A system for transradial percutaneous coronary intervention with improved safety configuration

Abstract

A system for transradial percutaneous coronary intervention with enhanced safety configuration, consisting of: a vascular access assembly configured to establish transradial access through the proximal right radial artery using a puncture needle and a venous cannula; a sheath selection unit configured to employ either a radial Cordis sheath 7F for the application of the mother-child technique or a radial Cordis sheath 6F for the application of the same size technique; a catheter guide unit configured to position a 6F percutaneous transluminal coronary angioplasty catheter through the deployed sheath for coronary intervention; a hemostasis control unit configured to achieve hemostasis of the radial artery by compression and application of a biopolymer dressing; and a safety monitoring unit configured to track vascular access complications and adverse events during transradial procedures.

Description

FIELD OF THE INVENTION

[0001] The present disclosure relates to a system for transradial percutaneous coronary interventions with an enhanced safety configuration. More specifically, the present invention relates to a system for applying a mother-child approach with a larger radial sheath and the same guide size for transradial PCI to perform a safety assessment during percutaneous coronary interventions with an enhanced safety configuration. BACKGROUND OF THE INVENTION

[0002] Transradial access (TRA) has emerged as the preferred method for coronary interventions due to its proven reduction in vascular complications and mortality rates, particularly in patients with ST-elevation myocardial infarction. Despite the overall improvements brought about by TRA, certain complications remain, including intraprocedural events such as radial artery perforation, radial spasm, catheter entrapment, dissection, and catheter kinking, as well as postprocedural complications such as wrist hematoma, compartment syndrome, radial artery occlusion, pseudoaneurysm, arteriovenous fistula, nerve damage, and infection. Current standard practice is to use the same sizes for both the radial sheath and the percutaneous coronary interventional catheter.However, there is a significant gap in our knowledge as to whether the use of a larger sheath with a smaller guide catheter, particularly the “mother-child technique” with a 7F sheath and a 6F guide catheter, offers advantages over the conventional approach with the same sheath and guide size.

[0003] Existing systems for conducting comparative safety assessments of different TRA techniques lack comprehensive integration of patient screening functions, standardized device use, and systematic data collection for statistical comparison of complication rates between different combinations of sheath and catheter sizes.

[0004] Therefore, there is a need for an integrated system that enables a systematic comparative evaluation of TRA techniques, in particular a comparison of the mother-to-child technique with conventional approaches of the same size, while providing comprehensive patient screening, standardized device deployment, and robust data collection capabilities for an evidence-based assessment of safety and efficacy outcomes in transradial coronary interventions. Summary of the invention

[0005] The present disclosure relates to a system for transradial percutaneous coronary interventions with an enhanced safety configuration. The present invention relates to a system for transradial percutaneous coronary interventions with an enhanced safety configuration that utilizes the mother-child approach to reduce vascular complications. The system includes integrated units for vascular access creation, selective sheath insertion, catheter guidance, hemostasis control, and safety monitoring. It was specifically designed to compare and optimize the use of 7F radial sheaths with 6F catheters compared to conventional accesses of the same size, thus improving patient outcomes in coronary interventions.

[0006] One objective of the present disclosure is to provide a system for transradial percutaneous coronary interventions with an enhanced safety configuration. The system includes: a vascular access unit that establishes transradial access via the proximal right radial artery using a puncture needle and venous cannula; a sheath selection unit that deploys either a 7F Radial Cordis sheath for the mother-and-child technique or a 6F Radial Cordis sheath for the same-size technique; a catheter guidance unit that positions a 6F catheter for percutaneous transluminal coronary angioplasty through the deployed coronary intervention sheath; a hemostasis control unit that achieves hemostasis of the radial artery through compression and the application of a biopolymer dressing; and a safety monitoring unit that tracks vascular access complications and adverse events during transradial procedures.

[0007] Another objective of the present disclosure is to provide a system for transradial percutaneous coronary interventions with improved safety configuration.

[0008] Another objective of the present disclosure is to provide a comprehensive system that enables systematic implementation and evaluation of the mother-child technique using 7F radial sheaths with 6F catheters for transradial coronary interventions with reduced vascular complications.

[0009] Another object of the present disclosure is to develop an integrated safety monitoring and hemostasis control system that minimizes both intraprocedural and postprocedural complications, including radial artery spasms, catheter kinks, and access site bleeding.

[0010] Another objective of this disclosure is to create a standardized platform for the comparative evaluation of different configurations of sheath catheters in transradial access procedures in order to optimize patient comfort and procedural efficiency.

[0011] Another object of the present disclosure is to provide a system for procedural optimization that reduces the number of required vascular access sites while ensuring successful outcomes in coronary interventions through improved device selection and deployment capabilities.

[0012] To further clarify the advantages and features of the present disclosure, the invention will be explained in more detail with reference to specific embodiments illustrated in the accompanying drawings. These drawings illustrate only typical embodiments of the invention and are therefore not to be considered as limiting its scope. The invention will be described and explained in more detail with reference to the accompanying drawings. SHORT DESCRIPTION OF THE FIGURE

[0013] These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read with reference to the accompanying drawings, in which like characters represent like parts throughout. Fig. 1 shows a block diagram of a system for transradial percutaneous coronary interventions with enhanced safety configuration according to an embodiment of the present disclosure.

[0014] Those skilled in the art will also appreciate that the elements in the drawings are shown for convenience and are not necessarily to scale. For example, the flowcharts illustrate the method by key steps to enhance understanding of aspects of the present disclosure. Furthermore, with respect to device construction, one or more components of the device may be represented in the drawings by conventional symbols. The drawing may show only the specific details relevant to understanding embodiments of the present disclosure in order not to clutter the drawing with details that would be readily apparent to those skilled in the art from the present description. DETAILED DESCRIPTION:

[0015] To facilitate understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and a clear description will be given. However, the scope of the invention is not limited thereby. Changes and further modifications to the illustrated system, as well as further applications of the principles of the invention, are possible, as would normally occur to one skilled in the art to which the invention pertains.

[0016] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be limiting thereof.

[0017] References in this specification to "one aspect," "another aspect," or similar language mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, the language "in one embodiment," "in another embodiment," and similar language throughout this specification may or may not refer to the same embodiment.

[0018] The terms "comprises," "comprising," or other variations thereof are intended to cover non-exclusive inclusion, such that a process or method comprising a list of steps may include not only those steps, but also additional steps not expressly listed or inherent in that process or method. Likewise, the statement "comprises" for one or more devices, subsystems, elements, structures, or components does not exclude, without further limitation, the existence of other devices, subsystems, elements, structures, components, or additional devices, subsystems, elements, structures, or components.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. The systems, methods, and examples provided herein are for illustrative purposes only and should not be considered limiting.

[0020] Embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings.

[0021] Fig. 1 shows a block diagram of a system (100) for transradial percutaneous coronary interventions with enhanced safety configuration according to an embodiment of the present disclosure.

[0022] According to Fig.1, the system (100) comprises: a vascular access assembly (102) configured to establish a transradial access through the proximal right radial artery using a puncture needle and a venous cannula; a sheath selection unit (104) configured to insert either a 7F radial Cordis sheath for the mother-child technique or a 6F radial Cordis sheath for the same-size technique; a catheter guidance unit (106) configured to position a 6F catheter for percutaneous transluminal coronary angioplasty through the inserted sheath during coronary interventions; a hemostasis control unit (108) configured to achieve hemostasis of the radial artery by means of compression and application of a biopolymer dressing; and a safety monitoring unit (110) configured to track vascular access complications and adverse events during transradial procedures.

[0023] In one embodiment, the vascular access assembly (102) is configured to use a 20G venous cannula to puncture the radial artery.

[0024] In one embodiment, the sheath selection unit (104) is configured to accept Cordis Corporation radial sheaths with selective deployment capability between 7F and 6F configurations.

[0025] In one embodiment, the catheter guide unit (106) is configured to position guide catheters selected from the group consisting of EBU 3.5, EBU 3, JL 3.5, JL 3 for left coronary artery interventions and JR 3.5 for right coronary artery interventions.

[0026] In one embodiment, the system (100) further comprises a local anesthesia unit (112) configured to deliver 5-10 ml of 2% lidocaine subcutaneously at the vascular access site.

[0027] In one embodiment, the safety monitoring unit (110) is configured to detect and record radial artery spasms, catheter kinks, and other vascular complications during the procedure.

[0028] In one embodiment, the sheath selection unit (104) is configured to enable implementation of the mother-child technique using the 7F sheath with the 6F catheter to reduce vascular complications.

[0029] In one embodiment, the hemostasis control unit (108) is configured to apply manual compression followed by a biopolymer dressing for optimal closure of the radial artery.

[0030] In one embodiment, the system (100) is configured to reduce patient discomfort and reduce procedure time through an optimized sheath-to-catheter size configuration.

[0031] In one embodiment, the system (100) further comprises an operation optimization unit (114) configured to minimize the number of vascular access sites required for a successful coronary intervention.

[0032] The present invention relates to a comprehensive system for transradial percutaneous coronary interventions that addresses the ongoing challenges associated with vascular access complications in coronary procedures. Although transradial access has become the preferred technique for coronary interventions due to its proven lower complication rate compared to femoral access, certain adverse events continue to occur, necessitating further optimization of techniques and device selection.

[0033] The system includes a vascular access device specifically configured for transradial puncture through the proximal right radial artery using standardized needle and venous cannula puncture techniques. This design ensures consistent and reliable access with minimal trauma to the radial artery. The system utilizes a 20G Smiths Medical Jelco venous cannula for precise puncture of the radial artery, thus providing an optimal balance between access security and vessel preservation.

[0034] A key innovation of the system is the sheath selection unit, which enables selective deployment between 7F and 6F radial sheaths from Cordis Corporation. This unit enables the use of the mother-child approach, which uses a larger 7F sheath with a smaller 6F catheter for percutaneous transluminal coronary angioplasty, as well as conventional approaches of the same size using 6F sheaths and 6F catheters. This flexibility enables comparative evaluation and optimization of procedural approaches based on patient-specific factors and procedural requirements.

[0035] The catheter guide unit is designed for various guiding catheter configurations, including EBU 3.5, EBU 3, JL 3.5, JL 3 for left-sided coronary interventions, and JR 3.5 for right-sided coronary interventions. This comprehensive catheter compatibility ensures that the system supports a wide range of coronary interventions while offering the benefits of the optimized sheath-to-catheter size ratio.

[0036] The system features a sophisticated hemostasis control unit that manages closure of the radial artery through a combination of manual compression and the application of a biopolymer dressing. This dual hemostasis strategy ensures reliable vessel closure, minimizes patient discomfort, and reduces the risk of access site complications such as hematoma formation or persistent bleeding.

[0037] Safety monitoring functions are integrated system-wide through a dedicated safety monitoring unit that captures vascular access complications and adverse events during transradial procedures. This unit is specifically designed to detect and record radial artery spasms, catheter kinks, and other vascular complications. This enables real-time assessment of procedural safety and postoperative outcome analysis.

[0038] The system also includes a local anesthesia unit that delivers precise amounts of 2% lidocaine subcutaneously to the vascular access site. This ensures patient comfort while maintaining procedural efficiency. In addition, a procedure optimization unit minimizes the number of vascular accesses required for a successful coronary intervention, thus reducing overall complexity and potential complications.

[0039] In an exemplary embodiment, the system established transradial access through the proximal right radial artery using a puncture needle and a 20G Smiths Medical Jelco venous cannula. All patients underwent an Allen test with pulse oximetry, and only patients with a palpable radial artery and a positive Allen test were included. A total of 132 patients were selected for TRA access PCI using this system. Emergency patients or hemodynamically unstable patients, patients with non-palpable radial arteries, and patients with a negative Allen test were excluded. The system allowed for the selective insertion of either a 7F Radial Cordis sheath for the mother-and-child technique (with a 6F PTCA guide catheter) or a 6F Cordis Radial sheath for the same-size technique (with a 6F PTCA guide catheter). Patients were divided into two groups based on sheath and catheter configuration.The system administered 5–10 ml of 2% lidocaine subcutaneously to the vascular access site in all patients. The system positioned guiding catheters through the deployed sheath. EBU 3.5, EBU 3, JL 3.5, and JL 3 catheters were used for the left-sided coronary intervention. A JR 3.5 catheter was used for the right-sided coronary intervention. Hemostasis of the radial artery was achieved by manual compression, followed by the application of a biopolymer dressing for optimal radial artery closure. The system recorded vascular access complications and adverse events during the procedure. The system was configured to minimize the number of vascular accesses required for a successful coronary intervention.

[0040] The system is also configured for computer-assisted data analysis. A dedicated unit for this purpose is implemented and configured with version 23.0 of the Statistical Package for the Social Sciences (SPSS). The results are presented using descriptive analysis. Means and standard deviations (SDs) were used to represent continuous variables, while numbers and percentages were used to represent categorical variables. Fisher's exact test was used to compare adverse events.

[0041] In one example, the system was evaluated for transradial percutaneous coronary interventions with an enhanced safety configuration in two groups: one with a 7F radial Cordis sheath and a 6F PTCA guide catheter (mother-child approach), the other with a 6F radial Cordis sheath and a 6F PTCA guide catheter. The results of the data analysis are described below.

[0042] Demographics and interventions: The majority of patients in both groups were male. The mean age was 55.52 years in the 7F group and 57.43 years in the 6F group. The most frequently performed interventions were the left anterior descending artery (LAD) and single-vessel disease (SVD). No interventions were performed for main stem (LM), chronic total occlusion (CTO), or bifurcation. Sirolimus-eluting stents (SES) were the most commonly used intervention in both groups. The most commonly used guiding catheters were EBU 3.5 and Judkins Right (JR), according to the catheter guide unit configuration.

[0043] Vascular Complications and Safety Monitoring: In the 6F group, the system's safety monitoring unit detected radial artery spasm (RAS) in 15 cases, catheter kinking in 9 cases, asymptomatic radial artery occlusion (RAO) in 6 cases, and radial artery perforation in 1 case. In the 7F group, mild RAS was detected in 3 cases (all cases resolved spontaneously), no catheter kinking, 8 cases of asymptomatic RAO, 2 cases of wrist hematoma, and 1 case each of both radial artery perforation and AV fistula. RAO was diagnosed by palpation of the radial arteries.

[0044] Procedure optimization and management: In RAS in the 6F group, the system enabled successful PCI after administration of nitroglycerin and diltiazem in four cases, conversion to a 7F sheath in nine cases, and conversion to femoral access due to severe spasms in two cases. Catheter kinks were resolved by replacing the guide catheter in five cases and by switching to a 7F sheath with guide catheter exchange in four cases.

[0045] Comparative results: Fisher's exact test showed that there were significantly fewer RAS and catheter kinks in the 7F group, while the incidence of wrist hematomas and asymptomatic RAO was higher, but not statistically significant. No cases of radial artery avulsion, arterial dissection, pseudoaneurysm, compartment syndrome, or infection were observed in either group, highlighting the overall safety of the system.

[0046] Statement of the invention: These results underscore the system's ability to optimize sheath and catheter selection, improve safety monitoring, and effectively manage vascular complications. The mother-child approach with the 7F sheath and 6F catheter configuration resulted in reduced procedural complications, thus supporting the invention's claims for improved safety and procedural efficiency in transradial coronary interventions.

[0047] Vascular access complications continue to contribute significantly to morbidity and mortality in percutaneous coronary intervention (PCI). The system's configuration, particularly the sheath selection unit, which allows the use of a 7F sheath with a 6F catheter (mother-and-child technique), has been shown to reduce the overall number of adverse events compared to the 6F sheath configuration. This approach, supported by the system's procedure optimization unit, resulted in increased safety, reduced patient discomfort, reduced procedure time, and minimized the number of required vascular accesses. The system's safety monitoring and hemostasis control units contributed to the effective reduction of transradial access (TRA) complications such as radial artery spasm and catheter kinking.These findings support the system's potential as an alternative method to improve safety and efficiency in TRA-PCI procedures.

[0048] The drawings and the foregoing description illustrate examples of embodiments. Those skilled in the art will recognize that one or more of the described elements may well be combined to form a single functional element. Alternatively, certain elements may be separated into multiple functional elements. Elements of one embodiment may be added to another embodiment. For example, the order of the processes described herein may be changed and is not limited to the manner described herein. Furthermore, the actions of a flowchart need not be performed in the order shown; nor do all actions need to be performed. Also, actions that are not dependent on other actions may be performed in parallel with the other actions. The scope of the embodiments is in no way limited by these specific examples.Numerous variations, whether explicitly stated in the specification or not, such as differences in structure, dimensions, and use of materials, are possible. The scope of the embodiments is at least as broad as indicated in the following claims.

[0049] Advantages, further benefits, and solutions to problems have been described above with reference to specific embodiments. However, the advantages, advantages, solutions to problems, and any components that may result in or enhance an advantage, advantage, or solution are not to be construed as critical, required, or essential features or components of any or all of the claims. REFERENCES 100 A system for transradial percutaneous coronary interventions with enhanced safety configuration. 102 Vascular access system 104 Sheath selection unit 106 Catheter guide unit 108 Hemostasis control unit 110 Security Monitoring Unit 112 Local Anesthesia Unit 114 An operational optimization unit

Claims

[1] A system for transradial percutaneous coronary intervention with enhanced safety configuration, comprising: a vascular access assembly configured to establish transradial access through the proximal right radial artery using a puncture needle and a venous cannula; a sheath selection unit configured to employ either a radial Cordis sheath 7F for the application of the mother-child technique or a radial Cordis sheath 6F for the application of the same size technique; a catheter guide unit configured to position a 6F percutaneous transluminal coronary angioplasty catheter through the deployed sheath for coronary intervention; a hemostasis control unit configured to achieve hemostasis of the radial artery by compression and application of a biopolymer dressing; and a safety monitoring unit configured to track vascular access complications and adverse events during transradial procedures. [2] The system of claim 1, wherein the vascular access assembly is configured to use a 20G venous cannula to puncture the radial artery. [3] The system of claim 1, wherein the cladding selection unit is configured to accept Cordis Corporation radial cladding having selective deployment capability between 7F and 6F configurations. [4] The system of claim 1, wherein the catheter guide unit is configured to position guide catheters selected from the group consisting of EBU 3.5, EBU 3, JL 3.5, JL 3 for left coronary artery intervention, and JR 3.5 for right coronary artery intervention. [5] The system of claim 1, further comprising a local anesthesia unit configured to deliver 5-10 ml of 2% lidocaine subcutaneously at the vascular access site. [6] The system of claim 1, wherein the safety monitoring unit is configured to detect and record radial artery spasms, catheter kinks, and other vascular complications during the procedure. [7] The system of claim 1, wherein the sheath selection unit is configured to enable implementation of the mother-child technique using the 7F sheath with the 6F catheter to reduce vascular complications. [8] The system of claim 1, wherein the hemostasis control unit is configured to apply manual compression followed by a biopolymer dressing for optimal closure of the radial artery. [9] The system of claim 1, wherein the system is configured to reduce patient discomfort and reduce procedure time through an optimized sheath-to-catheter size configuration. [10] The system of claim 1, further comprising an operation optimization unit configured to minimize the number of vascular access sites required for a successful coronary intervention.

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