Method for marking the marker position of a medical device and a medical device equipped with a marker

Abstract

In particular, improve the manufacturing of medical devices equipped with marker bands. [Solution] A medical device comprising a marker 100 for marking the marker position of the medical device, the medical device comprising a tube of the medical device and a radiopaque marking material 100 for marking the marker position of the medical device, the radiopaque marking material 100 being added to the tube by being added in fluid form at the marker position of the medical device to form a solid radiopaque marker 100 for increasing the X-ray opacity of the medical device in the radial direction R. In particular, the tube may contain fibers of a braided and / or coiled wire mesh 210, and the method includes the step of fixing the fibers of the braided and / or coiled wire mesh 210 with the marking material.

Description

Technical Field

[0001] The present invention relates to medical devices and a method of marking the position of a medical device provided with markers. In particular, a radiopaque marking material is added to a tube by being additively manufactured in fluid form at the marker positions of the medical device to form a solid radiopaque marker for fixing fibers of a braided and / or coiled wire mesh.

Background Art

[0002] Medical devices include, in particular, catheter tubes, stents, and heart valves. Medical devices, particularly catheters, are generally thin-walled tubes constructed from medical grade materials, inserted into the body, and guided through lumens such as blood vessels, tracheas, airways, urethras, and digestive tracts, and are medical devices that can treat diseases or perform medical procedures. Medical devices are manufactured for specific applications, such as procedures in the intravascular, urological, gastrointestinal, and ophthalmic fields.

[0003] As a typical application, there is a minimally invasive intravascular procedure performed intravascularly in which a physician makes a small incision in an artery or vein, inserts a medical device, and guides the medical device through the vascular structure to the treatment site. Intravascular procedures include cardiovascular procedures, neurovascular procedures, peripheral vascular procedures, and structural heart procedures.

[0004] Transluminal procedures are typically guided using fluoroscopy. Fluoroscopy is a medical imaging technique that uses pulsed X-ray beams to display continuous X-ray images of internal tissues and the movement of medical devices on a monitor in real time. Medical devices typically include one or more marker bands. The purpose of one or more marker bands is to provide assistance in navigating the medical device through the lumen to the treatment site and to precisely position the device for performing the procedure. This is done by improving visibility using fluoroscopy. In particular, radiopaque markers can be distinguished from radiolucent medical device tubes. Radiopaque materials used for marker bands are easily visible inside the body due to their high contrast.

[0005] Conventional marker bands are short, thin-walled tubes made from highly radiopaque materials such as platinum alloy (platinum iridium), gold, or tungsten.

[0006] Metal tubing marker bands can be secured to medical devices in various ways. For example, they can be crimped, compressed, bonded, or otherwise fixed to the outer surface of the medical device, or they can be embedded in the wall of the medical device during the jacket assembly process by being assembled to the inner layer / liner and held in place by bonding or other means.

[0007] Such assembly requires the involvement of skilled workers, resulting in significant manufacturing time and waste. Furthermore, automation of the assembly is difficult, and the materials used for conventional metal marker bands are expensive.

[0008] For example, as shown in Figures 7 and 8, the marker 1100 may be constructed using a metal band. The metal band is attached to the medical device, in particular to at least one of the braided wire mesh 210, hypotube, and coil. Furthermore, the medical device may include an inner liner 220 adjacent to the lumen 222. In addition, the medical device may include an outer jacket 230, which may form a seal designed to ensure that fluid can only enter and exit through an intended port 240, such as an end port or a specific side port.

[0009] As shown in Figures 7 and 8, the tubular structure of a medical device can be described in cylindrical coordinates. That is, the tube can be described by coordinates (R, C, A). Here, R represents the radial distance r from the central axis A, c represents the circumferential direction C around axis A, and a represents the height along axis A.

[0010] The manufacturing process for medical devices is typically manual, requiring the intensive involvement of highly skilled personnel, resulting in significant manufacturing time and waste. In particular, the construction and attachment of marker bands to medical devices, especially bonding, is time-consuming, costly, and difficult to automate. Furthermore, current medical device manufacturing processes require manual termination of the edges of medical devices adjacent to ports, particularly the ends of braided mesh fibers. [Overview of the project] [Problems that the invention aims to solve]

[0011] In light of the above, the aim is to improve the manufacturing of medical devices equipped with marker bands. In particular, the aim is to shorten assembly time and shift from time-consuming manual processes to lower-cost automated processes. [Means for solving the problem]

[0012] At least one of the above-mentioned objectives is resolved by the independent claim. Preferred embodiments are resolved by the dependent claim. Examples and embodiments mentioned in the following description, which are not necessarily within the scope of the independent claim, are useful for understanding the invention.

[0013] In general, a method for marking the marker position of a medical device, the method being: A step of preparing a tubing for a medical device (e.g., a catheter), wherein preferably, the medical device, e.g., the tubing for the medical device, comprises a generally radiopaque material. The steps include preparing a radiopaque marking material in fluid form for marking the location of a medical device or for marking multiple locations along a medical device, A step of adding radiopaque marking material to a tube at the marker position of a medical device, The steps include solidifying an added fluid radiopaque marking material to form a solid radiopaque marker, wherein the solid radiopaque marker increases the X-ray opacity of the medical device at the marker position in the radial direction R, and This includes, in particular, radiopaque marking materials that enhance the visibility of predefined or set factors. For example, solid radiopaque markers increase X-ray opacity by at least twofold.

[0014] This general embodiment makes it possible to automate the addition of marker bands to the tubular portion of medical devices using additive manufacturing processes, also known as 3D printing technology. In particular, markers added in fluid form make it easier to customize printing parameters and bring the material closer to radiopaqueness (also known as X-ray opacity) comparable to existing Pt-Ir and other metallic marker bands. That is, these markers increase the radiopaqueness of the medical device at the location of one or more printed marker bands in the radial direction R by, for example, at least by two times, so that the radiopaque marker material becomes visible by fluoroscopy.

[0015] The present invention will now be described in more detail and illustratively with reference to the drawings, using advantageous embodiments. The embodiments described are illustrative configurations in which the individual features described may be provided independently of each other or omitted.

[0016] The accompanying drawings are incorporated herein and form part of this specification to illustrate several embodiments of the present invention. These drawings, together with the description, serve to illustrate the principles of the present invention. The drawings are merely for illustrating preferred and alternative examples of how the present invention can be carried out and used, and should not be construed as limiting the present invention to only the illustrated and described embodiments. Furthermore, several aspects of the embodiments may form solutions according to the present invention, individually or in different combinations. Accordingly, the embodiments described below may be considered individually or in any combination thereof. It should be noted that the embodiments described are merely possible configurations, and when carrying out the present invention, the individual features described above may be provided independently of each other or omitted collectively. Further features and advantages will become apparent from the following more specific description of various embodiments of the present invention, as shown in the accompanying drawings. In the drawings, similar reference numerals refer to similar elements. [Brief explanation of the drawing]

[0017] [Figure 1] This is a cross-sectional view of a medical device equipped with a marker band added using additive manufacturing. [Figure 2] This is a cross-sectional view of a medical device during the additive manufacturing process. [Figure 3] This is a cross-sectional view of a medical device during the step of solidifying a radiopaque marking material in a fluid. [Figure 4] This is a cross-sectional view of a medical device during the step of finishing the ends of a metal reinforcement. [Figure 5] This figure shows a marker band equipped with a braided wire whose ends are treated at the distal end. [Figure 6] This is a diagram showing the X-ray opacity of the marker. [Figure 7]It is a diagram showing a medical device equipped with a metal band marker. [Figure 8] It is a cross-sectional view of a medical device equipped with a metal band marker.

Mode for Carrying Out the Invention

[0018] The first aspect relates to a method of marking the marker position of a medical device, as shown in FIG. 1. For an explanation of the medical device, refer to the above description of the medical device. In particular, as shown in FIGS. 7 and 8, the medical device may include one or more reinforcing material layers 210, such as braided or coiled wires, an inner liner 220, and an outer jacket 230.

[0019] More specifically, the medical device can be composed of multiple layers and materials, each having specific characteristics according to a specific application. For example, an inner liner layer that can be lubricated inside to facilitate the passage of internal devices, catheters, or fluids, one or more reinforcing material layers made of braided or coiled metal or polymer, and another layer that forms a composite material designed to improve the mechanical properties of the medical device, such as ease of pushing and torsional resistance, by coating the reinforcing material layer with a polymer material.

[0020] In many cases, the reinforcing wires need to be end-treated near the distal end of the medical device. The reinforcing wires are generally high-tensile stainless steel with high elasticity, and when these wires are cut into a braided or coiled configuration, they tend to pop out and unwind.

[0021] The coating polymer material or jacket is typically assembled by melting a thermoplastic material tube onto a reinforcing material using a heat shrink tube as a mold for covering the polymer tube, whereby the liquid polymer is pushed into and around the reinforcing material, the polymer is joined to the liner, and a smooth outer surface that completely covers the reinforcing material is formed.

[0022] The reinforcing wires need to be restrained to prevent them from flying out after being cut, and this restraint method must withstand the high temperatures of the jacket assembly process. Several methods exist to prevent the wires from flying out, including using thin-walled, high-temperature resistant heat shrink wrap or locally annealing the braided wires to remove their elasticity.

[0023] The medical device structure may also consist of a single polymer layer or multiple polymer layers without reinforcement.

[0024] According to the first embodiment, the method includes the step of preparing a tube for a medical device. Preferably, the tube comprises a radiolucent material.

[0025] As shown in Figure 2, the tube may comprise a reinforcing layer 210 which may consist of braided or coiled stainless steel wires, and an inner liner 220 which may be made of a polymer material. An outer jacket (not shown in Figure 2), which is attached later, may be made of a polymer material. All of the tube materials have relatively high radiotransparency compared to materials such as tungsten, platinum, iridium, and gold.

[0026] The intensity of X-rays passing through a material can be calculated using equation Eq1. Eq1: I=I o exp(-μ m ×ρ×x) Here, I is the transmitted X-ray intensity, o μ is the incident X-ray intensity. X-ray transmittance is the mass decay coefficient μ of the material. m It decreases as density ρ and thickness x increase.

[0027] There are several methods for comparing the X-ray opacity of different materials. Table 1 below lists the attenuation coefficients of various materials relative to platinum under common imaging conditions for an incident X-ray spectrum at 100 keV at a constant thickness. A value less than 100 indicates that the attenuation of the incident X-ray source is smaller than that of platinum.

[0028] [Table 1]

[0029] According to a first embodiment, the method includes the step of preparing a radiopaque marking material in the form of a fluid, particularly a liquid, for marking marker positions on a medical device, as shown in Figures 2 and 3. The thickness x in the radial direction R of the tubular medical device is a limiting factor for the marking material. In particular, the radial dimension R of the medical device should generally be as small as possible. In addition, as the thickness of the radiopaque marker in the radial dimension R increases, the radiopaqueness also increases. Therefore, materials with high density ρ and / or high mass attenuation coefficient μ can increase the radiopaqueness of the marker. Table 1 above shows some possible materials such as tungsten, platinum, iridium, and gold. In particular, the selection of materials for medical devices may be limited by the application of the medical device to the human body. For example, tin is generally unusable because it is toxic. Radioactive materials are also unusable.

[0030] As described above, the radiopaque marking material is provided in the form of a fluid, as shown in Figure 2. As used herein, a fluid material is any substance that is flowable and does not have a fixed shape. This includes both liquids and gases. The fluid conforms to the shape of its container and is flowable under the action of force.

[0031] According to the first embodiment, the method includes adding a radiopaque marking material to a tube at the marker position of a medical device, and solidifying the added fluid radiopaque marking material to form a solid radiopaque marker, as shown in Figure 3. The solid radiopaque marker (100) increases the X-ray opacity of the medical device at the marker position in the radial direction (R).

[0032] As used herein, additive manufacturing (commonly known as 3D printing) refers to the process of forming an object by adding material in layers, such as from a digital model. Unlike conventional subtractive manufacturing, where material is cut from a solid block, additive manufacturing constructs an object from scratch.

[0033] Additive manufacturing includes processes such as vat photopolymerization, material spraying, binder spraying, pad printing, powder bed fusion bonding, material extrusion, directed energy deposition, and sheet lamination.

[0034] Specifically, the radiopaque marking material in fluid form solidifies after being applied to a tube. This means that the radiopaque marking material undergoes a phase transition from liquid to solid. These transitions occur when a substance changes its physical state due to changes in temperature, pressure, or other environmental conditions. More specifically, as will be discussed later, the radiopaque marking material may solidify, or harden, through a chemical reaction with chemical components such as a curing agent. The process of solidifying the material through a chemical reaction often involves heat, pressure, or the addition of a curing agent.

[0035] In particular, by additive manufacturing using digital models to add marker bands to medical devices, solid radiopaque markers can increase the X-ray opacity of the medical device at the marker position in the radial direction R by at least twofold. This makes, for example, the distal end of the medical device identifiable in radiographic images.

[0036] In particular, marker bands are positioned on the reinforcing material at the distal end of the equipment to restrain the reinforcing wires from flying out after the reinforcing wires are cut. Additive manufacturing is more efficient than manually assembling the marker bands into the braid or coil, positioning them on the ends of the cut wires, and then gluing, crimping, or otherwise holding them in place. Metal marker bands can withstand the melting temperature of the jacket without losing their mechanical properties, allowing the jacket material to be assembled to the marker bands and wire ends without the wire ends flying out.

[0037] In medical imaging, the selection of X-ray energy varies depending on the specific application and the body part being examined. Low-energy X-rays are often used for imaging soft tissues, while high-energy X-rays are used for imaging denser structures such as bone. The range of X-rays considered for medical applications is typically 40 to 120 kiloelectron volts (KeV).

[0038] Increasing X-ray opacity by, for example, twofold means that the material's ability to attenuate or block X-rays changes by an amount that can be calculated using Equation 1. Preferably, the X-ray opacity of the marker band is increased by at least 10 times compared to bone or tissue. This exponentially reduces the intensity of X-rays passing through the material compared to the case without increased opacity. The exact amount varies depending on density and thickness. In particular, the increased X-ray opacity enhances the material's ability to absorb X-rays, reducing the intensity of passing X-rays, improving contrast in radiographic images, and making the marker location within the human body identifiable.

[0039] According to an advantageous modification of the first embodiment, the tube of the first embodiment comprises fibers of a braided and / or coiled wire mesh, also called a reinforcing layer wire, and the method comprises the step of fixing the fibers of the braided and / or coiled wire mesh with a marking material. For example, a fluid marking material enters between the fibers of the braided and / or coiled wire mesh and, once solidified, is fixed within the fibers of the braided or coiled wire mesh.

[0040] In other words, a portion of the marking material fills the space between the wires. The marking material also tends to flow around the reinforcing wires by capillary action, filling the gaps and enclosing the wires. The material also tends to come into contact with the surface of the liner material 220, forming a joint with that surface. In this case, the overall thickness of the marking material may include the thickness of the reinforcing layer and the allowable thickness on the reinforcing layer.

[0041] According to an advantageous modification example, the method further includes the step of trimming solid markers of the braided wire mesh, in particular trimming the distal ends of the braided wire mesh.

[0042] By enclosing the reinforcing wire with a braided and / or coiled wire mesh, the marker can hold the reinforcing wire in place. This allows the reinforcing wire to be cut distal to the marker, and prevents it from flying out even when the reinforcing wire, which is encased in the marker, is released from its restraint, preventing it from straightening or unraveling due to its high elasticity after cutting.

[0043] Advantageously, the marker material can include epoxy resin material, which, once cured, can withstand the high temperatures experienced during subsequent manufacturing process steps, such as during the assembly of the outer jacket material.

[0044] This ensures that the wire end enclosed in the marker remains straight, preventing it from potentially moving towards the outside of the medical device jacket and resulting in defective or discarded products.

[0045] A second aspect relates to the method according to the first aspect, wherein the tube (for example, comprising a reinforcing layer such as a braided wire mesh 210 as shown in Figure 1, an inner liner 220, and an outer jacket 230) extends along the axial direction A, and the marker is added in the form of a band around the tube in the circumferential direction C perpendicular to the axial direction A. Such a marker makes it possible to identify the axial position A of the medical device. In particular, the marker can form an annular ring surrounding the tube in the circumferential direction C. Such annular ring marker makes it possible to identify the axial position A independently of the circumferential position of the medical device.

[0046] According to the first example of the second embodiment, the band has a radial dimension R that is not larger than that of conventional metal marker bands, and is 1 μm or more and / or 50 μm or less. Such a radial thickness ensures sufficient X-ray opacity in the radial dimension R and / or does not affect the overall thickness of the tube's radial dimension compared to conventional metal marker bands. The thickness is measured from the outermost surface of the marker band to the outermost surface of the braided and / or coiled wire mesh.

[0047] In further examples, the bands have axial dimensions that meet visibility requirements during navigation and positioning, depending on the treatment or application. One or more marker bands may be applied to be 1 mm or more and / or 10 mm or less, depending on the application and the characteristics of the medical device or the visibility required at a particular location. Such axial lengths ensure sufficient radiopaqueness of axial dimension A and / or do not affect the flexibility of the tube, respectively.

[0048] A third embodiment relates to any one of the preceding embodiments, the method further comprising the step of rotating the tube about an axial direction A of the tube while applying the marking material. This facilitates the simple placement and uniform application of the marking material in the fluid.

[0049] A fourth aspect relates to a method according to any one of the preceding aspects, wherein the marker is added by depositing droplets of radiopaque marking material onto the tube, for example, as shown in Figure 2. The addition of individual droplets facilitates improvements in printing accuracy, efficiency, and versatility. In particular, this makes it possible to control the thickness of the diameter dimension, for example, to improve the printing speed when the tube is rotated, and to print various materials, including highly viscous materials, materials containing particles, or reactive materials.

[0050] In the fourth embodiment, droplets are added using a pulsejet printer. Therefore, material ejection is employed. A pulsejet printer is a type of printing technology that uses a pulsejet mechanism to deposit liquid material onto a tube. The printer ejects ink droplets through a small nozzle using rapidly controlled bursts, i.e., pulses. For example, the cycle time between droplet bursts is between 5 ms and 20 ms. The droplets can also be ejected at an air pressure of between 2 bar and 6 bar. Furthermore, the diameter of the printer nozzle is between 0.1 mm and / or 0.2 mm. In addition, the droplet temperature is advantageously between 15°C and / or 60°C. Pulsejet printers enable high precision and high resolution, making it possible to print complex patterns such as markers.

[0051] A fifth aspect relates to a method of any one of the preceding aspects, wherein solidifying the marking material includes imparting energy to the fluid marking material. This allows the fluid marking material to be effectively cured after additive manufacturing. Furthermore, this enables additive manufacturing processes by material jetting. For example, the marking material can be solidified by imparting energy using at least one of heat and UV irradiation.

[0052] A sixth aspect relates to a method according to any one of the preceding aspects, wherein the marking material comprises a fluid carrier material and / or radiopaque filler particles, the carrier material comprising a polymer, particularly an epoxy resin, and the radiopaque filler particles comprising at least one of tungsten, platinum, iridium, and gold. This enables an additive manufacturing process by material injection. Furthermore, the combination of the carrier material and radiopaque particles allows for increased versatility.

[0053] A seventh aspect relates to a method of any one of the preceding aspects, wherein the marking material comprises radiopaque filler particles, and the method comprises the step of selecting a subset of radiopaque filler particles having a smaller median diameter from a set of radiopaque filler particles having a larger median diameter, in particular the selecting step comprising sieving the set of radiopaque filler particles. This enables additive manufacturing processes such as material injection, in particular by increasing the uniformity of the particles.

[0054] The eighth aspect relates to a method according to any one of the preceding aspects, wherein the marking material comprises a curing agent, also called a curing agent, particularly a curing agent for epoxy resins. Additionally or alternatively, the marking material comprises a solvent, particularly benzyl alcohol. A solvent is a substance (typically a liquid) that has the ability to dissolve other substances (solutes) to form a homogeneous solution, thereby facilitating the use of additive manufacturing processes by material injection and facilitating the improvement of solute homogeneity. The use of benzyl alcohol as a solvent facilitates the use of antimicrobial agents.

[0055] The ninth aspect relates to the sixth and eighth aspects, and the method further includes the step of preparing a radiopaque marking material, and the preparation of the radiopaque marking material is The process involves mixing a fluid carrier material, radiopaque filler particles, and a solvent. The steps include adding a hardening agent to the mixed radiopaque marking material and Includes.

[0056] This facilitates additive manufacturing processes using material injection. In particular, the curing agent can be added immediately before the fluid marking material is added.

[0057] The tenth aspect relates to a method of any one of the preceding aspects, wherein the added marker is located near the distal end of the tube. In particular, as shown in Figure 4, for example, the marker is located near the end port 240, which extends perpendicular to the axial direction A of the tube.

[0058] An eleventh aspect relates to a method according to any one of the preceding aspects, the method further comprising the step of end-finishing the fibers of a braided and / or coiled wire mesh, which is a braided or coiled layer of stainless steel wires, by adding markers and then trimming the markers. The braided and / or coiled wire mesh may be end-finished using a plurality of methods, including manual cutting of the individual wires or cutting of the wires by applying laser energy to the individual wires.

[0059] A further embodiment relates to trimming the edges of a printed marker using laser energy to form a more distinct, straight edge. This can be done during a laser wire cutting process at the distal end of a marker printed on a reinforcing layer, or at the distal and / or proximal end of a marker positioned directly on the liner rather than on a reinforcing layer.

[0060] The second solution relates to a medical device comprising a marker for marking a marker position of the medical device, the medical device comprising, for example, a tube containing a radiopaque material and a radiopaque marking material at the marker position of the medical device, the radiopaque marking material being added to the tube by being added in fluid form at the position of the medical device to form a solid radiopaque marker for increasing the X-ray opacity of the medical device in the radial direction R by, for example, at least twice. In particular, the medical device may be manufactured according to any one of the first to eleventh embodiments, in particular an advantageous modification of the first embodiment. See above for a description of the first to thirteenth embodiments.

[0061] According to the second and first embodiments of the solution, the marker comprises radiopaque filler particles and a carrier material, wherein the volume fraction of filler particles in the marker is 20% or more and / or 50% or less, and in particular, the filler particles contain tungsten. This facilitates the additive manufacturing process by material injection.

[0062] The above embodiments will be further explained in connection with a detailed explanation of the figures.

[0063] In particular, Figure 1 shows a cross-sectional view of a medical device having a marker added using additive manufacturing. The medical device comprises an inner liner 220 surrounding a lumen 222 having a port 240. A braided and / or coiled wire mesh 210 is positioned between the inner liner 220 and the outer jacket 230. As described above, the medical device tube extends in the axial direction A. Furthermore, the medical device comprises a solid radiopaque marker 100, which increases the radiopaqueness of the medical device in the radial direction R perpendicular to the axial direction A by, for example, at least twice.

[0064] The method for marking the marker positions on medical devices will be explained in detail with reference to Figures 2 and 3.

[0065] Figure 2 shows a cross-sectional view of a medical device during the additive manufacturing step. In particular, a tube for the medical device is provided, comprising an inner liner 220 and a braided wire mesh 210. As described above, the tube preferably contains a radiopaque material.

[0066] Although not shown in Figure 2, the tube may be held by a support structure, such as a shaft passing through the lumen 222. In particular, the support structure may rotate about the axial direction A. This allows the tube to rotate about the axial direction A of the tube while the fluid marking material is added radially R during additive manufacturing.

[0067] Furthermore, as shown in Figure 2, the radiopaque marking material 100 is provided in fluid form. In particular, the marker is added by depositing droplets of the radiopaque marking material 100 onto a tube. For example, as shown in Figure 2, droplets of the radiopaque marking material 100 in fluid form are added using a pulse jet printer 300, passing from a reservoir 320 through a nozzle 310.

[0068] Various parameters can be selected to obtain droplets of radiopaque marking material 100 in a flowable form that can be dispensed from nozzle 310. For example, the temperature of the droplets, particularly measured in reservoir 320, is 15°C or higher and / or 60°C or lower.

[0069] For example, the radiopaque marking material in a flowable form filled in the reservoir 320 comprises a fluid carrier material and / or a curing agent, the carrier material particularly comprising a polymer such as an epoxy resin and a curing agent for epoxy resins. Preferably, the ratio of the fluid carrier material, including the curing agent, to the radiopaque marking material 100, measured particularly within the reservoir 320, is in the range of 7% to 12%, which facilitates the flowability of the droplets.

[0070] As an addition or alternative, for example, a radiopaque marking material in a flowable form filled in the reservoir 320 contains radiopaque filler particles, which in particular contain tungsten, platinum, iridium, and gold particles. Preferably, the ratio of radiopaque filler particles to radiopaque marking material by weight percentage (wt%), as measured particularly within the reservoir 320, is in the range of 80% to 90%, thereby facilitating the radiopaqueness of the added marker. In particular, epoxy resins can have a reasonable pot life that allows the pulse jet printer 300 to be used. Epoxy resins also have the advantages of low viscosity and mild solvents. Medical-grade epoxy resins are available. To reduce the amount of post-treatment required for complete curing, the droplet size can be changed, a curing agent can be added, and / or more energy can be applied during curing.

[0071] As an addition or alternative, for example, the radiopaque marking material in a flowable form filled in reservoir 320 may contain a solvent, the solvent of which may include benzyl alcohol. Preferably, the ratio of solvent to radiopaque marking material by weight percentage (wt%), particularly measured in reservoir 320, is in the range of 0.01% to 8%, which facilitates the dissolution of the components.

[0072] Table 2 below summarizes the weight percentages (wt%) of possible compositions for the two examples.

[0073] [Table 2]

[0074] For the preparation of radiopaque filler particles, it may be advantageous to select a subset of radiopaque filler particles with smaller median diameters from a set of radiopaque filler particles with larger median diameters. In particular, the selection step involves sieving the set of radiopaque filler particles. As an alternative to sieving, cohesive breakdown such as ball milling or resonant acoustic vibration may be performed. For example, sieving may be applied so that the median particle range is 10 μm or less, preferably 5 μm or less.

[0075] Furthermore, for the preparation of the radiopaque marking material, it may be advantageous to first mix the fluid carrier material, radiopaque filler particles, and solvent. After thorough mixing, a curing agent may be added to the mixed radiopaque marking material immediately before filling the reservoir 320.

[0076] Various parameters of the printer can be selected to obtain droplets of radiopaque marking material 100 in a flowable form that can be ejected from a nozzle 310 that can be used to form radiopaque markers. For example, the diameter of the printer nozzle 310 may be selected to be 0.1 mm or more and / or 0.3 mm or less. Furthermore, the cycle time, i.e., the series of cycles including the delay of opening and closing and reopening the nozzle 310, may be 2 ms or more and 20 ms or less. Additionally or alternatively, the droplets may be ejected at an air pressure of 2 bar or more and / or 6 bar or less.

[0077] Considering the above, it is possible to use additive manufacturing by material injection to place radiopaque marking material at the marker location on a medical device, i.e., at the specified location, onto a radiopaque tube. Alternative additive manufacturing processes such as sintering, pad printing, and / or paste extrusion may also be possible.

[0078] Furthermore, as shown in Figure 3, the added fluid radiopaque marking material solidifies to form a solid radiopaque marker 100, which increases the X-ray opacity of the medical device in the radial direction R by, for example, at least twice.

[0079] As described above, the shape of the solid radiopaque marker 100 can be controlled, for example, by controlling the ejection of droplets. In particular, the marker is added using a pulse jet valve incorporated into an automatic fluid supply system. The opening and closing cycle of the valve, i.e., the length of the "jet," is determined by individual droplets of the injected fluid. Also, the shaft holding the tubing of the medical device can rotate below the nozzle of the valve as droplets of ink are ejected to form the marker. The ejection parameters are adjusted according to the properties of the ink, including viscosity, surface energy, and particle concentration.

[0080] In particular, as shown in Figure 3, the marker is added to the band-shaped tube in a circumferential direction C perpendicular to the axial direction A. Although not evident from the cross-sectional view shown in Figure 3, the marker may also form an annular ring surrounding the tube in the circumferential direction C.

[0081] Typical dimensions for ensuring sufficient radiopaqueness, sometimes referred to as radiopaqueness, while allowing sufficient flexibility of the medical device, may be a radial thickness R of 1 μm or more and / or 50 μm or less. Additionally or alternatively, the band may have an axial dimension A of 1 mm or more and / or 10 mm or less.

[0082] As further shown in Figure 3, the tube may further contain fibers of the braided wire mesh 210, with at least a portion of the marking material 100 interspersed between the braided fibers. In other words, the marking material secures the fibers of the braided and / or coiled wire mesh.

[0083] Furthermore, as shown in Figure 3, solidifying the marking material involves imparting energy to the fluid marking material by an energy source 400. For example, as shown in Figure 3, the energy can be imparted by heat. Alternatively, according to a solution not shown, the marking material can be solidified by imparting energy by UV irradiation. In particular, the energy source can be selected considering the curing agents described above, for example, a thermosetting curing agent or a UV curing agent.

[0084] As further shown in Figure 4, after the marker 100 is added, the fixed braided and / or coiled wire mesh 210 may be end-finished. In particular, the distal end of the braided and / or coiled wire mesh (210) is end-finished. Here, end-finishing means, in particular, treating the ends of the fibers during the manufacturing process to prevent fraying or unraveling, for example, tying, cutting, or bundling the ends of the fibers.

[0085] For example, as shown in Figure 4, the tube is end-finished at the end adjacent to the end port 240. In particular, as shown in Figure 4, the fibers of the braided and / or coiled wire mesh 210 are end-finished. This further prevents the ends of the fibers of the braided and / or coiled wire mesh 210 from penetrating the outer jacket 230 or inner liner 220 shown in Figure 1. The marker band can also withstand the heat of any additional assembly steps, such as adding an outer jacket. This can be facilitated, for example, by using an epoxy resin material.

[0086] In order to process the ends of the braided and / or coiled wire mesh 210 and / or marker band, energy may be applied to the braided and / or coiled wire mesh 210 and / or marker band, particularly by cutting the braided and / or coiled wire mesh 210 and / or marker band using a laser 500.

[0087] In another step of the method not shown in the figure, the solid marker can be trimmed to form a distinct edge 150. In particular, the end of the marker 100 adjacent to the opening 240 may be trimmed. Thus, as shown in Figure 8, the marker 100 added by additive manufacturing has, at one end, the same radiopaqueness as the bonded marker 1100. In particular, a laser 500 may be used to finish the edges of the solid marker.

[0088] The resulting radiation measurement results for the marker 100, which has been trimmed and edge-finished in this manner, are shown in Figure 5. In particular, the marker 100 and the braided wire mesh 210 on the inner liner 220, which has a clear edge 150, are distinguishable by contrast in the X-ray image.

[0089] By considering the above process steps explained in Figures 2 to 4, the medical device shown in Figure 1 becomes feasible. In particular, the use of composite fluid materials that can penetrate braided and / or coiled wire meshes, as described above, and the solidification of the fluid material, makes it easy to increase X-ray opacity and maintain sufficient mechanical strength at high temperatures.

[0090] Figure 6 shows example measurement results of the radiopaqueness (also called radiopaqueness) of fluid marking materials for the outer diameter of markers solidified on tubes. Note that the outer diameter is measured in inches, and 1 inch is equal to 2.54 cm. The circular data points represent the measurement results of the fluid marking material according to Example 1 described in Table 2. The triangular data points represent the measurement results of the fluid marking material according to Example 2 described in Table 2. In particular, the markers contain radiopaque filler particles and carrier material, with a volume fraction of filler particles in the markers being 20% ​​or more and / or 50% or less, and the filler particles specifically contain tungsten. For reference, the measurement results of the radiopaqueness of the marking material described in Figure 8 are shown as squares.

[0091] Although not specifically shown in Figure 2, other additive manufacturing techniques may also be possible. Furthermore, alternative solidification steps may be used. In addition, the trimming step may be optional, and other energy sources may be used for trimming. [Explanation of symbols]

[0092] 100 markers 150 Clear margins 200 tubes 210 Braided Wire Mesh 220 Inner liner 222 Luminal part 230 Outer Jacket 240 ports 300 Pulse Jet Printers 310 nozzles 320 Reservoir 400 energy sources 500 lasers 1100 Metal band marker 1210 Braided Wire Mesh

Claims

1. A medical device comprising a marker (100) for marking the marker position of the medical device, the medical device is The tube of the aforementioned medical device, The radiopaque marking material (100) at the marker position of the medical device and Equipped with, A medical device wherein the radiopaque marking material (100) is added to the tube by being manufactured in fluid form at the marker position of the medical device, thereby forming a solid radiopaque marker (100) to increase the X-ray opacity of the medical device in the radial direction (R).

2. The medical device according to claim 1, wherein the marker (100) comprises radiopaque filler particles and a carrier material, the volume fraction of the filler particles in the marker (100) is 20% or more and / or 50% or less, and in particular the filler particles contain tungsten.

3. A method for marking the marker position of a medical device, wherein the method is: The steps include preparing the tube for the aforementioned medical device, The steps include preparing a radiopaque marking material (100) in the form of a fluid for marking the position of the medical device, The steps include: adding the radiopaque marking material to the tube at the marker position of the medical device; A step of solidifying the added fluid radiopaque marking material (100) to form a solid radiopaque marker (100), wherein the solid radiopaque marker (100) increases the X-ray opacity of the medical device at the marker position in the radial direction (R), and Methods that include...

4. The tube comprises fibers of a braided or coiled wire mesh (210), and the method comprises the step of fixing the fibers of the braided and / or coiled wire mesh (210) with the marking material. The method according to claim 3, wherein, optionally, the marker material of the fluid enters between the fibers of the braided and / or coiled wire mesh (210) and, upon solidification, is fixed within the fibers of the braided and / or coiled wire mesh (210).

5. The method according to claim 4, further comprising the step of end-finishing the fixed braided and / or coiled wire mesh (210), in particular the distal end of the braided or coiled wire mesh (210).

6. The method according to any one of claims 3 to 5, wherein the tube extends along an axial direction (A), the marker (100) is attached in the form of a band around the tube in a circumferential direction (C) perpendicular to the axial direction (A), optionally the marker (100) forms an annular ring surrounding the tube in the circumferential direction (C), optionally the marker (100) has a radial dimension (R) of 1 μm or more and / or 30 μm or less, and optionally the band has an axial dimension (A) of 1 mm or more and / or 10 mm or less.

7. The method according to any one of claims 3 to 6, further comprising the step of rotating the tube about the axial direction (A) of the tube while adding the marking material (100) of the fluid.

8. The method according to any one of claims 3 to 7, wherein the fluid marker (100) is added by depositing droplets of the radiopaque marking material (100) onto the tube, preferably the droplets are added using a pulse jet printer (300), optionally the diameter of the nozzle (310) of the printer (300) is 0.1 mm or more and / or 0.2 mm or less, optionally the temperature of the droplets is 15°C or more and / or 60°C or less, optionally the cycle time of the droplets is 5 ms or more and 20 ms or less, and optionally the droplets are sprayed at an air pressure of 2 bar or more and / or 6 bar or less.

9. The method according to any one of claims 3 to 8, wherein solidifying the radiopaque marking material (100) includes applying energy to the radiopaque marking material (100) in fluid form, particularly applying at least one of heat and UV irradiation, to solidify the radiopaque marking material (100).

10. The method according to any one of claims 3 to 9, wherein the radiopaque marking material comprises a fluid carrier material and / or radiopaque filler particles, the carrier material comprises a polymer, particularly an epoxy resin, and the radiopaque filler particles comprise at least one of tungsten, platinum, iridium, and gold.

11. The radiopaque marking material (100) comprises radiopaque filler particles, the method comprising the step of selecting a subset of radiopaque filler particles having a smaller median diameter from a set of radiopaque filler particles having a larger median diameter, in particular the step of selecting comprising sieving the set of radiopaque filler particles, according to any one of claims 3 to 10.

12. The method according to any one of claims 3 to 11, wherein the radiopaque marking material (100) comprises a curing agent, particularly a curing agent for epoxy resins, and / or a solvent, particularly benzyl alcohol.

13. The method further includes the step of preparing the radiopaque marking material (100), and the preparation of the radiopaque marking material (100) is The steps include mixing the fluid carrier material, the radiopaque filler particles, and the solvent, The steps include adding the curing agent to the mixed radiopaque marking material (100) and The method according to claims 9 and 12, including the method according to claims 9 and 12.

14. The method according to any one of claims 3 to 1213, wherein the added radiopaque marker (100) is located near the distal end of the tube.

15. The method further includes, after adding the marker (100), trimming the marker (100), in particular, the step of treating the ends of the fibers of the braided wire mesh (210) according to claim 4, The method according to any one of claims 3 to 14, wherein, optionally, trimming the marker includes trimming the marker using a laser (500) that imparts energy to the marker.

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