Disposable zero-exchange long sheath transradial artery passage covering assembly
By designing a disposable, zero-exchange long sheath transradial artery access kit, the problem of insufficient integration of radial artery access devices was solved, which simplifies operation and improves treatment efficiency. It is applicable to different vascular structures and reduces surgical complexity and complications.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- EASYCESS MEDICAL LTD
- Filing Date
- 2024-12-31
- Publication Date
- 2026-04-24
AI Technical Summary
In existing technologies, the radial artery approach does not have sufficient device integration in cerebrovascular interventional therapy, leading to difficulties in selection and increased additional costs, especially when superselective catheters are required, due to a lack of suitable catheter assemblies.
A disposable, zero-exchange long sheath transradial artery access kit was designed, comprising a needle, guidewire, long sheath, and dilator. The dilator has a soft beveled contact portion, the guidewire is coated with a hydrophilic layer, and the long sheath has a multi-strand spring layer and a hydrophilic coating, suitable for different vascular structures. The kit includes a Y-valve and an MP head, integrated into a single kit to simplify the operation process.
It enables simplified procedures applicable to both conventional and superselective blood vessels, reducing surgical difficulty, improving treatment efficiency, reducing complications, improving patient comfort, achieving "zero exchange" technology, and reducing surgical complexity.
Smart Images
Figure CN224156148U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical devices for stroke treatment, and in particular to a disposable, zero-exchange long sheath transradial artery access kit. Background Technology
[0002] In interventional vascular treatment, there are various approaches for device access, with the radial artery approach and the femoral artery approach being the two main surgical approaches. Currently, although the femoral artery is the most commonly used surgical approach for interventional cerebrovascular treatment compared to the radial artery, only a few interventional cerebrovascular centers have begun to experiment with the radial artery approach for DSA and interventional treatment. In clinical practice, the radial artery approach is mostly used for coronary artery interventional treatment. As early as 1989, CAMPEAU et al. first reported the use of the radial artery approach for coronary angiography, finding that this method had fewer complications, higher patient comfort, and did not affect postoperative ambulation. To date, the radial artery approach has become a routine approach for coronary angiography. In 2000, MATSUMOTO et al. proposed the concept of using the radial artery for whole-brain angiography. Although the femoral artery approach is currently widely used in neurointervention, some scholars still believe that the radial artery approach, as a more minimally invasive method, has a much lower severity of complications than the femoral artery approach, and more importantly, greatly improves patient comfort and acceptability. Therefore, it should be more widely used in cerebrovascular angiography and interventional treatment.
[0003] Choosing the radial artery approach has more advantages than the femoral artery approach. For example, (1) no perineal preparation is required, reducing the psychological discomfort of patients and making it easier for them to accept. (2) the tube can be removed immediately after the operation, and the joints of the limbs except the wrist joint on the puncture side are not restricted in their movement after the operation. This is especially advantageous for elderly patients who cannot stay in bed. The reduction of bed rest time after the operation has a positive effect on reducing the occurrence of deep vein thrombosis in the lower extremities. (3) dual circulation in the hand: reducing ischemia in the hand; (4) the bone surface of the puncture site is flat and without protruding bone: reducing bleeding at the puncture site; there is no major nerve and blood vessel course at the puncture site: no risk of nerve damage; (5) fewer complications, especially a significant reduction in serious complications such as retroperitoneal hematoma, pseudoaneurysm and arteriovenous fistula.
[0004] During routine physician consultations, situations requiring superselective catheters often necessitate a trade-off between convenience and cost in instrument preparation. This often necessitates the use of guidewires, short sheaths, long sheaths, etc. Currently, the integration of medical devices is insufficient, leading to difficulties in selection or potential increases in costs. Therefore, there is an urgent need for improved and integrated medical device solutions to meet these demands. Utility Model Content
[0005] This invention addresses the current deficiency in catheter assembly combinations for vascular embolization treatment, avoiding the need to disassemble and use other medical devices for matching when encountering vascular lesions requiring the use of superselective devices.
[0006] The disposable zero-exchange long sheath transradial artery access kit of this invention includes, but is not limited to: a needle and / or a skin incision device, a guidewire, a long sheath, and a dilator. The needle is used to pierce the skin, muscle, and vessel wall near the radial artery; the guidewire is used to enter the blood vessel and approach the lesion area; the long sheath has a channel for instrument passage, with a distal end for treatment and a proximal end for external manipulation; the dilator is catheter-shaped and movably sleeved on the outside of the guidewire and through the channel inside the long sheath, providing support for the proximal segment of the long sheath.
[0007] Furthermore, the expander has a soft, beveled contact portion at one end near the distal end.
[0008] Furthermore, the soft inclined contact portion has an inwardly tapered end.
[0009] Furthermore, the disposable zero-exchange long sheath via radial artery access kit also includes at least one Y valve, which has at least one bypass line connected to the channel of the long sheath.
[0010] Furthermore, at least one MP head is provided at the distal end of the long sheath, and the MP head has a corner section.
[0011] Furthermore, the guidewire includes a core and a sheath made of spring wire, and the guidewire also includes a hemispherical tip, and the outermost part of the guidewire is coated with a hydrophilic coating.
[0012] Furthermore, the long sheath includes an outer layer, a braided layer, a spring layer, or an inner layer.
[0013] Furthermore, the disposable zero-exchange long sheath transradial artery access kit also includes a packaging bag with several intervals.
[0014] The proximal section of the long sheath also includes a stress-relieving tube, which is sleeved on the outside of the connection gap between the long sheath and the Y valve.
[0015] Compared with the prior art, the technical effects of implementing this utility model are as follows:
[0016] (1) Applicable to blood vessels with conventional lesion range values, and also applicable to blood vessels that require the use of superselective instruments;
[0017] (2) The dilator has a structure that is more compatible with human blood vessels. When it is necessary to fill the gap between the guidewire and the long sheath, the dilator can be used to assist in the entry.
[0018] (3) Utilizing the function of the angiography guidewire, the procedure of puncture and superselective vessel operation can be completed directly in conjunction with the long sheath. This eliminates the need for a short puncture sheath, puncture guidewire, and other complex procedures, greatly reducing the difficulty of the operation, improving the treatment efficiency, and achieving the "zero exchange" technique. Attached Figure Description
[0019] Figure 1 This is a schematic diagram of the structure of the sleeve assembly after it has been threaded through.
[0020] Figure 2 This is a schematic diagram of the guide wire structure described in this utility model;
[0021] Figure 3 This is a schematic diagram of the structure of the expander described in this utility model;
[0022] Figure 4 This is a schematic diagram of the structure of the long sheath catheter described in this utility model;
[0023] Figure 5 This is a schematic diagram of another embodiment of the long sheath catheter described in this utility model;
[0024] Figure 6 This is a cross-sectional schematic diagram of one preferred embodiment of the present invention;
[0025] Figure 7 This is a schematic diagram showing the spacing and arrangement of the first and second springs of this utility model.
[0026] Figure 8 This is a schematic diagram showing the included angle between the first spring, the second spring, and the axial direction of this utility model.
[0027] Figure 9 This is a schematic diagram of the wire structure in the distal direction of the guide wire described in this utility model;
[0028] Figure 10 This is a schematic diagram of the structure of the core wire in the distal direction;
[0029] Figure 11 This is a schematic diagram of the head end structure;
[0030] Figure 12 This is a schematic diagram of the needle used for the puncture opening;
[0031] Figure 13 The packaged components of this utility model are packaged in a spaced-out packaging bag;
[0032] Figure 14 A schematic diagram of the selected morphological structure of the long sheath tip;
[0033] Figure 15 This is a schematic diagram showing the usage state of the expander and guidewire.
[0034] Among them, 1. Guidewire; 10. Tip; 100. Spherical tip; 101. Core; 11. Core wire; 12. Sheath; 13. Hydrophilic coating; 2. Diverter; 20. Soft beveled contact part; 21. Inward-curving tip; 3. Long sheath; 30. Imaging ring; 31. Distal tube segment; 310. Outer layer; 311. Braided layer; 312. Spring layer; 313. Inner layer; 32. Stress-relieving tube; 33. Grip part; 34. Conical opening; 4. Y valve; 40. First channel; 41. Second channel; 50. Flow valve; 51. Outer tube; 6. Needle; 7. Packaging bag. Detailed Implementation
[0035] This section will describe in detail the specific embodiments of this application. Preferred embodiments of this application are shown in the accompanying drawings. The purpose of the drawings is to supplement the textual description with graphics, so that people can intuitively and vividly understand each technical feature and the overall technical solution of this application, but they should not be construed as limiting the scope of protection of this application.
[0036] In the description of this application, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.
[0037] In the description of this application, "several" means one or more, "more than" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.
[0038] In the description of this application, unless otherwise expressly defined, terms such as "setup," "installation," and "connection" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this application in conjunction with the specific content of the technical solution.
[0039] To more clearly describe this invention, the concepts of "distal" and "proximal" are defined herein, and these are commonly used terms in the field of interventional medical devices. Specifically, "distal" refers to the end furthest from the operator during surgery, and "proximal" refers to the end closest to the operator during surgery. Of course, for a single device object, "proximal" can also describe the end closest to the operator, and "distal" can also describe the end furthest from the operator.
[0040] See Figures 1-15 .
[0041] The disposable zero-exchange long sheath transradial artery access kit of this invention includes, but is not limited to: a needle and / or a skin incision device, a guidewire, a long sheath, and a dilator. The needle and / or skin incision device are used to puncture the skin, muscle, and vessel wall near the radial artery; the guidewire is used to enter the blood vessel and approach the lesion area; the long sheath has a channel for instruments to pass through, with a distal end for treatment and a proximal end for external manipulation; the dilator is catheter-shaped and movably sleeved on the outside of the guidewire and through the channel inside the long sheath, providing support for the proximal segment of the long sheath.
[0042] To prevent the distal edge of the dilator from easily scraping against the inner wall of the blood vessel when it is inserted into a narrow blood vessel, as a preferred embodiment, the distal end of the dilator has a soft, beveled contact portion. As a further preferred embodiment, the soft, beveled contact portion has an inwardly tapering tip. This also reduces discomfort caused by minor radial vibrations of the guidewire or dilator.
[0043] As a more specific design, the disposable zero-exchange long sheath via radial artery access kit also includes at least one Y valve, which has at least one bypass line connected to the channel of the long sheath.
[0044] To facilitate access to difficult-to-enter bifurcated blood vessels during use, as a preferred embodiment, at least one MP head is provided at the distal end of the long sheath, and the MP head has a corner section.
[0045] As a more specific embodiment, the guidewire includes a core and a sheath made of spring wire, the guidewire also includes a hemispherical tip, and the outermost part of the guidewire is coated with a hydrophilic coating.
[0046] On the other hand, as a more specific embodiment, the long sheath includes an outer layer, a woven layer, a spring layer, or an inner layer. The method for manufacturing the long sheath is described in more detail in subsequent paragraphs.
[0047] To facilitate transportation and ensure cleanliness requirements, as a preferred embodiment, the disposable zero-exchange long sheath transradial artery access kit also includes a packaging bag with several compartments.
[0048] To reduce the potential impact of bending stress, as a preferred embodiment, the proximal section of the long sheath further includes a stress-relieving tube, which is sleeved on the outside of the connection gap between the long sheath and the Y valve.
[0049] Based on the aforementioned technical solution, a more specific manufacturing solution is provided:
[0050] (a) Method for preparing the long sheath:
[0051] (1) Dipping and etching of the inner lining: Using highly lubricating PTFE liquid material, silver-plated copper wires with a diameter of 0.056~0.109 inches are straightened and clamped and suspended on the dipping equipment. After starting the equipment, the silver-plated copper wires are immersed in liquid PTFE, left to stand for 2~5 minutes to stabilize, and then lifted up at a speed of 0.04~0.46 mm / s. After cooling and forming a film, the surface is treated with a chemical etching process to give it high adhesion.
[0052] (2) Winding and stacking of multi-strand spring layers: Using round and flat wires of metals such as stainless steel and nickel-titanium alloy, with wire size of 0.001~0.006 inches and 2~4 strands, the first spring layer is formed by winding with a slant angle of 20°~90° and a density of 0.05~0.6 mm. Then, using a second strand or other strands of metal wire, the second spring layer and the remaining spring layers are stacked by setting different slant angles and densities. Finally, a multi-strand spring layer is formed by interlocking and stacking the strands.
[0053] (3) Strengthening the braided mesh tube layer: Round and flat wires of metals such as nickel-titanium alloy and stainless steel, which have undergone a reinforced cold drawing process, are used. The wire size is 0.001~0.006 inches, the preferred number of spindles is 8, 16, or 32, and the braiding density is 25~120 PPI. After forming a uniform braided mesh tube by a braiding machine, it is cut at the tube opening and fitted with a developing ring made of platinum-iridium alloy.
[0054] (4) Rheological composite of the outer tube layer: Reinforced biocompatible polymer materials such as Nylon, Pebax, TPU, and PC are used for preparation through plunger extrusion or screw extrusion equipment. First, the raw materials are preheated and dried before plasticization, that is, the solid polymer granules are heated in the extruder and made into a viscous fluid material by relying on the internal friction heat between the polymer materials. The corresponding key process parameters are preferably a temperature of 180℃-290℃ and a pressure of ≤55Mpa. Then, it is shaped. Under the rotating pushing action of the extruder screw, the viscous fluid material formed by plasticization is made into a continuous profile through a die with a certain shape. The corresponding key process parameters are preferably a helix angle of 12.8°-29.1°. Finally, the extruded continuous profile is cooled and shaped into a tube product, that is, a single-cavity or multi-cavity tube body, which serves as the outer layer material of the conduit. This component can have different specifications and dimensions such as inner diameter, length, hardness, and thickness. The tube consists of 7-10 different functional segments, connected using hot air welding technology. Finally, through overall rheological technology, the outer material is softened at temperatures ranging from 220℃ to 378℃, rheologically bonding the inner lining, spring layer, braided mesh layer, and outer tube layer to form a complete tube body. Simultaneously, during the rheological process, a tension reducing fixture is used to further reduce the tube wall thickness.
[0055] (5) Bonding and assembly of conduit seat and stress relief component: A conduit seat made of rigid materials such as PC, PVC, and Nylon, with a standard 6% Luer connector, is bonded to the prepared tube body using UV photosensitive adhesive and ultraviolet light. Then, a stress relief component made of soft materials such as TPE and silicone, with a taper of 8° to 33°, is assembled onto the conduit seat through the bayonet of the conduit seat.
[0056] (6) Coating of hydrophilic coating: Specifically, seal the head and tail ends of the sheath with silicone plugs, then suspend it on the chuck of the coating equipment, immerse the entire sheath in the hydrophilic coating solution, lift it up at a slow speed of 0.11mm / s to 0.82mm / s, and finally use ultraviolet light to irradiate for 1 to 10 minutes to cure the coating.
[0057] And provide the design parameters and advantages of the main components in the (II) component section:
[0058] (1) The ultra-thin-walled long sheath has a single-sided wall thickness of only 0.004 to 0.006 inches. This maintains the commonly used clinical inner diameter while reducing the outer diameter of the sheath. Taking the commonly used 6F sheath as an example, the conventional inner diameter is 0.088 inches and the outer diameter is 0.108 inches (2.74 mm). The ultra-thin-walled long sheath of this invention maintains an inner diameter of 0.088 inches while having an outer diameter of only 0.098 to 0.100 inches (2.48 to 2.54 mm), achieving the characteristics of "large lumen and thin wall". At this outer diameter, it is more suitable for the diameter of the radial artery, reducing the probability of vasospasm and radial artery occlusion by at least 73%. At the same time, it greatly reduces patient discomfort or pain and significantly improves prognosis. In addition, the segments and structures designed specifically for the radial route have better compliance and stronger resistance to breakage. The ultra-thin-walled radial artery intervention sheath of this invention has 7 to 10 different functional segments. Each segment is designed based on real clinical vascular anatomy and data, with varying degrees of stiffness, deformation resistance, and compliance. The process and procedures from the radial artery approach to the target location are thoroughly analyzed to match the optimal functional segment. Furthermore, the spring structure in the sheath's middle layer incorporates multi-strand metal wires with different inclinations, enhancing both the sheath's compliance and resistance to bending.
[0059] (2) A long, stiffened puncture guidewire with a diameter of 0.025 inches and a length of over 150 cm. This simplifies surgical procedures, allowing a single guidewire to function as both a puncture guidewire and a 0.035-inch angiography guidewire, directly working with a long sheath to complete puncture and superselective vessel procedures. It eliminates the need for a short puncture sheath, puncture guidewire, and other complex procedures, significantly reducing surgical difficulty, improving treatment efficiency, and achieving "zero-exchange" technology. Conventional puncture guidewires are only 35-60 cm long and relatively soft, lacking sufficient support, making it difficult to work with a long sheath for puncture and superselective procedures. The long, stiffened puncture guidewire of this invention optimizes proximal support without increasing the outer diameter, enabling it to effectively guide puncture and provide sufficient pushing and supporting force to work with the long sheath or angiography catheter to complete the surgical procedure during subsequent arch formation and vessel superselective procedures.
[0060] The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention shall fall within the scope of protection claimed by the present invention.
Claims
1. A disposable, zero-exchange long sheath for radial artery access, characterized in that: include: Needles and / or skin cutters are used to puncture the skin, muscles, and blood vessel walls near the radial artery; Guide wires are used to enter blood vessels and approach the area near the lesion. The long sheath has a channel for instruments to pass through, with the distal end being the head end used for treatment and the proximal end being the end used for external manipulation. The dilator, in the form of a catheter, is movable and fits over the outside of the guidewire and through the inside of the long sheath, providing a support base for the proximal segment of the long sheath.
2. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: The expander has a soft, beveled contact portion at one end near the distal end.
3. The disposable zero-exchange long sheath transradial artery access kit as described in claim 2, characterized in that: The soft inclined surface contact portion has an inwardly tapered end.
4. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: It also includes at least one Y valve, which has at least one bypass line that communicates with a channel in the long sheath.
5. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: At least one MP head is provided at the distal end of the long sheath, and the MP head has a corner section.
6. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: The guidewire includes a core and a sheath made of spring wire, and the guidewire also includes a hemispherical tip. The outermost part of the guidewire is coated with a hydrophilic coating.
7. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: The long sheath includes an outer layer, a braided layer, a spring layer, or an inner layer.
8. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: It also includes packaging bags, which are provided with several intervals.
9. The disposable zero-exchange long sheath transradial artery access kit as described in claim 1, characterized in that: The proximal section of the long sheath also includes a stress-relieving tube, which is sleeved on the outside of the connection gap between the long sheath and the Y valve.