Percutaneous balloon device for compression of the semilunar ganglion and the third branch of the trigeminal nerve

Abstract

The present invention discloses a percutaneous puncture balloon device for compressing both the semilunar ganglion and the third ramus of the trigeminal nerve. The device comprises a catheter, wherein an inner balloon is provided on the outer wall of the catheter near the operating end, and an outer balloon is provided over the inner balloon. The catheter comprises a hollow tubular body, which is divided into an upper cavity and a lower cavity by a partition plate. The sidewall of the upper cavity is provided with an inner vent connected to the inner balloon, and the sidewall of the lower cavity is provided with an outer vent connected to the outer balloon. A rotary cavity switching mechanism is provided at the end of the partition plate away from the balloon for switching between the upper and lower cavities. The inner balloon comprises a balloon body, and an elastic binding membrane layer is provided in the middle of the balloon body. The present invention is characterized by being able to effectively improve the therapeutic effect of patients with pain in the ramus III region.

Description

Technical Field

[0001] The present invention relates to a percutaneous puncture balloon device, in particular to a percutaneous puncture balloon device capable of compressing the semilunar ganglion and the third branch of the trigeminal nerve. Background Art

[0002] Trigeminal neuralgia is a functional neurosurgical condition and a type of neuropathic pain with an incidence of approximately 182 per 100,000 people. It primarily occurs in adults and the elderly, with a wide age range, peaking between 48 and 59 years old. Due to its intense pain, it has been dubbed "the world's worst pain." Its primary clinical manifestations are intense, unbearable, and discharging-like pain within the sensory root area of the trigeminal nerve. The pathological mechanism of trigeminal neuralgia remains controversial, with most scholars believing it may be related to demyelinating lesions within the trigeminal nerve root. The pain associated with trigeminal neuralgia can involve one or more of its branches, with the sensory areas of branches II and III being the most common.

[0003] Microvascular decompression (MVD) is currently the preferred surgical option for patients with trigeminal neuralgia. However, because the procedure requires a craniotomy, it is highly invasive and requires a higher level of patient health. Compared with minimally invasive treatments, it carries a higher incidence and variety of surgical risks. Serious complications, such as damage to posterior cranial nerves, intracranial hemorrhage, cerebral infarction, and brain contusion, can have serious consequences. Therefore, for patients with trigeminal neuralgia who are not suitable for MVD for various reasons, percutaneous microballoon compression (PBC) is generally recommended.

[0004] PBC was first proposed by Mullan and Lichtor in 1983. It is a good choice for patients with trigeminal neuralgia who are unwilling or unable to tolerate craniotomy because of its simple operation, short operation time, high immediate efficiency, high repeatability, less pain for patients and high safety. This percutaneous microballoon compression technology requires the use of a special percutaneous balloon compression device. Whether the balloon shape during PBC surgery can achieve a satisfactory "pear shape" is directly related to the surgical effect. The more ideal the balloon shape, the more significant the postoperative effect. The balloon compression devices currently used in common use on the market can basically meet the requirements of forming an ideal "pear shape" in Meckel's cavity, achieving compression of the trigeminal ganglion, thereby physically destroying the trigeminal ganglion and achieving the surgical effect.

[0005] However, combined with long-term efficacy statistics, medical staff found that the existing percutaneous puncture balloon compression device has significant efficacy in patients with pain in the I and II branches by compressing the semilunar ganglion, but the efficacy is relatively unsatisfactory for patients with pain in the III branch alone, and there are problems such as a relatively increased area of numbness after surgery and a relatively high incidence of facial paresthesia. When treating pain in branches I and II, its immediate efficacy can reach 95%, but when treating patients with pain in the third branch alone, its immediate efficacy after surgery is about 83%, and there is a certain gap between the two. Patients with pain in the third branch alone account for a relatively high proportion of the total trigeminal neuralgia patient population, and the third branch of the trigeminal nerve is fixedly passed through the bony structure of the foramen ovale. Therefore, if the balloon device can effectively compress the third branch of the trigeminal nerve in the bony canal of the foramen ovale, then the surgical efficacy of patients with pain in the third branch will be significantly improved and guaranteed, and the compression will be more targeted.

[0006] However, the balloon compression devices currently on the market are basically uniformly inflated elliptical balloons, which can play a good compressive role on the trigeminal ganglion in soft tissue cavities such as Meckel's cave, and can present a good "pear shape". However, when simply compressing the third branch of the trigeminal nerve, the ideal balloon shape should be a "sausage-shaped" or "dog bone-shaped" shape. Since the third branch passes through the bony canal of the foramen ovale, when the conventional balloon is expanded, there are no rivet points at both ends. It is easy for the balloon to slip out of the bony canal or only partially remain in the canal due to the pressure difference, making it difficult to achieve the ideal purpose of compressing the third branch in the canal. This also makes the effect of targeted compression of the third branch worse than that of compression of the semilunar ganglion. This is also a shortcoming of conventional balloon devices when dealing with the third branch in the foramen ovale of the trigeminal nerve. Therefore, the existing conventional balloon devices have poor therapeutic effects on patients with pain in the III branch area. Summary of the Invention

[0007] The purpose of the present invention is to provide a percutaneous puncture balloon device that can compress both the semilunar ganglion and the third ramus of the trigeminal nerve. The present invention has the characteristic of being able to effectively improve the efficacy of patients with pain in the ramus III region.

[0008] The technical solution of the present invention is a percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, including a catheter, an inner balloon is provided on the outer wall of the catheter near the operating end, and an outer balloon is provided on the outer cover of the inner balloon; the catheter includes a hollow tube body, which is divided into an upper cavity and a lower cavity by a partition plate, the side wall of the upper cavity is provided with an internal vent connected to the inner balloon, and the side wall of the lower cavity is provided with an external vent connected to the outer balloon; the partition plate is provided with a rotary cavity switching mechanism at the end away from the balloon for switching between the upper cavity and the lower cavity; the inner balloon includes a balloon body, and an elastic binding membrane layer is provided in the middle of the balloon body.

[0009] In the aforementioned percutaneous puncture balloon device that takes into account the compression of the semilunar ganglion and the third branch of the trigeminal nerve, the length of the elastic binding membrane layer is two-thirds of the entire length of the inner balloon layer.

[0010] In the aforementioned percutaneous puncture balloon device that takes into account the compression of the semilunar ganglion and the third branch of the trigeminal nerve, the upper cavity is further connected to an upper exhaust pipe and an upper exhaust valve at a position away from the operating end.

[0011] In the aforementioned percutaneous puncture balloon device that takes into account the compression of the semilunar ganglion and the third branch of the trigeminal nerve, the lower cavity is connected to a lower exhaust pipe and a lower exhaust valve at a position away from the operating end.

[0012] In the aforementioned percutaneous puncture balloon device for compressing the semilunar ganglion and the third branch of the trigeminal nerve, the other end of the catheter is provided with an interface tube for connecting to an air tube or a contrast agent delivery tube, and a pressure gauge is provided on the interface tube.

[0013] In the aforementioned percutaneous puncture balloon device for compressing the semilunar ganglion and the third branch of the trigeminal nerve, the catheter is further provided with metal positioning marking lines at both ends of the outer balloon.

[0014] In the aforementioned percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, the rotary cavity switching mechanism includes a rotating shaft located in the middle of the tail end of the partition plate, the rotating shaft is connected to a semicircular sealing plate, and the outer circular end surface of the semicircular sealing plate is embedded with a magnetic sheet; the inner wall surface of the tube body is provided with a matching sealing step groove, and the outer wall surface of the tube body is provided with an annular slide corresponding to the position of the semicircular sealing plate, a sliding block is provided on the annular slide, the bottom of the sliding block is provided with an external driving magnet that matches the semicircular sealing plate, and the top of the sliding block is provided with a driving ring.

[0015] Compared with the prior art, the present invention mainly consists of a catheter with a double-lumen structure and an inner balloon and an outer balloon arranged on the outer wall of the catheter. The outer balloon can well complete the "pear shape" in Meckel's cavity, thereby ideally compressing the trigeminal ganglion; when compressing the third branch of the foramen ovale, the inner balloon can present an ideal "dog bone shape" when compressing the third branch of the foramen ovale, so that the inner balloon is stably located in the bony canal of the foramen ovale and will not shift inward or outward due to local pressure difference, thereby achieving the purpose of good targeted compression of the third branch of the trigeminal nerve. The present application can take into account both the ideal "pear shape" when compressing the trigeminal ganglion and the ideal "dog bone shape" when compressing the third branch of the foramen ovale, so that when the operator performs percutaneous balloon puncture, one balloon can simultaneously and specifically achieve the purpose of two balloon moldings. While ensuring the efficacy of patients with pain in the trigeminal nerve branches I and II, it significantly improves the pain relief rate of patients with pain in the third branch, which significantly benefits such patients. It also avoids the need for the operator to replace different balloons during surgery to achieve the purpose of different balloon shapes (and there are currently no specialized balloon devices on the market for compression molding of the third branch). In summary, the present invention can achieve the purpose of two balloon moldings simultaneously and specifically with one balloon. While ensuring the efficacy of patients with pain in the trigeminal nerve branches I and II, it significantly improves the pain relief rate of patients with pain in the third branch (i.e., it improves the treatment effect of patients with pain in the third branch).

[0016] In addition, by setting up a pressure gauge, the present application can effectively avoid the difference in therapeutic effect caused by local anatomical differences among different populations, so that when performing balloon compression on bony canals or Meckel's cavities of different sizes, the ideal compression force can be achieved while achieving the ideal balloon shape, thereby ensuring good surgical efficacy. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a structural schematic diagram of the present invention;

[0018] Figure 2 is a cross-sectional view of the present invention;

[0019] Figure 3 yes Figure 2 A partial enlarged view of .

[0020] The marks in the accompanying drawings are: 1-catheter, 2-inner balloon, 3-outer balloon, 101-tube body, 102-upper cavity, 103-lower cavity, 104-inner vent, 105-external vent, 4-partition plate, 5-rotary cavity switching mechanism, 201-balloon body, 202-elastic binding membrane layer, 121-upper exhaust pipe, 122-upper exhaust valve, 131-lower exhaust pipe, 132-lower exhaust valve, 6-interface tube, 7-pressure gauge, 8-metal positioning mark line, 501-rotating shaft, 502-semicircular sealing plate, 503-magnetic sheet, 504-sealing step groove, 505-annular slide, 506-sliding block, 507-external driving magnet, 508-driving ring. DETAILED DESCRIPTION

[0021] The present invention will be further described below with reference to the accompanying drawings and examples, but they are not intended to limit the present invention.

[0022] Example 1. A percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve is constructed as follows Figure 1 and 2 As shown, it includes a catheter 1, the outer wall of the catheter 1 near the operating end is provided with an inner balloon 2, and the inner balloon 2 is covered with an outer balloon 3; the catheter 1 includes a hollow tube body 101, and the tube body 101 is divided into an upper cavity 102 and a lower cavity 103 by a partition plate 4, the side wall of the upper cavity 102 is provided with an internal air vent 104 connected to the inner balloon 2, and the side wall of the lower cavity 103 is provided with an external air vent 105 connected to the outer balloon 3; the partition plate 4 is provided with a rotary cavity switching mechanism 5 away from the balloon end for switching between the upper cavity and the lower cavity; the inner balloon 2 includes a balloon body 201, and an elastic binding membrane layer 202 is provided in the middle of the balloon body 201.

[0023] The length of the elastic binding membrane layer 202 is two-thirds of the entire length of the inner balloon 2 .

[0024] The upper cavity 102 is further connected to an upper exhaust pipe 121 and an upper exhaust valve 122 at a position away from the operating end.

[0025] The lower cavity 103 is connected to a lower exhaust pipe 131 and a lower exhaust valve 132 at a position away from the operating end.

[0026] The other end of the catheter 1 is provided with an interface tube 6 for connecting to an air delivery tube or a contrast agent delivery tube, and a pressure gauge 7 is provided at the interface tube 6 .

[0027] The catheter 1 is also provided with metal positioning marking lines 8 at both ends of the outer balloon 3 .

[0028] Preferably, the exhaust valve includes a valve body having an inner cavity provided with a tapered opening, a valve cap provided on the top of the valve body, and an external support structure provided within the valve cap. When the valve cap is pulled outward, the tapered opening within the inner cavity is closed. When the valve cap is pressed downward, the tapered opening is propped open by the external support structure, allowing gas and contrast agent to escape from a hollow channel within the valve cap.

[0029] Preferably, the elastic binding membrane is adhered to the outer wall of the balloon body.

[0030] The inner balloon is connected to the inner vent, creating a "dogbone" shape. The outer balloon is connected to the outer vent, creating a "pear-shaped" balloon. Two-thirds of the inner balloon's length is covered by an elastic binding membrane. When the inner balloon is inflated, it expands significantly at the ends, while expansion in the middle is somewhat limited. This results in a larger inner balloon at the ends and smaller in the middle, ideally anchored to the foramen ovale. At this point, the outer balloon, in close contact with the inner balloon, maintains the same shape. When the outer balloon is inflated, it is unaffected by the inner balloon's binding membrane, remaining firmly attached to the catheter wall, allowing it to assume the ideal "pear" shape within the Meckel's cavity.

[0031] The rotating cavity switching mechanism has two adjustable positions. When in one position, one side is fully open and the other side is fully closed, allowing the two balloons to be switched freely.

[0032] The metal positioning markers on both sides of the outer balloon are used to determine the position of the balloon at the skull base under X-ray.

[0033] The pressure gauge can accurately provide the real-time pressure of the balloon during compression and determine whether the balloon compression pressure reaches the expected value.

[0034] The usage process of this application is as follows: connect the interface of the catheter to the corresponding gas supply tube, and then select the corresponding balloon and chamber through the rotary cavity switching mechanism according to actual usage needs (when compressing the third branch of the foramen ovale, switch to the upper chamber, so that the gas is input into the upper chamber and eventually enters the inner balloon, forming a "dog bone"; when compressing the trigeminal ganglion, switch to the lower chamber, and the gas is input into the lower chamber and eventually enters the outer balloon, forming a "pear-shaped" balloon). At the same time, during the gas supply process, by setting a pressure gauge, it is possible to effectively avoid the difference in therapeutic effect caused by local anatomical differences in different populations, so that when bony ducts or Meckel's cavities of different sizes are compressed by the balloon, the ideal compression force can be achieved while achieving the ideal balloon shape, ensuring good surgical efficacy. When the treatment is completed, deflation is achieved by pressing down the valve cap.

[0035] Example 2. The difference between this example and Example 1 is that the specific structure of the rotary cavity switching mechanism is as follows: Figure 3As shown, the rotary cavity switching mechanism 5 includes a rotating shaft 501 located in the middle of the tail end of the partition plate 4, the rotating shaft 501 is connected to a semicircular sealing plate 502, and the outer circular end surface of the semicircular sealing plate 502 is embedded with a magnetic sheet 503; the inner wall surface of the tube body 101 is provided with a matching sealing step groove 504, and the outer wall surface of the tube body 101 is provided with an annular slide 505 corresponding to the position of the sealing step groove 504, and a sliding block 506 is provided on the annular slide 505, and the bottom of the sliding block 506 is provided with an external driving magnet 507 that matches the semicircular sealing plate 502, and the top of the sliding block 506 is provided with a driving ring 508.

[0036] The bottom surface of the sealing step groove is provided with a set of limiting grooves, and the outer end surface of the semicircular sealing plate is provided with a set of grooves, in which springs and positioning balls are arranged. By providing the springs and balls, in conjunction with the limiting grooves, the semicircular sealing plate can be positioned to prevent accidental movement.

[0037] A rotation marking line is provided on the surface of the annular slide to indicate the switching position.

[0038] The rotary cavity switching mechanism operates as follows: The sliding block moves along the annular carriage. During this movement, an external drive magnet engages with the magnetic sheet on the semicircular sealing plate, driving the semicircular sealing plate to rotate around the axis of rotation. After a 180-degree rotation, the upper and lower chambers are switched. This rotary cavity switching mechanism features a simple structure and easy operation.

[0039] Example 3. This example differs from Example 1 in that a rotary cavity switching mechanism is provided between the tube body and the interface tube, the rotary cavity switching mechanism comprising an inner fixing seat fixed to the rear end of the tube body and an outer fixing seat fixed to the front end of the interface tube, a rotary sealing ring is provided between the inner fixing seat and the outer fixing seat, and a semicircular sealing plate is provided inside the rotary sealing ring.

[0040] The side walls of the inner fixing seat and the outer fixing seat are both provided with anti-slip convex rings with L-shaped cross sections.

[0041] The inner wall surface of the rotary sealing ring is provided with a rotating groove corresponding to the anti-slip convex ring, and the outer end surface of the rotary sealing ring is also provided with a group of annularly distributed grooves, in which springs and positioning balls are arranged; the side end surfaces of the inner fixed seat and the outer fixed seat are provided with corresponding positioning grooves.

[0042] The rotary sealing ring is composed of two upper and lower half sealing rings. A semicircular sealing plate is fixed to the middle position of the inner wall of one of the half sealing rings, and a rotating pin is provided between the semicircular sealing plate and the partition plate.

[0043] The switching process of the rotary cavity switching mechanism is as follows: rotating the rotary sealing ring drives the semicircular sealing plate to rotate 180 degrees to realize the switching of the upper and lower cavities; during the rotation of the rotary sealing ring, the positioning ball and the spring cooperate with each other, and when encountering the positioning groove, it pops out to achieve positioning and limiting, and retracts when leaving the positioning groove to facilitate rotation.

[0044] The rotary cavity switching mechanism has the advantages of simple structure, quick and easy installation and convenient operation.

Claims

1. A percutaneous balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve, characterized by: The invention comprises a catheter (1), wherein the outer side wall of the catheter (1) close to the operating end is provided with an inner balloon (2), and the inner balloon (2) is covered with an outer balloon (3); the catheter (1) comprises a hollow tube body (101), the tube body (101) is divided into an upper cavity (102) and a lower cavity (103) by a partition plate (4), the side wall of the upper cavity (102) is provided with an inner vent (104) connected to the inner balloon (2), and the side wall of the lower cavity (103) is provided with an outer vent (105) connected to the outer balloon (3); the partition plate (4) is provided with a rotary cavity switching mechanism (5) away from the balloon end for switching between the upper cavity and the lower cavity; the inner balloon (2) comprises a balloon body (201), and an elastic binding membrane layer (202) is provided in the middle of the balloon body (201).

2. The percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve according to claim 1, characterized in that: The length of the elastic binding membrane layer (202) is two-thirds of the overall length of the inner balloon (2).

3. The percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve according to claim 1, characterized in that: The upper cavity (102) is further connected to an upper exhaust pipe (121) and an upper exhaust valve (122) at a position away from the operating end.

4. The percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve according to claim 1, characterized in that: The lower cavity (103) is connected to a lower exhaust pipe (131) and a lower exhaust valve (132) at a position away from the operating end.

5. The percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve according to claim 1, characterized in that: The other end of the catheter (1) is provided with an interface tube (6) for connecting to an air delivery tube or a contrast agent delivery tube, and a pressure gauge (7) is provided on the interface tube (6).

6. The percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve according to claim 1, characterized in that: The catheter (1) is also provided with metal positioning marking lines (8) located at both ends of the outer balloon (3).

7. The percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve according to claim 1, characterized in that: The rotary cavity switching mechanism (5) comprises a rotating shaft (501) located in the middle of the tail end of the partition plate (4), the rotating shaft (501) being connected to a semicircular sealing plate (502), and a magnetic sheet (503) being embedded in the outer circular end surface of the semicircular sealing plate (502); the inner wall surface of the tube body (101) being provided with a matching sealing step groove (504), the outer wall surface of the tube body (101) being provided with an annular slide (505) corresponding to the position of the sealing step groove 504, a sliding block (506) being provided on the annular slide (505), an external driving magnet (507) matching the semicircular sealing plate (502) being provided at the bottom of the sliding block (506), and a driving ring (508) being provided at the top of the sliding block (506).

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