Trigeminal nerve compression balloon device with venting at the head

Abstract

The present invention provides a trigeminal nerve compression balloon device with exhaust at the head end, comprising a sealing member, a head end catheter, a capsule and a sealing ring, wherein the capsule is sleeved on the outside of the head end catheter, the head end catheter is provided with a hole, the hole is used to allow a contrast agent to enter the capsule, the sealing ring is embedded in the opening of the head end catheter, and the sealing member comprises a limiting portion; when the trigeminal nerve compression balloon device is in an exhaust state, gas can be discharged from the sealing ring, and when the trigeminal nerve compression balloon device is in a sealing state, the limiting portion extends into the inside of the head end catheter, and the limiting portion blocks the sealing ring. The trigeminal nerve compression balloon device of the present invention can completely exhaust the air in the lumen by one-way liquid inflow, and the exhaust effect is better.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a trigeminal nerve compression balloon device. Background Art

[0002] Trigeminal neuralgia is a neurological disease characterized by repeated short-term electric shock-like or needle-like severe pain in one or more branches of the trigeminal nerve in the head and face. It often occurs when the patient talks, chews, brushes teeth, or when the face is stimulated with cold or hot stimuli. The main treatments for trigeminal neuralgia include medication, blockade, radiofrequency thermocoagulation, glycerol injection, gamma knife therapy, microvascular decompression, percutaneous semilunar ganglion balloon compression, etc. Among the relatively numerous treatment methods, percutaneous semilunar ganglion balloon compression is increasingly used in clinical treatment due to its high technical success rate, safety, high patient comfort, humanization, fast recovery, low cost, repeatable surgery, and high patient acceptance.

[0003] The trigeminal nerve balloon compression technique uses a balloon to compress the trigeminal nerve semilunar node after it is expanded in the Michael's cavity to destroy its pain conduction function and achieve the effect of pain blocking. At present, the surgeon mainly uses the ideal balloon shape (such as pear shape) formed during the operation and the compression time of the balloon on the nerve as the basis for judging treatment. However, if there is both air and contrast agent in the expansion balloon, the air cannot be developed, resulting in a deviation between the balloon development shape under X-ray and the actual balloon filling shape, making it difficult for the surgeon to judge the effectiveness and authenticity of the balloon filling. Therefore, in clinical practice, balloon compression devices need to be vented before use to empty the air in the catheter and the balloon body to prevent the gas from interfering with the filling effect of the balloon during the operation. The contrast agent is a liquid, and air is lighter than liquid. Therefore, when the balloon expands, the liquid flows downward and the air escapes upward. During the operation, the contrast agent is injected by suction using a syringe. During the injection, the contrast agent flows downward and the balloon expands. During the air extraction, the original gas in the balloon and the lumen escapes upward into the syringe connected to the tail of the catheter. The syringe is repeatedly suctioned until the air in the balloon and the lumen is completely exhausted. In addition, since the lumen of the balloon compression device is relatively thin, it is difficult to exhaust the gas, and the exhaust operation is time-consuming and laborious. The above exhaust operation is cumbersome and inconvenient. Repeated suction causes the balloon to repeatedly expand and contract during the exhaust process, resulting in wrinkles on the balloon, causing the balloon to get stuck when entering and exiting the sheath, and even being scratched and damaged by the sheath, increasing the risk of using the instrument and increasing the operation time. In addition, the air exhaust effect is not good, and some air will still remain in the catheter. The presence of air will affect the contrast agent imaging and reduce the accuracy of the doctor's judgment.

[0004] In order to solve the above problems, the trigeminal ganglion compression balloon in the prior art realizes automatic exhaust. Figure 1 This is a schematic diagram of a trigeminal ganglion compression balloon with automatic exhaust in the prior art. Figure 2Schematic diagram of a support tube provided with a through hole in the prior art. Figure 1 and Figure 2 The trigeminal ganglion compression balloon with automatic exhaust includes an expansion balloon 111 and a support tube 12, wherein the expansion balloon 111 is located at the end of the support tube 12; a through hole 113 is provided in the wrapped section of the support tube 12 wrapped by the expansion balloon 111, and the through hole 113 is far away from the end of the support tube 12. A skeleton is arranged inside the support tube 12, and the skeleton is woven into a mesh by fibers, and the support strength and tensile strength of the support tube 12 are enhanced to prevent the balloon from breaking and failing during use. A through hole 5 is arranged in the wrapped section of the support tube covered by the expansion balloon to achieve liquid injection and exhaust. After the expansion balloon is filled, all the original gas in the balloon 111 and the support tube 12 is exhausted, and the contrast developer completely fills the balloon 111. During the operation, the contrast developer is injected by suction with a syringe. During the injection, the contrast developer flows downward and the balloon 111 expands; during the exhaust, the original gas in the balloon 111 and the support tube 12 escapes upward to the proximal end of the support tube 12 and the syringe. The proximal end refers to the end close to the operator, and the distal end refers to the direction away from the operator. However, when the existing balloon compression device is used, the air in the catheter and the balloon cannot be completely eliminated, and the exhaust operation is cumbersome and time-consuming. This technical solution uses the through holes set on the support tube for exhaust, but in order to ensure the support strength and tensile strength of the support tube, a skeleton is set in the support tube, and the skeleton is woven into a mesh by fibers. This technical solution has the following disadvantages: First, the syringe needs to be repeatedly sucked when exhausting, which causes wrinkles in the capsule, causing the capsule to get stuck when entering and exiting the sheath, and even being scratched by the sheath to cause damage, which not only increases the operation time, but also increases the risk of using the instrument. Secondly, the hardness of the support tube is greatly increased, which causes greater stimulation to the tissues in the Michael cavity, causing discomfort to the patient; thirdly, the support tube containing the skeleton is composed of a tube body layer and a skeleton layer, and its processing and manufacturing process is very complicated and the cost is relatively high.

[0005] Figure 3 It is a schematic diagram of another balloon dilatation device for percutaneous treatment of trigeminal nerve in the prior art. Figure 4 Schematic diagram of a prior art catheter assembly. Figure 3 and Figure 4Another balloon dilatation device of the prior art includes a catheter assembly 22 and a Y-type distribution head assembly 21; the catheter assembly 22 is composed of a central liquid inlet catheter 221 and an external exhaust catheter 222; the rear end of the Y-type distribution head body is connected to the Luer lock connector, and the side end is connected to a switchable valve. The front end of the central liquid inlet catheter is connected to the balloon through the liquid guide hole 223 to expand the balloon, and the air remaining inside the balloon is completely discharged by setting the external exhaust catheter 222. This technical solution has the following disadvantages: First, the exhaust catheter is sheathed on the outside of the central liquid inlet catheter, which is bound to increase the overall outer diameter of the catheter. If the overall outer diameter of the catheter is too large, the diameter of the surgical channel will increase, increasing the risk of infection for the patient. If the overall outer diameter of the catheter is ensured to be consistent with the diameter of the current clinical surgical channel, the exhaust channel of the catheter is bound to be narrow, the exhaust operation still takes a long time, and the exhaust channel is prone to blockage. Secondly, since the exhaust catheter is sheathed on the outside of the central liquid inlet catheter, the patent has a complex manufacturing process and high cost, which increases the economic burden on patients.

[0006] Therefore, it is necessary to provide a novel trigeminal nerve compression balloon device to solve the above problems existing in the prior art. Summary of the invention

[0007] The purpose of the present invention is to provide a trigeminal nerve compression balloon device with exhaust at the head end, which can completely exhaust the air in the lumen by one-way liquid inflow, and has a better exhaust effect.

[0008] To achieve the above-mentioned purpose, the trigeminal nerve compression balloon device of the present invention includes a seal, a head end catheter, a balloon body and a sealing ring, the balloon body is sleeved on the outside of the head end catheter, the head end catheter is provided with a hole, the hole is used to allow the contrast agent to enter the interior of the balloon body, the sealing ring is embedded in the opening of the head end catheter, and the seal includes a limiting portion; when the trigeminal nerve compression balloon device is in an exhaust state, the gas can be discharged from the sealing ring, and when the trigeminal nerve compression balloon device is in a sealed state, the limiting portion extends into the interior of the head end catheter, and the limiting portion blocks the sealing ring.

[0009] The beneficial effects of the trigeminal nerve compression balloon device of the present invention are as follows: the trigeminal nerve compression balloon device of the present invention only utilizes the exhaust structure arranged at the head end of the balloon catheter, and the air in the tube cavity can be completely exhausted by one-way liquid inlet. The exhaust operation is simple, time-saving and labor-saving, and the exhaust effect is better; there is no need for repeated suction, so that the balloon body is prevented from being damaged due to repeated expansion and contraction during the exhaust process, and the device is safer to use; and there is no need to set an independent exhaust pipe on the main catheter, the manufacturing process is simple, the processing feasibility is high and it is more economical.

[0010] Optionally, the outer diameter of one end of the limiting portion is smaller than the inner diameter of the sealing ring, and when the trigeminal nerve compression balloon device is in an exhaust state, the limiting portion is located inside the sealing ring and forms a gap with the sealing ring.

[0011] Optionally, the limiting portion comprises a limiting section and an extending section which are connected to each other, and a radial dimension of the limiting section gradually increases in a direction away from the extending section.

[0012] Optionally, the limiting section is truncated cone-shaped.

[0013] Optionally, it also includes a sleeve, which is sleeved on the outside of the seal and the head end catheter when the trigeminal nerve compression balloon device is in an exhausted state to fix the seal.

[0014] Optionally, the sleeve is provided with an exhaust hole.

[0015] Optionally, the trigeminal nerve compression balloon device further comprises a buckle, which is located at one end of the opening of the head end catheter, surrounds the outer circumference of the head end catheter and is connected to the head end catheter, and is used to seal the balloon body and the head end catheter.

[0016] Optionally, the seal also includes a connecting portion and a sealing head, the connecting portion connecting the sealing head and the limiting portion, when the trigeminal nerve compression balloon device is in a sealed state, the connecting portion is located inside the sealing ring, and the sealing head blocks the opening of the head end catheter to seal the opening of the head end catheter.

[0017] Optionally, the sealing ring is an elastic member.

[0018] Optionally, a main body catheter is further included, wherein the main body catheter is connected to the head end catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A schematic diagram of a trigeminal ganglion compression balloon with automatic exhaust in the prior art;

[0020] Figure 2 It is a schematic diagram of a support tube provided with a through hole in the prior art;

[0021] Figure 3 A schematic diagram of another balloon dilatation device for percutaneous treatment of trigeminal nerve in the prior art;

[0022] Figure 4 is a schematic diagram of a catheter assembly of the prior art;

[0023] Figure 5 It is a schematic diagram of the structure of the trigeminal nerve compression balloon device in some embodiments of the present invention in an exhaust state;

[0024] Figure 6 It is a schematic diagram of the structure of the trigeminal nerve compression balloon device in some embodiments of the present invention in a sealed state;

[0025] Figure 7 Schematic diagram of the trigeminal nerve compression balloon device in other embodiments of the present invention. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein should be understood by people with general skills in the field to which the present invention belongs. "Including" and similar words used in this article mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects.

[0027] Figure 5 is a schematic diagram of the structure of the trigeminal nerve compression balloon device in some embodiments of the present invention in an exhaust state, Figure 6 This is a schematic diagram of the structure of the trigeminal nerve compression balloon device in a sealed state in some embodiments of the present invention. Figure 5 The trigeminal nerve compression balloon device of the present invention comprises a sealing member 31, a head end catheter 32, a capsule 33 and a sealing ring 34, wherein the capsule 33 is sleeved on the outside of the head end catheter 32, the head end catheter 32 is provided with a hole 321, the hole 321 is used to allow the contrast agent to enter the capsule 33, the sealing ring 34 is embedded in the opening of the head end catheter 32, and the sealing member 31 comprises a limiting portion 311; Figure 5 When the trigeminal nerve compression balloon device is in an exhaust state, gas can be discharged from the sealing ring 34. When the trigeminal nerve compression balloon device is in a sealed state, the limiting portion 311 extends into the interior of the head end catheter 32, and the limiting portion 311 blocks the sealing ring 34.

[0028] The trigeminal nerve compression balloon device of the present invention only utilizes the exhaust structure arranged at the head end of the balloon catheter. The air in the lumen can be completely exhausted by one-way liquid inlet. The exhaust operation is simple, time-saving and labor-saving, and the exhaust effect is better. There is no need for repeated suction, so that the balloon body is prevented from being damaged due to repeated expansion and contraction during the exhaust process, and the device is safer to use. There is no need to set an independent exhaust duct on the main catheter, so the manufacturing process is simple, the processing feasibility is high and it is more economical.

[0029] In some embodiments, the outer diameter of one end of the limiting portion 311 is smaller than the inner diameter of the sealing ring 34 . When the trigeminal nerve compression balloon device is in an exhaust state, the limiting portion 311 is located inside the sealing ring 34 and forms a gap with the sealing ring 34 .

[0030] In some embodiments, the limiting portion 311 includes a limiting section 3111 and an extension section 3112 that are interconnected. The radial dimension of the limiting section 3111 gradually increases in a direction away from the extension section 3112. The radial dimension of the extension section 3112 is less than or equal to the end of the limiting section 3111 with a smaller radial dimension. This allows the limiting member to be inserted into the sealing ring more smoothly. The limiting member is inserted unidirectionally and cannot be pulled out after passing through the sealing ring, thereby ensuring the sealing performance of the trigeminal nerve compression balloon device.

[0031] In some embodiments, reference Figure 5 The limiting section 3111 is truncated cone-shaped. The limiting member 31 includes two limiting sections 3111, both of which are truncated cone-shaped and have the same size. The two truncated cone-shaped limiting sections 3111 are connected in sequence in the same direction. When the trigeminal nerve compression balloon device is in the exhaust state, refer to Figure 5The ends of the two limiting segments 3111 with smaller radial dimensions face the sealing ring 34, the outer diameter of the end of the limiting segment 3111 with smaller radial dimensions is smaller than the inner diameter of the sealing ring 34, the outer diameter of the end of the limiting segment 3111 with larger radial dimensions is larger than the inner diameter of the sealing ring 34, and the two limiting segments 3111 are located outside the head end catheter 32, so that the balloon device can smoothly extend the limiting segments 3111 into the sealing ring 34 during the sealing process, and when the limiting segments 3111 extend into the head end catheter 32 through the sealing ring 34, the inner diameter of the head end catheter 32 can be blocked, and the sealing ring 34 and the end of the limiting segment 3111 with larger dimensions abut against each other, thereby further improving the sealing performance. Using two limiting segments can achieve a better sealing effect. The two limiting sections 3112 are located at the opening of the head end catheter, the extension section 3112 is cylindrical, connected to the ends of the two limiting sections 3111 with smaller radial dimensions, and the outer diameter of the extension section 3112 is equal to the outer diameter of the end of the limiting section 3111 with smaller radial dimensions, the extension section 3112 extends into the interior of the sealing ring 34, and is coaxially arranged with the sealing ring 34, the extension section 3112 and the sealing ring 34 form a gap, when the trigeminal nerve compression balloon device is in the exhaust state, when the gas is discharged from the interior of the head end catheter 32, the gas is discharged from the interior of the head end catheter 32 in the first direction a and the second direction b. The connection between the extension section and the limiting section forms a smooth gas channel, which can form a gas channel without sharp points and steps when the gas is discharged from the interior of the head end catheter, and can prevent the formation of a gas dead zone.

[0032] In some embodiments, the trigeminal nerve compression balloon device further includes a sleeve 35, which is sleeved outside the seal 31 and the head end catheter 32 when the trigeminal nerve compression balloon device 33 is in an exhaust state, and is used to fix the seal 31. The sleeve 35 is a tearable sheath made of a polymer material, which is fixed to the outside of the head end catheter 32 by heating and shrinking, and is easy to tear.

[0033] In some embodiments, the trigeminal nerve compression balloon device further includes a buckle 36, which is located at one end of the opening of the head end catheter 32, surrounds the outer circumference of the head end catheter 32 and is connected to the head end catheter 32, and is used to seal the capsule 33 with the head end catheter 32. The two openings of the capsule 33 are sleeved on the outside of the head end catheter 32, and the buckle 36 and one end of the capsule 33 are both located at the opening of the head end catheter 32, and the buckle 36 surrounds the outer circumference of the capsule 33. The buckle 36 is fixedly connected to one end of the capsule 33 and one end of the head end catheter 32 through interference fit, and the clamping force generated by the buckle 36 prevents relative movement between the head end catheter 32, one end of the capsule 33 and the buckle 36.

[0034] In some embodiments, the sealing member 31 further includes a connecting portion 314 and a sealing head 313, wherein the connecting portion 314 connects the sealing head 313 and the limiting portion 311. Figure 6 When the trigeminal nerve compression balloon device is in a sealed state, the connecting portion 314 is located inside the sealing ring 34 , and the sealing head 34 blocks the opening of the head end catheter 32 , so that the opening of the head end catheter 32 is sealed. The sealing head 314 is a hemispherical body, and the connecting part 313 is cylindrical. The side plane of the sealing head 314 is connected to one end of the connecting part 313, and the other end of the connecting part 313 is connected to the end of the limiting section 3111 with a larger radial dimension. The sealing head 314, the connecting part 313, the limiting section 3111 and the extending section 3112 are coaxially arranged, and the axial length of the sealing ring 34 is equal to the axial length of the connecting part 313. When the limiting member 31 is pushed into the head end catheter 32, the shapes of the sealing ring 34 and the connecting part 313 match, and the opening of the head end catheter 32 is completely blocked. The side plane of the sealing head 314 is opposite to the side of the opening of the head end catheter 32, and the outer diameter of the side plane of the sealing head 314 is equal to the outer diameter of the buckle 36, which can enhance the sealing effect of the sealing member 31.

[0035] Reference Figure 5 The sleeve 35 is provided with an exhaust hole 351. When the trigeminal nerve compression balloon device is in an exhaust state, the sleeve 35 connects the sealing head 313 and the buckle 36, and the exhaust hole 351 is located between the opening of the head end catheter 32 and the sealing head 313, and is used to exhaust gas when the contrast agent is introduced.

[0036] In some embodiments, the sealing ring 34 is an elastic member, and the sealing member 34 is an elastic body or a rigid body, and the rigid body includes metal. Since the radial dimension of one end of the limiting segment is larger than the radial dimension of the sealing ring, the sealing ring has elasticity so that the sealing member can enter the head end catheter through the sealing ring.

[0037] Reference Figure 5 The trigeminal nerve compression balloon device further includes a main body catheter 4, which is connected to the head end catheter 32. The other end opening of the balloon body 33 is connected to the other end of the head end catheter 32, and the main body catheter 4 is connected to the other end of the head end catheter 32.

[0038] Figure 7 Schematic diagram of the trigeminal nerve compression balloon device in some other embodiments of the present invention, referring to Figure 7The trigeminal nerve compression balloon device also includes a tail connector 5, which is connected to the other end of the main catheter and is used to introduce contrast agent into the main catheter 4 and the head catheter 3.

[0039] Before using the trigeminal nerve compression balloon device of the present invention, the trigeminal nerve compression balloon device is Figure 5 In the exhaust state shown, when exhausting, use the inflator to inhale an appropriate amount of contrast agent and connect the tail connector, place the head end of the device in a high position, and slowly inject the contrast agent. As the contrast agent is injected, the air in the lumen and the balloon will be completely exhausted along the exhaust channel at the head end and the exhaust hole on the sleeve. Then push the seal in so that the seal and the sealing ring cooperate to block the head end catheter, the exhaust channel at the head end of the device is closed, and the exhaust operation is completed. After removing the sleeve, the trigeminal nerve compression balloon device is Figure 6 In the sealing state shown, the contrast agent is continuously injected so that the contrast agent enters the balloon from the hole of the head end catheter to fill the balloon.

[0040] Although the embodiments of the present invention are described in detail above, it is obvious to those skilled in the art that various modifications and variations can be made to these embodiments. However, it should be understood that such modifications and variations are within the scope and spirit of the present invention as described in the claims. Moreover, the present invention described herein may have other embodiments and may be implemented or realized in a variety of ways.

Claims

1. A trigeminal nerve compression balloon device with exhaust at the head end, characterized in that: It comprises a sealing member, a head end catheter, a capsule and a sealing ring, wherein the capsule is sleeved on the outside of the head end catheter, the head end catheter is provided with a hole, the hole is used to allow a contrast agent to enter the capsule, the sealing ring is embedded in the opening of the head end catheter, and the sealing member comprises a limiting portion; when the trigeminal nerve compression balloon device is in an exhaust state, gas can be discharged from the sealing ring, and when the trigeminal nerve compression balloon device is in a sealing state, the limiting portion extends into the head end catheter, and the limiting portion blocks the sealing ring; The outer diameter of one end of the limiting portion is smaller than the inner diameter of the sealing ring, and when the trigeminal nerve compression balloon device is in an exhaust state, the limiting portion is located inside the sealing ring and forms a gap with the sealing ring; The limiting portion comprises a limiting section and an extending section which are connected to each other, and a radial dimension of the limiting section gradually increases in a direction away from the extending section.

2. The trigeminal nerve compression balloon device according to claim 1, characterized in that: The limiting section is in the shape of a truncated cone.

3. The trigeminal nerve compression balloon device according to claim 1, characterized in that: It also includes a sleeve, which is sleeved on the outside of the sealing member and the head end catheter to fix the sealing member when the trigeminal nerve compression balloon device is in an exhausted state.

4. The trigeminal nerve compression balloon device according to claim 3, characterized in that: The sleeve is provided with an exhaust hole.

5. The trigeminal nerve compression balloon device according to claim 4, characterized in that: It also includes a buckle ring, which is located at one end of the opening of the head end catheter. The buckle ring surrounds the outer circumference of the head end catheter and is connected to the head end catheter to seal the balloon and the head end catheter.

6. The trigeminal nerve compression balloon device according to claim 5, characterized in that: The sealing member also includes a connecting portion and a sealing head, wherein the connecting portion connects the sealing head and the limiting portion. When the trigeminal nerve compression balloon device is in a sealed state, the connecting portion is located inside the sealing ring, and the sealing head blocks the opening of the head end catheter to seal the opening of the head end catheter.

7. The trigeminal nerve compression balloon device according to claim 1, characterized in that: The sealing ring is an elastic member.

8. The trigeminal nerve compression balloon device according to claim 1, characterized in that: Also included is a main body catheter, which is communicated with the head end catheter.

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