Esophageal fistula device

Abstract

The present invention relates to an esophageal fistula device comprising an esophageal fistula drainage tube and a sponge connected to the outside of one end of the esophageal fistula drainage tube, characterized by further comprising a compression housing. The sponge is compressed, and then the sponge with a compressed diameter is placed in the compression housing. After the sponge in the compression housing is delivered to an esophageal fistula opening, the compression housing is softened and ruptured, allowing the sponge at the esophageal fistula opening to re-expand. The present invention enables the sponge for occluding esophageal fistula to reach the lesion smoothly, thereby saving operation time, reducing the pain of a patient, and facilitating the operation of a doctor, and can also continuously remove pus, esophagus exudate, necrotic secretion, etc. at the esophageal fistula, ensuring adequate drainage of an abscess cavity.

Description

Esophageal fistula device Technical Field

[0001] The present invention relates to the field of medical devices, in particular to an esophageal fistula device. Background Art

[0002] How to effectively repair esophageal fistulas caused by esophageal perforation, rupture, and postoperative anastomotic leaks has long been a key research challenge in the field of digestive surgery. Failure to promptly seal the fistula can rapidly progress to empyema and mediastinal infection, ultimately leading to septic shock and multiple organ failure, significantly increasing the risk of death. Currently, there are no unified, standardized clinical guidelines for the treatment of esophageal fistulas. While there is expert consensus regarding the "three tubes and one prohibition" approach for asymptomatic, small esophageal fistulas, the treatment options for larger fistulas refractory to conservative treatment, particularly those complicated by mediastinal abscesses and sepsis, remain controversial. Clinical treatment options for esophageal fistulas in China primarily include endoscopic placement of biocompatible stents, particularly biodegradable, memory-rich metal stents; fistula closure using biological tissue glue, titanium clips, and clamps; and secondary esophagogastrostomy. However, these treatments remain unsatisfactory. With the continuous development of interventional, endoscopic, and biomaterial technologies, a new minimally invasive endoscopic technique has been gradually developed abroad for the treatment of different types of esophageal fistulas—endoscopic vacuum-assisted closure therapy (EVAC). An increasing number of clinical studies have found that this technique has a good therapeutic effect in treating esophageal fistulas, sometimes even surpassing traditional treatments. EVAC is being continuously promoted and applied by clinical centers abroad.

[0003] The EVAC procedure is usually as follows:

[0004] a) Thoroughly assess the esophageal lumen and fistula;

[0005] b) Preparation of the esophageal lumen and port (endoscopic removal of skin flow and necrotic tissue);

[0006] c) Place a drainage tube through the nasal cavity and remove the distal end through the mouth;

[0007] d) Trim the sponge and drainage tube and secure them;

[0008] e) Indwelling suture at the distal end of the drainage tube;

[0009] f) Endoscopic forceps grasp the distal suture and enter the esophagus;

[0010] g) Endoscopically guided sponge placement into the fistula;

[0011] h) Turn on the negative pressure and confirm the instrument position, then withdraw the endoscope.

[0012] The efficacy of EVAC has been demonstrated in numerous studies and is widely recognized by clinicians. However, due to the lack of specialized finished devices on the market, the sponge used in EVAC treatment of esophageal fistula still needs to be cut and fixed by hand, which greatly tests the operator's skill level.

[0013] For example, a Chinese utility model patent (authorization publication number: CN203861754U) discloses a negative pressure sponge occluder for esophageal fistulas. The device comprises a drainage tube, a cannula, a connecting tube, and a sponge head, one end of which is connected to the sponge head. During use, the cannula is inserted (through the nasal cavity) into the esophagus. The cannula guides the sponge head and drainage tube into the esophagus. Because the cannula is wrapped around the sponge head, it prevents esophageal material from entering the sponge head, preventing blockage and improving subsequent waste fluid aspiration. During cannula insertion, a developing line is provided on the sponge head, allowing the position of the sponge head to be clearly seen under X-ray irradiation, allowing the sponge head to be precisely inserted into the esophageal fistula. Once the sponge head is inserted into the esophageal fistula, the cannula is removed, releasing the sponge head. The sponge head adheres to the esophageal fistula, more effectively aspirating waste fluid and encouraging surrounding tissue to cover the esophagus. The free end of the drainage tube is connected to negative pressure, and the waste fluid is sucked out. As the waste fluid is sucked out and the surrounding tissues are covered and fibrotic, the esophageal fistula becomes smaller and smaller. Due to the elastic effect of the sponge head, it will become smaller as the esophageal fistula becomes smaller, and will not cause further damage to the esophageal fistula.

[0014] When the above-mentioned existing structure is used, the sponge is extended from the patient's nasal cavity into the esophagus in an expanded state. The expanded sponge (such as round, cylindrical, or hollow spindle-shaped) has a diameter of 10mm to 50mm and a length of 10mm to 100mm, which is obviously larger than the diameter of the nasal cavity. Moreover, the passage from the nasal cavity to the esophagus (fistula) has an irregular curved structure, which makes it more difficult for the doctor to insert the device, making it difficult for the doctor to operate, often resulting in a prolonged operation time (an average of 45 minutes), and is also likely to cause pain to the patient. Summary of the Invention

[0015] The purpose of the present invention is to provide an esophageal fistula device that solves the technical problems existing in the above-mentioned prior art. The present invention can enable the sponge for blocking esophageal fistula to reach the lesion smoothly, save operation time, reduce patient pain, facilitate doctor's operation, and at the same time provide esophageal fistula with the advantages of sustainable removal of pus, esophageal exudate, necrotic secretions, etc., ensuring sufficient drainage of the abscess cavity, etc.

[0016] To achieve the above object, the technical solution of the present invention is:

[0017] An esophageal fistula device comprises an esophageal fistula drainage tube and a sponge connected to one end of the esophageal fistula drainage tube. The device is characterized in that it further comprises a compression shell; the sponge is compressed, and then the sponge with a compressed diameter is placed in the compression shell; after the sponge in the compression shell is delivered to the esophageal fistula opening, the compression shell softens and ruptures, allowing the sponge at the esophageal fistula opening to expand again.

[0018] The esophageal fistula device is characterized in that the compression shell is a multi-section sponge compression shell with bending ability.

[0019] The esophageal fistula device is characterized in that the outer end of the compression shell has an opening, and a pull ring is provided through the opening to connect with the sponge.

[0020] The esophageal fistula device is characterized in that the sponge has a diameter of 10mm to 50mm and a length of 10mm to 100mm in an expanded state, and a diameter of 6mm to 15mm in a compressed shell-constrained state.

[0021] The esophageal fistula device is characterized in that: the device also includes a waste liquid collection container equipped with an aspirator, a drainage pipe with a quick interface at one end and an esophageal fistula drainage tube connector at the other end; one end of the drainage pipe is connected to the waste liquid collection container through the quick interface, and the other end is connected to the esophageal fistula drainage tube connector through the esophageal fistula drainage tube connector.

[0022] The esophageal fistula device is characterized in that the suction device has an adjustment button that can be used to start negative pressure or adjust the size of negative pressure or adjust the working state of continuous suction or intermittent suction.

[0023] The esophageal fistula device is characterized in that the device also includes a steel cable and a handle, and the liner core composed of the steel cable and the handle is inserted into the esophageal fistula drainage tube.

[0024] The structure of the device of the present invention has the following advantages when used:

[0025] 1. The sponge of the present invention is compressed by the compression shell before use and then expanded by water injection after reaching the lesion. The compressed product has a small overall outer diameter and can be inserted into the lesion through the nasal cavity, which is convenient for doctors and reduces pain for patients.

[0026] 2. The device of the present invention utilizes the characteristics of the sponge being porous, soft in texture and capable of providing uniform negative pressure to provide sustainable removal of pus, esophageal exudate, necrotic secretions, etc. for esophageal fistula, ensuring adequate drainage of the abscess cavity.

[0027] 3. The waste liquid collection container equipped with an aspirator of the present invention can have a continuous or intermittent aspiration function, and can provide targeted treatment for multiple patients.

[0028] 4. The use of the device of the present invention has shortened the operation time from the original average of 45 minutes to the current 15 minutes. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG1 is a schematic structural diagram of embodiment 1 of the present invention.

[0030] FIG2 is a schematic structural diagram of a waste liquid collection container with an aspirator in Example 1 of the present invention.

[0031] FIG3 is a schematic structural diagram of the drainage pipe portion in Example 1 of the present invention.

[0032] FIG4 is a schematic structural diagram of the esophageal fistula drainage tube and the sponge portion in Example 1 of the present invention.

[0033] FIG5 is a schematic structural diagram of an esophageal fistula drainage tube and a sponge portion having a sponge compression shell and a pull ring in Example 1 of the present invention.

[0034] FIG6 is a schematic structural diagram of embodiment 2 of the invention.

[0035] FIG7 is a schematic structural diagram of an esophageal fistula drainage tube with a sponge compression shell and a sponge portion in Example 2 of the present invention.

[0036] FIG8 is a partial cross-sectional view of FIG7.

[0037] FIG9 is a schematic structural diagram of embodiment 3 of the present invention. DETAILED DESCRIPTION

[0038] Please refer to Figures 1-5, which are schematic diagrams of the structure of Example 1 of an esophageal fistula device according to the present invention. As shown in Figure 1, the esophageal fistula device includes a waste liquid collection container 1 equipped with a suction device 2, a drainage tube 4 having a quick-connect interface 3 at one end and an esophageal fistula drainage tube connector 5 at the other end, an esophageal fistula drainage tube 8, a sponge 7 connected to one end of the esophageal fistula drainage tube 8, and a pull ring 9. Among them:

[0039] As shown in Figure 2 , the waste liquid collection container 1 has a quick-connect port 11, which allows for quick connection to the quick connector 3 at the proximal end of the drainage tube 4 in Figure 3 . An aspirator 2 is installed within the waste liquid collection container 1, which is used to generate negative pressure and generate negative pressure suction from the quick-connect port 11. In addition, the waste liquid collection container 1 also has a power button 23 (used to indicate whether the power is on), a function indicator light 22 (used to display the operating status of the device, such as whether the negative pressure has been activated), and a function adjustment button 21. The function adjustment button 21 can be used to activate or adjust the negative pressure (-2kPa to -80kPa), or to adjust the operating state, such as continuous or intermittent suction.

[0040] As shown in Figure 3 , one end (proximal end) of the drainage tube 4 has a quick connector 3 for connecting to a waste fluid collection container 1; the other end (distal end) has an esophageal fistula drainage tube connector 5 for connecting to the proximal end of an esophageal fistula drainage tube 8. This esophageal fistula drainage tube connector 5 is suitable for 8Fr to 36Fr tubes.

[0041] As shown in Figure 4, it is a schematic diagram of the structure of the esophageal fistula drainage tube and sponge portion in Example 1 of the present invention, wherein the sponge 7 is in an expanded state. The expanded sponge 7 can have various shapes (e.g., circular, cylindrical, hollow spindle-shaped, with a diameter of 10mm to 50mm and a length of 10mm to 100mm). The esophageal fistula drainage tube 8 has various specifications (including sizes from 14Fr to 36Fr), its proximal end is connected to the esophageal fistula drainage tube connector 5 via the esophageal fistula drainage tube connector 5, and its distal end is connected to the sponge 7. The esophageal fistula drainage tube 8 and sponge 7 can be chemically connected by glue, fixed by ultrasonic processing, or physically fixed by sutures, anchor hooks, etc.

[0042] Please refer to Figure 5, which is a schematic diagram of the structure of the esophageal fistula drainage tube and sponge portion, comprising a sponge compression housing and a pull ring, according to Example 1 of the present invention. Based on the structure of Figure 4 above, during manufacture, the sponge 7 must first be compressed (particularly, its diameter) before being placed into a compression housing 6. This sponge compression housing 6 can be made of gelatin, collagen, plant fibers, or derivatives thereof. While accommodating the compressed sponge, the compression housing 6 can compress the sponge 7 from a larger outer diameter of 10mm to 100mm to a smaller outer diameter of 6mm to 15mm. The reduced outer diameter of the sponge 7 due to the compression housing 6 makes it easier to smoothly insert the sponge 7 from the patient's nasal cavity into the esophagus, saving surgical time and reducing patient pain. Once the compressed sponge 7 is applied to the esophageal fistula opening by medical personnel, the compression housing 6 can be softened and ruptured by injecting water, allowing the sponge 7 to expand again to an outer diameter of 10mm to 100mm at the esophageal fistula opening, thereby subsequently draining the esophageal fistula. In addition, the outer end (ie, the distal end) of the compression shell 6 has an opening 61 , and the pull ring 9 is connected to the sponge 7 through the opening 61 .

[0043] This pull ring 9 makes it easier for medical staff to remove the sponge 7 from the body after the esophageal fistula drainage is completed. In specific operation, after the esophageal fistula treatment is completed, the doctor places the esophagoscope at the fistula opening through the other nasal cavity, finds the pull ring 9, and extends a clamp-like instrument from the esophagoscope to pull the pull ring. Then, the sponge 7 and the esophageal fistula drainage tube 8 can be withdrawn from the body together. The advantage of this method is that the sponge 7 and the esophageal fistula drainage tube 8 will be intertwined after long-term drainage. The original method of withdrawing the sponge 7 by simply pulling out the esophageal fistula drainage tube 8 is likely to stick to the wall, causing obstruction of the esophageal fistula. Adding the pull ring 9 can cleverly apply force and well remove the used esophageal fistula drainage device from the body.

[0044] The operation method of Example 1 of the present invention during surgery is:

[0045] Step 1: Place a guide wire through the esophagogastroscopy to the esophageal fistula, keep the guide wire in place, and remove the esophagogastroscopy.

[0046] Step 2, inserting the end of the guide wire into the inner hole of the device of the present invention (i.e., the hole of the esophageal fistula drainage tube 8);

[0047] Step 3: Push the device of the present invention (the sponge is in a compressed state under the action of the compression shell) along the guide wire from the nasal cavity to the esophageal fistula;

[0048] Step 4: Insert an esophagogastroscopy from the other nasal cavity to observe whether the device of the present invention is placed in the ideal position. If not, make minor adjustments until the ideal position is reached.

[0049] Step 5: Remove the esophagoscopy and guide wire;

[0050] Step 6: Inject about 200cc of normal saline into the esophageal fistula drainage tube from the external port to rupture the compressed shell and release the expanded state of the sponge, thus completing the implantation of the device of the present invention.

[0051] After the device of the present invention is implanted, its tubing is connected to the components shown in Figure 2 via the components shown in Figure 3, reaching the state shown in Figure 1. The appropriate suction mode can then be selected based on the patient's actual needs to begin draining the esophageal fistula. When the waste fluid is full, a new waste fluid collection bottle can be replaced to continue drainage. The waste fluid collection container 1, equipped with the suction device 2, can be plugged in or operated independently with batteries.

[0052] The device described in Example 1 of the present invention has the following advantages:

[0053] 1. The sponge 7 of the device of the present invention is compressed by the compression shell 6 before use, and then expanded by water injection after reaching the lesion. The overall outer diameter of the compressed product is small, and it can be inserted into the lesion through the nasal cavity, which is convenient for doctors and reduces pain for patients.

[0054] 2. The device of the present invention utilizes the characteristics of the sponge 7 being porous, soft in texture, and capable of providing uniform negative pressure to provide sustainable removal of pus, esophageal exudate, necrotic secretions, etc. for esophageal fistula, ensuring sufficient drainage of the abscess cavity.

[0055] 3. The waste liquid collection container 1 equipped with the aspirator 2 of the present invention can have a continuous or intermittent aspiration function, and can provide targeted treatment for multiple patients.

[0056] 4. The use of the device of the present invention has shortened the operation time from the original average of 45 minutes to the current 15 minutes.

[0057] Please refer again to Figures 6-8, which are schematic diagrams of the structure of Example 2 of the present invention. As shown in the figures, the device comprises an esophageal fistula drainage tube 8, a sponge 7 connected to one end of the esophageal fistula drainage tube 8, and a compression housing 6 into which the compressed sponge 7 is placed. The sponge compression housing 6 can be made of gelatin, collagen, plant fiber, or derivatives thereof. When accommodating the compressed sponge, the compression housing 6 can compress the sponge 7 from a larger outer diameter of 10mm to 100mm to a smaller outer diameter of 6mm to 15mm.

[0058] When the device of embodiment 2 of the present invention is used:

[0059] Step 1: Insert the liner core consisting of the steel cable 101 and the handle 102 into the device until it reaches the bottom;

[0060] Step 2: Pass the device in the above steps through the nasal cavity or oral cavity, and place the sponge 7 at the location of the esophageal fistula under the guidance of an esophagoscopy. For the device placed through the oral cavity, it is necessary to lead another drainage tube from the nasal cavity to the oral cavity, and connect the above tube to the tail end of the above device, and then lead the tail end tube through the nasal cavity and out of the body, thus completing the device placement operation.

[0061] Once the device is implanted, its tubing is connected to the components shown in Figure 2 via the components shown in Figure 3, resulting in the state shown in Figure 1. The appropriate suction mode can then be selected based on the patient's actual needs to begin draining the esophageal fistula. When the waste fluid collection bottle is full, a new waste fluid collection bottle can be replaced to continue drainage. The waste fluid collection container 1, equipped with the suction device 2, can be plugged in or operated independently with batteries.

[0062] Referring again to Figure 9, which illustrates Example 3 of the present invention, a multi-segmented sponge compression shell 6 suitable for use with Examples 1 and 2 of the present invention is disclosed. The surface of compression shell 6 features a multi-segmented, pleated, and retractable structure. Once the sponge is placed within compression shell 6, this multi-segmented structure allows the sponge to bend smoothly through the nasal bends during surgery.

[0063] The above description is only a preferred embodiment of the present invention and is not intended to limit the scope of the present invention. That is, any equivalent changes and modifications made according to the content of the patent application of the present invention should fall within the technical scope of the present invention.

Claims

1. An esophageal fistula device, comprising an esophageal fistula drainage tube and a sponge connected to one end of the esophageal fistula drainage tube, characterized in that: It also has a compression shell; the sponge is compressed, and then the sponge with a compressed diameter is placed in the compression shell; after the sponge in the compression shell is sent to the esophageal fistula, the compression shell softens and breaks, so that the sponge at the esophageal fistula expands again.

2. The esophageal fistula device according to claim 1, characterized in that: The compression shell is a multi-section sponge compression shell with bending ability.

3. The esophageal fistula device according to claim 1, characterized in that: The outer end of the compression shell has an opening, and a pull ring is arranged to be connected with the sponge through the opening.

4. The esophageal fistula device according to claim 1, characterized in that: The diameter of the sponge in the expanded state is 10mm to 50mm, and the length is 10mm to 100mm. The diameter of the sponge in the compressed shell restrained state is 6mm to 15mm.

5. The esophageal fistula device according to claim 1, 2, 3 or 4, characterized in that: The device also includes a waste liquid collection container equipped with an aspirator, a drainage pipe with a quick interface at one end and an esophageal fistula drainage tube connector at the other end; one end of the drainage pipe is connected to the waste liquid collection container through the quick interface, and the other end is connected to the esophageal fistula drainage tube connector through the esophageal fistula drainage tube connector.

6. The esophageal fistula device according to claim 5, characterized in that: The suction device has an adjustment button which can be used to start negative pressure or adjust the size of negative pressure or adjust the working state of continuous suction or intermittent suction.

7. The esophageal fistula device according to claim 1, 2, 3 or 4, characterized in that: The device also includes a steel cable and a handle. The liner core composed of the steel cable and the handle is inserted into the esophageal fistula drainage tube.

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