CN117653288A

CN117653288A - Delivery catheter

Info

Publication number: CN117653288A
Application number: CN202211066464.3A
Authority: CN
Inventors: 梁韬; 寸雨曦; 罗雪莉; 刘云云
Original assignee: Microport Neurotech Shanghai Co Ltd
Current assignee: Microport Neurotech Shanghai Co Ltd
Priority date: 2022-08-31
Filing date: 2022-08-31
Publication date: 2024-03-08

Abstract

The invention relates to the technical field of medical equipment, and provides a conveying catheter, which comprises: the pipe body is provided with a corrugated pipe section to form a bending guide area, and the coating covers at least the outer surface of the bending guide area. The invention realizes the bending performance of the conveying conduit by matching the bending guide area formed by the corrugated pipe section with the covering film, and the covering film covers the bending guide area and covers the trough, so that the stimulation of the corrugated pipe section to the wall of the blood vessel can be reduced, the damage of the corrugated pipe section to the blood vessel in the conveying process can be avoided, the thrombus in the clinical operation can be prevented from being formed at the corrugated pipe section, and various complications such as vascular damage, thrombus and the like in the operation process can be reduced.

Description

Delivery catheter

Technical Field

The invention relates to the technical field of medical appliances, in particular to a conveying catheter.

Background

Cerebral apoplexy, which is mainly the brain function injury caused by brain blood circulation disorder, is a common disease seriously threatening human health, is the third leading cause of death in the world today, and is also the first leading cause of long-term disability of adults.

At present, in the clinic, a treatment method of directly sucking thrombus by using a suction catheter or assisting in taking the thrombus by using a bracket is generally used for treating the ischemic stroke so as to remove the thrombus and realize vascular recanalization; the way of directly sucking thrombus by the suction catheter is that after the distal end of the suction catheter reaches the thrombus position along the blood vessel, negative pressure is given to the proximal end of the suction catheter, and thrombus is sucked into the catheter or adsorbed in the orifice of the catheter to be slowly dragged into the guiding catheter at the distal end of the suction catheter, so that the blood vessel regains blood flow force; the auxiliary stent thrombus taking mode is to convey the stent thrombus taking device along the blood vessel to the thrombus position and to cross the thrombus position, catch thrombus by the stent mesh, and then withdraw the stent thrombus taking device into the supporting catheter to re-communicate the blood vessel. For the treatment of cerebral apoplexy, the impact of blood flow on the aneurysm is reduced by using a spring ring to fill and a dense net stent to be implanted, so that the rupture of the aneurysm is prevented.

In the above treatment modes, a delivery catheter is required to be used for constructing a delivery system, and the delivery catheter is driven by a guide wire to finally reach the cerebral vessels along the arterial access. The delivery catheter can find out the aneurysm and the blocked vascular part under DSA radiography of the brain in the in-place process. In addition, the spring ring, the vascular stent, the thrombus taking stent and the suction catheter for treatment are used for achieving the guiding position through a conveying system built on the conveying catheter.

Conventional delivery catheters are designed to be very flexible at their distal ends in order to avoid damaging the intracranial vessels when they are in place, but this presents the disadvantage of difficult surgical maneuvers. Therefore, the femoral artery puncture path is generally used clinically, because the femoral artery puncture path is relatively straight through the femoral artery, the aorta and the carotid artery, and the operation is easy. Although the trans-femoral approach has the advantages of convenient puncture and simple delivery operation, certain complications are easily caused clinically, such as hematoma at puncture sites, vascular lesions, pseudoaneurysms, arterio-venous fistulae and other complications, and recovery after femoral artery puncture is difficult. And some patients have the problems of complex cerebral vascular tortuosity and complex aortic arch shape, and the problem of difficult transportation can be also encountered by penetrating a path through femoral artery.

In addition to femoral artery puncture routes, attempts have also been made clinically to construct intracranial delivery systems and implant stents from radial artery punctures. When the delivery catheter is routed from the radial artery, the catheter must pass through the subclavian artery, aortic arch, common carotid artery before reaching the cranium. In the process of aortic arch entering the common carotid artery, the delivery catheter needs to deflect at a large angle to enter the common carotid artery, and the flexible distal catheter clearly brings great difficulty to bending adjustment and in-place operation. Moreover, when the catheter passes through the aortic arch region, particularly when the arch of the aortic arch is a three-type arch, the front end of the catheter with softer texture can fall down in the aortic arch region under the action of gravity and blood flow impact, further causing the positioning and operation difficulty of the catheter.

At present, the delivery and in-place delivery of a delivery catheter are affected by the morphology of the blood vessel, whether through the femoral or radial access, in the field of intracranial intervention, which is particularly pronounced for radial access.

Disclosure of Invention

The invention aims to provide a conveying conduit which has bending performance, prevents blood vessels from being damaged in the conveying process, can prevent thrombus from being formed at the bending position of a corrugated pipe in clinical operation, and reduces various complications such as blood vessel damage, thrombus and the like in the operation process.

The invention provides a delivery catheter for radial artery access puncture, comprising:

the pipe body is provided with a corrugated pipe section to form a bending guide area, and the coating covers at least the outer surface of the bending guide area.

Optionally, the coating is configured to: when the bending guide region is not bent, the covering film exhibits a flat appearance.

Optionally, the delivery catheter further comprises a pull wire;

the traction wire is used to control the bending of the bending guide region.

Optionally, the tube body further has a traction lumen, a proximal end of the traction lumen being communicated to a proximal end of the tube body;

the traction wire is positioned in the traction lumen, the proximal end of the traction wire extends out through the proximal end of the traction lumen, the distal end of the traction wire is connected with the tube body, and the connection position of the distal end of the traction wire and the tube body is positioned at the distal end of the bending guide area or the distal end of the tube body.

Optionally, a connection location of the distal end of the traction wire and the tube body is located within the traction lumen.

Optionally, at least two traction lumens are arranged along the circumferential direction of the tube body, and each traction lumen is internally provided with the traction wire.

Optionally, the delivery catheter further comprises at least two developing elements, each of which is disposed on the tube body and is located on a distal side and a proximal side of the curved guide region, respectively.

Optionally, the delivery catheter further comprises a balloon, and the tube body is further provided with an filling lumen, and the distal end of the filling lumen is communicated with the inner cavity of the balloon.

Optionally, the delivery catheter includes at least two balloons, each balloon being disposed at a distal end of the tube and circumferentially spaced around the tube.

Optionally, the balloon is configured to: when the balloon is inflated so that the distal end of the tube body is anchored to the vessel wall, a gap is provided between adjacent balloons in the circumferential direction of the tube body.

Optionally, the delivery catheter further comprises a traction member disposed at the proximal end of the tube body, the traction member being configured to draw the proximal end of the traction wire to tighten or loosen the traction wire.

Optionally, the tube body comprises at least two layers, and the traction lumen is formed between the layers.

Optionally, the pipe body comprises at least two layers, wherein any one layer or any several layers form the corrugated pipe section through self deformation.

Optionally, the pipe body includes a first layer and a second layer, the first layer wraps the outer surface of the second layer, and the first layer forms the outer surface of the pipe body.

Optionally, the first layer forms the bellows segment by deforming itself.

Optionally, the pipe body further comprises a third layer, and the third layer is located inside the second layer.

Optionally, the outer surface of the pipe body forms a corrugated pipe section through self deformation.

In summary, the delivery catheter provided in the present invention includes:

the device comprises a tube body, a first guide tube and a second guide tube, wherein the tube body is provided with a traction tube cavity and a bending guide area, and the proximal end of the traction tube cavity is communicated with the proximal end of the tube body;

the traction wire is positioned in the traction lumen, the proximal end of the traction wire extends out through the proximal end of the traction lumen, the distal end of the traction wire is connected with the tube body, and the connection position of the distal end of the traction wire and the tube body is positioned on one side of the bending guide area close to the distal end of the tube body.

So configured, the invention realizes the bendable performance of the conveying conduit by matching the bending guide area formed by the corrugated pipe section with the coating film, the coating film covers the bending guide area and covers the wave crest and the wave trough, thereby reducing the stimulation of the corrugated pipe section to the wall of the blood vessel, avoiding the damage of the corrugated pipe section to the blood vessel in the conveying process, preventing the thrombus from forming at the corrugated pipe section in the clinical operation, and reducing the occurrence of various complications such as vascular injury, thrombus and the like in the operation process;

in addition, the corrugated pipe structure is selected as the bending guide area, and the corrugated pipe structure has both supporting performance and bending adjusting performance, wherein the supporting performance is characterized in that the corrugated pipe structure can provide radial physical support for the aortic arch, so that the intermediate catheter, the microcatheter and the guide wire pass through the conveying pipe smoothly and pass through the aortic arch and the tortuous vessel, and the corrugated pipe structure is also used for providing axial support for the distal end of the conveying pipe so as to ensure that the distal end of the conveying pipe is effectively pushed to run; the arrangement of the corrugated pipe section can ensure that the whole supporting performance and the controllable performance of the conveying catheter are better, and the distal end direction of the conveying catheter can be well controlled at the aortic arch, so that the distal end of the conveying catheter does not need to be designed to be particularly soft, and the whole physical supporting performance of the conveying catheter is ensured; in addition, the bending guide area formed by the corrugated pipe can be repeatedly bent and straightened, the configuration conversion time is short, the repeated positioning can be realized in the operation process, and the operation is simple and time-saving; the delivery catheter with the structure can be used for interventional operation of radial artery access puncture, also can be used for interventional operation of intracranial artery, and is also suitable for passing through an intermediate catheter by controlling the inner diameter of the delivery catheter.

The catheter body can be used together with a traction guide wire, the conveying catheter can be actively bent to adjust a proper implantation angle, the difficulty of conveying the catheter in place in cerebral apoplexy interventional operation is reduced, particularly, when the catheter is in a path from a radial artery, the control difficulty of the radial artery, an aorta and a carotid artery is reduced, the operation time is reduced, the catheter is not required to be bent by means of collision with the wall of a blood vessel in the process of implanting the conveying catheter into the turn, and the risk of vascular injury is reduced; in addition, based on the performance of actively bending the conveying conduit, the direction of the distal end of the conveying conduit is controlled, so that the damage to the intracranial blood vessel caused by the distal end of the conveying conduit in place in the cranium is avoided, the distal end of the conveying conduit does not need to be designed to be particularly soft, the technical problem of poor support of the distal end of the conveying conduit is solved, the interference of blood flow to the distal end of the conveying conduit is improved, and the control difficulty of the conveying conduit is further reduced.

Drawings

FIG. 1 is a schematic view showing the structure of a delivery catheter according to embodiment 1 of the present invention;

FIG. 2 is a schematic view showing a partial structure of a delivery catheter according to embodiment 1 of the present invention;

FIG. 3 is a schematic diagram showing a partial structure of a delivery catheter according to embodiment 1 of the present invention;

FIG. 4 is a schematic view showing a partial structure of a delivery catheter according to embodiment 2 of the present invention;

FIG. 5 is a schematic view showing the radial sectional structure of a delivery catheter according to embodiment 1 of the present invention;

fig. 6 is a schematic view showing a radial sectional structure of a delivery catheter according to embodiment 3 of the present invention.

Wherein, the reference numerals are as follows:

10-a tube body; 101-pulling a lumen; 102-a curved guiding region; 103-filling the lumen; 104-implantation of a lumen; 11-a first layer; 12-a second layer; 13-a third layer;

20-pulling wires;

30-developing member;

40-balloon;

50-coating;

60-traction element.

Detailed Description

The delivery catheter according to the present invention will be described in further detail with reference to the accompanying drawings and specific examples. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.

In the invention, the outer diameter and the inner diameter correspond to the diameter size for a circular structure, the inner diameter refers to the diameter of an inscribed circle of the circular structure for a non-circular structure, and the outer diameter refers to the diameter of an circumscribed circle of the circular structure; the axial direction corresponds to the direction of the central axis of the cylindrical rod body, and the axial direction corresponds to the length direction of the rod body when the rod body is not cylindrical; in the invention, the radial direction is the radial direction when taking the sleeve or the implantation rod as a reference, and the radial direction when taking the sleeve as a reference is practically consistent with the radial direction when taking the implantation rod as a reference because the implantation rod is penetrated in the sleeve;

in the present invention, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the product, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the product that is proximal to the physician during normal operation, and "distal" generally refers to the end that first enters the patient.

In the present invention, the definition of parallel and vertical should not be interpreted as being in a narrow sense as an absolute vertical or an absolute parallel relationship, and should be interpreted as allowing an error of a set angle, typically ±5°, under the corresponding vertical or parallel precondition, the specific value of the set angle being determined according to the required use conditions;

as used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "a first", "a second", "a third" may include one or at least two such features, either explicitly or implicitly. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. Furthermore, directional terms, such as above, below, upper, lower, upward, downward, left, right, etc., are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward toward the top of the corresponding drawing, downward or downward toward the bottom of the corresponding drawing.

In order to solve the technical problems that the prior intracranial delivery catheter is difficult to operate and is easy to damage the vessel wall in the delivery process, a delivery catheter is provided:

referring to fig. 1, the present embodiment provides a delivery catheter for radial artery access puncture, including:

the pipe body 10 and the coating film 50, wherein the pipe body 10 is provided with a corrugated pipe section to form a bending guide area 102, and the coating film 50 at least covers the outer surface of the bending guide area 102.

In this embodiment, the cover film 50 covers only the outer surface of the curved guide region 102; in some embodiments, the cover 50 extends axially beyond the curved guide region 102, covering the outer surface of the body of the delivery catheter; in other embodiments, the cover 50 covers the entire outer surface of the delivery catheter, i.e., the cover 50 extends from the proximal end of the delivery catheter to the distal end of the delivery catheter.

With continued reference to fig. 2 and 3, the tube 10 further has a pull wire 20 and a pull lumen 101 thereon, the proximal end of the pull lumen 101 being connected to the proximal end of the tube 10; the traction wire 20 is positioned in the traction lumen 101, the proximal end of the traction wire 20 extends out from the proximal end of the traction lumen 101, the distal end of the traction wire 20 is connected with the tube body 10, and the connection position of the distal end of the traction wire 20 and the tube body 10 is positioned at one side of the bending guide area 102 close to the distal end of the tube body 10; in other embodiments, the pull wire 20 may also be attached to the distal end of the tube at a location distal to the distal end of the curved guide region 102.

In this embodiment, the pull wire 20 is positioned within the pull lumen 101; in other embodiments, the tube 10 does not have the pull lumen 101 shown, and the pull wire 20 extends distally through the implant lumen 104 and is connected to the tube; in other embodiments, the pull wire 20 may also extend along the outer surface of the tube from the proximal end of the tube to the distal end of the tube, and preferably there is an element on the outer surface of the tube through which the pull wire passes.

The curved guide region 102 is used to guide the bending of the delivery catheter at this region, and the curved guide region 102 is preferably disposed near the distal end of the tube body 10 to guide the bending of the distal end of the delivery catheter thereof, and the curved guide region 102 is generally formed in two ways:

the first mode is that the structure of the pipe body 10 is modified, for example, trough grooves which are axially arranged at intervals are formed on the pipe body 10 by pure mechanical extrusion, the trough grooves are arranged at intervals so as to form corrugated pipe sections, the area where the trough grooves are located is a bending guide area 102, the trough grooves extend along the circumferential direction of the pipe body 10, and the trough grooves are mutually used for guiding the pipe body 10 to bend at the bending guide area 102; in another alternative embodiment, the valleys are formed in the material of the body 10 itself by means of mechanical working to remove the meat, and the relatively soft areas are formed in the body 10 by providing the valleys to guide the bending; the curved guiding region 102 may also be formed by other known modifications, which will not be described in detail herein;

the second way is to form the tube 10 by modifying its own material, for example, the bending guide area 102 is a section of a separate tube formed from other materials, or the bending guide area 102 is also formed by chemically modifying its own material locally in the tube 10.

In this embodiment, the pipe body 10 has a bellows section thereon, and the bellows section forms the bending guide region 102. The corrugated pipe refers to a structure in which at least the outer circumferential surface is axially provided with arc-shaped wave crests and arc-shaped wave troughs, the corrugated pipe section can be formed through a one-step molding extrusion process or through machining, preferably, the outer diameter of the wave crests at the outer circumferential surface of the corrugated pipe is not larger than the outer diameters of other parts of the pipe body 10, the outer diameter of the wave troughs at the outer circumferential surface of the corrugated pipe is smaller than the outer diameters of other parts of the pipe body 10, and the wave crests and the wave troughs of the corrugated pipe section are preferably sinusoidal or have other arc-shaped waveforms.

In addition, the delivery catheter further includes a coating 50, the coating 50 covering at least the curved guiding region 102 and covering the valleys of the curved guiding region 102, the coating 50 being configured to: when the bending guide region 102 is not bent, the coating film exhibits a flat profile. The flat profile prevents irritation of the catheter to the blood vessel during delivery of the catheter and facilitates delivery. When the bending guide region 102 is bent, the bending guide region 102 generates a large curved side with a larger radius of curvature and a small curved side with a smaller radius of curvature, the large curved side is more likely to contact the blood vessel, and the force at the time of bending can keep the membrane of the surface of the large curved side flat. In some embodiments, the material of the membrane is a highly elastic material, and when the bending guide region 102 is bent, the membrane on either the small or large bending side can maintain a flat profile due to the elastic action.

As shown in fig. 3 and 4, there are two general modes of passing the traction lumen 101 through the corrugated tube, and as shown in fig. 3, the radial position of a part section of the traction lumen 101 is just between the crest and the trough, the traction lumen 101 is communicated with a gap between the corrugated tube and the covering film through the corrugated tube, at this time, the traction wire 20 extends out of the position of the corrugated tube and is attached to the crest to extend axially, passes through the distal end of the corrugated tube and then passes back into the traction lumen 101 again, at this time, the whole traction lumen 101 is isolated at the corrugated tube; the drawing lumen 101 shown in fig. 4 is located below the trough of the corrugated tube, so that the drawing lumen 101 is a straight channel and is not affected by the corrugated tube, and therefore the drawing wire 20 passes through the area of the corrugated tube between the drawing lumens 101 below the trough, and in this embodiment, the drawing lumen 101 is preferably located below the trough of the corrugated tube so that the drawing wire 20 is not exposed at the corrugated tube.

The corrugated tube structure is selected as the bending guiding area 102, and the corrugated tube structure has both supporting performance and bending adjusting performance, wherein the supporting performance is characterized in that the corrugated tube structure can provide radial physical support for the conveying conduit on one hand, so that the middle conduit, the micro conduit and the guide wire pass through the conveying conduit to smoothly pass through a tortuous vessel such as an aortic arch or an intracranial tortuous vessel, and on the other hand, the corrugated tube structure is also used for providing axial support for the distal end of the conveying conduit so as to ensure that the distal end of the conveying conduit is effectively pushed to run; the arrangement of the corrugated pipe can ensure that the whole supporting performance and the controllable performance of the conveying catheter are better, and the distal end direction of the conveying catheter can be well controlled at the aortic arch, so that the distal end of the conveying catheter does not need to be designed to be particularly soft, and the whole physical supporting performance of the conveying catheter is ensured; in addition, the bending guide area 102 formed by the corrugated pipe can be repeatedly bent and straightened, the configuration conversion time is short, the repeated positioning can be realized in the operation process, and the operation is simple and time-saving; the delivery catheter with the structure can be used for interventional operation of radial artery access puncture, also can be used for interventional operation of intracranial artery, and is also suitable for passing through an intermediate catheter by controlling the inner diameter of the delivery catheter.

The covering film 50 can only cover the bending guide area 102, or the covering film 50 can cover the whole area of the pipe body, the covering film 50 is preferably a polymer film, the material of the covering film 50 can be, but not limited to PU, PE, EPTFE and other materials, the covering film 50 has good extensibility, so that the covering film 50 covering the large bending side of the corrugated pipe is ensured to be adaptively extended without breaking in the process of greatly bending the conveying pipe; the surface of the coating 50 may also be sprayed with an anticoagulant to avoid clinical thrombosis.

The thickness of the coating 50 is not limited, and is preferably less than 0.5mm, and the specific thickness depends on the characteristics of the material, and is based on the complete coating on the tube body without breaking;

referring to fig. 3 and 4, the proximal and distal ends of the cover 50 may be anchored to the transition regions of the proximal and distal ends of the bellows by a heat shrinking process; in the state that the tube body 10 is straight, the polymer coating 50 can cover the corrugated tube and further show a flat and smooth appearance, at this time, the coating can be attached to the wave crest of the corrugated tube and cover the wave trough, so that the stimulation to the vessel wall when the corrugated tube is designed in place can be reduced, the damage to the vessel in the conveying process of the corrugated tube section can be avoided, the thrombus in the clinical operation can be prevented from being formed at the wave trough of the corrugated tube section, and various complications such as vessel damage, thrombus and the like in the operation process can be reduced.

Referring to fig. 3 to 6, the middle part of the tube body 10 is provided with an implantation tube cavity 104, and the implantation tube cavity 104 is used for passing an intermediate catheter, a micro catheter and a guide wire; the body 10 is generally a circular tube with a smooth circular configuration on its outer circumference to minimize irritation to the vessel wall; the inner diameter and the outer diameter of the tube body 10 are not particularly limited, and the inner diameter thereof is adaptively adjusted according to the device to be implanted, and the outer diameter thereof is adapted to an applicable arterial vessel; the entire length of the tube body 10 is not particularly limited and is determined according to the length of implantation.

The drawn wire 20 is, for example, a twisted wire formed by twisting a plurality of monofilaments with each other, and the drawn wire 20 may be formed of a single wire;

the diameter of the drawing wire 20 is not particularly limited, but is preferably 0.2mm or more and 1mm or less, and the size thereof is determined depending on the drawing force required when the pipe body 10 is bent and the structural strength of the drawing wire 20 itself, and the material of the drawing wire 20 is not particularly limited, and may be, for example, a polymer wire, a low carbon steel, a stainless steel, a corrosion-resistant coated steel wire, titanium or titanium alloy, nickel or nickel alloy, or a metal wire such as chromium or chromium alloy, but is not limited thereto.

The position and size of the pulling lumen 101 are not particularly limited, and in general, the pulling lumen 101 is provided on the wall of the tube body 10, and the pulling lumen 101 extends in the axial direction of the tube body 10.

The number of pull wires 20 and pull lumens 101 is also not limited herein, but the number of pull wires 20 matches the number of pull lumens 101; one traction wire 20 can be arranged, unidirectional bending of the conveying conduit can only be realized at this time, and the return force generated by elastic deformation of the material of the traction wire 20 is needed for return of the conveying conduit at this time, in another alternative embodiment, the traction wires 20 can be arranged in a plurality of ways, for example, two traction wires 20 are arranged oppositely in the radial direction of the conveying conduit, bidirectional bending of the conveying conduit can be realized by controlling the two traction wires 20 at this time, and the return of the conveying conduit can be actively controlled, and more traction wires 20 can be arranged to realize bending in more directions, so that the description is omitted;

the proximal end of the traction wire 20 extends out of the pipe body 10, and the external device is used for applying an acting force to the traction wire 20 so as to strengthen the pipe body 10 to bend at the bending guide area 102, thereby achieving the purpose of actively controlling the pipe body 10 to bend; in clinic, the tension or loosening of the traction wire 20 is controlled by external force, so that the curvature conversion of the tube body 10 in the bending guide area 102 can be realized, when the traction wire 20 is tensioned, the bending guide area 102 is positioned at one side of the traction wire 20 and starts to bend along the stretching direction, the bending guide area 102 is positioned at one side of the pulled traction wire 20 and is a small bending side, the active control performance of the conveying catheter in a complex blood vessel is improved, when the traction wire 20 is relaxed, the tube body 10 can be reset by the self straightening force, and the tube body 10 can be straightened by the cooperation of the traction wires 20 and the active control, so that the tube body 10 can be conveniently repositioned, the feasibility of repeated operation is realized, and meanwhile, the postoperative catheter can be conveniently withdrawn from the blood vessel.

The delivery catheters of the prior art are typically non-adjustable bend catheters that require artificial bending of the catheter at the tortuous vessel by collision of the distal end of the delivery catheter with the vessel wall to find the appropriate angle to access the bifurcated vessel or the tortuous vessel. The above phenomenon is particularly evident in the interventional operation of radial artery access and intracranial vascular interventional operation. On the one hand, the conveying catheter in the prior art can increase operation time, on the other hand, the flow of blood in the aorta is extremely high, the distal end of the conveying catheter is extremely easy to be interfered by blood flow pressure in the process of colliding and bending with the vessel wall, the operation difficulty is high, the operation time is long, and the repeated collision with the vessel wall also increases the risk of vessel injury.

The invention can actively adjust the bend through the conveying conduit with the structure to adjust the proper implantation angle, so that the conveying conduit is suitable for the intervention operation of tortuous vessels, especially radial artery access puncture and intracranial artery intervention operation, reduces the operation difficulty of the tortuous vessels or bifurcated vessels in the intervention operation, is beneficial to reducing the operation time, such as the operation difficulty of radial artery, aorta and carotid artery when cerebral apoplexy intervention operation enters the path from the radial artery, does not need to rely on collision with the vessel wall to adjust the bent pipe body 10 in the implantation and turning process of the conveying conduit, and reduces the risk of vascular injury; in addition, based on the performance of actively bending the conveying conduit, the direction of the distal end of the conveying conduit is controlled, so that the damage to the blood vessel caused by the distal end of the conveying conduit in place is avoided, the distal end of the conveying conduit does not need to be designed to be particularly soft, the technical problem of poor support of the distal end of the conveying conduit is solved, the interference of blood flow to the distal end of the conveying conduit is improved, and the control difficulty of the conveying conduit is further reduced.

In some embodiments, the location of the connection of the distal end of the pull wire 20 to the tube 10 is within the pull lumen 101.

The traction wire 20 is positioned at a position farther from the distal end of the traction lumen 101, so that traction force is applied to the conveying catheter to bend the conveying catheter; the distal end of the traction wire 20 is generally connected in two ways, namely, the distal end of the traction wire 20 penetrates to the outside of the tube body 10 and is connected with the tube body 10, and the connection way is convenient for the connection of the traction wire 20, but the traction wire 20 is exposed and has hidden dangers of damaging the vessel wall, so that the distal end of the traction wire 20 is positioned in the traction lumen 101 and is connected with the tube body 10, and a series of hidden dangers caused by the exposure of the traction wire 20 are improved;

in this embodiment, the distal end of the traction lumen 101 is located at the side of the curved guiding area 102 near the distal end of the tube body 10, and the distal end of the traction wire 20 is connected with the distal end of the traction lumen 101, and since the traction wire 20 is not exposed, the connection of the distal end of the traction wire can be achieved in an injection-molded and pre-embedded manner or in a layered manner.

Further, at least two traction lumens 101 are disposed along the circumferential direction of the tube body 10, and the traction wires 20 are disposed in each traction lumen 101.

The number and location of the traction lumens 101 are not limited herein;

referring to fig. 2 and 5, two traction lumens 101 are provided, the two traction lumens 101 are oppositely arranged along the radial direction, and each corresponding traction lumen is internally provided with one traction wire 20, so that the bending and the straightening of the conveying catheter can be controlled by the two traction wires 20, and the bidirectional bending and the active straightening can be realized;

in other alternative embodiments, other numbers of traction lumens 101 may be provided, preferably the number of traction lumens 101 is even, and the traction lumens 101 are distributed in a rotationally symmetrical manner, so that the traction wires 20 in two diametrically opposite traction lumens 101 are used as a pair in a matched manner, and bidirectional bending and active straightening in corresponding directions can be realized. In other embodiments, the traction lumens may also be asymmetrically distributed in the radial direction. In other embodiments, only a plurality of traction wires may be provided, distributed radially symmetrically or asymmetrically, without providing a traction lumen. In addition, an annular traction lumen can be arranged on the tube body, and the traction wires are symmetrically or asymmetrically arranged along the axial direction of the traction lumen.

Further, the delivery catheter further includes at least two developing members 30, each of the developing members 30 being disposed on the tube body 10 and being located at the distal end side and the proximal end side of the curved guide area 102, respectively.

The developing member 30 is used for X-ray developing marks, the developing member 30 is generally in a ring structure, but is not limited to the ring structure, and may be a developing film, and the developing member 30 may be pressed or adhered on an outer circumferential surface of the conveying conduit, or may be integrated in a wall of the conveying conduit;

the material of the developing member 30 may be, but is not limited to, platinum, iridium, tantalum, noble metal alloy, etc.

In this embodiment, the developing members 30 are disposed on both sides of the curved guide area 102 for marking the position of the curved guide area 102, and it is preferable that the developing members 30 are located immediately on both sides of the curved guide area 102; in other alternative embodiments, the development member 30 may be added adaptively according to the function to be achieved, for example, a development member 30 may be provided at the distal-most end of the delivery catheter to mark the distal end position of the delivery catheter;

further, the delivery catheter also includes a balloon having an inflation lumen thereon in communication with the lumen of the balloon for anchoring the catheter during delivery or blocking blood flow in some surgical procedures. In the case where the balloon is used to anchor a catheter, there are preferably at least two balloons 40 on the body, each balloon 40 being disposed at the distal end of the body 10 and circumferentially spaced around the body 10, the balloons 40 being configured to: when the balloon 40 is inflated such that the distal end of the tube 10 is anchored to the vessel wall, there is a gap between adjacent balloons in the circumferential direction of the tube 10.

Balloon 40 is physically connected to the distal end of the delivery catheter, and balloon 40 is a polymeric membrane material, which may be, but is not limited to, PU, PE, EPTFE;

referring to fig. 6, a filling lumen 103 is disposed on the wall of the tube body 10 and extends along the axial direction, and a proximal end of the filling lumen 103 is communicated to a proximal end of the tube body 10 for connection with a liquid outlet of a filling pump, and when the filling pump fills physiological saline into the balloon 40 through the filling lumen 103, the balloon 40 expands to contact with the vessel wall, and anchors a distal end of the delivery catheter to the vessel wall;

in intracranial vascular intervention, the distal end of the delivery catheter is anchored by balloon 40 at its location when reaching the common carotid artery, to provide effective physical support for the intermediate catheter, microcatheter, guidewire.

In this embodiment, the number of the balloons 40 is not limited, for example, in this embodiment, four filling balloons 40 are uniformly arranged at the distal end of the delivery catheter along the circumferential direction, the distal end of the delivery catheter begins to fill the balloons 40 when reaching the position to be anchored, such as the common carotid artery, and the filling of the balloons 40 can be attached to the vessel wall, so as to achieve the effect of retaining the distal end of the delivery catheter, and more facilitate the establishment of an intracranial delivery channel; in addition, the four balloons 40 are not contacted with each other after filling, so that the distal end of the delivery catheter is anchored on the wall of the blood vessel, the blood vessel is not completely blocked, and the influence on a patient in clinical operation is reduced; in other alternative embodiments, two, three or more balloons 40 may be provided, and will not be described in detail here.

Further, the delivery catheter further comprises a pulling member 60, the pulling member 60 is disposed at the proximal end of the tube body 10, and the pulling member 60 is used for pulling the proximal end of the pulling wire 20 to tighten or loosen the pulling wire 20.

In the embodiment, the traction mode of the traction member is not limited, for example, the traction machine can be a linear motion traction mode or a rotary motion winding traction mode; when the traction wire 20 is required to be linearly pulled during the linear motion traction, the traction motion route is longer, so that the structural occupation space of the traction piece is larger; the rotary motion winding type traction is used for winding the traction wire 20 so as to apply external force to the traction wire 20, and the occupied space of a traction piece is small; the traction element in this embodiment is a rotary table installed at the proximal end of the conveying conduit, wherein the proximal end of the conveying conduit is provided with a control valve, the rotary table is installed on the control valve, and the connection mode of the traction wire 20 and the rotary table as well as the pipe body 10 can be through gluing or welding, but is not limited to this; the traction wire 20 adopts a rotary motion winding type traction mode, when the turntables rotate, the traction wire 20 is wound, the traction wire 20 in the traction lumen 101 is pulled to drive the pipe body 10 to bend, as shown in fig. 1 and 2, two turntables are arranged in the embodiment, which are adapted to the two traction wires 20, each turntable can independently control the corresponding traction wire 20, and the turntables rotate to tighten or loosen the traction wire 20; when the bending of the tube body 10 needs to be regulated, the turntable is rotated to tighten the traction wire 20 on the small bending side, loosen the traction wire 20 on the large bending side, and the pulling force acts on the tube body 10, so that the tube body 10 is bent at the bending guide area 102, and the bending degree of the tube body is controlled by controlling the winding amount of the traction wire on the small bending side and the release amount of the traction wire 20 on the large bending side, so that the conveying catheter smoothly passes through a tortuous or bifurcated blood vessel, for example, enters a right common carotid artery or a left common carotid artery from an aortic arch; when the operation is finished or the position needs to be adjusted, the rotary table is controlled to rotate reversely, the traction wire 20 on the small bending side is released, the traction wire 20 on the large bending side is tensioned, the conveying catheter can be actively controlled to be changed from a bending state to a straight tube state, and the conveying catheter is conveniently repositioned or the conveying catheter and thrombus are withdrawn from a blood vessel.

Further, the tube body comprises at least two layers, and the traction tube cavity is formed between the layers, wherein any one layer or any plurality of layers form a corrugated tube section through self deformation. The number of layers of the pipe body is not limited, and the number of layers can be adaptively adjusted according to the specific structure and functional requirements of the pipe body; referring to fig. 5, the tube body 10 includes a first layer 11 and a second layer 12, the first layer 11 is wrapped on the outer surface of the second layer 12, and the traction lumen 101 is formed between the first layer 11 and the second layer 12;

with continued reference to fig. 5, the tube 10 is layered, so as to facilitate the forming and assembling of the tube 10, wherein the distal end of the traction wire 20 can be fixedly connected with the second layer, and then the first layer is wrapped on the second layer, which is beneficial to the formation of the traction lumen 101 and the connection of the distal end of the traction wire 20 with the tube 10.

Further, the pipe body 10 further comprises a third layer 13, wherein the third layer 13 is located inside the second layer 12, i.e. the second layer 12 is located between the first layer 11 and the third layer 13.

The tube body 10 is in a three-layer structure, the first layer is used as the outer wall of the tube body 10 to be in contact with the blood vessel wall, the third layer is used as the inner wall of the tube body 10 to be used for conveying other instruments, therefore, the requirements of the first layer and the second layer are higher, the characteristic requirements of the first layer and the second layer are different, the second layer is positioned between the first layer and the third layer, the characteristic requirements of the second layer are lower, the second layer can be made of any material, the first layer and the second layer are not influenced, and the three-layer structure is beneficial to selecting corresponding materials according to respective characteristic requirements.

Wherein the first layer material can be one or more of nylon elastomer block polyether amide resin, nylon and polyurethane, and the third layer material can be one or more of polytetrafluoroethylene, high-density polyethylene, block polyether amide resin mixed with friction coefficient reducing additive or polyolefin elastomer;

the second layer of the tube body 10 includes, but is not limited to, a coil structure, a braid structure, or a medical cutting hypotube formed of a material such as stainless steel, nitinol, cobalt chrome, or polymer filaments, or a combination of two or more of the foregoing, such that the tube body 10 has good support properties. In other alternative embodiments, considering the bending adjustment function of the bellows, if the second layer adopts a structure of a braided or medical cutting hypotube in this area, the second layer may adopt a coil structure in this area, and the rest area is designed of the braided, coil or medical cutting hypotube structure, so as to achieve both the overall support and the flexibility of the delivery catheter.

In addition, the tube body 10 is arranged in a layered manner, so that the installation of the developing member 30 is facilitated, for example, the developing member 30 is arranged on the second layer, and the developing member 30 is covered by the first layer, so that the developing member 30 is not exposed, and the installation process of the developing member 30 is simplified.

Further, wherein the outer surface of the tube body 10 forms a bellows section by self-deformation, the first layer 11 forms the outer surface of the tube body, and thus, the first layer forms a bellows section by self-deformation; the bellows section forms the curved guiding region 102.

The first layer of the pipe body 10 is designed into a corrugated pipe similar to a straw structure, the corrugated pipe can be molded and extruded at one time, a heated and melted polymer material is injected into a molding cavity of the corrugated pipe, the solution can be rapidly filled into lines of the molding cavity, the filling material can be solidified and molded along with the forward movement of a mold, each pair of the molds can be automatically opened and demoulded, and the forward movement of the mold can continue to circularly mold the corrugated pipe. The corrugated pipe may be formed through hydraulic forming process, and the corrugated pipe may be combined with other straight pipe to form the first layer of pipe 10 or with integral pipe to form the corrugated pipe structure.

In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other.

The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.

Claims

1. A delivery catheter, comprising:

2. The delivery catheter of claim 1, wherein the coating is configured to: when the bending guide region is not bent, the covering film exhibits a flat appearance.

3. The delivery catheter of claim 1, wherein the catheter is configured to deliver,

the delivery catheter further comprises a pull wire;

the traction wire is used to control the bending of the bending guide region.

4. The delivery catheter of claim 3, wherein the tube further has a pull lumen, a proximal end of the pull lumen being in communication with a proximal end of the tube;

5. The delivery catheter of claim 4, wherein a location of connection of the distal end of the pull wire to the tube body is within the pull lumen.

6. The delivery catheter of claim 4, wherein at least two of said pull lumens are disposed circumferentially about said body, each of said pull lumens having said pull wire disposed therein.

7. The delivery catheter of claim 1, further comprising at least two visualization elements, each visualization element disposed on the tubular body and positioned on a distal side and a proximal side of the curved guide region, respectively.

8. The delivery catheter of claim 1, further comprising a balloon, wherein the body further has an inflation lumen thereon, wherein a distal end of the inflation lumen is in communication with a lumen of the balloon.

9. The delivery catheter of claim 8, comprising at least two balloons, each balloon disposed at a distal end of the tube and circumferentially spaced around the tube.

10. The delivery catheter of claim 9, wherein the balloon is configured to: when the balloon is inflated so that the distal end of the tube body is anchored to the vessel wall, a gap is provided between adjacent balloons in the circumferential direction of the tube body.

11. The delivery catheter of claim 3, further comprising a pulling member disposed at a proximal end of the tube body for pulling on a proximal end of the pull wire to tighten or loosen the pull wire.

12. The delivery catheter of claim 4, wherein the tube comprises at least two layers, the traction lumen being formed between the layers.

13. The delivery catheter of claim 1, wherein the tube comprises at least two layers, wherein any one or more of the layers is deformed by itself to form a bellows segment.

14. The delivery catheter of claim 13, wherein the tube comprises a first layer and a second layer, the first layer wrapping an outer surface of the second layer, the first layer forming the outer surface of the tube.

15. The delivery catheter of claim 14, wherein said first layer is deformed by itself to form a bellows segment.

16. The delivery catheter of claim 14, wherein said tube further comprises a third layer, said third layer being located inside said second layer.

17. The delivery catheter of claim 1, wherein the outer surface of the tube body is deformed by itself to form a bellows segment.