CN211022805U - Constant-pressure trigeminal semilunar compression balloon - Google Patents

Abstract

The constant-pressure trigeminal semilunar junction compression balloon 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 far end of the supporting tube is connected with an additional saccule which is positioned outside the body, and the additional saccule is connected with an input source of contrast medium; the utility model has the advantages that the additional saccule can buffer the injection pressure of contrast developer in vitro; when the pressure in the expansion sacculus changes, the pressure can be transmitted to the additional sacculus outside the body, so that an operator can observe the additional sacculus conveniently, and the operator can be reminded of possible abnormal conditions of the operation.

Description

Constant-pressure trigeminal semilunar compression balloon

Technical Field

The utility model relates to a trigeminal semilunar ganglion oppression sacculus of constant voltage.

Background

The existing expansion balloon has the problems that the balloon is uncontrollable and undetectable in vivo, the pressure in the balloon is unstable due to the extrusion of tissues in vivo, and the leakage or rupture of the expansion balloon cannot be known in time.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an instrument good reliability, the high device that is used for percutaneous trigeminal semilunar ganglion sacculus oppression art of security.

A 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 arranged at the end of the support tube. The dilation balloon is made of an elastic material and is a compliant balloon or a semi-compliant balloon. The contrast developer flows into the position of the expansion balloon through the lumen of the support tube by the injector, and the expansion balloon is inflated and expanded under the action of liquid along with the injection of the contrast developer, and forms a corresponding shape according to the space where the expansion balloon is located. During percutaneous trigeminal semilunar ganglion balloon compression, the Mickel's cavity is pear-shaped, thus indicating that the balloon has reached the correct position when the dilatation balloon is pear-shaped in the visualization image. The material of the expansion saccule can be medical materials with elasticity, such as natural latex, polyurethane, thermoplastic elastic high polymer materials, silica gel and the like.

The supporting tube is provided with a connecting seat, the connecting seat and the expansion saccule are respectively positioned at two ends of the supporting tube, and the additional saccule is connected with the connecting seat. The connecting seat can adopt a standard injection joint for matching with an injector, and the injector is used for injecting contrast developer into the expansion balloon.

The utility model discloses an aspect provides an avoid stay tube fracture inefficacy device.

Preferably, the support tube comprises a framework and a tube body. The skeleton runs through the effective use length of whole body, and the skeleton has toughness and rigidity, and the skeleton provides support intensity and tensile strength for the body. The tube body is made of medical polymer materials, and the 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 and the like.

Preferably, the support tube comprises a framework layer and a tube body layer, and the framework layer is coated in the tube body layer. The method comprises the steps of manufacturing a framework, sleeving a pipe body on the framework to form a framework layer, forming the pipe body into a pipe body layer, and performing heat treatment and the like on the pipe body and framework assembly to compound the pipe body layer and the framework layer together.

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. For example, the inner tube body (a polymer tube body can be obtained by extrusion molding or injection molding) is manufactured first, then the skeleton is wrapped on the inner tube body, and then the outer tube body layer is extruded outside the skeleton. The inner tube body layer and the outer tube body layer wrap the framework. The inner tube body layer and the outer tube body layer can be subjected to heat treatment or not.

The skeleton plays the effect of reinforcing body rigidity, as long as the skeleton does not fracture, then the body can not take place fracture inefficacy.

Or the framework is positioned in the pipe body, and the framework and the pipe body are in the same layer. For example, a framework is first fabricated and then filled with a catheter material, such that the framework is a part of the interior of the body. For example, the skeleton is firstly manufactured, then the skeleton is used as an insert to extrude the pipe body, the skeleton is embedded in the pipe body, and the skeleton and the pipe body are fused into a whole or a layer.

Preferably, the skeleton is formed by weaving at least 1 fiber, and the skeleton can be formed by winding the 1 fiber into a spiral form or weaving the fiber into a sweater form. Preferably, the skeleton is woven in a net shape. Preferably, the framework is woven into a hollow net shape; or the fibers of the framework are attached to each other, so that no cavity is left during weaving. The framework is woven into a net shape, so that the framework has both supporting strength and tensile strength. The skeleton has toughness and rigidity. The skeleton is the netted of fretwork, only needs trompil on the body, can be when pouring into contrast developer into, and the developer gets into the expansion gasbag through fretwork department, makes the expansion gasbag full. When the frame cannot be kept with a cavity, a hole needs to be formed in the tube body, and the developer flows into the expansion air bag through the gap between the fibers, or a plurality of holes are formed in the frame so that the developer can enter the expansion air bag.

Preferably, the skeleton is woven into a web from 2 to 64 strands of fibers. Even if a certain fiber is broken, the net-shaped structure can not lead to the failure of the skeleton and the whole supporting tube due to breakage, and the reliability is high.

Preferably, the skeleton is tubular; or the framework is a mesh, and the framework is in a tubular shape under the constraint of the pipe body. No matter the framework is directly woven into a tubular shape or the planar framework forms a tubular shape under the action of the pipe body, the framework can be in any original shape as long as the combination of the framework and the pipe body and the support of the framework on the pipe body are not influenced.

Preferably, at least one fiber in the framework is developable with X-rays. Thus, the framework not only can improve the supporting strength and the tensile strength of the supporting tube, but also has developing property. Preferably, the developable fibers are metal wires; alternatively, the developable fibers have a development layer. Preferably, the developing layer is a metal layer, such as a metal coating on plastic or fiberglass, or the developing layer is a metal wire with a polymer surface layer attached to the wire. The developer layer may also be a developer coating. The frame can provide intraoperative visualization during surgery, with the visualization area encompassing the entire support tube and not just the dilatation balloon.

Alternatively, at least one fiber in the scaffold has visualization in the region of the dilatation balloon. For example, the fibers of the skeleton are provided with the developing layer only in the region where the balloon is to be expanded, so that the developing property is achieved only in the balloon to be expanded.

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

The second aspect of the utility model provides a can be when contrast developing solution pours into, to the internal or expansion sacculus exhaust of geminate transistors, make the contrast developing solution be full of the device of sacculus.

As the preferred scheme, the wrapping section of the supporting tube wrapped by the expansion saccule is provided with a through hole, and the through hole is far away from the end of the supporting tube.

During the percutaneous trigeminal semilunar ganglion sacculus oppression art of going, the patient after general anesthesia takes the supine position, and shoulder pad drape book of suitable height is in order to guarantee that the neck slightly extends. Therefore, in a normal position, the supporting tube and the balloon penetrate into the human body obliquely downwards, and the end part of the supporting tube is the lowest. The through hole is far away from the end of the supporting tube, which indicates that the through hole is higher than the end of the supporting tube in the normal position in the operation. The contrast developer is a liquid, which is heavier than air, so when the balloon is inflated, the liquid flows down and the air escapes up. In the operation, the injection of the contrast developer is performed in a suction type by using an injector, and during the injection, the contrast developer flows downwards and the saccule expands; during air suction, the original gas in the saccule and the support tube escapes upwards to the proximal end of the support tube and the injector. Proximal refers to the end closer to the operator and distal refers to the direction away from the operator.

Preferably, the diameter of the through hole is 0.2-1.5 mm. The through hole with the size range not only avoids greatly reducing the rigidity of the supporting tube and reduces the risk of fracture failure of the supporting tube, but also can realize that the expansion balloon injects liquid and exhausts gas at the same time. Preferably, the number of the through holes is 1 or more. Preferably, when there are a plurality of through holes, there is a distance between the through holes. The number of the through holes is only required to ensure the supporting strength and/or the tensile strength of the supporting tube, so that the gas and contrast developer can smoothly enter and exit, and the pressure in the saccule can be accurately transmitted to the injector to provide operation hand feeling.

Preferably, the surface of the wrapping section is provided with a concave diversion trench. After the contrast developing solution flows out of the through hole, the contrast developing solution flows to the far end of the supporting tube along the diversion trench, so that the far end of the saccule is expanded and filled before the near end. Preferably, the diversion trench is beside the through hole, or the through hole is arranged on the diversion trench. Preferably, the number of the guide grooves is 1 or more. Preferably, each flow guide groove corresponds to at least one through hole. Preferably, the guide grooves are symmetrically distributed along the support tube, so that the contrast developing solution is uniformly injected, and the balloon is uniformly expanded.

As preferred scheme, the stay tube includes skeleton and body, and the skeleton is woven by the fibre and is formed, and the through-hole sets up in the body, and the fibre is kept away from to the through-hole. The through holes avoid the fibers, that is, the through holes are formed without interrupting the fibers, so that the fibers of the framework are prevented from being damaged, and the strength of the supporting tube is reduced.

The third aspect of the utility model provides a near-end and the distal end of sacculus are all tied up, and when contrast developer was injected, the sacculus radially expanded, only small or do not have the device of axial antedisplacement.

Preferably, the near end and the far end of the balloon are respectively provided with a tying piece for fixing the balloon and the support tube.

The purpose of the strapping is to form a closed capsule. The near end and the far end of the balloon are respectively fastened and fixed, when contrast developers are injected, the near end and the far end of the balloon are fixed, so that the balloon can only be radially inflated and expanded, the impact of the balloon on tissues in front is avoided, and all the injected contrast developers are concentrated in a designated area (an area between the near-end binding piece and the far-end binding piece), the complete developing of the balloon under X-rays is facilitated, and the supporting strength of the balloon is kept. Most importantly, the balloon is tightly attached to the supporting tube by the far-end binding piece, and the contrast developer cannot enter a position farther than the far-end binding piece, so that the balloon is in a capsule shape or a spherical shape when being naturally filled, the pear shape cannot be formed due to the restraint of the far-end binding piece, and the misjudgment of the shape of the balloon in the operation is avoided.

Preferably, the tying member of the balloon is a rope, or the tying member of the balloon is a reducing ring. When the rope or the reducing ring is assembled, the saccule and the supporting tube are tightly combined by external force to form a closed sac body.

Preferably, the reducing ring is a thin-wall pipe fitting with the diameter of 1-3 mm. Preferably, the reducing ring is a metal ring made of medical metal. The proximal end and the distal end of the balloon can both adopt reducing rings, or only the proximal end of the balloon can adopt a reducing ring. This is done by using the visualization of the metal ring under X-rays, with a proximal metal constricting ring to indicate whether the dilatation balloon is protruding from the catheter sheath.

Preferably, the support tube comprises a framework and a tube body, and the framework is formed by weaving fibers with developing performance. The binding piece only has the function of combining the balloon and the supporting tube to form a closed capsule body, and the skeleton plays a role in developing during operation.

Preferably, the support tube is provided with a through hole, the through hole is positioned between the two binding members, and the through hole is close to the binding member at the near end and is far away from the binding member at the far end.

The fourth aspect of the present invention provides a device for maintaining constant pressure of an inflatable balloon.

Preferably, the distal end of the support tube is connected to an additional balloon disposed outside the body, the additional balloon being connected to an input source of contrast media.

The additional balloon is arranged outside the body, the contrast developer is firstly input into the additional balloon and then input into the expansion balloon in the body through the additional balloon, and therefore the injection pressure of the contrast developer is buffered by the additional balloon. In addition, the pressure of the expansion balloon is reduced after the expansion balloon is injected with liquid and exhausted at the same time, or the contrast developer in the additional balloon is automatically supplemented into the expansion balloon due to the compressibility of air, so that the constant pressure in the expansion balloon is maintained. Or when the expansion balloon in the body leaks or is damaged, the contrast developer in the additional balloon is continuously input into the expansion balloon, so that the contrast developer in the additional balloon is rapidly consumed, and an operator is reminded of abnormal operation.

Preferably, the additional balloon comprises a catheter and a balloon, and the catheter has a second connector; the second connector is connected to an input source of contrast media. The second connector adopts a standard injection connector, so that the applicability is improved. The additional balloon is made of an expansible and deformable elastic material, and the catheter is made of a non-expansible and inflatable material.

Preferably, the balloon body is wrapped on the surface of the catheter, the near end and the far end of the balloon body are respectively connected with the catheter in a sealing mode, the balloon body is a closed balloon body, and the catheter is provided with a liquid through hole for inputting liquid into the balloon body. Preferably, the access port is proximal to the distal end and distal to the proximal end. The device is in a normal position during operation, and the far end is higher than the near end during injection in the operation, so that the injection and the exhaust are convenient. Preferably, the balloon body is an elastic membrane and is fixed with the catheter through a binding piece; or the balloon body is an elastic membrane, and the catheter balloon body is hermetically connected through bonding, hot pressing and other processes. Preferably, the number of the liquid through holes is 1 or more. The liquid through holes are micropores, so that the support strength and the tensile strength of the catheter are not influenced by the arrangement of the liquid through holes.

Preferably, the conduit comprises a support framework and a conduit body, wherein the support framework is woven by fiber yarns into a net; the liquid through hole avoids the fiber silk. The support framework enhances the support strength and tensile strength of the conduit, and the arrangement of the liquid through hole can not lead to the disconnection of the fiber yarns and does not influence the strength of the support framework.

Preferably, the catheter comprises a support scaffold layer and a catheter body layer, the support scaffold layer being encased within the catheter body layer. That is to say, support skeleton and pipe body are two-layer, support skeleton in the body, and support skeleton plays the effect of reinforcing body rigidity, as long as support skeleton does not fracture, then the body can not break failure.

Or the supporting framework is positioned in the catheter body, and the supporting framework and the catheter body are in the same layer. For example, a support framework is first fabricated, and then a catheter material is filled into the support framework, so that the support framework is used as a part of the catheter body. For example, a support framework is manufactured, a catheter is sleeved outside the support framework, and the catheter and the support framework assembly are subjected to heat treatment and the like, so that the framework and the catheter are integrated into a whole or a layer.

Preferably, the conduit is the same tube as the support tube. Or the guide pipe and the supporting pipe are independent, the guide pipe is provided with a first joint, and the first joint is detachably connected with the connecting seat of the supporting pipe. The first connector is a standard injection connector for connection with a connecting socket of the support tube.

Or the two ends of the bag body are respectively connected with the first pipe body and the second pipe body, one end of the first pipe body is hermetically connected with the bag body, the other end of the first pipe body is provided with a first connector, one end of the second pipe body is hermetically connected with the bag body, and the other end of the second pipe body is provided with a second connector. Or the tube body comprises a first tube body and a second tube body which are connected through a tee joint, and a third interface of the tee joint is connected with the capsule body in a sealing mode. Injecting contrast developer into the additional saccule firstly, and then injecting into the expansion saccule, wherein the additional saccule is communicated with the expansion saccule and the pressure is balanced; when the pressure in the expansion saccule changes, the pressure can be transmitted to the additional saccule outside the body, so that the observation of an operator is facilitated. Preferably, the catheter is a medical polymer catheter body.

The fifth aspect of the utility model provides a device that the catheter sheath is not disturbed when the puncture needle is separated from the catheter sheath.

The device for percutaneous trigeminal semilunar ganglion sacculus compression comprises a puncture needle kit, wherein the puncture needle kit comprises a puncture needle and a catheter sheath, the puncture needle is provided with a needle head seat and a needle tube, and the catheter sheath is provided with a sheath seat and a sheath tube; when the puncture needle and the catheter sheath are in a combined state, the needle tube is inserted into the sheath and is in clearance fit with the sheath, the needle head seat is locked with the sheath seat, and when the needle head seat is unlocked with the sheath seat, the puncture needle and the catheter sheath are not combined. After the puncture needle and the catheter sheath are disassembled, the needle tube can freely move in the sheath tube.

During percutaneous trigeminal semilunar ganglion sacculus compression, a puncture needle and a catheter sheath in a combined state are used for puncturing from a side incision of a patient in an X-ray environment. The puncture needle kit is guided into the oval hole under the influence of X-rays without piercing the upper edge of the oval hole, and after the puncture needle is punctured in place, the combination of the puncture needle and the catheter sheath is released, the puncture needle is pulled out, and the catheter sheath is left in the body. The compression balloon catheter assembly is then inserted along the lumen of the catheter sheath, the depth of insertion being determined by the X-ray effect.

As the preferred scheme, the needle head seat and the sheath seat are detachably combined through a rib-clamping hook mechanism, and when the clamping hook clamps the rib, the needle head seat is combined with the sheath seat; when the clamping hook releases the rib, the needle head seat and the sheath seat are disassembled. The combination of the puncture needle and the catheter sheath is realized by using the modes of the clamping hook and the rib hook buckle, when the locking is released and the combination is realized, only the clamping hook or the rib is needed to operate, the needle head seat has no rotary displacement, and the catheter sheath cannot be disturbed by the needle head seat, so that the stability of the position of the catheter sheath in the body is kept, and the deviation of a sheath tube is avoided.

Preferably, the ribs are in line contact with the clamping hooks, and the ribs are straight-line segments. The ribs and the clamping hooks are straight line segments respectively, so that the combination of the ribs and the clamping hooks is realized, and when the ribs and the clamping hooks are in a combined state, the rotational freedom degrees of the ribs and the clamping hooks are unified, so that the rotational freedom degrees of the needle head seat and the sheath seat are unified, when in puncture, the force of the handheld sheath seat can be completely transmitted to the needle tube, and the needle head seat and the sheath seat do not rotate relatively.

Preferably, the needle mount and sheath mount are a clearance fit. When the clamping hook releases the rib, the needle seat can be easily pulled away from the sheath seat, and the sheath seat can not be deviated.

Preferably, the clamping hook comprises a hook and a lever arm, a fulcrum is arranged on the lever arm and is connected with the needle head seat or the sheath seat, a force application part is arranged on the lever arm, and the force application part and the hook are respectively positioned on two sides of the lever arm. The force application part is a part for receiving external force, and when the external force acts on the force application part, the lever rotates around the fulcrum to hook and buckle or release the rib.

Or the clamping hook is fixed, the ribs are connected with the moving mechanism, the ribs protrude out to be buckled with the clamping hook when the moving mechanism is at the first position, and the ribs are separated from the clamping hook when the moving mechanism is at the second position; the moving mechanism comprises a shifting lever connected with the ribs and a guide groove allowing the ribs to move in the shifting lever.

Preferably, the clamping hook is positioned on the needle head seat, the fulcrum of the clamping hook is hinged with the needle head seat, and the rib is positioned on the sheath seat; or the clamping hook is positioned on the sheath seat, the fulcrum of the clamping hook is hinged with the sheath seat, and the rib is positioned on the needle head seat. Preferably, the pivot is provided with a pin shaft and a torsion spring. The torsion spring realizes the position locking and the automatic reset of the hook. Preferably, the hook is located at one end of the lever arm and the force application portion is located at the other end of the lever arm. Preferably, the distance between the urging portion and the fulcrum is smaller than the distance between the hook and the fulcrum. The lever arm effects a force amplification. Preferably, the clamping hooks are in a pair, the pair of clamping hooks is symmetrically arranged, and each clamping hook corresponds to one rib. When the clamping hooks release the ribs, the force application parts of the two clamping hooks are pinched by hands, and the clamping hooks swing outwards to release the ribs.

Preferably, the sheath seat is provided with a circle of flanges protruding outwards, the flanges are rectangular or square, and two opposite flange edges are used as ribs. Preferably, the two flanges except the ribs are respectively connected with respective reinforcing plates, and the reinforcing plates are connected with the sheath seat. The reinforcing plate plays a role in supporting and stabilizing. Preferably, the sheath seat is provided with an auxiliary support part, the auxiliary support part is parallel to the flange, and the reinforcing plate extends from the flange to the auxiliary support part. The shape of the auxiliary support part is the same as that of the flange. When the puncture action is carried out, an operator holds the reinforcing plate part to push the reinforcing plate part to the far end, so that the puncture direction and the puncture force can be conveniently controlled.

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

In a sixth aspect of the present invention, a device is provided for preventing the needle tip from damaging tissue during puncturing.

Preferably, when the puncture needle is combined with the catheter sheath, the needle head of the puncture needle is exposed out of the catheter sheath, and the needle head of the puncture needle is passivated. Preferably, the needle is tapered distally from the barrel, and the needle blunts without sharp corners or cutting edges. Preferably, the needle head is a ball head, and the radius of the ball head 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 comprises a non-metal body, and the surface of the non-metal body is provided with a developing layer. The developing layer is a developer coating or the developing layer is a metal layer. For example, the puncture needle comprises a plastic needle tube, wherein the surface of the plastic needle tube is provided with a metal coating, and the metal coating is used for developing under X-rays.

After the needle head is passivated, no cutting edge or sharp prick is arranged on the needle head. During percutaneous trigeminal semilunar ganglion sacculus compression, the puncture needle assembly is pushed to the far end, the needle head is passivated, and the injury such as cutting injury or puncture injury to internal tissues (such as blood vessels, nerves, muscles and the like) can not be caused. The radius of the needle head is set to be 0.3-0.5 mm, so that the needle head conforms to the tissue gap in a human body, and the tissues such as blood vessels and/or nerves are prevented from being injured due to puncture and extrusion.

When the utility model is used for percutaneous trigeminal semilunar ganglion sacculus compression, the patient takes the supine position after general anesthesia, and the shoulder pad is wrapped with cloth with proper height to ensure that the neck is slightly extended. Under the X-ray environment, puncture the face of the patient by using a puncture needle set, and the needle inserting point is about 2.5cm near the corner of the patient side mouth. The puncture needle tube and the sheath tube are guided into the foramen ovale through X-ray image positioning, but the upper edge of the foramen ovale is not punctured. After the puncture needle set is punctured in place, force is applied to the force application part of the clamping hook, the clamping hook releases the ribs, and the puncture needle is taken out. And then inserting the compression balloon catheter assembly into the sheath tube, positioning the insertion depth through X-ray images, injecting contrast developer through the tube cavity of the supporting tube after the expansion balloon enters the half-moon section of the trigeminal nerve of the Meckle's cavity, inflating and expanding the expansion balloon, and monitoring the inflation condition of the expansion balloon through the X-ray images. Allowing the injected control imaging agent to fill the Meckles's cavity at a dose that can be obtained by statistical data or limited experimentation, or image guidance; when the inflation shape of the expansion saccule is monitored to be the ideal pear-shaped appearance, the expansion saccule is kept to be expanded to press the trigeminal nerve semilunar junction 60S, the developer is drawn out, the compression saccule catheter assembly and the catheter sheath are withdrawn, the hemostasis is performed on the puncture point by compression, and the operation is completed.

The utility model has the advantages as follows:

1. the framework is arranged in the supporting tube and woven into a net shape by fibers, the supporting strength and the tensile strength of the supporting tube are enhanced, the balloon is prevented from being broken and losing efficacy in the using process, the broken part is prevented from remaining in the cranium, and the risk of iatrogenic injury and infection is avoided.

2. The metal fiber or the fiber with the developing layer is woven into a framework, and the framework bears the developing function.

3. The through hole is formed in the supporting tube wrapping section covered by the expansion balloon, liquid injection and air exhaust are achieved, after the expansion balloon is full, all original air in the balloon and the supporting tube is exhausted, the balloon is completely filled with contrast developer, the balloon is completely developed, and convenience of operation and accuracy of key points of the operation are improved.

4. The expansion saccule is tightly attached to the supporting tube by the binding piece, the axial position of the saccule is locked, after contrast developer is injected into the saccule, the saccule can be inflated and expanded only along the radial direction, the shape of the saccule is reliable, and the connection between the saccule and the supporting tube is reliable.

5. The catheter sheath and the puncture needle are combined in a clamping hook and rib mode, and when the puncture needle is unlocked and pulled out from the catheter sheath, the puncture needle does not rotate or shake, so that the disturbance to the catheter sheath when the puncture needle is withdrawn is avoided.

6. The needle head of the puncture needle is passivated, so that the puncture or the cut of tissues such as blood vessels, nerves, muscles and the like caused by the needle head in the puncture process is avoided, the operation safety is improved, and the operation risk is reduced.

Drawings

FIG. 1 is a schematic representation of the trigeminal nerve and semilunar junction on the face.

Fig. 2 is a schematic view of a compression balloon catheter assembly.

Fig. 3 is a schematic view of an inflation balloon.

FIG. 4 is a schematic view of a scaffold.

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

Fig. 6 is a schematic view of an additional balloon.

Fig. 7 is a schematic view of a compression balloon catheter assembly coupled to an additional balloon.

Fig. 8 is a schematic view of the needle in combination with the sheath.

Fig. 9 is a schematic view of the needle.

Figure 10 is a schematic view of a needle mount.

Fig. 11 is a schematic view of a catheter sheath.

Fig. 12 is a schematic view of a sheath seat.

Figure 13 is a perspective view of the needle mount in combination with the sheath mount.

Detailed Description

The structures referred to by the invention or the technical terms used therein are further described below, if not otherwise indicated, in accordance with the common general term of the art.

Detachable combination

A removable combination, as used herein, means that two elements are physically connected in a number of different positions or locations, e.g., when two elements are physically separated, when connected or combined together in a first instance where appropriate, and when two elements are separated in a second instance where appropriate, the separation being physically separate and not touching. Alternatively, the two components may initially be combined, and where appropriate, may be physically separated. In general, the combination of the two components or the separation of the two components can be easily performed, and the combination or the separation can be repeated for a plurality of cycles, and of course, the combination and the separation can be performed in a disposable manner. In addition, the two components can be detachably combined, and the three components or more than three components can be detachably combined. For example, there may be first, second and third parts, the first and second parts being removably combined, and the second and third parts also being removably combined.

Medical metal material

The common medical metal materials include, but are not limited to, medical stainless steel (316, 36L, 317L as main components), medical cobalt-based alloys, medical titanium and titanium alloys, medical magnesium alloys, gold, silver, platinum and other precious metals, and tantalum, niobium, zirconium, nickel titanium shape memory alloys with good chemical stability and good resistance to physical corrosion.

Device for percutaneous trigeminal semilunar ganglion balloon compression

As shown in fig. 2 and 3, the device for percutaneous trigeminal semilunar ganglion balloon compression comprises a compression balloon catheter assembly which comprises an expansion balloon 2 and a support tube 4, wherein the expansion balloon 2 is arranged at the end of the support tube 4. The dilatation balloon 2 is made of an elastic material and is a compliant balloon or a semi-compliant balloon. The contrast developer flows into the position of the expansion balloon 2 through the lumen of the support tube 4 by the injector, and along with the injection of the contrast developer, the expansion balloon 2 is inflated and expanded under the action of liquid, and the expansion balloon 2 forms a corresponding shape according to the space where the expansion balloon 2 is located. During percutaneous trigeminal semilunar ganglion balloon compression, the Mickel's chamber is pear-shaped, thus indicating that the balloon has reached the correct position when the dilatation balloon 2 is pear-shaped in the developed image. The material of the inflatable balloon 2 may be elastic medical materials such as natural latex, polyurethane, thermoplastic elastic polymer materials, and silica gel.

The pipe body is made of a high polymer material, and the high 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, and the connection seat and the expansion balloon 2 are respectively located at both ends of the support tube 4, and the additional balloon is connected to the connection seat. The connecting base may be a standard injection fitting for mating with an injector for injecting contrast developer into the dilatation balloon 2.

Framework for supporting

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

As shown in fig. 4, in some embodiments, the support tube 4 includes a frame 42 and a tube body 41. The frame 42 extends throughout the effective usable length of the tubular body 41, the frame 42 having toughness and rigidity, and the frame 42 providing the tubular body 41 with support strength and tensile strength.

In some embodiments, the support tube 4 comprises a carcass layer and a tube layer, the carcass layer being wrapped within the tube layer.

The carcass 42 is first manufactured, the pipe body 41 is then fitted over the carcass 42, the carcass 42 becomes a carcass layer, and the pipe body 41 becomes a pipe body layer, and then the pipe body 41 and carcass 42 combined member is subjected to, for example, heat treatment, so that the pipe body layer and the carcass layer are combined together.

Alternatively, the support tube 4 includes a carcass layer, an inner tube body layer and an outer tube body layer with the carcass layer therebetween. For example, the inner tube 41 (the polymer tube 41 can be obtained by extrusion molding or injection molding) is first manufactured, then the skeleton 42 is wrapped around the inner tube 41, and then the outer tube layer is extruded outside the skeleton 42. The inner and outer tubular layers enclose the carcass 42. The inner tube body layer and the outer tube body layer can be subjected to heat treatment or not.

In some embodiments, the frame 42 is woven from at least 1 fiber, and the frame 42 may be wound in a spiral when 1 fiber is used, or the frame 42 may be woven like a sweater. Preferably, the armature 42 is woven in a mesh. Preferably, the framework 42 is woven into a hollowed-out mesh shape; alternatively, the fibers of the armature 42 may abut one another, i.e., not intentionally woven with voids. Woven into a mesh shape, providing the frame 42 with both support and tensile strength. Preferably, the skeleton 42 has toughness and rigidity. Skeleton 42 is the netted of fretwork, only needs to go up the trompil at body 41, can be when pouring into contrast developer into, and the developer gets into the expansion gasbag through fretwork department, makes the expansion gasbag full. When the frame 42 cannot be left hollow, it is necessary to open a hole in the tube 41 and the developer flows into the expansion balloon through the gap between the fibers, or to provide several holes in the frame 42 so that the developer enters the expansion balloon.

In some embodiments, armature 42 is woven from 2-64 strands of fibers into a web. Even if one fiber is broken, the net-shaped structure does not cause the framework 42 and the whole supporting tube 4 to be broken and failed, and the reliability is high. The framework 42 is tubular; alternatively, the frame 42 is a mesh, and the frame 42 is tubular under the constraint of the tube 41. Whether the frame 42 is directly woven into a tubular shape or the planar frame 42 is formed into a tubular shape by the tube 41, the frame 42 may have any original shape as long as the combination of the frame 42 and the tube 41 and the support of the frame 42 to the tube 41 are not affected.

Developing skeleton 42

The support tube 4 and the inflatable balloon 2 are introduced into the patient's body, and the degree of introduction of the support tube 4 and the inflatable balloon 2 is monitored under the influence of X-rays, so that the skeleton 42 of the support tube 4 is woven from fibers that can be developed under X-rays, and the skeleton 42 performs a developing function to monitor the introduction of the inflatable balloon 2 into the body.

In some embodiments, armature 42 is woven from 2-64 strands of fibers into a web. Even if one fiber is broken, the net-shaped structure does not cause the framework 42 and the whole supporting tube 4 to be broken and failed, and the reliability is high.

The framework 42 is tubular; alternatively, the frame 42 is a mesh, and the frame 42 is tubular under the constraint of the tube 41. Whether the frame 42 is directly woven into a tubular shape or the planar frame 42 is formed into a tubular shape by the tube 41, the frame 42 may have any original shape as long as the combination of the frame 42 and the tube 41 and the support of the frame 42 to the tube 41 are not affected.

The developing skeleton 42 is different from the supporting skeleton 42 in the fiber woven into the skeleton 42. The developing skeleton 42 is woven from fibers having developing properties, and the supporting skeleton 42 may be used regardless of whether or not the developing skeleton has developing properties, as long as the fibers have toughness and supporting rigidity. The developing skeleton 42 is woven from fibers having developability, and the developing skeleton 42 is not prevented from having the same structure as the supporting skeleton 42.

In some embodiments, as shown in FIG. 4, at least one of the fibers in the framework 42 is capable of being visualized by X-rays. 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; alternatively, the developable fibers have a development layer. Preferably, the developing layer is a metal layer, such as a metal coating on plastic or fiberglass, or the developing layer is a metal wire with a polymer surface layer attached to the wire. The developer layer may also be a developer coating. During surgery, the scaffold 42 can provide intraoperative visualization, with the visualization area encompassing the entire support tube 4, and not just the dilatation balloon.

Alternatively, at least one fiber of the scaffold 42 may exhibit visualization in the region of the inflated balloon 2. For example, the fibers of the skeleton 42 are provided with a developing layer only in the region where the inflatable balloon 2 is located, and the developing property is achieved only in the inflatable balloon 2.

Exhaust micropore

In order to fill the balloon with the contrast developer by exhausting air from the inside of the tube 41 or from the expanded balloon 2 simultaneously with the injection of the contrast developer, the support tube 4 is provided with micropores (through holes) for allowing the passage of the contrast developer and the exhaust of the contrast developer, as shown in fig. 5.

In some embodiments, the wrapping section of the support tube 4 wrapped by the dilation 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 the percutaneous trigeminal semilunar ganglion sacculus oppression art of going, the patient after general anesthesia takes the supine position, and shoulder pad drape book of suitable height is in order to guarantee that the neck slightly extends. Therefore, in the normal position, the support tube 4 and the balloon are obliquely inserted into the human body, and the end of the support tube 4 is the lowest. The through hole 5 is far away from the end of the supporting tube 4, which means that the through hole 5 is higher than the end of the supporting tube 4 in the normal position in the operation. The contrast developer is a liquid, which is heavier than air, so when balloon 2 is inflated, the liquid flows down and the air escapes up. In operation, the injection of the contrast developer is performed in a suction type by using an injector, and during the injection, the contrast developer flows downwards and the balloon 2 expands; during evacuation, the gas present in the balloon and the support tube 4 escapes up to the proximal end of the support tube 4 and the syringe. Proximal refers to the end closer to the operator and distal refers to the direction away from the operator.

The diameter of the through hole 5 is 0.2-1.5 mm. The through holes 5 within the size range not only avoid greatly reducing the rigidity of the supporting tube 4 and reduce the risk of fracture failure of the supporting tube 4, but also realize that the expansion balloon 2 can inject liquid and exhaust gas at the same time. The number of the through holes 5 is 1 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 is only required to ensure the supporting strength and/or the tensile strength of the supporting tube 4, so that the gas and contrast developer can smoothly enter and exit, and the pressure in the saccule can be accurately transmitted to the injector to provide operation hand feeling.

In some embodiments, the surface of the wrapping section has recessed channels. After the contrast developing solution flows out from the through hole 5, the contrast developing solution flows to the far end of the supporting tube 4 along the flow guide groove, so that the far end of the saccule is expanded and filled before the near end. Preferably, the flow guide groove is beside the through hole 5, or the through hole 5 is arranged on the flow guide groove. Preferably, the number of the guide grooves is 1 or more. Preferably, each flow guide groove corresponds to at least one through hole 5. Preferably, the guiding grooves are symmetrically distributed along the support tube 4, so that the contrast developing solution is uniformly injected, and the balloon is favorably and uniformly expanded.

In some embodiments, the support tube 4 includes a skeleton 42 and a tube 41, the skeleton 42 is woven from fibers, the through holes 5 are disposed in the tube 41, and the through holes 5 avoid the fibers. The fact that the through-holes 5 are kept clear of fibers means that there is no need to interrupt fibers to form the through-holes 5, and the strength of the support tube 4 is not reduced by damaging the fibers of the framework 42.

Binding member

To expand the balloon only in the radial direction, the proximal and distal ends of the balloon are tightened by tightening, as shown in fig. 3 and 5.

In some embodiments, the proximal and distal ends of the balloon are provided with respective ties 1, 3 that secure the balloon to the support tube 4.

The purpose of the strapping 1, 3 is to form a closed capsule. The near end and the far end of the balloon are respectively fastened and fixed, when contrast developers are injected, the near end and the far end of the balloon are fixed, so that the balloon can only be radially inflated and expanded, the impact of the balloon on tissues in front is avoided, and all the injected contrast developers are concentrated in a designated area (the area between the near- end binding pieces 1 and 3 and the far-end binding pieces 1 and 3), the developing integrity of the balloon under X-rays is facilitated, and the supporting strength of the balloon is kept. Most importantly, the balloon is tightly attached to the support tube 4 by the far- end binding pieces 1 and 3, and contrast developer cannot enter the parts farther than the far- end binding pieces 1 and 3, so that the balloon is in a capsule shape or a spherical shape when being naturally filled, the balloon cannot be in a pear shape due to the restraint of the far- end binding pieces 1 and 3, and the misjudgment of the shape of the balloon in the operation is avoided.

The tying pieces 1 and 3 of the sacculus are ropes, or the tying pieces 1 and 3 of the sacculus are reducing rings. When the rope or the reducing ring is assembled, the saccule and the supporting tube 4 are tightly combined by external force to form a closed sac body. The proximal end and the distal end of the balloon can both adopt reducing rings, or only the proximal end of the balloon can adopt a reducing ring. This is done by using the visualization of the metal ring under X-rays, with a proximal metal constricting ring to indicate whether the dilatation balloon 2 is protruding from the catheter sheath.

In some embodiments, the support tube 4 includes a skeleton 42 and a tube body 41, and the skeleton 42 is woven from fibers having developing properties. The binding members 1 and 3 are used only for combining the balloon and the support tube 4 to form a closed bag body, the framework 42 plays a role in developing during operation, and after the framework 42 has developing performance, whether the contraction ring develops or not does not prevent the operation. The reducing ring functions to tightly seal and attach the balloon to the support tube 4.

In some embodiments, the support tube 4 is provided with a through-hole 5, the through-hole 5 being located between the two strapping members 1, 3, and the through-hole 5 being located close to the proximal strapping member 3 and remote from the distal strapping member 3.

Additional balloon

In order to keep the pressure inside the dilatation balloon 2 stable or to find leakage or rupture of the dilatation balloon 2 in time, an additional balloon is placed outside the body in communication with the compression balloon catheter assembly, as shown in fig. 6-8.

In some embodiments, the distal end of the support tube 4 is connected to an external supplemental balloon 6, and the supplemental balloon 6 is connected to an input source of contrast media.

The additional balloon 6 is in vitro, the contrast developer is firstly input into the additional balloon 6, and then is input into the expansion balloon 2 in vivo through the additional balloon 6, so that the injection pressure of the contrast developer is buffered by the additional balloon 6. Further, the pressure of the inflatable balloon 2 may be reduced after the inflatable balloon 2 is inflated with the liquid and exhausted, or after the syringe completes injecting the contrast developer due to the compressibility of air, and at this time, the contrast developer in the additional balloon 6 is automatically supplied into the inflatable balloon 2, thereby maintaining the constant pressure in the inflatable balloon 2. Or when the expansion balloon 2 in the body leaks or is damaged, the contrast developer in the additional balloon 6 is continuously input into the expansion balloon 2, so that the contrast developer in the additional balloon 6 is rapidly consumed, and an operator is reminded of abnormal operation.

In some embodiments, the additional balloon 6 comprises a catheter and a balloon, and the catheter has a second connector 7; the second connector 7 is connected to an input source of contrast agent. The second connector 7 is a standard injection connector, so that the applicability is improved, for example, the second connector 7 is a luer one-way valve. The additional balloon 6 is made of an expansible and deformable elastic material, and the catheter is made of a non-expansible and 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 respectively connected with the catheter in a sealing manner, the balloon 61 is a closed balloon, the catheter 62 has a liquid through hole 63 for inputting liquid into the balloon, and the liquid through hole 63 is close to the distal end and far away from the proximal end. The device is in a normal position during operation, and the far end is higher than the near end during injection in the operation, so that the injection and the exhaust are convenient. The balloon body 61 is an elastic membrane, and the balloon body 61 is fixed with the catheter through a binding piece; or the balloon body is 61 elastic membrane, and the catheter 62 body is hermetically connected by bonding, hot pressing and other processes. The number of the liquid through holes is 1 or more. The liquid passing holes 63 are micro-holes, so that the arrangement of the liquid passing holes does not affect the support strength and the tensile strength of the catheter.

As shown in fig. 4, the catheter includes a support frame 42 and a catheter body 41, the support frame 42 being woven of fiber filaments into a mesh; the liquid through hole avoids the fiber silk. The support framework 42 enhances the support strength and tensile strength of the catheter, and the arrangement of the liquid through holes does not cause the disconnection of the fiber yarns and influence the strength of the support framework 42.

The catheter 8 includes a support scaffold layer and a catheter body layer, the support scaffold layer being encased within the catheter body layer. That is, the support frame 42 and the catheter body are two layers, the support frame 42 is in the catheter body 41, the support frame 42 plays a role in enhancing the rigidity of the catheter body 41, and the catheter body 41 does not break or fail as long as the support frame 42 does not break.

Alternatively, the support frame 42 is located within the catheter body 8, with the support frame 42 and catheter body being in the same layer. For example, the support frame 42 may be fabricated and the support frame 42 may be filled with a catheter material such that the support frame 42 forms a portion of the catheter body. For example, the support frame 42 is fabricated, the catheter 8 is then placed over the support frame 42, and the catheter 8 and support frame 42 assembly is subjected to a heat treatment process, for example, to fuse the frame 42 and catheter 8 together into a single unit or layer.

In some embodiments, the conduit 8 is the same tube as the support tube 4.

In some embodiments, as shown in fig. 7, the guide tube 8 and the support tube 4 are independent, and the guide tube 8 has a first connector 9, and the first connector 9 is detachably connected to the connecting seat of the support tube 4. The first connector is a standard injection connector for connection with the connecting socket of the support tube 4. For example, the first connector is a luer male connector.

As shown in fig. 6 and 7, in some embodiments, the two ends of the bladder are respectively connected to a first tube 81 and a second tube 82, the first tube 81 is hermetically connected to the bladder at one end and provided with a first connector at the other end, and the second tube 82 is hermetically connected to the bladder at one end and provided with a second connector 7 at the other end.

Alternatively, as shown in fig. 8, the tube 41 comprises a first tube 81 and a second tube 82 connected by a tee, the third port of the tee being hermetically connected to the capsule. The contrast developer is firstly injected into the additional saccule 6 and then injected into the expansion saccule 2, and the additional saccule 6 is communicated with the expansion saccule 2 to balance the pressure; when the pressure in the expansion sacculus 2 changes, the pressure is transmitted to the additional sacculus 6 outside the body, so that the observation of an operator is facilitated, and the catheter 8 is a medical polymer catheter tube body.

Rib-hook mechanism

In order that the sheath is not disturbed when the puncture needle and the sheath are separated, a rib-hook mechanism is used to limit the detachable combination of the puncture needle and the sheath.

In some embodiments, a device for percutaneous trigeminal semilunar ganglion balloon compression comprises a puncture needle kit comprising a puncture needle 11 and a catheter sheath 10, the puncture needle 11 having a needle base 111 and a needle tube, the catheter sheath 10 having a sheath base 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 and is in clearance fit with the sheath, the needle base 111 is locked with the sheath base 101, and when the needle base 111 is unlocked with the sheath base 101, the puncture needle 11 and the catheter sheath 10 are unlocked. After the puncture needle 11 and the catheter sheath 10 are disengaged, the needle tube can move freely in the sheath.

The needle seat 111 and the sheath seat 101 are detachably combined through a rib-clamping hook mechanism, and when the clamping hook A hooks the rib B, the needle seat 111 is combined with the sheath seat 101; when the hook A releases the rib B, the needle seat 111 is disengaged from the sheath seat 101.

In the percutaneous trigeminal semilunar ganglion balloon compression, the puncture needle 11 and the catheter sheath 10 in a combined state are used for puncturing from a side incision of a patient under an X-ray environment. The puncture needle 11 kit is guided into the oval hole through X-ray influence positioning without piercing the upper edge of the oval hole, and after the puncture needle 11 is punctured in place, the puncture needle 11 is removed from combination with the catheter sheath 10, the puncture needle 11 is pulled out, and the catheter sheath 10 is left in the body. The compression balloon catheter 8 assembly is then inserted along the lumen of the catheter sheath 10, the depth of insertion being determined by X-ray influence. The combination of the puncture needle 11 and the catheter sheath 10 is realized by using the hook-and-loop mode of the hook A and the rib B, when the locking is released and the combination is realized, only the operation of the hook A or the rib B is needed, the needle head seat 111 has no rotary displacement, and the catheter sheath 10 cannot be disturbed by the needle head seat 111, so that the stability of the position of the catheter sheath 10 in the body is kept, and the deviation of a sheath tube is avoided.

The rib B is in line contact with the clamping hook A, and the rib B is in a straight line segment. The rib B and the clamping hook A are straight line segments respectively, so that the combination of the rib B and the clamping hook A is realized, and when the rib B and the clamping hook A are in a combined state, the rotational freedom degrees of the rib B and the clamping hook A are unified, so that the rotational freedom degrees of the needle head seat 111 and the sheath seat 101 are unified, the force for holding the sheath seat 101 can be completely transmitted to the needle tube during puncture, and the needle head seat 111 and the sheath seat 101 do not rotate relatively.

Needle mount 111 and sheath mount 101 are clearance fit. When the hook A releases the rib B, the needle seat 111 can be easily pulled away from the sheath seat 101, and the sheath seat 101 cannot be deviated.

The clamping hook A comprises a hook A1 and a lever arm A2, a fulcrum A3 is arranged on the lever arm A2, the fulcrum A3 is connected with the needle seat 111 or the fulcrum A3 is connected with the sheath seat 101, a force application part is arranged on the lever arm A2, and the force application part and the hook A1 are respectively positioned on two sides of the lever arm A2. The force application part is a part for receiving external force, when the external force acts on the force application part, the lever rotates around a fulcrum A3, and the hook A1 hooks or releases the rib B.

Or the clamping hook A is fixed, the rib B is connected with the moving mechanism, the rib B protrudes to be hooked with the clamping hook A when the moving mechanism is at the first position, and the rib B is separated from the clamping hook A when the moving mechanism is at the second position; the moving mechanism comprises a shifting lever connected with the rib B and a guide groove allowing the rib B to move in the shifting lever.

The clamping hook A is positioned on the needle head seat 111, the fulcrum A3 of the clamping hook A is hinged with the needle head seat 111, and the rib B is positioned on the sheath seat 101; or the hook A is positioned on the sheath seat 101, the pivot A3 of the hook A is hinged with the sheath seat 101, and the rib B is positioned on the needle seat 111. Preferably, the pivot A3 is provided with a pin and a torsion spring, or the pivot A3 is a flexible hinge. The torsion spring realizes the position locking and the automatic reset of the hook A. Preferably, hook A1 is located at one end of lever arm A2 and the force application location is located at the other end of lever arm A2. Preferably, the distance from the force application portion to the fulcrum A3 is less than the distance from the hook a1 to the fulcrum A3. Lever arm a2 effects a force amplification. Preferably, the hooks a are in a pair, the pair of hooks a is symmetrically arranged, and each hook a corresponds to one rib B. When the clamping hooks A release the ribs B, the force application parts of the two clamping hooks A are pinched by hands, and the clamping hooks A swing outwards to release the ribs B.

The sheath seat 101 is provided with a ring of outwardly protruding flanges having a rectangular or square shape, wherein two opposite flange edges are provided as ribs B. Preferably, the two flanges except the rib B are respectively connected with the respective reinforcing plates B1, and the reinforcing plate B1 is connected with the sheath seat 101. The reinforcing panel B1 serves to support and stabilize. The sheath seat 101 is provided with an auxiliary support portion parallel to the flange, and the reinforcing plate B1 extends from the flange to the auxiliary support portion. The shape of the auxiliary support part is the same as that of the flange. When the puncture is performed, an operator holds the reinforcing plate B1 part to push the reinforcing plate to the far end, so that the puncture direction and force can be conveniently controlled.

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

Passivated needle

In order to avoid that the needle 11 damages the tissue during the puncture, the tip of the puncture needle 11 is arranged as a blunted needle.

In some embodiments, the needle 11 is combined with the sheath 10 such that the tip 112 of the needle 11 is exposed to the sheath and the tip 112 of the needle 11 is blunted. Preferably, needle 112 is tapered distally from the barrel, and needle 112 is blunted without sharp corners or cutting edges. The needle head 112 is a ball head, and the radius of the ball head is 0.3-0.5 mm. Alternatively, needle 112 is domed or blunted. The puncture needle 11 is a metal needle, or the puncture needle 11 comprises a non-metal main body, and a developing layer is arranged on the surface of the non-metal main body. The developing layer is a developer coating or the developing layer is a metal layer. For example, the puncture needle 11 includes a plastic needle tube having a metal coating on the surface thereof, and the metal coating is used for developing under X-ray.

After blunting of the needle 112, there are no cutting edges and/or spikes on the needle 112. During percutaneous trigeminal semilunar ganglion sacculus compression, the puncture needle 11 assembly is pushed to the far end, the needle head 112 is passivated, and the injury such as cutting injury or puncture injury to internal tissues (such as blood vessels, nerves, muscles and the like) can not be caused. The needle head 112 is set to be 0.3-0.5 mm in diameter, so that the needle head conforms to the tissue gap in a human body, and the tissues such as blood vessels and/or nerves are prevented from being injured due to puncture and extrusion.

All patents and publications mentioned in the specification of the invention are indicative of the state of the art to which this invention pertains and of the technology disclosed herein as being applicable. All patents and publications cited herein are hereby incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, which limitation is not specifically disclosed herein. For example, the terms "comprising", "consisting essentially of … …" and "consisting of … …" in each instance herein may be substituted for the remaining 2 terms of either. The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described, but it is recognized that various modifications and changes may be made within the scope of the invention and the claims which follow. It is to be understood that the embodiments described herein are preferred embodiments and features and that modifications and variations may be made by one skilled in the art in light of the teachings of the present disclosure, and are to be considered within the purview of this disclosure and scope of the invention as defined by the appended claims and the independent claims.

Claims (11)

1. The constant-pressure trigeminal semilunar junction compression balloon 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 distal end of the support tube is connected to an additional balloon located outside the body, which is connected to an input source of contrast media.

2. The constant pressure trigeminal semilunar compression balloon as claimed in claim 1, wherein the additional balloon comprises a catheter and a balloon, the catheter having a second connector; the second connector is connected to an input source of contrast media.

3. The constant pressure trigeminal semilunar compression balloon as claimed in claim 2, wherein the catheter and the support tube are the same tube.

4. The constant pressure trigeminal semilunar compression balloon as claimed in claim 2, wherein the catheter and the support tube are independent of each other, the catheter having a first connector detachably connected to the connecting seat of the support tube.

5. The constant pressure trigeminal semilunar compression balloon as claimed in any one of claims 2 to 4, wherein the balloon is wrapped around the surface of the catheter, the proximal end and the distal end of the balloon are hermetically connected to the catheter, the balloon is a closed balloon, and the catheter has a fluid hole for inputting fluid into the balloon.

6. The constant pressure, semi-lunar pressure balloon for a trigeminal nerve as claimed in claim 5 wherein the fluid port is proximal to the distal end and distal to the proximal end.

7. The constant pressure trigeminal semilunar compression balloon as claimed in claim 1, wherein the number of the fluid passing holes is 1 or more.

8. The constant pressure trigeminal semilunar compression balloon as claimed in claim 1, wherein the balloon body is an elastic membrane, the balloon body being fixed to the catheter by a binding; or the balloon body is an elastic membrane, and the catheter balloon body is connected through bonding or hot-pressing sealing; and/or the conduit comprises a support framework and a conduit body, wherein the support framework is woven by fiber yarns into a net; the liquid through hole avoids the cellosilk; and/or the catheter comprises a support framework layer and a catheter body layer, wherein the support framework layer is coated in the catheter body layer, or the support framework is positioned in the catheter body, and the support framework and the catheter body are in the same layer; and/or the supporting framework is woven into a net shape by fibers.

9. The constant pressure trigeminal semilunar compression balloon as claimed in claim 2, wherein the balloon body is connected at its two ends to a first tube and a second tube, respectively, the first tube being sealed at one end to the balloon body and at the other end to a first connector, and the second tube being sealed at one end to the balloon body and at the other end to a second connector.

10. The constant pressure trigeminal semilunar compression balloon as claimed in claim 2, wherein the tube comprises a first tube and a second tube connected by a tee, the third port of the tee being sealingly connected to the bladder.

11. The constant pressure trigeminal semilunar pressure balloon as claimed in claim 9, wherein the support tube has a connection seat, the connection seat and the expansion balloon are respectively located at both ends of the support tube, and the additional balloon is connected to the connection seat; or, oppress the sacculus and include pjncture needle external member, this pjncture needle external member includes pjncture needle and catheter sheath, and the pjncture needle has syringe needle seat and needle tubing, and the catheter sheath has sheath seat and sheath pipe, the detachable combination of pjncture needle and catheter sheath.

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