Bending-adjustable nerve intervention micro catheter

Abstract

The invention relates to the technical field of medical instruments, in particular to a bending-adjustable nerve intervention microcatheter which comprises an outer-layer tube and an inner-layer tube. The inner-layer pipe is coaxially sleeved with the outer-layer pipe, the outer-layer pipe comprises a supporting section and a bending adjusting section, the far end of the inner-layer pipe is fixedly connected with the far end of the bending adjusting section, and the near end of the inner-layer pipe protrudes out of the supporting section and is movably arranged relative to the supporting section; wherein the bending adjusting section is provided with a plurality of first notches in the axial direction of the outer-layer pipe, when the inner-layer pipe moves towards the far end relative to the supporting section, the bending adjusting section bends towards one direction, and when the inner-layer pipe moves towards the near end relative to the supporting section, the bending adjusting section bends towards the other direction. Through the arrangement, the bending direction of the end part of the outer-layer tube can be changed only by pushing and pulling the inner catheter without pre-shaping the micro catheter or guiding a guide wire, so that the operation difficulty is reduced, and meanwhile, the time and the cost of an interventional operation are also saved.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an adjustable bend neural intervention microcatheter. Background Art

[0002] With the advancement of neurointerventional technology and consumables, interventional surgery is increasingly being chosen for the treatment of stroke. In the course of interventional surgery, most of the time, guidewires are operated in the blood vessels or interventional treatment devices are delivered; for example, in neurological interventional surgery, the general operation is to use a guidewire to establish a channel, and the distal access catheter uses the guidewire to aspirate or remove the occluded blood vessels; as for ischemic and hemorrhagic strokes caused by tortuous intracranial vessels, a distal access catheter is required to deliver coils and other devices directly to the diseased blood vessels.

[0003] In the related art, for the treatment of severe vascular tortuosity and complex intracranial aneurysms, the tip of the microcatheter needs to be pre-shaped before reaching the target position, and then the spring coil is delivered into the aneurysm. Sometimes, multiple shaping operations are required to reach the target position.

[0004] However, the pre-shaping of the microcatheter increases the time of the interventional procedure, and the control of the pre-shaped microcatheter is highly dependent on the operating skills of the interventional physician. Summary of the invention

[0005] In view of at least one of the above technical problems, the present invention provides an adjustable bend neurointervention microcatheter, which uses structural improvements to reduce the time and operation difficulty of interventional surgery.

[0006] According to a first aspect of the present invention, there is provided an adjustable bend neurointervention microcatheter, comprising an outer tube and an inner tube;

[0007] The inner tube is coaxially sleeved in the outer tube, and the outer tube includes a supporting section and a bending adjustment section. The distal end of the inner tube is fixedly connected to the distal end of the bending adjustment section, and the proximal end of the inner tube protrudes from the supporting section and is movably arranged relative to the supporting section; wherein, the bending adjustment section has a plurality of first incisions arranged along the axial direction of the outer tube, and when the inner tube moves toward the proximal end relative to the supporting section, the bending adjustment section bends in one direction, and when the inner tube moves toward the distal end relative to the supporting section, the bending adjustment section bends in another direction.

[0008] In some embodiments of the present invention, the first incisions are radially arranged, and the depth of the first incisions is smaller than the diameter of the outer tube, and the first incisions are arranged with gradually decreasing spacing in the distal direction away from the support segment.

[0009] In some embodiments of the present invention, the outer tube is a nickel-titanium hypotube.

[0010] In some embodiments of the present invention, the inner tube includes a push-pull section and a cut section connected to the push-pull section, the cut section has a plurality of second cuts arranged axially, the push-pull section partially overlaps with the support section, and the cut section is inside the outer tube.

[0011] In some embodiments of the present invention, the bending directions of the bending adjustment sections are in the same plane.

[0012] In some embodiments of the present invention, an opening direction of the first incision is arranged opposite to an opening direction of the second incision.

[0013] In some embodiments of the present invention, the inner layer tube includes an inner layer, a reinforcement layer and an outer layer from the inside to the outside.

[0014] In some embodiments of the present invention, the inner layer is made of PTFE, the reinforcement layer is woven from metal wires or polymer wires or formed by winding springs, and the outer layer is a nickel-titanium hypotube.

[0015] In some embodiments of the present invention, a bending controller is also included, which includes a shell and a slider slidably connected to the shell in a straight line direction, the support section is fixed to the proximal end of the shell, and the portion of the inner tube protruding from the support section is fixedly connected to the slider in the shell.

[0016] In some embodiments of the present invention, the two ends of the shell also have a first guide seat and a second guide seat arranged away from each other in a straight line direction, the first guide seat has a guide hole for fixing the outer layer tube, and the second guide seat has a guide channel for the inner layer tube to pass through, and the slider can slide between the first guide seat and the second guide seat.

[0017] The beneficial effects of the present invention are as follows: the present invention uses a coaxially arranged outer tube and inner tube, fixes the end of the outer tube to the end of the inner tube, and provides a first incision on the outer tube, so that when the inner tube is pulled outward, the end of the outer tube bends in one direction, and when the inner tube is pushed inward, the end of the outer tube bends in another direction. Compared with the prior art, there is no need to pre-shape the microcatheter or guide the guide wire, and the bending direction of the end of the outer tube can be changed by only pushing and pulling the inner catheter, thereby reducing the difficulty of operation and saving the time and cost of interventional surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0019] Figure 1 Schematic diagram of the structure of an adjustable nerve intervention microcatheter in an embodiment of the present invention (the bending controller is omitted);

[0020] Figure 2 Schematic diagram of the cross-sectional structure of the adjustable bend nerve intervention microcatheter in the embodiment of the present invention (when the inner tube is pulled);

[0021] Figure 3 Schematic diagram of the cross-sectional structure of the adjustable bend nerve intervention microcatheter in the embodiment of the present invention (when the inner tube is pushed);

[0022] Figure 4 This is a schematic diagram of the explosion decomposition structure of the inner tube and the outer tube in an embodiment of the present invention;

[0023] Figure 5 is a radial cross-sectional view of the inner tube in an embodiment of the present invention;

[0024] Figure 6 Schematic diagram of the structure of an adjustable curved nerve intervention microcatheter in an embodiment of the present invention;

[0025] Figure 7 Schematic diagram of the structure of the adjustable bend neural intervention microcatheter in an embodiment of the present invention (explosion diagram of the bend adjustment controller);

[0026] Figure 8 A schematic diagram of an unfolded structure of an outer tube of an adjustable bendable neural intervention microcatheter in an embodiment of the present invention;

[0027] Fig. 9 Schematic diagram of another unfolding structure of the outer tube of the adjustable bend nerve intervention microcatheter in an embodiment of the present invention. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0029] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0031] The microcatheters in the prior art have the defects of being difficult to operate, taking a long time for the operation, and having high operation costs, which are specifically manifested in the following aspects: when performing the operation, the operator needs to have rich operation skills, it is difficult to reach the complex anatomical structure, and the control stability at the treatment site is poor. During the embolization of the aneurysm coil, the stability of the tip of the microcatheter is a prerequisite for dense embolism. Improper shaping of the tip not only makes the superselection of the aneurysm difficult, but may even cause the catheter to be bent, and during the filling, the tip may withdraw from the aneurysm cavity and form a thrombus, or the tip may not swing in the aneurysm cavity as the coil is advanced, but a large tension may accumulate in the aneurysm, which may easily cause the aneurysm to rupture during the operation. The complex operation and exchange of the instruments prolong the operation time, and when the guide wire is used for guidance, each guide wire has an additional cost. The adjustable curved nerve intervention microcatheter provided in the embodiment of the present invention does not require frequent replacement of catheters and pre-molding, which reduces the interventional operation time and the difficulty of doctor's operation, thereby reducing the risk of various complications during the operation; at the same time, the adjustable curved nerve intervention microcatheter in the embodiment of the present invention does not require the use of a guide wire as a guide, thereby reducing the additional cost of the guide wire, saving manpower and material resources, and bringing good news to patients. The adjustable curved nerve intervention microcatheter in the embodiment of the present application is introduced in detail below.

[0032] like Figures 1 to 9 The adjustable curved neurointervention microcatheter shown in the figure comprises an outer tube 1 and an inner tube 2, as shown in FIG. Figures 1 to 3As shown in , in an embodiment of the present invention, the inner tube 2 is coaxially sleeved in the outer tube 1, and the outer tube 1 includes a support section 11 and a bending section 12, and the distal end of the inner tube 2 is fixedly connected to the distal end of the bending section 12; the fixed connection here can be fixed by laser welding, gluing and lighting technology. The proximal end of the inner tube 2 protrudes from the support section 11 and is movably arranged relative to the support section 11; wherein the bending section 12 has a plurality of first cutouts 12a arranged along the axial direction of the outer tube 1, and when the inner tube 2 moves toward the distal end relative to the support section 11, the bending section 12 bends in one direction, and when the inner tube 2 moves toward the proximal end relative to the support section 11, the bending section 12 bends in another direction. In an embodiment of the present invention, the proximal end refers to the end of the catheter close to the operator, and the distal end refers to the end away from the operator. It should be pointed out here that the inner tube 2 moves toward the distal end relative to the support section 11, which means that under the action of external force, the support section 11 does not move, and the inner tube 2 is pulled outward. Since the other end of the inner tube 2 is fixed to the end of the outer tube 1, and there is a first cutout 12a on the outer tube 1, when the inner tube 2 is pulled, as the distance of the inner tube 2 in the outer tube 1 is shortened, the outer tube 1 will undergo the following Figure 2 The bending shown in . In the embodiment of the present invention, the inner layer moves toward the proximal end relative to the support section 11, which means that the support section 11 does not move, and the inner tube 2 pushes inward relative to the support tube, so that the part of the inner tube 2 protruding from the support section 11 is squeezed into the outer tube 1. Similarly, since the end of the inner tube 2 is fixedly connected to the bending section 12 of the outer tube 1, when the distance of the inner tube 2 in the outer tube 1 increases, the bending section 12 of the outer tube 1 will bend in another direction to adapt to the increase in the distance of the inner tube 2. It should also be pointed out here that the first incision 12a in the embodiment of the present invention has a variety of structural forms, all of which are radially arranged. The shape of the first incision 12a can be an arc opening, or a rectangular opening, etc., which can be set by those skilled in the art as needed. It should also be pointed out here that in the embodiment of the present invention, one direction refers to the direction in which the bending direction is perpendicular to the axial direction of the outer tube 1, and the other direction refers to a direction different from one direction. Its specific direction can be changed according to the setting of the first incision 12a. By bending in different directions and cooperating with the doctor's rotation operation, a 360-degree range of bending can be achieved.

[0033] In the embodiments of the present application, the inner tube 2 is pushed and pulled to realize the change of the bending direction and degree of bending of the bending section 12 of the outer tube 1. The specific degree of bending can be achieved according to the moving distance of the inner tube 2 relative to the supporting section 11. Through the above arrangement, there is no need to use a guide wire as a guide, which reduces the additional cost of the guide wire, and the spring coil can be directly delivered into the hemangioma through the inner tube 2 for blocking, which can improve the success rate of the operation and reduce the pain of the patient.

[0034] In the above embodiment, by coaxially arranging the outer tube 1 and the inner tube 2, fixing the end of the outer tube 1 with the end of the inner tube 2, and setting the first incision 12a on the outer tube 1, the end of the outer tube 1 is bent in one direction when the inner tube 2 is pulled outward, and the end of the outer tube 1 is bent in another direction when the inner tube 2 is pushed inward. Compared with the prior art, there is no need to pre-shape the microcatheter, nor is there any need to guide the guide wire. Only the pushing and pulling of the inner catheter can achieve the change of the bending direction of the end of the outer tube 1, thereby reducing the difficulty of operation and saving the time and cost of interventional surgery. In addition, through the above arrangement, the microcatheter can be operated at the distal end, so that the interventional doctor can be more stable when passing the device through the trunk to the brain, which can solve the problem of difficulty in crossing the tortuous blood vessels near the lesion, and solve the problem of frequent replacement and shaping of the catheter during the operation, thereby reducing the risks of various complications and catheter instability during the operation.

[0035] On the basis of the above embodiments, in some embodiments of the present invention, the specific configuration of the first incision 12a is as follows: Figure 4 As shown in , the first incision 12a is radially arranged, and the depth of the first incision 12a is smaller than the diameter of the outer tube 1, and the first incision 12a is arranged with gradually decreasing spacing in the direction away from the distal end of the support section 11. That is, in an embodiment of the present invention, the first incisions 12a on the distal end of the outer tube 1 are denser, so as to maintain softness, that is, the first incisions 12a on the bending section 12 are denser, and the spacing of the first incisions 12a at the proximal end is increased to improve the support performance. The specific spacing can be set by those skilled in the art according to the set length of the bending section 12, which will not be elaborated here. In one embodiment of the present invention, the outer tube 1 is a nickel-titanium sea wave tube. As shown in FIG. Figure 8 and Fig. 9 As shown in, in an embodiment of the present invention, the outer tube 1 can be a single-layer nickel-titanium hypotube. When the first incision 12a is cut, it can be cut in the middle or on both sides to form a complete circular tube structure.

[0036] In some embodiments of the present invention, the specific structure of the inner tube 2 is as follows: Figure 4As shown in the figure, the inner tube 2 includes a push-pull section 21 and a cutout section 22 connected to the push-pull section 21. A plurality of second cutouts 22a are arranged axially on the cutout section 22. The push-pull section 21 partially overlaps with the support section 11, and the cutout section 22 is located inside the outer tube 1. In the embodiment of the present invention, the first cutout 12a and the second cutout 22a are both cut radially and spaced apart in the axial direction. In addition, in the embodiment of the present invention, the cutting depths of the first cutout 12a and the second cutout 22a are both smaller than the diameters of the outer tube 1 and the inner tube 2, in order to ensure the support of the outer tube 1 and the inner tube 2, so as to facilitate the direct delivery of the outer tube 1 to the lesion, and then the coil is delivered into the hemangioma through the inner tube 2.

[0037] In some embodiments of the present application, in order to alleviate the patient's pain and reduce the twisting of the microcatheter in the blood vessel, in some embodiments of the present invention, the bending direction of the bending section 12 is in the same plane. By setting it in this way, it is only necessary to adjust the angle when inserting the microcatheter so that the bending direction of the bending section 12 is toward the target position, and then directly bend the bending section 12 after reaching the target position. This structural setting can adapt to more complex situations. The specific structure of the bending direction of the bending section 12 in the same plane is as follows: Figure 4 As shown in FIG. 1 , the opening direction of the first incision 12a is arranged opposite to the opening direction of the second incision 22a. By so arranging, when pulling through the inner tube 2, the spacing of the first incision 12a becomes smaller, so that the end of the outer tube 1 is toward Figure 4 When the inner tube 2 extends toward the inner side of the outer tube 1, the spacing of the first cutout 12a becomes larger, so that the end of the outer tube 1 is toward Figure 4 The opening direction of the second cutout 22a on the inner tube 2 is opposite to that of the first cutout 12a, which not only guides the bending direction of the outer tube 1, but also balances the overall structural strength of the microcatheter, so that the non-cutout parts of the inner tube 2 and the outer tube 1 are respectively located on both sides of the entire microcatheter.

[0038] In some embodiments of the present invention, the specific structure of the inner tube 2 is as follows: Figure 5As shown in , the inner tube 2 includes an inner layer 211, a reinforcing layer 212 and an outer layer 213 from the inside to the outside. Specifically, the inner layer 211 is made of PTFE, the reinforcing layer 212 is woven or wound with metal wires or polymer wires, and the outer layer 213 is a nickel-titanium sea wave tube. It should be pointed out here that PTFE refers to polytetrafluoroethylene, which is stable, odorless, non-toxic, and highly lubricating and non-sticky. Through the setting of this structure, it is easy to transport the spring coil. Of course, it should be pointed out here that in the embodiment of the present invention, what enters from the inner tube 2 is not limited to the spring coil, but can also be other surgical instruments, which will not be repeated here; in the embodiment of the present invention, the metal wire in the reinforcing layer 212 can be stainless steel wire, nickel-titanium alloy wire, etc., and the polymer wire can be aramid wire, etc.

[0039] like Figure 6 As shown in , in some embodiments of the present invention, in order to further improve the convenience of the bending operation, a bending controller 3 is also included, the controller includes a housing 31 and a slider 32 slidably connected to the housing 31 in a straight direction, the support section 11 is fixed to the proximal end of the housing 31, and the portion of the inner tube 2 protruding from the support section 11 is fixedly connected to the slider 32 in the housing 31. Through such an arrangement, since the support section 11 is fixed to the proximal end of the housing 31, the inner tube 2 is fixedly connected to the slider 32, so that the movement of the slider 32 can drive the inner tube 2 to move relative to the outer tube 1, so that the user can hold the microcatheter when holding the housing 31, and only a single finger is needed to control the slider 32, so as to conveniently control the bending direction and degree of the bending section 12.

[0040] Please refer to Figure 7 In some embodiments of the present invention, in order to ensure the straightness of the inner tube 2 and the outer tube 1, the two ends of the shell 31 also have a first guide seat 311 and a second guide seat 312 that are arranged away from each other in a straight direction. The first guide seat 311 has a guide hole for fixing the outer tube 1, and the second guide seat 312 has a guide channel for the inner tube 2 to pass through. The slider 32 can slide between the first guide seat 311 and the second guide seat 312. When fixing, the support section 11 of the outer tube 1 is fixed in the guide hole of the first guide seat 311 by welding or bonding, such as Figure 7 As shown in the figure, when fixing, the support section 11 can be extended into a part of the inner part of the shell 31 to further improve the overall straightness of the microcatheter, avoid shaking or damage of the tube body due to force during use, and fix the outer tube 1 through the guide hole to improve the reliability of fixation, and avoid displacement of the outer tube 1 when the slider 32 slides. In some embodiments of the present application, a guide structure can also be set for the slider 32 to improve the accuracy of the operation. There are many specific guide structures, for example, it can be as follows Figure 7 In addition to the guide groove shown in the figure, those skilled in the art may also set a guide rail or a guide rod to realize the guiding function of the slider 32. In addition, in some embodiments of the present invention, the first cutout 12a and the second cutout 22a may be set to face the side of the housing 31. This setting may further improve the convenience of the doctor's operation. Figure 7 In some embodiments of the present invention, the end of the inner tube 2 protrudes from the second guide seat 312. Through this arrangement, the inner catheter is supported, thereby facilitating subsequent operations after the microcatheter reaches the target position.

[0041] In an embodiment of the present invention, when the distal end of the microcatheter is in an unshaped state, the microcatheter can easily pass through tortuous blood vessels. When the distal end of the microcatheter reaches the specified position, the slider 32 is moved forward and backward to drive the inner tube 2 to move forward and backward, thereby driving the shaping effect of the bending section 12 of the outer tube 1, and then the spring coil is delivered to the aneurysm through the proximal end of the inner tube 2.

[0042] Those skilled in the art should understand that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, and these changes and improvements fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. An adjustable bend neural intervention microcatheter, characterized in that: It includes an outer tube and an inner tube; The inner tube is coaxially sleeved in the outer tube, and the outer tube includes a supporting section and a bending adjustment section. The distal end of the inner tube is fixedly connected to the distal end of the bending adjustment section, and the proximal end of the inner tube protrudes from the supporting section and is movably arranged relative to the supporting section; wherein, the bending adjustment section has a plurality of first incisions arranged along the axial direction of the outer tube, and when the inner tube moves toward the proximal end relative to the supporting section, the bending adjustment section bends in one direction, and when the inner tube moves relative to the distal end of the supporting section, the bending adjustment section bends in another direction.

2. The adjustable bend neural intervention microcatheter according to claim 1, characterized in that: The first cutouts are radially arranged, and the depth of the first cutouts is smaller than the diameter of the outer tube. The first cutouts are arranged with gradually decreasing spacing in the distal direction away from the support segment.

3. The adjustable bend neural intervention microcatheter according to claim 1, characterized in that: The outer tube is a nickel-titanium hypotube.

4. The adjustable bend neural intervention microcatheter according to claim 2, characterized in that: The inner tube comprises a push-pull section and a cutout section connected to the push-pull section, the cutout section is axially arranged with a plurality of second cutouts, the push-pull section partially overlaps with the support section, and the cutout section is inside the outer tube.

5. The adjustable bend neural intervention microcatheter according to claim 4, characterized in that: The bending directions of the bending adjustment sections are in the same plane.

6. The adjustable bend neural intervention microcatheter according to claim 5, characterized in that: The opening direction of the first slit is arranged opposite to the opening direction of the second slit.

7. The adjustable bend neural intervention microcatheter according to claim 1, characterized in that: The inner layer tube comprises an inner layer, a reinforcement layer and an outer layer in sequence from the inside to the outside.

8. The adjustable bendable neural intervention microcatheter according to claim 7, characterized in that: The inner layer is made of PTFE, the reinforcement layer is formed by weaving metal wires or polymer wires or winding springs, and the outer layer is a nickel-titanium hypotube.

9. The adjustable bendable neural intervention microcatheter according to claim 1, characterized in that: It also includes a bending controller, which includes a shell and a slider slidably connected to the shell in a straight direction. The support section is fixed to the proximal end of the shell, and the part of the inner tube protruding from the support section is fixedly connected to the slider in the shell.

10. The adjustable bend neural intervention microcatheter according to claim 9, characterized in that: The two ends of the shell also have a first guide seat and a second guide seat arranged away from each other in a straight direction. The first guide seat has a guide hole for fixing the outer layer tube, and the second guide seat has a guide channel for the inner layer tube to pass through. The slider can slide between the first guide seat and the second guide seat.

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