CN111481240A - Percutaneous trigeminal semilunar ganglion sacculus compression device (skeleton) - Google Patents

Abstract

A device for percutaneous trigeminal nerve meniscus balloon compression, comprising a compression balloon catheter assembly, the compression balloon catheter assembly including a dilation balloon and a support tube, the dilation balloon is located at the end of the support tube; the support tube includes a skeleton and a tube body The advantage of the present invention is that a skeleton is arranged in the support tube, and the skeleton is woven into a mesh shape by fibers, so that the support strength and tensile strength of the support tube are enhanced, and the broken part of the balloon is prevented from being broken during use or remaining in the skull. inside, avoiding the risk of iatrogenic injury and infection.

Description

Device (skeleton) for percutaneous trigeminal meniscus balloon compression

Technical field:

The present invention relates to a device for percutaneous trigeminal nerve meniscus balloon compression.

Background technique:

The trigeminal nerve is a mixed nerve, the fifth pair of cranial nerves, and the largest nerve in the face, containing both general somatosensory and special visceral motor fibers. It controls the sensation of the face, mouth, and nasal cavity and the movement of the masticatory muscles, and transmits sensory information from the head to the brain. The trigeminal nerve is formed by the confluence of the ophthalmic (first), maxillary (second) and mandibular (third) branches, which respectively innervate the sensation above the eye cleft, between the eye cleft and the mouth cleft, and below the mouth cleft. The masticatory muscles contract.

The motor part of the trigeminal nerve exits the brain at the junction of the pons and the pontine wall, merges with the mandibular nerve, and exits the skull through the foramen ovale. The sensory part of the trigeminal nerve is located at the trigeminal semilunar ganglion at the tip of the petrous part of the temporal bone, as shown in Figure 1, C is the trigeminal semilunar ganglion; the trigeminal semilunar ganglion covers the dura and is included in the trigeminal lumen formed by the two layers of the dura mater. .

Trigeminal neuralgia is short-lived, recurrent paroxysmal pain in the distribution area of the facial trigeminal nerve, also known as painful convulsions. The symptoms of trigeminal neuralgia are: the pain is mainly in the distribution area of the trigeminal nerve on the head and face, and the sudden arrest occurs. Each attack can take 1-2 seconds to 1-2 minutes. Intractable, unbearable severe pain. Talking, washing your face, brushing your teeth, or the breeze, or even walking can cause pain flare-ups. The pain is cyclical, and the intermittent periods are the same as those of normal people.

The main methods of treating trigeminal neuralgia are: drug therapy, microvascular decompression surgery, percutaneous trigeminal semilunar ganglion balloon compression, and percutaneous trigeminal semilunar ganglion thermocoagulation radiofrequency.

Drug treatment methods, each patient's tolerance to drugs is different, and drugs have side effects, long-term medication requires regular review of liver function and blood.

Microvascular decompression surgery is an internationally recognized method for the treatment of primary trigeminal neuralgia. This surgery can control pain for a long time, with a low recurrence rate. There is almost no facial numbness after surgery. Permanent facial sensory disturbance. The main disadvantage of microvascular decompression surgery is that it needs to open the patient's posterior cranial fossa. It is a craniotomy. The operation time and anesthesia time are generally about 2 hours. There are certain requirements, and a small number of patients may experience complications of varying severity, such as facial paralysis, tinnitus, hearing loss, cerebrospinal fluid leakage, incision infection or unsatisfactory surgical results, etc. If postoperative bleeding or brainstem infarction occurs, it may be lethal.

Transcutaneous trigeminal meniscus radiofrequency thermocoagulation was performed under local anesthesia, and thermocoagulation damage to the meniscus was performed with temperature-controlled radiofrequency. It also has a high pain relief rate, a low recurrence rate, and can locate the damaged nerve branches during surgery; this method is relatively good for the treatment of trigeminal neuralgia caused by the inferior and superior mandibular branches. The pain caused by the ophthalmic branch is limited to a certain extent due to the difficulty in positioning and the severe postoperative complications; due to the completion of the operation under local anesthesia, there is often great pain and discomfort during the operation, and postoperative facial sensory loss is common.

Percutaneous trigeminal semilunar ganglion balloon compression in the treatment of trigeminal neuralgia began in 1978 by Mullan and Lichtor, and was published in 1983. This technique was originally intended to relieve trigeminal neuralgia that could not be controlled due to the failure of other techniques. In this operation, the 2.0-2.5cm side of the affected side of the mouth is punctured, and a micro-balloon is introduced into the meniscus of the trigeminal nerve in Meckle's cavity through a sheath tube under X-ray monitoring, and then a contrast medium is slowly injected to fill the balloon, and The meniscus of the trigeminal nerve was disrupted by compression with a dilated microballoon. The operation is simple and well tolerated by the patient. The operation is completed under general anesthesia without pain and discomfort for the patient. The operation time is short and can be completed within half an hour. The postoperative pain relief rate can be as high as 95%. You can get out of bed the next day. Surgery can be repeated for patients who fail or relapse. This operation does not require a craniotomy, and there is no need to enter the intensive care unit and no surgical scar after the operation. The main disadvantages are mild to moderate hemifacial numbness and weakened masticatory muscle strength after the operation, but the symptoms will partially improve with time. Because the efficacy of this operation is similar to that of microvascular decompression surgery, the indications are wide, no craniotomy is required, the postoperative complications are not serious, and the recovery is quicker, so it has been widely used in clinical practice.

Chinese patent application CN201610146176.7 discloses a trigeminal nerve meniscus compression device, including a compression balloon catheter assembly and a puncture needle kit; the compression balloon catheter assembly includes an expansion balloon, a connection seat, and a support connecting the expansion balloon and the connection seat The tube, the expansion balloon, the support tube and the connection seat are all connected; the puncture needle kit includes a puncture needle and a catheter sheath, and the catheter sheath is left in the tissue after puncturing to compress the balloon catheter assembly into the tissue; Metal buckles are respectively fixed at one end near the support tube and at the end away from the support tube, and the metal buckles are used to provide the visualization of the expansion balloon under X-rays during the operation. The support tube and the expansion balloon are provided with a traction wire that runs through the support tube and the expansion balloon. The traction wire is used to ensure the connection strength of the head and tail of the support tube. An elastic element (such as a spring) is arranged between the traction wire and the expansion balloon to contrast the contrast agent. When input into the expansion balloon, the spring is stretched, and the contrast medium enters the expansion balloon from the gap of the spring, and the expansion balloon is filled.

This compression device has the following problems:

1. In the area covered by the expansion balloon, some parts have no tube body. In this part of the area without the tube body, when the spring is stretched, the contrast agent enters the expansion balloon from the gap, that is, in the balloon. At the front end, the balloon is supported only by the spring and the traction wire, while the spring and the traction wire are connected by the solder joints. It is separated from the traction wire, and the reliability is poor.

2. The rigidity of the front end of the balloon is low, and the catheter component is prone to rupture and failure.

3. After the catheter assembly is broken, it is easy to puncture the balloon. If the balloon is broken, the broken and failed parts are prone to fall into the human body, which is a potential safety hazard.

4. In this compression device, the gas in the tube cannot be discharged while the contrast agent is input, because the expansion balloon contains both air and contrast contrast agent, and the air cannot be developed, resulting in the development of the balloon under X-ray. The inflated shape of the balloon is biased, resulting in lack of visualization and difficulty in judging the validity and authenticity of balloon inflation.

5. The pillow of the puncture needle is a sharp pillow, which is easy to cut or scratch the surrounding tissue during puncture, which is easy to cause damage to blood vessels and nerves.

6. The puncture needle and the catheter sheath are connected by threads. During percutaneous puncture, the puncture needle and the catheter sheath are screwed and locked together for puncture; The introducer sheath remains in the tissue; the action of rotating the puncture needle will cause the follower rotation of the introducer sheath, thereby producing a cutting effect on the tissue and easily damaging the surrounding tissue.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a device for percutaneous trigeminal nerve meniscus balloon compression with good reliability and high safety.

A device for percutaneous trigeminal nerve meniscus balloon compression includes a compression balloon catheter assembly including a dilation balloon and a support tube, the dilation balloon being located at the end of the support tube. The dilation balloon is made of elastic material and is a compliant balloon or a semi-compliant balloon. The contrast contrast agent flows into the position of the expansion balloon through the lumen of the support tube through the syringe. With the injection of the contrast contrast agent, the expansion balloon is filled and expanded under the action of the liquid, and the expansion balloon forms a corresponding shape according to the space in which it is located. During percutaneous trigeminal meniscus balloon compression, the shape of Mickel’s cavity is pear-shaped, so when the dilation balloon is pear-shaped on the radiographic image, it indicates that the balloon is in the correct position. The material of the expansion balloon can be elastic medical materials such as natural latex, polyurethane, thermoplastic elastic polymer material and silica gel.

The support tube has a connection seat, the connection seat and the expansion balloon are respectively located at two ends of the support tube, and the additional balloon is connected with the connection seat. The connector can use a standard injection connector for matching with a syringe that is used to inject contrast contrast agent into the dilation balloon.

In a first aspect of the present invention, there is provided a device for preventing failure of a support tube from being broken.

As a preferred solution, the support tube includes a frame and a tube body. The skeleton runs through the effective use length of the entire pipe body, the skeleton has toughness and stiffness, and the skeleton provides the pipe body with supporting strength and tensile strength. The tube body is a medical polymer material tube body. Medical polymer materials include but are not limited to polyurethane, silicone rubber, polyester fiber, polyvinylpyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid , polyethylene, etc.

As a preferred solution, the support tube includes a skeleton layer and a tube body layer, and the skeleton layer is wrapped in the tube body layer. First make a skeleton, then coat the skeleton with a tube body, the skeleton becomes the skeleton layer, and the tube body becomes the tube body layer, and then the tube body and the skeleton assembly are subjected to heat treatment, etc., so that the tube body layer and the skeleton layer are combined together.

Alternatively, the support tube includes a skeleton layer, an inner tube body layer and an outer tube body layer, and the skeleton layer is between the inner tube body layer and the outer tube body layer. For example, first make the inner tube body (the polymer tube body can be obtained by extrusion or injection molding), then wrap the skeleton in the inner tube body, and then extrude the outer tube body layer outside the skeleton. The inner tube body layer and the outer tube body layer encapsulate the skeleton. The inner tube body layer and the outer tube body layer can be heat treated or not.

The skeleton plays a role in enhancing the rigidity of the pipe body. As long as the skeleton does not break, the pipe body will not break and fail.

Alternatively, the skeleton is located in the tube body, and the skeleton and the tube body are on the same layer. For example, a skeleton is made first, and then the skeleton is filled with catheter material so that the skeleton is part of the body of the tube. For example, the skeleton is first made, and then the skeleton is used as an insert to extrude the tube body, the skeleton is embedded in the tube body, and the skeleton and the tube body are integrated into one or one layer.

As a preferred solution, the skeleton is woven from at least one fiber, and when one fiber is used for knitting, the skeleton can be wound into a spiral, or the skeleton is woven like a sweater. Preferably, the skeleton is woven in a mesh shape. Preferably, the skeleton is woven into a hollow mesh; alternatively, the fibers of the skeleton are abutted against each other, and no holes are deliberately left during weaving. Woven into a mesh, making the skeleton both supportive and tensile strength. The skeleton is tough and rigid. The skeleton is in the form of a hollowed-out mesh, and only a hole is needed on the tube body, and when the contrast developer is injected, the developer enters the expansion balloon through the hollowed-out part to fill the expansion balloon. When the skeleton cannot be left hollow, holes need to be opened on the tube body, and the developer flows into the expansion balloon through the gap between the fibers, or several holes are set on the skeleton so that the developer can enter the expansion balloon.

Preferably, the skeleton is woven into a net from 2-64 strands of fibers. The mesh structure, even if one fiber breaks, will not cause the skeleton and the entire support tube to break and fail, and the reliability is high.

Preferably, the skeleton is in a tubular shape; or, the skeleton is a mesh sheet, and the skeleton is in a tubular shape under the constraint of the tube body. Whether the skeleton is directly woven into a tubular shape, or the planar skeleton is formed into a tubular shape under the action of the tubular body, any original shape of the skeleton can be used as long as it does not affect the combination of the skeleton and the tubular body and the support of the skeleton to the tubular body.

As a preferred solution, there is at least one fiber in the skeleton that can be developed under X-rays. In this way, the skeleton can not only improve the support strength and tensile strength of the support tube, but also have developability. Preferably, the developable fibers are metal wires; or, the developable fibers have a developing layer. Preferably, the developing layer is a metal layer, such as plastic or glass fiber with a metal coating, or the developing layer is a metal wire, and a polymer surface layer is attached to the metal wire. The developer layer can also be a developer coating. During the operation, the skeleton can provide intraoperative visualization, and the visualization area includes the entire support tube, not only the expansion balloon.

Alternatively, at least one fiber in the scaffold is visualized in the area where the dilation balloon is located. For example, the fibers of the skeleton are provided with a developing layer only in the area where the expanding balloon is located, so that only the expanding balloon can be visualized.

Preferably, the pipe body is made of a polymer material, and the polymer material is Pebax, or PVC, or PE, or PP, or PTFE.

The second aspect of the present invention provides a device capable of degassing the inside of the tube or the inflation balloon while the contrast developing solution is injected, so that the contrast developing solution fills the balloon.

As a preferred solution, the wrapping section of the support tube wrapped by the expansion balloon is provided with a through hole, and the through hole is away from the end of the support tube.

During percutaneous trigeminal meniscus balloon compression, the patient after general anesthesia is placed in a supine position, and a wrapping roll with an appropriate height is placed under the shoulder to ensure mild neck extension. Therefore, in a normal body position, the support tube and the balloon are inserted into the human body obliquely downward, and the end of the support tube is the lowest. If the through hole is far away from the end of the support tube, it means that the through hole is higher than the end of the support tube in the normal body position during the operation. The control developer is a liquid, which is heavier than air, so when the balloon is inflated, the liquid flows down and the air escapes up. During the operation, the control contrast agent was injected by suction with a syringe. During the injection, the contrast contrast agent flowed down and the balloon was expanded; when the air was pumped, the original gas in the balloon and the support tube escaped upward to the support tube. proximal and in the syringe. The proximal end refers to the end that is close to the operator, and the distal end refers to the direction away from the operator.

As a preferred solution, the diameter of the through hole is 0.2 to 1.5 mm. The through hole in this size range not only avoids greatly reducing the rigidity of the support tube, reduces the risk of fracture and failure of the support tube, but also enables the expansion balloon to be vented while injecting liquid. Preferably, the number of through holes is one or more. Preferably, when there are multiple through holes, there is a distance between the through holes. The number of through holes can ensure the support strength and/or tensile strength of the support tube, so that the gas and contrast developer can enter and exit smoothly and the pressure in the balloon can be accurately transmitted to the syringe to provide an operating feel.

As a preferred solution, the surface of the wrapping section has concave guide grooves. After the control developer flows out of the through hole, it flows along the guide groove to the distal end of the support tube, so that the distal end of the balloon expands and fills before the proximal end. Preferably, the guide groove is beside the through hole, or the through hole is provided on the guide groove. Preferably, the number of guide grooves is one or more. Preferably, each guide groove corresponds to at least one through hole. Preferably, the diversion grooves are symmetrically distributed along the support tube, so that the control developer can be injected uniformly, which is beneficial to the uniform expansion of the balloon.

As a preferred solution, the support tube includes a skeleton and a tube body, the skeleton is woven from fibers, and through holes are provided in the tube body, and the through holes avoid fibers. The through holes avoid fibers means that there is no need to interrupt the fibers to form the through holes, so as to avoid damage to the fibers of the skeleton and reduce the strength of the support tube.

The third aspect of the present invention provides a device in which both the proximal and distal ends of the balloon are fastened, and when the contrast contrast agent is injected, the balloon expands radially with little or no axial advance.

As a preferred solution, the proximal end and the distal end of the balloon are respectively provided with binding members for fixing the balloon and the support tube.

The purpose of the tie is to form a closed bladder. The proximal and distal ends of the balloon are respectively tied and fixed. When the contrast agent is injected, the proximal and distal ends of the balloon are fixed, so the balloon can only be inflated and expanded radially to avoid the occurrence of balloon damage to the anterior tissue. impact, and all the injected contrast contrast agent is concentrated in the designated area (the area between the proximal and distal binding members), which is conducive to the complete visualization of the balloon under X-ray and maintains the support strength of the balloon . Most importantly, the distal bundling piece tightly fits the balloon to the support tube, and the contrast contrast agent cannot enter further than the distal bundling piece, so that the balloon is capsule-shaped or spherical when it is naturally inflated. It will appear pear-shaped due to the restraint of the distal bundle, avoiding the misjudgment of the balloon shape during the operation.

As a preferred solution, the binding member of the balloon is a rope, or the binding member of the balloon is a diameter reducing ring. When the rope or the diameter reducing ring is assembled, the balloon and the support tube are tightly combined by external force to form a closed balloon body.

Preferably, the diameter reducing ring is a thin-walled pipe fitting of 1 to 3 mm. Preferably, the diameter reducing ring is a metal ring made of medical metal. Both the proximal end and the distal end of the balloon may use a diameter reducing ring, or only the proximal end of the balloon may use a shrinking ring. This is using the visualization of the metal ring under X-rays, and the proximal metal tightening ring is used to identify whether the dilation balloon is protruding from the catheter sheath.

Preferably, the support tube includes a skeleton and a tube body, and the skeleton is woven from fibers with developing properties. The function of the binding member is only to combine the balloon and the support tube to form a closed balloon, and the skeleton undertakes the intraoperative imaging function.

Preferably, a through hole is formed on the support tube, the through hole is located between the two binding members, and the through hole is close to the proximal binding member and away from the distal binding member.

In a fourth aspect of the present invention, there is provided a device for maintaining a constant pressure of an inflation balloon.

As a preferred solution, the distal end of the support tube is connected to an additional balloon placed outside the body, and the additional balloon is connected to the input source of the contrast medium.

When the additional balloon is outside the body, the control contrast agent is first infused into the additional balloon, and then into the in vivo expansion balloon through the additional balloon, so that the additional balloon buffers the injection pressure of the contrast contrast agent. In addition, the inflation balloon is deflated while injecting liquid, or due to the compressibility of air, after the syringe completes the injection of the contrast contrast agent, the pressure of the inflation balloon will decrease. At this time, the contrast imaging in the additional balloon The agent will be automatically filled into the inflation balloon to maintain a constant pressure in the inflation balloon. Alternatively, when the dilation balloon in the body leaks or is damaged, the contrast contrast agent in the additional balloon will continue to be input into the expansion balloon, resulting in rapid consumption of the contrast contrast agent in the additional balloon and alerting the operator to abnormal operation.

Preferably, the additional balloon includes a catheter and a balloon body, and the catheter has a second connector; the second connector is connected to an input source of contrast medium. The second joint adopts standard injection joint to improve applicability. The additional balloon is made of an inflatable and deformable elastic material, and the catheter is made of a non-inflatable material.

Preferably, the balloon is wrapped on the surface of the catheter, the proximal end and the distal end of the balloon are sealed and connected to the catheter respectively, the balloon is a closed balloon, and the catheter has a liquid through hole for inputting liquid to the balloon. Preferably, the liquid through hole is close to the distal end and away from the proximal end. This is to comply with the normal body position during surgery. When injecting fluid during the operation, the distal end is higher than the proximal end, which is convenient for fluid injection and exhaust. Preferably, the balloon body is an elastic membrane, and the balloon body is fixed to the catheter through a fastening member; or, the balloon body is an elastic membrane, and the catheter balloon body is sealed and connected by processes such as bonding and hot pressing. Preferably, the number of liquid passage holes is one or more. The liquid through holes are micropores, so the arrangement of the liquid through holes does not affect the support strength and tensile strength of the catheter.

Preferably, the catheter includes a support frame and a catheter body, and the support frame is woven into a mesh by fiber filaments; the liquid through holes avoid the fiber filaments. The support skeleton enhances the support strength and tensile strength of the catheter, and the arrangement of the liquid through holes will not cause the fiber filaments to break, and will not affect the strength of the support skeleton.

Preferably, the catheter includes a support skeleton layer and a catheter body layer, and the support skeleton layer is wrapped in the catheter body layer. That is to say, the support frame and the catheter body are two layers, the support frame is in the tube body, and the support frame plays the role of enhancing the rigidity of the tube body. As long as the support frame does not break, the tube body will not break and fail.

Alternatively, the support frame is located in the catheter body, and the support frame and the catheter body are in the same layer. For example, a support frame is first fabricated, and then the support frame is filled with catheter material, so that the support frame is a part of the catheter body. For another example, a support frame is first fabricated, then a catheter is placed on the outer jacket of the support frame, and then the assembly of the catheter and the support frame is subjected to heat treatment, etc., so that the frame and the catheter are integrated into one body or one layer.

Preferably, the conduit and the support tube are the same tube. Alternatively, the conduit and the support tube are independent of each other, the conduit has a first joint, and the first joint is detachably connected to the connection seat of the support tube. The first joint adopts a standard injection joint, which is used for connecting with the connecting seat of the support tube.

Alternatively, the two ends of the bag body are respectively connected to the first tube body and the second tube body, one end of the first tube body is sealed and connected to the bag body, the other end is provided with a first joint, one end of the second tube body is sealed and connected to the bag body, and the other end is provided with a second tube body. connector. Alternatively, the tube body includes a first tube body and a second tube body connected by a tee, and the third interface of the tee is sealingly connected to the bladder. The contrast contrast agent is injected into the additional balloon first, and then into the expansion balloon. The additional balloon is connected to the expansion balloon, and the pressure is balanced; when the pressure in the expansion balloon changes, it will be transmitted to the additional balloon outside the body, which is convenient for operators to observe . Preferably, the catheter is a medical polymer catheter body.

A fifth aspect of the present invention provides a device in which the catheter sheath is not disturbed when the puncture needle and the catheter sheath are separated.

Apparatus for percutaneous trigeminal meniscus balloon compression, comprising a puncture needle set comprising a puncture needle and an introducer sheath, the puncture needle having a needle seat and a needle tube, and the introducer sheath having a sheath holder and a sheath tube; puncture needle When combined with the catheter sheath, the needle tube is inserted into the sheath tube and fits with the sheath tube, the needle seat and the sheath seat are locked, and when the needle seat and the sheath seat are unlocked, the puncture needle and the catheter sheath are released. After the puncture needle is released from the sheath, the needle can move freely in the sheath.

During percutaneous trigeminal meniscus balloon compression, the patient's lateral incision is punctured with the needle and introducer sheath in combination in an X-ray environment. Guide the puncture needle set into the foramen ovale through the influence of X-ray positioning, but do not pierce the upper edge of the foramen ovale. When the puncture needle is in place, release the combination of the puncture needle and the catheter sheath, pull out the puncture needle, and leave the catheter sheath in the in vivo. The compression balloon catheter assembly is then inserted along the lumen of the catheter sheath, and the insertion depth is determined by the influence of X-rays.

As a preferred solution, a detachable combination is realized between the needle seat and the sheath seat through a rib-clamping hook mechanism. When the hook hooks the rib, the needle seat and the sheath seat are combined; when the hook releases the rib, the needle seat and the sheath seat are combined. The sheath seat is released. The combination of the puncture needle and the catheter sheath is realized by using the hook and the rib hook. When unlocking and realizing the combination, you only need to operate the hook or the rib. The needle seat has no rotational displacement, and the catheter sheath will not be affected. The disturbance of the needle seat, so as to maintain the stable position of the introducer sheath in the body and avoid the deviation of the sheath tube.

Preferably, the rib and the hook are in line contact, and the rib is a straight line segment. The rib and the hook are respectively straight segments, which realizes the combination of the rib and the hook. Moreover, when the ribs and the hook are in the combined state, the rotational freedom of the ribs and the hook is unified, so the rotation of the needle seat and the sheath seat is achieved. The degrees of freedom are unified, and during puncture, the force of holding the sheath seat can be completely transmitted to the needle tube, and there is no relative rotation between the needle seat and the sheath seat.

Preferably, the needle seat and the sheath seat are in clearance fit. When the hook releases the rib, the needle seat can be easily withdrawn from the sheath without causing the sheath to drift.

Preferably, the hook includes a hook and a lever arm, the lever arm is provided with a fulcrum, the fulcrum is connected with the needle seat or the fulcrum is connected with the sheath seat, the lever arm has a force applying portion, and the force applying portion and the hook are respectively located on both sides of the lever arm. The force-applying part is the part that receives the external force. When the external force acts on the force-applying part, the lever rotates around the fulcrum, and the hook hooks or releases the rib.

Or, the hook is fixed, the rib is connected with the moving mechanism, when the moving mechanism is in the first position, the rib protrudes and hooks with the hook, and when the moving mechanism is in the second position, the rib and the hook are separated; the moving mechanism includes and the rib Connected levers and guide slots that allow the ribs to move within them.

Preferably, the hook is located in the needle seat, the fulcrum of the hook is hinged with the needle seat, and the rib is located in the sheath seat; or, the hook is located in the sheath seat, the fulcrum of the hook is hinged with the sheath seat, and the ribs are in the needle seat. Preferably, a pin shaft and a torsion spring are arranged on the fulcrum. The torsion spring realizes the position locking and automatic reset of the hook. Preferably, the hook is located at one end of the lever arm, and the force applying portion is located at the other end of the lever arm. Preferably, the distance between the force applying portion and the fulcrum is smaller than the distance between the hook and the fulcrum. The lever arm achieves force amplification. Preferably, there are a pair of hooks, the pair of hooks are symmetrically arranged, and each hook corresponds to a rib. To release the ribs from the hooks, pinch the force-applying parts of the two hooks with your hands, swing the hooks outward, and release the ribs.

Preferably, the sheath seat is provided with a ring of flanges protruding outward, the flanges are rectangular or square, and two opposite flange edges are used as ribs. Preferably, the two flange edges other than the ribs are respectively connected to the respective reinforcing plates, and the reinforcing plates are connected to the sheath base. The reinforcement plate plays the role of support and stability. Preferably, the sheath base is provided with an auxiliary support portion, the auxiliary support portion is parallel to the flange, and the reinforcing plate extends from the flange to the auxiliary support portion. The shape of the auxiliary support portion is the same as that of the flange. When performing the puncture action, the operator pushes the reinforcing plate part to the distal end, so as to control the direction and strength of the puncture.

The puncture needle is made of metal material, such as stainless steel, titanium, nickel, platinum, gold, silver or one or more alloys of them. The catheter sheath is made of metal material or medical polymer material.

A sixth aspect of the present invention provides a device for preventing the needle from damaging tissue during puncturing with a puncture needle.

As a preferred solution, when the puncture needle is combined with the catheter sheath, the needle of the puncture needle is exposed to the sheath, and the needle of the puncture needle is blunt. Preferably, the needle is formed by tapering distally from the needle tube, and the needle is blunt without sharp corners or cutting edges. Preferably, the needle is in the form of a ball, and the radius of the ball is 0.3-0.5 mm. Alternatively, the needle is domed or blunted. Preferably, the puncture needle is a metal needle, or the puncture needle includes a non-metallic body, and the surface of the non-metallic body has a developing layer. The developer layer is a developer coating, or the developer layer is a metal layer. For example, the puncture needle includes a plastic needle tube, and the plastic needle tube has a metal coating on the surface, and the metal coating is used for development under X-rays.

After blunting the needle, there are no cutting edges or spikes on the needle. During percutaneous trigeminal nerve meniscus balloon compression, the puncture needle assembly is advanced distally, and the needle tip is blunted, which will not cause cutting or stabbing injuries to body tissues (such as blood vessels, nerves, muscles, etc.). The needle is set to a radius of 0.3~0.5mm, which conforms to the interstitial space in the human body and avoids puncturing and squeezing the blood vessels and/or nerves and other tissues.

When using the present invention to perform percutaneous trigeminal nerve meniscus balloon compression, the patient is placed in a supine position after general anesthesia, and the under-shoulder pad is wrapped with a cloth roll at an appropriate height to ensure a slight extension of the neck. In the X-ray environment, use a puncture needle kit to puncture the patient's side, and the needle insertion point is about 2.5cm next to the corner of the patient's side mouth. Guide the needle and sheath into the foramen ovale by positioning the X-ray image, but do not pierce the upper edge of the foramen ovale. After the puncture needle kit is punctured in place, apply force to the force-applying part of the hook, the hook releases the ribs, and the puncture needle is taken out. Then insert the compression balloon catheter assembly into the sheath tube, and the insertion depth is determined by X-ray images. When the dilation balloon enters the trigeminal meniscus of Meckle's cavity, the contrast contrast agent is injected through the lumen of the support tube, and the dilation balloon is filled and inflated. , and monitor the inflation balloon filling status by X-ray imaging. Inject the control contrast agent with a dose that just fills Meckles's cavity, which can be obtained from statistical data or limited experiments, or imaging guidance; monitor the inflation balloon for the desired pear-shaped appearance, keep the inflation balloon inflated and compress Trigeminal nerve meniscus 60S, extract the contrast agent, withdraw the compression balloon catheter assembly and catheter sheath, compress the puncture point to stop bleeding, and the operation is completed.

The advantages of the present invention are as follows:

1. A skeleton is set in the support tube, and the skeleton is woven into a mesh shape by fibers. The support strength and tensile strength of the support tube are enhanced to prevent the balloon from breaking and failing during use, and the broken part remains in the skull, avoiding medical sources. Risk of sexual injury and infection.

2. Use metal fibers or fibers with a developing layer to weave into a skeleton, and the skeleton undertakes the developing function.

3. A through hole is set in the wrapping section of the support tube covered by the expansion balloon to realize liquid injection and exhaust. After the expansion balloon is filled, the original gas in the balloon and the support tube is completely discharged, and the contrast developer completely fills the balloon. The balloon visualization is complete, which improves the convenience of surgical operation and the clarity of surgical key correction.

4. The expansion balloon and the support tube are tightly attached with a binding piece, and the axial position of the balloon is locked. After the contrast contrast agent is injected into the balloon, the balloon can only be filled and expanded in the radial direction. The shape of the balloon is reliable and the ball The connection between the bladder and the support tube is reliable.

5. The catheter sheath and puncture needle are combined by hooks and ribs. When the puncture needle is unlocked and withdrawn from the catheter sheath, the puncture needle does not rotate or shake, so as to avoid disturbance to the catheter sheath when the puncture needle is withdrawn.

6. Make the needle of the puncture needle blunt, avoid puncture or cut the blood vessels, nerves, muscles and other tissues by the needle during the puncture process, improve the safety of the operation and reduce the risk of the operation.

Description of drawings

Figure 1 is a schematic representation of the trigeminal nerve and meniscus on the face.

Figure 2 is a schematic illustration of a compression balloon catheter assembly.

Figure 3 is a schematic illustration of a dilation balloon.

Figure 4 is a schematic diagram of a skeleton.

FIG. 5 is a schematic view of a support tube provided with a through hole.

Figure 6 is a schematic view of the attached balloon.

Figure 7 is a schematic diagram of the connection of the compression balloon catheter assembly to the additional balloon.

Figure 8 is a schematic diagram of the combination of the puncture needle and the introducer sheath.

Figure 9 is a schematic view of a puncture needle.

Figure 10 is a schematic view of a needle hub.

Figure 11 is a schematic illustration of a introducer sheath.

Figure 12 is a schematic view of the sheath.

Fig. 13 is a perspective view of the combination of the needle base and the sheath base.

Detailed ways

The structures involved in the present invention or the technical terms used are further described below. If there is no special indication, they should be understood and interpreted according to the general knowledge in the art.

Detachable combination

A detachable combination means that the connection relationship between the two components is in several different states or positional relationships. For example, when there are two physical components, they can be separated at the beginning. In one case connected or combined together, when in a suitable second case, the two parts may be separated, this separation being physically separated in space without touching. Alternatively, the two parts are initially combined, and when appropriate, the two parts can be physically separated. In a word, the combination of the two or the separation between the two can be easily carried out, and the combination or separation can be repeated for multiple cycles, of course, it can also be a one-time combination and separation. In addition, it may be a detachable combination of two components, or a detachable combination of three or more components. For example, there are first, second and third parts, the first part and the second part are detachable combination, the second part and the third part can also be detachable combination.

Metal Materials for Medical Use

Medical metal materials are metals or alloys used for biomedical materials, also known as surgical metal materials, which are a class of inert materials. Such materials have excellent properties such as high mechanical strength, fatigue resistance and easy processing. Common medical metal materials include but are not limited to: medical stainless steel (main components are 316, 36L, 317L), medical cobalt-based alloys, medical titanium and titanium alloys, medical magnesium alloys, gold, silver, platinum and other precious metals, as well as chemically stable Tantalum, niobium, zirconium, nickel-titanium shape memory alloys with good properties and good resistance to physiological corrosion.

Device for percutaneous trigeminal meniscus balloon compression

As shown in Figures 2 and 3, the device for percutaneous trigeminal nerve meniscus balloon compression includes a compression balloon catheter assembly, which includes a dilation balloon 2 and a support tube 4. The dilation balloon 2 At the end of the support tube 4. The expansion balloon 2 is made of elastic material, and is a compliant balloon or a semi-compliant balloon. The contrast contrast agent flows into the position of the expansion balloon 2 through the lumen of the support tube 4 through the syringe. With the injection of the contrast contrast agent, the expansion balloon 2 is filled and expanded under the action of the liquid, and the expansion balloon 2 is formed according to the space in which it is located. corresponding shape. During percutaneous trigeminal meniscus balloon compression, the shape of Mickel's cavity is pear-shaped, so when the dilation balloon 2 is pear-shaped on the radiographic image, it indicates that the balloon is in the correct position. The material of the expansion balloon 2 may be elastic medical materials such as natural latex, polyurethane, thermoplastic elastic polymer material, and silicone.

The pipe body is made of polymer material, and the polymer material is Pebax, or PVC, or PE, or PP, or PTFE.

As shown in FIG. 2 , the support tube 4 has a connection seat, the connection seat and the expansion balloon 2 are located at two ends of the support tube 4 respectively, and the additional balloon is connected to the connection seat. The connecting seat can use a standard injection connector for matching with a syringe, and the syringe is used to inject the contrast contrast agent into the expansion balloon 2 .

skeleton for support

In order to avoid fracture failure of the support pipe 4, a skeleton is arranged in the support pipe 4, and the rigidity and toughness of the support pipe 4 are improved by using the skeleton.

As shown in FIG. 4 , in some embodiments, the support tube 4 includes a frame 42 and a tube body 41 . The skeleton 42 runs through the entire effective use length of the pipe body 41 , the skeleton 42 has toughness and rigidity, and the skeleton 42 provides the pipe body 41 with supporting strength and tensile strength.

In some embodiments, the support tube 4 includes a skeleton layer and a tube body layer, and the skeleton layer is wrapped in the tube body layer.

First make the skeleton 42, and then coat the skeleton 42 with the tube body 41, the skeleton 42 becomes the skeleton layer, and the tube body 41 becomes the tube body layer, and then the assembly of the tube body 41 and the skeleton 42 is subjected to heat treatment, etc., so that the tube body layer and the skeleton are formed. Layers are compounded together.

Alternatively, the support tube 4 includes a skeleton layer, an inner tube body layer and an outer tube body layer, and the skeleton layer is between the inner tube body layer and the outer tube body layer. For example, first make the inner tube body 41 (the polymer tube body 41 can be obtained by extrusion or injection molding), then wrap the frame 42 in the inner tube body 41 , and then extrude the outer tube body layer outside the frame 42 . The inner and outer tubular body layers enclose the skeleton 42 . The inner tube body layer and the outer tube body layer can be heat treated or not.

In some embodiments, the skeleton 42 is woven from at least one fiber, and when one fiber is used for weaving, the skeleton 42 may be wound into a spiral, or the skeleton 42 may be woven like a sweater. Preferably, the skeleton 42 is woven in a mesh shape. Preferably, the skeleton 42 is woven into a hollow mesh; alternatively, the fibers of the skeleton 42 are abutted against each other, and no holes are deliberately left during weaving. It is woven into a mesh so that the skeleton 42 has both support strength and tensile strength. Preferably, the skeleton 42 has toughness and rigidity. The skeleton 42 is in the shape of a hollowed-out mesh, and only needs to open a hole on the tube body 41, and when the contrast developer is injected, the developer enters the expansion airbag through the hollowed-out part to fill the expansion airbag. When the skeleton 42 cannot be left hollow, holes need to be made on the tube body 41 to allow the developer to flow into the expansion balloon through the gap between the fibers, or several holes are provided on the skeleton 42 so that the developer can enter the expansion balloon.

In some embodiments, the backbone 42 is woven into a web from 2-64 fibers. With the mesh structure, even if a certain fiber breaks, it will not cause the skeleton 42 and the entire support tube 4 to break and fail, and the reliability is high. The skeleton 42 is in a tubular shape; or, the skeleton 42 is a mesh sheet, and the skeleton 42 is in a tubular shape under the constraint of the tube body 41 . Whether the skeleton 42 is directly braided into a tubular shape, or the planar skeleton 42 is formed into a tubular shape under the action of the tubular body 41, as long as the combination of the skeleton 42 and the tubular body 41 and the support of the skeleton 42 to the tubular body 41 are not affected, any The original form can be.

Skeleton for development 42

When the support tube 4 and the expansion balloon 2 enter the patient, it is necessary to monitor the degree of entry of the support tube 4 and the expansion balloon 2 under the influence of X-rays. Therefore, the frame 42 of the support tube 4 is woven with fibers that can be visualized under X-rays. Thus, the skeleton 42 undertakes the imaging function to monitor the situation of the expansion balloon 2 entering the body.

In some embodiments, the backbone 42 is woven into a web from 2-64 fibers. With the mesh structure, even if a certain fiber breaks, it will not cause the skeleton 42 and the entire support tube 4 to break and fail, and the reliability is high.

The skeleton 42 is in a tubular shape; or, the skeleton 42 is a mesh sheet, and the skeleton 42 is in a tubular shape under the constraint of the tube body 41 . Whether the skeleton 42 is directly braided into a tubular shape, or the planar skeleton 42 is formed into a tubular shape under the action of the tubular body 41, as long as the combination of the skeleton 42 and the tubular body 41 and the support of the skeleton 42 to the tubular body 41 are not affected, any The original form can be.

The difference between the skeleton 42 for developing and the skeleton 42 for supporting is that the fibers woven into the skeleton 42 are different. The skeleton 42 for developing is woven from fibers with developability, and the skeleton 42 for supporting can be used as long as the fibers have toughness and support rigidity regardless of whether the skeleton 42 has developability or not. The developing skeleton 42 is woven with developing fibers, which does not prevent the developing skeleton 42 from having the same structure as the supporting skeleton 42 .

In some embodiments, as shown in FIG. 4, the backbone 42 has at least one fiber that is imageable under x-ray. In this way, the frame 42 can not only improve the support strength and tensile strength of the support tube 4, but also have developability. Preferably, the developable fibers are metal wires; or, the developable fibers have a developing layer. Preferably, the developing layer is a metal layer, such as plastic or glass fiber with a metal coating, or the developing layer is a metal wire, and a polymer surface layer is attached to the metal wire. The developer layer can also be a developer coating. During the operation, the skeleton 42 can provide intraoperative visualization, and the imaged area includes the entire support tube 4, and is not limited to the expansion balloon.

Alternatively, at least one fiber in the skeleton 42 is visualized in the region where the expansion balloon 2 is located. For example, the fibers of the skeleton 42 are provided with an imaging layer only in the region where the expansion balloon 2 is located, so that only the expansion balloon 2 has imaging properties.

Exhaust Micro Holes

In order to be able to exhaust the inside of the tube body 41 or the expansion balloon 2 at the same time as the contrast developing solution is injected, so that the contrast developing solution can be filled with the balloon, micro-holes (through holes) are arranged on the support tube 4 to carry out liquid passing and exhausting. , as shown in Figure 5.

In some embodiments, the wrapping section of the support tube 4 wrapped by the expansion balloon 2 is provided with a through hole 5 , and the through hole 5 is far away from the end of the support tube 4 .

During percutaneous trigeminal meniscus balloon compression, the patient after general anesthesia is placed in a supine position, and a wrapping roll with an appropriate height is placed under the shoulder to ensure mild neck extension. Therefore, in a normal body position, the support tube 4 and the balloon are inserted into the human body obliquely downward, and the end of the support tube 4 is the lowest. The fact that the through hole 5 is far away from the end of the support tube 4 means that the through hole 5 is higher than the end of the support tube 4 under the normal body position during the operation. The contrast developer is a liquid, which is heavier than air, so when the balloon 2 is inflated, the liquid flows downward and the air escapes upward. During the operation, the injection of the contrast contrast agent was injected with a syringe by suction. When the contrast agent was injected, the contrast contrast agent flowed downward and the balloon 2 was expanded; when the air was pumped, the original gas in the balloon and the support tube 4 escaped upward to Support tube 4 proximal end and in the syringe. The proximal end refers to the end that is close to the operator, and the distal end refers to the direction away from the operator.

The diameter of the through hole 5 is 0.2 to 1.5 mm. The through hole 5 in this size range not only avoids greatly reducing the rigidity of the support tube 4 and reduces the risk of fracture and failure of the support tube 4, but also enables the expansion balloon 2 to be vented while injecting liquid. The number of the through holes 5 is one or more. When there are a plurality of through holes 5, there is a distance between the through holes 5. The number of the through holes 5 can ensure the support strength and/or tensile strength of the support tube 4, so that the gas and contrast developer can be smoothly passed in and out, and the pressure in the balloon can be accurately transmitted to the syringe to provide an operating feel.

In some embodiments, the surface of the wrapping segment has concave diversion grooves. After the control developer flows out of the through hole 5, it flows along the guide groove to the distal end of the support tube 4, so that the distal end of the balloon is expanded and filled before the proximal end. Preferably, the guide groove is beside the through hole 5, or the through hole 5 is arranged on the guide groove. Preferably, the number of guide grooves is one or more. Preferably, each guide groove corresponds to at least one through hole 5 . Preferably, the diversion grooves are symmetrically distributed along the support tube 4, so that the contrast developing solution can be injected uniformly, which is beneficial to the uniform expansion of the balloon.

In some embodiments, the support tube 4 includes a frame 42 and a tube body 41 , the frame 42 is woven from fibers, and the through holes 5 are provided in the tube body 41 , and the through holes 5 avoid fibers. The fact that the through holes 5 avoid fibers means that there is no need to interrupt the fibers to form the through holes 5 , so as to avoid damage to the fibers of the frame 42 and reduce the strength of the support tube 4 .

Binder

In order to expand the balloon only in the radial direction, the proximal and distal ends of the balloon are tied by tying, as shown in FIGS. 3 and 5 .

In some embodiments, the proximal and distal ends of the balloon are respectively provided with binding members 1 and 3 for fixing the balloon and the support tube 4 .

The purpose of the straps 1, 3 is to form a closed bag. The proximal and distal ends of the balloon are respectively tied and fixed. When the contrast agent is injected, the proximal and distal ends of the balloon are fixed, so the balloon can only be inflated and expanded radially to avoid the occurrence of balloon damage to the anterior tissue. impact, and all the injected contrast contrast agent is concentrated in the designated area (the area between the proximal bundles 1, 3 and the distal bundles 1, 3), which is conducive to the complete visualization of the balloon under X-ray, and Maintain the support strength of the balloon. The most important thing is that the distal bundles 1 and 3 closely fit the balloon to the support tube 4, and the contrast contrast agent cannot enter any part farther than the distal bundles 1 and 3, so that the balloon is naturally inflated. It is capsule-shaped or spherical, and will not be pear-shaped due to the restraint of the distal bundles 1 and 3, so as to avoid misjudgment of the shape of the balloon during surgery.

The binding members 1 and 3 of the balloon are ropes, or the binding members 1 and 3 of the balloon are diameter reducing rings. When the rope or the diameter reducing ring is assembled, the balloon and the support tube 4 are tightly combined by external force to form a closed balloon body. Both the proximal end and the distal end of the balloon may use a diameter reducing ring, or only the proximal end of the balloon may use a shrinking ring. This is by using the visualization of the metal ring under X-ray, and using the metal tightening ring at the proximal end to identify whether the dilation balloon 2 protrudes from the catheter sheath.

In some embodiments, the support tube 4 includes a frame 42 and a tube body 41 , and the frame 42 is woven from fibers with developing properties. The function of the binding members 1 and 3 is only to combine the balloon and the support tube 4 to form a closed bag body, and the skeleton 42 undertakes the intraoperative visualization function. The reducing ring functions to make the balloon and the support tube 4 a tight sealing fit.

In some embodiments, a through hole 5 is formed on the support tube 4 , the through hole 5 is located between the two binding members 1 and 3 , and the through hole 5 is close to the proximal binding member 3 and away from the distal binding member 3 .

Additional balloon

In order to keep the pressure in the expansion balloon 2 stable, or to detect the leakage or rupture of the expansion balloon 2 in time, an additional balloon connected to the compression balloon catheter assembly is provided outside the body, as shown in Figures 6-8.

In some embodiments, the distal end of the support tube 4 is connected to an externally placed additional balloon 6, and the additional balloon 6 is connected to the input source of the contrast medium.

The additional balloon 6 is outside the body, and the control contrast agent is firstly injected into the additional balloon 6, and then into the in vivo expansion balloon 2 through the additional balloon 6. In this way, the additional balloon 6 buffers the injection pressure of the control contrast agent. In addition, the inflation balloon 2 is exhausted while injecting liquid, or due to the compressibility of air, after the syringe completes the injection of the contrast developer, the pressure of the inflation balloon 2 will decrease. At this time, the additional balloon 6 The contrast contrast agent will be automatically filled into the expansion balloon 2, and the constant pressure in the expansion balloon 2 will be maintained. Alternatively, when the dilation balloon 2 in the body leaks or is damaged, the contrast contrast agent in the additional balloon 6 will continue to be input into the expansion balloon 2, resulting in rapid consumption of the contrast contrast agent in the additional balloon 6, reminding the operator of an abnormal operation .

In some embodiments, the additional balloon 6 includes a catheter and a balloon body, and the catheter has a second connector 7; the second connector 7 is connected to an input source of contrast medium. The second joint 7 adopts a standard injection joint to improve the applicability, for example, the second joint 7 is a Luer one-way valve. The additional balloon 6 is made of an inflatable and deformable elastic material, and the catheter is made of an inflatable material.

In some embodiments, as shown in FIG. 8 , the balloon 61 is wrapped on the surface of the catheter 62 , the proximal end and the distal end of the balloon 61 are sealed and connected to the catheter respectively, the balloon 61 is a closed balloon, and the catheter 62 has a direction toward the balloon. The liquid through hole 63 through which the body enters the liquid, and the liquid through hole 63 is close to the distal end and away from the proximal end. This is to comply with the normal body position during surgery. When injecting fluid during the operation, the distal end is higher than the proximal end, which is convenient for fluid injection and exhaust. The balloon body 61 is an elastic membrane, and the balloon body 61 is fixed to the catheter by a tightening member; or, the balloon body 61 is an elastic membrane, and the catheter 62 is sealed and connected by bonding, hot pressing and other processes. The number of liquid through holes is one or more. The liquid through holes 63 are micro holes, so the arrangement of the liquid through holes does not affect the support strength and tensile strength of the catheter.

As shown in FIG. 4 , the catheter includes a support frame 42 and a catheter body 41 , and the support frame 42 is woven into a net by fiber filaments; the liquid through holes avoid the fiber filaments. The support frame 42 enhances the support strength and tensile strength of the catheter, and the arrangement of the liquid through holes will not cause the fiber filaments to break, and will not affect the strength of the support frame 42 .

The catheter 8 includes a support skeleton layer and a catheter body layer, and the support skeleton layer is wrapped in the catheter body layer. That is to say, the support frame 42 and the catheter body are two layers, the support frame 42 is inside the tube body 41, and the support frame 42 plays a role in enhancing the rigidity of the tube body 41. As long as the support frame 42 does not break, the tube body 41 will not occur. Fracture failure.

Alternatively, the support frame 42 is located inside the catheter 8, and the support frame 42 and the catheter body are on the same layer. For example, the support frame 42 is first fabricated, and then the catheter material is filled into the support frame 42, so that the support frame 42 is a part of the catheter body. For another example, the support frame 42 is first fabricated, then the conduit 8 is coated on the support frame 42, and then the assembly of the conduit 8 and the support frame 42 is heat-treated, so that the frame 42 and the conduit 8 are integrated into one or one layer.

In some embodiments, the conduit 8 and the support tube 4 are the same tube.

As shown in FIG. 7 , in some embodiments, the conduit 8 and the support tube 4 are independent of each other, the conduit 8 has a first joint 9 , and the first joint 9 is detachably connected to the connection seat of the support tube 4 . The first joint adopts a standard injection joint, which is used for connecting with the connecting seat of the support tube 4 . For example, the first connector is a male Luer connector.

As shown in FIG. 6 and FIG. 7 , in some embodiments, the two ends of the balloon body are respectively connected to the first tube body 81 and the second tube body 82 , one end of the first tube body 81 is sealingly connected to the balloon body, and the other end is provided with a first joint One end of the second tube body 82 is sealed and connected to the bag body, and the other end is provided with a second joint 7 .

Alternatively, as shown in FIG. 8 , the tube body 41 includes a first tube body 81 and a second tube body 82 connected by a tee, and the third port of the tee is sealingly connected to the bladder. The contrast contrast agent is injected into the additional balloon 6 first, and then into the expansion balloon 2. The additional balloon 6 communicates with the expansion balloon 2 and the pressure is balanced; when the pressure in the expansion balloon 2 changes, it will be transmitted to the additional balloon outside the body. 6. It is convenient for operators to observe, and the catheter 8 is a medical polymer catheter tube body.

Rib - hook mechanism

In order to prevent the introducer sheath from being disturbed when the puncture needle and the introducer sheath are separated, a rib-hooking mechanism is used to limit the detachable combination of the puncture needle and the introducer sheath.

In some embodiments, a device for percutaneous trigeminal meniscus balloon compression includes a puncture needle set comprising a puncture needle 11 and a catheter sheath 10, the puncture needle 11 having a needle hub 111 and a needle tube, a catheter The sheath 10 has a sheath seat 101 and a sheath tube; when the puncture needle 11 and the catheter sheath 10 are in a combined state, the needle tube is inserted into the sheath tube and fits with the sheath tube, the needle seat 111 and the sheath seat 101 are locked, and the needle seat 111 and the sheath seat 101 are released When locked, the puncture needle 11 and the catheter sheath 10 are released from combination. After the puncture needle 11 is disassembled from the catheter sheath 10, the needle tube can move freely in the sheath tube.

A detachable combination is achieved between the needle base 111 and the sheath base 101 through a rib-clamping hook mechanism. When the hook A hooks the rib B, the needle base 111 is combined with the sheath base 101; when the hook A releases the rib B, The needle base 111 and the sheath base 101 are disassembled.

During percutaneous trigeminal meniscus balloon compression, the patient's lateral incision is punctured with the puncture needle 11 and the catheter sheath 10 in a combined state under an X-ray environment. Guide the puncture needle 11 set into the foramen ovale through the influence of X-ray positioning, but do not pierce the upper edge of the foramen ovale. When the puncture needle 11 is punctured in place, release the combination of the puncture needle 11 and the catheter sheath 10, and pull out the puncture needle 11 , the catheter sheath 10 is indwelling in the body. Then, the assembly of the compression balloon catheter 8 is inserted along the lumen of the catheter sheath 10, and the insertion depth is determined by the influence of X-rays. The combination of the puncture needle 11 and the catheter sheath 10 is realized by using the hook A and the rib B. When unlocking and realizing the combination, only the hook A or the rib B needs to be operated, and the needle holder 111 does not rotate. Displacement, the introducer sheath 10 will not be disturbed by the needle base 111 , so as to maintain the stable position of the introducer sheath 10 in the body and avoid the deviation of the sheath tube.

The rib B is in line contact with the hook A, and the rib B is a straight line segment. The rib B and the hook A are respectively straight segments, realizing the combination of the rib B and the hook A, and when the rib B and the hook A are in the combined state, the rotational degrees of freedom of the rib B and the hook A are unified, Therefore, the rotational degrees of freedom of the needle base 111 and the sheath base 101 are unified, and during puncture, the force of holding the sheath base 101 can be completely transmitted to the needle tube, and there is no relative rotation between the needle base 111 and the sheath base 101 .

The needle seat 111 and the sheath seat 101 are in clearance fit. When the hook A releases the rib B, the needle holder 111 can be easily pulled away from the sheath holder 101 without causing the sheath holder 101 to be displaced.

The hook A includes a hook A1 and a lever arm A2. The lever arm A2 is provided with a fulcrum A3, which is connected to the needle base 111 or the fulcrum A3 is connected to the sheath base 101. A1 is located on both sides of the lever arm A2, respectively. The force application part is the part that receives the external force. When the external force acts on the force application part, the lever rotates around the fulcrum A3, and the hook A1 hooks or releases the rib B.

Or, the hook A is fixed, the rib B is connected to the moving mechanism, the rib B protrudes and hooks with the hook A when the moving mechanism is in the first position, and the rib B is separated from the hook A when the moving mechanism is in the second position; The moving mechanism includes a lever connected with the rib B and a guide groove allowing the rib B to move in it.

The hook A is located at the needle base 111, the fulcrum A3 of the hook A is hinged with the needle base 111, and the rib B is located at the sheath base 101; The rib B is located in the needle seat 111 . Preferably, the fulcrum A3 is provided with a pin shaft and a torsion spring, or the fulcrum A3 is a flexible hinge. The torsion spring realizes the position locking and automatic reset of the hook A. Preferably, the hook A1 is located at one end of the lever arm A2, and the force applying portion is located at the other end of the lever arm A2. Preferably, the distance between the force applying portion and the fulcrum A3 is smaller than the distance between the hook A1 and the fulcrum A3. The lever arm A2 realizes the amplification of the force. Preferably, there is a pair of hooks A, a pair of hooks A are symmetrically arranged, and each hook A corresponds to a rib B. To release the rib B from the hook A, pinch the force-applying parts of the two hooks A with your hands, swing the hook A outward, and release the rib B.

The sheath seat 101 is provided with a ring of flanges protruding outward, the flanges are rectangular or square, and two opposite flange edges are used as ribs B. Preferably, the two flange edges except the rib B are respectively connected to the respective reinforcing plates B1 , and the reinforcing plates B1 are connected to the sheath seat 101 . The reinforcing plate B1 plays the role of support and stability. The sheath seat 101 is provided with an auxiliary support portion, the auxiliary support portion is parallel to the flange, and the reinforcing plate B1 extends from the flange to the auxiliary support portion. The shape of the auxiliary support portion is the same as that of the flange. During the puncture action, the operator holds the B1 part of the reinforcing plate and pushes it to the distal end, so as to control the direction and strength of the puncture.

The puncture needle 11 is made of metal material, such as stainless steel, titanium, nickel, platinum, gold, silver or one or more alloys thereof. The catheter sheath 10 is made of metal material or medical polymer material.

dulled needle

In order to prevent the needle of the puncture needle 11 from damaging the tissue during puncturing, the needle of the puncture needle 11 is set as a blunt needle.

In some embodiments, when the puncture needle 11 is combined with the catheter sheath 10, the needle 112 of the puncture needle 11 is exposed to the sheath, and the needle 112 of the puncture needle 11 is blunt. Preferably, the needle 112 is formed by tapering distally from the needle tube, and the needle 112 is blunt without sharp corners or cutting edges. The needle head 112 is a ball head, and the radius of the ball head is 0.3-0.5mm. Alternatively, the needle 112 is domed or blunted. The puncture needle 11 is a metal needle, or the puncture needle 11 includes a non-metallic body, and the surface of the non-metallic body has a developing layer. The developer layer is a developer coating, or the developer layer is a metal layer. For example, the puncture needle 11 includes a plastic needle tube, and the surface of the plastic needle tube has a metal coating, and the metal coating is used for developing under X-rays.

After blunting the needle 112, the needle 112 is free of cutting edges and/or spikes. During percutaneous trigeminal nerve meniscus balloon compression, the puncture needle 11 component is advanced distally, and the needle 112 is blunted, which will not cause cutting or stab wounds to body tissues (such as blood vessels, nerves, muscles, etc.) . The needle 112 is set to have a diameter of 0.3-0.5 mm, which conforms to the interstitial space in the human body, and avoids puncturing and squeezing tissues such as blood vessels and/or nerves.

All patents and publications mentioned in the specification of the present invention indicate that they are disclosed technology in the art and can be used in the present invention. All patents and publications cited herein are also incorporated by reference as if each publication was specifically and individually incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, no such limitation specifically stated herein. For example, the terms "comprising", "consisting essentially of" and "consisting of" in each instance herein may be replaced by either of the remaining two terms. The terms and expressions used herein are by way of description, not limitation, and there is no intention here to indicate that these terms and interpretations described in this book exclude any equivalent features, but it is understood that the present invention and the rights make any suitable changes or modifications to the extent required. It can be understood that the embodiments described in the present invention are all preferred embodiments and features, and any person skilled in the art can make some changes and changes according to the essence of the description of the present invention, and these changes and changes are also considered to belong to The scope of the invention is limited by the independent and dependent claims.

Claims (11)

1. The device for percutaneous trigeminal semilunar ganglion balloon compression comprises a compression balloon catheter assembly, wherein the compression balloon catheter assembly comprises an expansion balloon and a support tube, and the expansion balloon is positioned at the end part of the support tube; the method is characterized in that: the support tube comprises a framework and a tube body.

2. The device of claim 1 for percutaneous trigeminal meniscal balloon compression, wherein: the skeleton runs through the effective use length of whole body.

3. The device for percutaneous trigeminal meniscal balloon compression of claim 1 or 2, wherein: the supporting tube comprises a framework layer and a tube body layer; the framework layer is coated in the pipe body layer; alternatively, the support tube includes a carcass layer, an inner tubular layer and an outer tubular layer, the carcass layer being between the inner and outer tubular layers.

4. The device for percutaneous trigeminal meniscal balloon compression of claim 1 or 2, wherein: the framework is positioned in the pipe body, and the framework and the pipe body are in the same layer.

5. The device for percutaneous trigeminal meniscal balloon compression of claim 1 or 2, wherein: the skeleton is formed by weaving at least 1 fiber.

6. The device of claim 5 for percutaneous trigeminal meniscal balloon compression, wherein: the framework is woven into a net shape.

7. The device of claim 6 for percutaneous trigeminal meniscal balloon compression, wherein: the skeleton is woven into a hollow net shape; alternatively, the fibers of the skeleton abut one another.

8. The device for percutaneous trigeminal meniscal balloon compression of claim 1 or 2, wherein: at least one fiber capable of developing under X-ray in the framework; or at least one fiber in the skeleton has developing property in the area where the expansion balloon is positioned.

9. The device for percutaneous trigeminal meniscal balloon compression of claim 1 or 2, wherein: the skeleton is woven into a net by 2-64 strands of fibers.

10. The device for percutaneous trigeminal meniscal balloon compression of claim 1 or 2, wherein: the framework is tubular; or the framework is a mesh, and the framework is in a tubular shape under the constraint of the pipe body.

11. The device of claim 1 for percutaneous trigeminal meniscal balloon compression, wherein: the supporting tube is provided with a connecting seat, and the connecting seat and the expansion balloon are respectively positioned at two ends of the supporting tube; or the device comprises a puncture needle assembly which comprises a puncture needle and a catheter sheath, wherein the puncture needle is provided with a needle head seat and a needle tube, the catheter sheath is provided with a sheath seat and a sheath tube, and the puncture needle and the catheter sheath are detachably combined.

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