Multilayer catheter structure

Abstract

The present invention provides a design and configuration for a catheter shaft used in the delivery and placement of medical devices and in the aspiration removal of occlusions. [Solution] The present invention provides a catheter shaft design having a four-layer structure consisting of an ultrathin inner layer, a first coil intermediate layer, a second braided intermediate layer, and an outer jacket layer. The first coil intermediate layer of the catheter shaft is made from flat wire with a width-to-thickness ratio of at least 2:1. The outer jacket layer of the catheter shaft is made from three different materials: a soft durometer material forming the distal portion of the outer jacket, an intermediate durometer material forming the middle / transition portion of the outer jacket, and a hard durometer material forming the proximal portion of the outer jacket.

Description

Technical Field

[0001] Cross-reference to Related Applications This application claims priority and the benefit thereof to U.S. Provisional Patent Application No. 62 / 886,322, filed on August 13, 2019, entitled "Multi-layer Catheter Construction". All of the content of U.S. Provisional Patent Application No. 62 / 886,322 is incorporated herein by reference. r Construction (Multi-layer Catheter Structure)".

[0002] The present invention generally relates to the design of guide, aspiration or distal access catheters for use in neurovascular applications. The catheter shaft, in particular, provides excellent distal flexibility for tracking upper outer lubricity and upper inner lubricity for implant delivery within the neurovascular system, as well as proximal stability.

Background Art

[0003] Almost all installations or treatments of neurovascular devices are performed within or above the neck. For this reason, catheters used within the neurovascular system must be able to cross serpentine anatomical tissues. Such catheters must have the highest torque imparting and kink resistance properties within the catheter shaft, a flexible distal portion to reach the intended treatment location, and be designed to deliver treatment without damaging the surrounding vasculature. This requires careful balance between minimizing the outer surface as much as possible and maximizing the inner lumen as much as possible for the delivery of medical implants and the operation of other catheters for aspiration into reperfusion occluded vessels. Additionally, such catheters may also be fluorinated. ​​​​​​​​​​​​​It must be visible under optical fluoroscopy.

[0004] In designing catheters for neurovascular applications, engineers consider catheter traceability, Basic targets regarding flexibility, indentation, and torque application (permeability or torsional force) Therefore, it is essential to maintain a balance between functionality and structure.

[0005] PTFE material offers excellent wear resistance with superior lubrication, making it suitable for use on the inner walls of catheters. This would be an ideal choice. Because the inner surface of the lumen of the PTFE liner is smooth, the device can be used as a catheter. When pushed through the dense boundary of the lumen, friction between the medical device and the catheter is reduced. Immersion coating and extrusion are two common methods for producing PTFE liners. The immersion coating process is one method used to realize a PTFE liner. Yes, this process is part of the structure process of the catheter shaft, on the mandrel. This is feasible. Once the coating hardens, for example, nylon outer coverings, braided cords The additional components of the mandrel are placed on a cured, dipped-coated mandrel. Although it initially seems like a simple process, it has several limitations. The coating may have an uneven surface similar to that of an orange peel. The immersed coating surface may sometimes have a coating that Vibrations during the process can cause the appearance of numerous cross-sectional lines, known as chatter. The dipped coating surface also contains a hardened layer generated by moisture-containing contaminants during the coating process. It may have craters, depressions, or even holes. All these defects affect the catheter tube. These adversely affect the internal lubrication of the lumen, and therefore significantly hinder catheter use. While defects can be addressed in different ways, the highest precision required for the immersion coating process Strikes and their duration typically increase.

[0006] Laying extruded PTFE tubing is another method for fabricating PTFE catheter inner liners. Although extruded PTFE has the lowest coefficient of friction, a typical extruded PTFE pipe has a coefficient of friction of approximately 0. It has a wall thickness of 0.01 inches. This wall thickness results in the overall rigidity of the catheter. It can increase in number and is not ideal for traveling through the tortuous pathways of the neurovascular system.

[0007] An ideal catheter for neurovascular applications is one that can travel through small vascular systems. It should have an outer diameter and a maximum inner diameter for delivering medical devices / implants. Therefore, the need for ultra-thin catheter inner liners inevitably arises. However, The thin catheter inner liner allows engineers to either braided or coiled sides. In either case, a shaft support component such as a metal wire layer covering the internal catheter liner is incorporated. Therefore, it is necessary to improve the pushability and kink resistance of the catheter. The minimum contact pressure is the catheter In order to maintain the integrity of the tel structure, a crucial gap exists between the metal wire layer and the internal catheter liner. This minimum contact pressure increases the inner surface roughness of the internal catheter liner (20). Furthermore, a significant reduction in internal lubrication occurs frequently.

[0008] Therefore, the goals of increasing pushability, traceability, flexibility, and torque-generating ability are achieved. There is a need to develop catheters for nerve and vascular applications, and large lumens are maximized. The suction flow is reduced, and the catheter is made smaller without further damaging the blood vessels to the target treatment site. Achieve a reduction in outer diameter, outer surface lubricity, and optimal inner surface lubricity to enable tracking all the way to the blood vessels and it is required to reduce the deployment force.

Summary of the Invention

[0009] One aspect of the present invention is to provide a catheter shaft for delivering and positioning a medical device . The catheter shaft comprises an ultra-thin inner catheter liner, a first coil intermediate layer, a second braided intermediate layer, and an outer jacket layer. The first coil intermediate layer is made of flat wire with a width-to-thickness ratio of at least 2:1. The outer jacket layer is made of a material including a soft durometer material forming the distal portion of the outer jacket, an intermediate durometer material forming the intermediate portion of the outer jacket, and a hard durometer material forming the proximal portion of the outer jacket.

[0010] One embodiment of the present invention defines that the inner catheter liner of the catheter shaft has an outer diameter-to-thickness ratio of at least 10:1. The inner catheter liner has a minimum inner diameter of 0.8 mm. One embodiment of the present invention defines that the first coil intermediate layer of the catheter shaft has a maximum thickness of 0.06 mm. Another embodiment of the present invention defines that the first coil intermediate layer of the catheter shaft has a minimum width of 0.08 mm.

[0011] One embodiment of the present invention defines that the first coil intermediate layer of the catheter shaft covers at least 30% of the area of the outer surface of the lumen of the inner catheter liner. In another embodiment, due to the desired rigidity, across the outer surface of the lumen of the inner catheter line The covering area of ​​the first coil intermediate layer of the first coil is in the range of 30-75%. A person skilled in the art will know that the first coil The smaller the coverage area between the intermediate layer and the internal catheter liner, the more flexible the entire catheter becomes. Please understand that this increases flexibility.

[0012] One embodiment of the present invention is a second braided intermediate layer (40) of the catheter shaft, It is specified that the maximum thickness must be 0.03 mm.

[0013] One embodiment of the present invention relates to an internal catheter liner and an external casing of a catheter shaft. The jacket layers are specified to be of the same length. Another embodiment of the present invention is the first coil The intermediate layer and the second braided intermediate layer are both the internal catheter liner and the external jacket layer. It is defined that it is enclosed within the form.

[0014] One embodiment of the present invention is an outer jacket layer comprising a first coil intermediate layer (30) and a second It passes through the gaps between the wires that form the braided intermediate layer and connects with the internal catheter liner. This stipulates that...

[0015] One embodiment of the present invention is a catheter shaft in which the first coil intermediate layer is in the same direction It is specified that it is made from at least two wound wires. Another embodiment of the present invention The state is that the first coil intermediate layer of the catheter shaft is wound in opposite directions, at least two It is specified that it be made from one wire.

[0016] One embodiment of the present invention is such that a second braided intermediate layer (40) is outer the first coil intermediate layer. It is defined that it is placed between the jacket layers. Another embodiment of the present invention is the second The braided intermediate layer is positioned on at least the proximal and intermediate portions of the first coil intermediate layer. This defines the following. Another embodiment of the present invention is that the second braided intermediate layer is greater than the first coil intermediate layer. It also stipulates that it must be at least 20 mm shorter.

[0017] One embodiment of the present invention is a catheter shaft having an outer diameter pair of at least 1.2:1. It is stipulated that the internal diameter ratio must be present. [Brief explanation of the drawing]

[0018] [Figure 1A] Figure 1A is a perspective view of a catheter having a catheter shaft and a proximal control mechanism according to the present invention. [Figure 1B] Figure 1B is a perspective view of a typical embodiment of a multilayer catheter shaft structure according to the present invention. [Figure 2A] Figure 2A is a perspective view of a typical first coil intermediate layer of a catheter shaft according to the present invention. [Figure 2B] Figure 2B is a perspective view of a typical first coil intermediate layer of a catheter shaft according to the present invention. [Figure 2C] Figure 2C is a perspective view of a typical first coil intermediate layer of a catheter shaft according to the present invention. [Figure 3] Figure 3 is a perspective view of a typical second braided intermediate layer of a catheter shaft according to the present invention. [Figure 4] Figure 4 is a perspective view of a typical outer jacket layer of a catheter shaft according to the present invention. [Modes for carrying out the invention]

[0019] Specific details are provided below in order to understand the various embodiments of the present invention. As clearly stated in the drawings. A person skilled in the art will understand that the present invention is not necessary without one or more of the details described herein. It will be understood that other embodiments are possible. For this reason, the applicant has attached the Patent Application It is not intended to restrict or limit the scope of the request in such detail. No. The following disclosure describes various processes in accordance with steps and sequences. However, the steps and sequences of steps in question are used in all embodiments of the present invention. This should not be a requirement for implementation.

[0020] As used herein, the term "lumen" refers to a tube, conduit, or vein, artery, blood vessel, capillary, It refers to a roughly tubular space or cavity within the body, including the intestines. The term "tubular cavity" is also used in the context of catheterization. It can refer to tubular spaces such as telsons, sheaths, hollow needles, and tubes.

[0021] As used herein, the term "proximal" refers to the area close to the operator (with minimal inward movement). The term "distal" refers to a location that is further away from the operator (and more internally within the body). When placing medical devices inside a patient's body, "distal" refers to a direction relatively far from the catheter insertion site. "Proximal" refers to the direction relatively close to the insertion site.

[0022] As used herein, the term "wire" refers to a strand, string, fiber, thread, filament, These could be cables, twisted threads, etc., and these terms can be used interchangeably.

[0023] The term "sheath" as used in this specification may also be written as "catheter," therefore These terms can be used interchangeably.

[0024] Unless otherwise specified, quantities, measurements, and other information used in the specification and claims. All numbers representing characteristics or parameters are, in all cases, expressed in terms of the term "approximately". It shall be understood that the meaning is limited. Therefore, unless otherwise noted, Furthermore, the numerical parameters specified in the following specification and attached claims are approximate values. It should be understood that, at the very least, attempts to apply the doctrine of equivalents to the scope of claims. Rather than as such, considering the reported number of significant figures and the use of typical rounding techniques, numerical parameters You should read the meter.

[0025] "to possess, to include (comprising)" (any form of "to possess"), "to have "to have" (any form of "to possess"), "to include" (Any form of "to include") or "to contain" ("to include") When using any variation of "ru" in this specification, the described mechanisms, integers, steps, and operations Identifies the existence of a mechanism, element, and / or component, but one or more other mechanisms, integers, Eliminate the presence or addition of steps, operations, elements, components and / or groups thereof. Please understand that this is not meant to eliminate.

[0026] In this specification, terms such as first, second, third, etc., are used to refer to various limitations, elements, components, domains, layers. It can be used to describe names and / or parts, but these limitations, elements, components, Areas, layers, and / or parts should not be limited by these terms. These terms shall be understood as a single limit, element, component, domain, layer or Used solely to distinguish a part from another constraint, element, component, area, layer, or part. Therefore, the first restriction, element, component, region, layer, or part described below is not part of this application. Without deviating from the description thereof, the following shall be referred to as the second restriction, element, component, area, layer or part. It is possible.

[0027] One element is "on top of," "combined," "connected," or "linked" to another element. When referred to as "attached," the element is directly connected or linked to or above another element. It is possible, or it is acceptable for one or more intervening factors to be present. In contrast, when one element is "directly on top of" another element, "directly coupled," or "directly connected" When referred to as "directly linked" or "directly connected," there are no intervening elements. Other words used to describe relationships should be interpreted in a similar manner (e.g., " (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.)

[0028] When the first element is mentioned as being "inside," "on top of," and / or "inside" the second element, The first element is inside the internal space of the second element, inside the part of the second element (e.g., inside the wall of the second element). (part), on the outer and / or inner surfaces of the second element, and one or more combinations thereof Please understand further that it will be placed there.

[0029] For example, as shown in the diagram, "beneath", "below", "lower part ( Spatially relative terms such as "lower," "above," and "upper." These terms describe the relationship between one element and / or mechanism and other elements and / or mechanisms. It may be used for display purposes. Spatially relative terms are used for different orientations of the devices used and / or it should be understood that it is intended to include orientations other than the illustrated orientation. For example, if the device in the figure is turned upside down, the "downward" and of other elements or mechanisms / An element described as being "below" is oriented "above" other elements or mechanisms. The device can be oriented in other directions (e.g., rotated 90 degrees or to other orientations). (and so forth), spatially relative descriptive terms used herein shall be interpreted accordingly.

[0030] The terms "reduce", "reducing", and "decrease" are all related. "(reduction)" and similar terms include reductions in quantity, including reductions to zero. Reducing the likelihood of survival includes preventing its occurrence.

[0031] As used herein, the terms "and / or" refer to two specified mechanisms or components. Either one of them should be interpreted as being specifically disclosed, regardless of the other. For example, “A and / or B” are as if each were individually specified in this specification. (i) A, (ii) B, and (iii) A and B are to be disclosed separately. It should be done.

[0032] The term "diameter" as used herein to describe non-circular geometric shapes is: It shall be interpreted as the diameter of a virtual circle approximating the geometric shape described. For example, configuration When describing the cross-section of an element, the term "diameter (~diameter)" refers to the cross-section of the described component. It shall be interpreted as representing the diameter of a virtual circle having the same cross-sectional area.

[0033] As used herein, the terms "long axis" and "short axis" refer to the components as complete. These are the length and diameter of the smallest virtual cylinder that can completely enclose the entire volume.

[0034] A particular mechanism of the present invention, described for clarity in the context of a separate embodiment, is a single embodiment It should be understood that they may be provided in combination in terms of form. Conversely, a single implementation form Described for brevity purposes in the context of the present invention, the various mechanisms of the present invention are described separately or as appropriate. They may be provided in combination. For example, all the features specified in any of the claims. The features (whether independent or dependent) can be combined in any predetermined manner. It is assumed that this is understood.

[0035] The present invention relates to a catheter shaft having a single lumen, a large opening, and a thin catheter wall. Regarding this, according to one embodiment of the present invention, the disclosed catheter configuration provides excellent distal access. Flexibility, outstanding proximal pushability and torque application, superior external lubrication, and superior internal lubrication. To provide sex.

[0036] As shown in Figures 1A and 1B, the catheter shaft (10) has a four-layer structure. The inner layer (20) of the catheter shaft (10) extends from one end to the other in the middle. The catheter comprises a full-length, ultra-thin internal catheter liner (20) with a lumen (21). The first intermediate layer (30) of the shaft (10) is on the outer surface of the lumen of the internal catheter liner (20). The catheter has a flat wire coil (31) that is wound over (24). The second intermediate layer (40) of the thrust (10) extends over the outer surface of the lumen of the first coil intermediate layer (30). This includes the wire braiding that is arranged. The outer layer of the catheter shaft (10) is the catheter It is placed across the second braided intermediate layer (40) of the shaft (10), melted, and catheter It passes through the two intermediate layers (30, 40) and the inner layer (20) of the catheter shaft (10). It comprises a tubular jacket (50) that is coupled to it. Furthermore, in one embodiment of the present invention Therefore, the outer layer (50) and inner layer (20) of the catheter shaft (10) are approximately the same length. The two intermediate layers (30, 40) of the catheter shaft (10) are the outer layer (50) and the inner layer. Slightly shorter than both layers (20), and the outer layer (50) of the catheter shaft (10) It is enclosed between and within the inner layers (20).

[0037] Continuing to refer to Figure 1A, the radiopaque marker band is on the catheter shaft. (10) It is fixed at the distal end of the assembly and made visible by fluorescence fluoroscopy. Figure 1A is Furthermore, the proximal end (14) of the catheter shaft (10) is connected to the catheter proximal control mechanism (8). This indicates a connection to [a specific location]. The design of a particular proximal control mechanism varies depending on the intended application. Therefore, Figure 1A is merely an example intended to illustrate the present invention.

[0038] According to one embodiment of the present invention, the catheter shaft (10) assembly is 1100~ It has an overall length of 1400 mm, an outer diameter of 1.4 to 2.7 mm, and an inner lumen diameter of 1.2 to 2.3 mm. Those skilled in the art will know that the overall length and size of the catheter shaft (10) assembly are suitable for a particular application. It should be understood that it can be easily modified to suit the requirements. For this reason, the disclosures herein The number should be considered only as a reference and should not be regarded as limiting the scope of the patent claims. stomach.

[0039] Referring to Figure 1B, according to one embodiment of the present invention, the catheter shaft (10) The inner layer (20) is tubular, with a central lumen (21) extending from one end to the other. It has sides. According to one embodiment of the present invention, the inner layer of the catheter shaft (10) 20) has a length of 1150-1400 mm, an outer diameter of 1.75-1.85 mm, and 1.73- 1.83 mm lumen inner diameter, 0.013 mm to 0.025 mm (or 0.0005 inches) The tubular wall thickness is approximately 0.001 inches. According to one embodiment of the present invention, the catheter The inner layer (20) of the shaft (10) is designed to have a relatively thin lumen wall. By doing so, not only is the entire side surface of the catheter shaft (10) reduced, The overall flexibility of the catheter shaft (10) can also be improved.

[0040] According to one embodiment, the inner surface of the lumen of the inner layer (20) of the catheter shaft (10) is As the catheter shaft moves through the catheter, it directly contacts the medical device / implant. They come into contact. Therefore, the inner surface of the lumen of this inner layer (20) of the catheter shaft (10) is Minimize the force required to push the vice / implant through the catheter lumen (21). It is designed to provide sufficient lubrication.

[0041] According to one embodiment, the inner layer (20) of the catheter shaft (10) is made of extruded PTF. It is made from E (polytetrafluoroethylene). In another embodiment, a catheter The inner layer (20) of the shaft (10) is made from stretched PTFE, also known as ePTFE. The ePTFE internal catheter liner (20) heats the extruded PTFE tube to the desired temperature. Then, non-standard fabrication processes such as expanding the inner diameter across the core mandrel were carried out. It is manufactured by carefully expanding a PTFE tube using such a post-extrusion process. This increases the inner diameter of the tube and creates an ultra-thin tubular wall with micropores. The resulting ePT The FE internal catheter liner (20) has air permeable, soft, and flexible physical properties. It has a certain degree of smoothness and exhibits a film-like absorbent feel. The resulting ePTFE The internal catheter liner (20) also has high linear strength and chemical inert properties, and at low pressure. It maintains watertightness, has a low dielectric constant, and provides excellent radial expansion and UV resistance.

[0042] Those skilled in the art will see that extruded PTFE and stretched PTFE (ePTFE) pipes are used to illustrate the present invention. As described herein, the inner layer (20) of the catheter shaft (10) is ultrathin To realize the lumen wall, direct extrusion and / or post-extrusion axial stretching and / or radial stretching are performed. FEP (fluorinated ethylene propylene) is produced by any known manufacturing process in fields such as expansion. ), FEP (fluorinated ethylene propylene), HDPE (high-density polyethylene), LDP E (low-density polyethylene), polyethylene terephthalate (PET), polypropylene ( Please understand that it can be made from other materials such as PP, pyroamide / Pebax, etc.

[0043] In an alternative embodiment of the present invention, the inner layer is made from two materials that are joined together. For example, the distal portion of the inner layer can be made from a polyurethane tube, while the remainder of the inner layer is It is made from extruded PTFE. Extruded PTFE provides indentation to the catheter shaft. The polyurethane distal portion provides flexibility and a soft distal end to the catheter shaft, and nerve To enable better tracking within the vascular system. According to one typical embodiment, the distal polypyl in the inner layer The urethane portion is 0.013mm to 0.025mm (or 0.0005 inches to 0.0 It can be made from a polyurethane tube with a tubular wall thickness of 0.1 inches. Such distal poly The urethane tube is then heat-sealed, or by other known methods in the art, the PTFE portion It is joined to the remaining part. The combination of polyurethane and PTFE forms one typical inner layer structure. Although disclosed herein, those skilled in the art will see that other combinations of materials can be used for ultrathin tube walls. The design of the present invention includes an inner layer of a catheter shaft having a smooth and lubricated inner surface. It is understood that it can be incorporated to achieve its purpose and provide good processability for minimally invasive methods. I want to be treated that way.

[0044] Continuing to refer to Figure 1B, the first intermediate layer (30) of the catheter shaft (10) is , a wire coil (31) that is wound around the outer surface of the lumen of the internal catheter liner (20) It is equipped with. The wire coil intermediate layer (30) is a support for the internal catheter liner (20) and It is attached in such a way that it increases the flexibility of the distal outer side, while also providing better kink resistance. Hoop strength is added. According to one embodiment, the catheter shaft (10) assembly The wire used to form the coil intermediate layer (30) has a substantially flat structure. By using flat wire across the inner layer, the contact pressure between the flat wire and the inner layer is reduced. Therefore, the inner surface of the lumen becomes smooth. As a result of the low contact pressure, the coil layer is on top of the inner layer. The deformation and patterns formed are reduced. By incorporating a flat wire coil, the catheter The shaft's inner layer can be adapted to ultra-thin lumen wall thicknesses. It features a flat wire and ultra-thin inner layer structure. The catheter shaft provides the desired inner diameter for implant delivery, while also providing a suitable internal diameter for vascular delivery. To improve the performance of the unit, the external dimensions are kept smaller.

[0045] Those skilled in the art will know that Figure 1B shows a four-layer structure of a catheter shaft according to one embodiment of the present invention. Please understand that this is provided for the purpose of describing and explaining. Figure 1B shows the catheter shaft. It is not intended to actually display the length of each layer or its relative length.

[0046] That is, as shown in Figure 2A, the cross-section of the wire (100) has a width greater than its thickness. Therefore, in this embodiment, the maximum contact between the inner layer (20) of the catheter shaft (10) is achieved. A coil intermediate layer (30) with area is generated. Inner layer (2 0) Because it has an ultrathin lumen wall, the coil intermediate layer (30) and the internal catheter layer (20) The larger the contact area with the outer surface of the lumen, the smoother the lumen surface of the inner layer (20) becomes. Those skilled in the art will understand that The principle is that if the coil width is the same, the greater the coil thickness, the better the kink resistance. This should be understood. Therefore, the catheter shaft (10) should have appropriate kink resistance and a small overall side A trade-off in design must be achieved between the surface and the design.

[0047] According to one embodiment, and as shown in Figure 2A, the wire coil (31) is 0.04 It has a width of ~0.11 mm and a thickness of 0.02~0.06 mm. In one embodiment The wire coil (31) has a width of 0.003 inches and a thickness of 0.0015 inches. According to another embodiment of the present invention, the wire (100) forming the coil intermediate layer (30) The cross-sectional area is 0.001 to 0.007 mm². 2 The width-to-thickness ratio is at least 2:1. According to one embodiment, the first coil intermediate layer (30) is an internal catheter layer (20 ) covers at least 38% of the area of ​​the outer surface of the lumen. According to yet another embodiment of the present invention, The coil (31) has a pitch of 0.12 to 0.25 mm, and the minimum in the middle of each helical rotation. The gap is 0.025 mm. In another embodiment, the coil (31) is in the left-hand direction. It can be wound to the right.

[0048] According to another embodiment of the present invention, the first intermediate layer (30) is a spiral having a constant pitch This is a coil (31). According to another embodiment of the present invention, an intermediate layer (30) of the coil is formed. The wire (100) has a constant thickness and a constant width along its entire length. In yet another embodiment, to achieve the desired mobility of the catheter shaft (10) Alternatively, to increase flexibility in the distal portion of the catheter shaft (10), a helical coil (3 1) The catheter shaft (10) has a small pitch in the proximal part, and the catheter has a small pitch in the distal part It may have a large pitch in some parts and a gradually changing pitch in the middle. Another embodiment of the present invention In its form, the wire thickness is kept constant, while the wire forms a helical coil (31). (100) has a large width in the proximal portion of the catheter shaft (10), The distal portion of the thorax (10) has a narrow width on its sides, while the width gradually changes in the middle portion. Therefore, the specific embodiments described herein are intended to limit the scope of the invention. It will be used.

[0049] Those skilled in the art will see that, compared to round wire coils, flat wire coils are... If it has the same cross-sectional area as a round wire, it will have at least the same kink resistance as a round wire coil. While this provides a solution, please understand that the overall wall thickness will be reduced by at least 33%. Therefore, in the embodiments of the present invention, the increase in the radial side surface of the catheter is minimized. In short, the present invention provides the largest possible size for the internal catheter lumen, while the external Minimize the radial lateral surface of the catheter as much as possible.

[0050] According to one embodiment, the flat wire forming the coil intermediate layer (30) is stainless steel. It can be formed from steel, tungsten, cobalt-chromium alloy, etc. In another embodiment, The flat wire (100) forming the coil intermediate layer (30) is made of a superelastic material such as nitinol. It can be formed from a material. In one embodiment, the coil intermediate layer (30) is formed from nitinol. Even if the catheter twists during use, it returns to its pre-configured circular lumen shape. It is possible to do so.

[0051] Figure 2A shows a single-wire spiral coil (31). Those skilled in the art will know that a multi-wire coil ( 131, 231) Furthermore, the structure of the first coil intermediate layer (30) can be incorporated. Please understand this. For example, as shown in Figure 2B, the multilayer forming the coil intermediate layer (30) The ear coil (131) consists of two wires (11) made of different materials and wound in the same direction. It can be made from 0, 120). In this way, the coil intermediate layer (30) is two The composite strength and other mechanical properties of the material can be achieved. Another typical implementation is shown in Figure 2C. In this state, the multi-wire coils (231) that form the coil intermediate layer (30) are each different It can be made from a material consisting of two wires (130, 140) wound in opposite directions. According to one embodiment, for both typical embodiments shown in Figures 2B and 2C, The two wires (130, 140) can be wound alternately so that they are on approximately the same layer. In another embodiment, one wire is placed on top of a coil formed by the other wires. It can be wound around the section. Those skilled in the art will know each wire (110, 120, 13) including its width and thickness. The 0, 140) configuration, as well as the coil pitch and winding angle, is necessary to achieve optimal results. It should be understood that all of these can be adjusted independently. According to one embodiment, multi The wire coil (131, 231) comprises 2 to 4 wires. In another embodiment... The multi-wire coil (131, 231) can be wound in a left-handed or right-handed direction. In another embodiment, the multi-wire coil (131, 231) is 0.07~0.5 It may have a pitch of mm. Furthermore, in another embodiment, it can be used in a multi-wire coil tube structure. The wire used has a width of 0.04 to 0.11 mm and a thickness of 0.02 to 0.06 mm. be.

[0052] Continuing to refer to Figure 1B, according to one embodiment, the second intermediate layer (40) is the It is arranged across the outer surface of the first coil intermediate layer (30). The second intermediate layer (40) is tubular It is made from a wire braid (41). The tubular wire braid (41) is a catheter sheath Enhance axial and torsional control of the shaft (10) to allow for push / pull or rotational input by the physician. Reduces or virtually eliminates the associated delay.

[0053] Figure 3 shows one typical braiding pattern. According to one embodiment of the present invention, a second The tubular wire braid (41) of the braided intermediate layer (40) consists of 16 wires and a regular braiding pattern It is made from the formula. In another embodiment, the second braided intermediate layer (40) is made of 16 strands And regular diamond-shaped lacing tends to provide better torque and higher kink resistance. It can be made from a braiding pattern. Those skilled in the art will know that the braiding pattern and the number of wires used for braiding can be varied. It should be understood that this may be modified. For this reason, what is disclosed herein is not within the scope of the invention. It should not be used to limit something.

[0054] According to one embodiment of the present invention, the second intermediate layer (40) is as shown in Figure 1B, It is arranged across the outer surface of the coil intermediate layer (30). According to one embodiment of the present invention The second braided intermediate layer (40) has an overall thickness of 0.025 to 0.066 mm, and each The ear is made of a braid having an external thickness of 0.013 to 0.0033 mm. According to one embodiment, the second braided intermediate layer (40) has a length of 1150 to 1400 mm. It has a length that is approximately the same as the length of the first coil intermediate layer (30). According to another embodiment, The second braided intermediate layer (40) is the second braided intermediate layer (40) of the first coil intermediate layer ( Without covering the distal portion of 30), the intermediate and proximal portions of the first coil intermediate layer (30) To cover the entire surface, it is significantly shorter than the first coil intermediate layer (30), measuring 1100-1350 mm. It has the length of . In yet another embodiment, the second braided intermediate layer (40) is as shown in Figure 1B At the distal end of the first coil intermediate layer (30) shown, 2 cm from the first coil intermediate layer (30) short.

[0055] Continuing to refer to Figure 1B, according to one embodiment, a polymer jacket (50) This involves placing a second braided intermediate layer (40) that forms the outer layer of the catheter. One implementation According to the configuration, the outer jacket (50) is positioned horizontally on the second braided intermediate layer (40). It initially has a tubular structure. The entire catheter shaft (10) assembly is then re The outer jacket (50) and / or inner jacket are subjected to flow processing, thereby processing the outer jacket (50) and / or inner jacket. The liner material is melted to form a composite catheter shaft (10). One of the present inventions According to the embodiment, the outer jacket layer (50) material melts and the second braid (40) The fluid flows through the gaps between the wires in the first coil intermediate layer (30) and into the lower catheter shaft. It adheres to the inner layer (20) of the catheter shaft (10). A person skilled in the art can determine the inner layer of the catheter shaft (10) Used to melt the outer jacket layer (50) in order to form a bond with 20). The temperature can affect the smoothness and lubrication of the catheter lumen, including grooves and valleys. Without being introduced into the inner surface of the lumen of the shaft (10), it passes through the gap between the wires. Please understand that balance is maintained to allow for sufficient material flow.

[0056] According to one embodiment, the outer jacket layer (50) has a certain durometer. It is made from a single material such as nylon or PEBAX. According to another embodiment of the present invention The outer jacket layer (50) is 25-80 Shore D durometer, 20-500 It has a length of mm, an outer diameter of 2.0 to 2.5 mm, and a wall thickness of 0.025 to 0.13 mm. According to one embodiment, the outer jacket layer (50) consists of two intermediate layers (30, 40 It covers the entire length of the catheter shaft (10) and the entire length of the inner layer (20) of the catheter shaft (10).

[0057] Refer to Figure 4, which shows another embodiment of the outer jacket layer (50). Therefore, the outer jacket layer (50) is made of different materials having different durometers. It has a multilayered portion that is manufactured. For example, as shown in Figure 4, the distal part of the outer jacket layer (50) The parts are made from ultra-low durometer materials such as TPU with a durometer of approximately Shore 60A. The proximal portion of the outer jacket layer (50) has a durometer of approximately 75D. It is made from materials with a relatively high durometer, such as iron. (Outer jacket layer (50)) The transitional portion between the distal and proximal parts is in the range of Shore 30D to 63D. It is made from materials with a relatively high durometer, such as PEBAX. Therefore, low durometer The distal outer layer of the meter has a small tortuosic diameter of the vascular system within the catheter shaft (10) assembly. Provides maximum flexibility for movement across roads. High-density outer jacket layer (50) The proximal portion of the urometer provides rigidity and maximum flexibility to the catheter shaft (10) assembly. It provides support. Furthermore, the transition section is from the distal ultra-soft part to the proximal rigid and support part. It is possible to gradually transition to this.

[0058] Continuing to refer to Figure 4, according to one embodiment, the outer jacket layer (50) The positional portion has a length of 100-200 mm, and the transition portion of the outer jacket layer (50) is It has a length of 10-30 mm, and the proximal portion of the outer jacket layer (50) is 1000-12 It has a length of 00 mm. According to one embodiment of the present invention, the outer jacket layer (50) The distal, transitional, and proximal portions have approximately similar thicknesses.

[0059] According to another embodiment of the present invention, an additional coating layer is attached to the catheter structure described in the present invention. It is possible to add a hydrophilic coating to achieve a flat and slippery surface. The cells can be easily traced within the vascular system.

[0060] Although not specifically described in the above disclosure, a person skilled in the art would know one or more radiopaque properties The marker is detected by imaging devices such as fluoroscopes, X-rays, CT scanners, MRI, and ultrasound imagers. It should be understood that the imaging device is used to assist in visualization. The marker can be applied to any part of the catheter shaft (10) of the present invention. Radiopaque markers are attached to the catheter shaft by bonding, crimping, compression, or other methods. (10) can be placed and fixed in or on top of (10). The radiopaque marker is Tal, tungsten, platinum, iridium, gold, or alloys of these materials, or the same It can be made from other materials known to the human eye. Radiopaque markers can also be made from chromium (II I), manganese(II), iron(III), iron(II), cobalt(II), copper(II), Nickel(II), praseodymium(III), neodymium(III), samarium(III) ), ytterbium(III), gadolinium(III), terbium(III), dys Atomic numbers of elements such as prosium(III), holmium(III), and erbium(III) Multiple paramagnetic materials containing one or more elements with values ​​of 21-29, 42, 44, and 58-70 Alternatively, it can be made from other MR visible materials known to those skilled in the art.

[0061] Those skilled in the art will see that most of the typical embodiments described above are catheters used for neurovascular applications. Although referring to the 10-spoke shaft, a typical embodiment of the present invention is any other suitable embodiment. It should be understood that it can be used in minimally invasive applications. For example, a typical embodiment of the present invention is For ischemic stroke and other conditions, we deliver vascular occlusion devices, stents, suction devices, and stent retrieval devices. It can be used for that purpose. In another embodiment, a typical embodiment of the present invention is an implant This can be used to accurately deliver it to aneurysms such as cerebral aneurysms. In another embodiment, this A typical embodiment of the invention involves implanting a device into a blood vessel, such as a blood vessel in the brain, an open blood vessel, or another location. It can be used to deliver the product accurately.

[0062] The above description and attached drawings illustrate several examples of current representative embodiments. In light of the matters described above, this patent is as defined by the following claims, rather than as described above. Without departing from the spirit of the invention or exceeding the scope of the present invention, various modifications may be made. The alternative designs would be obvious to those skilled in the art. The meaning and scope of the equivalents of the claims are included. All changes and modifications shall be included within that scope.

Claims

1. A catheter shaft for delivering and positioning medical devices, An ultrathin inner catheter layer, a first coil intermediate layer, a second braided intermediate layer (40), It comprises an outer jacket layer, The aforementioned ultrathin internal catheter layer has a luminal wall thickness, The first coil intermediate layer comprises flat wire having at least a width-to-thickness ratio of 2:

1. Made from, The aforementioned outer jacket layer is a soft durometer that forms the distal portion of the outer jacket. Material, an intermediate durometer material in a certain range that forms the middle portion of the outer jacket, Multiple materials comprising a rigid durometer material forming the proximal portion of the outer jacket A catheter shaft made from a material.

2. The internal catheter liner is made from a stretched PTFE tube, as described in claim 1. -Telshaft.

3. The internal catheter liner is joined together with a distal polyurethane tube and a proximal PTF. A catheter shaft according to claim 1, made from an E tube.

4. The first coil intermediate layer has a maximum thickness of 0.06 mm, according to claim 1. -Telshaft.

5. The second braided intermediate layer has a diamond braided pattern, as described in claim 1. Le Shaft.

6. The first coil intermediate layer covers at least 30% of the outer surface of the lumen of the internal catheter liner. A catheter shaft according to claim 1, which covers the area of ​​the following.

7. The second braided intermediate layer has a maximum thickness of 0.066 mm, as described in claim 1. Tetel shaft.

8. The internal catheter liner and the external jacket layer are of the same length, claim. The catheter shaft described in 1.

9. The first coil intermediate layer and the second braided intermediate layer are the internal catheter liner and The catheter shaft according to claim 1, which is enclosed inside both the outer jacket layer and the outer jacket layer. to.

10. The outer jacket layer forms the first coil intermediate layer and the second braided intermediate layer. The wires pass through the gaps between them and connect to the internal catheter liner, as described in claim 1. Catheter shaft.

11. The first coil intermediate layer is made from at least two wires wound in the same direction. A catheter shaft as described in claim 1.

12. The first coil intermediate layer is made from at least two wires wound in opposite directions. A catheter shaft as described in claim 1.

13. The second braided intermediate layer is located between the first coil intermediate layer and the outer jacket layer. A catheter shaft according to claim 1, which is installed in [a specific location].

14. The second braided intermediate layer comprises at least the proximal and intermediate portions of the first coil intermediate layer. The catheter shaft according to claim 13, positioned on top.

15. The second braided intermediate layer is at least greater than the intermediate portion of the first coil intermediate layer. A catheter shaft according to claim 14, which is 20 mm shorter.

16. The catheter shaft has an outer diameter to inner lumen diameter ratio of at least 1.2:1, claim The catheter shaft described in item 1.

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