A delivery guidewire and therapeutic device

Abstract

This invention relates to a delivery guidewire and a treatment device. The treatment device includes a delivery guidewire, a medical implant, and a delivery tube. The delivery guidewire includes a mandrel and a driving member disposed on the mandrel. A recess is formed on the driving member. The medical implant is compressed by the delivery tube and sleeved on the delivery guidewire. The medical implant is at least partially embedded in the recess, thereby increasing the contact area between the medical implant and the delivery guidewire. This facilitates the synchronous movement of the medical implant with the delivery guidewire and reduces the difficulty of delivery.

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 intracranial aneurysm from 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) Intravascular 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 in the brain, the surgical clipping method 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 giant aneurysms and other complex aneurysms, the recurrence rate is high when the intra-aneurysmal embolization method is used alone. Currently, the most commonly used treatment for intracranial aneurysms is endovascular stenting.

[0004] In the prior art, treatment devices for intracranial aneurysms using endovascular stenting include... Figure 1As shown, the treatment device includes a delivery guidewire 10 and a delivery tube 20. The delivery tube 20 has an axially penetrating inner cavity, in which the stent 30 to be delivered is accommodated and sleeved on the delivery guidewire 10. The delivery guidewire 10, the stent 30, and the delivery tube 20 are in an interference fit. Thus, when the operator pushes the delivery guidewire 10 through the delivery tube 30, a first frictional force is generated between the delivery guidewire 10 and the stent 20. Under the action of this first frictional force, the stent 30 can move synchronously with the delivery guidewire 10 and eventually reach a predetermined position. During this process, a second frictional force, opposite to the first frictional force, is generated between the stent 30 and the inner wall of the delivery tube 20, thus hindering the movement of the stent 30 with the delivery guidewire 10. Since the stent plays a role in guiding blood flow when using endovascular stenting to treat intracranial aneurysms, the stent has a high metal coverage. However, intracranial blood vessels are thin and tortuous, requiring a small and flexible delivery device to deliver the stent. This means that, compared to the large conveying device, the fit between the support and the conveying device is tighter, resulting in excessive secondary friction during the conveying process, which makes it difficult to push the support.

[0005] To facilitate smooth delivery within the delivery tube 30, existing delivery guidewires 10 typically have a smooth outer surface. To enhance the initial frictional force between the delivery guidewire 10 and the stent 30, some delivery guidewires 10 are equipped with a drive member having a relatively high coefficient of friction. However, the inclusion of this drive member increases the outer diameter of the stent mounted on the delivery guidewire 10, thereby increasing the second frictional force between the stent and the inner wall of the delivery tube 30. Simultaneously, the overall outer diameter of the treatment device may also increase, making it difficult to use for treating distal vascular lesions. Furthermore, excessive number or excessive length of drive members can reduce the flexibility of the distal end of the delivery guidewire 10. Summary of the Invention

[0006] The purpose of this invention is to provide a guidewire delivery and treatment device that can reduce the difficulty of stent delivery.

[0007] To achieve the above objectives, the present invention provides a delivery guidewire for delivering medical implants, comprising a mandrel and a drive member disposed on the mandrel, wherein a recess is formed on the drive member.

[0008] Optionally, the driving member includes a body and a groove formed on the outer surface of the body, the groove constituting the recess.

[0009] Optionally, the structure of the groove matches at least a portion of the structure of the compressed medical implant.

[0010] Optionally, the groove is a mirror image of the inner surface of the compressed medical implant.

[0011] Optionally, the width of the groove is 0.0008 inches to 0.004 inches, and / or the depth of the groove is 0.0002 inches to 0.004 inches.

[0012] Optionally, the groove includes one or more sub-grooves, and the plurality of sub-grooves are arranged alternately, continuously, or at intervals on the outer surface of the body.

[0013] Optionally, the groove is spirally wound around the axis of the body to form one or more spiral grooves on the outer surface of the body.

[0014] Optionally, the driving member is formed by spiraling the winding wire around the axis of the mandrel to form one or more spiral structures, and the winding wires of adjacent turns are arranged at intervals to form the recess.

[0015] Optionally, the winding wire is a polymer wire or a metal wire with a polymer coating on its surface.

[0016] Optionally, the metal wire is reproducible, and / or the metal wire is a platinum-tungsten alloy wire or a platinum-iridium alloy wire.

[0017] Optionally, the driving component includes an inner layer and an outer layer, wherein the inner layer is made of a metal material and is fixedly sleeved on the mandrel; the outer layer is made of a polymer material and is fixedly sleeved on the inner layer.

[0018] Optionally, the inner layer has a void structure, the outer layer partially or completely fills the void structure, and at least a portion of the outer layer passes through the void structure to connect with the mandrel.

[0019] Optionally, the outer surface of the inner layer is provided with a recess, which constitutes the void structure.

[0020] 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.

[0021] Optionally, the inner layer is a tubular structure woven from threads, and the mesh of the tubular structure forms the void structure.

[0022] Optionally, the diameter of the yarn is less than or equal to 0.001 inches, and / or the number of braided intersections included per inch of the inner layer is 15-50.

[0023] Optionally, the inner layer is at least one tubular structure, and the outer layer partially or completely covers the inner layer.

[0024] 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.

[0025] Optionally, the diameter of the filament is less than or equal to 0.001 inches, and / or the pitch of the helical structure formed by the filament is 0.001-0.007 inches.

[0026] Optionally, the inner layer is made of a reproducible metallic material, wherein 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.

[0027] Optionally, the inner layer is welded or glued to the mandrel, and / or the outer layer covers the inner layer and extends to connect with the mandrel.

[0028] Optionally, the material of the outer layer includes one or more of block polyetheramide resin, thermoplastic polyurethane elastomer, silicone, nylon, and acrylic polymer.

[0029] 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.

[0030] 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.

[0031] Optionally, the distance between two adjacent driving components is 0.5mm-150mm.

[0032] Optionally, the distance between two adjacent driving components is 0.5mm-5mm.

[0033] Optionally, the mandrel is provided with one or more of the driving members, the outer diameter of the driving members being 0.01 inches to 0.03 inches, and the length of each driving member being 0.5 mm to 8 mm.

[0034] Optionally, the length of each of the driving components is 0.5mm-4mm.

[0035] Optionally, the guide wire further includes a first developing element and a second developing element, the first developing element being disposed at the distal end of the mandrel, the second developing element being disposed on the mandrel, and the driving member being disposed between the first developing element and the second developing element.

[0036] To achieve the above objectives, the present invention also provides a treatment device, including a delivery tube, a medical implant, and the aforementioned delivery guidewire; 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 it; the compressed medical implant is sleeved on the driving member, and the medical implant is at least partially embedded in the recess.

[0037] Optionally, the radial dimension of the cavity ranges from 0.017 inches to 0.029 inches.

[0038] Optionally, the medical implant is a self-expanding stent.

[0039] Compared with the prior art, the guidewire delivery and treatment device of the present invention has the following advantages:

[0040] The aforementioned treatment device includes a delivery guidewire, a medical implant, and a delivery tube. The delivery guidewire includes a mandrel and a drive member disposed on the mandrel, the drive member having a recessed portion. The medical implant is delivered using the delivery guidewire, the implant being housed within the delivery tube, and the wall of the delivery tube is used to compress the implant. The compressed implant is fitted onto the drive member, and at least partially embedded in the recessed portion. This increases the contact area between the stent and the drive member, improves the friction between the implant and the delivery guidewire, and makes the portion of the implant in contact with the delivery tube more flat, reducing the friction between the implant and the tube and simplifying the delivery of the implant. Meanwhile, the reduced outer diameter of the medical implant compressed in the delivery tube can also reduce the outer diameter of the delivery tube accordingly, enabling the treatment device to reach a more distant target treatment location, expanding the treatment range, and improving the overall flexibility of the treatment device, allowing it to pass smoothly through more tortuous blood vessels and increasing the success rate of the surgery.

[0041] In some embodiments, 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 are made of metal, the bonding strength is very high, and no displacement will occur between them. The outer layer, made of polymer, is fixedly connected to the inner layer through a specific structure. For example, by providing a void structure on the inner layer and partially or completely filling the void structure with the outer layer, the inner and outer layers can be interlocked and fitted. Alternatively, the outer layer can cover the inner layer and further extend to connect with the mandrel, achieving a tight fit between the outer layer, inner layer, and mandrel. The outer layer is disposed 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

[0042] Figure 1 This is a schematic diagram of the structure of a treatment device in the prior art;

[0043] Figure 2 This is a schematic diagram of the structure of the guide wire provided according to an embodiment of the present invention, where the recessed portion is not shown;

[0044] Figure 3 This is a schematic diagram of the structure of the guide wire provided according to an embodiment of the present invention, showing the recessed portion;

[0045] Figure 4 This is a schematic diagram of the structure of the bracket provided according to an embodiment of the present invention;

[0046] Figure 5 yes Figure 3 A schematic diagram of a modified structure of the guide wire shown;

[0047] Figure 6 yes Figure 3 A schematic diagram of another modified structure of the guide wire shown;

[0048] Figure 7 yes Figure 6 An enlarged schematic diagram of point A on the guide wire shown;

[0049] Figure 8 yes Figure 3 A schematic diagram of another modified structure of the guide wire shown;

[0050] Figure 9 yes Figure 8 An enlarged schematic diagram of point B on the guide wire shown;

[0051] Figure 10 yes Figure 3 A schematic diagram of another modified structure of the guide wire shown;

[0052] Figure 11 This is a schematic diagram of the structure of the guide wire provided according to another embodiment of the present invention;

[0053] Figure 12 This is a schematic diagram of the structure of the guide wire provided according to another embodiment of the present invention;

[0054] Figure 13 This is a schematic diagram of the structure of the guide wire provided according to another embodiment of the present invention.

[0055] In the picture:

[0056] 10, 100 - Conveyor guide wire;

[0057] 110-Mandrel;

[0058] 120-Driven component, 121-Body, 122-Groove, 123-Gap, 124-Inner layer component, 125-Outer layer component, 126-Void structure;

[0059] 130 - First developed piece;

[0060] 140 - Second developing piece;

[0061] 20 - Delivery pipe;

[0062] 30, 300 - bracket;

[0063] 310 - Braided yarn;

[0064] 311 - Weaving point. Detailed Implementation

[0065] 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.

[0066] 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.

[0067] 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.

[0068] This embodiment provides a delivery guidewire for delivering a medical implant to a predetermined location within a patient's body. The medical implant is, for example, 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 explanation, 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.

[0069] Please see Figure 2 and Figure 3 The guide wire 100 includes a spindle 110 and a driving member 120 disposed on the spindle 110, and the driving member 120 has a recessed portion formed thereon.

[0070] During the conveying of the support, the support is compressed within the inner cavity of a conveying pipe (at this time, the support is in a compressed state) and tightly fitted onto the driving member 120, so that the support exerts radial pressure on the driving member 120, and at least a portion of the support is embedded in the recessed portion. This significantly increases the contact area between the support and the driving member 120. When the operator pushes the conveying guide wire 100 axially within the conveying pipe, the first frictional force generated between the support and the driving member 120 also increases significantly, thus facilitating the synchronous movement of the support with the conveying guide wire 100. For braided supports, the braiding filaments used to braid the support are of varying thickness; similarly, for cut supports, the wave rods on the cut support are also of varying thickness. In this case, under the pressure of the conveying pipe, the thicker braiding filaments or wave rods can be more embedded in the recessed portion, making the surface of the support in contact with the conveying pipe (i.e., the outer surface of the support) tend to be flat, thereby reducing the second frictional force generated between the support and the inner wall of the conveying pipe, and reducing the pushing resistance during support conveying.

[0071] Similar to a conventional transport guide wire, the transport guide wire 100 described in this embodiment further includes a first developing element 130 and a second developing element 140. The mandrel 110 has a first distal end and a first proximal end opposite to each other. The first developing element 130 may be a developing spring and is disposed at the end of the first distal end. The second developing element 140 is disposed on the mandrel 110. The driving member 120 is disposed between the first developing element 130 and the second developing element 140, thereby the support is disposed between the first developing element 130 and the second developing element 140.

[0072] In some embodiments, the driving component 120 may be made of polymer materials such as silicone, thermoplastic polyurethane elastomer rubber (TPU), polyimide, thermoplastic elastomer (Pebax), and polytetrafluoroethylene (PTFE). In other embodiments, the driving component 120 may also be made of metal materials such as stainless steel, nickel-titanium alloy, and platinum-tungsten alloy.

[0073] The mandrel 110 is provided with a plurality of driving members 120, such as one, two, three, four, five, six, etc. The specific number of driving members 120 is determined according to the length of the bracket to be conveyed (i.e., the axial dimension of the bracket). Generally, if the length of each driving member 120 is fixed, the larger the length of the bracket, the greater the pushing resistance generated during conveying. In this case, more driving members 120 are needed to increase the initial friction between the conveying guide wire 100 and the bracket, thereby ensuring that the bracket moves synchronously with the conveying guide wire 100. In this embodiment, the outer diameter of each driving member 120 can be between 0.01 inches and 0.03 inches, and the length of each driving member 120 is between 0.5 mm and 8 mm, preferably between 0.5 mm and 4 mm. When the mandrel 110 is provided with two or more driving members 120, the two or more driving members 120 are spaced apart along the axial direction of the mandrel 110. Optionally, the distance between two adjacent driving components 120 is between 0.5mm and 150mm, preferably between 0.5mm and 5mm.

[0074] On the one hand, compared to simply increasing the friction coefficient of the driving member 120 itself to increase the first frictional force, it is easier to obtain a larger first frictional force by designing the number of driving members 120 provided on the mandrel 110 and the size of each driving member 120. On the other hand, compared to providing a continuous long driving member on the mandrel 110, providing at least two spaced and shorter driving members 120 on the mandrel 110 can reduce the total length of the driving members 120 and improve the recyclability of the stent (i.e., the smaller the total length of the driving members 120, the higher the recyclability of the stent). Furthermore, providing multiple spaced short driving members 120 can improve the flexibility of the guidewire 100, which is beneficial for the guidewire 100 to pass through tortuous blood vessels. At the same time, using multiple shorter driving members 120 allows the driving members 120 to be made of materials with relatively high hardness (relatively low friction coefficient), thereby making it easier to control tolerances and reducing manufacturing difficulty. It is understood that the recyclability of the stent described herein is common knowledge in the art, and for those skilled in the art, the following formula applies: stent recyclability = (total stent length - distance from the proximal end of the stent to the distal end of the drive component) / total stent length * 100%.

[0075] The structure of the driving component 120 will now be described in conjunction with the accompanying drawings. It should be understood that the specific structure of the driving component 120 described in the following embodiments is merely an optional implementation of the present invention and should not be construed as limiting the invention.

[0076] Please refer to Figures 2-4In one embodiment, the driving component 120 includes a body 121, which is a hollow tubular body and is sleeved on the mandrel 110. A groove 122 is formed on the outer surface of the body 121, which constitutes the recessed portion. It is understood that the "groove" in this embodiment includes a long and narrow recessed structure, as well as a circular, square, or irregularly shaped recessed structure (i.e., a pit). The groove 122 has different forms depending on actual needs.

[0077] For example, please continue to refer to Figure 3 The structure of the groove 122 matches at least a portion of the structure of the compressed support. Specifically, the shape and position of the groove 122 match the shape and position of the support, and the dimensions of the groove 122 also match the dimensions of the support's wave rod or braided wire. For example, the width of the groove 122 is greater than, equal to, or slightly smaller than the width of the braided wire or wave rod, and the depth of the groove 122 (the distance between the bottom of the groove 122 and the outer surface of the body 121 at the top of the groove 122) is greater than, equal to, or smaller than the radial dimension of the braided wire or wave rod, etc. Depending on the dimensions of the support, the width of the groove 122 is between 0.0008 inches and 0.004 inches, and the depth of the groove 122 is between 0.0002 inches and 0.004 inches. It is understood that the width of the groove 122 corresponds to the width of the braided wire or wave bar of the bracket. For example, when the braided wire of the bracket extends along the circumference of the bracket, the width of the braided wire refers to the size of the braided wire along the axial direction of the bracket, and the width of the groove 122 refers to the size of the groove 122 along the axial direction of the bracket.

[0078] The groove 122 may be a continuous structure formed on the outer surface of the body 121, or it may include multiple sub-grooves. On the outer surface of the body 121, the multiple sub-grooves may be arranged alternately, continuously, or at intervals.

[0079] by Figure 4 Taking the bracket 300 shown as an example, the bracket 300 is woven from multiple braided filaments 310. Corresponding to this bracket 300, the groove 122 may include multiple sub-grooves, which are arranged alternately so that the groove 122 is a mirror image of the inner surface of the compressed bracket (e.g., ...). Figure 3 As shown in the figure, the size and arrangement of the groove 122 match the size and arrangement of the braided filaments 310 of the compressed bracket. When the bracket 300 is fitted onto the conveying guide wire 100, each braided filament 310 can be at least partially embedded in the recess.

[0080] In this embodiment, the groove 122 can be formed in various ways. The body 121 is made of a polymer material, and while the body 121 is formed but not yet cured, threads are spirally or interlaced around the body 121 along its axis, with the threads in close contact with the surface of the body 121 to apply a radial force. Under the compression of the threads, the outer surface of the body 121 in contact with the threads deforms inward toward the axis of the body 121 to form the groove 122, after which the threads can be removed. The threads mentioned here can be metal wires, polymer wires, or other materials. In this embodiment, the diameter of the threads is the same as the diameter of the braided wire of the bracket 300 that needs to be sleeved on the conveying guide wire 100. In other embodiments, the diameter of the threads can be slightly larger or slightly smaller than the diameter of the braided wire of the bracket 300. The groove 122 can also be further processed and shaped after the body 121 has been solidified and shaped. For example, the body 121 can be softened by heating it first, and then the groove 122 can be formed by using wire; or, after the body 121 has been solidified and shaped, the groove 122 can be engraved on the outer surface of the body 121 using an engraving process.

[0081] When the material of the body 121 is metal, the groove 122 can also be formed on the outer surface of the body 121 by engraving process (e.g., laser engraving).

[0082] For brackets formed by cutting, grooves 122 that match the bracket can be formed on the surface of the body 121 by engraving.

[0083] Please refer to Figures 5 to 10 In some embodiments, the driving component 120 includes an inner layer 124 and an outer layer 125. The inner layer 124 is made of metal and is fixedly sleeved on the spindle 110. The outer layer 125 is made of polymer material and is fixedly sleeved on the inner layer 124.

[0084] The inner layer 124 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 124 will not shift on the mandrel 110. The outer layer 125 is connected to the mandrel 110 through the inner layer 124, indirectly increasing the connection area between the outer layer 125 and the mandrel 110, thereby enhancing the adhesion of the outer layer 125 to the mandrel 110 and reducing the possibility of the outer layer 125 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 124 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 124 and the mandrel 110 are integrally formed, but the inner layer 124 protrudes beyond the outer surface of the mandrel 110.

[0085] Furthermore, a void structure 126 may be formed on the inner layer 124, and the outer layer 125 may partially or completely fill the void structure 126 to increase the connection area between the outer layer 125 and the inner layer 124.

[0086] In this embodiment of the invention, the inner layer 124 can have various structural forms. The preferred structures of the inner layer 124 will be described below with reference to the accompanying drawings. It should be understood that the inner layer 124 in the following embodiments is merely an optional implementation of the invention and should not be construed as limiting the invention.

[0087] like Figure 5As shown, in one embodiment, the inner layer 124 includes a plurality of coils clamped onto the mandrel 110, the 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 126. 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. The outer layer 125 is formed on the outer surface of the coil by hot pressing and / or dip coating, and then molded and cooled. The hot-pressing method is as follows: First, a polymer tube is fitted onto the inner layer 124, and then a heat-shrink tubing is fitted over the polymer tube. Next, the heat-shrink tubing is heated and shaped using a mold, causing the polymer tube to melt and penetrate into the void structure 126 of the inner layer 124. After the polymer material cools and solidifies, the heat-shrink tubing is removed. The outer layer 125 is made of thermoplastic elastomers, such as block polyether amide resin (Pebax) or thermoplastic polyurethane elastomer (TPU), silicone, nylon, acrylic polymers, and other polymer materials, or any combination of one or more of these polymers. The polymer material fills the void structure 126, thereby increasing the contact area between the outer layer 125 and the inner layer 124 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 124 to the surface of the mandrel 110. This allows for tight bonding between the outer layer 125, the inner layer 124, and the mandrel 110, further reducing the possibility of wrinkles, loosening, or displacement of the outer layer 125. In other embodiments, the outer layer can be formed first, and the inner layer 124 can be connected to the outer layer 125 by adhesive bonding or other methods.

[0088] In some embodiments, multiple coils may be distributed at intervals on the mandrel, with the gap between two adjacent coils forming the void structure. In this case, the outer layer, the inner layer, and the mandrel are all bonded to each other.

[0089] Please refer to Figure 6 and Figure 7 As shown, in another embodiment of the present invention, the inner layer 124 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 124, adjacent turns of the threads can be in contact with each other or can be separated from each other. In this embodiment, the mandrel 110 may have only one driving member 120 or multiple driving members 120.

[0090] Optionally, the inner layer 124 in this embodiment can be made of polymer filaments or metal wires. For the inner layer 124 made of metal, the spiral structure is soft and flexible, giving the conveying guide wire 100 good overall flexibility.

[0091] Optionally, in this embodiment, the diameter of the filaments in the inner layer 124 is less than or equal to 0.001 inches. The pitch of the helical structure formed by the filaments of the inner layer 124 is 0.001-0.007 inches; in some embodiments, the pitch is 0.004-0.007 inches. A larger pitch facilitates the penetration of adhesives and other substances between the inner layer 124 and the mandrel 110, thereby improving the bonding strength between the inner layer 124 / outer layer 125 and the mandrel 110, without reducing the bonding strength between the inner layer 124 and the mandrel 110, and without affecting the flexibility of the guide wire.

[0092] Please refer to Figure 8 and Figure 9 In another embodiment of the present invention, the inner layer 124 is a tubular structure woven from silk threads, and the mesh in the tubular structure constitutes the void structure 126.

[0093] 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 124 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 124 should not be excessive; preferably, the number of braiding intersections per 1-inch length of the inner layer 124 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.

[0094] Figure 10 A schematic diagram of yet another embodiment of the present invention is shown. Please refer to... Figure 10 One or more inner layer components 124 are welded onto the mandrel 110, and the inner layer component 124 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 125 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 126), or the outer layer component 125 can be disposed on a single metal tube. Figure 9As shown), a single outer layer 125 encloses a single inner layer 124, and different outer layer 125s enclose different inner layer 124s. The outer layer 125 can also partially cover the mandrel 110 between multiple metal tubes (this part constitutes the void structure 126). The enclosure of the inner layer 124 by the outer layer 125 can be achieved by dip coating or hot pressing.

[0095] 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 126, thereby further increasing the contact area between the outer layer 125 and the inner layer 124 and improving the connection strength.

[0096] Furthermore, the inner layer 124 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 124 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 tubular structure of the inner layer). 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.

[0097] exist Figures 5-10In one embodiment, the driving member 120 is configured as an inner layer 124 and an outer layer 125. The inner layer 124 is a metal structure and is fixedly sleeved on the mandrel 110. The outer layer 125 is made of polymer material and is fixedly sleeved on the inner layer 124. The inner layer 124 indirectly enhances the bonding force between the outer layer 125 and the mandrel 110, making the driving member 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. On the other hand, by means of the groove 122 on the outer surface of the outer layer 125 of the driving member 120, at least a portion of the compressed medical implant is embedded in the groove 122, thereby increasing the contact area between the support and the driving member 120, increasing the friction between the medical implant and the delivery guide wire 100, and making the part of the medical implant in contact with the delivery tube tend to be flat, thereby reducing the friction between the medical implant and the delivery tube and reducing the difficulty of delivering the medical implant.

[0098] In some implementations, please refer to Figure 11 The groove 122 may be a continuous groove formed on the body 121, the continuous groove spirally surrounding the axis of the body 121 to form a spiral groove on the outer surface of the body 121. In this embodiment, the groove 122 is preferably formed using a thread.

[0099] For example, please refer to Figure 12 The groove 122 may include at least two sub-grooves spaced apart on the body 121. The sub-grooves may be of various shapes such as circular, square, or prismatic (i.e., the sub-grooves are recesses), and when the number of sub-grooves is greater than two, multiple sub-grooves are distributed on the outer surface of the body 121 as needed. In this embodiment, the groove 122 may be formed by processes such as engraving.

[0100] Still with Figure 4Taking the bracket 300 as an example, the braiding point 311 where the braided yarns 310 intersect has a larger radial thickness compared to other parts of the bracket 300. When the bracket 300 is fitted onto the conveying guide wire 100, the braiding point 311 can be partially embedded in the sub-groove. Alternatively, in other brackets, there is a point with a large radial dimension at a certain location. When the bracket is fitted onto the conveying guide wire, the point with the large radial dimension can be partially or completely embedded in the sub-groove. Thus, when the bracket 300 is sleeved on the conveying guide wire 100 and passes through the inner cavity of the conveying pipe, the contact area between the braided wire or wave bar of the bracket 300 and the body 121 increases, thereby increasing the first frictional force between the bracket 300 and the driving member 120. At the same time, the outer diameter of the bracket 300 becomes more uniform, and the surface of the bracket 300 in contact with the conveying pipe (i.e., the outer surface of the bracket 300) becomes smoother, thereby reducing the second frictional force between the bracket and the inner wall of the conveying pipe and reducing the pushing resistance when the bracket is conveyed.

[0101] like Figure 13 As shown, in another embodiment of the present invention, the driving member 120 is composed of a winding wire wrapped around the mandrel 110. The winding wire spirally wraps multiple times along the axis of the mandrel 110 to form a spiral structure, and there is a gap 123 between adjacent turns of the winding wire, which constitutes the recessed portion.

[0102] In this embodiment, the number of turns and pitch of the winding wire can be adjusted as needed. For example, when the bracket matching the conveying guide wire 100 has a large PPI (for a braided bracket, PPI refers to the number of braiding points per unit length, where length refers to the axial dimension of the bracket), the number of turns of the winding wire on the mandrel 110 can be increased and the pitch reduced to give the bracket and the driving member 120 a larger contact area.

[0103] Optionally, the winding filament may be a polymer filament, preferably having a large coefficient of surface friction, which can be selected according to needs.

[0104] Optionally, the winding wire is composed of a metal wire and a polymer coating covering the outer surface of the metal wire. Preferably, the metal wire is a platinum-tungsten alloy wire, platinum-iridium alloy wire, or other reproducible metal wire, thus making the driving member 120 reproducible. Because the driving member 120 is reproducible, the operator can easily determine the specific position of the stent within the body during stent transport and can further determine whether the partially released stent can still be retrieved into the transport tube. Specifically, the transport tube for transporting the stent has a second distal end and a second proximal end, and a third reproducible element is provided on the second distal end. During stent transport, when the operator observes through the reproducible device that the driving member 120 begins to overlap with the third reproducible element, the operator can determine that the stent can no longer be retrieved.

[0105] Understandable, Figures 11-12 In some embodiments, the driving component 120 may also have, for example... Figures 5-9 The inner layer 124 and outer layer 125 of any one of them can have the same structure and material as in the above embodiments, and will not be repeated here.

[0106] Furthermore, this embodiment also provides a treatment device, which includes a delivery tube, a medical implant, and a delivery guidewire as described above. 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 it. The compressed medical implant is tightly fitted onto the driving member 120, generating a first frictional force between it and the driving member 120, and the medical implant is at least partially embedded in the recess to increase the first frictional force. The medical implant described here is, for example, a self-expanding stent, specifically a braided stent or a cut stent.

[0107] It should be noted that, in order to improve the fit between the driving component 120 and the medical implant and simplify the assembly process of the treatment device, the delivery guide wire 100 described in this embodiment is preferably manufactured according to a specific medical implant. That is, in the process of producing the delivery guide wire 100, the medical implant to be delivered is first provided, then the form of the driving component 120 and the recess is determined according to the structure of the medical implant, and finally the delivery guide wire 100 is manufactured.

[0108] Furthermore, depending on actual needs, the inner cavity of the delivery tube has different radial dimensions. Preferably, the radial dimension of the inner cavity ranges from 0.017 inches to 0.029 inches. More preferably, the radial dimension of the inner cavity is less than or equal to 0.027 inches, or the radial dimension of the inner cavity is less than or equal to 0.021 inches. Because the delivery guidewire uses a drive member with a recessed portion, the outer diameter of the medical implant under compression can be reduced. Therefore, the treatment device of the present invention can use a delivery tube with a smaller inner radial dimension. This treatment device can correspondingly reduce the outer diameter of the delivery tube. The thinner delivery tube can reach more distal blood vessels or smaller lesions, expanding the treatment range. It also improves the overall flexibility of the treatment device, making it easier to reach the lesion site through more tortuous blood vessels, thus increasing the success rate of the surgery.

[0109] 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 delivery guidewire for delivering a medical implant, characterized in that, The driving member comprises a mandrel and a driving member arranged on the mandrel, and the driving member is provided with a recess; The driving member comprises an inner layer and an outer layer, The inner layer is made of a metal material and is fixedly sleeved on the mandrel; The outer layer is made of a high polymer material and is fixedly sleeved on the inner layer; The inner layer has a gap structure, and the outer layer partially or completely fills the gap structure, and at least part of the outer layer is connected with the mandrel through the gap structure; The inner layer is a tubular network structure woven by a wire, and the mesh of the tubular network structure constitutes the gap structure; The medical implant is a self-expanding stent, and the structure of the recess matches at least part of the structure of the medical implant in a compressed state.

2. The delivery guide wire of claim 1, wherein, The driving member comprises a body and a groove formed on the outer surface of the body, and the groove constitutes the recess.

3. The delivery guidewire of claim 2, wherein, The groove and the inner surface of the medical implant in a compressed state are mirror images of each other.

4. The delivery guidewire of claim 3, wherein, The width of the groove is 0.0008-0.004 inches, and / or the depth of the groove is 0.0002-0.004 inches.

5. The delivery guide wire of claim 2, wherein, The groove comprises one or more sub-grooves, and a plurality of the sub-grooves are arranged staggered, continuously or spaced on the outer surface of the body.

6. The delivery guidewire of claim 2, wherein, The groove spirally surrounds along the axis of the body to form one or more spiral grooves on the outer surface of the body.

7. The delivery guide wire of claim 1, wherein, The driving member is formed by a winding wire spirally surrounding along the axis of the mandrel to form one or more spiral structures, and adjacent two turns of the winding wire are spaced to form the recess.

8. The delivery guidewire of claim 7, wherein, The winding wire is a high polymer wire or a metal wire coated with a high polymer coating.

9. The delivery guidewire of claim 8, wherein, The metal wire has developing property, and / or the metal wire is a platinum-tungsten alloy wire or a platinum-iridium alloy wire.

10. The delivery guide wire of claim 1, wherein, The diameter of the wire is less than or equal to 0.001 inches, and / or the number of weaving intersections contained in the inner layer per inch is 15-50.

11. The delivery guide wire of claim 1, wherein, The inner layer is at least one tubular structure, and the outer layer partially or completely covers the inner layer.

12. The delivery guide wire of any of claims 1-11, wherein, The inner layer is made of a metal material having developing property, and the metal material is selected from one or more of platinum, gold, tungsten, platinum-gold alloy, platinum-tungsten alloy, platinum-iridium alloy and platinum-nickel alloy.

13. The delivery guide wire of any of claims 1-11, wherein, The inner layer is welded or cemented with the mandrel, and / or the outer layer covers the inner layer and extends to be connected with the mandrel.

14. The delivery guidewire of any of claims 1-11, wherein, The material of the outer layer comprises any one or more of block polyether amide resin, thermoplastic polyurethane elastomer, silica gel, nylon and acrylic polymer.

15. The delivery guide wire of any of claims 1-11, wherein, 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.

16. The delivery guidewire of claim 15, wherein, The recess is formed on the outer surface of the outer layer; and / or the structure of the recess matches at least part of the structure of the medical implant in a compressed state.

17. The delivery guidewire of claim 16, wherein, The recess comprises one or more sub-grooves, and a plurality of the sub-grooves are arranged staggered, continuously or spaced on the outer surface of the outer layer.

18. The delivery guidewire of any of claims 1-11, wherein, At least two driving members are arranged on the mandrel and are spaced along the axial direction of the mandrel.

19. The delivery guidewire of claim 18, wherein, The distance between two adjacent driving members is 0.5mm-150mm.

20. The delivery guidewire of claim 19, wherein, The distance between two adjacent driving members is 0.5mm-5mm.

21. The delivery guidewire of any of claims 1-11, wherein, The mandrel is provided with one or more driving members, the outer diameter of the driving member is 0.01 inch-0.03 inch, and the length of each driving member is 0.5mm-8mm.

22. The delivery guidewire of claim 21, wherein, The length of each driving member is 0.5mm-4mm.

23. The delivery guidewire of any of claims 1-11, wherein, Further comprising a first developing member and a second developing member, the first developing member is arranged at the end of the distal end of the mandrel, and the second developing member is arranged on the mandrel, and the driving member is arranged between the first developing member and the second developing member.

24. A treatment device, characterized by The delivery catheter has an inner lumen extending axially therethrough, the inner lumen is configured to receive the medical implant, and a wall of the inner lumen exerts a compression on the medical implant to make the medical implant in a compressed state. The medical implant in the compressed state is sleeved on the driving member, and the medical implant is at least partially embedded in the recess.

25. The treatment device of claim 24, wherein, The radial dimension of the inner lumen ranges from 0.017 inch to 0.029 inch.

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