A guide wire device for improving the support effect

Abstract

The present application discloses a guidewire device with improved support effects, comprising a guide tube and a guidewire slidably disposed within the guide tube. The guidewire has opposing distal and proximal ends, wherein the distal end of the guidewire has a stowed state within the guide tube and an expanded state in which the guidewire is exposed. In the expanded state, the distal end of the guidewire forms a three-dimensional mesh cage structure. Compared to existing technologies, this solution enables the guidewire device to form a three-dimensional mesh cage structure within the ventricle. The mesh cage structure and the inner wall of the left ventricle form a surface support as a whole. The stress acting on the distal end of the guidewire is dispersed by the mesh cage structure, thereby preventing damage to the left ventricle.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a guidewire device with improved support effect. Background Art

[0002] Interventional surgery causes little trauma to the human body and is less invasive. It is a commonly used medical technology nowadays. It usually requires a special delivery system to transport diagnostic and treatment equipment, implantable devices, etc. to the lesion site for corresponding treatment or auxiliary treatment operations.

[0003] A general delivery system mainly includes a sheath tube and a sheath core located within the sheath tube, and the proximal ends of both the sheath tube and the sheath core extend to an operating handle.

[0004] Figure 1 Taking interventional aortic valve replacement surgery as an example, during the operation, a thinner guidewire 1 is inserted through the femoral artery in advance. The front end of the guidewire 1 passes through the aortic valve and enters the left ventricle 2. Then the sheath 5 loaded with the aortic valve is sent along the guidewire 1 until it reaches the aortic valve 3, and then the sheath 5 is withdrawn to release the stent 4.

[0005] Most existing guidewires are linearly extended elastic metal wires, which are straight or slightly curved when stretched to facilitate insertion into blood vessels. After the guidewire is inserted into the left ventricle, in order to adjust the position of the aortic valve, it is sometimes necessary to apply force to push the guidewire. The guidewire gradually curls under the action of the distal ventricular wall, but the local pressure is relatively high, and there is a risk of injuring the left ventricular wall. Summary of the Invention

[0006] In response to the poor support effect of the guide wire in the existing technology and the risk of easily puncturing the ventricular wall, this application provides a guide wire device with improved support effect, which improves the support effect of the guide wire in the ventricular wall, effectively disperses stress concentration, and reduces damage to the ventricle.

[0007] A guide wire device with improved support effect includes a guide tube and a guide wire slidably inserted into the guide tube, wherein the guide wire has a relative distal end and a proximal end, wherein the distal end of the guide wire has a storage state loaded in the guide tube and an expanded state exposed to the guide tube, and the distal end of the guide wire is a three-dimensional mesh cage structure in the expanded state.

[0008] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0009] Optionally, the distal portion of the guidewire includes a central guidewire and multiple peripheral guidewires, and in the retracted state, all the guidewires are close to each other, and in the deployed state:

[0010] The radial distribution of the plurality of peripheral guide wire bends defines the outer contour of the mesh cage structure;

[0011] The central guide wire is helically coiled and supported inside the cage structure.

[0012] Optionally, the central guide wire and the plurality of peripheral guide wires are of equal length in the retracted state.

[0013] Optionally, the mesh cage structure has an axial direction that is consistent with the extension direction of the guide tube, and in the expanded state, all guide wires are gathered at both ends of the axial direction of the mesh cage structure.

[0014] Optionally, the central guide wire is spirally coiled and supported between the two axial ends of the cage structure.

[0015] Optionally, the central guide wire is spirally wound into a multi-turn structure, and is arranged turn by turn along the axial direction of the mesh cage structure, with adjacent turns abutting against each other.

[0016] Optionally, in a multi-ring structure, the closer to the axial end of the cage structure, the smaller the ring diameter.

[0017] Optionally, there are at least three peripheral guide wires.

[0018] Optionally, the peripheral guide wires are distributed equidistantly in the circumferential direction of the cage structure.

[0019] Optionally, in the expanded state, the outer contour of the mesh cage structure is roughly a rotating body, and each peripheral guide wire corresponds to the busbar of the rotating body; the busbar is a smooth curve.

[0020] The guidewire device of the present application can form a three-dimensional cage structure in the ventricle. The cage structure and the inner wall of the left ventricle can form a surface support as a whole. The stress acting on the distal end of the guidewire is dispersed by the cage structure to avoid puncturing the left ventricle. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a schematic diagram of a guidewire in the left ventricle during existing interventional surgery;

[0022] Figure 2 This is a structural view of a guidewire device according to an embodiment of the present application in an expanded state;

[0023] Figure 3 for Figure 2 Schematic diagram of the partial structure of the guide wire device;

[0024] Figure 4 It is a local structural view of the guidewire structure in the stowed state;

[0025] Figure 5 This is a diagram of the guidewire device according to one embodiment of the present application in use within the left ventricle.

[0026] The reference numerals in the figures are described as follows:

[0027] 1. Guidewire; 11. Distal end; 12. Proximal end; 13. Support segment; 14. Access segment; 2. Left ventricle; 3. Aortic valve; 4. Stent; 5. Sheath; 6. Guide tube;

[0028] 7. Cage structure; 71. Central guide wire; 72. Peripheral guide wire. DETAILED DESCRIPTION

[0029] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0030] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0032] In this application, the terms "first," "second," etc. are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly indicate the number or order of the technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0033] See also Figures 2 to 5 The present application provides a guide wire 1 device with improved support effect in an embodiment, including a guide tube 6 and a guide wire 1 slidingly inserted into the guide tube 6, the guide wire 1 having a relative distal end 11 and a proximal end 12, wherein the distal end 11 of the guide wire 1 has a storage state loaded in the guide tube 6 and an expanded state exposing the guide tube 6, and the distal end 11 of the guide wire 1 is a three-dimensional mesh cage structure 7 in the expanded state.

[0034] The following embodiments are described for ease of description using the application in interventional aortic valve replacement surgery as an example, but are of course also applicable to other scenarios, especially when the distal end of the guidewire 1 needs to support the internal body.

[0035] Unless otherwise specified, the “distal end” in this embodiment and the following embodiments refers to the end close to the lesion, that is, away from the operator, and the “proximal end” refers to the opposite.

[0036] The slender guide tube 6 is made of elastic material. In the retracted state, the front end of the guide wire 1 can bend and deform along the blood vessel through the guide tube 6 and extend into the left ventricle 2. The front end of the guide wire 1 is partially unfolded to form a cage structure 7 in the left ventricle 2. The cage structure 7 forms a support at the bottom of the left ventricle 2. Then the sheath tube 5 loaded with the valve is sent along the guide wire 1 until it reaches the aortic valve 3, and then the sheath tube 5 is withdrawn to release the stent 4 with the valve.

[0037] The mesh cage structure 7 and the wall of the left ventricle 2 can form a surface support as a whole. In terms of the specific structure, it can provide at least three support points. Compared with the two-dimensional structure of the prior art (the support points of the two-dimensional structure in contact with the left ventricle 2 are all in the same plane), the three-dimensional mesh cage structure 7 has a larger contact area with the inner wall of the left ventricle 2. After the guide wire 1 is inserted into the left ventricle 2, in order to adjust the position of the aortic valve 3 membrane, it is necessary to apply force to push the guide wire 1. At this time, the stress acting on the distal end 11 of the guide wire 1 is dispersed by the mesh cage structure 7 to avoid puncturing the left ventricle 2. In order to avoid safety hazards, the outer contour of the mesh cage structure 7 is roughly an arc surface, and when in use, at least the distal end 11 side is against the wall of the left ventricle 2.

[0038] Due to its large outer diameter, the cage structure 7 cannot pass directly through the guide tube 6. Therefore, when passing through the guide tube 6, the cage structure 7 is unfolded. Although not necessarily in a perfectly straight line, it can at least pass through the guide tube 6. After the support segment enters the left ventricle 2, it loses the restraint of the guide tube 6 and returns to its pre-set state. The cage structure 7 contacts the sidewalls and bottom of the left ventricle 2, significantly increasing its contact and force-bearing area. This disperses the local pressure and reduces the risk of puncturing the wall of the left ventricle 2.

[0039] When the front end of the guide wire 1 forms the mesh cage structure 7, a larger deformation amount is required to ensure that it can fit the position of the left ventricle 2 with different inner diameters. The mesh cage structure 7 can ensure a smaller volume and higher flexibility in the loaded state, a larger volume in the expanded state, and a controllable deformation process. The three-dimensional mesh cage shape can be, for example, spherical, ellipsoidal, cylindrical, etc., but its geometric shape is not required to be very regular, only the general shape characteristics are there. In addition, the density of the mesh cage is not strictly limited. From another perspective, the aforementioned spherical, ellipsoidal, and cylindrical shapes can also be regarded as the shape of a rotating body formed by the guide wire 1 around its own axis (generally the axis of the guide wire 1).

[0040] The guide wire 1 can be divided into a support section 13 and an insertion section 14. The support section 13 has an expanded state in which it forms a three-dimensional mesh cage structure 7, and a retracted state in which it passes through the guide tube 6. The insertion section 14 is connected to the support section 13 and drives the support section 13 to move along the introduction tube. In the retracted state, the extension direction of the support section 13 is consistent with that of the support section 13; in the expanded state, the axial direction of the support section 13 is roughly consistent with the extension direction of the support section 13. When the periphery of the mesh cage structure 7 rests against the side wall of the left ventricle 2, it can assist in centering the portion of the insertion section 14 adjacent to the mesh cage structure 7 (the insertion section 14 is at or near the geometric center of the tissue structure), thereby facilitating the subsequent installation of the stent 4.

[0041] The guidewire 1 is pre-shaped at least at its front end, which extends into the left ventricle 2. The support segment 13 does not require special pre-shaping, and this portion can adopt the shape and material of a conventional guidewire 1. The pre-shaping of the guidewire 1 can be achieved by heat-setting it into the desired initial shape. The guidewire 1 returns to its initial shape in the in vivo environment, reducing the need for intraoperative human intervention in the formation of the cage structure 7 and ensuring more precise formation of the cage structure 7. In one embodiment, the guidewire 1 is made of a memory alloy, such as nickel-titanium wire.

[0042] In this embodiment, the distal end 11 of the guidewire 1 includes a central guidewire 71 and a plurality of peripheral guidewires 72. In the retracted state, all the guidewires 1 are close to each other. In the deployed state:

[0043] The multiple peripheral guide wires 72 are bent and radially distributed to define the outer contour of the cage structure 7;

[0044] The central guide wire 71 is spirally coiled and supported inside the cage structure 7 .

[0045] The peripheral guidewires 72 cooperate with each other to form the outer contour of the cage structure 7 and directly contact the inner wall of the left ventricle 2 to provide a support point. The central guidewire 71 provides a certain amount of support to the cage structure 7, so that the cage structure 7 does not easily deform when subjected to force. In the stowed state, multiple peripheral guidewires 72 are arranged circumferentially around the central guidewire 71. In the deployed state, the central guidewire 71 is located inside the cage structure 7, and multiple peripheral guidewires 72 are arranged circumferentially around the central guidewire 71. Both the central guidewire 71 and the peripheral guidewires 72 are made of elastic material and are pre-shaped. To prevent the cage structure 7 from causing damage to the left ventricle 2, referring to one embodiment, the outer contour of the cage structure 7 is an arc or a smooth curve.

[0046] In the retracted state, multiple peripheral guide wires 72 are arranged in parallel around the circumference of the central guide wire 71. The central guide wire 71 fits closely with the multiple peripheral guide wires 72. When the gap between two adjacent peripheral guide wires 72 is ignored, the cross-section enclosed by the central guide wire 71 and the multiple peripheral guide wires 72 is roughly circular, which serves to reduce the radial dimension of the guide tube 6 and facilitate its passage through the blood vessel and the insertion of the sheath tube 5.

[0047] The mesh cage structure 7 has an axial direction consistent with the extension direction of the guide tube 6. In the expanded state, the curved portion of the single peripheral guide wire 72 is arranged in an arc shape, and all parts of the guide wire 1 are in the same plane, so that each guide wire 1 is radially distributed when bent. Figure 5 In the figure, the portion from point X1 to point X2 is the main load-bearing portion where the cage structure 7 abuts against the left ventricle.

[0048] The proximal end 12 of the guidewire 1 is partially exposed outside the guide tube 6. To drive the guidewire 1, the operator can directly or indirectly drive the support wires through a drive component. The drive component drives the guidewire 1 to reciprocate along the axial direction of the guide tube 6. To achieve this basic function, a motor, a cylinder, a hydraulic cylinder, or even a manual drive component can be selected from existing technologies. When the motion mode directly output by the drive component is inconsistent with the motion mode of the guidewire 1, an appropriate transmission component can be used to convert and transmit the motion mode.

[0049] In this embodiment, the mesh cage structure 7 has an axial direction aligned with the extension direction of the guide tube 6. In the deployed state, all guidewires 1 are gathered at either end of the axial direction of the mesh cage structure 7. The distal ends 11 of the peripheral guidewires 72 and the distal ends 11 of the central guidewires 71 are welded together. In the deployed state, the bottom surface of the mesh cage structure 7 is curved, increasing the contact area with the bottom of the left ventricle 2 and distributing stress.

[0050] In this embodiment, the central guide wire 71 is helically coiled and supported between the two axial ends of the mesh cage structure 7. The helically coiled structure formed by the central guide wire 71 has an axial direction that is consistent with the axial direction of the mesh cage structure 7, so that the central guide wire 71 is not easily distorted after being pressed against the left ventricle 2, thereby maintaining the outer contour of the mesh cage structure 7.

[0051] In order to enable the central guide wire 71 to support the entire mesh cage structure 7 axially, the number of spiral turns of the central guide wire 71 is at least greater than one turn. Referring to one embodiment, the spiral is a three-dimensional spiral, and the three-dimensional spiral has a center line. The center line is the geometric center of the three-dimensional spiral and is arranged in the same direction as the extension direction of the catheter. The spiral extends along the center line. Referring to one embodiment, the central guide wire 71 is spirally wound into a multi-turn structure and is arranged turn by turn along the axial direction of the mesh cage structure 7, with adjacent turns abutting against each other. When two adjacent turns abut against each other, the deformation of the central guide wire 71 can be reduced, thereby reducing the deformation of the mesh cage structure 7. Referring to one embodiment, in the loop structure, the closer to the axial end of the mesh cage structure 7, the smaller the loop diameter. Along the axial direction of the guide wire 1, the loop diameter at both ends of the loop structure is smaller to prevent the loop structure from interfering with the position of the peripheral guide wire 72 in the expanded state.

[0052] In order to facilitate the processing of the mesh cage structure 7, referring to one embodiment, the distal end 11 of the guide wire 1 is laser cut to form a plurality of wire strips with one end connected to the guide wire 1 and the other end extending away from the guide wire 1. The plurality of wire strips correspond to the central guide wire 71 and the peripheral guide wire 72 respectively. The distal ends of the wire strips are welded to form a three-dimensional mesh cage structure 7 in the unfolded state; each wire strip is integrally arranged with the guide wire 1 to strengthen the connection strength between the wire strip and the guide wire 1, while also reducing the processing technology between the wire strip and the guide wire 1. Of course, in other embodiments, when the wire strips are separated from the guide wire 1, the wire strips can also be connected to the guide wire 1 by welding.

[0053] If the central guide wire 71 and at least one peripheral guide wire 72 are not of equal length, when the central guide wire 71 and the peripheral guide wire 72 are fixed together at one end of the dorsal guide wire 1, at least one of them will curl up in the guide tube 6, which may cause the central guide wire 71 or the peripheral guide wire 72 to generate greater friction resistance with the inner wall of the guide tube 6, affecting the passage of the central guide wire 71 and the peripheral guide wire 72 in the guide tube 6; or it may increase the radial size of the central guide wire 71 and the peripheral guide wire 72 in the catheter, resulting in excessive local radial size of the guide tube 6, affecting the passage of the guide tube 6 in the blood vessel. In order to facilitate the passage of the guide wire 1 in the guide tube 6 in the stored state, referring to one embodiment, the central guide wire 71 and the multiple peripheral guide wires 72 in the stored state are of equal length. The shape of the central guide wire 71 and each peripheral guide wire 72 is roughly the same, which is convenient for processing.

[0054] In one embodiment, there are at least three peripheral guidewires 72. The bottom and circumference of the cage structure 7 form at least three support points with the inner wall of the left ventricle 2, thereby increasing the support points between the cage structure 7 and the inner wall of the blood vessel. This can disperse the stress exerted by the distal end 11 of the guidewire 1 on the inner wall of the left ventricle 2, reduce damage to the inner wall of the left ventricle 2, and simultaneously limit the radial movement of the cage structure 7 along the guidewire 1. Preferably, there are 12 peripheral guidewires 72. The number of peripheral guidewires 72 is selected based on actual application and will not be elaborated here.

[0055] In one embodiment, the peripheral guide wires 72 are equidistantly spaced around the circumference of the cage structure 7. In the deployed state, when the peripheral guide wires 72 abut the inner wall of the left ventricle 2, the forces acting on the peripheral guide wires 72 are uniform and directed toward the axial center of the cage structure 7, thereby preventing deformation of the cage structure 7. Referring to one embodiment, the peripheral guide wires 72 are equidistantly spaced around the circumference of the cage structure 7 along the cage axis.

[0056] In one embodiment, in the expanded state, the outer contour of the mesh cage structure 7 is roughly a rotating body, and each peripheral guide wire 72 corresponds to the busbar of the rotating body; the busbar is a smooth curve. In the expanded state, along the circumference of the guide tube 6, there is a certain gap between adjacent peripheral guide wires 72. When the gap is ignored, the mesh cage structure 7 can be regarded as a rotating body in which a peripheral guide wire 72 rotates axially around the guide wire 1. The rotating body has an axial direction that is consistent with the extension direction of the guide tube 6 and the extension direction of the guide wire 1. The extension direction of each peripheral guide wire 72 is the busbar of the rotating body. The smooth curve avoids puncturing the inner wall of the left ventricle 2 and can fit well with the inner wall of the left ventricle 2. Referring to one embodiment, in the expanded state, each peripheral guide wire 72 is connected to the other parts of the guide wire 1 in a smooth manner.

[0057] The technical features of the above embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there are no conflicts in the combination of these technical features, they should be considered to be within the scope of this specification. When technical features in different embodiments are reflected in the same figure, it can be regarded as that figure also discloses the combination examples of the various embodiments involved.

[0058] The above embodiments merely illustrate several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art could make numerous variations and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application.

Claims

1. A guide wire device with improved support effect, characterized in that: The invention comprises a guide tube and a guide wire slidably inserted into the guide tube, wherein the guide wire has a distal end and a proximal end opposite to each other, wherein the distal end of the guide wire has a storage state in which it is loaded into the guide tube and an expanded state in which it is exposed from the guide tube, and the distal end of the guide wire is a three-dimensional cage structure in the expanded state; the distal end of the guide wire comprises a central guide wire and a plurality of peripheral guide wires, wherein in the storage state, all the guide wires are close to each other, and in the expanded state: The radial distribution of the multiple peripheral guide wires defines the outer contour of the mesh cage structure, and the outer contour of the mesh cage structure is substantially an arc surface; The central guide wire is helically coiled and supported inside the cage structure.

2. A guide wire device with improved support effect according to claim 1, characterized in that: In the retracted state, the central guide wire and the plurality of peripheral guide wires are of equal length.

3. A guide wire device with improved support effect according to claim 1, characterized in that: The mesh cage structure has an axial direction that is consistent with the extending direction of the guide tube, and in the expanded state, all the guide wires are gathered at both ends of the axial direction of the mesh cage structure.

4. A guide wire device with improved support effect according to claim 3, characterized in that: The central guide wire is spirally coiled and supported between the two axial ends of the cage structure.

5. A guide wire device with improved support effect according to claim 4, characterized in that: The central guide wire is spirally wound into a multi-circle structure and is arranged circle by circle along the axial direction of the mesh cage structure, with adjacent circles abutting against each other.

6. A guide wire device with improved support effect according to claim 5, characterized in that: In a multi-ring structure, the closer to the axial end of the cage structure, the smaller the ring diameter.

7. A guide wire device with improved support effect according to claim 1, characterized in that: There are at least 3 peripheral guide wires.

8. A guide wire device with improved support effect according to claim 1, characterized in that: Around the cage structure, the guide wires are evenly distributed.

9. A guide wire device with improved support effect according to claim 1, characterized in that: In the unfolded state, the outer contour of the mesh cage structure is roughly a rotating body, and each peripheral guide wire corresponds to the generatrix of the rotating body; the generatrix is a smooth curve.

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