Laser welding of plastics for steerable catheter tips

Abstract

The present disclosure relates to a method, an apparatus, and a fixture for manufacturing. The apparatus includes an inner liner having a hollow chamber extending through the inner liner, at least two guide rings collectively disposed along the inner liner, and at least one lumen extending through each of the at least two guide rings and parallel to the hollow chamber, wherein the at least two components are secured together by welding. Additionally, a fixture and a method for manufacturing are provided.

Description

[Technical field]

[0001] Priority

[0002] This application claims the benefit of U.S. Provisional Patent Application Nos. 62 / 979930 (filed February 21, 2020) and 63 / 132743 (filed December 31, 2020), which are incorporated by reference in their entireties.

[0003] The present disclosure relates to methods, devices and fixtures. More specifically, the present disclosure relates to methods of manufacturing and bendable medical devices having hollow chambers and fixtures along the device. Guide Ring This applies to equipment having the above configuration and [Background technology]

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

[0005] Some bendable instruments have an inner liner and an outer liner, as well as any other components within the instrument that contribute to the actuation of the flexure. However, when the bendable instrument needs to have a small diameter and a high curvature at the distal end of the instrument, such a configuration is not very useful because the various liners and components add stiffness and prevent the instrument from bending sufficiently. Thus, a guide ring that is placed along the instrument to guide the wire is used to control the instrument. See, for example, U.S. Pat. No. 9,144,370. Another example of a bendable medical instrument with a guide ring is described in WO2018 / 204202. In this instrument, the guide ring is attached to the inner liner (or backbone) by an adhesive. However, using an adhesive during manufacturing is not always preferred because the adhesive is difficult to apply, can add unnecessary material, and the spacing of the guide ring structure cannot be adjusted. In particular, the spacing of the guide rings directly affects the functionality of the bendable medical instrument. The adhesive may act like a lubricant when first applied, which may cause the components to move around until the adhesive bond begins to set, making the spacing of the guide rings more prone to change or become inconsistent. It is also important for the catheter to function properly that there is no adhesive between the rings or that the small lumens in the rings are not blocked. If adhesive is placed between the rings or if the adhesive blocks the lumens, the bendable medical device may lose some of its flexibility to bend. The adhesive is typically applied manually, but depending on the size of the catheter components, it may be difficult to complete such a manual process without misapplication of the adhesive as described above. Furthermore, the adhesive bond strength may be inconsistent and may be less than necessary for the required catheter durability, but if any of the guide rings become loose or displaced, this may adversely affect the function of the catheter. Thus, there is a need for additional bendable devices and manufacturing methods to solve these problems. The guide rings, which are short in length and contain lumens within them, must be installed at regular intervals along the device.

[0006] Currently, there are several additive and non-additive methods for attaching components. Non-additive methods such as ultrasound and heat can be used, but the process can deform the surrounding material, cannot be used very locally, and is difficult to use for small diameter devices such as catheters. There are exceptions to this. In EP 1234595, a balloon catheter is provided that uses infrared wavelengths below 1580 nanometers (i.e., ND:YAG lasers and low power diode lasers) to perform plastic laser welding between the balloon and the catheter body. However, this is only effective for simply bonding the balloon, which is a thin sheet of material that runs along the entire length of the catheter. Thus, there is a need to overcome the deficiencies described herein to create a bendable device and manufacturing method for devices with guide rings that need to be attached without changing the configuration of the lumen through the guide ring, or guide rings that are bonded in a known spaced relationship. Summary of the Invention

[0007] According to at least one embodiment of the present invention, a device is provided that includes an inner liner having a hollow chamber that extends from one end of the inner liner to the other end of the inner liner; at least two guide rings collectively disposed along the inner liner; and at least one lumen that extends through each of the at least two guide rings and is parallel to the hollow chamber. The at least two components are secured by welding. The device may also include an outer liner, which may be a distal portion of a catheter. The device may further include an extrusion. In further embodiments, the at least two guide rings are welded to the inner liner and / or the outer liner is welded to the at least two guide rings and / or the extrusion is welded to the inner liner. In some embodiments, the device also includes a plurality of wires that extend through the lumen (through some or all of the guide rings) or through at least one section of the guide ring if the device has various sections.

[0008] According to another embodiment of the present invention, a method of manufacture is provided. The method includes: assembling a plurality of guide rings to an outer side of an inner liner to create an assembly; placing the assembly in a fixture configured to set a distance between the plurality of guide rings; and welding each of the plurality of guide rings to the inner liner. The plurality of guide rings are substantially transparent and include at least one lumen portion. According to a further embodiment, the welding is performed through both the lumen-containing region and the non-lumen-containing region. According to yet another embodiment of the present invention, a laser welding system is provided. The system may include a vision system, a laser generator, a delivery fiber, a beam shaper, a galvanometer head, a motorized fixture, and a controller in communication with the vision system, the motorized fixture, and the laser generator. The laser welding system is configured to weld two or more components of a steerable medical device. According to a further embodiment, the welding is performed through both the lumen-containing region and the non-lumen-containing region. In other exemplary embodiments, the system is configured to (i) weld an inner liner having a hollow chamber extending through the inner liner to at least two guide rings collectively disposed along the inner liner, (ii) weld an outer liner to one or more guide rings, and / or (iii) weld an extrusion to the inner liner.

[0009] These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments of the present disclosure, which should be read in conjunction with the accompanying drawings and the appended claims. [Brief description of the drawings]

[0010] Further objects, features and advantages of the present disclosure will become apparent from the following detailed description when taken in conjunction with the accompanying drawings illustrating exemplary embodiments of the present disclosure.

[0011] [Figure 1]FIG. 1 illustrates a three-dimensional side perspective view of an exemplary medical device in accordance with one or more embodiments of the subject devices, methods, or systems. [Diagram 2] FIG. 2 illustrates a three-dimensional side perspective view of an exemplary medical device in accordance with one or more embodiments of the subject devices, methods, or systems. [Diagram 3] FIG. 3 is a diagram of an embodiment showing a transparent ring welded to a light absorbing inner lumen in an exemplary medical device, in accordance with one or more embodiments of the subject devices, methods, or systems. [Figure 4] FIG. 4 is an illustration of an embodiment showing a weld configuration of a method of forming a medical device, in accordance with one or more embodiments of the subject devices, methods, or systems. [Diagram 5] FIG. 5 is an illustration of an embodiment showing another weld configuration of a method of forming a medical device, in accordance with one or more embodiments of the subject devices, methods, or systems. [Figure 6] FIG. 6 illustrates a three-dimensional side perspective view of an exemplary medical device in accordance with one or more embodiments of the subject devices, methods, or systems. [Figure 7] FIG. 7 is an exemplary laser configuration that may be used with the present invention. [Figure 8] FIG. 8 is an exemplary computer configuration that may be used with the present invention. [Figure 9] FIG. 9 is a diagram illustrating an example laser pattern that may be used in conjunction with the present invention. [Figure 10] 10A and 10B are three-dimensional side perspective views illustrating the difference in weld length in accordance with one or more embodiments of the subject apparatus, methods, or systems.

[0012] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the present disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrated embodiments. It is intended that changes and modifications can be made to the illustrated exemplary embodiments without departing from the true scope and spirit of the present disclosure as defined by the appended claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The devices, methods of manufacturing the devices, systems, and manufacturing configurations described herein relate to catheter manufacturing and attachment of components (e.g., (i) attachment of a guide ring to an inner liner, e.g., forming an inner lumen of the catheter; (ii) attachment of a guide ring to an outer liner, e.g., forming an outer portion of the catheter; and / or (iii) attachment of a guide ring to an extrusion, e.g., forming a portion of the catheter, and a medical device produced by this manufacturing).

[0014] In some embodiments, a distal portion of the medical device is shown in Figures 1 and 2, which show three-dimensional side perspective views of an exemplary bendable medical device. The bendable medical device includes at least two guide rings 36a, 36b (four are shown: 36a, 36b, 36c, 36d) constrained within a bendable body 26. The guide rings 36 are configured at a distance from each other and do not touch each other.

[0015] The bendable body 26 has an inner liner 44 and an outer liner 46 that provide bendable support to the bendable body 26 while keeping the guide rings 36 in a constant position along the axial direction of the bendable body 26. Inside the inner liner 44, a hollow chamber 28 extends from one end of the inner liner to the other end of the inner liner. The hollow chamber 28 can be used, for example, as a tool channel or working channel of a catheter. Each guide ring 36 includes at least two lumen portions 34 that are configured to accommodate anchor segments 32a, 32b embedded in the guide rings 36. The space between adjacent guide rings, combined with the resilient inner liner 44 and outer liner 46, allows the bendable body 26 to achieve a greater range of bending motion due to the open space between the guide rings 36.

[0016] The medical device is configured and / or adapted for use in vivo, including size and maneuverability. The configuration of the separate sections and the continuous outer liner 46 can be adjusted to accommodate the patient's anatomy and provide the necessary flexibility for navigation. The spacing of the guide rings 36 can be wider or narrower, for example, depending on the bending range, diameter, and configuration of the bendable body 26. As shown, all of the guide rings 36 are equally spaced apart. However, in some embodiments, the spacing can vary. For example, the distance between the guide rings 36 between different bendable segments of the bendable body 26 can be different, the guide ring spacing in one bendable segment can be different from the guide ring spacing in another bendable segment, or the guide ring spacing can be gradually wider or narrower along the bendable body 26. The diameter of the inner liner 44 and / or the outer liner 46 can also be modified based on the patient's anatomy. In some embodiments, the outer diameter of the bendable device (which is the outer diameter of the outer liner 46) is minimized to allow both less invasive procedures and the use of the medical device on smaller anatomy. For example, devices having outer diameters of less than 5 mm, 4 mm, 3 mm, or 2 mm may be used for navigation within the segmental or subsegmental bronchi of the lungs (see, e.g., U.S. Patent Application Publication No. 2019 / 0105468, incorporated herein by reference).

[0017] FIG. 2 further illustrates the use of nested control wires, with wires 40a, 42a shown within a set of lumens 34 along with at least two guide rings 36. Additionally, with this embodiment, multiple control wires 40a, 42a can be anchored at the anchor segments (32a, 32b) and slidably moved through the lumens 34 of the bendable body 26. Although nested control wires are shown as an exemplary configuration, alternative embodiments, such as separate wires, can be used. The separate wires can be fixed in one or more lumens or can be completely slidable. If fixed, the separate wires can be fixed in the same location or in different locations. Other suitable configurations of control wires will be apparent to those skilled in the art.

[0018] The guide rings 36 are attached to the inner liner 44 using laser welding instead of adhesives to form the bendable body 26 shown in Figure 3. The distal portion of the medical device is shown without any outer liner or sheath 46. The guide rings 36 are attached to the inner liner 44 using laser welding instead of adhesives to form the bendable body 26 shown in Figure 3. The distal portion of the medical device is shown without any outer liner or sheath 46. Guide Ring The lumen portions 34 are spaced apart along the inner liner 44 with all lumen portions 34 aligned so that wires 40a, 42a may be inserted through the lumen portions 34 of the guide ring 36. Thus, the bendable body 26 may also include wires 40a, 42a (not shown) that run parallel to the hollow chamber 28, with each of the wires 40a, 42a running through a lumen portion 34 of the guide ring 36. The array of lumen portions 34 extends proximally within the bendable body 26 between the inner liner 44 and the outer liner 46, effectively creating a lumen that controls the placement of the wires. In some embodiments, eight or more wires are positioned within at least a portion of the guide ring 36.

[0019] In an exemplary embodiment, the outer liner 46 can be fixed to the guide ring 36 by laser welding. Optionally, such guide ring 36 can also 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 with a higher transparency than the material of the guide ring 36, which can be made of a material with a higher transparency than the material of the inner liner 44. Thus, the components to be welded can be made of materials with different transparency so that the transparency of the outermost component to be welded is higher than the transparency of the component to which it is welded. Depending on the number of components to be welded, the transparency of all the components to be welded can be two, three, four, five or more different transparency levels (or levels) in total. In an exemplary embodiment, the components of the bendable body that require fixation can have fixation achieved by welding.

[0020] To form the bendable body as shown in FIG. 3, a fixture 50 is used to hold the components in place during the welding process as shown in FIG. 4. One or more wires can be inserted into the lumen 34 of each guide ring 36 to aid in the rotational placement of the guide rings 36. Alternatively, the guide rings 36 can include, for example, cavities or indentations in the outer portion of the guide rings to align multiple guide rings along the bendable body. The fixture 50 can include one or more fixture spacers 52 to ensure the desired alignment of the guide rings 36. The fixture spacers 52 can have the same or different dimensions based on whether the guide rings 36 are desired to have a consistent spacing or another desired configuration. Laser welding can be used to initially hold the components in place to prevent them from shifting out of position within the fixture 50.

[0021] The guide ring is made of a material that has lower light absorption than the inner liner. Thus, when focused on the bendable body, the light passes through the guide ring to the inner liner, allowing welding to occur at the interface of the two materials, for example, by transmission welding. For example, the guide ring can be made of an extrusion of polyolefin, polyamide, polyester, ethylene vinyl acetate (EVA), or thermoplastic elastomer (TPE, such as Pebax®). The constraint for these materials is that they must be weldable. The inner liner can be made of the same type of material with the same or different hardness, but with high light absorption. In some cases, the inner liner contains a percentage of dye or carbon black to increase the absorbency of the inner liner, for example Pebax with 0.1-5% (e.g., 0.1%, 0.5%, 1.0%, 2%, 3%, 4%, 5%) carbon black. In certain embodiments, the inner liner can contain at least 0.5% carbon black. In some embodiments, radiolucent additives are added to provide both x-ray visibility and favorable welding characteristics (eg, barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten).

[0022] What is important is that the guide ring absorbs less light than the inner liner, and in some embodiments the guide ring is substantially transparent at the wavelengths of light used in the welding process, although transparency is not required. Guide Ring 36 is sufficiently transparent so that the laser pattern is sufficiently focused; Guide Ring Preferably, the lumen portion 34 extending through the guide ring 36 is not melted or substantially deformed by the laser welding process. In some embodiments, it is preferred that the welding process that bonds the guide ring to the inner liner does not significantly change any of the lumen portions. A significant change in a lumen portion would occur if the insertion of a wire through the lumen portion 34 results in a reduced degree of freedom for the wire to slide through the lumen portion or if the structure of the lumen portion changes by more than 50 micrometers, or 10 micrometers, or 2 micrometers.

[0023] FIG. 4 shows a portion of a fixture 50 used during the welding process. In the configuration illustrated in this figure, the bendable body 26 is in a horizontal position with the fixture 50 having a number of fixture spacers 52 that separate the guide rings 36 by a certain amount determined by the spacing of the fixture spacers 52. The fixture spacers 52 in FIG. 4 are shown as square units, but could alternatively be designed as circular or triangular structures. A laser 54 is positioned to provide light 56 ​​on the bendable body 26 at the interface between the highly transparent guide ring 36 and the less transparent inner liner 44. In this exemplary embodiment, the laser 54 is fixed and the bendable body 26 rotates as indicated by arrow 64. As the bendable body 26 rotates, the laser pattern 58 is aligned with the guide ring 36 and the inner liner 44. Guide Ring 36 / inner liner 44 interface and a weld 60 may be formed.

[0024] Laser welding often requires a firm physical contact between the materials being welded. Thus, one aspect of the present invention is to provide tight tolerances to ensure such contact. In one example embodiment, a mandrel (not shown) can be inserted into the hollow chamber 28 (i.e., into the inner liner 44, which is made of a flexible material (e.g., a material having a flexural modulus of 15-55 GPa)) so that pressure can be applied from inside the inner liner 44 outwardly toward the inside of the guide ring 36. Within the scope of the present disclosure, the amount of pressure applied from inside the inner liner 44 outwardly toward the inside of the guide ring 36 can vary based on the size of the mandrel inserted into the hollow chamber 28. In some embodiments, the mandrel is combined with an inner liner that can easily adapt to the shape of the mandrel, thereby ensuring firm contact between the inner liner and the guide ring. In such applications, the mandrel sufficiently expands the diameter of the inner liner to allow the inner liner and the guide ring to be in intimate contact. Additionally, the inner liner may be designed such that the outer diameter of the inner liner and the inner diameter of the guide ring interfere (using the same material properties) to ensure contact. The mandrel may be left in the inner liner during the welding process. Additionally, the mandrel may be rotated to rotate the bendable body 26, such as by automated means that provide repeatable and consistent rotation. An exemplary mandrel may be easily inserted and removed from the hollow chamber 28 and may be made of a material that allows for such insertion and removal. In an exemplary embodiment, the mandrel may be coated with a substance that has a low coefficient of friction, such as Teflon or a similar non-stick material. The weld may extend around the entire circumference of the bendable body 26 or a portion of it. After welding one guide ring 36 to the inner liner 44, the fixture 50 may be configured such that the laser pattern 58 is aligned with the second guide ring 36. Guide Ring 4 and 5, the bendable body can be translated as shown by arrow 62 to enter the bendable body at the bendable body / inner liner interface. The fixture 50 provided in Figures 4 and 5 allows all of the parts used to form the bendable body to be held in place and aligned during welding.

[0025] An alternative configuration is to position the bendable body 26 vertically in a concave mirror 62 as shown in FIG. 5. The laser 54 can weld the circumference of one guide ring 36 at a time with a cylindrical laser pattern 58 without moving the fixture 50 or the bendable body 26. The mirror 62 is also fixed, and the bendable body 26 is pulled through the center of the mirror 62 to align the various guide rings 36 with the laser pattern 58. In a different embodiment of this configuration, an additional fixture (not shown) is attached to the bendable body to separate the guide rings 36 in a spaced apart relationship before performing the laser welding. This fixture can move with the bendable body when performing the laser welding. In some embodiments, this fixture is substantially transparent to the laser light so as not to absorb the welding radiation.

[0026] FIG. 6 further illustrates a longer portion of the bendable body 26 shown with a drive ring 38. The drive ring 38 can be located within a section of the guide ring 36 that includes the intersection of the various bendable sections of the bendable body 26. The guide ring 36 and the drive ring 38 can be the same or different widths and / or diameters, or can encompass a plurality or range of different widths and / or diameters along the length of the bendable body 26. In one embodiment, the drive ring 38 can be welded to the inner liner 44 using laser welding. Also shown is the extrusion 30. The extrusion 30 can be proximal to one or more of the various bendable sections of the bendable body 26, with the wires 40a, 42a slidingly moving through the lumen of the extrusion 30. The extrusion 30 is bonded to the inner liner 44 using laser welding instead of adhesives. Laser welding can be used to initially hold the components in place to prevent them from shifting out of position before all welding is completed.

[0027] Although Figures 1-6 show the distal end of the bendable body (with or without an outer liner or extrusion) having an inner liner, guide ring, and lumen of the relevant sizes shown, the method and fixture can be used for a variety of medical devices with other configurations. It is also contemplated that the bendable body has a continuous extrusion containing a lumen instead of a guide ring proximal to the portion of the bendable body shown. For example, WO2017 / 066253, WO2018 / 204202, U.S. Patent Application Publication Nos. 2018 / 0310804, 2018 / 0243900, 2018 / 0311006, 2019 / 0015978, and 2019 / 0105468 each provide bendable medical devices and their control and use, which can be made, at least in part, by the methods as provided herein.

[0028] 7 shows an example laser welding system 4 that may include the vision system 2. 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 emits light or emits a laser beam 56 by 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 sends it to the galvanometer head. The galvanometer head moves the laser beam along the weld path. The galvanometer head 29 outputs the laser beam 56 across the weld target 33.

[0029] 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, which receives input from the optical detector 25. The controller 6 of the laser welding system 4 receives the location of the target component part 24 via a communication port. The controller 6 then moves the necessary axes of the laser system via PID control to ensure that the laser 56 hits the target component part 24.

[0030] It is important to limit thermal damage to the transparent parts of the device and ensure that melting occurs substantially along the inner liner, which can be achieved by focusing the light at the inner liner interface and defining the associated materials of the guide ring and inner liner.

[0031] In some embodiments of the present invention, tight control of the power density of the laser 54 is particularly important. As the laser energy penetrates the guide ring and thus the lumen, it is important to localize the density at the inner liner interface to effect the weld. Guide Ring is thicker than the inner liner, which may be a very thin extruded tube. Guide Ring Such lumens may be particularly small and may necessarily need to remain sufficiently homogenous (non-deforming) to provide for the sliding of wires moving therethrough and for operation of the medical device.

[0032] Thus, in one example embodiment, the laser welding system 4 is configured to utilize such parameters or conditions that are optimal for the desired weld. Controllable parameters include, but are not limited to: (1) laser power (an example range is 18-30%, set by the controller 6 and the laser generator 14); (2) focal length (an example range is 150-200 mm, which will vary at least in part depending on the target component. The focal length is measured from the galvanometer to the target component portion of the workpiece); (3) clock speed (the speed at which the laser beam 54 moves across the workpiece. An example range is 20,000-50,000 galvanometer steps / second); (4) laser passes (the number of passes of the laser over the weld portion of the target component. An example range can be 2-20 laser passes); and (5) clamp pressure (the pressure between the parts being welded. An example range can vary based on the mandrel diameter). and can be 0.081" to 0.088"); (6) weld pattern (the pattern repeated by the laser during lasing, an example of which can be seen in FIG. 9, i.e., a straight line, overlapping circles, and overlapping squares); (7) weld time (the total time from start to stop of the weld, not including positioning / loading of the workpiece and / or target component. Range depends on clock speed and number of laser passes performed); (8) laser wavelength (an example range is 1.940 micrometers to 2 micrometers (1940 nanometers to 2000 nanometers)); (9) laser type (an example laser is a fiber laser, although other lasers may be suitable); and (10) laser power capability (an example range is up to 120 Watts).

[0033] 4 provides an exemplary embodiment of how the laser can repeatedly laser a component at the same settings with precision when directed by programming and control. Using a fixture 50, the welding system 4 can hold the bendable body 26 during lasing, allowing the component to remain 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 with five axes of motion: x-axis (width), laser head rotation, θ-axis (partial rotation), y-axis (depth travel), and z-axis (height travel). The motion control capability in the θ-axis (partial rotation) of the laser system can be used in combination with a mandrel as described herein, whereby a motor can control rotation in the θ-axis to precisely rotate the bendable body 26 to within a few microns of the desired position.

[0034] In combination with the vision system 2, the laser welding system 4 allows for automated movement of the target component and the laser itself, allowing the vision system to identify the location of the component and associated motors to control the movement of the laser and / or component in the X, Y, Z, θ and laser head rotation axes, providing repeatable, accurate and precise welds. The automation of laser welding as provided in the exemplary embodiments herein provides an advantage over the use of adhesives in that the welds formed can be designed with strength characteristics that meet or exceed performance specifications while remaining consistent between iterations on the same component or subsequent target components.

[0035] Control of the fixture 50, laser 54 and bendable body 26 during welding can be controlled by a computer system as shown in FIG. 7. As shown in more detail in FIG. 8, computer system 4 includes a controller or CPU 6, storage / RAM 8, I / O interface 10 and detector interface 12. Computer system 4 can be used in communication with vision system 2 or can be used separately. Computer system 4 can include one or more devices. For example, one computer can include components 6, 8, 10 and another computer can include component 12. CPU 6 is configured to read and execute computer executable instructions stored in storage / RAM 8. Computer executable instructions can include instructions 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 component portion 24 with laser 54 to achieve the desired weld.

[0036] Storage / RAM 8 optionally includes one or more computer readable and / or computer writeable media, and may include, for example, magnetic disks (e.g., hard disks), optical disks (e.g., DVDs, Blu-ray), magneto-optical disks, semiconductor memory (e.g., non-volatile memory cards, flash memory, solid state drives, SRAM, DRAM), EPROM, EEPROM, etc. Storage / RAM 8 may store computer readable data and / or computer executable instructions. The components of computer system 4 communicate via a bus.

[0037] The I / O interface 10 provides a communication interface for input / output devices, such as a keyboard, display, mouse, printing device, touch screen, light pen, optical storage device, scanner, microphone, camera, drive, communication cable, sensors such as temperature sensors, and network (either wired or wireless).

[0038] example

[0039] The functional requirements of the catheter components are shown in Table 1. [Table 1]

[0040] Example 1: Welding an inner cover to an extrusion

[0041] Welding the inner cover to the extrusions presented many technical challenges: (1) compensating for the difference in laser absorption between the areas with and without holes (lumens); (2) the walls of the inner cover were thin (less than 0.5 mm) and must be kept from tearing; (3) the diameter of the extrusions ranged less than 5 mm; (4) the welds had to be strong in tension; ( 5 ) that the weld must be sealed at 25 psi;( 6 ) The weld must be made around the wire passing through the extrusion.

[0042] Welds were performed under variable conditions with and without nitrogen. In the nitrogen tests, N2 was flowed through the inner cover before welding. To perform the weld, a vision system identified the location of the extrusion and moved the laser the desired distance from the end of the extrusion. The extrusion was held in place and the part was then rotated to complete the weld around the entire circumference of the part. Eighteen separate conditions were tested, varying the number of lines, spacing, number of passes of the laser over the weld seam, weld line width, laser pattern, clock speed (speed at which the laser beam moves over the weld seam), weld length (angle), and laser power. The tested laser patterns are shown in Figure 9. The resulting welds were tested for tensile strength and visually observed. Additionally, the welds were leak tested. A comprehensive analysis of the results provided favorable conditions for obtaining the welds with the highest tensile strength.

[0043] The parameters selected met the tensile strength requirements as well as passing the leak check at 25 psi. The use of nitrogen was not selected as it would have increased the variability of the trials.

[0044] Example 2: Welding a guide ring to an inner liner

[0045] Welding the inner cover and guide ring presented similar technical challenges as in Example 1: (1) compensating for the difference in laser absorption between the area with and without a hole (lumen); (2) the wall of the inner cover is thin (less than 0.5 mm) and must be kept from tearing; (3) the outer diameter of the guide ring must be in the range of less than 5 mm; (4) the weld must be strong in tension; ( 5 ) The width of the guide ring is less than 5 mm, and there is a reasonable gap between the guide rings; ( 6 )The weld must be made around the wire passing through the guide ring.

[0046] Using the results of Example 1, an experimental plan was created to explore eight conditions: presence or absence of N2, number of spot welds, number of passes, spot size, laser pattern, clock speed, weld length (Figure 9 shows how the weld length varies across the guide ring based on 20° between the holes (lumens)), and laser power. The resulting welds were tested for tensile strength and visually observed.

[0047] Ten more samples were prepared and the tensile strength was tested at two different locations, showing a good correlation.

[0048] During sample fabrication, a vision control system enabled the camera to locate the guide rings and center the guide rings to center the laser weld pattern. During the centering process, the part was controlled to be adjusted in microns in the X and Y axes, allowing for more precise positioning. The guide rings were first tack welded while positioned in a holding fixture, and then the fixture was removed to allow the rings to be rotated and welds to be performed around the entire circumference of each ring.

[0049] result:

[0050] Based on Examples 1 and 2, preferred settings for laser welding were identified as shown in Table 2 below.

[0051] [Table 2]

[0052] When referring to the description, specific details are set forth in order to provide a thorough understanding of the disclosed examples. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily lengthen the present disclosure.

[0053] It will be understood that when an element or component is referred to as "on," "to," "connected to," or "coupled to" another element or component, it may be directly on, to, connected to, or coupled to the other element or component, or there may be intervening elements or components present. In contrast, when an element is referred to as "directly on," "directly connected to," or "directly coupled to" another element or component, there are no intervening elements or components present. When used, the phrase "and / or," when so provided, includes any and all combinations of one or more of the associated listed items.

[0054] For ease of description to describe the relationship of one element or feature to another as shown in the various figures, spatially relative terms such as "below," "below," "lower," "upper," "top," "proximal," "distal," and the like may be used herein. However, it should be understood that the spatially relative terms are intended to encompass various orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, an element described as being "below" or "below" another element or feature would be oriented "above" that other element or feature if the device in the figures were flipped over. Thus, a relative spatial term such as "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatially relative descriptors used herein should be interpreted accordingly. Similarly, the relative spatial terms "proximal" and "distal" may be interchangeable, where applicable.

[0055] As used herein, the term "substantially" means allowing for deviations from the descriptor that do not adversely affect the intended purpose. For example, deviations resulting from limitations in measurements, differences within manufacturing tolerances, or variations of less than 5% can be considered to be within substantially the same range. The specified descriptors can be absolute (e.g., substantially spherical, substantially vertical, substantially concentric, etc.) or relative terms (e.g., substantially similar, substantially the same, etc.).

[0056] As used herein, the term "catheter" generally refers to a flexible, thin, tubular device made from medical grade materials 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, catheters may include "guide catheters" that function similarly to sheaths.

[0057] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. Furthermore, it is to be understood that the term "comprising," as used herein, specifies the presence of stated features, integers, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof that are not expressly stated.

[0058] In describing the exemplary embodiments shown in the drawings, specific terminology is used for clarity, however, the disclosure of this patent specification is not intended to be limited to the specific terminology so selected, and it is understood that each specific element includes all technical equivalents that function in a similar manner.

[0059] Although the present disclosure has been described with reference to exemplary embodiments, it is to be understood that the present disclosure is not limited to the disclosed exemplary embodiments, and the scope of the following claims should be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

1. an inner liner having a hollow chamber extending through the inner liner; At least two guide rings collectively disposed along the inner liner; At least one lumen portion extending through each of the at least two guide rings and parallel to the hollow chamber; An apparatus comprising: the at least two guide rings are made of a material that is less optically absorptive than the inner liner; the at least two guide rings are welded to the inner liner; Device.

2. an inner liner having a hollow chamber extending through the inner liner; At least two guide rings collectively disposed along the inner liner; At least one lumen portion extending through each of the at least two guide rings and parallel to the hollow chamber; An apparatus comprising: the at least two guide rings are made of a material that is less optically absorptive than the inner liner; The at least two guide rings are fixed to the inner liner by welding. Device.

3. the inner liner is disposed within a central lumen of the at least two guide rings; a lumen portion of each of the at least two guide rings is disposed to allow a wire to slide through the lumen of the at least two guide rings; 3. Apparatus according to claim 1 or 2.

4. at least one wire within said lumen; The apparatus of claim 3 further comprising:

5. an outer liner disposed around the at least two guide rings and extending across the inner liner; The apparatus of claim 1 or 2, further comprising:

6. At least six guide rings; Each of the at least two guide rings includes at least nine lumen portions.

3. Apparatus according to claim 1 or 2.

7. at least nine wires extending through at least two guide rings; The apparatus of claim 6 further comprising:

8. a weld between the at least two guide rings and the inner liner extends at least halfway around the circumference of the inner diameter of the guide rings and the outer diameter of the inner liner; 3. Apparatus according to claim 1 or 2.

9. the welds between the at least two guide rings and the inner liner extend around the entire circumference of the inner diameter of the guide rings and the outer diameter of the inner liner; 3. Apparatus according to claim 1 or 2.

10. the inner liner and the at least two guide rings are both formed from PEBAX.

3. Apparatus according to claim 1 or 2.

11. The inner liner contains 0.1 to 5% carbon black.

3. Apparatus according to claim 1 or 2.

12. a plurality of guide rings collectively disposed along the inner liner; 3. Apparatus according to claim 1 or 2.

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