A balloon catheter with positioning and protection functions

Abstract

A balloon catheter with positioning and protection functions is used for percutaneous microballoon compression surgery to treat trigeminal neuralgia. It includes a balloon assembly (1) and a catheter assembly (2). The balloon assembly (1) includes a first marker point (11), a second marker point (12), a latex balloon (13), and a third marker point (14). The latex balloon (13) consists of two parts. Its distal part has a smaller outer diameter after inflation and serves as the positioning part (131). Its proximal part has a larger outer diameter after inflation and serves as the compression part (132). The second marker point (12) is located at the junction of the positioning part (131) and the compression part (132) of the latex balloon (13) when it is inflated to the normal size. The positioning step on the latex balloon avoids excessive compression of the posterior fossa during the operation. The location of the balloon step is marked by the second marker point. With the help of preoperative 3D modeling, the balloon position is accurately determined, which reduces the difficulty of the operation.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically a surgical instrument for percutaneous microballoon compression surgery to treat trigeminal neuralgia. This utility model is applicable to McBurney's capsule expansion and compression, and is particularly a McBurney's capsule expansion and compression balloon catheter with positioning and protection functions. Background Technology

[0002] Percutaneous microballoon compression surgery has become increasingly popular in my country. Due to its simple and effective treatment method and lower intraoperative damage compared to traditional procedures, it has become one of the preferred treatment options for trigeminal neuralgia.

[0003] Currently, most trigeminal nerve balloon compression surgeries are performed based on the doctor's experience and intuition, lacking detailed quantitative indicators. For example, when inserting the balloon catheter, the doctor visually observes its position using imaging techniques. However, this method results in lower precision in balloon catheter insertion, easily leading to the balloon being positioned too deep or too shallow, resulting in poor treatment outcomes.

[0004] Furthermore, existing surgical instruments used for percutaneous microballoon compression surgery, due to the physical characteristics of the latex balloon itself, exhibit a tendency for the balloon catheter to shift towards the posterior fossa during inflation. This causes the latex balloon to advance towards the posterior fossa during inflation and compression. Since the effective compression site for the surgery is McBurney's capsule, the surgeon must pull the balloon catheter backward during inflation, which is inconvenient and still easily leads to the balloon catheter shifting towards the posterior fossa. Compression of the posterior fossa can result in sequelae such as diplopia and damage to the dura mater. Utility Model Content

[0005] This invention addresses the shortcomings of existing technologies by providing a surgical instrument and its method of use for percutaneous microballoon compression surgery to treat trigeminal neuralgia. By optimizing the structure to avoid compression of the posterior fossa during surgery, a step is provided on the latex balloon, and contrast-enhancing markers are provided on the corresponding catheters. The latex balloon is confined to the middle cranial fossa through the markers and step positioning.

[0006] The technical solution adopted by this utility model to solve its technical problem is as follows:

[0007] A balloon catheter with positioning and protection functions for percutaneous microballoon compression therapy of trigeminal neuralgia, characterized in that...

[0008] Includes a balloon assembly (1) and a catheter assembly (2);

[0009] The distal end of the catheter assembly (2) is provided with an injection port, the balloon assembly (1) is sleeved on the distal end of the catheter assembly (2), and the catheter assembly (2) is connected to the balloon assembly (1) through the injection port;

[0010] The balloon assembly (1) includes a first marker point (11), a second marker point (12), a latex balloon (13), and a third marker point (14).

[0011] The latex balloon (13) consists of two parts: the distal part has a smaller outer diameter after inflation and serves as the positioning part (131), and the proximal part has a larger outer diameter after inflation and serves as the compression part (132).

[0012] The second marker point (12) is located at the junction of the positioning portion (131) and the compression portion (132) of the latex balloon (13) when it is inflated to normal size.

[0013] Furthermore, the first marker point (11) is at the front end of the latex balloon (13), and the third marker point (14) is at the rear end of the latex balloon. The first marker point (11), the second marker point (12), and the third marker point (14) can be observed under imaging equipment.

[0014] Furthermore, the catheter assembly (2) is provided with a catheter portion (21) and a handle portion (22).

[0015] Furthermore, the ratio of the positioning part (131) to the compression part (132) in the latex balloon (13) is 3:7 or 1:1.

[0016] Furthermore, the latex balloon (13) is made of polymer material. The latex balloon (13) is a compliant balloon or a semi-compliant balloon. When the latex balloon (13) is inflated, it can fully compress the trigeminal ganglion.

[0017] Furthermore, the latex balloon (13) is composed of two parts with the contraction part as the boundary. Its distal part has a smaller outer diameter after being filled, serving as the positioning part (131); its proximal part has a larger outer diameter after being filled, serving as the compression part (132); there is a separating contraction segment between the positioning part (131) and the compression part (132), and the outer diameter of the separating contraction segment is smaller than that of the positioning part (131) and the compression part (132) on both sides.

[0018] Furthermore, the structure, thickness and / or material properties of the dividing shrinkage section are different from those of the positioning section (131) and the compression section (132), forming independent filling expansion cavities with different diameters in the positioning section (131) and the compression section (132).

[0019] Furthermore, the positioning part (131) and the pressing part (132) are different in structure, thickness and / or material properties.

[0020] Specifically, the advantages of this utility model are as follows:

[0021] 1. Precise Positioning: The location of the balloon step is marked by a second marker point. Combined with preoperative 3D modeling, this ensures that the balloon compression portion is located in the middle cranial fossa, preventing the balloon from being inserted too superficially or too deeply. This improves surgical precision, reduces surgical risks, and simplifies the surgical procedure.

[0022] 2. Fixed balloon: It can effectively protect the nerves and blood vessels in the posterior fossa. The positioning steps on the latex balloon can prevent the balloon from slipping out during the operation and entering the posterior fossa, compressing the trigeminal nerve root, oculomotor nerve, etc., which may cause sequelae such as diplopia, and reduce the occurrence of postoperative complications.

[0023] In summary, it can reduce the risks of intracranial hemorrhage and double vision; and avoid the balloon entering the posterior fossa during surgery, thus preventing unnecessary compression of the trigeminal nerve root. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the surgical instrument structure;

[0025] Figure 2 A schematic diagram of a latex balloon in its inflated state.

[0026] Figure 3 A schematic diagram of a latex balloon in its uninflated state;

[0027] Figure 4 A three-dimensional schematic diagram of a latex balloon in its inflated state.

[0028] In the figure: balloon assembly (1), catheter assembly (2), first marker point (11), second marker point (12), latex balloon (13), third marker point (14), positioning part (131), compression part (132), catheter part (21), handle part (22). Detailed Implementation

[0029] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, not the entire structure.

[0030] In the description of this utility model, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0031] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0032] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0033] This embodiment provides a McBurney balloon dilation and compression catheter kit with positioning and protection functions. The balloon catheter kit includes a puncture needle assembly, a blunt needle, a balloon catheter, and a syringe.

[0034] Specifically, the puncture needle assembly includes a puncture sheath and a puncture needle core. The inner lumen of the puncture needle core can pass through the puncture sheath. The puncture needle core is used to deliver the puncture sheath. In this embodiment, the puncture sheath and puncture needle core are made of metal and are radiopaque. The puncture needle core is used for puncture, and the puncture sheath slides freely within the inner lumen of the puncture needle core. After puncture, the puncture needle core is withdrawn. The puncture sheath remains in the body after puncture, providing a pathway for the balloon catheter to enter the foramen ovale. A blunt-tipped needle can penetrate the puncture sheath. The distal end of the blunt-tipped needle has an arc-shaped blunt portion. The blunt-tipped needle is used to puncture the septum, opening a pathway for the balloon catheter. The balloon catheter can penetrate the puncture sheath. A syringe is connected to the proximal end of the balloon catheter, and the syringe outlet is connected to the balloon catheter for delivering fluid to the balloon catheter.

[0035] like Figure 1 As shown, the balloon catheter includes a balloon assembly (1) and a catheter assembly (2).

[0036] The outer wall of the distal end of the catheter assembly (2) is provided with an injection hole, the balloon assembly (1) is sleeved on the distal end of the catheter assembly (2), and the catheter assembly (2) is connected to the balloon assembly (1) through the injection hole.

[0037] like Figure 2 , 3As shown, the balloon assembly (1) includes a first marker point (11), a second marker point (12), a latex balloon (13), and a third marker point (14).

[0038] The latex balloon (13) is made of polymer material. The latex balloon (13) is a compliant balloon or a semi-compliant balloon. After the latex balloon (13) is inflated, it can fully compress the trigeminal ganglion. The two ends of the latex balloon (13) are connected to the outer wall of the catheter assembly (2) by bonding or welding, so that the latex balloon (13) is fixed to the outer wall of the catheter assembly (2).

[0039] like Figure 4 As shown, the latex balloon (13) consists of two parts. The distal part, when inflated, has a smaller outer diameter and serves as the positioning part (131). The proximal part, when inflated, has a larger outer diameter and serves as the compression part (132). A separating contraction section exists between the positioning part (131) and the compression part (132). The outer diameter of this separating contraction section is smaller than that of the positioning part (131) and the compression part (132) on either side. This separating contraction section forms two separate and independent structures for the positioning part (131) and the compression part (132).

[0040] The structure, thickness and / or material properties of the dividing shrinkage section are set to be different from those of the positioning part (131) and the compression part (132), such as the dividing shrinkage section having a thicker wall or its material having a harder elastic strength.

[0041] By utilizing the segmented contraction section, independent filling and expansion cavities with different diameters are formed in the positioning section (131) and the compression section (132), allowing each cavity to perform its own independent working characteristics.

[0042] In addition, the structure, thickness and / or material properties of the positioning part (131) and the pressing part (132) can also be distinguished from each other. The wall thickness of the positioning part (131) is greater than the wall thickness of the pressing part (132), or the elastic strength of the material of the positioning part (131) is greater than the elastic strength of the material of the pressing part (132).

[0043] The positioning section (131) is mainly used for positioning. The structure after filling it with a relatively hard structure, a large wall thickness, and / or the elastic strength of a relatively hard material needs to have a large structural strength to ensure reliable positioning. The compression section (132) is mainly used to apply pressure to the surrounding tissues. The structure after filling it with a relatively soft structure, a small wall thickness, and / or the elastic strength of a relatively soft material can better apply expansion pressure to the surrounding tissues.

[0044] When the latex balloon (13) is inflated, a step is generated at the junction of the septal contraction segment because the outer diameters of the positioning part (131) and the compression part (132) are different. This step fixes the latex balloon (13) in the middle cranial fossa, avoiding excessive compression of the posterior cranial fossa by the balloon during the operation.

[0045] The ratio of the positioning part (131) to the compression part (132) in the latex balloon (13) is 3:7 or 1:1.

[0046] The latex balloon (13) has a positioning display function. The first marker point (11) is at the front end of the latex balloon (13), the second marker point (12) is at the junction of the positioning part (131) and the compression part (132) of the latex balloon (13) when it is filled to a normal size (0.5~0.7mL of liquid), that is, the septal contraction segment; and the third marker point (14) is at the rear end of the latex balloon. Using the first marker point (11), the second marker point (12), and the third marker point (14) under imaging equipment, the position of the latex balloon (13) and the position of the junction of the positioning part (131) and the compression part (132), that is, the septal contraction segment, can be observed.

[0047] The first marker point (11) is circular or elliptical. The first marker point (11) is a composite material of imaging material and polymer material. The outer diameter of the first marker point (11) is larger than the outer diameter of the catheter assembly (2), so that the balloon assembly (1) is not easily punctured when passing through the foramen ovale. The surface of the first marker point (11) is smooth and the material is soft. When the catheter assembly (2) is delivered, the trigeminal hilum has a restraining effect on the tip of the catheter, so that the first marker point (11) is pressed down and the head end is facing the posterior cranial fossa. When the catheter assembly (2) is delivered to the vicinity of McBurney's capsule of the trigeminal nerve, it will not puncture the dura mater, making it easier for the balloon assembly (1) to enter McBurney's capsule.

[0048] The specific location of the balloon assembly (1) in the human body can be determined by the third marker point (14) at the rear end and the first marker point (11) at the front end. The second marker point (12) at the diaphragm segment will be more helpful for doctors to correctly determine whether the balloon catheter is accurately positioned.

[0049] The material separating the shrinkage section can be a composite material formed of developing material and polymer material, so that the separating shrinkage section can be used as a second mark point (12) for developing positioning application.

[0050] The second mark point (12) can also be formed at the distal end of the catheter assembly (2), and its position corresponds to the junction of the positioning part (131) and the compression part (132) of the latex balloon (13), and is also a composite material of imaging material and polymer material.

[0051] The catheter assembly (2) includes a catheter portion (21) and a handle portion (22).

[0052] During the procedure, a puncture needle assembly is used to puncture and deliver the puncture sheath to the first preset position. In this embodiment, the first preset position is near the foramen ovale. The puncture needle core is then withdrawn. Then, a blunt needle is passed through the puncture sheath, with the distal end of the blunt needle extending 10-15 mm beyond the opening of the puncture sheath. The blunt needle punctures the barrier membrane and is then withdrawn.

[0053] Pass the balloon catheter through the puncture sheath.

[0054] 1. Entry: Insert the balloon catheter into McBurney's capsule through the already patent puncture sheath. Using imaging equipment, when the first marker point passes through the puncture sheath, slowly and gently continue advancing the balloon catheter. When the second marker point passes through the puncture sheath, compare it with the preoperative 3D model and place the second marker point at the junction of the middle and posterior cranial fossae. At this point, observe whether the third marker point passes through the puncture sheath. If it does not pass, withdraw the puncture sheath until the third marker point appears.

[0055] 2. Inflation: Connect the syringe to the handle of the balloon catheter and slowly inject contrast agent into the balloon by pushing the syringe plunger. Observe the shape of the balloon at the same time. Stop inflating when the balloon becomes a double-spherical shape.

[0056] 3. Compression: Keep the balloon double-spherical and apply pressure for 1-3 minutes, depending on the patient's condition.

[0057] 4. Withdrawal: After the surgical procedure is completed, drain the fluid from the balloon and slowly withdraw the balloon catheter and puncture needle sheath in sequence.

[0058] This embodiment, by forming different functional zones in the latex balloon and setting a second marker point for precise positioning, achieves two advantages. First, the second marker point can accurately control the delivery depth of the balloon catheter and position the different functional zones, improving the success rate of the surgery. Second, the positioning part of the latex balloon can prevent the balloon catheter from moving towards the posterior fossa and damaging the dura mater when the balloon is inflated. This eliminates the need for the doctor to pull the balloon catheter backward during balloon inflation, simplifying the operation, improving the stability of the balloon catheter during operation, and further increasing the success rate of the surgery.

[0059] This embodiment also provides an operating method applied to the above-mentioned balloon catheter kit, including the following steps:

[0060] S1. Use the puncture needle assembly to puncture and deliver the puncture sheath to the first preset position, then withdraw the puncture needle core and leave the puncture sheath in the body; wherein, the first preset position is near the foramen ovale.

[0061] S2. Pass the blunt-tipped needle through the puncture sheath, adjust the position of the blunt-tipped needle so that the distal end of the blunt-tipped needle extends 10-15mm beyond the puncture sheath, the blunt-tipped needle punctures the septum and opens a passage for the balloon catheter, and then withdraw the blunt-tipped needle.

[0062] S3. Insert the balloon catheter into McBurney's capsule through the already patent needle sheath. Using imaging equipment, when the first marker point passes through the needle sheath, slowly and gently continue advancing the balloon catheter. When the second marker point passes through the needle sheath, compare it with the preoperative 3D model and place the second marker point at the junction of the middle and posterior cranial fossae. At this point, observe whether the third marker point passes through the needle sheath. If it does not pass, withdraw the needle sheath until the third marker point appears.

[0063] S4. Use a syringe to deliver fluid into the balloon catheter to inflate the balloon.

[0064] S5. When the pressure inside the balloon reaches the preset pressure, and the balloon body forms a preset double-sphere shape within the trigeminal ganglion, the syringe stops inflating. After compressing the trigeminal ganglion for a preset time, the fluid in the balloon catheter is emptied, and the balloon catheter and puncture sheath are withdrawn sequentially. In this embodiment, the preset time is 1-5 minutes.

[0065] This technique improves the success rate of trigeminal nerve balloon compression surgery and reduces the difficulty of the procedure.

[0066] Finally, it should be noted that the above description is merely an explanation of this utility model and is not intended to limit it. Although this utility model has been described in detail, those skilled in the art can still modify the foregoing technical solutions or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A balloon catheter with positioning and protection functions for percutaneous microballoon compression therapy of trigeminal neuralgia, characterized in that, It includes a balloon assembly (1) and a catheter assembly (2); the distal end of the catheter assembly (2) is provided with an injection port, the balloon assembly (1) is sleeved on the distal end of the catheter assembly (2), and the catheter assembly (2) is connected to the balloon assembly (1) through the injection port; The balloon assembly (1) includes a first marker point (11), a second marker point (12), a latex balloon (13), and a third marker point (14); The latex balloon (13) consists of two parts: the distal part has a smaller outer diameter after inflation and serves as the positioning part (131), and the proximal part has a larger outer diameter after inflation and serves as the compression part (132). The second marker point (12) is located at the junction of the positioning portion (131) and the compression portion (132) of the latex balloon (13) when it is inflated to normal size.

2. The balloon catheter with positioning and protection functions according to claim 1, characterized in that, The first marker point (11) is at the front end of the latex balloon (13), and the third marker point (14) is at the rear end of the latex balloon. The first marker point (11), the second marker point (12), and the third marker point (14) can be observed under imaging equipment.

3. The balloon catheter with positioning and protection functions according to claim 1, characterized in that, The catheter assembly (2) includes a catheter portion (21) and a handle portion (22).

4. The balloon catheter with positioning and protection functions according to claim 1, characterized in that, The ratio of the positioning part (131) to the compression part (132) in the latex balloon (13) is 3:7 or 1:

1.

5. The balloon catheter with positioning and protection functions according to claim 1, characterized in that, The latex balloon (13) is made of polymer material. The latex balloon (13) is a compliant balloon or a semi-compliant balloon. When the latex balloon (13) is inflated, it can fully compress the trigeminal ganglion.

6. The balloon catheter with positioning and protection functions according to claim 1, characterized in that, The latex balloon (13) consists of two parts with the constricted part as the boundary. Its distal part has a smaller outer diameter after being inflated, which serves as the positioning part (131). Its proximal portion has a large outer diameter after being filled, serving as a compression portion (132); there is a separating contraction section between the positioning portion (131) and the compression portion (132), and the outer diameter of the separating contraction section is smaller than that of the positioning portion (131) and the compression portion (132) on both sides.

7. The balloon catheter with positioning and protection functions according to claim 6, characterized in that, The structure, thickness and / or material properties of the dividing contraction section are different from those of the positioning section (131) and the compression section (132), forming independent filling expansion cavities with different diameters in the positioning section (131) and the compression section (132).

8. The balloon catheter having a positioning and protection function according to claim 6, wherein, The positioning part (131) and the pressing part (132) are different in structure, thickness and / or material properties.

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