Esophageal stenosis dilation balloon

Abstract

The invention provides an esophageal stenosis dilatation balloon which comprises a dilatation tube mechanism, and a guide-in assembly and a suction tube are arranged in the dilatation tube mechanism; the balloon main body is arranged on the outer surface wall of the expansion tube mechanism, the balloon main body is communicated with the guide-in assembly, a contrast agent can be injected through the injection device to expand the balloon main body, the expansion diameter is matched with the injection pressure, repeated suction can be carried out to gradually expand the balloon main body to a target diameter, and marking lines visible under X rays are arranged at the two ends of the balloon main body. The invention relates to the technical field of medical instruments, in particular to a balloon which is convenient for real-time observation of dilatation during operation and capable of accurately controlling the dilatation diameter of a balloon main body by injecting a contrast agent and utilizing the matching relation between the contrast agent and pressure, avoiding blind operation and improving safety. Suction and injection can be repeatedly carried out, and progressive and controllable expansion is achieved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an esophageal stricture dilation balloon. Background Technology

[0002] Esophageal stricture is a common disease of the digestive system, which can be caused by various factors such as tumors, postoperative anastomosis, inflammation, and corrosion, leading to difficulty swallowing. Balloon dilation is currently one of the main minimally invasive methods for the palliative treatment of benign esophageal strictures and some malignant strictures.

[0003] Existing esophageal dilation balloons mostly use saline or air for filling and dilation. However, this method has the following drawbacks:

[0004] The dilation diameter is not easy to control precisely, and it mainly depends on the surgeon's experience. The relationship between pressure and diameter is unclear, which can easily lead to insufficient or excessive dilation and perforation.

[0005] The dilation process is poorly visualized, and is usually judged by direct endoscopic visualization or touch. It is difficult to accurately determine the position of the balloon in the stenotic segment and its adhesion to the vessel wall, especially in cases of severe or complex stenosis.

[0006] During the procedure, secretions in the esophageal lumen or refluxed gastric contents may obstruct the field of vision or cause aspiration, and there is a lack of effective means of immediate clearance.

[0007] Therefore, there is an urgent need for an esophageal stricture dilation balloon device that can achieve precise control of the dilation diameter, visualize the dilation process, and help maintain a clear operating field of vision. Summary of the Invention

[0008] The technical problem to be solved by the present invention is to overcome the defects of the prior art and provide an esophageal stricture dilation balloon with contrast and suction functions. This device can be clearly visualized under X-ray, achieve matching control of dilation diameter and injection pressure, and can simultaneously perform suction and cleaning, thereby improving the safety, precision and convenience of the operation.

[0009] The technical solution adopted by the embodiments of this application to solve its technical problem is:

[0010] An esophageal stricture dilation balloon, including a dilation tube mechanism;

[0011] A piping mechanism, disposed inside the expansion tube mechanism, the piping mechanism including an inlet component and a suction tube;

[0012] A balloon body disposed on the outer wall of the dilation tube mechanism, the balloon body being in fluid communication with the inlet assembly for injecting contrast agent through the inlet assembly to dilate it, wherein the dilation diameter of the balloon body is matched with the injection pressure.

[0013] The infusion assembly includes a connecting tube, a contrast agent tube, and a horizontal tube;

[0014] The connecting tube is used to connect to an external pressure pump injector, the contrast agent tube is used to transport the contrast agent, the horizontal tube connects to the contrast agent tube and extends axially along the dilation tube mechanism, and the horizontal tube is connected to the inner cavity of the balloon body.

[0015] Preferably, the two ends of the balloon body are provided with marking lines that are visible under medical imaging.

[0016] Preferably, the end of the expansion tube mechanism away from the suction tube is provided with a plug-in end, which is a hollow conical structure.

[0017] Preferably, the expansion tube mechanism is further provided with a guide wire, which is movably inserted into the cavity inside the expansion tube mechanism. The length of the guide wire is greater than the length of the expansion tube mechanism, and the distal end of the guide wire extends beyond the distal end of the expansion tube mechanism.

[0018] Preferably, the balloon body is made of a compliant or semi-compliant material, and the expansion diameter of the balloon body is matched with the pressure of the contrast agent injected into it.

[0019] Preferably, the suction tube is independent of the inlet component, with one end opening into the distal sidewall of the expansion tube mechanism and connecting to an external suction device, and the other end extending to the insertion end.

[0020] Preferably, the connecting tube, contrast agent tube, and horizontal tube are integrally formed to constitute the infusion assembly.

[0021] Preferably, the dilation tube mechanism has an independent central cavity and a contrast agent cavity, which respectively accommodate the guidewire, the induction assembly, and the suction tube.

[0022] Includes the following steps:

[0023] With endoscopic assistance, the guidewire is inserted and passes through the esophageal stricture.

[0024] The dilation tube mechanism is inserted to the target position along the guide wire, so that the balloon body spans the narrow section;

[0025] Contrast agent is injected into the balloon body via the inlet assembly, causing it to expand and apply pressure to the stenotic segment;

[0026] The expansion process is monitored by observing the position of the marker lines and the morphology of the balloon body under medical imaging.

[0027] Based on the expansion effect, the contrast agent is repeatedly aspirated and injected to gradually adjust the diameter of the balloon body until the expected expansion diameter is achieved.

[0028] The advantages of the embodiments of this application are:

[0029] By injecting contrast agent and utilizing its pressure-matching relationship, the expansion diameter of the balloon body can be precisely controlled, avoiding blind operation and improving safety. Repeated aspiration and injection can achieve gradual and controllable expansion.

[0030] The marking lines at both ends of the balloon body and the contrast agent filling it make it clearly visible under X-rays. The surgeon can observe the position, shape, dilation diameter, and dilation changes of the balloon in the stenotic segment in real time and accurately, achieving true visual dilation.

[0031] The built-in suction tube can clear the esophageal lumen at any time during dilation, maintaining a clear operating field and reducing the risk of complications. The structural design conforms to the operating habits of endoscopic surgery, and the guidewire guidance and insertion end design facilitates placement and fixation, improving surgical efficiency. Attached Figure Description

[0032] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0033] Figure 1 This is a schematic diagram of the overall structure of the esophageal stricture dilation balloon of the present invention;

[0034] Figure 2 This is a schematic diagram of the overall structure of the esophageal stricture dilation balloon for lateral guidewire removal according to the present invention;

[0035] Figure 3 This is a schematic diagram of the overall structure of the dilation tube mechanism in the esophageal stricture dilation balloon of the present invention;

[0036] Figure 4 This is a schematic diagram of the overall structure of the insertion component in the esophageal stricture dilation balloon of the present invention.

[0037] Explanation of key figure labels:

[0038] 1. Dilatation tube mechanism; 2. Insertion end; 3. Guide wire; 4. Introducing component; 41. Connecting tube; 42. Contrast agent tube; 43. Horizontal tube; 5. Suction tube; 6. Balloon body; 7. Marking line. Detailed Implementation

[0039] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention. In addition, for the sake of convenience, the terms "upper," "lower," "left," and "right" are equivalent to the upper, lower, left, and right directions of the accompanying drawings themselves, and the terms "first," "second," etc., are used for descriptive purposes and have no other special meaning.

[0040] This application provides an esophageal stricture dilation balloon, addressing the problems in the prior art. By injecting a contrast agent and utilizing its matching relationship with pressure, the dilation diameter of the balloon body can be precisely controlled, avoiding blind operation and improving safety. It allows for repeated aspiration and injection, achieving gradual and controllable dilation.

[0041] The marking lines at both ends of the balloon body and the contrast agent filling it make it clearly visible under X-rays. The surgeon can observe the position, shape, dilation diameter, and dilation changes of the balloon in the stenotic segment in real time and accurately, achieving true visual dilation.

[0042] The built-in suction tube can clear the esophageal lumen at any time during dilation, maintaining a clear operating field and reducing the risk of complications. The structural design conforms to the operating habits of endoscopic surgery, and the guidewire guidance and insertion end design facilitates placement and fixation, improving surgical efficiency.

[0043] The technical solution in this application is to solve the above problems, and the overall approach is as follows:

[0044] Example

[0045] This embodiment provides a specific structure of an esophageal stricture dilation balloon, such as... Figure 1-4 As shown, it includes an expansion tube mechanism 1;

[0046] The expansion tube mechanism 1 has a plug end 2 at the end away from the suction tube 5. The plug end 2 is a hollow conical structure.

[0047] The dilation tube mechanism 1 also includes a guidewire 3, which is movably inserted into the cavity within the dilation tube mechanism 1. The guidewire 3 is longer than the dilation tube mechanism 1, with its distal end extending beyond the distal end of the dilation tube mechanism 1. The guidewire 3 is movably inserted into the central lumen. The guidewire 3 is significantly longer than the dilation tube mechanism 1, and its distal end can extend beyond the distal end of the dilation tube mechanism 1 to allow it to pass through the stenotic segment first during surgery, providing track support for the entire catheter system.

[0048] The dilation tube mechanism 1 has an independent central cavity and a contrast agent cavity, which respectively accommodate the guide wire 3, the induction assembly 4, and the suction tube 5.

[0049] The dilator mechanism 1 is a slender tubular structure with a distal insertion end 2 for guiding insertion. The insertion end 2 is a hollow, tapered, and smooth structure, which facilitates advancement along the guidewire 3 and reduces tissue damage. The dilator mechanism 1 contains an independent, axially extending central lumen, a contrast agent lumen, and a suction lumen.

[0050] The pipe mechanism is located inside the expansion tube mechanism 1. The pipe mechanism includes an inlet component 4 and a suction tube 5. The suction tube 5 is independent of the inlet component 4. One end of the suction tube 5 opens into the distal side wall of the expansion tube mechanism 1 and connects to an external suction device. The other end extends to the insertion end 2.

[0051] The suction tube 5 is set independently of the inlet assembly 4 and is located in the suction lumen inside the dilation tube mechanism 1. The proximal end of the suction tube 5 opens into the proximal side wall of the dilation tube mechanism 1 for connecting to an external negative pressure suction device; its distal end extends to the insertion end 2, opening therein, so as to directly aspirate secretions, blood or refluxed gastric contents in front of the balloon during dilation, maintain a clear surgical field and reduce the risk of aspiration.

[0052] The balloon body 6 is disposed on the outer wall of the dilation tube mechanism 1. The balloon body 6 is in fluid communication with the infusion component 4 and is used to inject contrast agent through the infusion component 4 to dilate the balloon body 6. The dilation diameter of the balloon body 6 is matched with the injection pressure.

[0053] The balloon body 6 is made of compliant or semi-compliant material. The expansion diameter of the balloon body 6 is matched with the pressure of the contrast agent injected into it. Marking lines 7 visible under medical imaging are provided at both ends of the balloon body 6.

[0054] The balloon body 6 is fixedly fitted onto the outer wall of the dilation tube mechanism 1 and covers the outlet of the horizontal tube 43. The balloon body 6 is made of a compliant material. Its characteristic is that the balloon's expansion diameter is matched to the pressure of the contrast agent injected into it; that is, within a certain pressure range, the balloon diameter increases accordingly with increasing pressure. This allows the operator to steplessly adjust the expansion diameter by precisely controlling the injection pressure, achieving gradual and adaptive dilation of stenotic tissues of varying hardness. Marking lines 7, visible under X-ray or other medical imaging, are provided at both ends of the balloon body 6 for precisely locating the balloon's position relative to the stenotic segment.

[0055] Import component 4 includes a connecting tube 41, a contrast agent tube 42, and a horizontal tube 43;

[0056] The connecting tube 41 is used to connect to an external pressure pump injector, the contrast agent tube 42 is used to transmit the contrast agent, the horizontal tube 43 connects to the contrast agent tube 42 and extends along the axial direction of the dilation tube mechanism 1, and the horizontal tube 43 is connected to the inner cavity of the balloon body 6. The connecting tube 41, the contrast agent tube 42 and the horizontal tube 43 are integrally formed to constitute the introductory component 4.

[0057] The import component 4 is located inside the dilation tube mechanism 1 and within the contrast agent lumen. For example... Figure 2 As shown, the infusion assembly 4 includes an integrally formed connecting tube 41, a contrast agent tube 42, and a horizontal tube 43. The proximal end of the connecting tube 41 is used to connect to an external pressure pump injector (not shown); the contrast agent tube 42 is used to deliver the contrast agent; the horizontal tube 43 communicates with the contrast agent tube 42 and extends axially along the dilation tube mechanism 1, with its end connected to the inner cavity of the balloon body 6. This integrated design ensures the sealing and unobstructed flow of the contrast agent.

[0058] Includes the following steps:

[0059] Under endoscopic guidance, guidewire 3 was inserted and passed over the esophageal stricture.

[0060] Insert the dilation tube mechanism 1 along the guide wire 3 to the target position, so that the balloon body 6 spans the narrow section;

[0061] Contrast agent is injected into the balloon body 6 via the import component 4, causing it to expand and apply pressure to the stenotic segment;

[0062] Under medical imaging, the expansion process is monitored by observing the position of the marker line 7 and the morphology of the balloon body 6;

[0063] Based on the expansion effect, the contrast agent is repeatedly aspirated and injected to gradually adjust the diameter of the balloon body 6 until the expected expansion diameter is reached.

[0064] The operation steps are as follows:

[0065] Guidewire 3 is inserted. Under endoscopic assistance, guidewire 3 is inserted through the mouth and its tip is carefully guided past the esophageal stenosis and into the stomach.

[0066] Keeping the guidewire 3 in the same position, push the dilator mechanism 1 into the esophagus along the guidewire 3. Under real-time X-ray fluoroscopy, observe the marking lines 7 at both ends of the balloon and ensure that they are accurately positioned across the middle of the esophageal stenosis.

[0067] A pressure pump injector is connected via connecting tube 41, and diluted contrast agent is slowly injected into the balloon body 6. Under X-ray imaging, the following can be clearly observed:

[0068] The pressure marks on the balloon body 6 at the narrow part gradually disappear, and the shape of the balloon body 6 changes from a dumbbell shape to a regular cylinder. The position of the marking line 7 is stable, ensuring that the expansion force acts on the target segment. The injection pressure is precisely controlled by the pressure pump. The compliant material properties of the balloon make its diameter increase slowly with the pressure, achieving controllable expansion.

[0069] During dilation, the negative pressure suction device connected to suction tube 5 can be activated at any time to remove any liquid or food residue that may have accumulated near the stenosis, ensuring operational safety. The pressure, balloon morphology, and position throughout the dilation process are monitored in real time on the imaging equipment.

[0070] Based on imaging assessment, if the initial dilation does not achieve the desired effect, the balloon can be slightly depressurized, allowing it to rotate a certain angle within the lumen before re-injecting contrast agent for dilation, addressing non-circumferential stenosis. The injection pressure is adjusted repeatedly and gradually until the balloon's waist sign completely disappears and the desired dilation diameter is achieved. Finally, the contrast agent is completely withdrawn, causing the balloon to collapse, and the entire catheter system, along with the guidewire, is withdrawn.

[0071] Finally, it should be noted that the above embodiments are merely examples for clearly illustrating the present invention and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An esophageal stricture dilation balloon, characterized by, The application relates to a balloon dilator device, which comprises: a dilator tube (1); a tube mechanism arranged inside the dilator tube (1), which comprises a lead-in assembly (4) and a suction tube (5); a balloon body (6) arranged on the outer wall of the dilator tube (1), which is in fluid communication with the lead-in assembly (4) and is used for injecting contrast medium through the lead-in assembly (4) to dilate the balloon body (6), wherein the dilated diameter of the balloon body (6) matches the injection pressure.

2. The esophageal stricture dilation balloon of claim 1, wherein, The lead-in assembly (4) comprises a connecting tube (41), a contrast medium tube (42) and a cross tube (43); the connecting tube (41) is used for connecting with an external pressure pump injector, the contrast medium tube (42) is used for transmitting contrast medium, and the cross tube (43) is in communication with the contrast medium tube (42) and extends axially along the dilator tube (1) and is in communication with the inner cavity of the balloon body (6).

3. The esophageal stricture dilation balloon of claim 1, wherein, Marking lines (7) visible under medical imaging are arranged at both ends of the balloon body (6).

4. The esophageal stricture dilation balloon of claim 1, wherein, The dilator tube (1) is provided with a plug-in end (2) away from the suction tube (5), and the plug-in end (2) is a hollow conical structure.

5. The esophageal stricture dilation balloon of claim 1, wherein, A guide wire (3) is further arranged in the dilator tube (1) and movably arranged in the cavity of the dilator tube (1), the length of the guide wire (3) is greater than the length of the dilator tube (1), and the distal end of the guide wire (3) extends out of the distal end of the dilator tube (1).

6. The esophageal stricture dilation balloon of claim 1, wherein, The balloon body (6) is made of a compliant material or a semi-compliant material, and the dilated diameter of the balloon body (6) matches the pressure of the contrast medium injected into the balloon body (6).

7. The esophageal stricture dilation balloon of claim 1, wherein, The suction tube (5) is independent of the lead-in assembly (4), one end of the suction tube (5) is open to the distal side wall of the dilator tube (1) and connected with external suction equipment, and the other end of the suction tube (5) extends to the plug-in end (2).

8. The esophageal stricture dilation balloon of claim 1, wherein, The connecting tube (41), the contrast medium tube (42) and the cross tube (43) are integrally formed to constitute the lead-in assembly (4).

9. The esophageal stricture dilation balloon of claim 1, wherein, The dilator tube (1) is provided with a central cavity and a contrast medium tube cavity which are independent of each other and respectively accommodate the guide wire (3) and the lead-in assembly (4) and the suction tube (5).

10. A method of performing esophageal stricture dilation using the esophageal stricture dilation balloon of any one of claims 1-9, wherein, The application further discloses a balloon dilator device operation method, which comprises the following steps: under the assistance of an endoscope, a guide wire (3) is placed into and beyond an esophageal stenosis section; the dilator tube (1) is placed along the guide wire (3) to a target position, so that the balloon body (6) is arranged across the stenosis section; contrast medium is injected into the balloon body (6) through the lead-in assembly (4) to dilate the balloon body (6) and press the stenosis section; under medical imaging, the position of the marking lines (7) and the shape of the balloon body (6) are observed to monitor the dilating process; according to the dilating effect, the contrast medium is repeatedly sucked and injected, the diameter of the balloon body (6) is gradually adjusted, and the expected dilated diameter is reached.

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