three-tube one-out," there is still controversy over treatment regimens for repairing larger and conservative treatment ineffective, particularly those which have incorporated mediastinal pyogenic cavities, sepsis. The method for clinically treating the esophageal fistula in China mainly comprises the following steps: the biological stent, in particular the degradable novel memory metal stent, is placed under the endoscope, or the biological tissue glue, the titanium clip, the forceps clip and the like are utilized to seal the fistula, or the secondary esophageal-gastric anastomosis operation treatment is selected, but the treatment effect is still unsatisfactory. With the continuous development of interventional, endoscopic and biological material technologies, a new endoscopic minimally invasive technology is gradually developed abroad for treating various types of esophageal fistulae-endoscopic vacuum assisted closure treatment (endoscopic vacuum-assisted closure therapy, EVAC), and more clinical researches find that the technology has better curative effect in the aspect of treating esophageal fistulae, is sometimes even better than the traditional treatment means, and is continuously popularized and applied by the clinical centers abroad.

The EVAC generally operates as follows:

a) Thoroughly evaluating the esophagus cavity and the fistula;

b) Preparation of esophageal cavity and interface (endoscopic removal of skin flow and necrotic tissue);

c) Placing the drainage tube through the nasal cavity and taking out the distal end through the mouth;

d) Trimming the sponge and the drainage tube and then fixing;

e) A suture is reserved at the distal end of the drainage tube;

f) The endoscope forceps grasp the distal suture line and enter the esophagus;

g) Guiding and placing a sponge fistula under the endoscope;

h) And opening the negative pressure, confirming the instrument, and withdrawing the endoscope.

The curative effect of EVAC has been embodied in many researches and widely accepted by clinicians, but because of the lack of specific finished products of instruments in the market at present, the sponge for treating esophageal fistula by EVAC still needs to be cut and fixed by hands, which greatly examines the skill level of operators.

For example, chinese patent (issued publication number: CN 203861754U) discloses an esophageal fistula negative pressure sponge plugging device, which comprises a drainage tube, a sleeve, a connecting tube and a sponge head, wherein one end of the connecting tube is connected with the sponge head. When the device is used, the sleeve (from the nasal cavity) stretches into the esophagus, the sponge head and the drainage tube enter into the esophagus through the guiding function of the sleeve, and substances in the esophagus can be prevented from entering into the sponge head due to the fact that the sleeve is wrapped outside the sponge head, so that the sponge head is prevented from being blocked, and the waste liquid sucking effect at the back is improved. In the process of inserting the sleeve, as the development line is arranged on the sponge head, the position of the sponge head can be clearly seen under the irradiation of X rays, so that the sponge head can accurately extend into the esophageal fistula. When the sponge head is put into the esophageal fistula, the sleeve is pulled out, at the moment, the sponge head is released, the sponge head is attached to the esophageal fistula, so that the waste liquid is sucked out more effectively, and surrounding tissues are promoted to cover the esophagus. The free end of the drainage tube is connected with negative pressure, waste liquid is sucked out, and along with the suction of the waste liquid and the coverage of surrounding tissues, fibrosis and esophageal fistula are smaller and smaller, the waste liquid can be smaller along with the reduction of the esophageal fistula due to the elastic action of the sponge head, and the esophageal fistula can not be further damaged.

When the prior structure is used, the sponge stretches into the esophagus from the nasal cavity of a patient in an expanded state, and after the sponge is expanded (such as round, cylindrical and hollowed spindle-shaped), the diameter of the sponge is 10-50 mm, the length of the sponge is 10-100 mm, the sponge is obviously larger than the diameter of the nasal cavity, moreover, in the process from the nasal cavity part to the esophagus (fistula), the passage also has an irregular bending structure, so that the device stretches into the esophagus to cause great difficulty, the operation difficulty of doctors is great, the operation time is often prolonged (average 45 min), and pain of the patient is also easily caused.

Disclosure of Invention

The utility model aims to provide an esophageal fistula device, which solves the technical problems in the prior art, can enable the sponge for plugging the esophageal fistula to smoothly reach a focus, saves operation time, reduces pain of a patient, is beneficial to operation of doctors, and simultaneously provides the advantages of continuously removing pus, esophageal exudates, necrotic secretions and the like for the esophageal fistula, ensuring full drainage of a pus cavity and the like.

In order to achieve the above purpose, the technical scheme of the utility model is as follows:

an esophageal fistula device, it includes the drainage tube of esophageal fistula and connects the sponge outside one end of the drainage tube of esophageal fistula, its characterized in that: also has a compression housing; the sponge is compressed, and then the sponge with the compressed diameter is placed into a compression shell; after the sponge of the compressed shell is delivered to the esophageal stoma, the compressed shell softens and ruptures, allowing the sponge at the esophageal stoma to re-expand.

The esophageal fistula device is characterized in that: the compression shell is a multi-section sponge compression shell with bending capability.

The esophageal fistula device is characterized in that: the outer end of the compression shell is provided with an opening through which the set pull ring is connected with the sponge.

The esophageal fistula device is characterized in that: the diameter of the sponge in the expansion state is 10mm to 50mm, the length is 10mm to 100mm, and the diameter of the sponge in the compression shell constraint state is 6mm to 15mm.

The esophageal fistula device is characterized in that: the device also comprises a waste liquid collecting container provided with an aspirator, wherein one end of the waste liquid collecting container is provided with a quick connector, and the other end of the waste liquid collecting container is provided with a drainage pipeline with an esophageal fistula drainage pipe joint; one end of the drainage pipeline is connected with the waste liquid collecting container through a quick connector, and the other end is connected with the esophageal fistula drainage tube connector through an esophageal fistula drainage tube connector.

The esophageal fistula device is characterized in that: the aspirator can be used for starting negative pressure or adjusting the magnitude of the negative pressure or adjusting the working state of continuous suction or intermittent suction by an adjusting button.

The esophageal fistula device is characterized in that: the device also comprises a steel cable and a handle, wherein a lining core formed by the steel cable and the handle is inserted into the esophageal fistula drainage tube.

Through the structure of the device, the device has the following advantages in use:

1. the sponge of the device is compressed by the compression shell before use, and is injected with water to expand after focus. The compressed product has small overall outer diameter, and can be placed into a focus through a nasal cavity, thereby being convenient for doctors and reducing pain of patients.

2. The device provided by the utility model utilizes the characteristics of porous sponge, soft texture and capability of providing uniform negative pressure, and can provide sustainable cleaning of pus, esophageal exudates, necrotic secretions and the like for esophageal fistulae, so that the adequate drainage of a pus cavity is ensured.

3. The waste liquid collecting container with the aspirator can perform continuous or intermittent aspiration function, and can perform targeted quality for multiple patients.

4. The device of the utility model shortens the operation time from the original average 45min to about 15min at present.

Drawings

Fig. 1 is a schematic structural view of embodiment 1 of the present utility model.

FIG. 2 is a schematic view showing the structure of a waste liquid collecting container having an aspirator in example 1 of the present utility model.

Fig. 3 is a schematic structural view of a drainage pipe portion in embodiment 1 of the present utility model.

FIG. 4 is a schematic view showing the structure of an esophageal fistula drainage tube and sponge portion of example 1 of the utility model.

Fig. 5 is a schematic structural view of an esophageal fistula drainage tube and sponge portion of example 1 of the utility model having a sponge compression shell and pull ring.

Fig. 6 is a schematic structural diagram of embodiment 2 of the utility model.

Fig. 7 is a schematic view of the structure of an esophageal fistula drainage tube and sponge portion having a sponge compression shell in example 2 of the utility model.

Fig. 8 is a partial cross-sectional view of fig. 7.

Fig. 9 is a schematic structural view of embodiment 3 of the present utility model.

Detailed Description

Referring to fig. 1-5, a schematic structural diagram of an esophageal fistula device of example 1 of the utility model is shown. As shown in fig. 1, the esophageal fistula device comprises a waste liquid collecting container 1 provided with an aspirator 2, a drainage pipeline 4 with a quick connector 3 at one end and an esophageal fistula drainage tube joint 5 at the other end, an esophageal fistula drainage tube 8, a sponge 7 connected outside one end of the esophageal fistula drainage tube 8, and a pull ring 9. Wherein:

as shown in fig. 2, the waste liquid collecting container 1 is provided with a quick connection port 11, and the quick connection port 11 can be connected with the quick connector 3 at the proximal end of the drainage pipeline 4 in fig. 3 quickly. An aspirator 2 is installed in the waste liquid collection container 1 to generate negative pressure and negative pressure suction force from the quick connection port 11. In addition, the waste liquid collecting container 1 is provided with a power button 23 for displaying whether or not to be electrified, a function display lamp 22 for displaying the operating state of the apparatus, such as whether or not the negative pressure has been activated, and a function adjusting button 21. The function adjusting button 21 can be used for starting negative pressure or adjusting the magnitude of the negative pressure (-2 kPa to-80 kPa) or adjusting the working states such as continuous suction or intermittent suction.

As shown in fig. 3, one end (proximal end) of the drainage tube 4 has a quick connector 3 for connecting to the waste collection container 1; the other end (distal end) is provided with an esophageal fistula drainage tube connector 5 for connecting with the proximal end of an esophageal fistula drainage tube 8. The esophageal fistula drainage tube joint 5 is matched with an 8 Fr-36 Fr pipeline.

FIG. 4 is a schematic view showing the structure of the esophageal fistula drainage tube and the sponge portion in example 1 of the utility model, wherein the sponge 7 is in an expanded state, and the expanded sponge 7 can be in various shapes (e.g., circular, cylindrical, hollow spindle-shaped, diameter 10mm to 50mm, length 10mm to 100 mm). The esophageal fistula drainage tube 8 has various specifications (all the sizes from 14Fr to 36Fr are contained), the proximal end of the esophageal fistula drainage tube 8 is connected with the esophageal fistula drainage tube joint 5 through the esophageal fistula drainage tube joint 5, and the distal end of the esophageal fistula drainage tube 8 is connected with the sponge 7. The esophageal fistula drainage tube 8 and the sponge 7 can be fixed by a chemical connection mode such as glue connection and the like through an ultrasonic process, and also can be fixed by a physical connection mode such as suture, anchoring hook fixation and the like.

Referring again to fig. 5, a schematic structural view of the esophageal fistula drainage tube and sponge portion of example 1 of the utility model having a sponge compression shell and pull ring is shown. On the basis of the structure shown in fig. 4, the device needs to compress the sponge 7 (especially compress the diameter thereof) during manufacturing, then the sponge 7 with the compressed diameter is placed in the compression shell 6, the sponge compression shell 6 can be made of gelatin, collagen, plant fibers and derivatives thereof, and the compression shell 6 can compress the sponge 7 from a larger outer diameter of 10 mm-100 mm to a smaller outer diameter of 6 mm-15 mm in a state of accommodating the compressed sponge. Due to the existence of the compression shell 6, the outer diameter of the sponge 7 is reduced, so that the sponge can easily and smoothly extend into the esophagus from the nasal cavity of a patient, the operation time is saved, and the pain of the patient is reduced. After the sponge 7 after compression is used to the esophageal fistula by medical staff, the compression shell 6 can be softened and ruptured by means of water injection and the like, so that the sponge 7 at the esophageal fistula is re-expanded to the outer diameter of 10 mm-100 mm, and the sponge is subjected to the drainage effect of the esophageal fistula. In addition, the outer end portion (i.e., distal end portion) of the compression casing 6 has an opening 61, and the setting tab 9 is connected to the sponge 7 through the opening 61.

The pull ring 9 can facilitate medical staff to withdraw the sponge 7 for body operation after the esophageal fistula drainage is finished. In the specific operation, after the treatment of the esophageal fistula is finished, a doctor puts the esophagoscope at the position of the fistula opening from the other nasal cavity, finds the pull ring 9, stretches out the clamp-shaped instrument from the esophagoscope to pull the pull ring, and can withdraw the sponge 7 and the esophageal fistula drainage tube 8 from the body together. The method has the advantages that the sponge 7 subjected to long-term drainage and human tissues are interwoven together, and the original mode of withdrawing the sponge 7 only through the esophageal fistula drainage tube 8 is easy to adhere to the wall, so that the esophageal fistula is blocked from withdrawing. The pull ring 9 is added, so that the force can be skillfully applied, and the used esophageal fistula drainage device can be well taken out of the body.

The operation mode of the embodiment 1 in the operation is as follows:

step1, placing a guide wire to an esophageal fistula through an esophagoscope, keeping the position of the guide wire still, and taking out the esophagoscope;

step2, inserting the end part of the guide wire into an inner hole (namely a duct of the esophageal fistula drainage tube 8) of the device;

step3, pushing the device of the utility model along the guide wire (the sponge is in a compressed state under the action of the compression shell) from the nasal cavity to the esophageal fistula;

step4, inserting an esophagoscope from the other nasal cavity, observing whether the device is placed at an ideal position, and if not, performing fine adjustment until the ideal placement position is reached;

step5, withdrawing the esophagoscope and the guide wire;

step6, injecting about 200cc of physiological saline into the tube from the external port of the esophageal fistula drainage tube, and releasing the expansion state of the sponge by breaking the compression shell, thus completing the operation of placing the device into the body.

After the device of the utility model is placed in the body, the pipeline is connected with the component shown in fig. 2 through the component shown in fig. 3 to the state shown in fig. 1. Then, a proper suction mode can be selected according to the actual needs of the patient, and the esophageal fistula drainage is started. When the waste liquid is full, the waste liquid collecting bottle can be replaced with a new one for continuous drainage. The waste liquid collection container 1 with the aspirator 2 installed can be operated by plugging in a battery.

The device disclosed by the embodiment 1 of the utility model has the following advantages:

1. the sponge 7 of the device is compressed by the compression shell 6 before use, and is injected with water to expand after focus. The compressed product has small overall outer diameter, and can be placed into a focus through a nasal cavity, thereby being convenient for doctors and reducing pain of patients.

2. The device of the utility model utilizes the characteristics of porous sponge 7, soft texture and capability of providing uniform negative pressure to provide sustainable cleaning of pus, esophageal effusion, necrotic secretion and the like for esophageal fistula, and ensures adequate drainage of the pus cavity.

3. By means of the continuous or intermittent suction function of the waste liquid collection container 1 provided with the suction device 2, the targeted quality can be achieved for multiple patients.

Referring to fig. 6-8, a schematic structural diagram of embodiment 2 of the present utility model is shown. As shown in the figure: the device is provided with an esophageal fistula drainage tube 8, a sponge 7 connected outside one end of the esophageal fistula drainage tube 8, and a compression shell 6 which can be used for placing the sponge 7 with a compressed diameter. The sponge compression shell 6 can be a shell made of gelatin, collagen, plant fibers and derivatives thereof, and the compression shell 6 can compress the sponge 7 from a larger outer diameter of 10 mm-100 mm to a smaller outer diameter of 6 mm-15 mm in a state of accommodating the compressed sponge.

The device of example 2 of the present utility model, when in use:

step1, inserting the liner core formed by the steel cable 101 and the handle 102 into the device until the bottom of the device;

step2, placing the sponge 7 at the position of the esophageal fistula through the nasal cavity or the oral cavity under the guidance of an esophagoscope, for the device placed through the oral cavity, additionally guiding a drainage tube from the nasal cavity to extend out of the oral cavity, connecting the pipeline with the tail end of the device, and then guiding the tail end pipeline out of the body through the nasal cavity along the nasal cavity, thereby completing the operation of placing the device into the body.

When the device is placed in the body, its tubing is connected to the components of fig. 2 by the components of fig. 3 to the state of fig. 1. Then, a proper suction mode can be selected according to the actual needs of the patient, and the esophageal fistula drainage is started. When the waste liquid is full, the waste liquid collecting bottle can be replaced with a new one for continuous drainage. The waste liquid collection container 1 with the aspirator 2 installed can be operated by plugging in a battery.

Referring to fig. 9, it is embodiment 3 of the present utility model. It discloses a multi-section sponge compression housing 6 suitable for use in embodiments 1 and 2 of the present utility model. The surface of the compression shell 6 can be seen to have a multi-section fold telescopic structure, and after the compression shell 6 is placed into a sponge, the sponge can have better bending capability through the multi-section structure, so that the sponge can smoothly pass through the bending position of the nasal cavity in the operation process.

The foregoing description is merely illustrative of the preferred embodiments of the present utility model, and is not intended to limit the scope of the present utility model. Equivalent changes and modifications are intended to be within the scope of the present utility model as defined in the appended claims.

Claims

1. An esophageal fistula device, it includes the drainage tube of esophageal fistula and connects the sponge outside one end of the drainage tube of esophageal fistula, its characterized in that: also has a compression housing; the sponge is compressed, and then the sponge with the compressed diameter is placed into a compression shell; after the sponge of the compressed shell is delivered to the esophageal stoma, the compressed shell softens and ruptures, allowing the sponge at the esophageal stoma to re-expand.

2. The esophageal fistula device of claim 1, wherein: the compression shell is a multi-section sponge compression shell with bending capability.

3. The esophageal fistula device of claim 1, wherein: the outer end of the compression shell is provided with an opening through which the set pull ring is connected with the sponge.

4. The esophageal fistula device of claim 1, wherein: the diameter of the sponge in the expansion state is 10mm to 50mm, the length is 10mm to 100mm, and the diameter of the sponge in the compression shell constraint state is 6mm to 15mm.

5. The esophageal fistula device of claim 1 or 2 or 3 or 4, wherein: the device also comprises a waste liquid collecting container provided with an aspirator, wherein one end of the waste liquid collecting container is provided with a quick connector, and the other end of the waste liquid collecting container is provided with a drainage pipeline with an esophageal fistula drainage pipe joint; one end of the drainage pipeline is connected with the waste liquid collecting container through a quick connector, and the other end is connected with the esophageal fistula drainage tube connector through an esophageal fistula drainage tube connector.

6. The esophageal fistula device of claim 5, wherein: the aspirator can be used for starting negative pressure or adjusting the magnitude of the negative pressure or adjusting the working state of continuous suction or intermittent suction by an adjusting button.

7. The esophageal fistula device of claim 1 or 2 or 3 or 4, wherein: the device also comprises a steel cable and a handle, wherein a lining core formed by the steel cable and the handle is inserted into the esophageal fistula drainage tube.