Guiding extension catheter
By introducing elastic wedge sleeves and bridged mortise and tenon structures into the transition connection section of the guide extension catheter, the shortcomings of the guide extension catheter in terms of mechanical transmittance and transition are solved, and the flexibility and connection strength of the guide extension catheter are significantly improved, ensuring that it is more reliable and effective in actual use.
Patent Information
- Application Number
- CN202420742390.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-10
- Publication Date
- 2025-04-25
- Estimated Expiration
- 2034-04-10
AI Technical Summary
The transition connection sections of the existing guide extension catheter have insufficient mechanical transmittance and transitionality, resulting in the guide extension catheter being unable to be effectively placed in the designated position and are prone to deformation, failure or breaking during the propulsion process.
A tubular structure including an inner layer extension section, an elastic body wedge sleeve and an outer layer extension section is adopted as the transition connection section. The elastic body wedge sleeve is arranged at the distal end of the guide shaft and is not connected to the intermediate layer. It is wrapped in the outer layer extension section by hot melt welding to form a bridged mortise and tenon structure.
This design improves the flexibility, mechanical transferability and transition of the guide extension catheter, enhances the connection strength and tensile strength, making the guide extension catheter more reliable in actual use, can effectively pass through narrow channels and reduce resistance during propulsion.
Smart Images
Figure CN222788292U_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the field of medical products, and in particular to a guide extension catheter. Background Art
[0002] The guide extension catheter is used in conjunction with the guide catheter or sheath during vascular intervention to enter the coronary artery and assist in the placement of interventional treatment devices. The transition connection segment design of the existing guide extension catheter technology is generally divided into two categories, the first category is plastic skirt transition, and the second category is metal skirt transition. The structural feature of the plastic skirt transition is that the metal reinforcement layer of the guide tube is directly connected to the metal guide shaft to ensure the tensile strength, and the plastic layer of the guide tube extends to the guide shaft and is cut in the transition zone to form an arc-shaped or stepped plastic bevel (or skirt). The plastic bevel is also the entrance to the inner cavity of the guide tube, and the transition is completed through the arc or stepped shape of the plastic bevel. The advantage is that the main part of the transition connection section is plastic, so it has good flexibility. The disadvantage is that the stiffness of the plastic is poor, so the mechanical transmission and mechanical transition of the plastic skirt transition are not good, there is a large stress concentration, it is easy to deform, resulting in the loss of the inner cavity entrance and the deformation is irreversible, and the tensile strength is poor. In actual use, it is easy to have insufficient push force transmission, resulting in the inability to place the guide extension catheter at the specified position, and the inner cavity entrance is lost due to deformation of the transition connection section, resulting in failure or breakage of the guide extension catheter; The structural features of the metal skirt transition are A metal ring is connected to the end of the guide shaft (usually by welding or riveting), and the metal ring is then covered and embedded with the plastic layer of the guide tube to ensure tensile strength. The metal ring usually extends from the end of the plastic layer of the guide tube to the guide shaft, and is cut in the transition zone to form an arc-shaped or stepped metal skirt. The metal skirt is also the entrance to the inner cavity of the guide tube, and the transition is completed by the arc or stepped shape of the metal skirt. The advantages are that the metal structure has good support for the inner cavity entrance and is not easy to collapse, has good mechanical transmission and good tensile strength. The disadvantages are that the transition connection section is too hard, has poor bending performance and poor mechanical transition. There is a large stress concentration at the junction between the end of the metal ring and the guide tube, which causes the tube body to bend at the junction and the inner cavity to be lost. In actual use, the poor bending performance makes it impossible for the guide extension catheter to reach the designated position to play a role, or the patient's blood vessels are damaged due to excessive resistance during the advancement process. Summary of the invention
[0003] One aspect of the present application is a guide extension catheter, comprising: a guide tube, comprising a proximal port and a distal port, the guide tube comprising an inner layer, a middle layer, and an outer layer; a guide shaft, arranged at one side of the proximal port, the guide shaft being used to guide the guide tube into a target position; a transition connection section, which is used to connect the guide tube and the guide shaft; the transition connection section is a tubular structure including an oblique opening formed along the axial direction of the proximal port, and comprises an inner layer extension section, an elastomeric wedge sleeve, and an outer layer extension section; the elastomeric wedge sleeve provides rigidity and connection strength for the transition connection section; wherein the elastomeric wedge sleeve is arranged at the distal end of the guide shaft; the distal end of the guide shaft is aligned with the middle layer but not connected, and is separated by a second distance of 0.1mm-10mm; wherein the outer layer and the outer layer extension section wrap the inner layer, the inner layer extension section, the middle layer, the elastomeric wedge sleeve, and the distal end of the guide shaft and then are hot-melt welded together.
[0004] Another aspect of the present application is a guide extension catheter, comprising: a guide tube, comprising a proximal port and a distal port, the guide tube comprising an inner layer, a middle layer, and an outer layer; a guide shaft, arranged on one side of the proximal port, the guide shaft being used to guide the guide tube into a target position; the distal end of the guide shaft is a round metal rod, and the proximal end of the guide shaft is a flat metal rod; a transition connection section, which is used to connect the guide tube and the guide shaft; the transition connection section is a tubular structure including an oblique opening formed along the axial direction of the proximal port, comprising an inner layer extension section, an elastomeric wedge sleeve, and an outer layer extension section; wherein the elastomeric wedge sleeve is arranged at the distal end of the guide shaft; the elastomeric wedge sleeve provides rigidity and connection strength for the transition connection section; the distal end of the guide shaft is aligned with the middle layer but not connected, and is separated by a second distance of 0.1mm-10mm; wherein the outer layer and the outer layer extension section wrap the inner layer, the inner layer extension section, the middle layer, the elastomeric wedge sleeve, and the distal end of the guide shaft and then are hot-melt welded together.
[0005] At least some embodiments have the following advantages: the transition connection section of the guide extension catheter includes an elastomeric wedge sleeve, which is not connected to the middle layer, so that the transition connection section has ultra-flexibility, good mechanical transmission and transition properties, and reliable connection strength, so that this guide extension catheter has significant improvements in key performance including passability and operational reliability compared to the prior art. BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The features and advantages of the present application may be further understood by reference to the remainder of this specification and the accompanying drawings; the same reference numerals are used for the same components in the accompanying drawings. In some cases, a sub-label is placed after a reference numeral and a hyphen to indicate one of a number of similar components. When a reference numeral is mentioned without specifying an existing sub-label, all of these similar components are referred to.
[0007] Figure 1 It is a schematic diagram of a usage scenario of a guide extension catheter according to an embodiment of the present application.
[0008] Figure 2 It is a schematic diagram of the structure of a guide extension catheter according to an embodiment of the present application.
[0009] Figure 3 yes Figure 2 A cross-sectional view of the guide extension catheter of the described embodiment along the 3-3 direction.
[0010] Figure 4A for Figure 3 A partial forward schematic diagram of the structure shown.
[0011] Figure 4B for Figure 3 A schematic diagram of a partial top view of the structure shown. DETAILED DESCRIPTION
[0012] Embodiments are described in more detail below with reference to the following examples, which are provided herein by way of illustration only and are not intended to be limiting.
[0013] The present application has many variations that can be expected by those skilled in the art, and can achieve the use effect of the present application.
[0014] The limiting words used in this application for space or position, such as inside, outside, up, down, left, right, top, bottom, front, and back, are defined with reference to the placement position of the guide extension catheter when in use.
[0015] In the present application, the term "comprising" means including but not limited to the following elements, that is, it does not exclude other elements.
[0016] In the present application, when the guide extension catheter is in use, the end of the guide extension catheter itself or any part of the guide extension catheter that is relatively close to the operator's hand is the "proximal end", and correspondingly, the end that is relatively far away from the operator's hand is the "distal end".
[0017] In the present application, the term "axial direction" refers to 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" refers to the direction in which the circumferential wall of the guide extension catheter is located.
[0019] In the present application, the term "oblique direction" refers to a direction of a line intersecting at an acute angle with the central axis of the guide tube.
[0020] In this application, the term "connected" refers to a physical rigid connection between two specific parts, including but not limited to physical connection methods such as welding, brazing, riveting, etc. "Not connected" means that the two specific parts are not directly physically rigidly connected.
[0021] In this application, the terms "about" and "approximately" represent the range of accuracy that a person skilled in the art will understand to still ensure the technical effect of the feature in question. The term generally means a deviation of 10%, preferably 5%, from the indicated numerical value.
[0022] The transition section of the guide extension catheter between the guide tube and the guide shaft is the key to the entire guide extension catheter. The connection performance and transition performance of the guide extension catheter determine whether the guide extension catheter can play its role in actual use. During the process of pushing the guide extension catheter into the body, it usually encounters tortuosity or vascular stenosis. At this time, due to the large cross-section of the guide tube, it is easy to be blocked first, while the cross-section of the guide shaft is small, so the cross-sectional area ratio of the two is usually large (for example, 80:1). At the same time, the hardness of the two structures is quite different, so that the guide extension catheter usually produces a large stress concentration in the transition section during the actual advancement process, and it is easy to deform and bend in the transition section. Therefore, the coaxiality of the mechanical transmission of the guide extension catheter is destroyed, resulting in the inability of the pushing force applied from the operating end of the guide shaft outside the body to be effectively transmitted to the guide tube body through the transition section, which causes the guide extension catheter to be unable to continue to move forward and cannot reach the designated position to play a role. When the transition section deforms during operation, it will also directly cause deformation at the entrance of the inner cavity of the guide tube. The deformation at the entrance of the inner cavity can easily lead to the loss of the effective inner cavity of the guide extension catheter, so that the originally matched interventional treatment device will be blocked at the entrance of the guide tube and cannot enter the inner cavity, making the guide extension catheter ineffective. When the guide extension catheter is withdrawn, the guide tube may be stuck due to deformation or channel collapse, resulting in a higher than normal guide tube withdrawal resistance. At this time, the overall tensile strength of the guide extension catheter is tested, and the transition section is usually a weak part due to the aforementioned structural reasons. It is easy to be damaged first when it is pulled, which in turn causes the product to break and endangers the patient's life.
[0023] The guide extension catheter of the present application has a transition section comprising an elastomeric wedge sleeve, which is not connected to the middle layer, so that the transition section has super flexibility, good mechanical transmission and transition, and reliable connection strength, which makes this guide extension catheter significantly improved in key performance including passability and mechanical transmission reliability compared with the prior art. It further enables the guide extension catheter to fully and reliably play its role in surgical operations, helping to shorten the operation time and improve the success rate of the operation. The specific technical solution is as follows:
[0024] One aspect of the present application provides a guide extension catheter, comprising: a guide tube, comprising a proximal port and a distal port, the guide tube comprising an inner layer, a middle layer, and an outer layer; a guide shaft, arranged at one side of the proximal port, the guide shaft being used to guide the guide tube into a target position; a transition connection section, which is used to connect the guide tube and the guide shaft; the transition connection section is a tubular structure including an oblique opening formed along the axial direction of the proximal port, comprising an inner layer extension section, an elastomeric wedge sleeve, and an outer layer extension section; the elastomeric wedge sleeve provides rigidity and connection strength for the transition connection section; wherein the elastomeric wedge sleeve is arranged at the distal end of the guide shaft; the distal end of the guide shaft is aligned with the middle layer but not connected, and is separated by a second distance of 0.1mm-10mm; wherein the outer layer and the outer layer extension section wrap the inner layer, the inner layer extension section, the middle layer, the elastomeric wedge sleeve, and the distal end of the guide shaft and then are hot-melt welded together.
[0025] In at least one embodiment, the distal end of the guide shaft is a round metal rod, and the proximal end of the guide shaft is a flat metal rod.
[0026] In at least one embodiment, the outer layer and the outer layer extension are made of nylon, polyurethane or thermoplastic elastomer, the inner layer and the inner layer extension are made of high molecular polymer; the middle layer is a metal mesh layer; and the elastomeric wedge sleeve is made of nylon, polyurethane or thermoplastic elastomer.
[0027] Another aspect of the present application provides a guide extension catheter, comprising: a guide tube, comprising a proximal port and a distal port, the guide tube comprising an inner layer, a middle layer, and an outer layer; a guide shaft, arranged on one side of the proximal port, the guide shaft being used to guide the guide tube into a target position; the distal end of the guide shaft is a round metal rod, and the proximal end of the guide shaft is a flat metal rod; a transition connection section, which is used to connect the guide tube and the guide shaft; the transition connection section is a tubular structure including an oblique opening formed along the axial direction of the proximal port, comprising an inner layer extension section, an elastomeric wedge sleeve, and an outer layer extension section; wherein the elastomeric wedge sleeve is arranged at the distal end of the guide shaft; the elastomeric wedge sleeve provides rigidity and connection strength for the transition connection section; the distal end of the guide shaft is aligned with the middle layer but not connected, and is separated by a second distance of 0.1mm-10mm; wherein the outer layer and the outer layer extension section wrap the inner layer, the inner layer extension section, the middle layer, the elastomeric wedge sleeve, and the distal end of the guide shaft and then are hot-melt welded together.
[0028] The various aspects of the embodiments of the present application will be described in detail below in conjunction with the accompanying drawings.
[0029] like Figure 1As shown, it is a schematic diagram of the guide extension catheter 10 and the supporting device 200 when used in combination. Among them, the supporting device 200 includes a guide catheter 11 and a guide sheath 14 that together form a primary intervention channel, the guide catheter distal end 12 enters the blood vessel, the guide catheter proximal end 13 is connected to the Y-type hemostatic valve 15, and the guide extension catheter 10 enters the primary intervention channel through the Y-type hemostatic valve 15, advances along the inner cavity of the guide catheter 11, and finally exceeds the guide catheter distal end 12 and is placed in a more distant blood vessel (such as a coronary artery).
[0030] Figure 2 FIG. 1 is a simplified diagram of the appearance of the guide extension catheter 10 described in one embodiment of the present application. Figure 2 As shown, the guide extension catheter 10 includes three parts: a guide tube 20, a transition connection section 30 and a guide shaft 40. The guide tube is also called a distal tube, the guide shaft is also called a proximal shaft, and the transition connection section can also be called a transition section. The guide tube 20 is located at the distal end of the guide extension catheter 10, the guide shaft 40 is located at the proximal end of the guide extension catheter 10, and the transition connection section 30 is used to achieve the connection between the guide tube 20 and the guide shaft 40.
[0031] Figure 3 This application Figure 2 The cross-sectional view of the embodiment in the direction 3-3. Figure 3 As shown in the figure, the guide tube 20 is a tubular structure, which serves as a channel for interventional medical devices. The structure of the guide tube 20 is an inner layer 21, a middle layer 22 and an outer layer 23 from the inside to the outside of the inner cavity, wherein the inner layer 21, the middle layer 22 and the outer layer 23 form a tubular structure including an inner cavity 24; the material of the inner layer 21 can be PTFE or other plastics, the material of the middle layer 22 can be a stainless steel woven mesh or other metal woven mesh, and the material of the outer layer 23 can be a thermoplastic elastomer, a polyurethane elastomer or other plastics. The guide shaft 40 is an elongated solid rod, which includes a main body portion 41 and a distal portion 42. The main body portion 41 can be a cylindrical stainless steel rod or other metal rod, and the distal portion 42 is an extension of the main body portion 41. The extension method can be stamping flattening, laser cutting flattening, grinding and refinement or other processing methods. The length of the distal portion 42 can be 1mm-50mm. Figure 3It can be seen that the transition section 30 is a part extending axially from the proximal port 26 of the guide tube 20, which connects the guide tube 20 and the guide shaft 40 together, and has an oblique opening 25, which is connected to the inner cavity 24 of the guide tube 20. The transition section 30 includes an inner extension section 211, an outer extension section 231 and an elastomeric wedge sleeve 35, and the intermediate layer 22 is not connected to the distal end of the guide shaft 40, but is separated by a distance, which can be 0.1mm-10mm. The outer periphery of the distal end 42 of the guide shaft 40 is coated with a section of the elastomeric wedge sleeve 35, and the coating method can be hot-melt coating or stamping, welding, brazing, riveting, etc. The material of the elastomeric wedge sleeve 35 can be plastic such as nylon or metal. The elastic wedge sleeve 35 is coated between the outer layer 23 and the guide shaft 40 and is inlaid with the two to form a bridge mortise and tenon structure, which greatly enhances the structural firmness and tensile strength while maintaining the structural flexibility; after the redundant tube body part without the middle layer 22 and the elastic wedge sleeve 35 is cut off at the proximal end of the guide tube 20, an arc-shaped oblique opening, i.e., the oblique opening 25, will eventually be formed, which is also the entrance for other interventional instruments to enter the guide extension catheter 10. At this point, the above components can be hot-melt-coated as a whole by the outer layer 23 of the guide tube 20 after assembly, forming the main structure of the guide extension catheter 10.
[0032] The proximal end of the guide tube 20, the elastomeric wedge sleeve 35 and the distal end of the guide shaft 40 together constitute the transition section 30 of the guide extension catheter. The presence of the elastomeric wedge sleeve 35 alleviates the large stress concentration at both ends of the transition section 30 due to the large cross-sectional area difference (ratio, for example, 80:1) and the difference in hardness and softness of the structure, and improves the mechanical transmission and transition of the transition section 30. This design greatly reduces the metal coverage of the transition section, thereby significantly improving the flexibility and cornering ability of the transition section 30, while improving the connection strength and structural rigidity of the transition section, thereby significantly improving the overall key performance of the guide extension catheter 10, including passability and operating reliability.
[0033] Figure 4A-4B Shown Figure 3 A partial schematic diagram of the structure shown. The figure shows the relative positions of the main components of the guide extension tube skeleton structure, mainly including the middle layer 22 and the guide shaft 40. The proximal end of the middle layer 22 is aligned with the distal end of the guide shaft 40 but not connected, and has a second interval 312, and the distance of the second interval 312 can be 0.1mm-10mm; the above interval design enhances the softness of the structure and avoids the increase in thickness caused by stacking to reduce the overall structural thickness, significantly improving the mechanical transmission and transition of the transition connection section 30.
[0034] The methods provided in the example embodiments of this specification are only examples, and the example of one method does not limit the example of another method. The device / method discussed in one figure can be added to or exchanged with the device / method in other figures. In addition, specific numerical data values (such as specific quantities, quantities, categories, etc.) or other specific information are only used to discuss the example embodiments, and such specific information is not used to limit the example embodiments.
Claims
1. A guide extension catheter, characterized in that include: A guide tube, comprising a proximal port and a distal port, wherein the guide tube comprises an inner layer, a middle layer, and an outer layer; A guide shaft, disposed at one side of the proximal port, the guide shaft being used to guide the guide tube into a target position; A transition connecting section, which is used to connect the guide tube and the guide shaft; the transition connecting section is a tubular structure including an oblique opening and extending axially from the proximal port, and includes an inner layer extension section, an elastomeric wedge sleeve, and an outer layer extension section; the elastomeric wedge sleeve provides rigidity and connection strength for the transition connecting section; Wherein, the elastic wedge sleeve is arranged at the distal end of the guide shaft; The distal end of the guide shaft is aligned with the middle layer but not connected, and is separated by a second distance of 0.1 mm to 10 mm; The outer layer and the outer layer extension section wrap the inner layer, the inner layer extension section, the middle layer, the elastomeric wedge sleeve and the distal end of the guide shaft and then are hot-melt welded together.
2. The guide extension catheter according to claim 1, characterized in that: The distal end of the guide shaft is a round metal rod, and the proximal end of the guide shaft is a flat metal rod.
3. The guide extension catheter according to claim 1, characterized in that: The outer layer and the outer layer extension section are made of nylon, polyurethane or thermoplastic elastomer, the inner layer and the inner layer extension section are made of high molecular polymer; the middle layer is a metal mesh layer; and the elastomer wedge sleeve is made of nylon, polyurethane or thermoplastic elastomer.
4. A guide extension catheter, characterized in that include: A guide tube, comprising a proximal port and a distal port, wherein the guide tube comprises an inner layer, a middle layer, and an outer layer; A guide shaft is arranged at one side of the proximal port, and is used to guide the guide tube into a target position; the distal end of the guide shaft is a round metal rod, and the proximal end of the guide shaft is a flat metal rod; A transition connection section, which is used to connect the guide tube and the guide shaft; the transition connection section is a tubular structure including an oblique opening and extending axially from the proximal port, and includes an inner extension section, an elastomeric wedge sleeve, and an outer extension section; wherein the elastomeric wedge sleeve is arranged at the distal end of the guide shaft; the elastomeric wedge sleeve provides rigidity and connection strength for the transition connection section; The distal end of the guide shaft is aligned with the middle layer but not connected, and is separated by a second distance of 0.1 mm to 10 mm; The outer layer and the outer layer extension section wrap the inner layer, the inner layer extension section, the middle layer, the elastomeric wedge sleeve and the distal end of the guide shaft and then are hot-melt welded together.