A delivery guidewire and therapeutic device

Abstract

The present application relates to a kind of delivery guide wire and the therapeutic device comprising the delivery guide wire, the delivery guide wire includes mandrel and the driving member being arranged on the mandrel, including mandrel and the driving member being arranged on the mandrel, the driving member includes inner layer piece and outer layer piece, wherein, the inner layer piece is made of metal material, and is fixedly sleeved on the mandrel;The outer layer piece is made of high polymer material, and is fixedly sleeved on the inner layer piece. The binding force between the outer layer piece and the mandrel is indirectly enhanced by the inner layer piece fixedly sleeved on the mandrel, so that the outer layer piece is difficult to loosen, wrinkle, shift and other phenomena, improve the security and reliability of delivery guide wire use.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a guidewire delivery and treatment device. Background Technology

[0002] Intracranial aneurysms are abnormal bulges that occur on the walls of intracranial arteries and are the leading cause of subarachnoid hemorrhage. Among cerebrovascular diseases, the incidence of intracranial aneurysms is second only to cerebral thrombosis and hypertensive intracerebral hemorrhage, posing a significant threat to health.

[0003] In the existing technology, there are three main methods for treating intracranial aneurysms: (1) Surgical clipping, which uses metal clips to clip the neck of the aneurysm to block the blood flow between the intracranial aneurysm and the cerebral circulation, thereby restoring the normal blood supply to the carrier artery and preventing the aneurysm from rupturing and bleeding. (2) Intra-aneurysmal embolization, which uses embolizing material to fill the aneurysm, causing thrombus formation within the aneurysm and preventing further enlargement and rupture. (3) Endovascular stenting, which involves implanting a stent into the blood vessel to interfere with the blood flow from the carrier artery into the aneurysm, causing blood to stagnate and accumulate in the aneurysm, thereby forming an aneurysmal thrombus and further promoting the closure of the aneurysm to prevent rupture. Since aneurysms generally grow around the circle of arteries in the brain, and there are many important blood vessels, nerves and brain tissues around the circle of arteries, the surgical clipping method for treating aneurysms requires a high level of medical skill from the doctor, and the mortality rate of patients treated with surgical clipping is still as high as 50%. For large or locally large and complex aneurysms, the recurrence rate is high when using intra-aneurysmal embolization alone. Currently, the most commonly used treatment for intracranial aneurysms is endovascular stenting.

[0004] In intracranial aneurysm treatment using endovascular stenting, the stent is delivered into the blood vessel via a guidewire. The guidewire includes a mandrel and a membrane structure mounted on the mandrel. The stent is loaded onto the membrane structure, and the friction between the membrane structure and the stent causes the stent to move synchronously with the guidewire. In existing technology, the membrane structure is directly adhered to the mandrel. When using an adhesive method to connect the membrane structure and the mandrel, the small contact area results in poor bonding strength between the membrane structure and the mandrel. This makes the membrane structure prone to loosening, wrinkling, or displacement during stent delivery, potentially leading to stent detachment. Summary of the Invention

[0005] The purpose of this invention is to provide a delivery guidewire and a medical device. The delivery guidewire has good flexibility and can effectively prevent stent detachment caused by loosening or displacement of the outer layer during stent delivery.

[0006] To achieve the above objectives, the present invention provides a guide wire for conveying wires, comprising a mandrel and a driving member disposed on the mandrel, wherein the driving member comprises an inner layer and an outer layer.

[0007] The inner layer is made of metal and is fixedly sleeved on the mandrel;

[0008] The outer layer is made of polymer material and is fixedly fitted onto the inner layer.

[0009] Optionally, the inner layer has a void structure, and the outer layer partially or completely fills the void structure.

[0010] Optionally, the outer layer is at least partially connected to the mandrel through the void structure.

[0011] Optionally, the outer surface of the inner layer is provided with a recess, which constitutes the void structure.

[0012] Optionally, the inner layer includes a plurality of coils arranged sequentially along the axial direction of the mandrel, with the gap structure formed between adjacent coils.

[0013] Optionally, the inner layer is a spiral structure formed by spirally winding silk threads around the axis of the mandrel, with the gap structure formed between adjacent turns of the silk threads.

[0014] Optionally, the inner layer is a tubular structure woven from threads, and the mesh of the tubular structure forms the void structure.

[0015] Optionally, the diameter of the wire is less than or equal to 0.001 inches.

[0016] Optionally, the number of braided intersections included on the inner layer per inch of length is 15-50.

[0017] Optionally, the inner layer is at least one tubular structure, and the outer layer partially or completely covers the inner layer.

[0018] Optionally, the tubular structure is provided with a void structure, and the outer layer partially or completely fills the void structure;

[0019] Alternatively, the inner layer may consist of at least two tubular structures, with a gap structure formed between adjacent tubular structures, and the outer layer may partially or completely fill the gap structure.

[0020] Optionally, the inner layer is made of a reproducible metallic material.

[0021] Optionally, the metallic material is selected from one or more of platinum, gold, tungsten, platinum-gold alloys, platinum-tungsten alloys, platinum-iridium alloys, and platinum-nickel alloys.

[0022] Optionally, the inner layer is welded to the mandrel, or the inner layer is glued to the mandrel.

[0023] Optionally, the material of the outer layer includes one or more of block polyetheramide resin, thermoplastic polyurethane elastomer, silicone, nylon, and acrylic polymer.

[0024] Optionally, the outer layer covers the inner layer and extends to connect with the mandrel.

[0025] Optionally, the outer layer is formed on the inner layer by hot pressing and / or dip coating, or the inner layer and the outer layer are bonded together.

[0026] Optionally, the inner layer is integrally formed with the mandrel.

[0027] Optionally, the mandrel is provided with at least two driving members, and the at least two driving members are arranged at intervals along the axial direction of the mandrel.

[0028] To achieve the above objectives, the present invention also provides a treatment device comprising a delivery tube, a medical implant, and a delivery guidewire as described in any of the preceding claims, the delivery tube having an axially penetrating inner cavity for accommodating the medical implant, and the wall of the inner cavity compressing the medical implant to compress the medical implant; the compressed medical implant is fitted onto the actuating member.

[0029] Optionally, the radial dimension of the cavity ranges from 0.017 inches to 0.029 inches.

[0030] Compared with the prior art, the delivery guidewire and medical device of the present invention have the following advantages:

[0031] The aforementioned guide wire includes a mandrel and a driving component mounted on the mandrel. The driving component includes an inner layer and an outer layer. The inner layer is made of metal and is fixedly sleeved on the mandrel; the outer layer is made of polymer and is fixedly sleeved on the inner layer. Since the inner layer is fixed (e.g., welded) to the mandrel, and both the inner layer and the mandrel are made of metal, the bonding strength is very high, and there will be no displacement between them. The outer layer, made of polymer, is fixedly connected to the inner layer through a specific structure. For example, by providing a gap structure on the inner layer and partially or completely filling the gap structure with the outer layer, the inner and outer layers can be interlocked and fitted; or by having the outer layer cover the inner layer and further extend to connect with the mandrel, a tight fit can be achieved between the outer layer, the inner layer, and the mandrel. The outer layer is mounted on the mandrel through the inner layer, and the inner and outer layers have a large contact area, thus further improving the connection strength. All of the above methods have changed the connection method in the existing technology, so that the entire driving component can be firmly fixed on the mandrel, avoiding the phenomenon of loosening, wrinkling or displacement of the driving component during the delivery of the support, thereby improving the reliability of the delivery guide wire in the delivery of medical implants. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the structure of a treatment device in the prior art;

[0033] Figure 2 A schematic diagram of the structure of the guide wire provided according to an embodiment of the present invention;

[0034] Figure 3 This is a partial cross-sectional view of the guide wire provided according to an embodiment of the present invention, in which multiple coils are arranged adjacent to each other;

[0035] Figure 4 yes Figure 3 An enlarged schematic diagram of point A on the guide wire shown;

[0036] Figure 5 This is a schematic diagram of the structure of the guide wire provided according to an embodiment of the present invention. Only a portion of the mandrel and the inner layer component disposed on that portion of the mandrel are shown in the figure.

[0037] Figure 6 This is a schematic diagram of the conveying guide wire provided by the present invention according to another embodiment;

[0038] Figure 7 yes Figure 6 An enlarged schematic diagram of point B on the guide wire shown;

[0039] Figure 8 This is a schematic diagram of the structure of the guide wire provided according to yet another embodiment of the present invention;

[0040] Figure 9 yes Figure 8 The diagram shows an enlarged view of point C on the guide wire.

[0041] Figure 10 This is a schematic diagram of the structure of the guide wire provided in another embodiment of the present invention;

[0042] In the picture:

[0043] 10, 100 - Conveyor guide wire;

[0044] 11, 110 - Mandrel;

[0045] 12-Membrane structure,

[0046] 120 - Driven component;

[0047] 121-Inner layer component, 122-Outer layer component, 123-Void structure;

[0048] 130 - First developed piece;

[0049] 140 - Second developing piece;

[0050] 150-Variable Diameter Spring;

[0051] 20-Staff;

[0052] 30 - Delivery pipe. Detailed Implementation

[0053] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention.

[0054] As used herein, the singular forms “a,” “an,” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless otherwise expressly indicated. As used herein, the term “or” is generally used to include the meaning of “and / or,” unless otherwise expressly indicated, and the terms “installed,” “connected,” and “linked” should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection. Connections can be mechanical or electrical. Connections can be direct or indirect through an intermediate medium, and can represent internal communication between two elements or an interaction between two elements. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. The same or similar reference numerals in the drawings represent the same or similar parts.

[0055] In this article, the terms “proximal” and “distal” refer to the relative orientation, position, and direction of elements or actions relative to each other from the perspective of the operator using the medical device. Although “proximal” and “distal” are not restrictive, “proximal” usually refers to the end of the medical device that is closer to the operator during normal operation, while “distal” usually refers to the end that first enters the patient’s body.

[0056] Figure 1 A schematic diagram of a prior art treatment device is shown, which is used to deliver a medical stent to a predetermined location within a patient's body. Figure 1 As shown, the treatment device includes a delivery guidewire 10, a support 20, and a delivery tube 30. The delivery guidewire 10 includes a mandrel 11 and a membrane structure 12 disposed on the mandrel 11. The delivery tube 30 has an axially penetrating inner cavity for accommodating the support 20, and the wall of the inner cavity compresses the support 20 to compress it. The compressed support 20 is then fitted onto the membrane structure 12. To facilitate smooth delivery within the delivery tube 30, existing delivery guidewires 10 typically have a smooth outer surface. The membrane structure 12 is provided on the mandrel 11 of the delivery guidewire 10 to increase the initial frictional force between the delivery guidewire 10 and the support 30. Generally, the membrane structure 12 is made of a polymer material with a relatively high coefficient of friction and is bonded to the mandrel 11, which is made of a metal material.

[0057] In the treatment device, the delivery tube 30, the support 20, and the delivery guide wire 10 are in an interference fit; that is, the delivery tube 10 applies a radial force to the support 20, and the support 20 applies a radial force to the delivery guide wire 10 (specifically, the membrane structure 12). When the operator pushes the delivery guide wire 10 to move axially within the delivery tube 30, a first frictional force is generated between the delivery guide wire 10 and the inner surface of the support 20. Under the action of this frictional force, the support 20 can move synchronously with the delivery guide wire 10. At the same time, a second frictional force is generated between the outer surface of the support 20 and the inner wall of the delivery pipe 30. Since the diameter of the mandrel 11 is very small, the bonding area between the membrane structure 12 and the mandrel 11 is also very small, resulting in a small bonding force between the membrane structure 12 and the mandrel 11. Furthermore, the mandrel 11 and the membrane structure 12 are made of different materials, resulting in a low connection strength. When the second frictional force is too large, it is very easy to cause the membrane structure 12 to loosen, wrinkle, or even shift, thereby causing the support 20 to detach.

[0058] To address this problem, the purpose of this embodiment is to provide a delivery guidewire for delivering medical implants to a predetermined location within a patient's body. This delivery guidewire can effectively reduce the probability of implant dislodgement and improve the safety and reliability of the delivery guidewire. The medical implant is, for example, a self-expanding stent (i.e., a self-expanding stent), which can specifically be a braided stent or a cut stent. In other embodiments, the medical implant can also be a medical embolization coil, a vascular occlusion device, etc., and this invention is not limited thereto. In the following description, for ease of description, a self-expanding stent will be used as an example, and for simplicity, the term "stent" will be used to refer to a self-expanding stent.

[0059] Please refer to Figures 2 to 4 The conveying guide wire 100 provided in this embodiment includes a mandrel 110 and a driving member 120 disposed on the mandrel 110. The driving member 120 includes an inner layer 121 and an outer layer 122. The inner layer 121 is made of metal material and is fixedly sleeved on the mandrel 110. The outer layer 122 is made of polymer material and is fixedly sleeved on the inner layer 121.

[0060] The inner layer 121 is made of metal and can be fixed to the mandrel 110 by bonding, welding, or other means. The bonding strength between the two is very high, so the inner layer 121 will not shift on the mandrel 110. The outer layer 122 is connected to the mandrel 110 through the inner layer 121, indirectly increasing the connection area between the outer layer 122 and the mandrel 110, thereby enhancing the adhesion of the outer layer 122 to the mandrel 110 and reducing the possibility of the outer layer 122 loosening, wrinkling, or shifting during the transport of the support. It is understood that the term "nested" in this document has two meanings: first, the inner layer 121 is an independent component relative to the mandrel 110, and the two are assembled into one after being processed separately; second, during processing, the inner layer 121 and the mandrel 110 are integrally formed, but the inner layer 121 protrudes beyond the outer surface of the mandrel 110.

[0061] Furthermore, a void structure 123 may be formed on the inner layer 121, and the outer layer 122 may partially or completely fill the void structure 123 to increase the connection area between the outer layer 122 and the inner layer 121.

[0062] In this embodiment of the invention, the inner layer 121 can have various structural forms. The preferred structures of the inner layer 121 will be described below with reference to the accompanying drawings. It should be understood that the inner layer 121 in the following embodiments is merely an optional implementation of the invention and should not be construed as limiting the invention.

[0063] like Figures 2-4 As shown, in one embodiment, the inner layer 121 includes a plurality of coils clamped onto the mandrel 110, the plurality of coils being arranged axially along the mandrel 110. In this embodiment, since the coils can be made of metal wire with a circular or elliptical cross-section, adjacent coils can contact each other, thus forming a V-shaped recess between adjacent coils, which constitutes the gap structure 123. In other embodiments, depending on the shape of the radial cross-section of the coil, the recess can also be a U-shaped groove, a cube, a cuboid, or a hemispherical pit, etc.

[0064] The outer layer 122 is formed on the outer surface of the coil by hot pressing and / or dip coating, followed by molding and cooling. Specifically, the hot pressing method involves first fitting a polymer tube onto the inner layer 121, then fitting a heat-shrink tubing over the polymer tube. The heat-shrink tubing is then heated and molded to melt and penetrate the polymer tube into the void structure 123 of the inner layer 121. After the polymer material cools and solidifies, the heat-shrink tubing is removed. The outer layer 122 is made of thermoplastic elastomers such as block polyetheramide resin (Pebax) or thermoplastic polyurethane elastomer (TPU), silicone, nylon, acrylic polymers, or any combination of one or more of these polymer materials. The polymer material fills the void structure 123, thereby increasing the contact area between the outer layer 122 and the inner layer 121 and strengthening the connection between them. Furthermore, even before curing, the polymer material can penetrate from between adjacent coils to the surface of the mandrel 110, and simultaneously extend from both ends of the inner layer 121 to the surface of the mandrel 110. This allows for tight bonding between the outer layer 122, the inner layer 121, and the mandrel 110, further reducing the possibility of wrinkles, loosening, or displacement of the outer layer 122. In other embodiments, the outer layer can be formed first, and the inner layer 121 and the outer layer 122 can be connected by adhesive bonding or other methods.

[0065] Or, such as Figure 5 As shown, multiple coils can also be distributed at intervals on the spindle 110, and the gap between two adjacent coils constitutes the gap structure 123. In this case, the outer layer 122, the inner layer 121 and the spindle 110 are all bonded to each other.

[0066] The inner layer 121 is tightly wound around the mandrel 110 to generate a large radial pressure on the mandrel 110. When the operator pushes the delivery guide wire 100, the friction between the mandrel 110 and the inner layer 121 increases, which helps to keep the inner layer 121 and the mandrel 110 relatively stationary. The outer layer 122 covers the outer surface of the inner layer 121 to be connected to the mandrel 110 through the inner layer 121, and the outer layer 122 has a large contact area with the inner layer 121. Furthermore, the inner layer 121 can be fixedly connected to the mandrel 110 by welding (specifically, soldering or laser welding). The bonding strength between the inner layer 121 and the mandrel 110 is much greater than the bonding strength when the membrane structure is directly connected to the mandrel 110. The outer layer 122 can wrap the inner layer 121 by dip coating or hot pressing. On the one hand, there are contact surfaces between the outer layer 122, the mandrel 110, and the inner layer 121, which improves the bonding strength among the three and prevents the outer layer 122 from loosening, shifting, or deforming. On the other hand, due to the high bonding strength between the inner layer 121 and the mandrel 110, the loosening or shifting of the entire driving component 120 relative to the mandrel 110 can be avoided, thereby effectively preventing the support from detaching. In other embodiments, the inner layer 121 can also be fixedly connected to the mandrel 110 by bonding (adhesive bonding) or other connection methods.

[0067] Please refer to Figure 6 and Figure 7 As shown, in another embodiment of the present invention, the inner layer 121 is a spiral structure formed by threads spirally wound around the axis of the mandrel 110. Similar to the previous embodiment, for this spiral structure of the inner layer 121, adjacent turns of the threads can be in contact with each other or can be separated from each other.

[0068] Optionally, the inner layer 121 in this embodiment can be made of polymer filaments or metal wires. For the inner layer 121 made of metal, the spiral structure is soft and flexible, giving the conveying guide wire 100 good overall flexibility.

[0069] Generally, the longer the support to be transported (i.e., the larger the axial dimension of the support), the longer the driving member 120 on the mandrel 110 should be, so as to generate a sufficiently large frictional force between the support and the transport guide wire 100. In this embodiment, the total length of the driving member 120 can be increased by providing multiple driving members 120 on the mandrel 110, and the multiple driving members 120 can be distributed at intervals along the axial direction of the mandrel 110.

[0070] Please refer to Figure 8 and Figure 9In another embodiment of the present invention, the inner layer 121 is a tubular structure woven from silk threads, and the mesh in the tubular structure constitutes the void structure 123.

[0071] In this embodiment, the mandrel 110 may have only one driving member 120 or multiple driving members 120. For each driving member 120, the yarn used to braid the inner layer 121 should be as thin as possible, for example, the diameter (or cross-sectional width) of the yarn should be less than or equal to 0.001 inches. Furthermore, the number of braiding intersections per inch of the inner layer 121 should not be excessive; preferably, the number of braiding intersections per 1-inch length of the inner layer 121 can be between 15 and 50. In this way, the driving member 120 enhances the connection strength with the mandrel 110 without affecting the flexibility of the guide wire 100.

[0072] Figure 10 A schematic diagram of another embodiment of the present invention is shown. Please refer to... Figure 10 One or more inner layer components 121 are welded onto the mandrel 110, and the inner layer component 121 is a metal tube. In this embodiment, the metal tube is a tubular structure with a flat surface. The length of the metal tube can be 0.3-2mm to avoid affecting the flexibility of the guide wire 100. When there are at least two metal tubes, the outer layer component 122 can be configured to completely cover all the metal tubes and can extend to the mandrel 110. It can also simultaneously cover the exposed portion of the mandrel 110 between multiple metal tubes (this portion constitutes the gap structure 123), or the outer layer component 122 can be disposed on a single metal tube. Figure 10 As shown), a single outer layer 122 encloses a single inner layer 121, and different outer layers 122 enclose different inner layers 121. The outer layer 122 can also partially cover the mandrel 110 between multiple metal tubes (this part constitutes the void structure 123). The encapsulation of the inner layer 121 by the outer layer 122 can be achieved by dip coating or hot pressing.

[0073] In other embodiments, the metal tube may also have pits, grooves or through holes formed by laser etching or other methods to create more void structures 123, thereby further increasing the contact area between the outer layer 122 and the inner layer 121 and improving the connection strength.

[0074] Furthermore, the inner layer 121 described in the above embodiments can be made of a non-radioactive metal or a radioactive metal. The non-radioactive metal includes, but is not limited to, stainless steel, and the radioactive metal includes, but is not limited to, platinum-tungsten alloy or platinum-iridium alloy. Preferably, the inner layer 121 is made of a radioactive metal (or radiopaque metal) to make the driving member 120 radioactive. Specifically, the material of the inner layer can be selected from one or more of platinum, gold, tungsten, platinum-gold alloy, platinum-tungsten alloy, platinum-iridium alloy, and platinum-nickel alloy. For example, it can be made solely of platinum-tungsten alloy, or solely of platinum-iridium alloy, or simultaneously of platinum-tungsten alloy and platinum-iridium alloy (for example, using platinum-tungsten alloy wire and platinum-iridium alloy wire woven together to form the inner layer of the tubular structure). The advantage of this arrangement is that during the transport process, the operator can promptly and accurately determine whether the support can still be retrieved. Specifically, in actual use, the support is sleeved on the transport guide wire and compressed in a transport tube. The transport tube has a first proximal end and a first distal end, and a radioactive ring (not shown in the figure) is provided on the first distal end. During the transport process, when the driving component 120 begins to overlap with the developing ring, if the support is pushed further to the far end, the support can no longer be retrieved. Therefore, if the driving component 120 itself has developing properties, the operator can accurately position and judge through the developing device, which greatly facilitates the operator's operation.

[0075] For further information, please continue to refer to [the relevant resources / references]. Figure 2 Similar to the guidewires in existing technologies, the guidewire 100 described in this embodiment may further include a first imaging element 130 and a second imaging element 140. The mandrel 110 has a second proximal end and a second distal end. The first imaging element 130 may be an imaging spring, and is disposed at the end of the second distal end. The second imaging element 140 is disposed on the mandrel 110, and the driving member 120 is disposed between the first imaging element 130 and the second imaging element 140. Thus, in the treatment device, the stent is located between the first imaging element 130 and the second imaging element 140. During stent delivery, the operator can determine the position of the stent using the first imaging element 130 and the second imaging element 140.

[0076] The mandrel 110 may include at least one variable-diameter section (not shown in the figure) and at least one constant-diameter section (not shown in the figure). Along the direction from the second proximal end to the second distal end, the constant-diameter section and the variable-diameter end are alternately arranged and interconnected. Each variable-diameter section has opposing third proximal and third distal ends. From the third proximal end to the third distal end, the diameter of the variable-diameter section gradually decreases. For the same variable-diameter section, the diameter of the constant-diameter section connected to the third proximal end is larger than the diameter of the constant-diameter section connected to the third distal end. The variable-diameter section arrangement makes the entire delivery guide wire 100 approximately tapered, improving the flexibility, force transmission, and tracking performance of the delivery guide wire, which is beneficial for the delivery and release of the support.

[0077] The maximum outer diameter of the second developing element 140 can be approximately equal to or slightly smaller than the inner diameter of the delivery tube. The second developing element 140 has opposing fourth proximal and fourth distal ends. Typically, the outer diameter of the mandrel 110 adjacent to the fourth proximal end of the second developing element 140 is smaller than the inner diameter of the delivery tube, creating a cavity between the mandrel 110 and the delivery tube. If the cavity is large, the second distal end of the mandrel 110 may become unstable during the pushing of the delivery guide wire 100, increasing the pushing resistance of the delivery guide wire 100. To address this, the mandrel 110 is adjusted so that the section of the mandrel 110 adjacent to the fourth proximal end of the second developing element 140 is a variable diameter section, and a variable diameter spring 150 is fitted onto this variable diameter section, while simultaneously connecting the variable diameter spring 150 to the second developing element 140. A variable-diameter spring 150 fills the cavity between the mandrel 110 and the delivery tube, ensuring the stability of the second distal end of the mandrel 110 during pushing, without negatively affecting the flexibility of the mandrel 110. Optionally, the second developing element 140 may include a body with a mounting through hole (not shown in the figure) along the axial direction of the body. The diameter of the mounting through hole gradually decreases along the direction from the fourth proximal end to the fourth distal end, and there is a gap between the hole wall of the mounting through hole near the first proximal end and the mandrel 110. Thus, the distal end of the variable-diameter spring 150 can be inserted into the interior of the second developing element 140, so that the variable-diameter spring 150 is coaxial with the mandrel 110. In addition, in the embodiments of the present invention, the spacing between two adjacent spring coils in the variable diameter spring 150 gradually increases along the direction from the second proximal end to the second distal end (that is, the spring coils of the variable diameter spring 150 become increasingly sparse from the second proximal end to the second distal end), thereby ensuring that the second distal end of the spindle 110 has sufficient flexibility without affecting the transmission of the pushing force.

[0078] A second objective of this invention is to provide a treatment device comprising a delivery tube, a medical implant, and a delivery guidewire as described in any of the preceding embodiments. The medical implant is sleeved on the actuating member. The delivery tube has an axially penetrating inner cavity for accommodating the delivery guidewire, and the wall of the inner cavity compresses the medical implant to compress it and accommodate it within the inner cavity. In embodiments of this invention, the medical implant may be a self-expanding stent, specifically a braided stent or a cut stent; the medical implant may also be a coil, a vascular occlusion device, etc.

[0079] Furthermore, a void structure 123 may be formed on the inner layer 121, and the outer layer 122 is at least partially embedded in the void structure 123. With a fixed contact area between the outer layer 122 and the medical implant, the contact area between the outer layer 122 and the mandrel 110 and the inner layer 121 is increased to improve friction. In other words, by making the outer layer 122 at least partially embedded in the void structure 123, the outer diameter of the outer layer 122 can be reduced, thus making it suitable for delivery tubes with different inner diameters. In this embodiment, the size of the inner cavity can be selected in various ways. For example, the radial dimension of the inner cavity can be between 0.017 inches and 0.029 inches, or the radial dimension of the inner cavity can be smaller, for example, less than or equal to 0.027 inches, or even less than or equal to 0.021 inches.

[0080] In this embodiment of the invention, the driving component 120 is configured as an inner layer 121 and an outer layer 122. The inner layer 121 is a metal structure and is fixedly sleeved on the mandrel 110. The outer layer 122 is made of polymer material and is fixedly sleeved on the inner layer 121. The inner layer 121 indirectly enhances the bonding force between the outer layer 122 and the mandrel 110, making the driving component 120 less prone to loosening, wrinkling, or displacement during the delivery of the stent, thereby improving the safety and reliability of the delivery guidewire 100 in the process of delivering medical implants.

[0081] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. A guide wire for delivery, characterized in that, It includes a mandrel and a driving component disposed on the mandrel, the driving component comprising an inner layer and an outer layer. The inner layer is made of metal and is fixedly sleeved on the mandrel; The outer layer is made of polymer material and is fixedly sleeved on the inner layer; the outer layer is used to generate friction with the medical implant in a compressed state sleeved on the driving component, so that the medical implant moves synchronously with the delivery guidewire. The inner layer has a void structure, and the outer layer partially or completely fills the void structure; the outer layer at least partially passes through the void structure and is connected to the mandrel. The inner layer is a spiral structure formed by spiraling threads around the axis of the mandrel, with the gap structure formed between adjacent turns of the threads. Alternatively, the inner layer is a tubular structure woven from threads, with the mesh of the tubular structure forming the gap structure.

2. The guide wire according to claim 1, characterized in that, The diameter of the thread is less than or equal to 0.001 inches.

3. The guide wire according to claim 1, characterized in that, The number of braided intersections contained on the inner layer per inch of length is 15-50.

4. The guide wire according to claim 1, characterized in that, The inner layer is at least one tubular structure, and the outer layer partially or completely covers the inner layer.

5. The guide wire according to claim 4, characterized in that, The tubular structure has a void structure, and the outer layer part may partially or completely fill the void structure. Alternatively, the inner layer may be at least two tubular structures, with a gap structure formed between adjacent tubular structures, and the outer layer may partially or completely fill the gap structure.

6. The guide wire according to claim 1, characterized in that, The inner layer is made of a radiopaque metallic material.

7. The guide wire according to claim 5, characterized in that, The metallic material is selected from one or more of platinum, gold, tungsten, platinum-gold alloys, platinum-tungsten alloys, platinum-iridium alloys, and platinum-nickel alloys.

8. The guide wire according to claim 1, characterized in that, The inner layer is welded to the mandrel, or the inner layer is glued to the mandrel.

9. The guide wire according to claim 1, characterized in that, The outer layer is made of one or more of block polyetheramide resin, thermoplastic polyurethane elastomer, silicone, nylon, and acrylic polymer.

10. The guide wire according to claim 1, characterized in that, The outer layer covers the inner layer and extends to connect with the mandrel.

11. The guide wire according to claim 1, characterized in that, The outer layer is formed on the inner layer by hot pressing and / or dip coating, or the inner layer and the outer layer are bonded together.

12. The guide wire according to claim 1, characterized in that, The inner layer component is integrally formed with the mandrel.

13. The guide wire according to claim 1, characterized in that, The spindle is provided with at least two driving members, and the at least two driving members are arranged at intervals along the axial direction of the spindle.

14. A treatment device, characterized in that, The device includes a delivery tube, a medical implant, and a delivery guidewire as described in any one of claims 1-12, wherein the delivery tube has an axially penetrating inner cavity for accommodating the medical implant, and the wall of the inner cavity compresses the medical implant to compress the medical implant; the compressed medical implant is fitted onto the drive member.

15. The treatment device as claimed in claim 13, characterized in that, The radial dimension of the cavity ranges from 0.017 inches to 0.029 inches.

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