An apparatus arrangement

Abstract

The application provides an apparatus device for lung volume reduction, and relates to the technical field of medical apparatuses, which comprises a core wire and an elastic implant, the core wire is used to move in the elastic implant, the distal end of the core wire comprises a distal end rigid section and a distal end flexible section, the distal end rigid section is farther away from the proximal end of the core wire than the distal end flexible section, when the distal end rigid section is subjected to the force of the elastic implant, the distal end flexible section adjusts the position of the distal end rigid section in the elastic implant by deformation, so that the axis of the core wire in the elastic implant is close to the axis of the elastic implant. The apparatus provided by the application solves the problems that the core wire is difficult to move into the elastic implant and is easy to move out of the cutting groove of the elastic implant.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a device. BACKGROUND

[0002] Emphysema is a common lung disease. In recent years, in order to improve the treatment effect and reduce trauma, endobronscope lung volume reduction (ELVR) has gradually developed as a treatment method. Current ELVR techniques mainly include one-way valve, biological glue, water vapor thermal ablation, and elastic coil intervention methods. Among them, the elastic coil intervention technology utilizes its own deformation ability to restore to a coiled state after being implanted in the emphysema area, compresses the lung tissue in the emphysema area, discharges the gas in the bronchus, and reduces the volume of the lung tissue in the emphysema area, so that the relatively healthy lung tissue around can better play a physiological function. Since the elastic coil is easy to cause damage to the bronchus during implantation into the bronchus, a new device composed of an elastic implant and a core wire is introduced in further development.

[0003] The core of this device is that the elastic implant is a hollow tubular structure, at least at the proximal end opening, which is provided with an elastic deformation part with shape memory function, and the elastic deformation part further comprises a plurality of cut grooves which are separated from each other and connected to the lumen of the elastic deformation part. The plurality of cut grooves are beneficial to the elastic deformation part of the elastic implant to bend into a predetermined shape in a natural state. In the intervention operation, the elastic deformation part is in a coiled predetermined shape when not subjected to external force, and the core wire is delivered into the lumen of the elastic deformation part by means of a pushing mechanism. The elastic deformation part can be constrained into an approximately straight shape, which is convenient for the implant to be delivered to the lesion site, and restores to the predetermined shape by bending and twisting after the external force is removed.

[0004] However, such a device still faces the following challenges in actual use:

[0005] Core wire insertion difficulty: after the elastic implant is implanted into the human body, it needs sufficient restoring force to restore the preset shape to fold and compress the tissue wrapped therein, so the elastic deformation part of the elastic implant must be designed with corresponding bends or arcs. Before being implanted into the human body, the core wire needs to be inserted into the lumen of the elastic implant to straighten the elastic implant. When the core wire passes through the positions of these bends or arcs, a large pushing force needs to be applied, which makes it difficult to insert the core wire and even breaks the core wire, thereby causing the operation to fail.

[0006] The core wire is easy to pass out of the cutting groove: in order to prevent the core wire from being easily broken, a metal wire with high strength and hardness is usually selected as the core wire. However, when the core wire with high strength and hardness passes into the lumen of the elastic implant, it needs to pass through the cutting groove arranged on the lumen one by one, especially at the bending or arc position. The core wire with high strength and hardness is easy to pass out of the cutting groove position and pierce the elastic membrane, resulting in damage to the structure of the implant.

[0007] In addition, during clinical use, the doctor needs to push the core wire in and out of the implant because the position or shape of the implant after being implanted into the human body is not suitable. Once the core wire accidentally passes out of the cutting groove position during frequent operation, it will damage the human tissue and cause harm to the human body. SUMMARY

[0008] In view of the above problems, the present application provides an apparatus device to solve the problems of difficulty in passing the core wire into the elastic implant and easy to pass out of the cutting groove of the elastic implant.

[0009] The present application provides an apparatus device, which adopts the technical scheme:

[0010] An apparatus device, comprising a core wire and an elastic implant, the core wire is used to move in the elastic implant; the distal end of the core wire comprises a distal end rigid segment and a distal end flexible segment, and the distal end rigid segment is farther away from the proximal end of the core wire than the distal end flexible segment.

[0011] When the distal end rigid segment is subjected to the force of the elastic implant, the distal end flexible segment adjusts the position of the distal end rigid segment in the elastic implant by deformation, so that the axis of the core wire in the elastic implant is close to the axis of the elastic implant.

[0012] As one of the preferred schemes, the distal end flexible segment comprises a first material, and the core wire and / or the distal end rigid segment comprises a second material.

[0013] Wherein, the flexibility of the first material is higher than that of the second material; or,

[0014] When the first material and the second material comprise the same material, the distal end flexible segment is heat treated, so that the phase transition temperature of the distal end flexible segment is greater than that of the core wire and / or the distal end rigid segment.

[0015] As one of the preferred schemes, at least one groove is arranged on the distal end flexible segment in the circumferential direction.

[0016] As one of the preferred schemes, the distal end flexible segment comprises an elastic member.

[0017] As one of the preferred solutions, the distal end face of the distal rigid section is provided with a distal spherical surface.

[0018] As one of the preferred solutions, the distal spherical surface is provided with a lubricating area.

[0019] As one of the preferred solutions, the outer surface of the core wire is attached with a lubricating film.

[0020] As one of the preferred solutions, the first material comprises at least one of a nickel-titanium material and a polymer material.

[0021] As one of the preferred solutions, the elastic implant is provided with a cutting groove, and the inner wall of the cutting groove is provided with a circular arc.

[0022] As one of the preferred solutions, the inner wall of the elastic implant is attached with a lubricating film.

[0023] Compared with the prior art, the present application has the following advantages:

[0024] The device provided by the embodiment of the present application comprises a core wire and an elastic implant, the core wire is arranged to move in the elastic implant, the distal end of the core wire comprises a distal rigid section and a distal flexible section, and the distal rigid section is farther away from the proximal end of the core wire than the distal flexible section, when the distal rigid section is subjected to the force of the elastic implant, the distal flexible section adjusts the position of the distal rigid section in the elastic implant by deforming, so that the axis of the core wire in the elastic implant is closer to the axis of the elastic implant.

[0025] By adopting the technical solution of the present application, the distal end of the core wire comprises the distal rigid section and the distal flexible section arranged adjacently, the distal rigid section is connected to the distal end of the distal flexible section, when the distal rigid section is subjected to a larger frictional force, the distal flexible section deforms, thereby adjusting the position of the distal rigid section, and the axis of the distal rigid section is closer to the central axis of the elastic implant, that is, the axis of the core wire is more coaxial with the axis of the elastic implant, thereby avoiding that the distal rigid section deviates from the center of the lumen and reducing the frictional force between the core wire and the elastic implant, and further enabling the core wire to smoothly pass through the elastic implant with a smaller frictional force while straightening the elastic implant, and also avoiding that the core wire is broken due to the force in the deviated position and damages the implant to cause damage to the human tissue. Meanwhile, the problem that the core wire is easily passed out of the cutting groove of the elastic implant is solved, and the core wire is not damaged by passing through the cutting groove of the implant when passing through the implant, thereby avoiding damage to the human tissue. BRIEF DESCRIPTION OF DRAWINGS

[0026] To more clearly illustrate the technical solution of this application, the drawings used in the description of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a diagram showing the usage state of a core wire passing through an elastic implant according to an embodiment of this application;

[0028] Figure 2 This is a cross-sectional view of the distal end of a core wire provided in an embodiment of this application;

[0029] Figure 3 This is a schematic diagram of the position of the core wire inserted into the elastic implant body in an embodiment of this application when subjected to a large frictional force at the uncut section (D1);

[0030] Figure 4 yes Figure 3 Enlarged diagram of point D1 in the diagram;

[0031] Figure 5 This is a schematic diagram of the state of the core wire overcoming friction at point D1 according to an embodiment of this application;

[0032] Figure 6 yes Figure 5 Enlarged diagram of point D1 in the diagram;

[0033] Figure 7 This is a schematic diagram of the position of the core wire inserted into the elastic implant body under a large frictional force at the groove (D2) according to an embodiment of this application;

[0034] Figure 8 yes Figure 7 Enlarged diagram of point D2 in the diagram;

[0035] Figure 9 This is a schematic diagram of the state of the core wire overcoming friction at point D2 according to an embodiment of this application;

[0036] Figure 10 yes Figure 9 Enlarged diagram of point D2 in the diagram;

[0037] Figure 11 This is a schematic diagram of a waist-shaped flexible segment at the distal end of a core wire provided in an embodiment of this application;

[0038] Figure 12 This is a schematic diagram of a structure in which a symmetrical groove is provided on the distal flexible segment of a core wire according to an embodiment of this application;

[0039] Figure 13Fig. 7 is a structural schematic diagram of a distal end flexible section of a core wire being a spring according to an embodiment of the present application;

[0040] Figure 14 Fig. 8 is a structural schematic diagram of a distal end of a core wire being provided with a distal end spherical surface according to an embodiment of the present application;

[0041] Figure 15 Fig. 9 is a structural schematic diagram of an outer surface of a core wire being provided with a film according to an embodiment of the present application;

[0042] Figure 16 Fig. 10 is a structural schematic diagram of a distal end spherical surface of a core wire being provided with micro grooves according to an embodiment of the present application;

[0043] Figure 17 Fig. 11 is a structural schematic diagram of a distal end spherical surface of a core wire being provided with micro holes according to an embodiment of the present application.

[0044] Legend of reference signs:

[0045] 51, elastic implant; 5101, circular arc; 514, cutting groove; 71, core wire; 7100, distal end; 7101, distal end rigid section; 7102, distal end flexible section; 7103, distal end spherical surface; 71031, micro groove; 71032, micro hole; 7104, lubricating film. DETAILED DESCRIPTION

[0046] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all the other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0047] According to the problems mentioned in the background, it can be known that the existing elastic instrument for lung volume reduction has the problems of difficulty in passing the core wire 71 through the elastic implant 51 and easy to pass out from the cutting groove 514 of the elastic implant 51 before being implanted into the human body. Even if the outside of the implant is covered with a thin film, the risk of the core wire 71 breaking through is still great. In the related design, although the researchers set a guide component at the distal end 7100 of the core wire 71, the guide component is set at the most end and itself as the distal end 7100 of the core wire 71. If the guide component is used as the distal end 7100 of the core wire 71, it can only guide the core wire 71 to initially enter the elastic implant 51. However, after entering the elastic implant 51, due to the irregular curved shape of the elastic implant 51 under the unstressed state, the operator still needs to push the core wire 71 through the elastic implant 51 with a large force. And after entering the elastic implant 51, the guide component as the distal end 7100 of the core wire 71 is more likely to bend and deform by friction with the inner wall of the elastic implant 51, and then the whole core wire 71 behind is deviated from the center of the lumen of the elastic implant 51, so that the core wire 71 and the elastic implant 51 are misaligned, which causes the core wire 71 to be stuck during the passing process, and a larger pushing force is needed to push the core wire 71, or even the core wire 71 is stuck in the implant, and finally the straightening fails. At the same time, the core wire 71 is also more likely to pass out from the cutting groove 514 of the elastic implant 51 under the dual action of the larger pushing force and the axial deviation.

[0048] Therefore, one of the purposes of the present application is to achieve that a smaller pushing force can smoothly push the core wire 71 through the elastic implant 51, while ensuring that the core wire 71 has enough force to straighten the implant, reducing or avoiding the difficulty of the core wire 71 entering the implant or the core wire 71 breaking, and ensuring the normal operation of the surgery. Figure 1 and Figure 2 As shown in the use state diagram of the core wire 71 passing through the elastic implant 51 of the present application, Figure 1 As shown in the cross-sectional development diagram of the distal end 7100 of the core wire 71 of the present application, Figure 2 As shown in the use state diagram of the core wire 71 passing through the elastic implant 51 of the present application, Figure 1 and Figure 2 As shown in the use state diagram of the core wire 71 passing through the elastic implant 51 of the present application, the present application provides an instrument device, which comprises a core wire 71 and an elastic implant 51, and the core wire 71 is used to be movably arranged in the elastic implant 51; the distal end 7100 of the core wire 71 comprises a distal end rigid segment 7101 and a distal end flexible segment 7102, and the distal end rigid segment 7101 is farther away from the proximal end of the core wire 71 than the distal end flexible segment 7102; when the core wire 71 moves in the elastic implant 51, the distal end flexible segment 7102 adjusts the position of the distal end rigid segment 7101 in the elastic implant 51 by deforming when the distal end rigid segment 7101 is subjected to the force of the elastic implant 51, so that the axis of the core wire 71 in the elastic implant 51 is close to the axis of the elastic implant 51.

[0049] Specifically, during the process of the core wire 71 passing through the elastic implant 51, the two interact with each other, the core wire 71 needs to straighten the elastic implant 51, send it to the lesion site, and then the core wire 71 is withdrawn, and the elastic implant 51 restores to the preset shape. The present application mainly improves the problems generated when the elastic implant 51 and the core wire 71 interact with each other, and the embodiments of the present application are used to illustrate the improvement mode of the core wire 71, refer to Figure 1 , Figure 1 In the F of the above formula, the F represents the distal end 7100, and the N represents the proximal end. Similarly, Figure 2 、 Figure 3 、 Figure 5 、 Figure 7 、 Figure 9 In the F of the above formula, the F represents the distal end 7100, and the N represents the proximal end. Similarly,

[0050] In the present embodiment, the core wire 71 is generally a metal wire made of a metal material, and the metal material can be selected from stainless steel, nickel-titanium material, etc. The distal end 7100 of the core wire 71 is a composite structure, that is, the distal end 7100 includes the adjacent distal end rigid section 7101 and the distal end flexible section 7102, and the proximal end of the distal end rigid section 7101 is connected to the distal end of the distal end flexible section 7102, and the proximal end of the distal end flexible section 7102 is connected to the remaining section of the core wire 71. Therefore, during the process of the core wire 71 passing through the elastic implant 51, the distal end rigid section 7101 first contacts the proximal end of the elastic implant 51, then the distal end flexible section 7102, and finally the remaining section of the core wire 71.

[0051] When the core wire 71 penetrates into the elastic implant 51 from the proximal end to the distal end of the elastic implant 51, the distal end 7100 of the core wire 71 gradually approaches the distal end of the elastic implant 51 until the elastic implant 51 is straightened. Refer to Figure 2, the distal end 7100 of the core wire 71 is composed of a distal end rigid section 7101 and a distal end flexible section 7102 (the shaded part). The distal end rigid section 7101 first contacts the inner wall of the elastic implant 51. Due to the structural characteristics of the elastic implant 51 itself, the distal end rigid section 7101 encounters a larger friction force during the advancing process because of the bending or arc region of the elastic implant 51. Since the distal end rigid section 7101 is connected to the distal end flexible section 7102, when the distal end rigid section 7101 is subjected to a larger friction force, the distal end flexible section 7102 deforms, thereby adjusting the position of the distal end rigid section 7101, so that the axis of the distal end rigid section 7101 is retracted to the central axis of the elastic implant 51, that is, the core wire 71 and the elastic implant 51 tend to be concentric, thereby avoiding the distal end rigid section 7101 deviating from the central axis of the lumen, reducing the friction between the distal end rigid section 7101 and the elastic implant 51, and further enabling the core wire 71 to smoothly pass through the elastic implant 51 while straightening the elastic implant 51, and also avoiding the core wire 71 being forced to pass through the elastic implant 51 at the axial deviation position.

[0052] Similarly, when the core wire 71 passes out of the elastic implant 51 from the distal end to the proximal end direction, the same principle as when the core wire 71 passes into the elastic implant 51 applies, except that the deformation direction of the distal end flexible section 7102 is opposite, and the friction is also reduced, so that the elastic implant 51 recovers to the preset shape while the core wire 71 does not get stuck inside the elastic implant 51.

[0053] For example, taking a certain segment of the elastic implant 51 that is curved in an arc shape as an example, referring to Figure 3 and Figure 4 When the distal end 7100 of the core wire 71 passes into the elastic implant 51, the axis of the core wire 71 (such as the A2 dashed line segment in Figure 3 ) and the axis of the elastic implant 51 (such as the A1 dashed line segment in Figure 3 ) form an included angle, and A2 deviates upward from A1, then the distal end 7100 of the core wire 71 will push upward against the inner wall of the elastic implant 51 during the advancing process, and a larger friction force will be generated at the axial deviation position, and the core wire 71 must overcome this friction force to further advance in the distal end direction. In this case, a larger pushing force needs to be applied. Referring to Figure 5 and Figure 6 In order to better overcome this friction force, the distal end flexible section 7102 will bend and deform upward toward the pipe wall when subjected to the resistance of the friction force. When the distal end flexible section 7102 deforms, it will adjust the position of the distal end rigid section 7101, and the distal end rigid section 7101 will tend to adjust downward toward the pipe wall, so that the included angle between A1 and A2 is reduced to nearly zero, that is, A1 and A2 are collinear, and the friction force between the two will be small, and the core wire 71 will smoothly pass through the axial deviation position and continue to move in the distal end direction.

[0054] Referring to Figure 7 and Figure 8 In the process of penetration, when the axis of the core wire 71 (such as the A2 dashed line segment in Figure 7 ) and the axis of the elastic implant 51 (such as the A1 dashed line segment in Figure 7 ) form an angle, and A2 deviates downward from A1, the distal end 7100 of the core wire 71 will be pressed against the inner wall of the elastic implant 51 in the process of pushing, and a large friction force will also be formed at the axis deviation position. The core wire 71 must overcome this friction force to further push in the distal direction, and in this case, a large pushing force needs to be applied. Referring to Figure 9 and Figure 10 , in order to better overcome this friction force, the distal flexible segment 7102 will be bent and deformed downward toward the pipe wall due to the resistance of the friction force. When the distal flexible segment 7102 is deformed, the position of the distal rigid segment 7101 is adjusted, and the distal rigid segment 7101 tends to be adjusted upward toward the pipe wall, so that the angle between A1 and A2 is reduced to nearly zero, that is, A1 and A2 are collinear, and the friction force between the two will be small, and the core wire 71 will smoothly penetrate the axis deviation position and continue to move in the distal direction.

[0055] In this embodiment, the elastic implant 51 in the predetermined shape of the curling can be a hollow tubular body without the cut groove 514.

[0056] Preferably, the elastic implant 51 is provided with the cut groove 514 arranged at intervals along the length direction. Another great progress of this embodiment is to solve the problem that the core wire 71 is easy to penetrate out of the cut groove 514 of the elastic implant 51 provided with the cut groove 514, so that the core wire 71 will not penetrate and damage the implant at the cut groove 514 of the implant when penetrating the implant, and further avoid the damage of the human tissue caused by the penetration of the core wire 71 to the implant.

[0057] As shown in Figures 3-10 , the core wire 71 provided by the embodiment of the present application is particularly suitable for the elastic implant 51 provided with the cut groove 514. Figure 3 shows a position state schematic diagram of the core wire 71 of the present application penetrating into the elastic implant 51 and being subjected to a large friction force at a position without the cut groove 514 (D1); Figure 4 is an enlarged schematic diagram of D1 in Figure 3 ; Figure 5 shows a state schematic diagram of the core wire 71 of the present application overcoming the friction force at D1; Figure 6 is an enlarged schematic diagram of D1 in Figure 5 ; Figure 7 shows a position state schematic diagram of the core wire 71 of the present application penetrating into the elastic implant 51 and being subjected to a large friction force at the cut groove 514 (D2); Figure 8 is an enlarged schematic diagram of D2 in Figure 7an enlarged schematic view of D2 in FIG. 1; Figure 9 a schematic view of the state of the core wire 71 of the present application when overcoming the frictional force at D2; Figure 10 is Figure 9 an enlarged schematic view of D2 in FIG. 1. The elastic implant 51 has a plurality of alternating D1 positions and D2 positions divided by the cut slots 514, the D1 position being the position of the elastic implant 51 at a location without the cut slot 514, and the D2 position being the position of the elastic implant 51 at a location with the cut slot 514. In particular, the cut slots 514 are provided at the bending or arc positions, and the core wire 71 is easily pushed out from the position of the cut slot 514 and pierces the elastic film, causing the implant structure to be damaged.

[0058] Referring to Figure 3 and Figure 4 , when the core wire 71 enters the elastic implant 51, the axis A2 of the core wire 71 and the axis A1 of the elastic implant 51 form an angle at the D1 position, and a larger frictional force is formed at the D1 position. Figure 5 and Figure 6 , the distal flexible section 7102 is deformed due to the resistance of the frictional force during the pushing process, and when the distal flexible section 7102 is deformed, the position of the distal rigid section 7101 is adjusted, i.e. the distal rigid section 7101 is adjusted towards the lower part of the pipe wall, the frictional force becomes smaller, and the core wire 71 can smoothly pass through the D1 position and continue to move in the distal direction.

[0059] Referring to Figure 7 and Figure 8 , when the distal rigid section 7101 of the core wire 71 reaches the D2 position, the axis A2 of the core wire 71 and the axis A1 of the elastic implant 51 form an angle, and a larger frictional force is formed at the D2 position. Figure 9 and Figure 10 , the distal flexible section 7102 is deformed due to the resistance of the frictional force during the pushing process, and when the distal flexible section 7102 is deformed, the position of the distal rigid section 7101 is adjusted, i.e. the distal rigid section 7101 is adjusted towards the upper part of the pipe wall, the frictional force becomes smaller, and the core wire 71 can smoothly pass through the D2 position and move in the distal direction, without penetrating out of the cut slot 514 and thus penetrating through the elastic implant 51.

[0060] It can be understood that the core wire 71 continuously penetrates through a plurality of similar D1 positions and D2 positions during the penetration process, until reaching the distal end of the elastic implant 51, and straightening the elastic implant 51. When the instrument reaches the lesion site, the core wire 71 is withdrawn, i.e. the core wire 71 moves in the proximal direction, and when the core wire 71 passes through the D1 position and the D2 position again, it will follow the same principle, but the deformation of the distal flexible section 7102 will be opposite to the case when the core wire 71 moves in the distal direction, ensuring that the core wire 71 is smoothly withdrawn from the distal end of the elastic implant 51 to the proximal end.

[0061] In summary, the distal end 7100 of the core wire 71 has a composite structure of "stiff first and then flexible" along the penetration direction, and the distal end rigid segment 7101 is located at the distal end of the core wire 71, which can effectively support the thrust transmitted by the core wire, and when the distal end rigid segment 7101 interacts with the inner wall of the implant during the pushing process, it does not or less bend and deform (less than the bending deformation of the distal end flexible segment 7102), ensuring that the core wire 71 can be pushed into the elastic implant 51 and does not hinder its movement in the elastic implant 51. During the pushing process, the force acting on the distal end rigid segment 7101 is transmitted to the distal end flexible segment 7102 near the proximal end, and the distal end flexible segment 7102 can deform flexibly when the distal end rigid segment 7101 is forced to deviate, automatically correcting the position and angle of the distal end rigid segment 7101 to make the core wire 71 approach the central axis of the implant, avoiding top-piercing or misplacement, and reducing the resistance during penetration, so that a smaller thrust can overcome the friction. In particular, when the distal end rigid segment 7101 passes through the bending area or the cut groove 514 of the elastic implant 51, it prevents the core wire 71 from penetrating out of the cut groove 514 and causing damage to the implant. Therefore, the core wire 71 can easily and smoothly complete the straightening of the elastic implant 51 required during the surgical process without damaging the structure of the implant, and has the functions of guidance and controllability, improving the accuracy and success rate of the core wire 71 penetration.

[0062] In addition, if the clinician pushes the core wire 71 back and forth because the position or shape of the implant after being implanted into the human body is not suitable, the core wire 71 will not accidentally penetrate out of the position of the cut groove 514 during frequent operation, which can avoid the core wire 71 damaging the bronchus or lung tissue, and significantly reduce the risk of accidental puncture or damage to the instrument during the operation.

[0063] Specifically, the axial length of the distal end rigid segment 7101 is usually 0.5-1.5 times the diameter of the core wire 71, and the axial length of the distal end flexible segment 7102 is usually 0.5-1 times the diameter of the core wire 71. In some embodiments, the distal end rigid segment 7101 is the distal end part of the core wire 71 that first contacts the elastic implant 51, and by controlling its length to be 0.5-1.5 times the diameter of the core wire 71, it ensures that it has sufficient rigidity to orient and withstand the thrust during the pushing process, and does not deform under stress in the implant, while the friction force with the pipe wall is transmitted to the distal end flexible segment 7102 near the proximal end, causing the distal end flexible segment 7102 to deform under stress. The length of the distal end flexible segment 7102 is set to 0.5-1 times the diameter of the core wire 71, providing sufficient deformation capability while ensuring that the core wire 71 does not produce excessive flexion to effectively correct the position of the distal end rigid segment 7101.

[0064] As a further illustration of the present embodiment, the distal flexible section 7102 comprises a first material, and the core wire 71 and / or the distal rigid section 7101 comprises a second material; wherein the flexibility of the first material is higher than the flexibility of the second material; or when the first material and the second material comprise the same material, the distal flexible section 7102 is heat treated so that the phase transition temperature of the distal flexible section 7102 is higher than the phase transition temperature of the core wire 71 and / or the distal rigid section 7101. In the present embodiment, the distal flexible section 7102 comprises or is made of a first material. The core wire 71 and / or the distal rigid section 7101 comprises or is made of a second material. The distal flexible section 7102 obtains flexibility by using a suitable first material and using its memory characteristics.

[0065] In an alternative embodiment, the flexibility of the first material is higher than the flexibility of the second material, so that the distal flexible section 7102 is more easily deformed than the distal rigid section 7101, or in other words, the distal flexible section 7102 can preferentially deform when stressed, thereby causing the distal rigid section 7101 to adjust its position and angle.

[0066] In some embodiments, the second material can be a relatively strong and hard metal material such as stainless steel and nickel-titanium material, and the core wire 71 and the distal rigid section 7101 can both be made of a relatively strong and hard metal material, which is not easily deformed when stressed. The material of the core wire 71 and the distal rigid section 7101 can be the same or different.

[0067] In some embodiments, the first material can be a high polymer material such as silicone. The high polymer material itself has good elasticity and is softer than metal and is easily deformed when stressed. The first material can be a nickel-titanium material with deformation characteristics combined with a heat treatment process to form a suitable flexible state. The first material can be a mixture of high polymer material and metal material, i.e. the distal flexible section 7102 is made of a mixture of high polymer material and metal material, for example, is synthesized by silicone and fine nickel-titanium wire, and is connected by fusion.

[0068] The distal flexible section 7102 formed by the high polymer material can be connected to the core wire 71 at both ends by fusion.

[0069] In another alternative embodiment, the core wire 71 is made of the same shape memory alloy material throughout, for example, both the first material and the second material are selected to be a nickel-titanium material, and the flexibility of the distal flexible section 7102 and the core wire 71 at the phase transition temperature is controlled by differential heat treatment, and the distal rigid section 7101 is the same as the material of the core wire 71. Specifically, the core wire 71 is made of a nickel-titanium material, and the distal flexible section 7102 of the core wire 71 is subjected to special heat treatment, so that the phase transition temperature of the distal flexible section 7102 is greater than 37°C, preferably 37°C-42°C, and the phase transition temperature of the other parts of the core wire 71 is less than 37°C, preferably 20°C-35°C. When the core wire 71 is in the human body, the distal flexible section 7102 is completely flexible below its phase transition temperature, and when the distal rigid section 7101 of the core wire 71 is subjected to a large frictional force, the distal flexible section 7102 will deform to adjust the position of the distal rigid section 7101, thereby reducing the frictional force, and the core wire 71 will move smoothly in the distal direction.

[0070] As a further illustration of the present embodiment, in addition to selecting a suitable material to achieve the flexibility of the distal flexible section 7102, the flexibility of the distal flexible section 7102 can also be achieved by a pre-set structure. Specifically, the distal flexible section 7102 is provided with at least one groove along the circumference.

[0071] In an alternative embodiment, as shown in Figure 11 , Figure 11 a structure schematic diagram of the distal flexible section 7102 of the core wire 71 of the present application is shown in a thin-waisted structure. The outer wall of the distal flexible section 7102 is provided with a continuous groove along the circumference, such as a U-shaped groove, a V-shaped groove, a semicircular groove, etc. Preferably, the width of the continuous groove gradually decreases from the outside to the inside, so that the radial width of the distal flexible section 7102 decreases from the two ends to the middle region to form a thin-waisted structure.

[0072] In yet another alternative embodiment, as shown in Figure 12 , Figure 12 a structure schematic diagram of the distal flexible section 7102 of the core wire 71 of the present application is shown in a symmetric groove structure, and the section at B-B is also shown. The outer wall of the distal flexible section 7102 is provided with a plurality of grooves arranged at intervals along the circumference, such as a U-shaped groove, a V-shaped groove, a semicircular groove, etc. Preferably, the plurality of grooves are arranged symmetrically along the axis of the distal flexible section 7102. More preferably, two grooves symmetrically arranged on the outer wall of the distal flexible section 7102 form a symmetric groove structure.

[0073] Specifically, the thin-waisted structure or the symmetric groove structure can be achieved on the distal flexible section 7102 by commonly used mechanical processing methods.

[0074] As a further illustration of the present embodiment, as shown in Figure 13 , Figure 13A structural diagram of the spring of the distal flexible section 7102 of the core wire 71 of the present application is shown. The distal flexible section 7102 comprises elastic members to realize the flexibility of the distal flexible section 7102. For example, the distal flexible section 7102 is made of a spring. The spring has good elasticity, and when the core wire 71 is pressed by the cavity wall of the implant, the spring can adapt to the bending shape of the channel by its own elastic deformation, which helps to actively restore the core wire 71 to be coaxial with the elastic implant 51.

[0075] It can be understood that, based on the above-mentioned instrument device, some specific embodiments of the present application provide examples, which can be combined arbitrarily between each other without mutual contradiction to form a new instrument device. For example, the spring is made of a high polymer material or a nickel-titanium material; or for example, the spring is sleeved on the outer periphery of the slim waist structure or the symmetrical groove structure.

[0076] It can also be understood that the wire diameter, coil diameter, coil number and spiral mode of the spring, the groove depth, groove width, groove number, groove spacing and groove shape of the symmetrical groove structure, and the width, length and curvature of the slim waist structure can be adjusted to control the deformation ability of the distal flexible section 7102, which is not specifically limited in the present embodiment.

[0077] As a further improvement of the present embodiment, the distal end face of the distal rigid section 7101 is provided with a distal spherical surface 7103. In the present embodiment, the distal spherical surface 7103 is further provided on the distal end 7100 of the core wire 71, and the distal spherical surface 7103 serves as the farthest end of the core wire 71. The distal end face of the core wire 71 can be a smooth spherical surface structure. The spherical surface structure is a hemispherical, spherical or circular arc transition structure, which is used to reduce the frictional resistance between the distal end 7100 of the core wire 71 and the inner wall of the elastic implant 51, and to improve the smoothness of the core wire 71 during the pushing process. As shown in Figure 14 Figure 14 A structural diagram of the core wire 71 of the present application provided with the distal spherical surface 7103 at the distal end 7100 is shown. The spherical surface structure is the distal spherical surface 7103, which is in the shape of a hemisphere, which can effectively avoid the phenomenon of sharp corner jamming, scratching the pipe wall or the edge of the groove 514 of the implant during the pushing process of the core wire 71. The distal spherical surface 7103 can be made by conventional mechanical processing.

[0078] In order to further reduce the friction between the distal end 7100 of the core wire 71 and the inner wall of the elastic implant 51, a lubricating film 7104 can also be attached to the outer surface of the core wire 71, as shown in Figure 15 Figure 15 ​​The structure of the outer surface coating of the core wire 71 of the present application is shown. Similarly, a lubricating film can be attached to the inner wall of the elastic implant 51. The lubricating film 7104 is preferably a thin film made of polytetrafluoroethylene (PTFE) or other high molecular material with good lubricating properties. A continuous and dense coating layer can be formed on the surface of the core wire 71 or the inner wall of the implant by hot melting or dipping and curing, thereby reducing the friction coefficient between the core wire 71 and the inner wall of the implant.

[0079] In some embodiments, the entire outer surface of the core wire 71 and the entire inner wall surface of the elastic implant 51 can be coated. In some embodiments, the distal end 7100 of the core wire 71 can be partially coated.

[0080] In order to further reduce the friction between the distal end 7100 of the core wire 71 and the inner wall of the elastic implant 51, in another way, a lubricating area is provided on the distal spherical surface 7103. The lubricating area can be a microstructure provided on the outer surface of the distal spherical surface 7103 of the core wire 71, which can be a micro groove 71031 or a micro hole 71032, etc. The lubricating area can be realized by common mechanical processing, etching, etc.

[0081] As shown in Figure 16 , Figure 16 The structure of the distal spherical surface 7103 of the core wire 71 of the present application is shown. The micro groove 71031 can be a strip-shaped groove distributed in a ring, radial or longitudinal and horizontal manner on the surface of the distal spherical surface 7103. As shown in Figure 17 , Figure 17 The structure of the distal spherical surface 7103 of the core wire 71 of the present application is shown. The micro groove 71031 can be a strip-shaped groove distributed in a ring, radial or longitudinal and horizontal manner on the surface of the distal spherical surface 7103. As shown in

[0082] The width and depth of the micro groove 71031 can be (0.05-0.1mm)*(0.05-0.2mm). The diameter and depth of the micro hole 71032 can be (0.05-0.1mm)*(0.05-0.2mm).

[0083] The micro groove 71031 can also be combined with the micro hole 71032 and arranged on the distal spherical surface 7103.

[0084] When performing surgery, medical silicone oil is usually applied to the surface of the core wire 71, which can be contained in the micro groove 71031 and the micro hole 71032, so that the core wire 71 can be fully lubricated when acting on the inner wall of the elastic implant 51, thereby minimizing the friction between the core wire 71 and the inner wall of the elastic implant 51, and allowing the core wire 71 to smoothly pass through the elastic implant 51.

[0085] To further reduce the friction between the distal end 7100 of the core wire 71 and the inner wall of the elastic implant 51, this embodiment also improves the elastic implant 51. For the elastic implant 51 with a groove 514, an arc 5101 is provided on the inner wall of the groove 514. More preferably, the arc 5101 is provided at the corner or edge of the inner wall of the groove 514. The arc 5101 can be a rounded corner or an arc-shaped chamfer, or the corner or edge of the inner wall of the groove 514 can be rounded or an arc-shaped chamfer. The inner diameter of the arc structure can be designed according to the diameter of the core wire 71 and the width of the groove 514. Typically, the width of the groove 514 is less than 0.5 times the diameter of the core wire 71.

[0086] like Figure 4 As shown, in this embodiment, an arc 5101 is provided on the inner wall of the groove 514 of the elastic implant 51. When the distal rigid section 7101 of the core wire 71 reaches the inner wall of the groove 514, the presence of the arc structure reduces the frictional resistance between the core wire 71 and the groove 514 when passing through the groove 514 area, further preventing the core wire 71 from getting stuck. The arc 5101 is located on the inner wall of the groove 514 of the elastic implant 51. Since general machining is difficult to achieve, it can be achieved by electrochemical etching. During the manufacturing process, other areas that do not require machining are covered with a polymer film. After the electrochemical etching of the arc 5101 is completed, the polymer film is removed.

[0087] In summary, the inner wall of the groove 514 of the elastic implant 51 can be rounded, and / or the inner wall can be coated with a polymer film, and / or a distal spherical surface 7103 can be set at the distal end 7100 of the distal rigid section 7101; and / or microgrooves 71031 and micropores 71032 can be designed on the distal spherical surface 7103; and / or a polymer film can be applied to the outer surface of the core wire 71. Through multi-level and multi-component collaborative structural optimization design, the problem of the core wire 71 becoming difficult to implant due to jamming during the implantation process in the prior art can be effectively solved, and the core wire 71 can be smoothly passed through the elastic implant 51 with a smaller thrust.

[0088] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0089] It should be noted that, in this article, the terms "upper", "lower", "left", "right", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In addition, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between the entities or operations, nor can it be understood as indicating or implying relative importance. Moreover, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, so that a process, method, article or terminal device including a series of elements includes not only those elements, but also other elements not explicitly listed or inherent to such a process, method, article or terminal device.

[0090] The above describes in detail an apparatus provided by the present application, and the principles and implementation modes of the present application are described by applying specific examples. The above example is only used to help understand the present application, and the content of the description should not be understood as a limitation on the present application. Meanwhile, for those skilled in the art, according to the present application, there will be different forms of changes in specific implementation modes and application ranges, which do not need and cannot be exhausted here, and the obvious changes or changes derived therefrom are still within the protection scope of the present application.

Claims

1. An apparatus device comprising a core wire for active threading within an elastic implant, characterized in that, The distal end of the core wire comprises a distal end rigid section and a distal end flexible section, and the distal end rigid section is farther away from the proximal end of the core wire than the distal end flexible section; When the core wire moves in the elastic implant, the distal end flexible section adjusts the position of the distal end rigid section in the elastic implant by deforming when the distal end rigid section is subjected to the force of the elastic implant, so that the axis of the core wire in the elastic implant is close to the axis of the elastic implant; wherein the axial length of the distal end rigid section is 0.5-1.5 times the diameter of the core wire, and the axial length of the distal end flexible section is 0.5-1 times the diameter of the core wire; The distal end flexible section comprises a first material, and the core wire and / or the distal end rigid section comprises a second material; when the first material and the second material comprise the same material, the distal end flexible section is heat treated so that the phase transition temperature of the distal end flexible section is greater than the phase transition temperature of the core wire and / or the distal end rigid section; The elastic implant is provided with a cutting groove, and the inner wall of the cutting groove is provided with a circular arc; the elastic implant comprises a plurality of D1 positions and a plurality of D2 positions, the D1 position is a position without the cutting groove, and the D2 position is a position with the cutting groove; When the core wire passes through each D1 position, the distal end flexible section deforms upwards of the pipe wall, driving the distal end rigid section to adjust downwards of the pipe wall; When the core wire passes through each D2 position, the distal end flexible section deforms downwards of the pipe wall, driving the distal end rigid section to adjust upwards of the pipe wall.

2. An apparatus as in claim 1, wherein The flexibility of the first material is higher than that of the second material.

3. An apparatus as in claim 1, wherein The distal end flexible section is provided with at least one groove in the circumferential direction.

4. An apparatus as in claim 1, wherein The distal end flexible section comprises an elastic member.

5. An apparatus as in claim 1, wherein The distal end surface of the distal end rigid section is provided with a distal end spherical surface.

6. An apparatus as defined in claim 5, wherein The distal end spherical surface is provided with a lubricating area.

7. An apparatus as in claim 1, wherein The outer surface of the core wire is attached with a lubricating film.

8. An apparatus as in claim 2, wherein, The first material comprises at least one of a nickel-titanium material and a high polymer material.

9. The apparatus of claim 1, wherein The inner wall of the elastic implant is attached with a lubricating film.

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