Guide wire and interventional medical equipment

Abstract

The invention belongs to the technical field of medical instruments, and discloses a guide wire and interventional medical equipment. The guide wire is used in an interventional operation. The guide wire comprises a core wire body, a head assembly and a wire winding assembly. Wherein one end of the core wire body is sleeved with the head assembly, and the head assembly is used for guiding the core wire body to reach a target position; the wire winding assembly is detachably connected with the head assembly, the core wire body is sleeved with the wire winding assembly, and the wire winding assembly is used for supporting and positioning other interventional instruments. By means of the guide wire, the number of instruments used by medical staff in an operation can be reduced, the operation of inserting a catheter and the operation of replacing a guide wire with an exchange guide wire are avoided, the treatment process of an interventional operation is effectively simplified, the operation difficulty and the operation intensity of the medical staff are reduced, the operation efficiency is improved, and the operation risk is also reduced.

Description

TECHNICAL FIELD

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

[0002] Interventional medical devices have occupied an indispensable position in the treatment of various diseases due to their significant advantages of minimally invasive, precision, and rapid recovery. Among them, catheters and guide wires, as the core instruments of interventional surgery, provide a basic path for the delivery of diagnostic and therapeutic instruments.

[0003] According to different stages and purposes of interventional surgery, guide wires can be divided into various types, each having unique structural and functional characteristics. Among them, the guide guide wire is mainly used to cross complex tissues, and has a lower hardness, usually with a soft and shaped tip, which facilitates the selection of blood vessel branches and the crossing of narrow lesions. The exchange guide wire, also known as the support guide wire, is a support body in interventional surgery, and its main function is to provide a stable support platform for the delivery of catheters and various therapeutic instruments. The exchange guide wire usually has high hardness and kink resistance, which can ensure that deformation or displacement does not occur during catheter exchange. The length of the exchange guide wire is usually longer to maintain a stable position during catheter exchange. The catheter, as a channel builder in interventional surgery, can be divided into various types according to structural design and functional characteristics, such as contrast catheters, guide catheters, and microcatheters.

[0004] The typical procedure of current interventional surgery follows the basic mode of guide wire path establishment-catheter channel formation-exchange guide wire replacement-therapeutic instrument introduction. Once the guide wire reaches the predetermined position, the operator will send the guide catheter along it to establish a stable working channel. At this time, due to the softness of the guide wire, the support force is insufficient, and it is difficult to directly guide other therapeutic instruments, so guide wire exchange is required. The operator replaces the soft guide wire with a guide catheter that is already in place with a support guide wire that has a stronger support force, which requires maintaining the position of the guide wire tip and ensuring that the exchange guide wire has sufficient length. After completing the guide wire exchange, the operator can introduce various therapeutic instruments, such as balloon catheters, stent systems, or embolic coils, along the exchange guide wire. During the entire process, any improper operation at any step can lead to surgical failure or complications.

[0005] Currently, two different types of guide wires and one catheter are needed from the establishment of the path to the insertion process of the medical instrument, the number of instruments used in the operation is large, and the process is complicated; in addition, the multi-instrument sequential use mode requires the doctor to have higher operation skills, which also increases the operation time and uncertainty, especially for complex cases, the doctor may need to perform multiple instrument exchanges and attempts, further amplifying the above shortcomings; moreover, during the multi-instrument exchange process, the risk of blood vessel injury, thrombosis, instrument failure, etc. increases; the surgical procedure means longer operation time, which not only increases the labor intensity of the doctor, but also limits the utilization efficiency of medical resources. SUMMARY

[0006] The purpose of the present application is to provide a guide wire and an interventional medical device for reducing the number of instruments used in the operation, simplifying the treatment process of interventional surgery, reducing the operation difficulty and intensity of medical personnel, improving the operation efficiency, and also reducing the operation risk.

[0007] To achieve this purpose, the present application adopts the following technical solutions:

[0008] A guide wire, comprising:

[0009] A core wire body;

[0010] A head assembly, which is sleeved on one end of the core wire body, and is used to guide the core wire body to reach the target position;

[0011] A winding wire assembly, which is detachably connected with the head assembly, is used to be sleeved on the core wire body, and is used to support and position other interventional instruments.

[0012] As an optional solution of the guide wire, the head assembly comprises a guide head, and the guide head has an outward convex arc surface.

[0013] As an optional solution of the guide wire, the head assembly comprises a first winding wire, which is spirally wound to form a first winding wire, which is sleeved on the core wire body and connected with the guide head.

[0014] As an optional solution of the guide wire, the first winding wire is circular in the cross section perpendicular to the axial direction of the core wire body.

[0015] As an optional solution of the guide wire, the head assembly further comprises a first connecting piece, which is connected with one end of the first winding wire away from the guide head, is sleeved on the core wire body, and is threadedly connected with the winding wire assembly.

[0016] As an optional solution of the guide wire, the first winding wire has a pitch of a (unit: mm) and a wire diameter of b (unit: mm), where 1.1≤a / b≤2.

[0017] As an optional solution of the guide wire, the winding wire assembly comprises a second winding wire, which is spirally wound to form a second winding wire sleeve on the core wire body.

[0018] As an optional solution of the guide wire, the second winding wire is rectangular in a cross section perpendicular to the axial direction of the core wire body.

[0019] As an optional solution of the guide wire, the winding wire assembly further comprises a second connecting piece connected to one end of the second winding wire away from the head assembly, and the second connecting piece is sleeved on the core wire body, and the guide wire further comprises a third connecting piece connected to the second connecting piece, and the third connecting piece has a clamping portion for clamping the core wire body.

[0020] The intervention medical device comprises a delivery mechanism and the guide wire of any one of the above solutions, and the delivery mechanism is used to deliver the core wire body.

[0021] The beneficial effects of the present application are as follows:

[0022] In the first aspect of the present application, the medical staff first places the head assembly and the core wire body into the patient's body and forms a guide path, so that the combination of the head assembly and the core wire body plays the role of the guide wire in the prior art, that is, the head assembly as a guide part forms a guide path for the subsequent winding wire assembly to be implanted smoothly. Further, the winding wire assembly is extended through the guide path formed by the core wire body and connected with the head assembly, thereby enhancing the strength and rigidity of the guide wire, which can support and position other interventional instruments. Therefore, the winding wire assembly cooperates with the head assembly and the core wire body to play the role of the exchange guide wire in the prior art, and the entire process does not require the use of a catheter, thereby reducing the number of instruments used during the operation, avoiding the operation of the catheter and the replacement of the guide wire by the exchange guide wire, simplifying the treatment process of the interventional surgery, reducing the operation difficulty and operation strength of the medical staff, improving the operation efficiency, and reducing the operation risk.

[0023] In the second aspect of the present application, the interventional medical device based on the guide wire can significantly improve the operation efficiency of the medical staff, reduce the operation difficulty, and improve the operation safety. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 is a structural schematic diagram of the guide wire provided by the embodiment of the present application;

[0025] Figure 2 is a structural schematic view of the core wire body and the head assembly provided by the embodiment of the present application;

[0026] Figure 3 is Figure 2 a sectional view at A-A;

[0027] Figure 4 is a structural schematic view of the winding wire assembly provided by the embodiment of the present application;

[0028] Figure 5 is Figure 4 a sectional view at B-B;

[0029] Figure 6 is a structural schematic view of the third connecting piece provided by the embodiment of the present application.

[0030] in the figure:

[0031] 1, core wire body;

[0032] 2, head assembly; 21, guide head; 211, arc surface; 22, first winding wire; 23, first connecting piece;

[0033] 3, winding wire assembly; 31, second winding wire; 32, second connecting piece; 33, fourth connecting piece;

[0034] 4, third connecting piece; 41, clamping portion; 42, connecting portion; 43, end head. DETAILED DESCRIPTION

[0035] The present application will be further described below in conjunction with the accompanying drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application. In addition, it should be noted that, for the convenience of description, only the parts related to the present application are shown in the drawings, but not all the structures.

[0036] In the description of the present application, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0037] In the present application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the first feature "on", "above" and "over" the second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher in horizontal height than the second feature. The first feature "under", "below" and "underneath" the second feature includes that the first feature is directly below and obliquely below the second feature, or only indicates that the first feature is lower in horizontal height than the second feature.

[0038] In the description of the present embodiment, the terms "upper", "lower", "right", "left", and other orientation or position relationships are based on the orientation or position relationships shown in the drawings, and are only for the convenience of description and simplification of operation, 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, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0039] Please refer to the accompanying Figure 1 The first aspect of the present embodiment relates to a guide wire, especially in interventional medical devices, and is applied to interventional surgery. The guide wire comprises a core wire body 1, a head assembly 2 and a winding wire assembly 3. The head assembly 2 is sleeved on one end of the core wire body 1, and the head assembly 2 is used to guide the core wire body 1 to reach the target position; the winding wire assembly 3 is detachably connected with the head assembly 2, and the winding wire assembly 3 is used to sleeve the remaining part of the core wire body 1, and the winding wire assembly 3 is used to support and position other interventional instruments.

[0040] Specifically, the core wire body 1 has a small diameter and a relatively soft texture, a large elasticity and a certain toughness. When passing through extremely tortuous blood vessels, the core wire body 1 can better conform to the natural anatomical direction of the blood vessels, reduce the stimulation and damage risk to the blood vessel wall, greatly improve the safety of operation, and at the same time reduce the risk of breakage. Therefore, the core wire body 1 can be made of a metal material with a small diameter, such as nickel-titanium alloy or stainless steel. The core wire body 1 is guided by the head assembly 2 to form a guide path for the subsequent winding wire assembly 3 to smoothly enter the human body. The core wire body 1 can be a cylinder with a uniform diameter, or can form a structure with a gradually changing diameter at the distal end, which can be designed according to the use requirements.

[0041] The diameter of the head assembly 2 is greater than that of the core wire body 1, and the head assembly 2 is sleeved on one end of the core wire body 1 in the axial direction. The head assembly 2 is the key part of the guide wire that first contacts the diseased tissue and explores the path, and the rationality of the design of the head assembly 2 is related to the safety of the operation.

[0042] In the embodiment, the core wire body 1 can be directly connected with the head assembly 2 as a whole, and the connection mode such as welding can be adopted, which can simplify the operation of medical staff. Of course, the medical staff can also connect the core wire body 1 with the head assembly 2 before the operation, and the connection mode such as clamping can be adopted, which is beneficial to the management of the core wire body 1 and the head assembly 2 respectively.

[0043] The winding wire assembly 3 is implanted through the end of the core wire body 1 away from the head assembly 2, and extends along the guide path formed by the core wire body 1. When the winding wire assembly 3 contacts the head assembly 2, the two are connected. The winding wire assembly 3 matched with the head assembly 2 can have strong support stiffness, which is used to support and position other interventional instruments. Here, the "other interventional instruments" include but are not limited to balloon catheters, stent systems or embolization coils.

[0044] In the embodiment, the medical staff first places the head assembly 2 and the core wire body 1 into the patient's body and forms a guide path. Therefore, the combination of the head assembly 2 and the core wire body 1 plays the role of the guide wire in the prior art, that is, the head assembly 2 as a guide head forms the core wire body 1 into a guide path for the subsequent winding wire assembly 3 to smoothly enter the human body. Further, the winding wire assembly 3 extends through the guide path formed by the core wire body 1 and is connected with the head assembly 2, thereby enhancing the strength and rigidity of the guide wire, which can support and position other interventional instruments. Therefore, the winding wire assembly 3 matched with the head assembly 2 and the core wire body 1 plays the role of the exchange guide wire in the prior art, and the whole process does not need to use a catheter, which reduces the number of instruments used in the operation, avoids the operation of the catheter and the operation of replacing the guide wire by exchanging the guide wire, simplifies the treatment process of the interventional surgery, reduces the operation difficulty and operation strength of the medical staff, improves the operation efficiency, and reduces the operation risk.

[0045] Please refer to the accompanying drawings Figure 2 and the accompanying drawings Figure 3 Optionally, the head assembly 2 comprises a guide head 21, and the guide head 21 has an outward convex arc surface 211.

[0046] Specifically, the guide head 21 is the core of the guide wire to efficiently and safely perform the navigation function. The guide head 21 can be made of stainless steel or nickel-titanium alloy, and the surface is coated with a hydrophilic coating to significantly reduce the friction coefficient. The arc surface 211 can be a spherical surface, an ellipsoidal surface, a parabolic surface, etc. The guide head 21 has a significant advantage in mechanical principle compared to a flat or sharp corner design when entering the human body. When the guide head 21 contacts the tissue, the arc surface 211 can uniformly disperse the pressure to a continuous contact surface, avoiding stress concentration, thereby smoothly separating the tissue fibers rather than "cutting" or "tearing". This design is particularly suitable for entering a relatively soft thrombus. In addition, the convex arc surface 211 reduces the friction between the tissue, making it smoother when passing through narrow or tortuous lesions, which helps the guide wire to follow the natural anatomical direction of the blood vessel; the convex arc surface 211 also greatly reduces the probability of serious complications caused by accidental perforation when accidentally contacting the blood vessel wall due to its non-invasive nature.

[0047] Further, the head assembly 2 includes a first wire 22, which is spirally wound, and the first wire 22 is sleeved on the core wire body 1 and connected with the guide head 21.

[0048] Specifically, in the present guide wire, the first wire 22 is the core force-bearing and function-implementation structure of the head assembly 2. It is usually made of high-performance metal wire and precisely wound in a spiral manner, tightly sleeved on one end of the core wire body 1, and firmly connected with the guide head 21. The first wire 22 and the guide head 21 can be connected by welding.

[0049] In the present embodiment, the first wire 22 efficiently and accurately transmits the pushing force and torque applied by the medical staff at the proximal end of the guide wire to the distal end of the guide head 21, so that it can navigate or reach the lesion tissue in the blood vessel as expected. The spiral structure itself has certain axial rigidity and torsional resistance, ensuring the directness and authenticity of force transmission. The spiral structure makes the head assembly 2 have excellent flexibility and elasticity. This enables the guide wire to bend smoothly when passing through tortuous and fragile blood vessels, avoiding direct insertion and breaking the blood vessel wall, greatly reducing the risk of perforation and dissection.

[0050] Further, the first wire 22 is circular in cross-section perpendicular to the axial direction of the core wire body 1.

[0051] Specifically, the first wire 22 forms a cylindrical spiral structure after winding, which has good flexibility and is very soft as a whole, and can easily pass through extremely tortuous and delicate blood vessels. At the same time, it can protect the blood vessel from being punctured by the relatively thin core wire body 1, and further protect the core wire body 1 from breaking when passing through the tortuous blood vessels.

[0052] Optionally, the first wire 22 has a pitch a in mm and a wire diameter b in mm, and 1.1≤a / b≤2.

[0053] Specifically, the first wire 22 has a thin wire diameter, usually 0.03mm-0.5mm. The first wire 22 has a short overall length, usually 10mm-20mm. The pitch a of the first wire 22 refers to the axial distance between the center points of two adjacent wire turns, and the wire diameter b refers to the diameter of the first wire 22 itself.

[0054] The conventional guide wire has a pitch substantially consistent with the wire diameter, thereby forming a tightly wound spiral state. In the present embodiment, by limiting 1.1≤a / b≤2, i.e., the pitch a is greater than the wire diameter b, the pitch a is relatively large to achieve sparse winding of the first wire 22, which can prevent collapse of the first wire 22 due to excessive compression between adjacent wire turns when the guide head 21 passes through a blood vessel with a large bending angle. Meanwhile, after the first wire 22 passes through a curved blood vessel, the first wire 22 with sparse winding can also quickly recover its shape, avoiding permanent bending deformation of the inner core wire body 1 beyond the elastic limit for a long time.

[0055] Please refer to the accompanying drawings Figure 4 and the accompanying drawings Figure 5 Optionally, the wire assembly 3 comprises a second wire 31, which is formed by helical winding, and the second wire 31 is sleeved on the core wire body 1.

[0056] Specifically, the second wire 31 also has a spiral structure, like a spring, and the second wire 31 has a rectangular cross section perpendicular to the axial direction of the core wire body 1, and of course can also have a square cross section. When the tightly wound wire with a rectangular or square cross section is wound on the core wire body 1, the second wire 31 can achieve greater contact area between adjacent wire turns, thereby forming a more continuous and uniform support structure for the guide wire. Compared with the conventional circular cross section wire, the rectangular or square cross section can significantly improve the anti-compression and anti-bending ability of the guide wire. In addition, the edges of the rectangular cross section on the second wire 31 need to be appropriately treated (such as sharp corner blunting) when in contact with the inner wall of the blood vessel or other instruments, to improve the hydrodynamic characteristics and help reduce the pushing resistance under certain conditions.

[0057] Please refer to the accompanying drawings Figure 4 - the accompanying drawings Figure 6 Optionally, the wire assembly 3 further comprises a second connecting piece 32, which is connected to one end of the second wire 31 away from the head assembly 2, and the second connecting piece 32 is sleeved on the core wire body 1. The guide wire further comprises a third connecting piece 4, which is connected to the second connecting piece 32, and the third connecting piece 4 has a clamping portion 41 for clamping the core wire body 1.

[0058] Specifically, the second connecting piece 32 is welded with the second winding wire 31, the second connecting piece 32 is a metal fixing sleeve with an internal thread, and the third connecting piece 4 includes a clamping portion 41, a connecting portion 42 and a head 43, wherein the head 43 is an operating end of a medical staff, the connecting portion 42 is in a cylindrical shape and has an external thread on the outer wall, and the clamping portion 41 is formed at one end of the connecting portion 42 away from the head 43, wherein the clamping portion 41 includes a plurality of elastic clamping jaws arranged along the circumference, when the medical staff connects the third connecting piece 4 with the second connecting piece 32, the third connecting piece 4 is rotated to make the connecting portion 42 threadedly connected with the second connecting piece 32, and the core wire body 1 is clamped by the clamping portion 41, so that the core wire body 1 does not move during the subsequent introduction of other interventional instruments, and the risk of breakage of the core wire body 1 during the process is avoided.

[0059] It should be noted that the third connecting piece 4 is in an integrated structure, so as to reduce the assembly steps and reduce the cost.

[0060] Optionally, the head assembly 2 further includes a first connecting piece 23, the first connecting piece 23 is connected with one end of the first winding wire 22 away from the guide head 21, the first connecting piece 23 is sleeved on the core wire body 1, and the first connecting piece 23 is threadedly connected with the winding wire assembly 3.

[0061] Specifically, the winding wire assembly 3 further includes a fourth connecting piece 33, the fourth connecting piece 33 is arranged at one end of the second winding wire 31 away from the second connecting piece 32, and the fourth connecting piece 33 is welded with the second winding wire 31. The fourth connecting piece 33 is a metal fixing sleeve with an external thread, and the first connecting piece 23 is also a metal fixing sleeve with an internal thread, when the winding wire assembly 3 contacts the first connecting piece 23 along the path of the core wire body 1, the first connecting piece 23 is threadedly connected with the fourth connecting piece 33 by rotating the second winding wire 31. The threadedly connected manner facilitates the connection and disassembly of the winding wire assembly 3 and the head assembly 2, and is convenient for the operation of the medical staff.

[0062] The second aspect of the present application also relates to an interventional medical device, wherein the interventional medical device includes a delivery structure and the above guide wire, and the delivery structure is used to deliver the core wire body 1.

[0063] Specifically, the storage device of the core wire body 1 draws out the core wire body 1 through the delivery structure, and provides a sufficient length of the core wire body 1 according to the use demand of the medical staff, wherein the delivery structure can refer to the existing wire feeding structure in the interventional medical device, and the structure and principle of the present embodiment will not be described in detail.

[0064] In the present embodiment, based on the interventional medical device of the present guide wire, the operation efficiency of the medical staff can be significantly improved, the operation difficulty is reduced, and the operation safety is improved.

[0065] Obviously, the above embodiments of the present application are merely example for clearly explaining the present application, and are not intended to limit the embodiments of the present application. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, it is not necessary and also impossible to enumerate all the embodiments. Any modification, equivalent replacement and improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the claims of the present application.

Claims

1. A guidewire, characterized in that, include: Core wire body (1); Head assembly (2), the head assembly (2) is sleeved on one end of the core wire body (1), the head assembly (2) is used to guide the core wire body (1) to the target position; The wire winding assembly (3) is detachably connected to the head assembly (2). The wire winding assembly (3) is used to be sleeved on the core wire body (1), and the wire winding assembly (3) is used to support and position other interventional instruments.

2. The guidewire according to claim 1, characterized in that, The head assembly (2) includes a guide head (21) having an outwardly convex arcuate surface (211).

3. The guidewire according to claim 2, characterized in that, The head assembly (2) includes a first winding wire (22), which is spirally wound and sleeved on the core wire body (1) and connected to the guide head (21).

4. The guidewire according to claim 3, characterized in that, The first winding wire (22) is circular in cross section perpendicular to the axial direction of the core wire body (1).

5. The guidewire according to claim 4, characterized in that, The head assembly (2) further includes a first connector (23), which is connected to the end of the first winding wire (22) away from the guide head (21). The first connector (23) is sleeved on the core wire body (1) and is threadedly connected to the winding wire assembly (3).

6. The guidewire according to claim 3, characterized in that, The pitch of the first winding wire (22) is a (unit: mm), and the wire diameter of the first winding wire (22) is b (unit: mm), wherein 1.1≤a / b≤2.

7. The guidewire according to claim 1, characterized in that, The winding assembly (3) includes a second winding wire (31), which is formed by spiral winding and is sleeved on the core wire body (1).

8. The guidewire according to claim 7, characterized in that, The second winding (31) is rectangular in cross-section perpendicular to the axial direction of the core wire body (1).

9. The guidewire according to claim 7, characterized in that, The winding assembly (3) further includes a second connector (32), which is connected to the end of the second winding wire (31) away from the head assembly (2). The second connector (32) is sleeved on the core wire body (1). The guide wire further includes a third connector (4), which is connected to the second connector (32). The third connector (4) has a clamping part (41) for clamping the core wire body (1).

10. An interventional medical device, characterized in that, It includes a conveying mechanism and a guide wire as described in any one of claims 1-9, wherein the conveying mechanism is used to convey the core wire body (1).

Images