Guide extension catheter

Abstract

To provide a guide extension catheter which has both flexibility and supporting strength, and achieves comprehensive and significant improvements in the passability, pushability, effective cavity channel retention capability, and reliability.SOLUTION: A guide extension catheter comprises: a guide tube, which comprises a proximal port and a distal port and comprises an inner layer, an intermediate layer, and an outer layer; a guide shaft on the side of the proximal port configured to guide the guide tube into a target position; and a transitional connection segment configured to connect the guide tube and the guide shaft. The transitional connection segment is of a tubular structure axially extending from the proximal port and comprising an inclined opening, and comprises an inner-layer extension segment, an outer-layer extension segment, and a rib component. The rib component is sized and shaped to adapt to the transitional connection segment. The rib component and the intermediate layer are coaxial with but not connected to each other, and are spaced apart by a first spacing of 0.1 mm to 10 mm. The rib component and the guide shaft are spaced apart by a third spacing of 0.1 mm to 2 mm. The intermediate layer, the rib component, the inner layer and the inner-layer extension segment are wrapped by the outer layer and the outer-layer extension segment and are then hot-melt welded together.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] This application relates to the field of medical products, particularly to guide extension catheters.

Background Art

[0002] A guide extension catheter is used in combination with a guiding catheter or sheath in vascular intervention procedures, enters the coronary artery, and assists in the placement of intervention treatment devices. The design of the transition connection segment in conventional guide extension catheter technology can be classified into approximately two types. The first is the transition by a plastic skirt, and the second is the transition by a metal skirt.

[0003] The characteristics of the plastic skirt transition structure are that the metal reinforcement layer of the guide tube is directly connected to the metal guide shaft to ensure tensile strength. The plastic layer of the guide tube extends to an arc-shaped or stepped plastic bevel (or skirt) formed by cutting the guide shaft in the transition area. The plastic bevel is also the entrance of the lumen of the guide tube, and the transition is completed by the arc-shaped or stepped shape of the plastic bevel.

[0004] Its advantage is that the main part of the transition connection segment is plastic, so it has good flexibility. Its disadvantage is that due to the low rigidity of plastic, the mechanical transmission and mechanical transition of the plastic skirt transition are not good, there is significant stress concentration, it is easy to deform, resulting in the disappearance of the lumen entrance, and the deformation is irreversible and the tensile strength is low. In actual use, due to insufficient transmission of the push force, the guide extension catheter cannot be placed at the designated position, and it is easy to cause the failure or damage of the guide extension catheter due to the disappearance of the lumen entrance caused by the deformation of the transition connection segment.

[0005] The characteristic of the transient structure with a metal skirt is that a metal ring is connected (generally by welding or riveting) to the end of the guide shaft, and the metal ring is further inlaid into the plastic layer of the guide tube to ensure tensile strength. The metal ring generally extends from the end of the plastic layer of the guide tube to an arc-shaped or stepped metal skirt formed when the guide shaft is cut in the transient area. This metal skirt also serves as the entrance to the lumen of the guide tube, and the transient is completed by the arc-shaped or stepped metal skirt.

[0006] The advantages are that the metal structure has good support at the entrance of the lumen, making it resistant to collapse, good mechanical transmission, and good tensile strength. The disadvantages are that the transient connection segment is too rigid, resulting in poor bending performance and poor mechanical transients. There is a large stress concentration at the joint between the end of the metal ring and the guide tube, causing the tube body to bend at the joint and thereby eliminating the lumen. In actual use, the poor bending performance prevents the guide extension catheter from reaching the designated position and functioning, or the resistance during advancement is too great, causing damage to the patient's blood vessels. [Overview of the Initiative]

[0007] This application provides, in one embodiment, a guide extension catheter. The system includes a guide tube comprising a proximal port and a distal port, an inner layer, an intermediate layer and an outer layer, a guide shaft installed on the proximal port side for guiding the guide tube into a target position, and a transient connection segment for connecting the guide tube and the guide shaft, the transient connection segment being a tubular structure including an oblique opening formed axially extending from the proximal port, where the transient connection segment comprises an inner layer extension segment, an outer layer extension segment and a rib component, the size and shape of the rib component being the transient connection segment The components are configured to match the size and shape of the unit, with the inner layer extension segment being part of the inner layer and the outer layer extension segment being part of the outer layer. Here, the rib component is coaxial with the intermediate layer but not connected, and a first gap of 0.1 mm to 10 mm remains in between. The rib component is not connected to the guide shaft at a certain distance, and a third gap of 0.1 mm to 2 mm is also present. Here, the outer layer and outer layer extension segment enclose the intermediate layer, rib component, inner layer, and inner layer extension segment, and are then heat-welded together to form a single unit.

[0008] In another embodiment of this application, a guide extension catheter is provided, A guide tube comprising a proximal port and a distal port, comprising an inner layer, an intermediate layer and an outer layer, the inner and outer layers being made of plastic; a guide shaft installed on the proximal port side for guiding the guide tube into a target position; and a transient connection segment for connecting the guide tube and the guide shaft, the transient connection segment being a tubular structure with an oblique opening formed axially extending from the proximal port, wherein the transient connection segment comprises an inner layer extension segment, an outer layer extension segment and a rib component, the rib component comprising a C-shaped circumferential rib and a C-shaped oblique rib, the contour of the oblique rib corresponding to the shape of the oblique opening, and the circumferential rib and oblique rib overlapping the connection segment at the position of the proximal port. The circumferential ribs and diagonal ribs are formed as an overall integrated structure, with the diagonal ribs including left and right ribs, the shape and position of the left and right ribs corresponding to the shape and position of the diagonal opening, and multiple groups of auxiliary circumferential ribs distributed within the length range of the left and right ribs, used to support the circumferential rigidity of the transient connection segment, where the rib components are coaxial with the intermediate layer but not connected, and a first gap of 0.1 mm to 10 mm remains in between, the rib components are not connected to the guide shaft at a certain distance, and a third gap of 0.1 mm to 2 mm is separated from them, where the outer layer and outer layer extension segments are integrated by heat welding after enclosing the intermediate layer, rib components, inner layer, and inner layer extension segments.

[0009] At least some embodiments have the following advantages: the transient connection segment of the guide extension catheter includes a rib component, which is not connected to any adjacent metal components, thereby combining ultra-flexibility, strong lumen support, excellent mechanical transmission and transients, and ultra-strong memory recall ability. As a result, such guide extension catheters are significantly improved overall in core performance, including passability, pushability, effective lumen retention, and reliability, compared to conventional technologies. [Brief explanation of the drawing]

[0010] The performance and merits of this application can be further understood by referring to the remaining parts of this specification and the drawings, where the symbols for the same components in these drawings are the same. In some cases, a sub-symbol is placed after a symbol and a hyphen to indicate one of several similar components. Where a symbol is mentioned but an existing sub-symbol is not explicitly shown, it refers to all of these similar components.

[0011] [Figure 1] This is a schematic diagram illustrating a usage scenario of a guide extension catheter according to one embodiment of this application. [Figure 2] This is a schematic diagram of the structure of a guide extension catheter according to one embodiment of this application. [Figure 3] Figure 2 shows a cross-sectional view of the guide extension catheter in the embodiment described, along the 3-3 direction. [Figure 4A] Figure 3 is a schematic front view of a portion of the structure shown. [Figure 4B] Figure 3 is a schematic partial plan view of the structure shown. [Figure 4C] Figure 3 is a schematic side view of a portion of the structure shown. [Figure 5A] This is a front view of the structure of a rib component according to one embodiment of this application. [Figure 5B] This is a plan view of the structure of the rib component of the embodiment shown in Figure 5A of this application. [Figure 5C] This is a left side view of the structure of the rib component of the embodiment shown in Figure 5A of this application. [Figure 6A] This is a front view of the structure of a rib component in another embodiment of this application. [Figure 6B] This is a side view of the structure of the rib component of the embodiment shown in Figure 6A of this application. [Figure 7A] This is a front view of the structure of a rib component in yet another embodiment of the present application. [Figure 7B] This is a side view of the structure of the rib component of the embodiment shown in Figure 7A of this application. [Figure 8A] This is a front view of the structure of a rib component in yet another embodiment of this application. [Figure 8B] It is a side view of the structure of the rib part of the embodiment shown in FIG. 8A of the present application.

Mode for Carrying Out the Invention

[0012] Hereinafter, the embodiments will be described in more detail with reference to the following examples. Here, the examples are provided merely for illustration and are not intended to be limiting.

[0013] There are multiple variations that those skilled in the art can anticipate in the present application, and the effects of the present application can be achieved.

[0014] The limiting terms for the space or position in the present application, such as inside, outside, above, below, left, right, top, bottom, front, and back, are limited with reference to the position where the guide extension catheter is arranged in the usage state.

[0015] In the present application, the term "comprising" means including the following elements but not limited thereto, that is, it does not exclude other elements.

[0016] In the present application, when the guide extension catheter is in the usage state, at both ends of the guide extension catheter itself or any part of the guide extension catheter, the end relatively close to the operator's hand is defined as the "proximal end", and correspondingly, the end relatively far from the operator's hand is defined as the "distal end".

[0017] In the present application, the term "axial direction" means the direction in which the central axis of the guide extension catheter or the extension line of the central axis is located.

[0018] In the present application, the term "circumferential direction" means the direction in which the circumferential wall of the guide extension catheter is located.

[0019] In the present application, the term "oblique direction" means the direction forming an acute intersection line with the central axis of the guide tube.

[0020] In this application, the term “connected” means achieving a physical rigid connection between two specific parts, and includes, but is not limited to, physical connection methods such as welding, brazing, and riveting. “Not connected” means that two specific parts are not physically directly rigidly connected.

[0021] In this application, the terms “about” and “approximately” mean a range of accuracy that a person skilled in the art would understand to still ensure the technical effect of the discussed feature. These terms generally indicate a deviation of 10%, preferably 5%, from the given numerical value.

[0022] The transient connection segment of the guide extension catheter, located between the guide tube and guide shaft, is a key point for the entire guide extension catheter. The quality of its connection and transient performance determines whether the guide extension catheter can perform its role in actual use.

[0023] During the process of inserting and pushing a guide extension catheter into the body, it may encounter detours or narrowing of blood vessels. In such cases, the guide tube is more likely to be the first to be obstructed due to its large cross-sectional area, while the guide shaft has a smaller cross-sectional area. As a result, the ratio of their cross-sectional areas is generally large (e.g., 80:1), and the difference in their structural stiffness is also large. Consequently, during the actual advancement of the guide extension catheter, significant stress concentration occurs in the transient connection segment, causing deformation and bending in the transient area.

[0024] This disrupts the coaxiality of the mechanical transmission in the guide extension catheter, preventing the pushing force applied from the operating end of the external guide shaft from being effectively transmitted to the guide tube body via the transient connection segment. As a result, the guide extension catheter cannot advance any further, reach its designated position, and function.

[0025] If the transient connection segment deforms during the procedure, it directly leads to deformation of the lumen entrance of the guide tube. This deformation at the lumen entrance can easily result in a loss of effective lumen for the guide extension catheter. Thus, an interventional device that is normally fitted may be obstructed at the guide tube entrance and unable to enter the lumen, rendering the guide extension catheter ineffective.

[0026] When withdrawing a guide extension catheter, the guide tube may get stuck due to deformation or collapse of the passage, resulting in a higher-than-normal resistance to withdrawal of the guide tube. At this time, the overall tensile strength of the guide extension catheter is relied upon, but the transient connection segment is generally a weak point due to the aforementioned structural reasons and is prone to breaking first when pulled, potentially leading to product rupture and endangering the patient's life.

[0027] This application provides a guide extension catheter having a free rib component, the transient connection segment of which includes a free rib component not connected to any metal component, thereby giving the transient connection segment ultra-flexible, strong lumen support, excellent mechanical transmission and transients, and ultra-strong memory recall ability. As a result, several core performance characteristics of such a guide extension catheter, such as passability, pushability, effective lumen retention ability, and reliability, are comprehensively and significantly improved. Furthermore, it ensures that the guide extension catheter functions adequately and reliably during surgical procedures, leading to reduced surgical time and improved surgical success rates. The specific technical solution is as follows.

[0028] In one embodiment, a guide extension catheter is provided. The system includes a guide tube comprising a proximal port and a distal port, an inner layer, an intermediate layer and an outer layer, a guide shaft installed on the proximal port side for guiding the guide tube into a target position, and a transient connection segment for connecting the guide tube and the guide shaft, the transient connection segment being a tubular structure including an oblique opening formed axially extending from the proximal port, where the transient connection segment comprises an inner layer extension segment, an outer layer extension segment and a rib component, the size and shape of the rib component being the transient connection segment The components are configured to match the size and shape of the tubing, with the inner extension segment being part of the inner layer and the outer extension segment being part of the outer layer. Here, the rib component is coaxial with the intermediate layer but not connected, and a first gap of 0.1 mm to 10 mm remains in between. The rib component is not connected to the guide shaft at a certain distance, and a third gap of 0.1 mm to 2 mm is also present. Here, the outer layer and outer extension segment enclose the intermediate layer, rib component, inner layer, and inner extension segment, and are then heat-welded together to form a single unit. The rib component provides rigid support to the transient connection segment, and since the rib component is not connected to the intermediate layer of the guide tube, it increases the flexibility of the transient connection segment, thereby ensuring that the guide extension catheter as a whole balances rigidity and flexibility.

[0029] In at least one embodiment, the rib component includes circumferential ribs and oblique ribs, the contour of the oblique ribs corresponding to the shape of an oblique opening, the circumferential ribs and oblique ribs forming overlapping connecting segments at the location of the proximal port, and the circumferential ribs and oblique ribs forming an overall integrated structure.

[0030] In at least one embodiment, the circumferential rib is C-shaped and includes two arc-shaped ribs extending circumferentially from both ends of the overlapping connecting segments.

[0031] In at least one embodiment, the circumferential rib is a circumferentially closed ring passing through overlapping connecting segments.

[0032] In at least one embodiment, the oblique ribs are C-shaped and include a left rib and a right rib, the shape and position of the left rib and the right rib corresponding to the shape and position of the oblique opening, and multiple groups of auxiliary circumferential ribs are distributed within the length range of the left rib and the right rib, used to support the circumferential rigidity of the transient connection segment.

[0033] In at least one embodiment, the tails of the auxiliary circumferential ribs are not joined to each other and are separated by a certain distance.

[0034] In at least one embodiment, the circumferential rib or auxiliary circumferential rib is an S-shaped curve along the circumferential direction.

[0035] In at least one embodiment, the circumferential rib or auxiliary circumferential rib includes a basic segment and a reinforcing segment, wherein the width or surface area of ​​the reinforcing segment is greater than that of the basic segment.

[0036] In at least one embodiment, the reinforcing segment includes a branch or a hole.

[0037] In at least one embodiment, the rib component is made of a nitinol alloy, cobalt alloy, titanium alloy, platinum-iridium alloy, stainless steel, or carbon fiber material. In at least one embodiment, the nitinol alloy, cobalt alloy, titanium alloy, platinum-iridium alloy, stainless steel, or carbon fiber forming the rib component is in the form of round threads or square rods.

[0038] In at least one embodiment, the outer layer material is nylon, polyurethane, or thermoplastic elastomer, the inner layer material is a high-molecular polymer, and the intermediate layer is a metal mesh layer.

[0039] In another embodiment of this application, a guide extension catheter is provided, A guide tube comprising a proximal port and a distal port, comprising an inner layer, an intermediate layer and an outer layer, the inner and outer layers being made of plastic; a guide shaft installed on the proximal port side for guiding the guide tube into a target position; and a transient connection segment for connecting the guide tube and the guide shaft, the transient connection segment being a tubular structure with an oblique opening formed axially extending from the proximal port, wherein the transient connection segment comprises an inner layer extension segment, an outer layer extension segment and a rib component, the rib component comprising a C-shaped circumferential rib and a C-shaped oblique rib, the contour of the oblique rib corresponding to the shape of the oblique opening, and the circumferential rib and oblique rib overlapping the connection segment at the position of the proximal port. The circumferential ribs and diagonal ribs are formed as an overall integrated structure, with the diagonal ribs including left and right ribs, the shape and position of the left and right ribs corresponding to the shape and position of the diagonal opening, and multiple groups of auxiliary circumferential ribs distributed within the length range of the left and right ribs, used to support the circumferential rigidity of the transient connection segment, where the rib components are coaxial with the intermediate layer but not connected, and a first gap of 0.1 mm to 10 mm remains in between, the rib components are not connected to the guide shaft at a certain distance, and a third gap of 0.1 mm to 2 mm is separated from them, where the outer layer and outer layer extension segments are integrated by heat welding after enclosing the intermediate layer, rib components, inner layer, and inner layer extension segments.

[0040] The embodiments of this application will be described in detail below in relation to the drawings.

[0041] As shown in Figure 1, this is a schematic diagram of the use of the guide extension catheter 10 and the accessory device 200 in combination. Here, the accessory device 200 includes a guiding catheter 11 and a guide sheath 14, both of which constitute the primary intervention passage. The distal end 12 of the guiding catheter enters the blood vessel, and the proximal end 13 of the guiding catheter is connected to a Y-shaped hemostatic valve 15. The guide extension catheter 10 enters the primary intervention passage via the Y-shaped hemostatic valve 15, advances along the lumen of the guiding catheter 11, and eventually extends beyond the distal end 12 of the guiding catheter to be positioned in a more distant blood vessel (e.g., a coronary artery).

[0042] Figure 2 is a schematic external view of a guide extension catheter 10 described in one embodiment of this application. As shown in Figure 2, the guide extension catheter 10 includes three parts: a guide tube 20, a transient connection segment 30, and a guide shaft 40. The guide tube is also called the distal tube, the guide shaft is also called the proximal shaft, and the transient connection segment is also called the transient portion. Here, the guide tube 20 is at the distal end of the guide extension catheter 10, the guide shaft 40 is at the proximal end of the guide extension catheter 10, and the transient connection segment 30 is used to connect the guide tube 20 and the guide shaft 40.

[0043] Figure 3 is an axial cross-sectional view of a guide extension catheter described in one embodiment of the present application. As shown in Figure 3, the guide tube 20 has a tubular structure and serves as a passage for an interventional medical device. The structure of the guide tube 20 consists of an inner layer 21, an intermediate layer 22, and an outer layer 23, in order from the inside to the outside of the lumen. Here, the inner layer 21, intermediate layer 22, and outer layer 23 form a tubular structure including a lumen 24. The material of the inner layer 21 may be PTFE or other plastic, the material of the intermediate layer 22 may be a stainless steel mesh or another metal mesh, and the material of the outer layer 23 may be a thermoplastic elastomer, polyurethane elastomer, or other plastic.

[0044] The guide shaft 40 is a slender, solid rod, comprising a main body 41 and a distal part 42. The main body 41 may be a cylindrical stainless steel rod or a rod made of other metals, and the distal part 42 is an extension of the main body 41. The extension method may be flattening by pressing, flattening by laser cutting, subdivision by polishing, or other processing methods, and the length of the distal part 42 may be 1 mm to 50 mm.

[0045] As can be seen in Figure 3, the transient connection segment 30 is a part that extends axially from the proximal port 26 of the guide tube 20, connecting the guide tube 20 and the guide shaft 40, and has an oblique opening 25 that communicates with the lumen 24 of the guide tube 20.

[0046] The transient connection segment 30 includes an inner layer extension segment 211, an outer layer extension segment 231, and a rib component 31. The rib component 31 covers the space between the inner layer extension segment 211 and the outer layer extension segment 231. The rib component 31 is coaxial with the proximal end of the intermediate layer 22 but is not connected, and the distance between them may be 0.1 mm to 10 mm. At the same time, the rib component 31 is not connected to the guide shaft 40 at a certain distance, and the distance between them may be 0.1 mm to 2 mm. In this way, the flexibility of the structure is increased, and the overall thickness of the structure is reduced by avoiding an increase in thickness due to lamination.

[0047] The material of the rib component 31 may be nitinol alloy, cobalt alloy, titanium alloy, platinum-iridium alloy, stainless steel, carbon fiber, or other metals, and at the same time, it may be in any strip-like form such as a round thread or a square rod. The rib component may be a whole that is integrally molded, or it may be a whole formed by welding segments together or by other methods.

[0048] A bridging wedge sleeve 35 is provided around the distal end 42 of the guide shaft 40. The covering method may be hot melt coating, pressing, welding, brazing, riveting, etc., and the material of the bridging wedge sleeve 35 may be plastic such as nylon or metal.

[0049] The bridging wedge sleeve 35 is covered between the outer layer 23 and the guide shaft 40 and inlaid with both to form a bridging mortise and tenon joint structure, maintaining structural flexibility while significantly enhancing structural rigidity and tensile strength. The rib component 31 is also covered between the outer layer 23 and the inner layer 21 and inlaid with both to form a harmonious structure. After removing the excess tubular portion at the proximal end of the guide tube 20 that does not include the intermediate layer 22 and the rib component 31, an arc-shaped oblique opening, or oblique opening 25, is ultimately formed. The oblique opening 25 is also an entry point for other interventional instruments to enter the guide extension catheter 10.

[0050] Thus, after the assembly is complete, the aforementioned parts are hot-melt coated with the outer layer 23 of the guide tube 20 to form a single unit, which then forms the main structure of the guide extension catheter 10.

[0051] The proximal end of the guide tube 20, the rib component 31, the bridging wedge sleeve 35, and the distal end of the guide shaft 40 all constitute the transient connection segment 30 of the guide extension catheter. The presence of the rib component 31 significantly alleviates the large stress concentration at both ends of the transient connection segment 30 caused by large differences in cross-sectional area (such as a ratio of 80:1) and structural stiffness, thereby dramatically improving the mechanical transmission and transient properties of the transient connection segment 30.

[0052] At the same time, the rib component 31, which utilizes nitinol alloy, cobalt alloy, titanium alloy, platinum-iridium alloy, stainless steel, or carbon fiber, can significantly improve both the lumen support force of the oblique opening 25 and the memory recovery force after deformation under force. The structural design of the rib component 31 takes into account flexibility to adapt to deformation at any angle, leading to improved bending passage ability of the transient connection segment 30, thereby significantly improving the core performance of the guide extension catheter 10 as a whole, including passability, pushability, effective lumen retention ability, and reliability.

[0053] Figures 4A to 4C are simplified schematic diagrams of parts of the structure shown in Figure 3, and Figure 4C is a cross-sectional view along 4C-4C of Figure 4B. The drawings show the relative positions of the main components of the skeletal structure of the guide extension catheter, mainly including the intermediate layer 22, the rib component 31, and the guide shaft 40. The rib component 31 is coaxial with the proximal end of the intermediate layer 22 and is located above the guide shaft 40. The rib component 31 is coaxial with the proximal end of the intermediate layer 22 but is not connected, and there is a first gap 311 between the rib component 31 and the intermediate layer 22, the distance of which the first gap 311 may be 0.1 mm to 10 mm, the proximal end of the intermediate layer 22 is centered with the distal end of the guide shaft 40 but is not connected, and there is a second gap 312, the distance of which the second gap 312 may be 0.1 mm to 10 mm.

[0054] As shown in Figure 4, the relative positional relationship between the rib component 31 and the guide shaft 40 is such that the rib component 31 and the guide shaft 40 are distributed in the circumferential direction of the transient connection segment, and there is a third spacing 313, the distance of which the third spacing 313 may be 0.1 mm to 2 mm. This spacing design enhances structural flexibility, avoids thickness increase due to lamination, and reduces the overall thickness of the structure. As a result, the rib component provides sufficient rigid support to the transient connection segment while avoiding stacking, significantly improving the mechanical transmission and transient properties of the transient connection segment 30.

[0055] Figures 5A to 5C are a front view, a top view, and a left side view of the structure of a rib component according to one embodiment of this application. As shown in Figure 5A, the rib component 31 includes a plurality of ribs, which are circumferential ribs 32, oblique ribs 33, and auxiliary circumferential ribs 34.

[0056] As shown in Figure 5C, the circumferential ribs 32 are C-shaped in the circumferential direction and are distributed perpendicular to the axial direction of the guide extension catheter. The circumferential ribs 32 and oblique ribs 33 form an overlapping connection segment at the position of the proximal port 26 of the guide tube. The contour of the oblique ribs 33 corresponds to the shape of the oblique opening 25 and includes a left rib 331 and a right rib 332. The shape and position of the left rib 331 and the right rib 332 correspond to the shape and position of the oblique opening and are used to support the circumferential rigidity of the transient connection segment. The oblique ribs 33 intersect the axial direction of the guide extension catheter at a certain angle and / or radians. Within the length range of the left rib 331 and the right rib 332, auxiliary circumferential ribs 34 are distributed in pairs of multiple groups. The auxiliary circumferential ribs 34 are C-shaped in the circumferential direction and may be in two or more pairs.

[0057] The processing method for the rib component 31 may be laser cutting, wire cutting, welding, bonding, or other methods. In some embodiments, the circumferential ribs 32 and auxiliary circumferential ribs 34 of the rib component 31 may be O-shaped in the circumferential direction, that is, both ends are connected to form a closed ring. In some embodiments, the diagonal ribs 33 may also be O-shaped.

[0058] Figures 6A and 6B are front and side views of the structure of a rib component in another embodiment of the present application. In this embodiment, the circumferential ribs 32 and auxiliary circumferential ribs 34 of the rib component 31 may be meandering, S-shaped curves along the circumferential direction, or other irregularly shaped ribs, in order to further enhance the circumferential support of the circumferential ribs 32 and auxiliary circumferential ribs 34 to the transient connection segments.

[0059] Figures 7A and 7B are front and side views of the structure of a rib component in yet another embodiment of the present application. In this embodiment, the circumferential rib 32 and auxiliary circumferential rib 34 of the rib component 31 include a basic segment and a reinforcing segment, and as shown in Figure 7B, the basic segment 321 and the reinforcing segment 322 are located in the circumferential rib 32, and the reinforcing segment 322 has holes, thereby forming a branch with a wider or larger surface area than the basic segment 321, further strengthening the circumferential support of the circumferential rib 32 and the auxiliary circumferential rib 34 to the transient connection segment.

[0060] Figures 8A and 8B are front and side views of the structure of a rib component in yet another embodiment of this application. In this embodiment, the circumferential ribs 32 and auxiliary circumferential ribs 34 of the rib component 31 include a basic segment and a reinforcing segment, the reinforcing segment having branches, the branches being joined integrally with the main body by connection methods such as welding, brazing, or bonding, thereby satisfying different performance requirements.

[0061] The methods provided by the exemplary embodiments herein are for illustrative purposes only, and an example of one method does not limit examples of other methods. Apparatus / methods described in one drawing may be added to or substituted for apparatus / methods in other drawings. Furthermore, specific numerical data values ​​(e.g., specific quantities, numbers, categories, etc.) or other specific information are used solely to illustrate the exemplary embodiments and do not limit the exemplary embodiments by such specific information.

Claims

1. It is a guide extension catheter, A guide tube including a proximal port and a distal port, and including an inner layer, an intermediate layer and an outer layer, A guide shaft is installed on the proximal port side to guide the guide tube into the target position, The guide tube and the guide shaft are connected by a transient connection segment, the transient connection segment being a tubular structure including an oblique opening, which extends axially from the proximal port. The transient connection segment includes an inner layer extension segment, an outer layer extension segment, and a rib component, wherein the size and shape of the rib component are configured to match the size and shape of the transient connection segment, the inner layer extension segment is a part of the inner layer, and the outer layer extension segment is a part of the outer layer. The rib component is coaxial with the intermediate layer but is not connected to it, and the rib component is separated from the intermediate layer by a first distance of 0.1 mm to 10 mm, and the rib component is not connected to the guide shaft by a certain distance, and is separated by a third distance of 0.1 mm to 2 mm, The outer layer and outer layer extension segments enclose the intermediate layer, rib components, inner layer, and inner layer extension segments, and are then heat-welded together to form a guide extension catheter.

2. The guide extension catheter according to claim 1, wherein the rib component includes a circumferential rib and an oblique rib, the contour of the oblique rib corresponds to the shape of the oblique opening, and the circumferential rib and the oblique rib form an overlapping connecting segment at the position of the proximal port, thereby making the circumferential rib and the oblique rib an overall integrated structure.

3. The guide extension catheter according to claim 2, wherein the circumferential rib is C-shaped and includes two arc-shaped ribs extending circumferentially from both ends of the overlapping connecting segments.

4. The guide extension catheter according to claim 2, wherein the circumferential rib is a circumferentially closed ring passing through the overlapping connecting segments.

5. The guide extension catheter according to claim 2, wherein the oblique ribs are C-shaped and include a left rib and a right rib, the shape and position of the left rib and the right rib correspond to the shape and position of the oblique opening, and multiple groups of auxiliary circumferential ribs are distributed within the length range of the left rib and the right rib, and are used to support the circumferential rigidity of the transient connection segment.

6. The guide extension catheter according to claim 5, wherein the tail portions of the auxiliary circumferential ribs are not joined together and are separated by a certain distance.

7. The guide extension catheter according to claim 5, wherein the circumferential rib or auxiliary circumferential rib has an S-shaped curve along the circumferential direction.

8. The guide extension catheter according to claim 5, wherein the circumferential rib or auxiliary circumferential rib includes a basic segment and a reinforcing segment, and the width or surface area of ​​the reinforcing segment is greater than that of the basic segment.

9. The guide extension catheter according to claim 8, wherein the reinforcing segment includes a branch or a hole.

10. The guide extension catheter according to claim 1, wherein the rib component is made of nitinol alloy, cobalt alloy, titanium alloy, platinum-iridium alloy, stainless steel, or carbon fiber material.

11. The guide extension catheter according to claim 1, wherein the material of the outer layer is nylon, polyurethane, or thermoplastic elastomer, the material of the inner layer is a polymer, and the intermediate layer is a metal mesh layer.

12. The guide extension catheter according to claim 10, wherein the material of the rib component is a round thread or a square rod.

13. It is a guide extension catheter, A guide tube comprising a proximal port and a distal port, and comprising an inner layer, an intermediate layer and an outer layer, wherein the materials of the inner layer and the outer layer are plastic, A guide shaft is installed on the proximal port side to guide the guide tube into the target position, The guide tube and the guide shaft are connected by a transient connection segment, the transient connection segment being a tubular structure including an oblique opening, which extends axially from the proximal port. The transient connection segment includes an inner layer extension segment, an outer layer extension segment, and a rib component, the rib component includes a C-shaped circumferential rib and a C-shaped oblique rib, the contour of the oblique rib corresponds to the shape of the oblique opening, the circumferential rib and the oblique rib form an overlapping connection segment at the location of the proximal port, the circumferential rib and the oblique rib form an overall integrated structure, the oblique rib includes a left rib and a right rib, the shape and position of the left rib and the right rib correspond to the shape and position of the oblique opening, multiple groups of auxiliary circumferential ribs are distributed within the length range of the left rib and the right rib, and are used to support the circumferential rigidity of the transient connection segment. The rib component is coaxial with the intermediate layer but is not connected to it, and the rib component is separated from the intermediate layer by a first distance of 0.1 mm to 10 mm, and the rib component is not connected to the guide shaft by a certain distance, and is separated by a third distance of 0.1 mm to 2 mm, The outer layer and outer layer extension segments enclose the intermediate layer, rib components, inner layer, and inner layer extension segments, and are then heat-welded together to form a guide extension catheter.

Images