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 present invention relates to a percutaneous puncture balloon device, in particular to a percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch. Background Art

[0002] Trigeminal neuralgia belongs to functional neurosurgery diseases and is a kind of neuropathic pain. The incidence rate is about 182 per 100,000 people. It mostly occurs in adults and the elderly, with a large age span. The peak age is between 48 and 59 years old. Because of its severe pain, it is called "the most painful disease in the world". Its clinical manifestations mainly include electric shock-like and stabbing pain in the area controlled by the trigeminal sensory root. The pain is extremely severe and unbearable. The pathological mechanism of trigeminal neuralgia is still controversial at present. Most scholars believe that it may be related to the demyelination lesion of the trigeminal nerve root. The pain area of trigeminal neuralgia can involve one or more of its branches, and the sensory areas of the II and III branches are often more common.

[0003] Microvascular decompression (MVD) is currently the preferred surgical option for patients with trigeminal neuralgia. However, because the surgery requires craniotomy, the surgical trauma is large, the requirements for the patient's physical condition are relatively high, and the types and incidence rates of corresponding surgical risks are also increased compared with minimally invasive treatment. More serious complications such as damage to the posterior cranial nerve function, intracranial hemorrhage, cerebral infarction, and cerebral contusion may all bring serious consequences. Therefore, for some patients with trigeminal neuralgia who are not suitable for microvascular decompression for various reasons, percutaneous puncture microballoon compression (abbreviated as PBC) is generally recommended.

[0004] PBC was first proposed by Mullan and Lichtor in 1983. Because of its simple operation, short operation time, high immediate efficiency, high repeatability, little pain for patients and high safety, it is a better choice for patients with trigeminal neuralgia who are unwilling or unable to tolerate craniotomy. This percutaneous puncture microballoon compression technology requires the use of a special percutaneous puncture balloon compression device. The shape of the balloon during PBC is directly related to the surgical effect. The more ideal the balloon shape, the more significant the postoperative curative effect. The balloon compression devices commonly used on the market at present can basically meet the requirement of forming an ideal "pear shape" in the Meckel's cave to compress the trigeminal ganglion, so as to physically damage the trigeminal ganglion and achieve 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 above 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 above percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, an upper exhaust pipe and an upper exhaust valve are also connected to the upper cavity at a position far from the operating end.

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

[0012] In the above percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, the other end of the catheter is provided with an interface tube for connecting an air delivery tube or a contrast agent delivery tube, and a pressure gauge is provided on the interface tube.

[0013] In the above percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch, metal positioning marking lines are also provided on the catheter at both ends of the outer balloon.

[0014] In the above 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 with a semi-circular sealing plate, and a magnetic sheet is embedded on the outer circular end face of the semi-circular sealing plate; a matching sealing stepped groove is provided on the inner wall surface of the tube body, and an annular sliding frame corresponding to the position of the semi-circular sealing plate is provided on the outer wall surface of the tube body. A sliding block is provided on the annular sliding frame, an outer driving magnet matching with the semi-circular sealing plate is provided at the bottom of the sliding block, and a driving ring is provided at the top of the sliding block.

[0015] Compared with the prior art, the present invention mainly consists of a catheter with a double - cavity structure, an inner balloon and an outer balloon arranged on the outer wall of the catheter. The outer balloon can well present a "pear - shape" in the Meckel's cavity, thus ideally compressing the trigeminal ganglion while; when targeting the third branch of the foramen ovale for compression, the inner balloon can present an ideal "dog - bone shape" during the compression of the third branch of the foramen ovale, enabling the inner balloon to be stably located in the bony canal of the foramen ovale and not shift inward or outward due to local pressure differences, thereby achieving the purpose of well - targeted compression of the third branch of the trigeminal nerve. This application can take into account the ideal "pear - shape" during the compression of the trigeminal ganglion and the ideal "dog - bone shape" during the compression of the third branch of the foramen ovale, enabling an operator, during percutaneous balloon puncture, to achieve the purpose of two balloon shaping simultaneously with one balloon. While ensuring the curative effect for patients with pain in the first and second branches of the trigeminal nerve, it significantly improves the pain remission rate for patients with pain in the third branch, making such patients significantly benefit. At the same time, it also avoids the operator having to replace different balloons during the operation to achieve different balloon shapes (and currently there is no dedicated balloon device for the third - branch compression shaping on the market). In summary, the present invention can achieve the purpose of two balloon shaping simultaneously with one balloon, while ensuring the curative effect for patients with pain in the first and second branches of the trigeminal nerve, and significantly improving the pain remission rate for patients with pain in the third branch (i.e., improving the treatment effect for patients with pain in the third branch).

[0016] In addition, by setting a pressure gauge, this application can very well avoid the difference in curative effect caused by the local anatomical differences among different people, enabling different - sized bony canals or Meckel's cavities to achieve an ideal compression force while achieving an ideal balloon shape during balloon compression, ensuring a good surgical curative effect. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0019] Figure 3 is Figure 2 a partial enlarged view of

[0020] The reference signs in the drawings are: 1 - catheter, 2 - inner balloon, 3 - outer balloon, 101 - tube body, 102 - upper cavity, 103 - lower cavity, 104 - inner ventilation port, 105 - outer ventilation port, 4 - partition plate, 5 - rotary cavity switching mechanism, 201 - balloon body, 202 - elastic binding film 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 marker line, 501 - rotating shaft, 502 - semi-circular sealing plate, 503 - magnetic sheet, 504 - sealing step groove, 505 - annular sliding carriage, 506 - sliding block, 507 - outer drive magnet, 508 - drive ring. Detailed implementation mode

[0021] The present invention will be further described below in conjunction with the drawings and embodiments, but it shall not be used as a basis for limiting the present invention.

[0022] Embodiment 1. A percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch is configured as shown in Figure 1 and 2 and includes a catheter 1. An inner balloon 2 is provided on the outer side wall of the catheter 1 near the operating end, and an outer balloon 3 is sleeved outside the inner balloon 2; the catheter 1 includes a tube body 101 with a hollow structure. The inner diameter of the tube body 101 is divided by a partition plate 4 to form an upper cavity 102 and a lower cavity 103. An inner ventilation port 104 communicating with the inner balloon 2 is provided on the side wall surface of the upper cavity 102, and an outer ventilation port 105 communicating with the outer balloon 3 is provided on the side wall surface of the lower cavity 103; a rotary cavity switching mechanism 5 is provided at the end of the partition plate 4 far from the balloon for switching between the upper cavity and the lower cavity; the inner balloon 2 includes a balloon body 201, and an elastic binding film layer 202 is provided in the middle of the balloon body 201.

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

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

[0025] A lower exhaust pipe 131 and a lower exhaust valve 132 are connected to the lower cavity 103 at a position far from the operating end.

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

[0027] Metal positioning marker lines 8 are also provided on the catheter 1 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 in the figure, the rotary cavity switching mechanism 5 includes a rotary shaft 501 located in the middle of the tail end of the partition plate 4. The rotary shaft 501 is connected with a semi-circular sealing plate 502, and magnetic sheets 503 are embedded in the outer circular end face of the semi-circular sealing plate 502. A mating sealing step groove 504 is provided on the inner wall surface of the pipe body 101, and an annular sliding frame 505 corresponding to the position of the sealing step groove 504 is provided on the outer wall surface of the pipe body 101. A sliding block 506 is provided on the annular sliding frame 505. An external driving magnet 507 that mates with the semi-circular 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.

[0036] A set of limiting grooves is provided on the inner bottom surface of the sealing step groove, and a set of grooves is provided on the outer end face of the semi-circular sealing plate. Springs and positioning balls are provided in the grooves. By providing the springs and balls and cooperating with the limiting grooves, positioning of the semi-circular sealing plate can be achieved to prevent mis-movement.

[0037] Rotary marking lines are provided on the surface of the annular sliding frame. It is used to indicate the switching position.

[0038] The usage process of the rotary cavity switching mechanism is as follows: Move the sliding block so that the moving block moves along the annular sliding frame. During the movement, through the cooperation of the external driving magnet and the magnetic sheet on the semi-circular sealing plate, the semi-circular sealing plate is driven to rotate around the rotary shaft. After rotating 180 degrees, the switching between the upper and lower cavities is realized. This rotary cavity switching mechanism has a simple structure and is convenient to operate.

[0039] Embodiment 3. The difference between this embodiment and Embodiment 1 is that a rotary cavity switching mechanism is provided between the pipe body and the interface pipe. The rotary cavity switching mechanism includes an inner fixed seat fixed to the tail end of the pipe body and an outer fixed seat fixed to the head end of the interface pipe. A rotary sealing ring is provided between the inner fixed seat and the outer fixed seat, and a semi-circular sealing plate is provided inside the rotary sealing ring.

[0040] Anti-detachment convex rings with an L-shaped cross-section are provided on the side wall surfaces of the inner fixed seat and the outer fixed seat.

[0041] Rotary grooves corresponding to the anti-detachment convex rings are provided on the inner wall surface of the rotary sealing ring. A set of annularly distributed grooves are also provided on the outer end face of the rotary sealing ring. Springs and positioning balls are provided in the grooves; corresponding positioning grooves are provided on the side end faces of the inner fixed seat and the outer fixed seat.

[0042] The rotary sealing ring is composed of two semi-sealing rings spliced together. The semi-circular sealing plate is fixed at the middle position of the inner wall surface of one of the semi-sealing rings, and a rotary pin shaft is provided between the semi-circular sealing plate and the partition plate.

[0043] The switching process of this rotary cavity switching mechanism is as follows: Rotate the rotary sealing ring, which drives the semi-circular 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 balls and the spring cooperate with each other, pop out when encountering the positioning groove to achieve positioning and limiting, and contract when leaving the positioning groove to facilitate rotation.

[0044] This rotary cavity switching mechanism has the advantages of simple structure, convenient and fast installation, and convenient operation.

Claims

1. A percutaneous puncture balloon device that takes into account the trigeminal ganglion and the third branch compression, characterized in that: It includes a catheter (1). An inner layer balloon (2) is provided on the outer side wall of the catheter (1) near the operating end, and an outer layer balloon (3) is sleeved outside the inner layer balloon (2); the catheter (1) includes a tube body (101) with a hollow structure. The inner diameter of the tube body (101) is separated by a partition plate (4) to form an upper cavity (102) and a lower cavity (103). An inner air vent (104) communicating with the inner layer balloon (2) is provided on the side wall surface of the upper cavity (102), and an outer air vent (105) communicating with the outer layer balloon (3) is provided on the side wall surface of the lower cavity (103); a rotary cavity switching mechanism (5) is provided at the end of the partition plate (4) away from the balloon end for switching between the upper cavity and the lower cavity; the inner layer balloon (2) includes a balloon body (201), and an elastic restraint film layer (202) is provided in the middle of the balloon body (201).

2. The percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch according to claim 1, wherein: The length of the elastic restraint film layer (202) is two-thirds of the overall length of the inner layer balloon (2).

3. The percutaneous puncture balloon device for taking into account the compression of the trigeminal ganglion and the third branch according to claim 1, wherein: An upper exhaust pipe (121) and an upper exhaust valve (122) are also connected to the upper cavity (102) at the end away from the operating end.

4. The percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch according to claim 1, wherein: A lower exhaust pipe (131) and a lower exhaust valve (132) are connected to the lower cavity (103) at the end away from the operating end.

5. The percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch according to claim 1, characterized in that: An interface pipe (6) is provided at the other end of the catheter (1) for connecting an air delivery pipe or a contrast agent delivery pipe, and a pressure gauge (7) is provided on the interface pipe (6).

6. The percutaneous puncture balloon device that takes into account the compression of the trigeminal ganglion and the third branch according to claim 1, wherein: Metal positioning marking lines (8) are also provided at both ends of the outer layer balloon (3) on the catheter (1).

7. The percutaneous puncture balloon device for taking into account the compression of the trigeminal ganglion and the third branch according to claim 1, wherein: The rotary cavity switching mechanism (5) includes a rotary shaft (501) located in the middle of the tail end of the partition plate (4). The rotary shaft (501) is connected with a semi-circular sealing plate (502), and a magnetic sheet (503) is embedded on the outer circular end face of the semi-circular sealing plate (502); a matching sealing step groove (504) is provided on the inner wall surface of the tube body (101), and an annular sliding frame (505) corresponding to the position of the sealing step groove 504 is provided on the outer wall surface of the tube body (101). A sliding block (506) is provided on the annular sliding frame (505). An outer driving magnet (507) matching with the semi-circular 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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