Percutaneous puncture balloon device giving consideration to trigeminal nerve meniscus and third branch compression

Abstract

The percutaneous puncture balloon device comprises a catheter, the outer side wall, close to the operation end, of the catheter is provided with an inner-layer balloon, and the inner-layer balloon is sleeved with an outer-layer balloon; the catheter comprises a catheter body of a hollow structure, the interior of the catheter body is divided into an upper cavity and a lower cavity through a partition plate, the side wall face of the upper cavity is provided with an inner ventilation opening communicated with the inner-layer balloon, and the side wall face of the lower cavity is provided with an outer ventilation opening communicated with the outer-layer balloon. A rotary cavity switching mechanism is arranged at the end, away from the balloon, of the partition plate and used for switching between the upper cavity and the lower cavity. The inner-layer balloon comprises a balloon body, and an elastic binding film layer is arranged in the middle of the balloon body. The traditional Chinese medicine composition has the characteristic of effectively improving the curative effect of a patient suffering from pain in the third branch area.

Description

Technical Field

[0001] The invention relates to a percutaneous puncture balloon device, in particular to a percutaneous puncture balloon device which can compress both the semilunar ganglion and the third branch of the trigeminal nerve. Background Art

[0002] Trigeminal neuralgia is a functional neurosurgical disease and a type of neuropathic pain with an incidence of about 182 people per 100,000. It mostly occurs in adults and the elderly, with a wide age range and a peak age of 48 to 59 years old. Because of its severe pain, it is called "the world's number one pain." Its main clinical manifestations are discharge-like and needle-like pain in the area controlled by the trigeminal nerve sensory root. The pain is severe and unbearable. The pathological mechanism of trigeminal neuralgia is still controversial. Most scholars believe that it may be related to demyelinating lesions in the root of the trigeminal nerve. The pain area of ​​trigeminal neuralgia may involve one or more of its branches, and is often seen in the sensory areas of branches II and III.

[0003] Microvascular decompression (MVD) is currently the first choice for patients with trigeminal neuralgia, but because the surgery requires craniotomy, it is very traumatic and requires a high level of basic physical condition for the patient. Compared with minimally invasive treatment, the types and incidence of corresponding surgical risks are also increased. More serious complications such as damage to the posterior cranial nerve function, intracranial hemorrhage, cerebral infarction, and cerebral contusion may lead to serious consequences. Therefore, for some patients with trigeminal neuralgia who are not suitable for microvascular decompression 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 shape of the balloon during PBC 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 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 for patients with pain in the I and II branches by compressing the semilunar ganglion, but the efficacy for patients with pain in the III branch alone is relatively unsatisfactory, 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 expanded elliptical balloons, which can play a good compressive role on the trigeminal ganglion in soft tissue cavities such as Meckel's cavity, 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" or "dog bone" type. 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 ganglion compression. 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 takes into account the compression of the trigeminal ganglion and the third branch. The present invention has the characteristic of being able to effectively improve the efficacy of patients with pain in the area of ​​the third branch.

[0008] The technical solution of the present invention is as follows: a percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, comprising a catheter, wherein an inner balloon is provided on the outer wall of the catheter close to the operating end, and an outer balloon is provided on the outer sleeve of the inner balloon; the catheter comprises a hollow tube body, the tube body 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 inner vent connected to the inner balloon, and the side wall of the lower cavity is provided with an outer vent connected to the outer balloon; a rotary cavity switching mechanism is provided at the partition plate away from the balloon end for switching between the upper cavity and the lower cavity; the inner balloon comprises 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 trigeminal ganglion and the third branch, the length of the elastic binding membrane layer is two-thirds of the overall length of the inner balloon.

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

[0011] In the aforementioned percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, 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 trigeminal ganglion and the third branch, the other end of the catheter is provided with an interface tube for connecting 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 both the semilunar ganglion and the third branch of the trigeminal nerve, the catheter is also 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 a magnetic sheet is embedded on the outer circular end surface of the semicircular sealing plate; a matching sealing step groove is provided on the inner wall surface of the tube body, and an annular slide corresponding to the position of the semicircular sealing plate is provided on the outer wall surface of the tube body, a sliding block is provided on the annular slide, an external driving magnet matching the semicircular sealing plate is provided at the bottom of the sliding block, and a driving ring is provided on the top of the sliding block.

[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 inwards or outwards due to local pressure differences, 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 trigeminal nerve branches I and II, the pain relief rate of patients with pain in the third branch is significantly improved, which significantly benefits such patients, and also avoids the need for the operator to replace different balloons during surgery to achieve the purpose of different balloon shapes (and there is currently no special balloon device 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 achieve one balloon, while ensuring the efficacy of patients with pain in trigeminal nerve branches I and II, the pain relief rate of patients with pain in the third branch is significantly improved (that is, the treatment effect of patients with pain in the third branch is improved).

[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 balloon compression is performed 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 schematic diagram of the structure 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-outer 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 pipe, 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 is further described below in conjunction with the accompanying drawings and embodiments, 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, comprising: Figure 1 and 2 As shown, it includes a catheter 1, the outer 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 includes 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 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 also 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 with a lower exhaust pipe 131 and a lower exhaust valve 132 at a position away from the operation 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 located at both ends of the outer balloon 3 .

[0028] Preferably, the exhaust valve comprises a valve body, the inner cavity of the valve body is provided with a conical opening, the top of the valve body is provided with a valve cap, and the valve cap is provided with an external support structure. When the valve cap is pulled outward, the conical opening in the inner cavity is closed, and when the valve cap is pressed down, the conical opening is opened by the external support structure, and the gas and contrast agent can be discharged from the hollow pipe of the valve cap.

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

[0030] The inner balloon is connected to the inner vent, and the inner balloon plays the role of forming a "dog bone" shape; the outer balloon is connected to the outer vent, and serves the purpose of a "pear-shaped" balloon. There is an elastic binding membrane of two-thirds of the length outside the inner balloon. When the inner balloon is expanded, the two ends expand significantly, and the expansion in the middle is limited to a certain extent, making the inner balloon large at both ends and small in the middle, and ideally riveted to the oval foramen. At this time, the outer balloon is in close contact with the inner balloon and has the same shape as the inner balloon. When the outer balloon is expanded, it is not affected by the inner balloon binding membrane, and the inner balloon is in close contact with the catheter wall, so the outer balloon can present an ideal "pear shape" in the Meckel's cavity.

[0031] The rotating cavity switching mechanism has 2 adjustable positions. When it is in one of the positions, one side is completely open and the other side is completely closed, so that the two balloons can 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 use process of this application is as follows: connect the interface of the catheter to the corresponding gas delivery tube, and then select the corresponding balloon and chamber through the rotary cavity switching mechanism according to the actual use needs (when compressing the third branch of the oval foramen, switch to the upper chamber, so that the gas is input into the upper chamber and finally enters the inner balloon to form a "dog bone"; when compressing the trigeminal ganglion, switch to the lower chamber, the gas is input into the lower chamber and finally enters the outer balloon to form a "pear-shaped" balloon). At the same time, during the gas delivery process, by setting a pressure gauge, the difference in efficacy caused by local anatomical differences in different populations can be avoided very well, so that when performing balloon compression on bony ducts or Meckel's cavities of different sizes, 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] Embodiment 2. The difference between this embodiment and embodiment 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 rear end of the partition plate 4, the rotating shaft 501 is connected to a semicircular sealing plate 502, and a magnetic sheet 503 is embedded on the outer circular end surface of the semicircular sealing plate 502; 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 annular sealing groove 504, and a sliding block 506 is provided on the annular slide 505, and an external driving magnet 507 matching the semicircular sealing plate 502 is provided at the bottom of the sliding block 506, and a driving ring 508 is provided on the top of the sliding block 506.

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

[0037] The surface of the annular slide is provided with a rotation mark line to indicate the switching position.

[0038] The use process of the rotary cavity switching mechanism is as follows: move the sliding block to make the moving block move along the annular slide. During the movement, the outer driving magnet cooperates with the magnetic sheet on the semicircular sealing plate to drive the semicircular sealing plate to rotate around the rotation axis. After rotating 180 degrees, the upper and lower cavities are switched. The rotary cavity switching mechanism has a simple structure and is easy to operate.

[0039] Embodiment 3. The difference between this embodiment and embodiment 1 is that a rotary cavity switching mechanism is provided between the tube body and the interface tube, the rotary cavity switching mechanism comprises an inner fixing seat fixed to the rear end of the tube body and an outer fixing seat fixed to the head 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-dropping 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 spliced ​​together. A semicircular sealing plate is fixed to the middle position of the inner wall surface of one of the semicircular sealing rings, and a rotating pin is arranged 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 to drive the semicircular sealing plate to rotate 180 degrees to achieve 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 when leaving the positioning groove, it shrinks to facilitate rotation.

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

Claims

1. A percutaneous puncture balloon device for compressing both the semilunar ganglion and the third branch of the trigeminal nerve, characterized in that: The invention comprises a catheter (1), wherein an inner balloon (2) is provided on the outer side wall of the catheter (1) close to the operating end, and an outer balloon (3) is provided on the outer cover of the inner balloon (2); the catheter (1) comprises a hollow tube body (101), wherein the tube body (101) is divided into an upper cavity (102) and a lower cavity (103) by a partition plate (4), wherein the side wall surface of the upper cavity (102) is provided with an inner vent (104) connected to the inner balloon (2), and the side wall surface of the lower cavity (103) is provided with an outer vent (105) connected to the outer balloon (3); a rotary cavity switching mechanism (5) is provided at a position away from the balloon end of the partition plate (4) 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 layer 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 also connected to an upper exhaust pipe (121) and an upper exhaust valve (122) at a location 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 location 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 rear 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) is provided with a matching sealing step groove (504), the outer wall surface of the tube body (101) is provided with an annular slide (505) corresponding to the position of the semicircular sealing plate (502), a sliding block (506) is provided on the annular slide (505), an external driving magnet (507) matching the semicircular sealing plate (502) is provided at the bottom of the sliding block (506), and a driving ring (508) is provided at the top of the sliding block (506).

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