Patent Application
20220111182
The present invention relates to a guide wire having a sensor, and a method and a device for assembling the guide wire having plural sensors incorporated within or along a main body of the guide wire. In particular, the present invention relates to a guide wire incorporating a pressure sensor within or along the main body of the guide wire, and to a method and a device for assembling the guide wire.
The guide wire can have a large number of sensors or a sensor assembly incorporated directly into the guide wire. A guide wire including such sensors may be adapted to measure various physiological parameters in a patient's body. For example, the sensor typically has one or more cables that are passed through the guide wire to electrically combine a sensor element to an electronic assembly.
Generally, the guide wire is composed of a hypotube of a core wire capable of extending along a length or a partial length of the guide wire, and a coiled segment. The guide wire core may be made of stainless steel or Nitinol, and the coiled segment may be made of a wire or a braid that provides flexibility, pushability, and kink resistance to the guide wire. A Nitinol wire can be used by itself or in combination with a stainless steel to further help to improve flexibility and to allow the wire to return to an original shape.
Additionally, a standard diameter of the guide wire is 0.014 inches (0.356 mm), and as a result, accommodation of certain types of sensors or incorporation of plural sensors may be limited due to a relatively small space provided by the guide wire. Furthermore, the guide wire is typically used so as to be inserted and advanced into blood vessels having very tortuous pathways. Thus, the guide wire, and the sensors and electrodes along the guide wire may receive a relatively high stress when the guide wire is pushed, pulled, and twisted on a pathway having many curves and bends.
A guide wire incorporating one or more electrodes along a length of the guide wire may cause additional problems in a structure and use of the guide wire. For example, the presence of plural electrodes along the guide wire may require additional conductive wiring to be passed along the length of the guide wire. Since the guide wire requires a limited space and flexibility, it is desirable that the sensors and/or electrodes arranged along the length of the guide wire are configured so as to meet the limited space and flexibility.
As a result, it is required to design a guide wire, which provides an effective construction of the guide wire incorporating one or more electrodes and/or sensors along the length of the guide wire.
The present disclosure provides a guide wire including a guide wire core, a first insulating layer provided on a surface of the guide wire core, and plural conductive traces provided spaced from each other in a lateral direction of the guide wire core on a surface of the first insulating layer, wherein at least one of the plural conductive traces has a sectional area different from those of the other conductive traces in a transverse-sectional view of the guide wire core.
At least one of the plural conductive traces may have a width dimension different from those of the other conductive traces in the transverse-sectional view of the guide wire core.
At least one of the plural conductive traces may have a thickness dimension different from those of the other conductive traces in the transverse-sectional view of the guide wire core.
At least one of the plural conductive traces may have a thickness dimension different from those of the other conductive traces in the transverse-sectional view of the guide wire core at different positions in the length direction.
At least one of the plural conductive traces may have a width dimension different from those of the other conductive traces in the transverse-sectional view of the guide wire core at different positions in the length direction.
A width dimension of at least one of the gaps between the plural conductive traces may be constant in the transverse-sectional view of the guide wire core.
Among the gaps between the plural conductive traces, gaps on a small-outer diameter portion of the guide wire core may have width dimensions larger than those of gaps on a large-outer diameter portion of the guide wire core in the transverse-sectional view of the guide wire core.
Among the gaps between the plural conductive traces, gaps on a small-outer diameter portion of the guide wire core may have width dimensions smaller than those of the gaps on a large-outer diameter portion of the guide wire core in the transverse-sectional view of the guide wire core.
At least one of the plural conductive traces may have a changed shape in the transverse-sectional view of the guide wire core at different positions in the length direction.
The guide wire core includes a large-diameter portion on a butt side, a small-diameter portion located on a front end side of the large-diameter portion, and a tapered portion located between the large-diameter portion and the small-diameter portion, wherein width dimension of at least one of the plural conductive traces may change on the tapered portion.
The guide wire core includes the large-diameter portion on the butt side, the small-diameter portion located on the front end side of the large-diameter portion, and the tapered portion located between the large-diameter portion and the small-diameter portion, wherein thickness dimension of at least one of the plural conductive traces may change on the tapered portion.
The guide wire core includes the large-diameter portion on the butt side, the small-diameter portion located on the front end side of the large-diameter portion, and the tapered portion located between the large-diameter portion and the small-diameter portion, wherein width dimension of at least one of the plural conductive traces may change on the small-diameter portion in the transverse-sectional view of the guide wire core at different positions in the length direction.
The guide wire core includes the large-diameter portion on the butt side, the small-diameter portion located on the front end side of the large-diameter portion, and the tapered portion located between the large-diameter portion and the small-diameter portion, wherein thickness dimension of at least one of the plural conductive traces may change on the small-diameter portion in the transverse-sectional view of the guide wire core.
Each of the plural conductive traces has each electrical connection portion, and the plural electrical connection portions may be arranged on one straight line of the guide wire core.
Each of the plural conductive traces has each electrical connection portion. Among the plural electrical connection portions, first plural electrical connection portions and second plural electrical connection portions may be arranged in parallel along the length direction of the guide wire core.
The guide wire core has a flat attachment portion, each of the plural conductive traces has each electrical connection portion, and at least some of the plural electrical connection portions may be disposed on the attachment portion.
The guide wire core has the flat attachment portion, each of the plural conductive traces has each electrical connection portion, at least some of the plural electrical connection portions may be disposed on the attachment portion, and the electrical connection portions disposed on the attachment portion may be arranged on one straight line along the length direction of the guide wire core.
The guide wire core has the flat attachment portion, each of the plural conductive traces has each electrical connection portion. Among the plural electrical connection portions, the first plural electrical connection portions and the second plural electrical connection portions may be arranged in parallel on the attachment portion.
A second insulating layer that covers the first insulating layer and the plural conductive traces is provided, and the first insulating layer may be made of a material having a lower dielectric constant than of the second insulating layer.
The second insulating layer that covers the first insulating layer and the plural conductive traces is provided, and the first insulating layer may be made of a material having a higher adhesiveness with the surface of the guide wire core than of the second insulating layer.
The second insulating layer that covers the first insulating layer and the plural conductive traces is provided, and the second insulating layer may be made of a material having a higher moisture resistance than of the first insulating layer.
An aspect of the present disclosure provides a guide wire including a guide wire core, a first insulating layer provided on a surface of the guide wire core, and plural conductive traces provided spaced from each other in a lateral direction of the guide wire core on a surface of the first insulating layer, wherein at least one of the plural conductive traces has a changed shape in a transverse-sectional view of the guide wire core at different positions in the length direction.
The width dimension of at least one of the plural conductive traces may change in the transverse-sectional view of the guide wire core at different positions in the length direction.
The thickness dimension of at least one of the plural conductive traces may change in the transverse-sectional view of the guide wire core at different positions in the length direction.
An aspect of the present disclosure provides a guide wire including a guide wire core, a first insulating layer provided on a surface of the guide wire core, and plural conductive traces provided spaced from each other in a lateral direction of the guide wire core on a surface of the first insulating layer and having electrical connection portions at predetermined positions, and a second insulating layer that covers the first insulating layer and the conductive traces, wherein at least some of the plural electrical connection portions are arranged on one straight line along a length direction of the guide wire core.
First plural electrical connection portions and second plural electrical connection portions of the plural electrical connection portions may be arranged in parallel along the length direction of the guide wire core.
The first insulating layer provided on a surface side of the guide wire core, and the plural conductive traces provided spaced from each other in a lateral direction of the guide wire core on a surface side of the first insulating layer are formed in a build-up manner, wherein at least one of the plural conductive traces may have a sectional area different from those of the other conductive traces in a transverse-sectional view of the guide wire core.
A second insulating layer that covers the first insulating layer and the plural conductive traces is provided, a conductive layer is provided on a surface of the second insulating layer, and the conductive layer may be electrically connected to at least one of the plural conductive traces.
The second insulating layer that covers the first insulating layer and the plural conductive traces is provided, the conductive layer is provided on the surface of the second insulating layer, and a part of the conductive layer may be electrically connected to the guide wire core.
A metal layer made of a material having a higher conductivity than of a material for the guide wire core may be disposed on the surface of the guide wire core.
The present disclosure is also applied to a long medical equipment including any of the aforementioned guide wires.
Yet another aspect of the present disclosure executes a step of providing a guide wire core, a step of forming a first insulating layer on a surface of the guide wire core, a step of forming plural conductive traces spaced from each other in a lateral direction of the guide wire core on a surface of the first insulating layer in which the plural conductive traces have different sectional areas in a transverse-sectional view of the guide wire core, and a step of forming a second insulating layer that covers the first insulating layer and the plural conductive traces.
The guide wire can incorporate a large number of different sensors within or along a main body of the guide wire. In a certain modification example, optionally, a pressure sensor having one or more electrodes may be incorporated in the guide wire along the main body of the guide wire or on the distal end of the guide wire. The guide wire having one or more electrodes directly integrated along the main body of the guide wire may have a proximal coil attached to an electrode assembly having one or more electrodes, and a distal coil attached to a distal end of the electrode assembly. The guide wire core may extend through the guide wire assembly in the length direction, or may extend partially or thoroughly through the electrode assembly.
A modification example for assembling a guide wire assembly may generally include a step of providing a core wire having a tapered distal portion, a step of fixing one or more conductive wires to the core wire by passing the core wire through a wire receiving channel demarcated via or along a sensor package, and then a step of sealing the one or more conductive wires and the core wire.
An example of a method for forming the guide wire assembly may generally include a step of providing the guide wire core, a step of disposing an insulating layer on the surface of the guide wire core, and a step of printing one or more conductive traces directly on the surface of the insulating layer.
Another example of the method for forming the guide wire assembly may generally include a step of providing the guide wire core, a step of disposing the insulating layer on the surface of the guide wire core, and a step of disposing an aerosolized conductive ink on the surface of the insulating layer to form one or more conductive traces.
Yet another example of the method for forming the guide wire assembly may generally include a step of providing the guide wire core, a step of disposing the insulating layer on the surface of the guide wire core, and a step of removing a part of the conductive layer such that one or more conductive traces are formed on the insulating layer.
In a modification example, when forming the guide wire assembly, generally, a pressure sensor packaging may include a sensor casing constituting a cylindrical housing that surrounds or supports constituents of the pressure sensor fixed therein. In the sensor casing, a detection window may be demarcated along a lateral face of the casing, and this detection window allow the internal pressure sensor to be exposed to a fluid environment. A sensor core is fixed within the sensor casing and connected to a flex circuit extending from a proximal end of the sensor casing, and, in some cases, connected to a controller or processor via one or more lead wires extending along the length of the guide wire. The conductive traces or wires along the flex circuit may be attached directly to one or more corresponding conductive wires extending toward the proximal side through the guide wire main body, so that the conductive traces or wires are electrically connected to the controller or processor.
Another modification example includes a configuration in which the flex circuit extends toward the proximal direction from the sensor casing, but the flex circuit may be electrically connected to one or more conductive ring elements instead of being directly attached to one or more conductive wires. The ring elements are electrically connected to one or more conductive wires. The ring elements are arranged coaxially with and adjacent to each other, and the number of the elements used may depend on the number of required electrical connections. One or more conductive wires may be selectively and electrically combined with a specific pad or trace of the flex circuit, such that each ring element is electrically connected to a single pad or trace. Subsequently, each ring element may be selectively and electrically combined with the conductive wire along an inner diameter of the ring element, and the remainder of the ring element can be electrically connected to another conductor or component as needed.
The sensor casing may demarcate a longitudinal passage penetrating the whole casing to allow the guide wire core to pass therethrough. Furthermore, the casing may demarcate a distal opening portion on which the front end of the guide wire is positioned and fixed so as to extend from the distal end of the casing, and the core of the guide wire longitudinally extends through the casing adjacent to or below the flex circuit, the pressure sensor, and the detection window. The sensor core is shown to be fixed within the casing adjacent to the flex circuit proximally extending from the casing.
In yet another modification example for electrically combining elements within or along the guide wire, the guide wire assembly may have a conductive ink printed on a polymer substrate to form a subassembly for transmitting signals from one end of the guide wire or catheter to the other end. The conductive traces are used directly on a device substrate, and then the traces are insulated by a dielectric material, so that necessity of the conductive wire, and relevant treatment and handling can be eliminated.
A polymer layer (e.g., PET, PTFE, etc.) may be coated over the core of the guide wire via heat shrink to provide an insulating substrate. The polymer layer may be coated or laid over the whole guide wire core, or a part of the distal end of the guide wire core may be left non-coated in order to fix a pressure sensor assembly. Subsequently, one or more conductive traces (e.g., nanosilver, nanogold, nanocopper, etc.) may be printed directly on the polymer layer such that the traces extend from one or more corresponding distal pads to one or more corresponding proximal pads.
The one or more conductive traces are printed directly on the polymer layer and therefore can be configured in a large number of various patterns. Once one or more conductive traces are printed on the polymer layer, the traces may be subsequently insulated. In one variation for insulating the trace, the edge of the trace that need to be left exposed for forming the electrical connection pad is masked, and then another polymer layer is deposited over the conductive trace. For example, another polymer layer (PTFE, Paralin, etc.) can be deposited on the exposed conductive trace using another heat shrinkable tube and layer, or using a physical vapor growth method, a dip coating method, or the like.
In yet another variation, a conductive coating can be provided on the dielectric layer by a bulk metallization process such as physical vapor growth deposition (PVD) or by electroplating, electroless plating, a method of printing a broader metal layer on a dielectric layer using conductive inks, or the like. Such a metal layer can eliminate or reduce noises and improve Signal to Noise Ratio (SNR) of the system by providing an EM shield.
As another variation for insulating the traces, a dielectric polymer is printed directly on the conductive traces using a polymer ink. When the dielectric polymer is printed directly on the conductive traces using the polymer ink, in a printing process, the polymer ink is selectively printed to form an insulating layer, meanwhile the polymer ink can be used to form the conductive pad for electrically combining with components by exposing a part of the conductive traces.
Regardless of which method is used, the resulting guide wire core and polymer layer may be combined with the pressure sensor assembly. One or more ring elements may be, along a part of their inner diameter, electrically combined with corresponding pads exposed along the flex circuit. A second portion along the one or more ring elements may be electrically combined with the corresponding pads of the conductive traces disposed on the polymer layer to electrically combine with the pressure sensor assembly (or any other component). Subsequently, the distal coil tip may be attached to the distal end of the sensor casing to reflow or mold the polymer on the guide wire core along the center portion, the distal coil or tip along the distal portion, and the remainder of the guide wire core along the proximal portion, as well as (if used) a portion between the electrodes.
Another modification example of the assembly method includes a polymer layer separately formed prior to being disposed on the guide wire core. The conductive traces may be printed directly on the outer layer of the polymer, together with their corresponding exposed pads extending over the length of the polymer layer. Similarly, the insulating layer may also be printed directly on the conductive traces. Using a previously printed polymer layer, the guide wire core may be inserted into the polymer layer and bonded to the polymer layer with any number of suitable adhesives, e.g. cyanoacrylate. Subsequently, the pressure sensor assembly is fixed to the guide wire core, and the flex circuit may be directly and electrically combined with the exposed pads of the attachment to complete the electrical connection. In another variation for printing the conductive traces, a polymer tube may be disposed on the guide wire core to print one or more conductive traces on the outer layer of the tube. Subsequently, circular rings may be printed on the polymer tube using the conductive ink such that the rings coincide with exposed regions of the conductive traces, and the flex circuit and other components of the pressure sensor assembly can electrically combine with the conductive traces via the connection to the circular rings. Since the circular rings are printed in a circumferential direction of the tube, the exposed regions may be displaced from each other in the longitudinal direction such that the rings can be printed on the whole circumference of the tube. In addition, preferably, there are sufficient spaces in the longitudinal direction between the exposed regions, so that the rings can be printed coaxially with each other without interfering the rings. In another modification example, partial circumferential rings may be printed rather than entire circumferential ring.
Yet another modification example for producing conductive traces may include a first insulating polymer layer disposed on the outer face of the guide wire core (e.g. PARYLENE (Specialty Coating Systems, Inc., Indianapolis, Ind.), TEFLON (E. I. Du Pont De Nemours, Wilmington, Del.), polyimide, etc.). Subsequently, a second conductive polymer layer containing a conductive material (gold, silver, copper, etc.) may be coated on the first polymer layer using any number of processes, such as electroless deposition, and physical vapor growth. The thickness of the conductive layer depends on the application and is often determined in consideration of both electrical requirements (current-carrying capacity) and mechanical requirements (rigidity, etc.) of the device. This second conductive layer may be separated into individual conductive elements using laser microfabrication, photochemical etching, or the like.
Subsequently, the whole assembly can be insulated by using a dielectric insulating polymer, in a form of either coating or heat shrink (Teflon, PET, etc.), depending on the application. Depending on the application, a plurality of individual conductive elements can be formed. In addition, depending on the application, both ends of connection terminals can be formed into various sizes and shapes to facilitate connection with the individual conductive elements formed. Since such a structural technique makes it possible to directly form a plurality of individual conductive elements on the device, it is not required to remove materials for the purpose of accommodating individual conductive wires, or to hollow the device for the purpose of accommodating the conductive wires and elements. Thus, the performance of the intended device is significantly improved and the manufacturing cost is reduced.
In the present disclosure, plural conductive traces can be formed on at least a part of a longitudinal region of a guide wire. The plural conductive traces are electrically connected to at least one sensor provided on the guide wire. The sensor measures e.g. parameters such as a pressure, a temperature, and a flow rate of a body tissue into which the guide wire is inserted. The sensor physically or chemically measures these parameters or other parameters. Signals measured by the sensor are output to a measuring device disposed outside the guide wire via the conductive traces.
In the present disclosure, for example, a guide wire will be explained as a long medical equipment. However, the present disclosure can be applied not only to guide wires but also catheters. The present disclosure can also be applied to e.g. balloon catheters, microcatheters, cardiac catheters, pulmonary artery catheters, angiographic catheters, urinary catheters, gastrointestinal catheters, or the like.
In addition to the embodiments described below, various modification examples are included in the present disclosure. It would be possible to replace a part of the configurations described in an embodiment with a configuration described in another embodiment. It would be possible to add a configuration of another embodiment to a configuration of an embodiment.
The guide wire core 20 is made of e.g. Nitinol or stainless steel. The guide wire core 20 includes a large-diameter portion 21 on the butt side, the small-diameter portion 22 located on the front end side of the large-diameter portion 21, and a tapered portion 23 located between the large-diameter portion 21 and the small-diameter portion 22. On the distal end side of the small-diameter portion 22, a sensor attachment portion 221 is formed as illustrated in
The tapered portion 23 is formed so as to gradually decrease in diameter such that smooth connection from the distal end side of the large-diameter portion 21 to the proximal end side of the small-diameter portion 22 is achieved. The plural coil bodies 31 and 32 are provided outside the small-diameter portion 22. The sensor assembly 40 is disposed between the coil body 31 on the proximal end side and the coil body 32 on the distal end side. The coil bodies 31 and 32 are made of e.g. stainless steel, platinum (Pt), a platinum-iridium alloy (Pt/Ir), or the like. As described below, the guide wire core 20 may have one coil body. Another example of arrangement for the sensor assembly 40 will be described below.
The sensor housing 41 is formed in an almost cylindrical shape in which a central portion in the longitudinal direction is opened. The sensor attachment portion 221 of the guide wire core 20 is provided so as to penetrate the sensor housing 41 in the longitudinal direction. As described below, plural conductive traces 25 are formed spaced from each other in the lateral direction on the outside of the guide wire core 20 from the sensor attachment portion 221 to the external connection portion 211. The plural conductive traces 25 include electrical connection portions on both the sensor attachment portion 221 and the external connection portion 211. The lateral direction of the guide wire core 20 refers to e.g. a circumferential direction of the guide wire core 20. The cross section of the guide wire core 20 is not only the circular shape but also an oval or polygonal shape.
Although the present disclosure will be explained with reference to a case that five conductive traces 25 are provided, the number of conductive traces 25 only needs to be two or more. Conductive traces used for shielding lines or the like can be provided as needed.
The sensor 42 is attached to the outside of the sensor attachment portion 221 by the wiring portion 43. Each electrical terminals of the sensor 42 is electrically connected to the corresponding conductive trace 25 among the plural conductive traces 25 via the wiring portion 43. The wiring portion 43 is formed e.g. as an interposer substrate. The wiring portion 43 may be attached to the sensor attachment portion 221 directly or via a flexible wiring board.
The sensor housing 41 prevents a pressure of a blood or the like from being applied to the sensor 42 and the wiring portion 43 from the longitudinal direction of the guide wire core 20 on a wall portion 412 on the distal end side. A wall portion 411 on the proximal end side of the sensor housing 41 is formed in an almost U-shape or C-shape in a transverse-sectional view, and pinches the wiring portion 43 from both sides in the width direction to support the wiring portion 43. Thereby, the sensor housing 41 firmly holds the sensor 42 and the wiring portion 43 to suppress a relative displacement with respect to the small-diameter portion 22.
The plural conductive traces 25 on the distal end side have electrical connection portions for the connection with the wiring portion 43. To form the electrical connection portions, predetermined portions of a second insulating layer 26 that covers the surface sides of the respective conductive traces 25 are opened, and the respective conductive traces 25 are exposed, as described below. That means, the opening portions provided on the insulating layer that covers the surface of the guide wire core 20 for the purpose of enabling electrical connection between the conductive traces 25 and the wiring portion 43 are referred to as electrical connection portions in the present disclosure. In the present disclosure, the opening portions 261-1 formed on predetermined portions of the insulating layer 26 are referred to as electrical connection portions 261-1 for convenience sake in some cases.
The plural conductive traces 25 on the proximal end side also have the electrical connection portions 261-2. The plural conductive traces 25 on the proximal end side are electrically connected to the ring electrodes 50 or second conductive traces 51 described below.
As described below, when other conductive traces 51 are provided outside the conductive traces 25 while interposing the second insulating layer 26 therebetween, predetermined portions of a third insulating layer 28 that covers the other conductive traces 51 are opened to form electrical connection portions. The electrical connection portions can be rephrased as opening portions, i.e. via holes, which are formed at predetermined positions on the insulating layer for the purpose of the electrical connection.
The width dimensions of the respective gaps 27 may be set to the same value or to different values. For example, as illustrated in
In the example of
In the present disclosure, a width dimension t6 of at least one of the gaps 27 between the plural conductive traces 25 formed spaced from each other in the lateral direction of the guide wire core 20 can be different from width dimensions t5 of the other gaps 27. Thereby, an electrical effect such as noise reduction can be provided to at least one conductive trace 25. For example, a gap between the conductive trace used as a signal wire and the conductive trace used as the ground wire can be narrowed to reduce noises generated in the signal. In a case that the guide wire core 20 used as the ground is connected with the ring electrodes 50 via the via holes, a via diameter is larger than a via diameter in a case that only the second insulating layer 26 is opened and the via holes are connected to the conductive traces 25. Thus, the width dimensions of the gaps 27 corresponding to these via holes are different from each other.
The electrical connection portions 261-1 of the respective conductive traces 25 on the distal end side are arranged on one straight line in the longitudinal direction of the guide wire core 20, as illustrated in
As described below, a transmission property suitable for a role of the respective conductive traces 25 can be achieved by varying the width dimensions of the respective conductive traces 25.
The wiring portion 43 includes a sensor connection portion 432 and a pad-formed portion 433 extending from the sensor connection portion 432 toward the proximal end side. The plural pads 431 are arranged on the one straight line on the guide wire core 20 side of both sides of the pad-formed portion 433. The interval of the formed plural pads 431 coincide with the interval of the formed electrical connection portions of the plural conductive traces 25. Thus, as illustrated in
The respective pads 431 and the respective conductive traces 25 can be electrically connected to each other using e.g. a conductive adhesive. Alternatively, each pad 431 is fitted into a corresponding electrical connection portion, so that the sensor 42 and the respective conductive traces 25 can be electrically connected to each other using no conductive adhesive. As illustrated in
The first insulating layer 24 is formed over the whole periphery on the surface of the guide wire core 20. On the surface of the first insulating layer 24, the plural conductive traces 25 spaced from each other via the gaps 27 in the lateral direction of the guide wire core 20 are formed, as described above. The second insulating layer 26 is formed so as to cover both the first insulating layer 24 and the plural conductive traces 25. The first insulating layer 24, the conductive traces 25, and the second insulating layer 26 are formed in a build-up manner. For the first insulating layer 24 and the second insulating layer 26, a material according to properties required for the guide wire 10 can be used. The properties required for these insulating layers 24 and 26 include e.g. electrical insulation, core adhesiveness, dielectric property (low £), heat resistance, sterilization resistance, scratch resistance, abrasion resistance, chemical resistance, good slidability, water and moisture resistance, rust resistance, adhesiveness with hydrophilic coating agents (hyaluronic acid, silicone, etc.), and the like.
The properties of the first insulating layer 24 can be different from those of the second insulating layer 26. In an example, the first insulating layer 24 may be made of a material having a dielectric constant lower than of the second insulating layer 26. When the dielectric constant of the first insulating layer 24 is decreased, a parasitic capacitance between the conductive traces 25 and the guide wire core 20 can be decreased. That means, when the guide wire core 20 is used as an electrical wiring together with the conductive traces 25, the mutual capacitance between the conductive traces 25 and the guide wire core 20 tends to be significantly higher than the mutual capacitance between the conductive traces. When suppressing increase in this mutual capacitance, it is effective that the first insulating layer 24 sandwiched between the conductive traces 25 and the guide wire core 20 is made of a dielectric material having a lower dielectric constant. In another example, the first insulating layer 24 may be made of a material having a higher adhesiveness with the surface of the guide wire core 20 than of the second insulating layer 26. In yet another example, the second insulating layer 26 may be made of a material having a moisture resistance higher than of the first insulating layer 24.
Examples of the material that can be used for the first insulating layer 24 and/or the second insulating layer 26 include an epoxy resin, a glass epoxy resin, a bismaleimide triazine resin, BCB, polyimide, polyamide, polyamideimide, polyurethane, LCP (liquid crystal polymer), PE (polyethylene), PET (polyethylene terephthalate), PFA (perfluoroalkoxy fluororesin), PTFE (polytetrafluoroethylene), ETFE (copolymer of tetrafluoroethylene (C2F4) and ethylene (C2H4)), PEEK (polyetheretherketone), a parylene resin, solder resist, and the like.
As an example, the first insulating layer 24 may be made of a polyimide, and the second insulating layer 26 may be made of a polyimide (filler-containing reinforced grade). As another example, the first insulating layer 24 may be made of an LCP, and the second insulating layer 26 may be made of a polyimide. As yet another example, the first insulating layer 24 may be made of an LCP, and the second insulating layer 26 may be made of a PEEK. As yet another example, the first insulating layer 24 may be made of a polyimide, and the second insulating layer 26 may be made of a PTFE. As another example, the first insulating layer 24 may be made of a polyimide, and the second insulating layer 26 may be made of a parylene.
In
For example, the conductive trace 25 (C1) has a sectional area larger than of the conductive trace 25 (C2) or the conductive trace C25 (C5). The conductive trace 25 (C2) has a sectional area smaller than of the conductive trace 25 (C1), the conductive trace 25 (C3) or the conductive trace 25 (C4). From another viewpoint, there are plural groups with different sectional areas: a first group of the conductive traces 25 (C1), 25 (C3), and 25 (C4) having large sectional areas; and a second group of the conductive traces 25 (C2) and 25 (C5) having small sectional areas.
The sectional area of one conductive trace 25 is determined by multiplying a width dimension and a thickness dimension. Thus, difference in the sectional area of one conductive trace 25 from the sectional areas of the other conductive traces 25 means difference in at least either the width dimension or the thickness dimension.
In both examples of
When the conductive traces 25 have the same thickness dimensions, the parasitic capacitance (also called stray capacitance.) can be increased by widening the width dimensions of the conductive traces of the power supply system (VCC, GND), and the increase of the parasitic capacitance can decrease the power supply noises. The conductive traces 25 having the small width dimensions may be used as signal wires.
When contrasting
In
When the thickness dimensions of the respective conductive traces 25A (C1) to 25A (C5) are increased, necessary electrical properties can be ensured while meeting the constraints of the outer dimensions of the guide wire 10.
The example in
Some examples of the shape of the conductive traces 25 will be explained with reference to
As illustrated in
Width dimensions of a gap 27F (C1) and a gap 27F (C5) are smaller than width dimensions of a gap 27F (C2), a gap 27F (C3), and a gap 27F (C4). Occurrence of a so-called crosstalk can be prevented by increasing the gaps 27F between the conductive traces 25F.
As a modification example,
An example of a method for determining the sectional areas of the respective conductive traces 25 will be explained. For example, as in the conductive traces 25 used as the power supply system wirings (VCC, GND), the width dimensions of the conductive traces 25 having a restricted upper limit of a resistance value are set such that the resistance value is within a required resistance value range. From the remaining circumferential length, width dimensions are assigned to the other conductive traces used as the other wirings (e.g. signal wirings). For example, if a simulation or an experiment has a problem that a signal delay time is long in the conductive traces used as signal system wirings, increase in the thickness dimensions of the conductive traces is considered. In this way, in the first step, the width dimensions of the conductive traces are determined, and in the second step, the thickness dimensions of the conductive traces are determined. This makes it possible to achieve high functionality of the guide wire 10 while the increase in the diameter dimension of the guide wire 10 is suppressed as much as possible. However, the determination method described above is merely an example, and the dimensions can be determined according to another determination method. For example, in the first step, the thickness dimensions of the conductive traces may be determined based on electrical specifications required for the conductive traces, and in the second step, the width dimensions of the conductive traces may be determined.
An example that a sensor attachment portion 221J of the guide wire core 20 has a flat portion 2210 will be explained with reference to
The sensor attachment portion 221J having the flat portion 2210 is provided on the distal end side of the guide wire core 20. For example, a half part of the sensor attachment portion 221J is cut out along an axial center of the sensor attachment portion 221J to form the flat portion 2210. As a result, the sensor attachment portion 221J is formed into a semi-cylindrical shape. As illustrated in
As illustrated in
As illustrated in
Some examples of mounting the sensor 42 to the guide wire 10 will be explained with reference to
In the example of
In a guide wire 10L illustrated in
In a guide wire 10M illustrated in
In a guide wire 10N of
Respective wiring portions 43N1 and 43N2 are connected to the electrical connection portions (not illustrated) that are opened corresponding to the respective conductive trace layers. The sensors 42N1 and 42N2 are provided on the wiring portions 43N1 and 43N2 respectively. The respective sensors 42N1 and 42N2 are arranged spaced from each other in the lateral direction of the guide wire core 20. In
A variation in a longitudinal section of the guide wire will be explained with reference to
In the example of
The thickness dimension of the first insulating layer 24 varies following the variation in the thickness dimension of the conductive trace layer so as to meet the constraints of the outside dimension of the guide wire 10. That means, the first insulating layer 24 is thinner in the region with the thicker conductive trace 25, and the first insulating layer 24 is thicker in the region with the thinner conductive trace 25.
Also, the thickness dimension of the second insulating layer 26 basically varies following the variation in the thickness dimension of the conductive trace layer so as to meet the constraints of the outside dimension of the guide wire 10. However, since the restrictions of the outside dimensions are loose on the butt side (proximal end side) of the guide wire 10, the second insulating layer 26 can be made thicker.
In the example of
Since the constraints of the external dimension on the external connection portion 211 are looser than those on the small-diameter portion 22, the thickness dimensions of the conductive trace 25 and the second insulating layer 26 on the external connection portion 211 can be made larger than those on the small-diameter portion 22. In this example, since the conductive trace 25 can be made thicker on the large-diameter portion 21 that accounts for the largest proportion of the total length of the guide wire 10, the impedance can be decreased to improve the noise resistance.
In the example of
For example, when the guide wire core 20 is made of a conductive material such as stainless steel, the guide wire core 20 can be used alone as a ground electrode. For the purpose of further increasing the conductivity, the high-conductivity metal layer 29 may be formed on the surface of the guide wire core 20. The high-conductivity metal layer 29 is not limited to metals such as copper, gold, and silver. The high-conductivity metal layer 29 may be made of a conductive polymer. Examples of the conductive polymer includes, but are not limited to, polypyrrole, polythiophene, polyacetylene, and polyaniline. The high-conductivity metal layer 29 is formed on the surface of the guide wire core 20, so that a return path for using the guide wire core 20 as a ground layer (GND) can be endured. The guide wire core 20 alone can be used as a ground electrode.
The variation in the thickness dimensions of the first insulating layer 24, the conductive trace layer, and the second insulating layer 26 in
In the example of
Also in the example of
In
As illustrated in
An approach for building the plural conductive trace layers into separate insulating layers to incorporate the plural conductive traces 25 into the guide wire 10 will be explained with reference to
It is difficult to incorporate a conductive element into a typical 0.014 inch (0.356 mm)-diameter guide wire core 20 without affecting mechanical properties such as followability and torque responsibility. Use of a layering manufacture method as described in patent application No. US20190821 makes it possible to form a conductive element directly on a core for the purpose of maintaining basic mechanical performances of a guide wire device. However, it is very difficult to incorporate more conductive elements, e.g. four or more conductive elements (conductive trace layers) into the typical guide wire core 20 having a diameter of 0.014 inches (0.356 mm) or smaller. If two or more types of sensors, or a sensor requiring four or more independent communication channels should be incorporated into one device, it is beneficial to have four or more different signaling elements in one device in some cases. To achieve this configuration, a layering approach as described below is effective. The present disclosure is applied to not only to the 0.014-inch guide wire core 20 but also to another guide wire core 20 having a typical diameter dimension.
A typical guide wire core is illustrated in
As illustrated in
As illustrated in
As illustrated in
As illustrated in
As illustrated in
As illustrated in
As illustrated in
Next, opening portions are formed on the second insulating layer 26 and the third insulating layer 28 by etching, laser ablation, or the like, to form vias for accessing the corresponding conductive traces directly beneath the insulating layer. These vias constitute connection pads for connecting or combining the formed conductive traces to the outside of the guide wire 10. Thereby, the conductive traces are connected to e.g. one or more sensors located on the distal end of the guide wire, the connection terminal located on the appropriate proximal end, or the like.
In another embodiment, the vias 52 may be formed such that specific conductive traces on the first conductive layer are connected to specific conductive traces or the ring electrodes 50 on the second conductive layer. This configuration can be made for the purpose of decreasing the impedance or connecting specific sensor terminals from two different sensors to a common input conductor, a common same signal output conductor, ground plane, or the like. The sensors connected to the common input may be adjusted to use a single input signal transmitted by a common conductor, or one or more different signals transmitted within the conductor. For example, plural input signals separated in a time domain and/or in a frequency domain for enabling identification of information directed to the respective sensors and preventing loss of the information may transmit in a single conductor. Similarly, the output signals from the plural sensors are connected to a single output conductor, and the signals may be combined by a method for irreversibly combining the outputs of the sensors, or a method for allowing the output signals to be separated such that information from the outputs of the respective sensors are maintained and not lost. For example, the output signals can be separated in a time domain and/or a frequency domain such that information from the respective sensors are not lost and can be identified.
Since radial spaces are often limited, the sensors can be directly attached to the formed connection pads by using the wiring portion 43 such as a flex wiring board as a combining medium between the sensors and the connection pads on the distal end. To combine the plural sensors in a common space, a long flex circuit capable of connecting with the plural sensors or plural flex circuits are used, and the flex circuit (s) is oriented in the radial direction so as to fit the spaces, so that a common guide wire main body can be formed. Also, a metal housing for sealing the sensors, the flex wiring board, and a portion of the guide wire may be used.
In a further embodiment, the plural sensors may be attached to a single conductive element layer via a single flex connector, and input signals to be transmitted to the sensors may be kept separable, identifiable, and usable using one or more sensors by a multiplexing technique such as variation in frequency and/or time domain. Similarly, plural output signals from one or more sensors transmit in a single conductor, and can be kept separable, identifiable, and usable by the multiplexing technique such as variation in frequency and/or time domain.
The guide wire core 20 of the guide wire 10 can be terminated in the vicinity the distal end of the sensor housing 41 within the sensor housing 41, and thereby additional spaces for accommodating the sensor 42 can be made within the sensor housing 41 on the distal end of the guide wire core 20. If the size of the sensor permits, a suitably-sized continuous core may thoroughly penetrate the sensor housing 41. The sensor housing 41 may include a concave portion for accommodating the sensor 42, and an opening portion for enabling communication between the sensor 42 and an outside environment of the sensor housing 41. The sensor housing 41 may further include a distal core wire to which an attractive coil can be attached. Alternatively, the sensor housing 41 may be a hollow tube regardless of presence/absence of an opening portion to the outside, and a second distal core wire may be attached to the distal end of the sensor housing 41, allowing attachment of an atraumatic distal coil to the end portion of the guide wire e.g. via attachment of the coil to the distal end of the distal core and the distal end of the sensor housing 41 and/or via attachment of the coil to the proximal end of the distal core wire.
An approach with the aforementioned layered structure also makes it possible to form third and fourth conductive layers having individual conductors, depending on an application and dimensions. We were able to achieve formation of an electrically insulated two-layered conductive trace with a thickness of 7.5 μm or a diameter of 15 μm.
This application submits a claim to United States Patent and Trademark Office for a history of a priority to No. 63/090,487 filed Oct. 12, 2020. The entirety of that application is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63090487 | Oct 2020 | US |
