Plastic Laser Welding for a Manipulable Catheter Tip

Abstract

The present disclosure relates to a manufacturing method, an apparatus, and a fixing device. An apparatus is provided that includes a liner having a hollow cavity with an extended liner length, at least two guide rings deployed together along the liner, and at least one lumen portion extending through each of the at least two guide rings and parallel to the hollow cavity, wherein the at least two components are fixed by welding. A fixing device and a manufacturing method are also provided.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 979,930, filed on February 21, 2020, and U.S. Provisional Patent Application No. 63 / 132,743, filed on December 31, 2020, the entire contents of which are incorporated herein by reference. Technical field

[0003] The present disclosure relates to manufacturing methods, devices, and fixtures. More particularly, the subject disclosure relates to manufacturing methods and a flexible medical device having a hollow cavity and an annular guide along the device. Background art

[0004] Flexible medical devices such as endoscopic surgical instruments and catheters are well - known and continue to gain acceptance in the medical field. Flexible medical devices typically include a flexible body commonly referred to as a cannula or sheath. One or more tool channels extend along (usually internally) the flexible body to allow access to a target located at the distal end of the flexible body.

[0005] Some bendable devices have an inner liner, an outer liner, and optionally other components provided within the device for actuation of a flexible body. However, for bendable devices that require a small diameter and a large degree of curvature at the distal end of the device, such configurations are not particularly useful because the various liners and components increase rigidity and prevent the device from bending sufficiently. Accordingly, guide rings are used that are disposed along the device to guide a wire for controlling the device. For example, see U.S. Patent 9,144,370. Another example of a bendable medical device with guide rings is described in WO 2018 / 204202. In this device, the guide rings are attached to the inner liner or the skeleton by an adhesive. However, the use of adhesives in manufacturing is not always preferred because the adhesives can be difficult to apply, may add unwanted materials, and the spacing of the guide ring structure cannot be controlled. In particular, the spacing of the guide rings directly affects the function of the bendable medical device. When the adhesives are first applied, they can typically act like a lubricant, causing the components to move more easily until the adhesive bonding characteristics are formed, making it more likely that the guide ring spacing can be altered or be inconsistent. It is also important that there is no adhesive between the rings or that the adhesive does not block small lumens within the rings for the catheter to function properly. If the adhesive is placed between the rings or if the adhesive blocks the lumen, the bendable medical device may lose some degrees of freedom of bendability. The adhesives are typically applied manually, and due to the size of the catheter components, such manual handling can be difficult to accomplish without the misapplication of the adhesives described previously. Additionally, because any loosening or displacement of the guide rings can also negatively affect catheter function, the bonding strength with the adhesive may be inconsistent and lower than the bonding strength required for the desired catheter durability. Accordingly, additional bendable devices and manufacturing methods are needed to overcome these problems. There is a need to attach guide rings that can have a short length and that contain a lumen within the guide rings, the guide rings having a set spacing along the device.

[0006] There are currently a variety of additive and non-additive methods for attaching components together. Non-additive methods such as ultrasonic and heating can be used, but the process may deform the surrounding material and is not very localized, making it difficult to use on small-diameter devices such as catheters. There are exceptions to this; EP 1234595 provides a balloon catheter that uses an infrared wavelength of no more than 1580 nanometers (i.e., an ND:YAG laser or a low-power diode laser) between the balloon and the catheter body for plastic laser welding. However, this is applicable to a balloon, which is a thin sheet-like material that only needs to be adhered and extends a certain length along the catheter. Therefore, it is necessary to overcome the defects described herein to form a flexible device and a manufacturing method for a device having a guide ring that needs to be attached without changing the configuration of the lumen portion running through it or for a guide ring that is adhered at known spaced relationships. Summary of the Invention

[0007] According to at least one embodiment of the present invention, there is provided a device comprising: a liner having a hollow cavity extending the length of the liner; at least two guide rings disposed together along the liner; at least one lumen portion extending through each of the at least two guide rings and parallel to the hollow cavity, wherein at least two components are fixed by welding. The device may further comprise an outer liner, which may be the distal end of a catheter. The device may additionally comprise an extrusion. In a further embodiment, at least two guide rings are welded to the liner, and / or the outer liner is welded to at least two guide rings, and / or the extrusion is welded to the liner. In some embodiments, the device further comprises a plurality of wires that extend through the lumen, or through some or all of the guide rings, or through at least one portion of the guide rings if the device has different parts.

[0008] According to other embodiments of the present invention, there is provided a manufacturing method. The method comprises: combining a plurality of guide rings around the outer side of a liner to create an assembly; placing the assembly on a fixing device adapted to set the distance between each of the plurality of guide rings; and welding each of the plurality of guide rings to the liner. The plurality of guide rings are substantially transparent and contain at least one lumen portion. According to another embodiment, the welding occurs through both a region containing a lumen and a region not containing a lumen.

[0009] According to another embodiment of the present invention, a laser welding system is provided, which may include a vision system, a laser generator, a transmission fiber, a beam shaper, a galvanometer head, an electric fixing device, and a controller in communication with the vision system, the electric fixing device, and the laser generator. Among them, the laser welding system is configured to weld two or more components of a manipulable medical device. According to another embodiment, the welding occurs through both an area containing a lumen and an area not containing a lumen. In other exemplary embodiments, the system is configured to (i) weld a liner having a hollow cavity with a length of an extended liner and at least two guide rings deployed together along the liner; (ii) weld an outer liner to one or more guide rings; and / or (iii) weld an extrusion to the liner.

[0010] These and other objects, features, and advantages of the present disclosure will become apparent when the following detailed description of the exemplary embodiments of the present disclosure is read in conjunction with the accompanying drawings and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] More objects, features, and advantages of the present disclosure will become apparent from the following detailed description when read in conjunction with the drawings showing exemplary embodiments of the present disclosure.

[0012] Figure 1 A side perspective three-dimensional view of an exemplary medical device according to one or more embodiments of the subject device, method, or system is depicted.

[0013] Figure 2 A side perspective three-dimensional view of an exemplary medical device according to one or more embodiments of the subject device, method, or system is depicted.

[0014] Figure 3 Is a diagram showing an embodiment of a transparent ring welded to a light-absorbing internal lumen in an exemplary medical device according to one or more embodiments of the subject device, method, or system.

[0015] Figure 4 Is a diagram showing an embodiment of a welding configuration in a method of forming a medical device according to one or more embodiments of the subject device, method, or system.

[0016] Figure 5 Is a diagram showing an embodiment of another welding configuration in a method of forming a medical device according to one or more embodiments of the subject device, method, or system.

[0017] Figure 6 A side perspective three-dimensional view of an exemplary medical device according to one or more embodiments of the subject device, method, or system is depicted.

[0018] Figure 7 Is an exemplary laser configuration that can be used with the present invention.

[0019] Figure 8 are exemplary computer configurations that can be used with the present invention.

[0020] Figure 9 is a diagram depicting an exemplary laser pattern that can be used with the present invention.

[0021] Figure 10A and Figure 10B is a side perspective three-dimensional view depicting the difference in weld length according to one or more embodiments of the subject device, method, or system.

[0022] Throughout the drawings, unless otherwise noted, the same reference symbols and characters are used to denote similar features, elements, components, or parts of the illustrated embodiments. Additionally, while the present subject matter will now be described in detail with reference to the drawings, this is done in conjunction with illustrative exemplary embodiments. It is intended that changes and modifications can be made to the described exemplary embodiments without departing from the true scope and spirit of the subject matter disclosed by the appended claims. Detailed Description

[0023] The devices, methods of manufacturing the devices, systems, and manufacturing configurations as described herein relate to catheter manufacturing and (i) the attachment of components such as guide rings to a liner forming an internal lumen of, for example, a catheter; (ii) the attachment of components such as guide rings to an outer liner forming an outer portion of, for example, a catheter and / or (iii) the attachment of components such as guide rings to an extrudate forming a portion of, for example, a catheter and to a medical device formed by manufacturing.

[0024] In some embodiments, the distal portion of the medical device such as Figure 1 and Figure 2 as shown, the Figure 1 and Figure 2 depict a side perspective three-dimensional view of an exemplary bendable medical device, where the bendable medical device includes at least two guide rings 36a, 36b (four are shown - 36a, 36b, 36c, 36d) confined within a bendable body 26, where the guide rings 36 are configured to be separated from each other by a certain distance and not in contact with each other.

[0025] The flexible body 26 includes an inner liner 44 and an outer liner 46, which provide flexible support for the flexible body 26 while maintaining the guide rings 36 in a constant position along the axial direction of the flexible body 26. Inside the inner liner 44 is a hollow cavity 28 that extends the length of the liner. This hollow cavity 28 can be used, for example, as a tool channel or working channel for a catheter. Each guide ring 36 includes at least two lumen portions 34 and is configured to receive anchoring segments 32a, 32b that are embedded within the guide ring 36. The space between adjacent guide rings cooperates with the elastic inner liner 44 and outer liner 46, allowing the flexible body 26 to achieve a large range of bending motion due to the open space between the guide rings 36.

[0026] The medical device is configured and / or adapted for in vivo use, including in terms of size and maneuverability. The configuration of the discrete and continuous outer liner 46 can be adjusted to the flexibility required for navigation to accommodate the patient's anatomy. The spacing of the guide rings 36 can be increased or decreased depending on, for example, the bending range, diameter, and structure of the flexible body 26. As shown, all the guide rings 36 are equally spaced. However, in some embodiments, the spacing can vary. For example, there can be different distances between the guide rings 36 between different flexible segments of the flexible body 26; the guide ring spacing within one flexible segment can be different from the guide ring spacing within another flexible segment; or the guide ring spacing can gradually increase or decrease along the flexible body 26. The diameter of the inner liner 44 and / or outer liner 46 can also be modified based on the patient's anatomy. In some embodiments, the outer diameter of the flexible device (which is the outer diameter of the outer liner 46) is minimized to simultaneously allow minimally invasive surgery and allow the medical device to be used in smaller anatomies. For example, a device having an outer diameter of less than 5 mm, 4 mm, 3 mm, or 2 mm can be used for manipulation within the segmental or sub-segmental bronchi of the lung (see, for example, U.S. Patent Publication 2019 / 0105468, which is incorporated herein by reference).

[0027] Figure 2 Also depicted is an exemplary use of nested control wires, showing wires 40a and 42a within a set of lumen portions 34 in combination with at least two guide rings 36. Additionally, this embodiment allows multiple control wires 40a and 42a to be anchored at the anchoring segments (32a and 32b) and slidably move through the lumen portions 34 of the flexible body 26. While the nested control wires are depicted as an exemplary configuration, alternative embodiments can also be used, including, for example, the use of individual wires that can be anchored within one or more lumen portions or be fully slidable within one or more lumen portions, and where, if anchored, the individual wires can be anchored at the same or different locations. Other suitable configurations of control wires will be apparent to those skilled in the art.

[0028] The plurality of guide rings 36 joined to the inner liner 44 will use laser welding instead of adhesives to create Figure 3 the flexible body 26 shown in. The distal portion of the medical device is shown without an optional outer liner or sheath 46. The plurality of guide rings 36 are spaced along the inner liner 44, with all lumen portions 34 aligned such that wires can be inserted through the lumen portions 34 of each of the annular guides 36. Thus, the flexible body 26 can also include wires 40a and 42a (not depicted) extending parallel to the hollow cavity 28, with each of the wires 40a and 42a extending through the lumen portion 34 of the guide ring 36. An array of lumen portions 34 extending proximally within the flexible body 26 and between the inner liner 44 and the outer liner 46 creates an effective lumen for controlling the placement of the wires. In some embodiments, nine or more wires are located within at least some of the guide rings 36.

[0029] In one exemplary embodiment, the outer liner 46 can be fixed to the guide ring 36 by laser welding. Such guide rings 36 can also optionally be fixed to the inner liner 44 by laser welding. In such an exemplary embodiment, the outer liner 46 can be made of a material more transparent than the guide ring 36, and the guide ring 36 can be made of a material more transparent than the inner liner 44. Thus, the components to be welded can be made of materials with different transparencies such that the outermost component to be welded has a greater transparency than the component to which it is to be fixed. Depending on the number of components to be welded, there may be a total of 2, 3, 4, 5, or more different transparencies (or levels) between all the components to be welded. In one exemplary embodiment, any component of the flexible body that needs to be fixed can have a fixation accomplished by welding.

[0030] To form the flexible body as Figure 3 shown, as Figure 4 depicted, a fixture 50 is used to hold the components in place during the welding process. One or more wires can be inserted into the lumen portion 34 of each guide ring 36 to assist in the rotational placement of the guide ring 36. Alternatively, the guide ring 36 can include, for example, cavities or indentations on the outside of the guide ring to align the plurality of guide rings along the flexible body. The fixture 50 can also include one or more fixture shims 52 to ensure the desired alignment of the guide rings 36 relative to each other. Depending on whether a consistent spacing or other desired configuration of the guide rings 36 is desired, the fixture shims 52 can have the same or different sizes. Laser welding can be used to first fix the components in place to prevent the components from moving out of position within the fixture 50.

[0031] The guide ring is made of a material with less light absorption compared to the inner liner. Thus, when light is focused into the flexible body, the light will transmit through the guide ring and reach the inner liner, and welding is allowed, for example, by transmission welding at the interface between the two materials. For example, the guide ring can be made of extruded polyolefin, polyamide, polyester, ethylene-vinyl acetate (EVA), or thermoplastic elastomer (TPE, such as ). The limitation of these materials is that they must be weldable. The inner liner can be formed of the same type of material with the same or different hardnesses, but will have high light absorption. In some examples, the inner liner contains a certain percentage of dye or carbon black to increase the absorption rate of the inner liner, such as 0.1% to 5% of Pebax, such as 0.1%, 0.5%, 1.0%, 2%, 3%, 4%, 5% carbon black. In certain embodiments, the inner liner may include at least 0.5% carbon black. In some embodiments, radiopaque additives are added (e.g., barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, or tungsten) to provide both X-ray visibility and preferred welding characteristics.

[0032] Importantly, the guide ring absorbs less light compared to the inner liner, and in some embodiments, the guide ring is substantially transparent at the wavelength of the light used for the welding process. However, transparency is not required. Importantly, the annular guide 36 is sufficiently transparent and the laser pattern is sufficiently focused such that the lumen portion 34 extending through the annular guide 36 is not melted or significantly deformed by the laser welding process. In some embodiments, preferably, no lumen portion is significantly altered by the welding process that adheres the guide ring to the inner liner. If the wire slides less freely through the lumen portion when the wire is inserted through the lumen portion 34, or if the structure of the lumen portion is changed by more than 50 microns, or more than 10 microns, or more than 2 microns, then the lumen portion will be significantly altered.

[0033] In Figure 4 , a portion of the fixture 50 used in the welding process is shown. This figure illustrates the configuration of the flexible body 26 in a horizontal position with the fixture 50, the fixture 50 having a plurality of fixture spacers 52 that separate the guide ring 36 by a fixed amount defined by the spacing of the fixture spacers 52. Figure 4 The fixture spacers 52 in are shown as rectangular units, but can alternatively be designed with a circular or triangular structure. The laser 54 is positioned to provide light 56 to the flexible body 26 at the interface between the more transparent guide ring 36 and the less transparent inner liner 44. In this exemplary embodiment, the laser 54 is fixed and the flexible body 26 rotates as indicated by the arrow 64. As the flexible body 26 rotates, this allows the laser pattern 58 to travel around the inner side of the annular guide 36 / inner liner 44 interface and create the weld portion 60.

[0034] Laser welding generally requires a firm physical contact between the materials to be welded. Thus, one aspect of the present invention is to provide strict tolerances to ensure such contact. In one exemplary embodiment, a mandrel (not depicted) may be inserted into the hollow cavity 28 (i.e., within the liner 44 made of a flexible material such as a material having a flexural modulus between 15 GPa and 55 GPa), such that pressure can be applied from the inside of the liner 44 outwardly towards the interior of the guide ring 36. It is within the scope of the present disclosure that the amount of pressure applied from the inside of the liner 44 outwardly towards the interior of the guide ring 36 can be varied based on the size of the mandrel inserted into the hollow cavity 28. In some embodiments, the mandrel is paired with a liner that can readily accommodate the geometry of the mandrel, thus ensuring a firm contact between the liner and the guide ring. In such use, the mandrel will fully expand the diameter of the liner, thereby creating a tight fit between the liner and the guide ring. Additionally, the liner can be designed to have an interference between the outer diameter of the liner and the inner diameter of the guide ring to ensure contact (using the same material properties). During the welding process, the mandrel can remain within the liner. Additionally, the mandrel can be rotated to cause the flexible body 26 to rotate, including providing repeatable and consistent rotation through an automated component. Exemplary mandrels should be readily insertable into and removable from the hollow cavity 28 and can be made of a material that permits such insertion and removal. In one exemplary embodiment, the mandrel can be coated with a substance having a low coefficient of friction, such as polytetrafluoroethylene or a similar non-stick material. The welding portion can extend completely or partially around the circumference of the flexible body 26. After welding one guide ring 36 to the liner 44, the fixture 50 can be translated as shown by arrow 62 such that the laser pattern 58 is incident on the flexible body at the second annular guide / liner interface. Figure 4 And Figure 5 The fixture 50 provided in [reference] allows all components used to create the flexible body to be held in place and aligned during welding.

[0035] As Figure 5 shown, an alternative configuration is to vertically position the flexible body 26 within the concave mirror 62. The laser 54 is capable of welding in a cylindrical laser pattern 58 around a single guide ring 36 simultaneously without moving the fixture 50 or the flexible body 26. The mirror 62 is also fixed, and the flexible body 26 will be pulled through the center of the mirror 62 to align the various guide rings 36 with the laser pattern 58. In different embodiments of this configuration, additional fixtures (not shown) are attached to the flexible body to separate the guide rings 36 in a spaced relationship prior to performing laser welding. When laser welding occurs, this fixture can move with the flexible body. In some embodiments, the fixture is substantially transparent to the laser so as not to absorb the welding radiation.

[0036] Figure 6 Also depicted is a longer portion of the flexible body 26 showing the drive ring 38, which can be placed within a portion of the guide ring 36, including at the intersection of different flexible portions of the flexible body 26. The guide ring 36 and the drive ring 38 can be the same or different widths and / or diameters, or can include a plurality or series of different widths and / or diameters along the length of the flexible body 26. In one exemplary embodiment, laser welding can be used to weld the drive ring 38 to the inner liner 44. Also depicted is the extrusion 30, which can be proximate one or more different flexible portions of the flexible body 26, and through which the wires 40a and 42a slidably move through the lumen portion of the extrusion 30. The extrusion 30 is joined to the inner liner 44 using laser welding instead of an adhesive. Laser welding can be used to first fix the components in place to prevent the components from moving out of position before the entire welding is completed.

[0037] Although Figures 1 - 6 the distal end of the flexible body (with or without an outer liner or extrusion) having the inner liner, guide ring, and lumen portion of the relative sizes shown is depicted, the method and fixation device can be used for a series of different medical devices having other configurations. It is also contemplated that closer to the portion of the flexible body shown, the flexible body will have a continuous extrusion containing a lumen instead of a guide ring. For example, WO 2017 / 066253, WO 2018 / 204202, U.S. Patent Publications 2018 / 0310804, 2018 / 0243900, 2018 / 0311006, 2019 / 0015978, and 2019 / 0105468 each provide flexible medical devices and their control and use, and can be made at least in part by the methods provided herein.

[0038] Figure 7 An exemplary laser welding system 4 that can include a vision system 2 is shown. The laser welding system 4 includes a laser generator 14, a transmission fiber 16, a beam shaper 18, a CPU or controller 6, and a galvanometer head 20. The laser generator 14 generates light or a laser beam 56 through a diode laser pump. The transmission fiber 16 transmits the light 56 generated by the laser generator 14 to the beam shaper 28. The beam shaper reshapes the laser beam and transmits it to the galvanometer head. The galvanometer head moves the laser beam along the welding path. The galvanometer head 29 outputs the laser beam 56 across the welding target 33.

[0039] The vision system 2 of the laser welding system 40 may include a vision system controller 22 and an optical detector 25. The vision system 2 locates each component via the vision system controller 22 that receives inputs from the optical detector 25. The controller 6 of the laser welding system 4 receives the position of the target component 24 through a communication port. The controller 6 then moves the axes required for the laser system by PID control to ensure that the laser 56 hits the target component 24.

[0040] Importantly, any thermal damage to the transparent portion of the device is limited and melting occurs substantially along the inner liner. This can be done by focusing the light at the interface of the inner liner and by defining the relative materials of the guide ring and the inner liner.

[0041] In some embodiments of the present invention, strict control of the power density of the laser 54 is particularly important. Since the energy from the laser will be transmitted through the guide ring and then the lumen portion, it is important to position the density at the inner liner interface and provide welding. In some embodiments, the annular guide is relatively thick compared to the inner liner which may be a very thin extruded tube. Additionally, there may be multiple lumen portions located within the annular guide and they may be particularly small and must be kept sufficiently uniform (non-deformed) to provide slidability for wires to move through the lumen portion and provide actuation of the medical device.

[0042] Thus, in one exemplary embodiment, the laser welding system 4 is configured to utilize those parameters or conditions that are most suitable for the desired welding. Parameters that can be controlled include but are not limited to: (1) Laser power - an exemplary range is 18% to 30% and is set by the controller 6 and the laser generator 14; (2) Focal length - an exemplary range is 150 mm to 200 mm, although this will vary at least in part over the target component; the focal length is measured from the galvanometer to the workpiece target component; (3) Clock speed - the speed at which the laser beam 54 moves across the workpiece, an exemplary range is 20,000 to 50,000 galvanometer steps / second; (4) Number of laser passes - the number of times the laser passes through the weld point on the target component; an exemplary range can be 2 to 20 laser passes; (5) Clamping pressure - the pressure between the mating parts to be welded; the exemplary range can vary based on the mandrel diameter and can range from 0.081” to 0.088”; (6) Welding pattern - the pattern repeated by the laser during laser irradiation, examples of which are shown in Figure 9, namely - straight lines, overlapping circles, and overlapping squares; (7) Welding time - the total amount of time from the start to the stop of welding, excluding the positioning / loading of the workpiece and / or target component; the range depends on the clock speed and the number of laser passes to be performed; (8) Laser wavelength - an exemplary range is from 1.940 microns to 2 microns (1940 nanometers to 2000 nanometers); (9) Laser type - although other lasers may be suitable, an exemplary laser is a fiber laser; (10) Laser power capability - an exemplary range is up to 120 watts.

[0043] Figure 4 Exemplary embodiments of ways in which a laser irradiates a component precisely and repeatedly with the same settings when guided through programming and control are provided. The use of the fixture 50 allows the welding system 4 to hold the flexible body 26 during laser irradiation, thus allowing the component to be fixed in place before the fixture 50 is removed. In one embodiment, the laser welding system 4 can be a 1940 nanometer (2 micron) laser system having five moving axes (x-axis (width), laser head rotation, θ-axis (component rotation), y-axis (depth movement), and z-axis (height movement)). The ability of the laser system to control the movement on the θ-axis (component rotation) can be used in combination with the mandrel discussed herein such that the motor controls the rotation on the θ-axis to precisely rotate the flexible body 26 with a precision level within the micron range at the desired position.

[0044] In combination with the vision system 2, the laser welding system 4 allows for the automatic movement of the target component and the laser itself such that the vision system can position the component and the associated motor controls the movement of the laser and / or the component on the X, Y, Z, θ, and laser head rotation axes, providing repeatable, accurate, and precise welding. As provided herein as exemplary embodiments, the automation of laser welding provides advantages over the use of adhesives because the resulting weld points can be designed to have strength characteristics that meet and / or exceed the performance specifications while remaining consistent during repeated iterations of the same or subsequent target components.

[0045] During welding, the control of the fixture 50, the laser 54, and the flexible body 26 can be controlled by a computer system as Figure 7 shown. As Figure 8More specifically shown, computer system 4 includes a controller or CPU 6, a storage device / RAM 8, an I / O interface 10, and a detector interface 12. Computer system 4 can be used to communicate with vision system 2 or can be used alone. Computer system 4 can include one or more devices. For example, one computer can include components 6, 8, and 10, while other computers can include component 12. CPU 6 is configured to read and execute computer-executable instructions stored in storage device / RAM 8. The computer-executable instructions can include those for performing the methods and / or calculations described herein. For example, CPU 6 can calculate the amount of rotational and / or translational movement required to properly align target member 24 with laser 54 to successfully perform the desired welding.

[0046] Storage device / RAM 8 optionally includes one or more computer-readable and / or writable media and can include, for example, magnetic disks (e.g., hard disks), optical disks (e.g., DVDs, Blu-ray), magneto-optical disks, semiconductor memories (e.g., non-volatile memory cards, flash memories, solid state drives, SRAM, DRAM), EPROM, EEPROM, etc. Storage device / RAM 8 can store computer-readable data and / or computer-executable instructions. The components of computer system 4 communicate via a bus.

[0047] I / O interface 10 provides a communication interface for input and output devices, which can include a keyboard, a display, a mouse, a printing device, a touch screen, a light pen, an optical storage device, a scanner, a microphone, a camera, a drive, a communication cable, sensors (such as temperature sensors), and networks (wired or wireless).

[0048] Example

[0049] The functional requirements of the catheter components are provided in Table 1.

[0050]

[0051] Example 1: Welding of the inner cover to the extrusion

[0052] Welding of the inner cap to the extruded part presents many technical challenges: (1) compensation for different laser absorptions through areas with or without holes (lumens); (2) the inner cap has a thin wall (less than 0.5 mm) and must be kept undamaged; (3) the extrusion diameter is in the range of less than 5 mm; (4) the weld points must be strong under tension; (4) the weld points must be sealed at 25 psi; (5) the welding must be performed around the wires passing through the extruded part.

[0053] Welding is performed under variable conditions with and without nitrogen. For the tests using nitrogen, N2 is flowed into the inner lid before welding. To perform the welding, the vision system locates the extruded part and moves the laser a desired distance across the edge of the extruded part. The extruded part is fixed in place before the assembly is rotated to complete welding around the entire circumference of the assembly. Eighteen separate conditions were tested where the number of passes of the laser over the weld, number of lines, spacing, weld line width, laser pattern, clock speed (speed at which the laser beam moves across the weld), weld length in degrees, and laser power were varied. The laser patterns tested are as Figure 9 depicted. The resulting weld points were tested for tensile strength and visually inspected. In addition, leak checks were performed on the weld points. The overall analysis of the results provided preferred conditions for obtaining weld points with the highest tensile strength.

[0054] The parameters selected met the tensile strength requirements and passed the leak check at 25 psi. The use of nitrogen was not selected as it increased the variability of the tests.

[0055] Example 2: Welding of the guide ring to the inner lining

[0056] Welding of the inner lid to the guide ring presented similar technical challenges as in Example 1: (1) compensation for different laser absorptions through areas with or without holes (lumens); (2) the inner lid has a thin wall (less than 0.5 mm) and must be kept from being damaged; (3) the outer diameter of the guide ring is in the range of less than 5 mm; (4) the weld points must be strong under tension; (4) the guide ring is in a width range of less than 5 mm with corresponding spacing between the guide rings; (5) the welding must be performed around the wires passing through the guide ring.

[0057] Using the results of Example 1, an experimental design was created to consider eight conditions: the presence of N 2 , number of spot welds, number of passes, spot size, laser pattern, clock speed, weld length (a description of how the weld length varies based on 20° across the guide ring between holes (lumens) is shown in Figure 9 ). The resulting weld points were tested for tensile strength and visually inspected.

[0058] Ten additional samples were fabricated and tested for tensile strength at two different locations, and these tests showed good correlation.

[0059] During the preparation of the sample, the vision control system enables the camera to locate the guide ring and center it to center the laser welding pattern. During the centering process, the controls are able to incrementally adjust the components in the X and Y axes in microns, allowing for a high positioning accuracy. The guide rings are initially tack-welded when placed in the clamping device, after which the fixing device is removed to allow the rings to rotate and allow welding to be performed around the entire circumference of each ring.

[0060] Result:

[0061] Based on Example 1 and Example 2, the preferred settings for laser welding are identified in Table 2 as follows

[0062] Table 2

[0063] Condition Preferred setting range <![CDATA[Nitrogen (N 2 )]]> Not used Number of spot welds 2-12 Number of passes 2-20 Spot size 0.5 mm - 2 mm Laser pattern Circles, squares Clock speed 20000-50000 Welding length 20-80° Laser power 18-30

[0064] In referring to the description, specific details are set forth to provide a thorough understanding of the disclosed examples. In other instances, well-known methods, procedures, components, and circuits are not described in detail so as not to unnecessarily extend the present disclosure.

[0065] It should be understood that if an element or component is referred to herein as "on another element or component", "against", "connected to", or "coupled to" another element or component, then it can be directly on, against, connected to, or coupled to the other element or component, or intervening elements or components may be present. In contrast, if an element is referred to as "directly on another element or component", "directly connected to", or "directly coupled to" another element or component, then no intervening elements or components are present. When used, if so provided, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0066] For ease of description, spatial relative terms such as "below", "beneath", "under", "lower than", "above", "on top", "proximal", "distal", etc. may be used herein to describe the relationship of one element or feature to another element(s) or feature(s) as shown in the various figures. However, it should be understood that the spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature will be oriented "above" the other element or feature. Thus, relative spatial terms such as "below" can encompass both upward and downward orientations. The device may be oriented in other ways (rotated 90 degrees or in other directions), and the spatial relative descriptions used herein will be interpreted accordingly. Similarly, the relative spatial terms "proximal" and "distal" may be interchanged where applicable.

[0067] As used herein, the term "substantially" means allowing deviations from the description that do not negatively impact the intended purpose. For example, deviations from limitations in measurements, differences within manufacturing tolerances, or variations less than 5% may be considered to be within substantially the same range. The specified description may be an absolute value (e.g., substantially spherical, substantially vertical, substantially concentric, etc.) or a relative term (e.g., substantially similar, substantially the same, etc.).

[0068] As used herein, the term "catheter" generally refers to a flexible and thin tubular device made of a medical-grade material, designed to be inserted through a narrow opening into a body cavity (e.g., a blood vessel) to perform a wide range of medical functions. In some applications, a catheter may include a "guide catheter" that functions similarly to a sheath.

[0069] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting. As used herein, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" are intended to include the plural forms as well. It should also be understood that when used in this specification, the terms "includes" and / or "including" specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof that are not expressly stated.

[0070] In describing the example embodiments illustrated in the drawings, specific terms are employed for the sake of clarity. However, the disclosure of this patent specification is not intended to be limited to the specific terms so chosen, and it should be understood that each specific element includes all technical equivalents that operate in a similar manner.

[0071] Although the present disclosure has been described with reference to exemplary embodiments, it should be understood that the present disclosure is not limited to the disclosed exemplary embodiments. The scope of the following claims should be given the broadest interpretation to cover all such modifications as well as equivalent structures and functions.

Claims

1. An apparatus, comprising: a liner having a hollow cavity extending the length of the liner; at least two guide rings deployed together along the liner; at least one lumen portion extending through each of the at least two guide rings and parallel to the hollow cavity; wherein the guide rings are made of a material with less light absorption compared to the liner, wherein the guide rings are made of a more transparent material than the liner, and wherein the at least two guide rings are laser welded to the liner.

2. An apparatus, comprising: a liner having a hollow cavity extending the length of the liner; at least two guide rings deployed together along the liner; at least one lumen portion extending through each of the at least two guide rings and parallel to the hollow cavity; wherein the guide rings are made of a material with less light absorption compared to the liner, wherein the guide rings are made of a more transparent material than the liner, and wherein the at least two guide rings are fixed by laser welding.

3. The apparatus according to claim 1 or 2, wherein, one lumen portion in each of the at least two guide rings is positioned to form a lumen in a flexible body such that a wire can slide through the lumen.

4. The apparatus according to claim 3, further comprising at least one wire in the lumen.

5. The apparatus according to claim 1 or 2, further comprising an outer liner that is deployed around the at least two guide rings and extends the length of the liner.

6. The apparatus according to claim 1 or 2, comprising at least six guide rings, wherein, at least two of the guide rings each contain at least nine lumen portions.

7. The apparatus according to claim 6, further comprising at least nine wires, each wire extending through at least two guide rings.

8. The apparatus according to claim 1 or 2, wherein, the at least one lumen portion is not significantly altered by the process of welding the at least two guide rings to the liner.

9. The apparatus according to claim 1 or 2, wherein, the welding between the at least two guide rings and the liner extends at least half of the circumference of the inner diameter of the guide ring and the outer diameter of the liner.

10. The apparatus according to claim 1 or 2, wherein, the welding between the at least two guide rings and the liner extends the entire circumference of the inner diameter of the guide ring and the outer diameter of the liner.

11. The apparatus according to claim 1 or 2, wherein, both the liner and the at least two guide rings are formed of PEBAX.

12. The apparatus according to claim 1 or 2, wherein, the liner contains between 0.1% and 5% carbon black.

13. The apparatus according to claim 1 or 2, comprising a plurality of guide rings deployed together along the liner.

14. A manufacturing method, comprising: combining at least two guide rings each having at least one lumen portion around the outer side of a liner to create an assembly; placing the assembly on a fixing device adapted to set the distance between each of the at least two guide rings; laser welding each of the at least two guide rings to the liner; wherein the at least two guide rings are made of a material with less light absorption compared to the liner, and Wherein, the fixing device includes one or more fixing device shims to separate the at least two guide rings by a fixed amount defined by the spacing of the one or more fixing device shims.

15. The method according to claim 14, wherein, the fixing device is configured to linearly move at discrete intervals, the intervals being the spacing of the guide rings.

16. The method according to claim 14, wherein, the fixing device is configured to rotate based on a set welding length.

17. The method according to claim 14, further comprising inserting a mandrel into the liner before welding.

18. The method according to claim 14, wherein, after welding is completed at a first position on each of the at least two guide rings, the fixing device is configured to rotate such that the at least two guide rings are in a second position where welding is to be performed.

19. The method according to claim 18, wherein, the steps of performing welding on each of the at least two guide rings and rotating the at least two guide rings to positions for subsequent welding are repeated until all desired welding has been completed.

20. The method according to claim 14, wherein, the at least two guide rings are made of Pebax.

21. The method according to claim 14, wherein, the liner is made of Pebax having at least 0.5% carbon black.

22. The method according to claim 14, wherein, welding each of the at least two guide rings to the liner requires welding through both a region including the lumen and a region not including the lumen.

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