Disclosure of Invention
The invention aims to provide a slow-closing opening guide wire, which solves the problems that the hardness of the distal end of the existing guide wire is insufficient, the guide wire is difficult to smoothly pass through a vascular occlusion part, and the guide wire is difficult to pass through an intracranial vascular occlusion region.
In order to achieve the above object, the present invention provides the following technical solutions:
a slow closing opening guide wire comprises an outer sleeve with a hollow cavity;
the opening wire is arranged in the outer sleeve;
The guide wire is arranged in the outer sleeve;
the torsion control assembly is respectively connected to the proximal ends of the opening wire and the guide wire and is used for independently driving the opening wire or the guide wire to move along the axial direction of the outer sleeve;
The opening wire is made of hard alloy, and the hardness of the distal end of the opening wire is larger than that of the distal end of the guide wire.
Preferably, the distal end of the opening wire is ground, a first developing wire is arranged at the position, close to the distal end, of the opening wire, and the distance between the first developing wire and the distal end of the opening wire is 20-30mm.
Preferably, the opening wire and the guide wire are integrally processed by adopting a coiling process, the spring spacing of the opening wire is gradually increased from the proximal end to the distal end, so that the distal end of the opening wire is compliant, and the spring spacing of the guide wire is consistent with the opening wire.
Preferably, the torsion control assembly comprises a connector connected with the opening wire and the guide wire, an internal thread groove is formed in the proximal end of the connector, and the connector is connected with a rotary handle through the internal thread groove in a threaded manner.
Preferably, the opening wire is made of stainless steel.
Preferably, the guide wire is made of nickel-titanium alloy, and the distal end of the guide wire is shaped like an ellipse.
Preferably, the outer diameter of the outer sleeve is gradually reduced from the proximal end to the distal end, the distal end of the outer sleeve is a flexible section, and the proximal end is a supporting section.
Preferably, the flexible section is made of a tube through compact cutting, the supporting section is made of a tube with uniform outer diameter through cutting, and the cutting gap of the supporting section is larger than that of the flexible section.
Preferably, the distal end of the outer sleeve is provided with a developing ring.
Preferably, the distal end of the guide wire is provided with a second visualization wire.
The beneficial effects are that:
(1) According to the invention, the opening wire and the guide wire which are positioned in the outer sleeve are independently driven by the torsion control assembly, firstly, the hard opening wire is utilized to open the vascular occlusion, then the guide wire with a softer distal end passes through the vascular occlusion, the passing difficulty of the guide wire is greatly reduced, and the outer sleeve is pushed forward after the guide wire passes through, so that the outer sleeve also passes through the vascular occlusion, thereby realizing successful in-place operation, and overcoming the problem that the guide wire passes through the intracranial vascular occlusion area difficultly;
(2) The positions of the outer sleeve, the opening wire and the guide wire are judged by arranging the developing ring, the first developing wire and the second developing wire, so that the judgment of an operator is facilitated, and the success rate of the operation is improved;
(3) According to the invention, the torsion control assembly is arranged and independently controls the opening wire and the guide wire, the rotary handle is held, and the rotary connector enables the connector to do axial linear motion and radial rotary motion along the rotary handle, so that the opening wire and the guide wire are enabled to rotate forwards or backwards, and the opening wire and the guide wire are controlled stably.
Detailed Description
The following description of the technical solutions in the embodiments of the present invention will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the invention, fall within the scope of protection of the invention.
In the description of the present invention, it should be understood that references to orientation descriptions such as upper, lower, front, rear, left, right, etc. are based on the orientation or positional relationship shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the guide wires or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention.
In the description of the present invention, a number means one or more, a number means two or more, and greater than, less than, exceeding, etc. are understood to not include the present number, and above, below, within, etc. are understood to include the present number. The description of the first and second is for the purpose of distinguishing between technical features only and should not be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first" and "second" may explicitly or implicitly include one or more features.
In the description of the present invention, unless explicitly specified and limited otherwise, the term "connected" shall be construed broadly, and may be, for example, fixedly connected or movably connected, detachably connected or non-detachably connected, integrally connected, mechanically connected or electrically connected or communicable with each other, directly connected or indirectly connected through intermediaries, or in communication with each other, or in an interaction relationship between two elements.
In the description of the present invention, "before use" refers to a state of the slow-open/close guidewire before being used, not entering the human body, or before being in contact with the body fluid such as blood or tissue fluid in the human body, and "during use" refers to a state of the slow-open/close guidewire having entered the human body or being in contact with the body fluid such as blood or tissue fluid in the human body.
In the description of the present invention, the "gathered state" refers to a state in which the "branch ducts" are fitted to each other over a partial length or over the entire length.
In the description of the present invention, the "in vivo environment" refers to an environment under the epidermis of the skin in which body fluids exist, such as dermis and subcutaneous tissue, or blood vessels, the inside of organs, and the like.
In the description of the present invention, "proximal" refers to the end that is closer to the operator at the time of surgery and "distal" refers to the end that is farther from the operator at the time of surgery.
The present invention will be described in detail with reference to examples. In addition, the embodiments of the present invention and the features of the embodiments implemented in the description of the present invention may be combined with each other without conflict.
Aiming at the problems that the use requirement of a guide wire in the prior art is proximal support and distal softness, the hardness of the distal end of the guide wire is insufficient, and the guide wire is difficult to smoothly pass through a vascular occlusion. And the distal end of the guide wire is hardened, so that the risk of the guide wire poking the blood vessel can occur, and the guide wire and the blood vessel cannot be simultaneously used, and the guide wire is difficult to penetrate through the intracranial vascular occlusion area.
The invention discloses a slow-closing open guide wire, which comprises an outer sleeve 1 with a hollow cavity, wherein the outer sleeve 1 is made of stainless steel, has certain hardness and is not easy to break, and referring to fig. 2 and 3. In a preferred embodiment, the outer sleeve 1 is made of stainless steel, and a PTFE coating is attached to the outer layer, so that the PTFE coating has good chemical stability and has little influence on the intravascular environment. The outer sleeve 1 has good flexibility at the distal end by a cutting mode of dense distal end and sparse proximal end, so that the possibility of puncturing blood vessels is reduced. Preferably, the hollow cavity of the outer sleeve 1 is arranged in a penetrating way along the axial direction of the hollow cavity.
Referring to fig. 2,3 and 4, the opening wire 2 is arranged in the outer sleeve 1, the opening wire 2 surrounds and forwards passes through the hollow cavity along the hollow cavity, and the whole opening wire 2 is in a coiled spring shape. The opening wire 2 is used to first pass through an intracranial arterial occlusion.
Referring to fig. 2, 3 and 5, a guide wire 3 is arranged in the outer sleeve 1, the guide wire 3 is preferably a nickel-titanium alloy wire, and the guide wire 3 also passes through the hollow cavity. The shape of the guide wire 3 is consistent with that of the opening wire 2.
Referring to fig. 2, 6 and 7, the torsion control assemblies 4 are respectively connected to the proximal ends of the opening wire 2 and the guide wire 3 and are used for independently driving the opening wire 2 or the guide wire 3 to move along the axial direction of the outer sleeve 1, and the torsion control assemblies 4 are provided with two groups, one group is welded, adhered or hot-melt connected with the opening wire 2, the other group is welded, adhered or hot-melt connected with the guide wire 3, and each group of torsion control assemblies 4 is used for independently controlling the opening wire 2 or the guide wire 3. Specifically, the torsion control assembly 4 includes a connector 41 having a threaded groove at a proximal end and a rotation handle 42 having an external thread at a distal end, and the rotation handle 42 is connected to the connector 41 by threads. The distal end of the connector 41 is welded to the opening wire 2 or the guide wire 3, and in a preferred embodiment, the connector 41 is connected to the opening wire 2 or the guide wire 3 by heat fusion. When in use, the rotary handle 42 is held, the rotary connector 41 is rotated, and the connector 41 rotates along the external thread and moves forward along the axial direction of the rotary handle 42, so as to drive the opening wire 2 or the guide wire 3 to move along the axial direction of the outer sleeve 1. It should be noted that the opening wire 2 or the guide wire 3 rotates along with the rotation of the rotating handle 42, and rotates radially relative to the outer sleeve 1, and also moves axially along with the connecting head 41. Through setting up the accuse subassembly 4 of turning round, can be convenient and fast carry out position control to opening silk 2 or guide wire 3 alone.
Wherein, opening silk 2 is made for the carbide, and opening silk 2 distal end hardness is greater than guide wire 3 distal end hardness. In a preferred embodiment, the opening wire 2 is cut from stainless steel. The stainless steel has stronger hardness and corrosion resistance, and can ensure certain puncture performance.
In another embodiment of the invention, the opening wire 2 is cobalt-chromium alloy, the cobalt-chromium alloy has higher strength and hardness, has stronger penetrability to intracranial vascular occlusion, can bear external force applied to the instrument in the interventional operation process, and can not generate harmful substances due to chemical reaction in the physiological environment of a human body.
In another embodiment of the present invention, the opening wire 2 is made of nickel-titanium alloy, and in this embodiment, the front end of the opening wire 2 is required to be ground to have a higher penetration capability. Nickel titanium alloys also have good biocompatibility and cause relatively little immune and inflammatory responses in vivo.
Referring to fig. 8 and 9, the working principle of the present invention is that after the outer sleeve 1 approaches the occlusion part, the rotary handle 42 is held, the rotary connector 41 is rotated along the external thread, the connector 41 moves forward along the axial direction of the rotary handle 42, so as to drive the opening wire 2 to move along the axial direction of the outer sleeve 1, and the outer sleeve 1 and the guide wire 3 remain in place. The distal end of the opening wire 2 is relatively sharp, and meanwhile, the connector 41 drives the opening wire 2 to axially move back and forth and radially rotate along the outer sleeve 1, so that the opening wire 2 opens the occluded blood vessel in a rotary pushing mode. After the opening wire 2 opens the occluded blood vessel, the opening wire 2 is withdrawn by rotating the connector 41 in the reverse direction. Until the opening wire 2 is completely retracted into the outer sleeve 1. At this time, the opening wire 2 with a hard distal end is integrally positioned in the outer sleeve 1, so that the risk of poking the blood vessel by the opening wire 2 can be reduced. The connector 41 connected with the guide wire 3 is rotated, the connector 41 drives the guide wire 3 to axially move back and forth and radially rotate along the outer sleeve 1, and the distal end of the guide wire 3 can easily pass through the vascular occlusion section because the vascular occlusion section is initially opened. Then the outer sleeve 1 is pushed to pass through the occluded blood vessel, so that the guide wire is in place.
Through setting up opening silk 2 and guide wire 3 in outer tube 1, through turning round the advancing or backing of accuse subassembly 4 independent control opening silk 2 and guide wire 3, open vascular occlusion department with harder opening silk 2 at first, pass vascular occlusion department with the softer guide wire 3 in distal end again, the passageway degree of difficulty of guide wire 3 is greatly reduced, guide wire 3 passes back and pushes forward outer tube 1 again, lets outer tube 1 pass vascular occlusion department too, realizes success in place. Overcomes the problems that the hardness of the distal end of the guide wire is insufficient and the guide wire is difficult to smoothly pass through the vascular occlusion in the prior art. The combination of the soft guide wire and the hard guide wire overcomes the problem that the guide wire is difficult to pass through the intracranial vascular occlusion region.
Referring to fig. 4 and 5, in the preferred embodiment of the present invention, both the opening wire 2 and the guide wire 3 are integrally treated with a wrap spring. Through setting opening silk 2 and guide wire 3 to the form of coiling, rotatory torsion control subassembly 4 can control opening silk 2 and guide wire 3 advance and the back, reaches the purpose of simple operation.
In the preferred embodiment of the invention, the spring spacing of the opening wire 2 is gradually increased from the proximal end to the distal end, so that the distal end of the opening wire 2 is compliant, and the spring spacing of the guide wire 3 is consistent with the opening wire 2. Specifically, the distance between the proximal springs of the opening wire 2 and the guide wire 3 is smaller, the structural strength is high, and the stability is strong. The distance between the distal springs of the opening wire 2 and the guide wire 3 is gradually increased, so that the distal flexibility is high, the distal spring is smoother, and the distal spring can more conveniently pass through the vascular occlusion.
Referring to fig. 2, 6 and 7, in a preferred embodiment of the present invention, the torsion control assembly 4 includes a connector 41 connected to the opening wire 2 and the guide wire 3, an internal thread groove is provided at a proximal end of the connector 41, and the connector 41 is screwed with a rotation handle 42 through the internal thread groove. The connector 41, the opening wire 2 and the guide wire 3 can be fixed by adopting a welding and hot melting connection mode. The surface of the rotary handle 42 is integrally formed with external threads which are adapted to the internal thread grooves. Through setting up connector 41 and rotary handle 42 threaded connection, rotary connector 41 can realize axial and radial motion, lets connector 41 drive opening silk 2, guide wire 3 realize axial and radial motion.
In another embodiment of the application, the distal end of the connector 41 is provided with a claw-shaped connecting groove, and the harness cord 3 is inserted into the connecting groove and fixed with the connector 41 by friction.
Further, the cross section of the connector 41 along the axial direction thereof is T-shaped, and the surface of the connector 41 is provided with an anti-slip strip 43. The anti-slip strips 43 are adhered to the outer peripheral surface of the connector 41, and the anti-slip strips 43 are preferably made of rubber materials and used for increasing the contact area between the connector 41 and the palm of a user, so that friction force is increased and an anti-slip effect is achieved.
Referring to fig. 4, in a preferred embodiment of the present invention, the opening wire 2 is made of stainless steel, and the distal end of the opening wire 2 is ground. The stainless steel material has higher hardness, and the hardness of the distal end of the opening wire 2 is further improved after grinding, so that the vascular occlusion part can be opened efficiently.
Referring to fig. 5, in the preferred embodiment of the present invention, the guide wire 3 is made of nitinol, and the distal end of the guide wire 3 is shaped like an ellipse. The nitinol guidewire 3 has good biocompatibility and reduced impact on the in vivo environment. The oval shape of the distal end of the guidewire 3 reduces the sharpness of the distal end of the guidewire 3 and reduces trauma to the vessel wall. Because the scheme of opening the occlusion section by the opening wire 2 is adopted, the guide wire 3 passes through the opened occlusion section easily, and the guide wire 3 which is more flexible can be in place conveniently.
Referring to fig. 2, in a preferred embodiment of the present invention, the outer diameter of the outer sleeve 1 gradually decreases from the proximal end to the distal end, the distal end of the outer sleeve 1 being a compliant section 11 and the proximal end being a support section 12.
In the preferred embodiment of the invention, the compliant section 11 is made of a tube material by dense cutting, the support section 12 is made of a tube material with uniform outer diameter, and the cutting gap of the support section 12 is larger than the cutting gap of the compliant section 11.
In a preferred embodiment of the invention, the distal end of the outer sleeve 1 is provided with a developing ring 5. The developing ring 5 is a ring wound on the distal end of the outer sleeve 1, the developing ring 5 can be made of platinum iridium alloy, and the position of the developing ring 5 can be conveniently seen in an operation, so that the specific position of the outer sleeve 1 can be judged in an auxiliary manner.
In the preferred embodiment of the present invention, the distal end of the opening wire 2 is provided with a first developing wire 21, and the distal end of the guide wire 3 is provided with a second developing wire 31. By arranging the first developing wire 21 at the distal end of the opening wire 2, arranging the developing ring 5 at the distal end of the outer sleeve 1, and judging whether the opening wire 2 is completely retracted into the outer sleeve 1 by observing the relative positions of the first developing wire 21 and the developing ring 5. The first developing wire 21 and the second developing wire 31 are provided for assisting in judging the positions of the opening wire 2 and the guide wire 3. Preferably, the first developing wire 21 and the second developing wire 31 are platinum iridium alloy wires. The first developing wire 21 is connected to the opening wire 2 at a distance of 20-30mm from the distal end by winding. The second developing wire 31 is connected to the oval shape of the guide wire 3 by winding. The distal end of the opening wire 2 protrudes out of the first developing wire 21, and since the distal end of the opening wire 2 is thinner, the opening wire 2 has a sharper opening capability after grinding treatment compared with the guide wire with the distal end being a developing ring in the prior art.
The following is a detailed description of a slow closing open guidewire according to the present invention by way of specific examples.
Example 1
Referring to fig. 1, the embodiment provides a slow-closing open guide wire, which comprises an outer sleeve 1, wherein the outer sleeve 1 is a pipe made of stainless steel materials, and a hollow cavity penetrating along the axial direction of the outer sleeve 1 is arranged in the middle of the outer sleeve 1. The outer sleeve 1 is processed into two sections by a far-close and near-loose cutting mode. Wherein, the distal end is the compliant section 11, the proximal end is the supporting section 12, the cutting clearance of the supporting section 12 is bigger, the cutting clearance of the compliant section 11 is smaller.
The outer diameter of the outer sleeve 1 gradually decreases from the proximal end to the distal end. It is understood that the outer diameter refers to the distance from the outer circumferential surface of the outer sleeve 1 to the central axis. The diameter of the hollow cavity remains unchanged, and therefore the wall thickness of the outer sleeve 1 gradually decreases. The compliant segment 11 has a smaller outer diameter and a higher compliance. The support section 12 has a larger outer diameter, a larger hardness and a strong support.
The distal end of the outer sleeve 1 is connected with a developing ring 5 in a laser welding mode, the developing ring 5 is annular, preferably made of platinum iridium alloy, and the position of the developing ring 5 can be clearly observed through a developing device during operation, so that the position of the outer sleeve 1 is judged in an auxiliary mode.
Referring to fig. 3, 4, 5, 8 and 9, the outer sleeve 1 is provided with an opening wire 2 and a guide wire 3 penetrating through the hollow cavity, the opening wire 2 and the guide wire 3 are processed by winding springs, the distance between the springs is gradually increased from the proximal end to the distal end, so that the proximal end of the opening wire 2 and the guide wire 3 is high in structural strength and high in stability, and the distal ends of the opening wire 2 and the guide wire 3 are better in flexibility.
The opening wire 2 is made of stainless steel, and the stainless steel has higher hardness, so that the penetrating capacity of the opening wire 2 to the vascular occlusion can be improved. And the stainless steel has good corrosion resistance and can adapt to the environment in blood vessels.
In other embodiments of the present application, the opening wire 2 is cobalt-chromium alloy, which has high strength and hardness, has high penetration ability to the intracranial vascular occlusion, and can withstand external forces applied to the instrument during the interventional operation.
The distal end of the opening wire 2 is ground, so that the hardness of the distal end of the opening wire 2 is improved.
The opening wire 2 is provided with a first developing wire 21 near the distal end position, and the distance between the first developing wire 21 and the distal end of the opening wire 2 is 20-30mm (for example, 20mm, 22mm, 23.5mm, 25mm, 26.5mm, 28mm, 30 mm). In a specific embodiment, the first developing filament 21 is spaced 20mm from the distal end of the opening filament 2. In another embodiment of the application, the distance between the first developing filament 21 and the distal end of the opening filament 2 is 30mm. The first developing wire 21 is wound around the opening wire 2 in a self-encircling manner. During operation, the position of the first developing wire 21 can be conveniently observed through the developing device, so that an operator can conveniently judge the position of the distal end of the opening wire 2, and the probability of the distal end of the opening wire 2 from being offset to stab the vascular wall is reduced. Compared with the guide wire in the prior art, the distal end of the opening wire 2 protrudes out of the first developing wire 21, the distal end of the opening wire 2 is sharp, and the penetrating capability is stronger when the opening wire contacts with a vascular occlusion part, so that the opening capability is stronger.
The guide wire 3 is made of nickel titanium, the distal end of the guide wire 3 is shaped like an ellipse, the distal end of the ellipse is more flexible, and the damage to blood vessels in the penetrating process is reduced.
Preferably, the distal end of the guide wire 3 is wound with the second developing wire 31, and the position of the second developing wire 31 can be conveniently observed through the developing device, so that the operator can conveniently judge the position of the distal end of the opening wire 2.
Preferably, the first developing wire 21 and the second developing wire 31 are both made of platinum iridium alloy, and a bright area different from surrounding tissues can be displayed on the developing device, so that an operator can conveniently judge the specific positions of the opening wire 2 and the guide wire 3.
Referring to fig. 1, 8 and 9, in use, opening wire 2 is rotated proximally and opening wire 2 is pushed distally, leaving opening wire 2 axially forward along outer sleeve 1 while guidewire 3 remains in place. The distal end of the opening wire 2 is relatively sharp, and the opening wire 2 is opened to occlude the blood vessel in a rotary pushing mode in the forward rotation process. After the opening wire 2 opens the occluded blood vessel, reversely rotating and pulling the opening wire 2 to the proximal end until the distal end of the opening wire 2 enters the outer sleeve 1, and the auxiliary judgment mode is that the first developing wire 21 is positioned at the rear end of the developing ring 5. The guide wire 3 is rotated proximally and the guide wire 3 is pushed distally, allowing the guide wire 3 to move axially forward along the outer cannula 1 while the opening wire 2 remains in place. Because the opening wire 2 is used for initially opening the occluded blood vessel, the guide wire 3 is easy to pass through the occluded part of the blood vessel, and then the outer sleeve 1 is pushed to the distal end, so that the outer sleeve 1 also passes through the occluded blood vessel, and the guide wire is in place.
By arranging the outer sleeve 1, the opening wire 2 and the guide wire 3, the advancing or retreating of the opening wire 2 and the guide wire 3 can be manually and independently controlled. Firstly, the hard opening wire 2 is used for opening the vascular occlusion, the penetration difficulty of the guide wire 3 is reduced, and then the guide wire 3 passes through the blood vessel, so that the problem of penetration difficulty caused by the distal compliance of the guide wire 3 is solved. The outer sleeve 1 is guided to pass through the vascular occlusion part distally by the guide wire 3, so that the guide wire is in place, and the problem that the guide wire passes through the intracranial vascular occlusion area is solved.
Example 2
Referring to fig. 2, 6 and 7, the present embodiment is different from embodiment 1 in the driving manner of the opening wire 2 and the guide wire 3.
The proximal ends of the opening wire 2 and the guide wire 3 are respectively provided with a torsion control component 4. The torsion control assembly 4 comprises a connector 41 welded with the opening wire 2 and the guide wire 3, and a rotary handle 42 in threaded connection with the connector 41. Specifically, an internal thread groove is axially provided in the middle of the proximal end of the connector 41, and an external thread is provided on the outer circumferential surface of the distal end of the rotation handle 42, and the external thread is adapted to the internal thread groove.
When in use, the rotary handle 42 is held, and the rotary connector 41 can enable the opening wire 2 and the guide wire 3 to axially move and radially rotate, so that the driving mode is more stable and reliable.
In another embodiment of the present application, the torque control assembly 4 is a luer adapter. The opening wire 2 and the guide wire 3 are driven by the rotary torsion control assembly 4.
Example 3
Referring to fig. 2, 6 and 7, this embodiment is different from embodiment 2 in the torsion control assembly 4.
The torsion control assembly 4 comprises a T-shaped connector 41, and the distal end of the connector 41 is connected with the opening wire 2 and the guide wire 3 through hot melting. The proximal end of the connector 41 protrudes outwards, the outer circular surface of the connector 41 is adhered with the anti-slip strip 43, the anti-slip strip 43 is made of rubber materials, an anti-slip effect can be achieved, and an operator can conveniently exert force.
In summary, the invention drives the opening wire 2 and the guide wire 3 in the outer sleeve 1 by the torsion control component 4, firstly opens the vascular occlusion by using the harder opening wire 2, then passes the guide wire 3 with a softer distal end through the vascular occlusion, greatly reduces the passing difficulty of the guide wire 3, and pushes the outer sleeve 1 forward after the guide wire 3 passes, so that the outer sleeve 1 also passes through the vascular occlusion to realize successful in-place.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.