Wire guide device

Abstract

The invention provides a guide wire device which comprises a guide wire body, the guide wire body comprises a flexible structure and a core wire which are connected from the far end to the near end, and at least part of the flexible structure is prepared from a deformation material; and an elastic bag is arranged in the flexible structure. The elastic bag is used for expanding and contracting in the deformation material, and the deformation material is used for deforming in the direction away from the elastic bag when the elastic bag expands and deforming in the direction close to the elastic bag when the elastic bag contracts, so that the flexible structure is bent in the preset direction. According to the guide wire device, the guide wire body can be controlled to bend in the preset direction repeatedly, the bending angle of the guide wire body can be controlled, the passing rate of the guide wire body in a blood vessel is increased, and then the success rate of an operation is increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a guide wire device. Background Art

[0002] In surgical treatment, a guide wire is an important instrument in interventional diagnosis and treatment. Whether the guide wire can smoothly pass through the lesion site during the operation plays a crucial role in the success rate of cardiocerebral surgery. A guide wire that can smoothly pass through tortuous blood vessels requires a soft distal end, easy to bend and deform, and the entire guide wire needs to have excellent torque control.

[0003] In the prior art, due to the small bendable angle at the distal end of the guide wire, it is often difficult to pass through different tortuous blood vessels; at the same time, the shape of the guide wire after bending is difficult to maintain, and it is not easy to selectively pass through the curved blood vessel, which will lead to an extended operation time and increase the risk of the operation.

[0004] Therefore, there is an urgent need for a guide wire device that can accurately control the bending angle of the distal end of the guide wire and can maintain the bent shape of the guide wire for a long time. Summary of the Invention

[0005] The purpose of the present invention is to provide a guide wire device that can control the guide wire body to bend repeatedly in a predetermined direction and can control the bending angle of the guide wire body to improve the passing rate of the guide wire in the blood vessel and thus improve the success rate of the operation.

[0006] To achieve the above purpose, the present invention provides a guide wire device, including a guide wire body, the guide wire body includes a flexible structure and a core wire connected from the distal end to the proximal end, at least part of the flexible structure is made of a deformable material; an elastic capsule is arranged inside the flexible structure;

[0007] The elastic capsule is used to expand or contract in the deformable material; the deformable material is used to deform in a direction away from the elastic capsule when the elastic capsule expands and is used to deform in a direction close to the elastic capsule when the elastic capsule contracts, thereby causing the flexible structure to bend in a predetermined direction.

[0008] Optionally, the guide wire device further includes a control mechanism, the control mechanism is connected to the proximal end of the guide wire body and is used to control the expansion or contraction of the elastic capsule.

[0009] Optionally, the elastic capsule is placed at the distal end of the flexible structure, the number of the elastic capsules is multiple groups, and the multiple groups of elastic capsules are arranged at intervals along the circumferential direction of the flexible structure; the control mechanism can respectively control the expansion or contraction of the multiple groups of elastic capsules so that the flexible structure bends in different predetermined directions each time.

[0010] Optionally, the guide wire body further includes a connection part, and the number of the connection parts corresponds to the number of the elastic sacs; one end of the connection part is connected to a corresponding group of the elastic sacs, and the other end extends out of the flexible structure and is connected to the control mechanism; the control mechanism is configured to control the expansion or contraction of the corresponding group of the elastic sacs through the connection part.

[0011] Optionally, the connection part is a pipeline, and the control mechanism can pressurize or evacuate the elastic sac through the pipeline to cause the elastic sac to expand or contract.

[0012] Optionally, the elastic sac is filled with a temperature-sensitive material; the connection part includes a wire, and the control mechanism controls the temperature of the temperature-sensitive material through the wire, and the temperature-sensitive material is configured to expand or contract correspondingly according to the change of temperature so as to cause the elastic sac to expand or contract.

[0013] Optionally, each group of the elastic sacs includes a plurality of vesicles arranged in sequence in the radial direction and / or the axial direction of the flexible structure, and adjacent vesicles are communicated with each other; the connection part is communicated with at least one of the vesicles.

[0014] Optionally, in the axial direction of the flexible structure, the inner diameters of all the vesicles are the same; in the direction from the inside to the outside of the cross-section of the flexible structure, the inner diameter of the vesicles gradually decreases.

[0015] Or, the inner diameter of the vesicles gradually decreases; in the direction from the inside to the outside of the cross-section of the flexible structure, the inner diameter of the vesicles gradually decreases.

[0016] Optionally, the distal end of the core wire extends into the flexible structure; the other end of the connection part sequentially passes through the flexible structure and the core wire and is then connected to the control mechanism.

[0017] Optionally, the core wire extends to the proximal end of the flexible structure, or the core wire extends to the distal end of the flexible structure, and the distal end of the core wire abuts against the outer surface of the elastic sac.

[0018] Optionally, the number of the elastic sacs is one group or multiple groups, and each group of the elastic sacs includes at least one long hole, and the size of the long hole in the axial direction of the flexible structure is larger than the size of the long hole in the radial direction or the circumferential direction of the flexible structure, and the long hole is configured to expand in the radial direction and / or the circumferential direction of the flexible structure.

[0019] Optionally, a protrusion is arranged on one side of the long hole close to the outer surface of the flexible structure, and the protrusion protrudes outwards when the elastic sac expands to increase the bending angle of the flexible structure.

[0020] Optionally, the deformable material is one or a combination of polyurethane, polyolefin, and polyester, and / or the material of the core wire is a polymer material or a metal material.

[0021] Optionally, the interior of the denatured material has a number of holes; in the direction of the axis of the flexible structure from the distal end to the proximal end, the inner diameter of the holes gradually decreases; in the direction of the cross-section of the flexible structure from the inside to the outside, the inner diameter of the holes gradually decreases.

[0022] As described above, the present invention provides a guide wire device, including a guide wire body, the guide wire body includes a flexible structure and a core wire connected from the distal end to the proximal end, at least a part of the flexible structure is prepared from a deformable material; an elastic capsule is arranged inside the flexible structure; the elastic capsule is used for expanding or contracting in the flexible structure, and the deformable material is used for deforming in a direction away from the elastic capsule when the elastic capsule expands, and is used for deforming in a direction close to the elastic capsule when the elastic capsule contracts, thereby causing the flexible structure to bend in a predetermined direction.

[0023] With such an arrangement, the guide wire device can control the bending direction and bending angle of the guide wire body through the elastic capsule, so that the guide wire body can smoothly pass through the diseased tortuous blood vessels. At the same time, the guide wire body can alternately control the expansion and contraction of the elastic capsule, thereby realizing the reciprocating bending of the guide wire body, and can maintain or adjust the bending angle of the guide wire body as needed, so that the guide wire device can adapt to different tortuous blood vessels, improve the versatility of the guide wire device, increase the passing rate of the guide wire body in the blood vessels, and further improve the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is an axial sectional structure schematic diagram of the guide wire device in a preferred embodiment of the present invention;

[0025] Figure 2 It is an axial sectional structure schematic diagram of the flexible structure and the elastic capsule in a preferred embodiment of the present invention;

[0026] Figure 3 It is a partial axial sectional structure schematic diagram of the guide wire body in a preferred embodiment of the present invention;

[0027] Figure 4 It is a partial axial sectional structure schematic diagram of the guide wire body in another preferred embodiment of the present invention;

[0028] Figure 5 It is an axial sectional structure schematic diagram of the core wire in a preferred embodiment of the present invention;

[0029] Figure 6 It is an axial sectional structure schematic diagram of a part of the guide wire device in a preferred embodiment of the present invention;

[0030] Figure 7 It is a schematic diagram of the partial axial sectional structure of the guide wire body in another preferred embodiment of the present invention;

[0031] Figure 8 It is a schematic diagram of the partial axial sectional structure of the guide wire body in another preferred embodiment of the present invention;

[0032] Figure 9 It is a schematic diagram of the axial sectional structure of a part of the guide wire device in another preferred embodiment of the present invention;

[0033] Figure 10 It is a schematic diagram of the axial sectional structure of a part of the guide wire device in another preferred embodiment of the present invention;

[0034] Figure 11 It is a schematic diagram of the partial axial sectional structure of the guide wire body in another preferred embodiment of the present invention;

[0035] Figure 12 It is a schematic diagram of the axial sectional structure of a part of the guide wire device in another preferred embodiment of the present invention.

[0036] In the figure:

[0037] Guide wire body 1; flexible structure 11; hole 111; elastic sac 12; vesicle 121; long hole 122; protrusion 123; connecting part 13; control mechanism 2; core wire 31; through hole 311; first section 312; second section 313; delivery tube 32. Detailed implementation manners

[0038] The following further describes the present invention in detail with reference to the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the present invention will be clearer. It should be noted that the accompanying drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the purpose of the embodiments of the present invention.

[0039] The orientation or positional relationship indicated by terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention.

[0040] As used in this specification, the "distal end" generally refers to the end of the guide wire device away from the operator; the term "proximal end" is opposite to the "distal end", and generally refers to the end of the guide wire device close to the operator; the term "axial direction" refers to the extension direction of the axis of the flexible structure, that is, the extension direction of the axis of the core wire.

[0041] In the present invention, unless otherwise clearly specified and limited, the terms "installation", "connection", "fixation" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or a connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0042] The exemplary embodiments of the present application are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

[0043] like Figure 1 As shown, a preferred embodiment of the present invention provides a guidewire device, including a guidewire body 1, the guidewire body 1 includes a flexible structure 11 and a core wire 31 connected from the distal end to the proximal end, that is, the flexible structure 11 is arranged at the distal end of the guidewire body 1, and the flexible structure 11 is the distal end (i.e., the head end) of the guidewire body 1. When the guidewire body 1 is implanted into a diseased tortuous blood vessel, the flexible structure 11 needs to be bent and deformed so that the guidewire body 1 can pass through the tortuous blood vessel smoothly and be implanted into the diseased part.

[0044] Furthermore, at least part of the flexible structure 11 is made of a deformable material, and an elastic capsule 12 is disposed inside the flexible structure 11, that is, the elastic capsule 12 is disposed in the deformable material. The elastic capsule 12 is used to expand or contract in the flexible structure 11, and the deformable material is used to deform in a direction away from the elastic capsule 12 when the elastic capsule 12 expands, that is, the elastic capsule 12 can squeeze the deformable material when it expands, so that the deformable material is deformed, thereby causing the flexible structure 11 to bend in a predetermined direction. The deformable material is also used to deform in a direction close to the elastic capsule 12 when the elastic capsule 12 contracts, that is, the deformable material can expand by itself when the elastic capsule 12 contracts, so that the deformable material is close to the outer surface of the elastic capsule 12, thereby causing the flexible structure 11 to bend in a predetermined direction.

[0045] In one example, the entire area of the flexible structure 11 is made of a deformable material. In another example, the area of the flexible structure 11 covering the elastic bag 12 is made of a deformable material, and the rest of the flexible material 11 can be made of other materials, for example, the rest of the flexible material 11 can be made of a non-deformable material.

[0046] Specifically, after the volume of the elastic capsule 12 changes, the guide wire body 1 is easy to bend. At this time, the bending angle of the guide wire body 1 can be controlled by controlling the amplitude of the volume change of the elastic capsule 12, thereby achieving control of the distal bending of the guide wire body 1. It should be known that after the elastic capsule 12 expands or contracts, the flexible structure 11 can bend in its own axial direction. The predetermined direction of the bending of the flexible structure 11 is the direction in which the guide wire body 1 needs to bend when passing through a tortuous blood vessel.

[0047] It should be explained that the deformable material used to prepare the flexible structure 11 is a material that can expand and contract by itself following the external pressure, that is, the deformable material is relatively soft and can deform synchronously following the expansion or contraction of the elastic capsule 12. Specifically, when the elastic capsule 12 expands, the deformable material can contract under the squeezing of the elastic capsule 12, thereby providing space for the expansion of the elastic capsule 12. When the elastic capsule 12 contracts, the deformable material can expand to fill the pores in the flexible structure 11 after the elastic capsule 12 contracts. In other words, whether the elastic capsule 12 expands or contracts, the deformable material can deform in accordance with the deformation of the elastic capsule 12, so that the deformable material always sticks to the outer wall of the elastic capsule 12.

[0048] The guidewire device provided by the present invention can control the bending direction and bending angle of the distal end of the guidewire body 1 through the elastic capsule 12, so that the guidewire body 1 can smoothly pass through the diseased tortuous blood vessels. At the same time, the guidewire body 1 can realize the reciprocating bending of the guidewire body 1 by alternately controlling the expansion and contraction of the elastic capsule 12, and can maintain or adjust the bending angle of the guidewire body 1 as needed, so that the guidewire device can adapt to different tortuous blood vessels, improve the versatility of the guidewire device, and improve the passing rate of the guidewire body 1 in the blood vessel, thereby improving the success rate of the operation.

[0049] Generally speaking, during the expansion of any group of elastic bladders 12 , the flexible structure 11 may bend on the side away from the elastic bladders 12 ; during the contraction of any group of elastic bladders 12 , the flexible structure 11 may bend on the side where the elastic bladders 12 are provided.

[0050] In addition, when the guidewire body 1 needs to bend in a predetermined direction, the elastic bag 12 arranged in the bending direction can be contracted (i.e., the volume is reduced), and the elastic bag 12 arranged away from the bending direction (i.e., the opposite direction of the predetermined direction) can be expanded (i.e., the volume is increased), thereby achieving control of the bending of the guidewire body 1 in the predetermined direction.

[0051] The present application does not limit the shape of the flexible structure 11. For example, the flexible structure 11 may be configured as Figure 1 The cylindrical shape in the figure can also be set to other shapes as needed.

[0052] The present application does not limit the specific material for preparing the elastic sac 12. The elastic sac 12 is preferably prepared from an elastic material and needs to be tough enough to ensure that it does not rupture when its volume increases.

[0053] It should be noted that the deformable material can be any suitable polymer material with thermoplasticity, biocompatibility and softness at human body temperature. The deformable material (i.e., the material for preparing the flexible structure 11) is preferably a thermoplastic polymer material, such as a combination of one or more of polyurethane, polyolefin and polyester. Such materials can be bent repeatedly without fatigue, facilitating the repeated adjustment of the bending angle of the guide wire body 1 in the body. In actual design, the type of the deformable material can be adjusted to make the flexible structure 11 take into account both softness and supportiveness to meet the use requirements of the guide wire body 1.

[0054] In the prior art, it is often difficult to process a guide wire into a shape that conforms to the shape of a blood vessel in the blood vessel, and the shape of the guide wire after processing is difficult to maintain, and it is not easy for the guide wire to super-select and pass through tortuous blood vessels. The deformable material in the present application can be shaped by heating, with easy forming and a larger shaping angle, and can have good shape retention at room temperature, so as to improve the forming ability and shape retention ability of the guide wire.

[0055] Continue to refer to Figure 1 As shown, the guide wire device further includes a control mechanism 2. The control mechanism 2 is connected to the proximal end of the guide wire body 1 and is used to control the expansion or contraction of the elastic sac 12. After the elastic sac 12 expands or contracts, it can cause the flexible structure 11 to bend in a predetermined direction.

[0056] Preferably, the elastic sac 12 is placed at the distal end of the flexible structure 11. The distance between the distal end of the flexible structure 11 and the elastic sac 12 in its own axial direction is preferably 10 mm to 200 mm, and the length of the elastic sac 12 in the axial direction of the flexible structure 11 is preferably 10 mm to 100 mm. The operator can design the specific structure of the flexible structure 11 according to the shape of the diseased blood vessels of different patients.

[0057] In a preferred embodiment, the number of the elastic sacs 12 can be one group or multiple groups. The number of the elastic sacs 12 is preferably multiple groups, and the multiple groups of elastic sacs 12 are arranged at intervals along the circumferential direction of the flexible structure 11, that is, all groups of elastic sacs 12 are arranged at intervals along the circumferential direction of the flexible structure 11 within the flexible structure 11. The control mechanism 2 can respectively control the expansion or contraction of the multiple groups of elastic sacs 12 so that the flexible structure 11 bends in different predetermined directions each time. That is to say, the control mechanism 2 can select to control one group or multiple groups of elastic sacs 12 to expand or contract successively or synchronously according to needs, so that the flexible structure 11 has different bending directions each time it bends.

[0058] A plurality of elastic sacs 12 are arranged within the flexible structure 11. The operator can drive the change of the bending angle of the distal end of the guide wire body 1 by controlling the volume change of one or more groups of elastic sacs 12, so as to quickly respond to the bending control of the guide wire body 1. At the same time, the bending angle of the guide wire body 1 can be adjusted repeatedly to smoothly pass through tortuous blood vessels of different shapes.

[0059] Referring to Figure 2 As shown, in one example, the number of elastic sacs 12 is 4 groups, and the 4 groups of elastic sacs 12 are evenly distributed in the circumferential direction of the flexible structure 11, and the distances between adjacent elastic sacs 12 in the circumferential direction of the flexible structure 11 are the same. The number of elastic sacs 12 in this application is not limited, and the number of elastic sacs 12 can also be 1 group, 2 groups, 3 groups or more groups.

[0060] More specifically, if multiple groups of elastic sacs 12 are inflated, the guide wire body 1 will bend towards the direction of the non-inflated elastic sacs 12; if multiple groups of elastic sacs 12 are contracted, the guide wire body 1 will bend towards the direction of the contracted elastic sacs 12. At this time, the operator can select one or more different elastic sacs 12 to inflate or contract as needed to control the bending direction of the guide wire body 1.

[0061] Continuing to refer to Figure 2 , in one example, when adjacent elastic sacs 12 are inflated, the guide wire body 1 will bend towards the middle position between the two non-inflated elastic sacs 12; when adjacent elastic sacs 12 are contracted, the guide wire body 1 will bend towards the middle position between the two contracted elastic sacs 12.

[0062] Returning to refer to Figure 1 , the guide wire body 1 further includes a connecting portion 13, and the number of connecting portions 13 corresponds to the number of elastic sacs 12. One end of the connecting portion 13 is connected to a corresponding group of elastic sacs 12, and the other end extends out of the flexible structure 11 and is connected to the control mechanism 2. The control mechanism 2 is used to control the inflation or contraction of a corresponding group of elastic sacs 12 through the connecting portion 13, that is, the control mechanism 2 can independently control each group of elastic sacs 12 to make it expand or contract.

[0063] In a schematic embodiment, the connecting portion 13 is a pipeline. The control mechanism 2 can pressurize or evacuate the elastic sac 12 through the pipeline to make the elastic sac 12 expand or contract. The materials of the pipeline include but are not limited to polymer materials or metal materials.

[0064] As a specific embodiment, the elastic sac 12 contains a filling medium. The control mechanism 2 is a hydraulic device, and the operator can inject the filling medium into the elastic sac 12 through the hydraulic device to achieve the expansion of the elastic sac 12 after pressurization; at the same time, the elastic sac 12 can also be evacuated through the hydraulic device to achieve the contraction of the elastic sac 12 after decompression.

[0065] In another illustrative embodiment, the elastic bladder 12 can be filled with a temperature-sensitive material (such as hydrogel). The connecting portion 13 includes a wire, and the control mechanism 2 controls the temperature of the temperature-sensitive material through the wire. The temperature-sensitive material is used to expand or contract correspondingly according to the change of temperature, and further cause the elastic bladder 12 to expand or contract. Specifically, the temperature-sensitive material can expand when the temperature rises, so that the volume of the elastic bladder 12 increases (i.e., the elastic bladder 12 expands); the temperature-sensitive material is also used to contract when the temperature drops, so that the volume of the elastic bladder 12 decreases (i.e., the elastic bladder 12 contracts).

[0066] In one example, the temperature-sensitive material in the elastic bladder 12 can be heated or cooled by controlling the energization time of the wire, so as to control the volume change of the elastic bladder 12 through the temperature of the temperature-sensitive material, and further realize the bending of the flexible structure 11.

[0067] Referring to Figure 3 and Figure 4 As shown, in an alternative embodiment, each group of elastic bladders 12 includes a plurality of vesicles 121 (i.e., hollow circular bladders) arranged in sequence in the radial direction and the axial direction of the flexible structure 11. The adjacent vesicles 121 communicate with each other to increase the total volume of the elastic bladder 12, and further enable the flexible structure 11 to have a larger bending angle.

[0068] In another alternative embodiment, each group of elastic bladders 12 can also include only a plurality of vesicles 121 arranged in sequence in the radial direction or the axial direction of the flexible structure 11. In actual design, the shape and distribution of the vesicles 121 can be designed according to needs, and then the guide wire body 1 with different strengths and toughnesses can be prepared, so that the performance of the guide wire body 1 meets the use requirements.

[0069] In actual design, the bending angle and bending ability of the flexible structure 11 can be regulated by adjusting the shape, size, circumferential distribution of the elastic bladder 12 on the flexible structure 11, and the number of layers of the vesicles 121 in the elastic bladder 12, the shape and distribution of the vesicles 121.

[0070] Further, the connecting portion 13 communicates with at least one vesicle 121. The operator can inject a filling medium into one or more of the vesicles 121 through the connecting portion 13. Since all the vesicles 121 communicate with each other, the filling medium can enter all the vesicles 121, so that the volume of each vesicle 121 increases, thereby realizing the overall expansion of the elastic bladder 12; on the contrary, the operator can also extract the filling medium in one or more of the vesicles 121 through the connecting portion 13. At this time, the filling medium in each vesicle 121 can be extracted, so that the volume of each vesicle 121 decreases, and further the overall contraction of the elastic bladder 12 is realized.

[0071] Referring to Figure 2As shown, the number of elastic sacs 12 is 4 groups, and each group of elastic sacs 12 includes 4 vesicles 121. The 4 vesicles 121 are aggregated and arranged in a square structure.

[0072] In a preferred case, the inner diameters of all the vesicles 121 are the same. At this time, the control mechanism 2 injects or extracts a filling medium into one or more vesicles 121 of the elastic sac 12 through a pipeline, so that all the vesicles 121 can expand or contract synchronously (refer to Figure 2 ).

[0073] Refer to Figure 3 and Figure 4 As shown, in another preferred case, the inner diameters of at least some of the vesicles 121 are different, so that the flexibility of different regions of the flexible structure 11 is different.

[0074] In the prior art, when passing through a bifurcated blood vessel, the guide wire needs to be twisted, so the requirement for the twist control of the guide wire is relatively high. However, the existing guide wire has poor twist control, making it difficult for the torsional force at the proximal end of the guide wire to be transmitted to the distal end. As a result, it is difficult to control the distal end of the guide wire to pass through the bifurcated blood vessel smoothly at the proximal end. At the same time, excessive twisting of the guide wire may cause the guide wire to break.

[0075] Refer to Figure 3 As shown, in a schematic embodiment, in the axial direction of the flexible structure 11, that is, in each layer of vesicles 121 parallel to the axis of the flexible structure 11, the inner diameters of all the vesicles 121 are the same. In the direction from the inside to the outside of the cross-section of the flexible structure 11 (i.e., the plane perpendicular to the axis of the flexible structure 11), that is, in the direction from the innermost layer of vesicles 121 (i.e., the layer of vesicles 121 closest to the axis of the flexible structure 11) to the outermost layer of vesicles 121 (i.e., the layer of vesicles 121 farthest from the axis of the flexible structure 11), the inner diameter of the vesicles 121 gradually decreases. That is to say, the inner diameter of the innermost layer of vesicles 121 of the flexible structure 11 is the largest, and the inner diameter of the outermost layer of vesicles 121 is the smallest.

[0076] Since the larger the inner diameter of each layer of vesicles 121, the lower the hardness of the part where this layer of vesicles 121 is located. With such a setting, the hardness of the flexible structure 11 can gradually decrease in the direction from the inside to the outside. At this time, the hardness of the central part of the flexible structure 11 (i.e., the position close to the axis) is lower, and the inner layer of the flexible structure 11 is relatively soft, so that the flexible structure 11 is easy to bend. At the same time, the hardness of the edge part of the flexible structure 11 (i.e., the position far from the axis) is higher, and the strength and hardness of the outer layer of the flexible structure 11 are higher. In this way, the twist control of the guide wire body 1 can be improved, so that the torsional force at the proximal end of the guide wire body 1 can be smoothly transmitted to the distal end of the guide wire body 1, which helps the guide wire body 1 to pass through the bifurcated blood vessel smoothly and improves the success rate of the operation.

[0077] Refer to Figure 4As shown, in another exemplary embodiment, in the direction of the axis of the flexible structure 11 from the distal end to the proximal end, the inner diameter of the vesicle 121 gradually decreases. In the direction of the cross-section of the flexible structure 11 from the inside to the outside (i.e., from the innermost vesicle 121 to the outermost vesicle 121), the inner diameter of the vesicle 121 gradually decreases. That is to say, the innermost and most distal vesicle 121 in the elastic bladder 12 has the largest inner diameter, and the inner diameters of the remaining vesicles 121 gradually decrease in the direction from the innermost layer to the outermost layer of the flexible structure 11 and in the direction from the distal end to the proximal end of the flexible structure 11.

[0078] With such a configuration, on the one hand, the distal end of the flexible structure 11 can be made softer than the proximal end to meet the usage requirements that the proximal end of the flexible structure 11 has support and the distal end is easy to bend; on the other hand, the outer surface of the flexible structure 11 can have higher strength and hardness, so that the flexible structure 11 has better torsional controllability.

[0079] Referring to Figure 5 and in combination with Figure 1 as shown, the distal end of the core wire 31 extends into the flexible structure 11, wherein the core wire 31 can extend into the distal end, the middle section or the proximal end of the flexible structure 11. The flexible structure 11, the core wire 31 and the control mechanism 2 are connected in sequence in the direction from the distal end to the proximal end. One end of the connecting portion 13 (such as Figure 1 the pipeline in Figure 1 ) is connected to the elastic bladder 12, and the other end passes through the flexible structure 11 and the core wire 31 in sequence and is connected to the control mechanism 2, that is, the pipeline is embedded in the flexible structure 11 and the core wire 31.

[0080] This application does not limit the material of the core wire 31. Generally speaking, the core wire 31 is a metal pipe or a polymer pipe with relatively high hardness, so as to provide support for the middle section and the proximal end of the guide wire body 1. Optionally, the core wire 31 can also be prepared with other materials.

[0081] Referring to Figure 6 as shown, the guide wire device further includes a delivery tube 32. The proximal end of the core wire 31 is placed inside the delivery tube 32, the distal end of the core wire 31 extends out of the delivery tube 32 and extends into the flexible structure 11, and the delivery tube 32 is connected to the flexible structure 11 through the core wire 31.

[0082] This application does not limit the connection method between the flexible structure 11 and the core wire 31. In a preferred example, the flexible structure 11 is used to bond with the part of the core wire 31 extending into the flexible structure 11 during the preparation process. In another preferred example, the flexible structure 11 and the core wire 31 can also be bonded through an adhesive.

[0083] More specifically, the deformable material within the flexible structure 11 can adhere to the core wire 31 when in a molten state, so that the flexible structure 11 can be connected to the core wire 31 when cooled to room temperature. During this process, it is optional to coat an adhesive on the outer surface of the core wire 31 inserted into the flexible structure 11, or increase the surface roughness of the outer surface of the core wire 31 inserted into the flexible structure 11, so as to make the bonding between the core wire 31 and the flexible structure 11 stronger.

[0084] When preparing the guide wire body 1, in one example, the elastic capsule 12 can be formed in the deformable material in a molten state by the foaming method, the template method, the 3D printing method or the electrospinning method. In another example, the elastic capsule 12 can also be prepared in advance and fixed at the distal end of the core wire 31. Then, the core wire 31 equipped with the elastic capsule 12 is inserted into the distal end of the flexible structure 11, and the flexible structure 11 and the core wire 31 are cured into an integral body by heating.

[0085] Refer to Figures 3 to 5 As shown, at least part of the core wire 31 has a through hole 311 penetrating along its own axis, and the through hole 311 is used for the connecting portion 13 to penetrate.

[0086] Combined with Figure 2 and Figure 5 As shown, the number of the through holes 311 is the same as the number of the elastic capsules 12, and the positions of the through holes 311 match the positions of a corresponding group of elastic capsules 12. In this way, the axis of the connecting portion 13 after installation can coincide with the axis of the flexible structure 11, so as to avoid deformation or torsion of the connecting portion 13.

[0087] Return to refer to Figure 1 , in an alternative embodiment, the core wire 31 extends into the proximal end of the flexible structure 11, and at this time the through hole 311 can penetrate the entire core wire 31. One end of the connecting portion 13 is connected to the elastic capsule 12, and the other end passes through the through hole 311 of the flexible structure 11 and the core wire 31 in sequence and is connected to the control mechanism 2.

[0088] Refer to Figure 6 As shown, in another alternative embodiment, the core wire 31 extends into the distal end of the flexible structure 11, and the distal end of the core wire 31 abuts against the outer surface of the elastic capsule 12. At this time, the through hole 311 penetrates at least part of the core wire 31. Since the core wire 31 has a higher hardness, the supportability of the flexible structure 11 can be increased, which is convenient for manipulating the flexible structure 11 at the distal end of the guide wire body 1 at the proximal end.

[0089] Refer to Figure 7 As shown, the core wire 31 preferably includes a first section 312 and a second section 313 connected along its own axis. The first section 312 abuts against the outer surface of the elastic capsule 12, and the outer diameter of the first section 312 is smaller than the outer diameter of the second section 313.

[0090] Continue to refer toFigure 7 As shown, in a specific example, the through-hole 311 penetrates the axis of the second section 313. One end of the connecting portion 13 is connected to the elastic sac 12, and the other end extends outside the first section 312 and is connected to the control mechanism 2 after passing through the through-hole 311 of the second section 313.

[0091] More specifically, the connecting portion 13 abuts against the outer surface of the first section 312, that is, the other end of the connecting portion 13 extends on the outer surface of the first section 312.

[0092] Referring to Figure 8 As shown, in another specific example, the through-hole 311 penetrates the axes of the first section 312 and the second section 313, that is, the through-hole 311 penetrating along the axis of the flexible structure 11 is provided on the first section 312 and the second section 313. One end of the connecting portion 13 extends out of the first section 312 and is connected to the elastic sac 12, and the other end is connected to the control mechanism 2 after passing through the through-hole 311.

[0093] Preferably, the first section 312 forms a plurality of connecting portions in its own axis, and at least some of the connecting portions have different outer diameters. Since the outer diameter of the core wire 31 is related to the strength and flexibility of the core wire 31, in actual design, the core wire 31 can be divided into a plurality of connecting portions in its own axis as needed, and each connecting portion can be designed with a different outer diameter, so that different support and flexibility can be obtained at each position of the core wire 31 to meet different implantation requirements of the guide wire body 1.

[0094] Referring to Figure 9 As shown, in an alternative embodiment, the number of elastic sacs 12 is one group or multiple groups (for example Figure 9 two groups in

[0095] each group of elastic sacs 12 includes at least one elongated hole 122, and the dimension of the elongated hole 122 in the axial direction of the flexible structure 11 is larger than the dimensions of the elongated hole 122 in the radial and circumferential directions of the flexible structure 11. The elongated hole 122 is used for expanding in the radial and / or circumferential directions of the flexible structure 11, that is to say, when the elongated hole 122 expands, it mainly increases the inner diameter in the radial and / or circumferential directions of the flexible structure 11, and less increases the inner diameter in the axial direction of the flexible structure 11. With such a structure, the responsiveness and flexibility of the distal end of the flexible structure 11 to bend can be further increased, and the bending angle of the flexible structure 11 can be increased, improving the operator's use experience.

[0095] Referring to Figure 10 and Figure 11As shown, a protrusion 123 is provided on one side of the long hole 122 close to the outer surface of the flexible structure 11. The shape of the protrusion 123 includes, but is not limited to, a rhombus or a triangle. The protrusion 123 protrudes outward when the elastic bladder 12 expands, so as to increase the expansion volume of the elastic bladder 12 and further increase the bending angle of the flexible structure 11. It should be understood that the protrusion 123 protruding outward means that the protrusion 123 protrudes from the remaining outer surface of the elastic bladder 12 other than the protrusion 123.

[0096] Referring to Figure 12 As shown, in a preferred case, a plurality of holes 111 are provided inside the deformable material to further improve the softness of the flexible structure 11. The inner diameters of all the holes 111 are the same, or at least some of the holes 111 have different inner diameters.

[0097] In a specific example, in the direction from the distal end to the proximal end along the axis of the flexible structure 11, the inner diameter of the hole 111 preferably gradually decreases, that is, the hole 111 at the distal end of the flexible structure 11 is preferably larger than the hole 111 at the proximal end of the flexible structure 11.

[0098] At the same time, in the direction from the distal end to the proximal end along the axis of the flexible structure 11, the porosity of the flexible structure 11 preferably also gradually decreases. At this time, the density of the holes 111 at the distal end of the flexible structure 11 is greater than the density of the holes 111 at the proximal end of the flexible structure 11, so that the total volume of the holes 111 gradually increases from the proximal end to the distal end. The advantage of doing this is that the flexible structure 11 gradually becomes softer from the distal end to the proximal end, making the distal end of the flexible structure 11 easy to bend and the proximal end having good support.

[0099] In another specific example, in the direction from the inside to the outside of the cross-section of the flexible structure 11, the inner diameter of the hole 111 preferably gradually decreases, that is, the hole 111 at the central position of the flexible structure 11 is preferably larger than the hole 111 at the edge position of the flexible structure 11.

[0100] At the same time, in the radial direction of the flexible structure 11 from the inside to the outside, the porosity of the flexible structure 11 preferably also gradually decreases. At this time, the density of the holes 111 at the center of the flexible structure 11 is greater than the density of the holes 111 at the edge of the flexible structure 11, and the total volume of the holes 111 gradually increases from the inside to the outside. In this way, the center of the flexible structure 11 is softer and the outside is harder, which can better transmit the torsional force of the flexible structure 11 and further improve the torsional controllability of the flexible structure 11.

[0101] It should be noted that the softness and hardness of each position of the flexible structure 11 can be adjusted by adjusting the porosity of the flexible structure 11, the shape of the holes 111 in the flexible structure 11, and the hole distribution of the holes 111 segmented or layered in the radial and axial directions of the flexible structure 11 and the inner diameters of the holes 111 at different positions, so as to prepare the guide wire body 1 with various strengths and toughnesses, making the distal end of the guide wire take into account flexibility, supportability and torsional controllability, and further meeting different clinical needs.

[0102] In summary, the guide wire device provided by the present invention can control the bending direction and bending angle of the guide wire body 1 through the elastic capsule 12, so that the guide wire body 1 can smoothly pass through the diseased tortuous blood vessel. At the same time, the guide wire body 1 can alternately control the expansion and contraction of the elastic capsule 12, and then realize the reciprocating bending of the guide wire body 1, and can maintain or adjust the bending angle of the guide wire body 1 as needed, so that the guide wire device can adapt to different tortuous blood vessels, improve the versatility of the guide wire device, increase the passing rate of the guide wire body 1 in the blood vessel, and further increase the success rate of the operation.

[0103] The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the art of the present invention according to the above disclosure are within the protection scope of the present invention.

Claims

1. A guide wire device, characterized in that, It includes a guide wire body, the guide wire body includes a flexible structure and a core wire connected from the distal end to the proximal end, and at least part of the flexible structure is made of a deformable material; an elastic capsule is arranged inside the flexible structure; The elastic capsule is used to expand or contract in the deformable material; the deformable material is used to deform away from the elastic capsule when the elastic capsule expands, and is used to deform towards the elastic capsule when the elastic capsule contracts, thereby causing the flexible structure to bend in a predetermined direction.

2. The guide wire device according to claim 1, characterized in that, It further includes a control mechanism, the control mechanism is connected to the proximal end of the guide wire body, and is used to control the expansion or contraction of the elastic capsule.

3. The guide wire device according to claim 2, characterized in that The elastic capsule is placed at the distal end of the flexible structure, and the number of the elastic capsules is multiple groups, and multiple groups of the elastic capsules are arranged at intervals along the circumferential direction of the flexible structure; the control mechanism can respectively control the expansion or contraction of multiple groups of the elastic capsules, so that the flexible structure bends in different predetermined directions each time.

4. The guide wire device according to claim 3, characterized in that, The guide wire body further includes a connection part, and the number of the connection parts corresponds to the number of the elastic capsules; one end of the connection part is connected to a corresponding group of the elastic capsules, and the other end extends out of the flexible structure and is connected to the control mechanism; the control mechanism is used to control the expansion or contraction of a corresponding group of the elastic capsules through the connection part.

5. The guide wire device according to claim 4, characterized in that The connection part is a pipeline, and the control mechanism can pressurize or evacuate the elastic capsule through the pipeline to make the elastic capsule expand or contract.

6. The guide wire device according to claim 4, characterized in that The elastic capsule is filled with a temperature-sensitive material; the connection part includes a wire, the control mechanism controls the temperature of the temperature-sensitive material through the wire, and the temperature-sensitive material is used to expand or contract correspondingly according to the change of temperature, so that the elastic capsule expands or contracts.

7. The guide wire device according to claim 5, characterized in that, Each group of the elastic capsules includes a plurality of vesicles arranged in sequence in the radial direction and / or the axial direction of the flexible structure, and adjacent vesicles are communicated with each other; the connection part is communicated with at least one of the vesicles.

8. The guide wire device according to claim 7, characterized in that, In the axial direction of the flexible structure, the inner diameters of all the vesicles are the same; in the direction from the inside to the outside of the cross-section of the flexible structure, the inner diameter of the vesicles gradually decreases. Or, in the direction from the distal end to the proximal end of the axis of the flexible structure, the inner diameter of the vesicles gradually decreases; in the direction from the inside to the outside of the cross-section of the flexible structure, the inner diameter of the vesicles gradually decreases.

9. The guide wire device according to any one of claims 4-8, characterized in that, The distal end of the core wire extends into the flexible structure; the other end of the connection part sequentially passes through the flexible structure and the core wire and then is connected to the control mechanism.

10. The guide wire device according to claim 9, characterized in that, The core wire extends to the proximal end of the flexible structure, or the core wire extends to the distal end of the flexible structure, and the distal end of the core wire abuts against the outer surface of the elastic capsule.

11. The guide wire device according to any one of claims 1-8, characterized in that, The number of the elastic capsules is one group or multiple groups, and each group of the elastic capsules includes at least one elongated hole, and the size of the elongated hole in the axial direction of the flexible structure is larger than the size of the elongated hole in the radial direction and / or the circumferential direction of the flexible structure, and the elongated hole is used to expand in the radial direction and / or the circumferential direction of the flexible structure.

12. The guide wire device according to claim 11, characterized in that, A protrusion is provided on one side of the long hole close to the outer surface of the flexible structure, and the protrusion protrudes outward when the elastic capsule expands to increase the bending angle of the flexible structure.

13. The guide wire device according to any one of claims 1-8, characterized in that, The deformable material is a combination of one or more of polyurethane, polyolefin and polyester, and / or the material of the core wire is a polymer material or a metal material.

14. The guide wire device according to any one of claims 1-8, characterized in that, The interior of the deformable material has a number of holes; in the direction of the axis of the flexible structure from the distal end to the proximal end, the inner diameter of the holes gradually decreases, and / or in the direction of the cross-section of the flexible structure from the inside to the outside, the inner diameter of the holes gradually decreases.

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