Assisted guidewire transvalvular device

Abstract

The present invention discloses an auxiliary guidewire transvalvular device, comprising a guidewire, a deformable member, and a first outer tube. A portion of the guidewire is located within the first outer tube, allowing the guidewire to move relative to the first outer tube along the extension direction of the first outer tube; the deformable member is capable of radially contracting and expanding between a radially contracted configuration and a radially expanded configuration, and the distal end of the deformable member is connected to the guidewire; the proximal end of the deformable member is connected to the first outer tube, and the guidewire is capable of moving proximally relative to the first outer tube under the action of an external force, thereby driving the distal end of the deformable member to move proximally, bringing the distal end of the deformable member closer to the proximal end of the deformable member, and causing the deformable member to expand radially. Therefore, the user can drive the guidewire to move proximally to cause the deformable member to expand radially, and the expanded deformable member will propel the valve open to facilitate guidewire entry.

Description

Technical Field

[0001] The present disclosure relates to the field of medical equipment, and in particular to an auxiliary guidewire transvalvular device. Background Art

[0002] Each year, 1-2 million heart disease patients worldwide require heart valve repair or replacement surgery due to factors such as progressive valvular degeneration. Transcatheter aortic valve replacement (TAVR) plays a key role in the treatment of symptomatic severe aortic stenosis. During TAVR, a transvalvular guidewire is first used to cross the native valve to establish a track. The valve delivery system is then delivered to the native valve position over the guidewire. However, when the native valve is narrowed due to factors such as calcification, the transvalvular guidewire is impacted by blood flow, making it difficult to cross the native valve. This requires the skilled surgeon to maneuver the guidewire back and forth until it can cross the valve and enter the left ventricle.

[0003] With the continuous development of transcatheter valve technology and transcatheter valve products, more and more doctors have begun to perform transcatheter valve replacement surgery. However, when doctors perform the surgery, they cannot clearly understand the spatial structure of the diseased native valve position, so the operation is relatively accidental. Sometimes it takes a long time to complete the transvalvular operation, and even other ways to complete the guidewire transvalvular operation, which greatly prolongs the operation time, increases the chance of surgical complications, and reduces the safety of the surgery. Summary of the Invention

[0004] The present disclosure addresses at least one of the above-mentioned deficiencies in the prior art and provides an auxiliary guidewire transvalvular device.

[0005] In a first aspect, the present disclosure provides an auxiliary guidewire transvalvular device, comprising a guidewire, a deformable member and a first outer tube, wherein a portion of the guidewire is located inside the first outer tube so that the guidewire can move relative to the first outer tube along the extension direction of the first outer tube; the deformable member can radially contract and expand between a radially contracted configuration and a radially expanded configuration, the distal end of the deformable member is connected to the guidewire, and the proximal end of the deformable member is connected to the first outer tube; under the action of external force, the guidewire moves relative to the first outer tube to drive the distal end and the proximal end of the deformable member to approach each other, so that the deformable member expands radially.

[0006] Optionally, the deformable member includes multiple deformable strips; the distal end of the deformable strip is connected to the guide wire, and the proximal end of the deformable strip is connected to the first outer tube. The guide wire can move proximally relative to the first outer tube under the action of external force to drive the distal ends of the multiple deformable strips close to the proximal end of the deformable strip, so that each deformable strip protrudes radially outward to radially expand the deformable member.

[0007] Optionally, the length of at least one deformation bar is different from that of the other deformation bars.

[0008] Optionally, the deformation strip is constructed so that when the proximal end of the deformation strip and the distal end of the deformation strip approach each other along the extension direction of the guide wire, the deformation strip bends radially outward to form a shape that protrudes radially outward; when the proximal end of the deformation strip and the distal end of the deformation strip move away from each other along the extension direction of the guide wire, the deformation strip retracts radially inward.

[0009] Optionally, a second outer tube is further included, which is sleeved outside the first outer tube so that the second outer tube can move relative to the extension direction of the first outer tube. By moving the second outer tube relative to the first outer tube, the guide wire and the deformable part are accommodated in the second outer tube.

[0010] In the second aspect, the present disclosure provides an auxiliary guidewire transvalvular device, including a guidewire, a deformable member, a third outer tube and a first inner tube. The first inner tube can move relative to the third outer tube along the extension direction of the third outer tube. The guidewire is arranged in the first inner tube, and the guidewire can move relative to the third outer tube and the first inner tube along the extension direction of the first inner tube; the deformable member can radially contract and expand between a radially contracted configuration and a radially expanded configuration. The proximal end of the deformable member is connected to the third outer tube, and the distal end of the deformable member is connected to the first inner tube. The first inner tube and the third outer tube can move relative to each other under the action of external force to drive the distal end of the deformable member and the proximal end of the deformable member closer, so that the deformable member expands radially.

[0011] Optionally, the deformation member includes multiple deformation strips; the distal end of the deformation strip is connected to the first inner tube, and the proximal end of the deformation strip is connected to the first outer tube. Under the action of external force, the first inner tube can move proximally relative to the third outer tube to drive the distal ends of the multiple deformation strips close to the proximal end of the deformation strip, so that each deformation strip protrudes radially outward to expand and deform radially.

[0012] Optionally, the length of at least one deformation bar is different from that of the other deformation bars.

[0013] Optionally, the deformation strip is constructed so that when the proximal end of the deformation strip and the distal end of the deformation strip approach each other along the guide wire extension direction, the deformation strip bends radially outward to form a shape that protrudes radially outward; when the proximal end of the deformation strip and the distal end of the deformation strip move away from each other along the guide wire extension direction, the deformation strip contracts radially inward.

[0014] Optionally, a fourth outer tube is further included, which is sleeved outside the third outer tube and can move relative to the extension direction of the third outer tube. By moving the fourth outer tube relative to the third outer tube, the guide wire and the deformable part are accommodated in the fourth outer tube.

[0015] The auxiliary guidewire transvalvular device of the first aspect provided by the present disclosure is connected to the first outer tube through the proximal end of the deformable member, and the distal end of the deformable member is connected to the guidewire, so that when the guidewire moves along the proximal end relative to the first outer tube, the proximal end and the distal end of the deformable member approach each other to cause the deformable member to deform and expand radially outward. Therefore, the user can use a radially contracted deformable member before the guidewire reaches the valve to assist the guidewire transmembrane device in delivering the guidewire. After reaching the position in front of the valve, the user can drive the guidewire to move proximally to allow the deformable member to expand radially. The expanded deformable member will open the valve to facilitate the entry of the guidewire.

[0016] The second aspect of the auxiliary guidewire cross-valve device provided by the present disclosure is connected to the third outer tube through the proximal end of the deformable part, and the distal end of the deformable part is connected to the first inner tube, so that the user can control the first inner tube to move proximally relative to the third outer tube to make the proximal end and the distal end of the deformable part approach each other to allow the deformable part to expand radially, and at the same time the guidewire and the first inner tube can move relative to each other, so the user can move the guidewire to allow the guidewire to pass through the valve and the shape of the deformable part will not be affected during the movement of the guidewire so that the valve can always be in an expanded state. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 Schematic diagram of the structure of the auxiliary guidewire transmembrane device in one embodiment (when the deformable member is in a radially expanded configuration).

[0018] Figure 2 It is a schematic structural diagram of the auxiliary guidewire transmembrane device in another embodiment (when the deformable member is in a radially contracted configuration).

[0019] Figure 3 yes Figure 1 Diagram of the usage scenario of the auxiliary guidewire transmembrane device.

[0020] Figure 4a It is a structural schematic diagram when the deformation strip is in a radially retracted configuration.

[0021] Figure 4b It is a structural schematic diagram when the deformation strip is in a radially convex configuration.

[0022] Figure 5 It is a schematic structural diagram of an auxiliary guidewire transvalvular device in another embodiment.

[0023] Figure 6 for Figure 5 The diagram shows the usage scenario of the auxiliary guidewire transvalvular device.

[0024] Markings in the figure: 10, deformation part; 11, deformation strip; 12, rubber sleeve; 13, proximal end of deformation strip; 14, distal end of deformation strip; 2, first outer tube; 3, guide wire; 4, metal tube; 5, third outer tube; 51, first sleeve; 6, first inner tube; 61, second sleeve; 7, fourth outer tube; 8, operating part; H3, radial protrusion distance of deformation strip. DETAILED DESCRIPTION

[0025] In the description of the present disclosure, it should be understood that the terms "center", "longitudinal", "lateral", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present disclosure 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 understood as limiting the scope of protection of the present disclosure.

[0026] like Figure 1 As shown, the auxiliary guidewire transvalvular device includes a guidewire 3, a deformable member 10, and a first outer tube 2. A portion of the guidewire 3 is located inside the first outer tube 2 so that the guidewire 3 can move relative to the first outer tube 2 along the extension direction of the first outer tube 2; the distal end of the deformable member 10 is connected to the guidewire 3; and the proximal end of the deformable member 10 is connected to the first outer tube 2. Under normal circumstances, Figure 2 As shown, the deformable member 10 is in a radially contracted configuration and has not yet expanded radially outward, so the transvalvular device including the deformable member 10 can easily pass through the blood vessel. When reaching the front of the valve, the user can pull the proximal end of the guide wire 3 to move the guide wire 3 proximally relative to the first outer tube 2. At this time, since the distal end of the deformable member 10 is connected to the guide wire 3, the distal end of the deformable member 10 will move proximally, and the proximal end of the deformable member 10 is connected to the first outer tube 2, so the distal end of the deformable member 10 will move closer to the proximal end of the deformable member 10, thereby deforming the deformable member 10 to expand radially, thereby expanding the valve so that the guide wire 3 can pass through the valve, as shown in FIG. Figure 3 Specifically, the deformable member 10 includes a plurality of deformable strips 11, the distal end 14 of the deformable strip is connected to the guide wire 3, and the proximal end 13 of the deformable strip is connected to the first outer tube 2. Figure 2 As shown, the deformation strip 11 has not yet protruded radially outward, and the deformation member 10 is in a radially contracted configuration. The user can pull the proximal end of the guide wire 3 to move the guide wire 3 proximally relative to the first outer tube 2. At this time, since the distal end 14 of the deformation strip is connected to the guide wire 3, the distal end 14 of the deformation strip will move proximally, and the proximal end 13 of the deformation strip is connected to the first outer tube 2. If the first outer tube 2 is stationary, the proximal end 13 of the deformation strip is also relatively stationary. Therefore, the distal end 14 of the deformation strip will approach the proximal end 13 of the deformation strip, thereby causing the deformation member 10 to deform and expand radially, as shown in FIG. Figure 1As shown, each deformation strip 11 protrudes radially outward to radially expand the deformation member 10, so that the deformation member 10 is in a radially expanded configuration.

[0027] Although Figure 1 As shown, the number of the deformation bars 11 is 3, but the number of the deformation bars 11 can be adjusted according to the situation, and 2, 4, 5, 6 or more than 6 are all possible, and the present disclosure does not limit this.

[0028] It should be understood that the deformation strip 11 is constructed to be able to change between a radially retracted configuration and a radially protruding configuration; when the proximal end 13 of the deformation strip and the distal end 14 of the deformation strip approach each other along the extension direction of the first outer tube 2, the deformation strip 11 bends radially outward from a radially retracted configuration to a radially protruding configuration; when the distal ends 14 of the deformation strip move away from each other along the extension direction of the first outer tube 2, the deformation strip 11 retracts inward from a radially protruding configuration to a radially retracted configuration.

[0029] When the deformation strip 11 changes from the radially retracted configuration to the radially protruding configuration, the specific shape of the deformation strip changes from Figures 4a to 4b As shown, the radial protrusion distance H3 of the deformation strip gradually increases; when the deformation strip 11 changes from a radially protruding configuration to a radially retracted configuration, the specific shape of the deformation body changes from Figure 4b to Figure 4a As shown, the radial protrusion distance H3 of the deformation strip gradually decreases. The radial protrusion distance H3 of the deformation strip refers to the radial distance between the position of the deformation strip 11 that is radially farthest from the guidewire 3 and the guidewire 3, which reflects the degree of radial outward protrusion of the deformation strip 11. The more radially outwardly the deformation strip 11 protrudes, the greater the radial protrusion distance H3 of the deformation strip. In some embodiments, when the deformation strip 11 is in the radially retracted configuration, the radial protrusion distance H3 of the deformation strip can be the distance H1 from the proximal end of the deformation strip to the guidewire, that is, the proximal end 13 of the deformation strip is the position of the deformation strip 11 that is radially farthest from the guidewire 3.

[0030] Optionally, the deformable member 10 further includes a rubber sleeve 12, to which the distal end 14 of the deformable strip is fixed. The rubber sleeve 12 surrounds and is fixed to the guide wire 3. It should be understood that in some embodiments, the distal end 14 of the deformable strip can be fixed to the guide wire by gluing, welding, or the like, and the rubber sleeve 12 is not necessarily required.

[0031] Optionally, the first outer tube 2 is provided with a metal tube 4, which is positioned between the first outer tube 2 and the guidewire 3. The metal tube 4 is fixed to the first outer tube 2, and the metal tube 4 surrounds the guidewire 3, allowing the guidewire 3 to move relative to the metal tube 4 along the extension direction of the first outer tube 2. The proximal end 13 of the deformation strip is fixed to the metal tube 4, so that the proximal end 13 of the deformation strip is relatively fixed to the first outer tube 2. It should be understood that the metal tube 4 can be a thermosetting plastic tube, a nickel-titanium alloy, or other safe material of suitable strength. Moreover, the proximal end 13 of the deformation strip can be fixed to the first outer tube 2 by welding, gluing, etc., and the metal tube 4 is not necessarily required.

[0032] To meet the needs of different patients, in some embodiments, at least one deformable strip 11 has a different length than the other deformable strips 11. Because different lengths of the deformable strips 11 result in different radially outwardly projecting shapes, this facilitates varying degrees of expansion of the deformable member 10 in different directions. In some directions, the deformable strips 11 have larger outward expansion spans, while in others, the deformable strips 11 have smaller outward expansion spans. This allows the deformable member 10 to better meet the spatial structural requirements of different aortic valve locations. In other embodiments, the lengths of the deformable strips 11 may differ.

[0033] Optionally, a second outer tube is further included, which is sleeved outside the first outer tube 2 so that the second outer tube can move relative to the extension direction of the first outer tube 2. By moving the second outer tube relative to the first outer tube 2, the guide wire 3 and the deformable member 10 are accommodated within the second outer tube. The second outer tube protects the guide wire 3 and the deformable member 10, preventing them from contacting internal human tissue when the guide wire 3 is delivered to the valve, thereby preventing damage to the deformable member 10 or the internal human tissue.

[0034] Moreover, after the guide wire 3 passes through the valve, the user can push the guide wire 3 to move distally, thereby driving the distal end of the deformable member 10 to move distally. At this time, since the first outer tube 2 is stationary, the distance between the proximal end of the deformable member 10 and the distal end of the deformable member 10 becomes larger; the deformable member 10 contracts radially, from a radially expanded configuration to a radially contracted configuration, and the radial span of the deformable member 10 becomes smaller, so that the auxiliary guide wire can be passed through the valve through the valve device.

[0035] Optionally, the auxiliary guidewire transvalvular device may further include an operating portion 8 connected to the guidewire 3, and the user may control the guidewire 3 to move proximally and distally through the operating portion 8. The operating portion 8 may be an operating handle or other similar structure, and the present disclosure does not impose any specific limitations thereto.

[0036] In some embodiments, as Figure 5As shown, the auxiliary guidewire transvalvular device includes a guidewire 3, a deformable member 10, a third outer tube 5 and a first inner tube 6. The first inner tube 6 can move relative to the third outer tube 5 along the extension direction of the third outer tube 5. The guidewire 3 is arranged in the first inner tube 6, and the guidewire 3 can move relative to the third outer tube 5 and the first inner tube 6 along the extension direction of the first inner tube 6. The proximal end of the deformable member 10 is connected to the third outer tube 5, and the distal end of the deformable member 10 is connected to the first inner tube 6. Under normal circumstances, as shown in FIG. Figure 5 As shown, the deformable member 10 is in a radially contracted configuration. When an external force acts on the first inner tube 6 to move toward the proximal end, the first inner tube 6 will move the distal end of the deformable member 10 toward the proximal end. The proximal end of the deformable member 10 is arranged on the third outer tube 5, so the distal end of the deformable member 10 will move relative to the proximal end of the deformable member 10, causing the deformable member 10 to radially expand from the radially contracted configuration to the radially expanded configuration, as shown in FIG. Figure 6 Of course, when the deformable member 10 is in the radially contracted configuration, an external force can also act on the third outer tube 5 to cause the third outer tube 5 to move distally. The third outer tube 5 will move the proximal end of the deformable member 10 toward the distal end, bringing the proximal and distal ends of the deformable member 10 closer to each other, and similarly causing the deformable member 10 to radially expand from the radially contracted configuration to the radially expanded configuration.

[0037] Since the proximal end of the deformable member 10 is connected to the third outer tube 5, and the distal end of the deformable member 10 is connected to the first inner tube 6, and the guide wire 3, the third outer tube 5 and the first inner tube 6 are all movable relative to each other, the user does not need to and will not move the guide wire 3 when adjusting the configuration of the deformable member 10, thereby avoiding the movement of the guide wire 3 and the need to readjust the position of the auxiliary transmembrane device to align the guide wire 3 with the valve. Moreover, when the guide wire 3 moves, it will not affect the relative position of the third outer tube 5 and the first inner tube 6, thereby avoiding the deformation member 10 from changing its configuration when the guide wire 3 passes through the valve, causing the valve to narrow and affecting the guide wire 3's penetration of the membrane. For details, please refer to Figure 6 At this time, the third outer tube 5 has moved distally relative to the first inner tube 6, carrying the deformable member 10 to the distal end, so that the proximal and distal ends of the deformable member 10 are close to each other, allowing the deformable member 10 to radially expand from a radially contracted configuration to a radially expanded configuration, thereby opening the valve. At this time, since the guidewire 3, the third outer tube 5, and the first inner tube 6 are all movable relative to each other, the user can directly push the guidewire 3 to move through the valve. At this time, since the third outer tube 5 and the first inner tube 6 are relatively stationary, the deformable member 10 is still in a radially expanded state. After the guidewire 3 passes through the valve, the user can move the third outer tube 5 proximally to allow the deformable member 10 to change from a radially expanded configuration to a radially contracted configuration so that the auxiliary guidewire 3 transmembrane device can pass through the membrane.

[0038] Specifically, the deformable member 10 includes a plurality of deformable strips 11; the distal end 14 of the deformable strip is connected to the first inner tube 6, and the proximal end 13 of the deformable strip is connected to the third outer tube 5. When the first inner tube 6 moves proximally relative to the third outer tube 5 under the action of an external force, the distal ends 14 of the plurality of deformable strips can be driven to move proximally to bring the distal ends 14 of the deformable strips closer to the proximal ends 13 of the deformable strips, so that each deformable strip 11 protrudes radially outward to radially expand the deformable member 10, allowing the deformable member 10 to change from a radially contracted configuration to a radially expanded configuration.

[0039] Optionally, the length of at least one deformation strip 11 is different from that of the other deformation strips 11 .

[0040] It should be understood that the deformation strips 11 are configured such that when the proximal end 13 and the distal end 14 of the deformation strip approach each other along the extension direction of the first inner tube 6, the deformation strips 11 bend radially outward to form a radially outwardly protruding shape; and when the distal end 14 and the proximal end 13 of the deformation strip move away from each other along the extension direction of the first inner tube 6, the deformation strips 11 contract radially inward. Therefore, after the guidewire 3 passes through the valve, the user can move the third outer tube 5 proximally relative to the first inner tube 6, or move the first inner tube 6 distally relative to the third outer tube 5, so that the proximal end 13 and the distal end 14 of the deformation strip move away from each other, causing the multiple deformation strips 11 to contract radially inward, thereby changing the deformation member 10 from a radially expanded configuration to a radially contracted configuration.

[0041] Optionally, a fourth outer tube 7 is further included, which is sleeved outside the third outer tube 5 so that the fourth outer tube 7 can move relative to the extension direction of the third outer tube 5. By moving the fourth outer tube 7 relative to the third outer tube 5, the guide wire 3 and the deformable member 10 can be accommodated in the fourth outer tube 7.

[0042] Optionally, a first sleeve 51 is provided at the distal end of the third outer tube 5 , and the proximal end 13 of the deformation strip is fixedly connected to the first sleeve 51 .

[0043] Optionally, a second sleeve 61 is provided at the distal end of the first inner tube 6 , and the distal end 14 of the deformation strip is fixedly connected to the second sleeve 61 .

[0044] It should be understood that the first and second sleeves 51, 61 can be made of stainless steel, nickel-titanium alloy, or other safe materials with sufficient strength, such as thermosetting plastic. Furthermore, in some embodiments, the proximal end 13 of the deformable strip can be directly secured to the third outer tube 5 by welding, gluing, or the like, while the distal end 13 of the deformable strip can be directly secured to the first inner tube by welding, gluing, or the like.

[0045] It should be understood that the proximal end refers to the end close to the operator manipulating the valve-span assisting device, and the distal end refers to the end away from the operator. Figure 1 and Figure 5 As shown, Figure 1 and Figure 5 The direction A is from the proximal end to the distal end.

[0046] It should be understood that radial expansion refers to expansion in the radial direction. Radial contraction refers to contraction in the radial direction. Therefore, when the deformable member 10 is in the radially expanded configuration, its radial span is greater than its span when it is in the radially contracted configuration. Those skilled in the art can adjust the radial span of the deformable member 10 in the radially contracted configuration and the radially expanded configuration according to the circumstances, so that when the deformable member 10 is in the radially contracted configuration, it can pass through the blood vessel (artery), and when the deformable member 10 is in the radially expanded configuration, it can expand the valve. The present disclosure does not limit the radial span of the deformable member 10.

[0047] The deformation strip 11 can be made of nickel-titanium alloy wire, polyurethane elastic rubber and other materials with good biocompatibility with the human body and non-toxic. The deformation strip 11 has good toughness and a certain strength to open the valve without failing and causing damage to the human body. The guide wire 3 can include a core steel wire and a steel wire coating. The steel wire coating is coated on the outside of the core steel wire to prevent the core steel wire from damaging the human body. The core steel wire is usually made of stainless steel or nickel-titanium memory metal. The steel wire coating can be a polytetrafluoroethylene coating, a hydrophilic coating or a hydrophobic coating. The guide wire 3 is a commonly used device for coronary interventional treatment surgery, and the specific structure is diverse, so the present disclosure does not make specific restrictions.

[0048] The above embodiments are only used to illustrate the technical solutions of the present disclosure, and are not intended to limit them. Although the present disclosure has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present disclosure. All other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present disclosure.

Claims

1. Auxiliary guidewire transvalvular device, characterized in that: The invention comprises a guide wire, a deformable member and a first outer tube, a part of the guide wire is located in the first outer tube so that the guide wire can move relative to the first outer tube along the extension direction of the first outer tube; the deformable member can radially contract and expand between a radially contracted configuration and a radially expanded configuration, the distal end of the deformable member is connected to the guide wire, and the proximal end of the deformable member is connected to the first outer tube; under the action of an external force, the guide wire moves relative to the first outer tube to drive the distal end and the proximal end of the deformable member to approach each other, so that the deformable member expands radially, and the deformable member comprises a plurality of deformable strips; the distal end of the deformable strip is connected to the guide wire, and the proximal end of the deformable strip is connected to the first outer tube, and the length of at least one deformable strip is different from that of the other deformable strips. When the proximal end of the deformation strip and the distal end of the deformation strip approach each other along the extension direction of the first outer tube, the deformation strip bends radially outward and changes from a radially retracted configuration to a radially convex configuration; when the proximal end of the deformation strip and the distal end of the deformation strip move away from each other along the extension direction of the first outer tube, the deformation strip retracts inward and changes from the radially convex configuration to the radially retracted configuration. When the length of the deformation strip is different, the shape of the deformation strip after radially protruding outward will be different, so that the degree of expansion of the deformation part in each direction is different when it expands radially outward, wherein the deformation strip has toughness, and the material of the deformation strip is nickel-titanium alloy wire or polyurethane elastic rubber.

2. The auxiliary guidewire transvalvular device according to claim 1, characterized in that: Under the action of external force, the guide wire moves relative to the first outer tube to drive the distal ends of the multiple deformation strips close to the proximal end of the deformation strip, so that each deformation strip protrudes radially outward to radially expand the deformation member.

3. The auxiliary guidewire transvalvular device according to claim 2, characterized in that: The deformation strip is constructed so that when the proximal end of the deformation strip and the distal end of the deformation strip approach each other along the extension direction of the guide wire, the deformation strip bends radially outward to form a shape that protrudes radially outward; when the proximal end of the deformation strip and the distal end of the deformation strip move away from each other along the extension direction of the guide wire, the deformation strip retracts radially inward.

4. The auxiliary guidewire transvalvular device according to any one of claims 1 to 3, characterized in that: It also includes a second outer tube, which is sleeved outside the first outer tube so that the second outer tube can move relative to the extension direction of the first outer tube. By moving the second outer tube relative to the first outer tube, the guide wire and the deformable member are accommodated in the second outer tube.

5. Auxiliary guidewire transvalvular device, characterized in that: The invention comprises a guide wire, a deformable member, a third outer tube and a first inner tube, the first inner tube can move relative to the third outer tube along the extension direction of the third outer tube, the guide wire is arranged in the first inner tube, and the guide wire can move relative to the third outer tube and the first inner tube along the extension direction of the first inner tube; the deformable member can radially contract and expand between a radial contraction configuration and a radial expansion configuration, the proximal end of the deformable member is connected to the third outer tube, and the distal end of the deformable member is connected to the first inner tube; the first inner tube and the third outer tube can move relative to each other under the action of an external force to drive the distal end of the deformable member to approach the proximal end of the deformable member, so that the deformable member expands radially, and the deformable member comprises a plurality of deformable strips; the distal end of the deformable strip is connected to the first inner tube, the proximal end of the deformable strip is connected to the third outer tube, and at least one The length of the deformation strip is different from that of other deformation strips. When the proximal end of the deformation strip and the distal end of the deformation strip approach each other along the extension direction of the first inner tube, the deformation strip bends radially outward from a radially retracted configuration to a radially protruding configuration; when the proximal end of the deformation strip and the distal end of the deformation strip move away from each other along the extension direction of the first inner tube, the deformation strip retracts inward from the radially protruding configuration to the radially retracted configuration. When the lengths of the deformation strips are different, the shapes of the deformation strips after radially protruding outward will be different, so that the expansion degrees of the deformation part in each direction are different when it expands radially outward. The deformation strip has toughness, and the material of the deformation strip is nickel-titanium alloy wire or polyurethane elastic rubber.

6. The auxiliary guidewire transvalvular device according to claim 5, characterized in that: Under the action of external force, the first inner tube can move proximally relative to the third outer tube to drive the distal ends of the multiple deformation strips close to the proximal ends of the deformation strips, so that each deformation strip protrudes radially outward to expand and deform radially.

7. The auxiliary guidewire transvalvular device according to claim 5, characterized in that: The deformation strip is constructed so that when the proximal end of the deformation strip and the distal end of the deformation strip approach each other along the extension direction of the first inner tube, the deformation strip bends radially outward to form a shape that protrudes radially outward; when the proximal end of the deformation strip and the distal end of the deformation strip move away from each other along the extension direction of the first inner tube, the deformation strip contracts radially inward.

8. The auxiliary guidewire transvalvular device according to any one of claims 5 to 7, characterized in that: It also includes a fourth outer tube, which is sleeved outside the third outer tube and can move relative to the extension direction of the third outer tube. By moving the fourth outer tube relative to the third outer tube, the guide wire and the deformable member are accommodated in the fourth outer tube.

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